(261 days)
The Varian Urethral Warming Catheter Kit, a set of disposable components used in conjunction with a warmer system, sterile water or saline, and peristaltic pump, is intended to transfer heat to urethra during urological cryosurgery with Varian CRYOCARE Systems.
The Urethral Warming Catheter Kit (CRYO-77) warms a patient's urethra during the cryoablation procedure by transferring heat through a catheter inserted within the urethra. The catheter contains fluid that is warmed using dry heat from an electrical heating unit (Warming unit) and circulated in a closed circuit using a peristaltic pump (circulating pump).
The Urethral Warming Catheter Kit contains the following:
- 22 french urethral balloon catheter
- Tubing
- Flow indicator
- Tubing clamp ●
- IV bag decanter
- Two luer connections
- Tube placement markers for pump ●
- Tube retainer ●
and is used in conjunction with a compatible fluid warming system and peristaltic pump. The fluid warming system supplies a steady flow of warm, sterile water or saline to the urethral catheter which transfers heat to the urethra during urological cryosurgery. The water or saline is circulated by a peristaltic pump from the catheter to the I.V. bag in a closed circuit.
The provided text describes a medical device called the "Urethral Warming Catheter Kit" (K211149) and its substantial equivalence to a predicate device, the "Urethral Warming System" (K963970). However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of diagnostic accuracy, which would typically involve metrics like sensitivity, specificity, or AUC, as seen in AI/ML medical devices.
Instead, the document focuses on the performance data (non-clinical testing) to demonstrate that the device performs as intended and meets its essential performance specifications. This type of device (a catheter kit for warming) is unlikely to have performance metrics like those for diagnostic AI, but rather functional and safety performance.
Here's a breakdown of the requested information based on the provided text, recognizing that some points are not applicable to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) or a corresponding reported device performance, because this is a physical medical device, not a diagnostic AI/ML system.
However, the "Performance Data (Non-Clinical Testing)" section (VII) lists functional and safety performance aspects that were tested:
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| Catheter to include flow indicator to ensure fluid is not impeded and flowing correctly through closed circuit system. | Design Verification and Design Validation test results showed the catheter performs as intended. |
| Catheter is closed-circuit, free of fluid leaking or component separation. | Design Verification and Design Validation test results showed the catheter performs as intended. |
| Catheter is designed to dissipate cold thermal energy from the urethral mucosa. | Design Verification and Design Validation test results showed the catheter performs as intended. |
| Biocompatibility | Testing in accordance with ISO 10993 series of standards. |
| Sterilization Validation | Testing in accordance with EN 556-1, ANSI/AAMI ST67, ISO 11137-1, ISO 11137-2, ISO 11737-1 and ISO 11737-2. |
| Usability | Testing in accordance with IEC 62366-1 Annex C. |
| Equivalent heat transfer to urethra during cryoablation procedure. | Test results showed the subject device and its compatible on-market components (warmer and pump) perform equivalent to the predicate cleared device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Bench testing" and "Design Verification and Design Validation testing." It does not specify the sample size for these tests. There is no information regarding data provenance (e.g., country of origin, retrospective or prospective) as these are bench tests on the physical device, not data from patients or clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The device is a physical urethral warming catheter kit, not a diagnostic system requiring expert interpretation of results or establishment of ground truth in a clinical sense. The "ground truth" for this device would be its functional performance and safety characteristics as determined by engineering and laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic devices where subjective interpretations need to be reconciled. The testing described for this device is physical and engineering-based.
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
No. This is not applicable as the device is a physical medical device (catheter kit) and not an AI/ML diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device (catheter kit), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance would be established through:
- Engineering specifications and design requirements.
- Physical measurements and observations during bench testing to verify functionality (e.g., fluid flow, leak integrity, heat transfer).
- Compliance with recognized international standards for biocompatibility, sterility, and usability.
8. The sample size for the training set
This is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. As stated above, the device is a physical medical device, not an AI/ML algorithm that requires a training set and corresponding ground truth.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.