(80 days)
Air compressor supplying compressed air for medical ventilators.
The device is electric and produces compressed air from the normal environment to supply compressed air for medical ventilators.
This K982789 submission is for a Medical Air Compressor "Model 98", not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert adjudication, MRMC studies, and standalone performance, are not applicable.
The submission focuses on establishing substantial equivalence to a legally marketed predicate device, the Dräger Medical Air Compressor (K951126), through a comparison of specifications and intended use.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "Medical Air Compressor Model 98" were based on demonstrating substantial equivalence to its predicate device, the "Medical Air Compressor (K 951126)". The reported performance for the new device matches the criteria set by the predicate.
| Specification | Acceptance Criteria (from Predicate Device K951126) | Reported Device Performance (Medical Air Compressor Model 98) |
|---|---|---|
| Intended Use | Air compressor supplying compressed air for medical respirators | Air compressor supplying compressed air for medical respirators |
| Safety: | ||
| High temperature alarm? | Yes | Yes |
| Audible alarm? | Yes | Yes |
| Visible alarm? | Yes | Yes |
| Main Fuses? | Yes | Yes |
| Performance Characteristics: | ||
| Dew point depression: below room temperature? | Yes | Yes |
| Air quality: Dust and oil free? | Yes | Yes |
| Installed filter? | Yes | Yes |
| Standby-Mode? | Yes | Yes |
| Operating Characteristics | Substantially equivalent to predicate | All operating characteristics of both devices are substantially equivalent |
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. This is a conventional medical device without AI/ML components. The evaluation method relies on direct comparison of specifications and functionality rather than data-driven performance metrics on 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. This is a conventional medical device. Ground truth as typically defined for AI/ML devices is not relevant here. The evaluation is based on engineering specifications and adherence to existing medical device standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 is a conventional medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a conventional medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this conventional device, the "ground truth" for demonstrating substantial equivalence is the established specifications, performance characteristics, and safety features of the predicate device (Dräger Medical Air Compressor K951126), as well as relevant medical device standards. The "Model 98" is deemed acceptable if it meets or matches these established benchmarks.
8. The sample size for the training set
Not applicable. This is a conventional medical device.
9. How the ground truth for the training set was established
Not applicable. This is a conventional medical device.
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.