(74 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, N2O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or latent heat of vaporization. The iovera" System may be used in conjunction with standard of-the-shelf nerve stimulator device in applications where precise nerve location is desired.
The device comprises four main components:
- A reusable Handpiece
- A Charging Dock
- An assortment of single-patient-use Smart Tips
- A Cartridge containing nitrous oxide
The iovera® System Handpiece is battery powered and provides feedback to the user during device preparation and use. The Handpiece connects to both the Cartridge and to the Smart Tip. The user activates a treatment cycle through a control on the Handpiece, which starts and stops the treatment. The Handpiece contains an LCD display for providing feedback to the user when the device is ready to use. The Charging Dock stores the Handpiece between uses and provides power for charging the battery.
An assortment of Smart Tips is available for the ioveraº system. All Smart Tip needles are made of stainless steel and have a closed-end design that fully contains the cryogen so that it does not enter the target tissue. The Smart Tip is the only patient contacting component of the iovera® System. The user removes the Smart Tip from its sterile packaging and attaches it to the Handpiece immediately before use. Certain Smart Tip designs provide a connection to an external nerve stimulator to facilitate nerve location prior to treatment.
The iovera System uses a commercially available nitrous oxide cylinder. The Cartridge is filled with pure N20.
This document is a 510(k) premarket notification for the iovera® System, a cryogenic surgical device. The purpose of this notification is to demonstrate that the modified iovera® System is substantially equivalent to previously cleared iovera® Systems (K211334 and K173763).
Based on the provided text, the device is evaluated against its product specifications. The document describes a series of engineering and performance tests rather than a clinical study evaluating diagnostic or prognostic performance with human readers. Therefore, several of the specific questions related to clinical studies (e.g., sample size for training/test sets, expert ground truth, MRMC studies) are not directly applicable or are not detailed in this submission.
Here's a breakdown of the acceptance criteria and the study (design verification testing) that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "The subject iovera® System device met the design verification and validation inputs, passing all predetermined acceptance criteria." However, it does not provide a specific table with numerical acceptance criteria and corresponding reported performance values for each parameter. Instead, it lists categories of testing performed to demonstrate compliance.
| Category of Testing | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functional & Product Performance | Device operates according to design specifications for its intended use (e.g., proper cooling, cryogen flow). | Met product specifications for intended clinical use. Passed all predetermined acceptance criteria. |
| Smart Tip Functional Testing | Smart Tips perform as designed (e.g., proper cooling, nerve stimulation capability for compatible tips). | Met product specifications. Passed all predetermined acceptance criteria. |
| User Interface Testing (IEC 62366-1) | User interface is safe and effective, and meets usability standards. | Conforms to IEC 62366-1:2015. Passed all predetermined acceptance criteria. |
| Software Testing (IEC 62304) | Software functions correctly and safely. | Conforms to IEC 62304:2006/A. Passed all predetermined acceptance criteria. |
| Electrical & EMC Safety (IEC 60601-1, -1-2) | Device meets electrical safety and electromagnetic compatibility standards. | Conforms to IEC-60601-1: A1 2012 and 60601-1-2:2014. Passed all predetermined acceptance criteria. |
| Mechanical & Thermal Safety (IEC 60601-1) | Device meets mechanical and thermal safety standards. | Conforms to IEC 60601-1: A1:2012. Passed all predetermined acceptance criteria. |
| Sterility Testing (ASTM F1980-16, ISO 11135:2014/A) | Smart Tips achieve and maintain required sterility assurance level (SAL). | Conforms to ASTM F1980-16 and ISO 11135:2014/A. Smart Tip individually packaged and sterile with a SAL of 10-6. Passed all predetermined acceptance criteria. |
| Packaging Testing (ASTM D4332-14) | Packaging protects the device and maintains sterility. | Conforms to ASTM D4332-14. Passed all predetermined acceptance criteria. |
| Biocompatibility Testing (ISO 10993-1) | Patient-contacting materials are biocompatible. | Conforms to ISO 10993-1. All patient contacting materials tested to ISO 10993-1; found biocompatible. Passed all predetermined acceptance criteria. |
| Clinical Effect (Cryoneurolysis) | Device achieves cellular death through cryoneurolysis and Wallerian degeneration, leading to second-degree nerve injury (axonotmesis). | Stated as the Clinical Effect of the device. (This is a principle of operation rather than an acceptance criterion met by a specific test in this submission). |
| Treatment Temperature | Achieves a temperature between -55°C to -75°C (-67°F to -103°F) during treatment. | Stated as the achieved treatment temperature range. (This is a performance characteristic). |
| Timing Parameters (Pre-heat, Cooling, Post-heat) | Meets specified pre-heat, cooling, and post-heat durations for different Smart Tips. | 12 seconds (8.5mm), 1 second (90mm) pre-heat; 33 seconds (8.5mm), 60 seconds (90mm) max cooling; 20 seconds (8.5mm), 45 seconds (90mm) post-heat. |
| Skin Warmer Set Point | Maintains Skin Warmer Set Point at 30°C. | 30°C. |
2. Sample size used for the test set and the data provenance:
The document describes "Design Verification testing" and "Verification and validation testing." These are engineering and performance validation tests, not clinical efficacy or diagnostic performance studies involving patient data. Therefore, the concept of a "test set" in the context of a dataset with patient outcomes or images is not applicable here. The "samples" would be units of the device or its components tested in a lab setting. The document does not specify the number of device units or components tested for each category.
- Data Provenance: Not applicable in the context of patient data. The tests are likely conducted in-house or by accredited testing laboratories.
- Retrospective or Prospective: Not applicable as it's not a clinical study involving patient data. These are design verification tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for these engineering performance tests is established by product specifications, recognized standards (e.g., ISO, IEC, ASTM), and internal design requirements, not by expert consensus on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is for performance testing against established engineering specifications, not for interpretation of clinical data requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This submission is for a medical device (cryogenic surgical system), not an AI/CADe or CADx device that assists human readers in interpreting medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The iovera® system is a physical device used by a human practitioner. It's not a standalone algorithm.
7. The type of ground truth used:
The ground truth for this device's performance is based on:
- Engineering Specifications: Pre-defined design requirements and performance parameters for the device and its components (e.g., temperature range, timing, electrical properties).
- Recognized Standards: Compliance with international and national standards (IEC, ISO, ASTM) for medical devices, software, electrical safety, biocompatibility, and sterility.
- Predicate Device Equivalence: The claim of substantial equivalence to previously cleared iovera® Systems (K211334 and K173763) implies that their performance characteristics serve as a benchmark.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, this is not an AI/machine learning device, so there is no "training set." The performance verification relies on meeting established design specifications and adhering to relevant industry standards.
§ 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).