True Indicating Announces FDA Clearance for New Device
True Indicating Secures FDA Clearance for CSPN-15 Device
True Indicating, LLC, a prominent name in sterilization monitoring technologies, has achieved an important milestone by obtaining FDA 510(k) clearance for the CSPN-15 Type 5 Integrating Indicator for Steam. This significant approval highlights the product's equivalence to existing legally marketed devices and signifies a step forward in enhancing sterilization assurance in various healthcare settings.
The Importance of Sterilization Indicators
Sterilization indicators are essential in maintaining infection control in environments such as hospitals, dental clinics, and surgical facilities. The CSPN-15 Type 5 Integrating Indicator has been specifically designed to monitor critical parameters throughout the sterilization cycle, including time, temperature, and steam. With its unique visual transition from pink to dark brown or black, it effectively obscures the word 'NOT', signifying that sterilization conditions have been successfully met.
Performance Validation and Safety Assurance
The CSPN-15 has undergone rigorous validation and meets specific minimum stated resistometer values, including:
- 121°C for 16.5 minutes
- 132°C for 2.0 minutes
- 134°C for 1.4 minutes
- 135°C for 1.2 minutes
It is suitable for both gravity displacement and dynamic air removal sterilization cycles. This versatility not only minimizes risk but also enhances compliance with vital regulatory standards. The FDA's endorsement of this product underlines its efficacy and reinforces True Indicating's dedication to providing scientifically validated sterilization solutions.
Leadership Insights
Bob Napierala, the Co-Founder & CEO, expressed his pride in the FDA clearance, emphasizing the years of research and hard work that went into developing the CSPN-15. "This approval strengthens our mission to aid healthcare practitioners with products that adhere to the highest standards," he remarked.
Thomas Riha, the Chief Scientific Officer, added, "Our CSPN-15 indicator is meticulously engineered for accuracy and reliability, providing assurance during every sterilization cycle, particularly in high-pressure clinical situations."
Key Features of the CSPN-15 Indicator
The CSPN-15 boasts an array of significant features, including:
- FDA-cleared Class II medical device (21 CFR 880.2800, Product Code: JOJ)
- Independent monitoring capability for steam sterilization parameters
- Visual endpoint transitioning from pink to dark brown/black, effectively concealing the word 'NOT'
- Validated in accordance with ISO 11140-1:2014 and FDA guidance
- A shelf life of 48 months with a 6-month stability period following exposure
About True Indicating, LLC
Founded in 2017, True Indicating, LLC is dedicated to producing top-level sterilization and disinfection monitoring products. Headquartered in Toledo, Ohio, the company serves a variety of sectors, including medical device manufacturers, healthcare providers, laboratories, industrial and pharmaceutical entities, as well as life sciences and biotechnology firms. With over 35 years of combined expertise, they prioritize science-based services, enabling them to form genuine partnerships and provide authentic solutions.
Contact Information
For inquiries, reach out to:
Rick Daschner
Director of Sales & Marketing
True Indicating, LLC
946 Kane St, Suite A
Toledo, Ohio 43612
(916) 755-2718
Frequently Asked Questions
What is the CSPN-15 Type 5 Integrating Indicator?
The CSPN-15 Type 5 Integrating Indicator is a device that monitors critical parameters during steam sterilization, confirming compliance with sterilization standards.
Why is FDA approval important?
FDA approval validates the safety and effectiveness of medical devices, ensuring they meet necessary regulatory requirements for clinical use.
Which parameters does the CSPN-15 indicator monitor?
It monitors time, temperature, and steam during the sterilization cycle, providing a visual confirmation of proper sterilization conditions.
What settings typically use sterilization indicators like the CSPN-15?
This indicator is commonly utilized in hospitals, dental offices, and surgical centers where instrument sterility is crucial.
What features make the CSPN-15 standout?
It features a clear visual endpoint, is validated per ISO standards, has a long shelf life, and offers independent monitoring of sterilization parameters.
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