(63 days)
THE NORTECH GAS WARMER II IS INDICATED FOR WARMING GAS (95-1059F/35-40.5°C) USED FOR THE DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND/OR OPERATIVE LAPAROSCOPY.
The CO, Gas Warmer II Unit is designed to be used in conjunction with an insufflator to provide continuous non-adjustable heating of gas to a laparoscopic instrument. The CO2 Gas Warmer II Unit is comprised of a control unit and reusable heat exchanger and power cords.
The provided text describes a medical device, the Northgate Technologies Inc. CO2 Gas Warmer II, and its regulatory clearance based on substantial equivalence. It does not contain information about acceptance criteria or a study demonstrating device performance against specific criteria in the way typically seen for AI/ML-driven devices or those requiring extensive clinical studies to prove effectiveness.
The clearance is based on substantial equivalence to predicate devices. This means that instead of conducting new performance studies to meet new acceptance criteria, the manufacturer demonstrated that their device is as safe and effective as a device already legally marketed.
Therefore, most of the requested information about acceptance criteria and performance studies is not applicable to this type of regulatory submission in the way the questions are framed for AI/ML or efficacy-proving studies.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The implicit acceptance criterion for this device, based on the provided document, is that it warms gas to a range of 95-105°F / 35-40.5°C. This is stated as the "Indications For Use" and is the essential function described. There are no other performance metrics or specific thresholds (e.g., accuracy, sensitivity, specificity, or response time) explicitly mentioned as acceptance criteria for regulatory clearance.
- Reported Device Performance: The document does not provide a specific performance study or test results demonstrating that the CO2 Gas Warmer II achieves this temperature range. The substantial equivalence argument implies that it does achieve this, or would be expected to, based on the design, materials, and intended use being similar to already-cleared devices.
| Acceptance Criteria (Implicit from Indications for Use) | Reported Device Performance |
|---|---|
| Warms gas to 95-105°F / 35-40.5°C | Not explicitly reported in the provided text, but implied to meet this by substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. The provided document is a 510(k) clearance letter and a summary of safety and effectiveness, which relies on substantial equivalence. It does not describe a clinical or performance study with a test set.
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)
- Not applicable. There was no test set or ground truth established for this type of submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. There was no test set.
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 device is an insufflator accessory, not an AI-driven diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is hardware for warming gas, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No ground truth in the context of diagnostic performance was established or required for this 510(k) submission. For warming devices, "ground truth" would typically refer to measured temperature in design validation, but this specific data is not in the provided documents.
8. The sample size for the training set
- Not applicable. As a hardware device cleared through substantial equivalence, there is no "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.