The various sizes of Polyethylene Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. These covers are not intended to be used as patient drapes and do not have patient contact.

Device Description

ValuMed's Cover Alls, the Sterile Equipment Covers by Custom Medical Products(K931417), Equipment Covers by United States Surgical(K964699) and the Equipment Snap Covers by Advance Medical Designs(K850959) consist of various sizes and shapes of polvethvlene covers that are positioned on surgical equipment. The covers are used to maintain a sterile field and as an aid in the clean up of equipment after surgery.

AI/ML Overview

The provided documents describe a 510(k) premarket notification for "Cover All Equipment Covers" by ValuMed. This notification does not pertain to an AI/ML device, but rather to a simple medical device (protective covers). Therefore, many of the requested categories related to AI/ML device studies, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance, and data provenance, are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Maintain a sterile field	Implied by "intended to cover equipment" and "aid in the clean up of equipment after surgery" and comparison to predicate devices, but no specific performance metric related to sterility maintenance is provided.
Aid in the clean-up of equipment after surgery	Implied by the intended use and comparison to predicate devices, but no specific performance metric is provided.
Physical properties similar to predicate devices	Verified through "Seal Peel Test, Tear Resistance Test, and Flammability Test." No specific quantitative results are provided, only that testing was conducted.
Made of polyethylene	Stated as a characteristic of the device.
Intended use is the same as predicate devices	Stated as a characteristic and confirmed by FDA's substantial equivalence determination.
Size, configuration, color are similar to predicate devices	Stated as a characteristic.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a non-clinical evaluation of physical properties of a protective cover, not a study involving a "test set" of data in the context of an AI/ML device. The testing conducted (Seal Peel Test, Tear Resistance Test, Flammability Test) would have involved samples of the product, but the specific sample sizes are not reported. The data provenance is internal testing by ValuMed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth, in the context of expert review, is not relevant for this type of device and testing.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the AI/ML sense requiring adjudication.

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 a passive equipment cover, not an AI/ML diagnostic or assistive tool.

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 system.

7. The Type of Ground Truth Used

The "ground truth" here is based on engineering specifications and comparison to predicate devices. For physical properties, standard material testing methods (Seal Peel, Tear Resistance, Flammability) were used to confirm similarity with existing, legally marketed devices. The "truth" is that the material's properties meet certain standards or are comparable to those of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no AI/ML training set.

Summary

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FEB 0.4 2003

510(k) SUMMARY OF INFORMATION

K023540

SUBMITTER:

ValuMed 1439 Live Oak Street. Suite A Niceville, Florida 32578 (850) 897-3321 - Phone (850) 897-1280 – Fax

CONTACT PERSON: Wynne Barnes
January 13, 2003 DATE PREPARED:

CLASSIFICATION NAME: Cover, Barrier, Protective

COMMON NAME: Equipment Covers

PROPRIETARY NAME: Cover All Equipment Covers

PREDICATE DEVICES:

Sterile Equipment Covers – Custom Medical Products - K931417 Equipment Covers - United States Surgical - K964699 Equipment Snap Covers - Advance Medical Designs -K850959

ValuMed's Cover Alls, the Sterile Equipment Covers by Custom Medical DEVICE DESCRIPTION: Products(K931417), Equipment Covers by United States Surgical(K964699) and the Equipment Snap Covers by Advance Medical Designs(K850959) consist of various sizes and shapes of polvethvlene covers that are positioned on surgical equipment. The covers are used to maintain a sterile field and as an aid in the clean up of equipment after surgery. INDENTED USE: These equipment covers are intended to cover equipment and are not intended to

be used as patient drapes or have patient contact.

SUBSTANTIAL EQUIVALENCE:

ValuMed's Equipment Covers are substantially equivalent to the above-mentioned predicate devices in that they provide the following characteristics:

Intended use is the same
. Size, configuration, color are similar
. Made of polyethylene
. Physical properties are similar

NON-CLINICAL TEST DATA:

Testing conducted: Seal Peel Test. Tear Resistance Test, and Flammability Test

ATTACHMENT 8

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a bird or a stylized human figure, composed of flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 4 2003

·Mr. Thomas E. Cottone President ValuMed 1439 Live Oak Street, Suite A Niceville, Florida 32578

Re: K023540

Trade/Device Name: Covers All Equipment Covers Banded Bags & Dome Bags Various Models, Sterile Non-Sterile Regulation Number: None Regulation Name: Cover, Barrier, Protective Regulatory Class: Unclassified Product Code: MMP Dated: December 12, 2002 Received: December 20, 2002

Dear Mr. Cottone:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Cottone

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Quos

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 3

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K023540
Device Name: CoverAlls-Equipment Covers

STATEMENT OF INDICATIONS FOR USE

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Qlin S. Lin

sion of Anesthesiology. General Hospital. ion Control, Dental D

510(k) Number. K023540

Regulation Number and Section

§ 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.