HVO surgical drapes are made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination. They are designed to be repackaged and/or sterilized before use. This single use product is a disposable non-sterile drape designed to be re-packaged and/or sterilized prior to use. This product may be sterilized using Ethylene Oxide (EO) following the Validation and Routine Control under ANSI/AMMI/ISO 11135. For more information about sterilization of this product, contact HVO, Inc.

Device Description

The proposed HVO, Inc. Various Disposable Non-Sterile Surgical Drapes function in the same manner as predicate devices in that they are intended to be used as protective patient coverings, such as used to isolate a site of surgical incision from microbial and other contamination. Device Design/ Materials Used/ Physical Properties: The HVO, Inc. Various Disposable Non-Sterile Surgical Drapes are made of materials commonly used for their purpose. The primary material components are SMS, Micro-embossed LDPE, Clear LDPE, Nonwoven (wetlaid cellulose), Airtex, Sontara, Krayton, Medical Grade Single and Double Coated Tapes, Bridging, Polyfoam, Velcro, Polyester Mesh, Hot Melt, Cold Glue and Coated Medical Grade Liners. Primarily all of our drapes are offered in the color blue, which is the common color for medical device materials, but some materials are offered in white or with white backing. These materials include Nonwovens, SMS, Airtex, Sontara, Polyfoam, Back Table Covers, Bridging, and LDPE's. All other materials are clear plastics or adhesives, which are not colored, but natural.

AI/ML Overview

The provided text describes a 510(k) submission for "Haywood Vocational Opportunities, Inc. Various Disposable Non-Sterile Surgical Drapes." This document primarily focuses on establishing substantial equivalence to existing predicate devices based on material composition, intended use, and general characteristics rather than presenting a performance study with specific acceptance criteria and detailed statistical analysis for a novel device.

Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment from a study is not present in the provided text.

Here's an analysis of the available information:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide specific numerical acceptance criteria or performance metrics in the format of a table you'd typically see for an AI algorithm or a device requiring specific functional performance targets. Instead, the "performance" is implicitly demonstrated through a comparison of characteristics to predicate devices.

Characteristics	Acceptance Criteria (Implicit - Same or Similar to Predicate)	Reported Device Performance (HVO, Inc. Devices)
Materials	Must be same or similar to predicate devices	SMS, Micro-Embossed LDPE, Clear LDPE, Sontara, Nonwoven, Krayton, Airtex, Polyfoam, Medical Grade Single And Double Coated Tapes, Velcro, Cold Glue, Hot Melt, Bridging, Polyester Mesh Coated Medical Grade Liners
Absorbency	Same as predicate devices	Absorbent and Non-Absorbent
Packaging	Same as predicate devices	Bulk and Single Use
Disposable	Same as predicate devices	Yes
Sterility	Non-Sterile or Sterile (predicate allows both, HVO is Non-Sterile)	Non-Sterile
Function	Isolate a site of surgical incision from microbial and other contamination (intended use)	Intended to be used as protective patient coverings, such as used to isolate a site of surgical incision from microbial and other contamination.

Study that proves the device meets the acceptance criteria:

The "study" presented is a comparison to legally marketed predicate devices. The sponsor argues that their devices are substantially equivalent to these predicates due to similar design, materials, and intended use. The FDA concurred with this assessment, indicating that the device meets the regulatory requirements for market entry based on this comparison. The FDA's 510(k) clearance letter (K050508) serves as the "proof" that the device met the criteria for 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):

Sample Size for Test Set: Not applicable. This submission is for surgical drapes and relies on a comparison to existing devices, not a performance study with a test set of data. There are no "data" in the sense of patient cases or images.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Adjudication Method: 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:

MRMC Study: No, this is not an AI-assisted device.
Effect Size: Not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Performance: No, this is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness profile of the legally marketed predicate devices. The HVO drapes are deemed "substantially equivalent" if they share similar technological characteristics and intended use with these predicates, implying they would also share similar safety and effectiveness.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established:

Ground Truth for Training Set: Not applicable.

