(97 days)
MICROTEK MEDICAL EQUIPMENT DRAPES ARE TO BE USED TO COVER A VARIETY OF SURGICAL AND NON-SURGICAL EQUIPMENT IN VARIOUS SETTINGS THE CHOUSE HOUSE THE CUNICAL SETTING. THESE DRAPES ARE USED TO PROFECT THE OQUIPMENT FROM CONTAMINATION DURING VARIOUS PROCEOURES.
The Microtek Equipment Drapes consist of poly film and non-woven material, separately and in combination, manufactured to protect a variety of surgical and non-surgical equipment from contamination during various procedures throughout the clinical setting. These equipment drapes are similar to other equipment drapes currently being marketed for the same intended use.
The provided text describes a 510(k) premarket notification for "Microtek Medical, Inc., Equipment Drapes." This device is a surgical drape designed to protect equipment from contamination. The information provided heavily focuses on regulatory aspects and substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria typically seen for AI/ML-based medical devices or devices with measurable diagnostic/performance outputs.
Based on the provided text, the acceptance criteria and study information are limited and primarily refer to material testing rather than clinical performance with human readers or AI.
Here's an attempt to extract and format the requested information, noting where specific data is not present in the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Viral Penetration (ASTM Method F 1671) | "material used in these products has been tested to ASTM Method F 1671 for Viral Penetration." (No specific pass/fail threshold or quantitative result is provided in the text beyond stating it was tested) |
| Biocompatibility (ISO 10993-1) | "...materials have been tested in other applications to ISO 10993-1 standards, however, since these products are non-patient contact..." (Indicates compliance for materials in other applications, but clarifies it's not directly applicable for this specific device's non-patient contact use, hence the focus on viral penetration for this product). |
| Substantial Equivalence to Predicate Devices | Determined to be substantially equivalent by the FDA to predicate devices: |
- Medline band Bags and Equipment Drapes (K032065)
- Custom Medical Products Equipment Drapes (K931417) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the ASTM F 1671 testing.
- Data Provenance: Not specified.
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)
- Experts: Not applicable. The testing described (ASTM F 1671) is a laboratory material testing standard, not a clinical study requiring expert reviews for ground truth.
- Qualifications: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This is not a clinical study involving adjudication of clinical findings.
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
- MRMC Study: No. The device is a surgical drape, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. The device is a physical product (surgical drape), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth: For the material testing (ASTM F 1671), the "ground truth" would be established by the standardized methods and controls defined within the ASTM standard itself, which dictates how viral penetration is measured and interpreted. It's a laboratory standard, not a clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is not an AI/ML product developed with training data.
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable. This device is not an AI/ML product developed with training data.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.