(29 days)
The iovera® System is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera System is not indicated for treatment of central nervous system tissue.
When stimulation compatible components are used, the iovera System can also facilitate target nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator.
The iovera System is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, NoO) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or latent heat of vaporization. The iovera8 System may be used in conjunction with standard of-the-shelf nerve stimulator device in applications where precise nerve location is desired.
The device is comprised of four main components:
- A reusable Handpiece .
- A Charging Dock ●
- An assortment of single-patient-use Smart Tips ●
- A Cartridge containing nitrous oxide ●
The provided text describes the iovera® System, a cryogenic surgical device cleared by the FDA (K243677). The document focuses on demonstrating substantial equivalence to predicate devices (K220656 and K211334) for a new Smart Tip configuration (STT21180STIM) that also facilitates nerve location.
Here's a breakdown of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily relies on adherence to recognized standards and satisfactory completion of design verification testing. Specific quantitative acceptance criteria for each test (e.g., specific thresholds for biocompatibility, precise tolerances for mechanical tests) are not explicitly detailed in this summary, but the general outcome of "meets all ISO10993-1 and USP acceptance criteria" or "complied with standards" is stated.
| Acceptance Criterion Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Conformed to ISO 10993-1:2022. No signs of acute systemic toxicity and pyrogenic response, sensitization, or skin irritation. All extractables below Analytical Evaluation Threshold (AET), no unexpected contaminants or material degradation. Negligible toxicological risk with a significant margin of safety. |
| Electrical Safety & EMC | Complied with IEC 60601-1:2005+AMD1:2012+AMD2:2020 Edition 3.2, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 Edition 3.2, and IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 Edition 2.2 for safety (e.g., electric shock), usability, and alarms. Met all EMC requirements per IEC TS 60601-4-2:2024 (specific clauses listed). |
| Software V&V | Documentation provided per FDA guidance. Software classified as "Class B" concern. Followed IEC 62304:2006/AMD1:2015 and relevant FDA guidance documents for software development, risk management, software life cycle processes, and cybersecurity. Specific performance metrics are not provided but the implication is that all V&V activities were completed satisfactorily. |
| Functional & Product Perf. | Testing performed on Handpiece, stim cable, cartridges, and Smart Tip STT21180STIM. Indicated that the device meets product specifications and is safe and effective. Specific performance metrics (e.g., temperature ranges, cooling times) are listed in the comparison table for different Smart Tips, and implied to be met for the new STT21180STIM tip. For example, cooling time for STT21180STIM is 70 seconds. Post-heat time is 15 seconds. Skin Warmer Set Point is 15°C. |
| Usability Engineering/UI | Conformed to IEC 62366-1 Ed. 1.1. Assessed usability by identifying hazards and hazardous situations associated with the user interface, ensuring safety features are intuitive and support proper usage. Simulated use testing (Human Factors Study) with the Smart Tip and Stim cable assembly attached was performed. |
| Mechanical & Resistance | Resistance Testing (difficulty in securing connection between needle and PCBA), Flex Introducer and Leak Test (to ensure needle does not break), Heater Block-to-Needle Bond Strength Test. All tests were conducted successfully, indicating mechanical strength and reliability. Specific quantitative acceptance criteria are not mentioned beyond "ensuring mechanical strength and reliability." |
| Packaging Evaluation | Conformed to ASTM D4332-22 and ASTM D4169. Package Integrity Peel Strength Testing, Inspection, and bubble test performed. Validated packaging integrity and compliance with ISO 11607 requirements for sterile barrier systems. ASTM F1886/F1886M-16 and ASTM F88/F88M-23 are referenced. |
| Sterility Assurance | Conformed to ASTM F1980-21 and ISO 11135:2014. Sterilization validation performed (EO). Smart Tip individually packaged and sterile with a SAL of 10-6. Ensured compliance. Also referenced EN ISO 10993-7:2008+A1:2022 (Ethylene oxide sterilization residuals) and BS EN ISO 11737-1:2018+A1:2021 (Microbiological methods-Determination of a population of microorganisms on products). |
2. Sample Size Used for the Test Set and Data Provenance:
The document summarizes design verification testing rather than a clinical study with a "test set" of patient data. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this regulatory summary. The testing focuses on engineering verification (e.g., number of units tested for mechanical properties, number of samples for biocompatibility, etc.), not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Again, this pertains to a clinical study with patient data and does not apply to the design verification testing described. The "ground truth" for the engineering tests would be the compliance with recognized standards and specified performance parameters.
4. Adjudication Method for the Test Set:
Not applicable, as this is design verification testing rather than a clinical study requiring consensus from experts on case interpretation.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing and comparison to predicate devices, not on evaluating human reader performance with or without AI assistance. The device in question is a physical cryogenic surgical device, not an AI diagnostic tool that assists human readers with interpretations.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:
Not applicable. The iovera® System is a physical medical device, not an algorithm. Performance is assessed through engineering tests of the device itself. While it facilitates nerve location, its primary function is direct tissue destruction via freezing, with a human operator always in the loop.
7. The Type of Ground Truth Used:
For the design verification testing, the "ground truth" used is:
- Compliance with recognized international and national standards (e.g., ISO 10993-1, IEC 60601-1, IEC 62366-1, ISO 11135, ASTM standards).
- Pre-defined product specifications and design input requirements for physical, electrical, mechanical, software, and biological properties.
- Laboratory test results (e.g., chemical analysis for extractables, temperature measurements for cooling performance, force measurements for bond strength).
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device that requires a training set of data.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of medical device submission.
§ 882.4250 Cryogenic surgical device.
(a)
Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.(b)
Classification. Class II (performance standards).