Summary

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APR 2 7 2005

K050508

Haywood Vocational Opportunities, Inc. Various Disposable Non-Sterile Surgical Drapes

510(k) Summary

Summary of the Safety and Effectiveness Information Upon Which An Equivalence Could Be Based

SPONSOR INFORMATION

Haywood Vocational Opportunities, Inc. Name: P.O. Box 7 Address: Hazelwood, N.C. 28738 Telephone: (828) 456-4455 (828) 456-4401 Fax:

DEVICE NAMES

HVO, Inc., Various Disposable Non-Sterile Surgical Drapes Name: Surgical Drapes Common/Usual Name: Classifications Name (if known): Surgical and Drape Accessories Device Names: Table Covers, OB GYN, General Surgery, Orthopedic, ENT and EENT, Drape Sheets, Cystoscopy, Craniotomy, Angiography, Fluid Pouches, and Instrument Covers.

PREDICATE OR LEGALLY MARKETED DEVICES

There are several predicate devices currently on the market that have similar function and are made from same or similar materials.

DEVICE DESCRIPTION

Device Design/ Materials Used/ Physical Properties: The HVO, Inc. Various Disposable Non-Sterile Surgical Drapes are made of materials commonly used for their purpose. The primary material components are SMS, Micro-embossed LDPE, Clear LDPE, Nonwoven (wetlaid cellulose), Airtex, Sontara, Krayton, Medical Grade Single and Double Coated Tapes, Bridging, Polyfoam, Velcro, Polyester Mesh, Hot Melt, Cold Glue and Coated Medical Grade Liners.

Primarily all of our drapes are offered in the color blue, which is the common color for medical device materials, but some materials are offered in white or with white backing. These materials include Nonwovens, SMS, Airtex, Sontara, Polyfoam, Back Table Covers, Bridging, and LDPE's. All other materials are clear plastics or adhesives, which are not colored, but natural.

DEVICE INTENDED USE

The HVO, Inc. Various Non-Sterile Surgical Drapes are intended to be used as protective patient covering, such as to isolate surgical incisions from microbial and other contamination. These proposed devices are intended to undergo sterilization by the customer prior to use in the sterile setting. These products can be sterilized by ETO. The products may be sterilized using Ethylene Oxide following the Validation and Routine Control under ANSVAAMI/ISO 11135, see section 12 for more details on sterilization.

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Haywood Vocational Opportunities, Inc. Various Disposable Non-Sterile Surgical Drapes

510(k) Summary

TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)

Characteristics	HVO, Inc. Devices	Other Devices
Materials	SMS, Micro-Embossed LDPE, ClearLDPE, Sontara, Nonwoven, Krayton,Airtex, Polyfoam, Medical Grade SingleAnd Double Coated Tapes, Velcro, ColdGlue, Hot Melt, Bridging, Polyester MeshCoated Medical Grade Liners	Same or similar materials
Absorbency	Absorbent and Non-Absorbent	Same
Packaging	Bulk and Single Use	Bulk and Single Use
Disposable	Yes	Yes
Sterility	Non-Sterile	Non-Sterile and Sterile

Page 2

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.

APR 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tim Kelley Director of Regulatory Affairs Haywood Vocational Opportunities, Incorporated 56 Scates Street Waynesville, North Carolina 28786

Re: K050508

Trade/Device Name: Various Disposable Non-Sterile Surgical Drapes (Table Covers, OB GYN, General Surgery, Orthopedic, ENT and ENNT, Drape Sheets, Cystoscopy, Craniotomy, Angiography, Fluid Pouches, and Instrument Covers) Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: April 19, 2005 Received: April 20, 2005

Dear Mr. Kelley:

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. Kelley

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 (QS) 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 your 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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Sultie Y. Michie Omd.

Chr. Livia Ph.D.

Chíu Lin, Ph.D. 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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Indication for Use

510(k) Number: K050508

Device Name: HVO, Inc. Various Disposable Non-Sterile Surgical Drapes (Table Covers, OB GYN, General Surgery, Orthopedic, ENT and ENNT, Drape Sheets, Cystoscopy, Craniotomy, Angiography, Fluid Pouches, and Instrument Covers).

Indications For Use:

This single use product is a disposable non-sterile drape designed to be re-packaged and/or sterilized prior to use. This product may be sterilized using Ethylene Oxide (EO) following the Validation and Routine Control under ANSI/AMMI/ISO 11135. For more information about sterilization of this product, contact HVO, Inc.

Prescription Use X (Part 21 CFR 801 Subpart D) and/or

Over-The-Counter Use (21 CFR 807 Subpart C)

Laird H. Mingay 13

on Sign-Off) sion Sign-Off)
sion of Anesthesiology, General Hospital, rection Control. Dental Devices

:(k) Number. 4656508

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.