(176 days)
Guangzhou Fortunique's Drapes, Bags and Covers are intended to cover equipment, to maintain a sterile field and as an aid in the clean up of equipment after surgery or other medical procedures. These drapes, bags and covers are not intended to be used as patient drapes and they have no patient contact.
Fortunique intends to manufacture and market Drapes, Bags and Covers sterile in ready to use form and will also provide them in non-sterile form to other companies for inclusion in convenience packages which they will then sterilize.
Guangzhou Fortunique Drapes, Bags and Covers are made of low density polyethylene film ir various sizes and shapes for use in covering equipment. These drapes, bags and covers are offered non-sterile in bulk quantities and sterile in individual packs.
This submission, K041501, is for Guangzhou Fortunique Drapes, Bags and Covers. This is a 510(k) summary for a Class II medical device, and as such, it does not typically involve the types of studies (like MRMC or standalone performance studies with ground truth established by experts) that are common for AI/ML-driven devices or diagnostic tools. Its clearance is based on substantial equivalence to predicate devices, which focuses on comparing physical characteristics and intended use rather than quantitative performance metrics against a defined acceptance criterion.
Therefore, many of the requested categories are not applicable to this type of device submission.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate Device Comparison) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Same intended use as predicate devices | "have the same intended use" |
| Manufactured of same polyethylene film | "are manufactured of the same polyethylene film" |
| Offered in same sizes and configurations | "they are offered in the same sizes and configurations" |
| Same physical characteristics | "they have the same physical characteristics" |
2. Sample size used for the test set and the data provenance
Not applicable. Substantial equivalence for this type of device is based on a direct comparison of features and intended use to existing predicate devices, not on a performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth establishment by experts is not relevant for this type of device comparison.
4. Adjudication method for the test set
Not applicable. There was no test set or adjudication method described.
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 not an AI/ML-driven device or a diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
Not applicable. The basis for clearance is substantial equivalence to predicate devices, not a ground truth against which a device's diagnostic performance is measured. The "ground truth" implicitly used is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.