Details on FDA Clearance now available in 'Summary Document'
510k Number - K192234
Device Name - ActiPatch
Indications for Use - Adjunctive treatment of Musculoskeletal Pain
Clinical Data:
The clinical data in this 510(k) includes results from three IRB approved, randomized, controlled studies. Additionally, usability testing was conducted to support the OTC use of the device.
• A randomized, controlled trial on chronic cervical osteoarthritis (neck pain): This was a randomized, active-treatment controlled study to evaluate the safety and effectiveness of the ActiPatch medical device to reduce the pain level of patients diagnosed with cervical osteoarthritis. The active-treatment control was an NSAID of the Cox-2inhibitor family. There were 200 intent-to-treat patients, out of which 197 completed the four-week study. There were 142 women (71%) and 58 (29%) men in the study, with an average age of 45 years. The primary endpoint for efficacy was reduction in pain (VAS score) while at rest and being active, over four weeks, when compared to the beginning of the study. The results indicate that ActiPatch significantly reduced pain (measured by VAS pain) associated with COA in the device treatment group, and that the treatment differences between device-treatment and NSAID-treatment groups was significant (p<0.05).
* A randomized controlled trial on osteoarthritis of the knee: The osteoarthritis of the knee study was a double-blinded, randomized, placebo-controlled study to evaluate the safety and effectiveness of the ActiPatch medical device to reduce the pain level of patients diagnosed with knee osteoarthritis. The placebo treatment was a device that was identical to ActiPatch but did not produce an
electromagnetic field when turned on. There were 66 intent-to-treat patients, out of which 60 patients completed the four-week study. There were 43 women (71.6%) and 17 (16.4%) men in the study, with the following average demographics at baseline: 68 years of age, BMI of 27.4 and disease duration of 12.1 years. The primary effectiveness endpoints were improvements in pain level over the four weeks as measured by the before and after VAS score and WOMAC scores, and the primary safety endpoint was all treatment-related adverse events during the study. The results indicate that ActiPatch significantly reduced pain (measured by VAS pain) associated with KOA in the device treatment group, and that the treatment differences between active and placebo treatment groups was significant (p<0.05).
• A randomized controlled trial on plantar fasciitis (heel pain): This was a randomized, double-blinded, placebo-controlled study to evaluate the safety and effectiveness of the ActiPatch medical device to reduce the pain level of patients diagnosed with plantar fasciitis. The placebo treatment was a device that was identical to ActiPatch but did not produce an electromagnetic field when turned on. A total of 70 patients were recruited into the study, and all 70 completed the study. There were 52 women (74.4%) and 18 (25.6%) men in the study, with the following average demographics at baseline: 51.5 years of age, BMI of 31.8 and disease duration of 1.1 years. The primary effectiveness endpoint was the daily morning (AM) VAS score, and the primary safety endpoint was all treatment-related adverse events during the 7-day study. The results indicate that ActiPatch significantly reduced pain (measured by VAS pain) associated with PF in the device treatment group, and that the treatment differences between active and placebo treatment groups was significant (p<0.05).
Conclusion: The non-clinical data, clinical data, and extensive real-world registry data demonstrate that the ActiPatch is at least as safe and effective as the predicate device and can be used as an over-the-counter device for adjunctive treatment of musculoskeletal pain.
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192234.pdf
510k Number - K192234
Device Name - ActiPatch
Indications for Use - Adjunctive treatment of Musculoskeletal Pain
Clinical Data:
The clinical data in this 510(k) includes results from three IRB approved, randomized, controlled studies. Additionally, usability testing was conducted to support the OTC use of the device.
• A randomized, controlled trial on chronic cervical osteoarthritis (neck pain): This was a randomized, active-treatment controlled study to evaluate the safety and effectiveness of the ActiPatch medical device to reduce the pain level of patients diagnosed with cervical osteoarthritis. The active-treatment control was an NSAID of the Cox-2inhibitor family. There were 200 intent-to-treat patients, out of which 197 completed the four-week study. There were 142 women (71%) and 58 (29%) men in the study, with an average age of 45 years. The primary endpoint for efficacy was reduction in pain (VAS score) while at rest and being active, over four weeks, when compared to the beginning of the study. The results indicate that ActiPatch significantly reduced pain (measured by VAS pain) associated with COA in the device treatment group, and that the treatment differences between device-treatment and NSAID-treatment groups was significant (p<0.05).
* A randomized controlled trial on osteoarthritis of the knee: The osteoarthritis of the knee study was a double-blinded, randomized, placebo-controlled study to evaluate the safety and effectiveness of the ActiPatch medical device to reduce the pain level of patients diagnosed with knee osteoarthritis. The placebo treatment was a device that was identical to ActiPatch but did not produce an
electromagnetic field when turned on. There were 66 intent-to-treat patients, out of which 60 patients completed the four-week study. There were 43 women (71.6%) and 17 (16.4%) men in the study, with the following average demographics at baseline: 68 years of age, BMI of 27.4 and disease duration of 12.1 years. The primary effectiveness endpoints were improvements in pain level over the four weeks as measured by the before and after VAS score and WOMAC scores, and the primary safety endpoint was all treatment-related adverse events during the study. The results indicate that ActiPatch significantly reduced pain (measured by VAS pain) associated with KOA in the device treatment group, and that the treatment differences between active and placebo treatment groups was significant (p<0.05).
• A randomized controlled trial on plantar fasciitis (heel pain): This was a randomized, double-blinded, placebo-controlled study to evaluate the safety and effectiveness of the ActiPatch medical device to reduce the pain level of patients diagnosed with plantar fasciitis. The placebo treatment was a device that was identical to ActiPatch but did not produce an electromagnetic field when turned on. A total of 70 patients were recruited into the study, and all 70 completed the study. There were 52 women (74.4%) and 18 (25.6%) men in the study, with the following average demographics at baseline: 51.5 years of age, BMI of 31.8 and disease duration of 1.1 years. The primary effectiveness endpoint was the daily morning (AM) VAS score, and the primary safety endpoint was all treatment-related adverse events during the 7-day study. The results indicate that ActiPatch significantly reduced pain (measured by VAS pain) associated with PF in the device treatment group, and that the treatment differences between active and placebo treatment groups was significant (p<0.05).
Conclusion: The non-clinical data, clinical data, and extensive real-world registry data demonstrate that the ActiPatch is at least as safe and effective as the predicate device and can be used as an over-the-counter device for adjunctive treatment of musculoskeletal pain.
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192234.pdf
3
