The Busse Surgical Drape is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide. There are various models of drapes: Non-woven drapes, Tissue Drape, & SMS Drapes with round, oval & square fenestration shapes.

Device Description

Surgical drapes described in this submission are one piece, single use, designed to provide an absorbent sterile barrier & protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Busse Surgical Drapes." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way a clinical trial for a new therapeutic or diagnostic device would.

Therefore, many of the typical data points requested for clinical studies (like reader performance, MRMC studies, ground truth establishment for a training set, etc.) are not applicable to this type of regulatory submission. The assessment here is primarily focused on biocompatibility and technological characteristics compared to an already approved device.

Here's the information extracted from the document relevant to your request, with an explanation for the non-applicable sections:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	1. Kligman Maximization Test	Acceptable for intended use	Met testing requirements, found acceptable for intended use.
	2. Intracutaneous Injection Test	Acceptable for intended use	Met testing requirements, found acceptable for intended use.
	3. Systemic Injection Test	Acceptable for intended use	Met testing requirements, found acceptable for intended use.
	4. Rabbit Pyrogen Test	Acceptable for intended use	Met testing requirements, found acceptable for intended use.
	5. L929 Mem Elution Test	Acceptable for intended use	Met testing requirements, found acceptable for intended use.
Technological Characteristics	Comparison to Predicate Device	Same Technological Characteristics as legally marketed predicate device	Stated to have the same Technological Characteristics as the predicate device (3M Company, Drapes, K031287).
Intended Use	Protective patient covering, isolating surgical site from contamination	Met for intended use	"A Surgical Drape is a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination."
Sterilization	Ethylene Oxide sterilization	Provided sterile	"They are provided sterile using ethylene oxide."

Explanation of Acceptance Criteria and Performance:
The document states, "All materials used in the fabrication of the surgical drapes were evaluated through biological qualification safety tests" and that these materials "have met the testing requirements and were found to be acceptable for the intended use." The explicit quantitative acceptance criteria are not detailed in this summary for each test but are implied by the statement of "meeting testing requirements" and "found to be acceptable." The primary "performance" metric for a 510(k) submission for this type of device is demonstrating substantial equivalence to a predicate, rather than achieving specific performance thresholds in a clinical study.

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

Sample Size for Test Set: Not explicitly stated. The document refers to "All materials used... were evaluated," suggesting material samples were tested. This is not a human subject test set.
Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing by Busse Hospital Disposables for biocompatibility and comparison with the predicate device. It is a retrospective comparison against an existing predicate device for substantial equivalence.

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

Not Applicable. This submission is for a medical device (surgical drape) where ground truth is established through laboratory material testing (biocompatibility) and comparison of technical specifications, not through expert review of clinical cases.

4. Adjudication Method for the Test Set

Not Applicable. As explained above, this isn't a study involving human readers or clinical case 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 surgical drape, not an AI-powered diagnostic or therapeutic device. No MRMC study was performed.

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

Not Applicable. This device is a physical surgical drape, not an algorithm or AI.

7. The Type of Ground Truth Used

Technical Specifications and Biocompatibility Test Results: The "ground truth" for this type of submission is based on established industry standards for material biocompatibility and physical characteristics, and the technical specifications of a legally marketed predicate device (3M Company, Drapes, K031287). The "truth" is whether the Busse Surgical Drapes meet these established safety and performance benchmarks and are comparable to the predicate.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this 510(k) submission for a surgical drape. This is not a machine learning or AI-driven device.

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

Not Applicable. As explained above, there is no "training set" for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Busse Hospital Disposables. The logo features the word "busse" in a bold, sans-serif font, with the letters closely spaced together. Below the word "busse" are the words "Hospital Disposables" in a smaller, sans-serif font. The logo is black and white.

1083424

FEB 2 6 2009

510(k) Summary

Regulatory Affairs Contact:

Muhamad Ansari Busse Hospital Disposables PO Box: 11067 75 Arkay Dr. Hauppauge NY 11788

Telephone:

631-435-4711 Ext: 254

Fax:

631-435-2849

November 6, 2008

Date Summary Prepared:

Product Trade Name:

Common Name:

Classification Name:

Busse Surgical Drapes

Surgical Drapes Class II, 21 CFR 878.4370, Product code KKX

Predicate Device:

Device Description:

3M Company, Drapes, K031287

Surgical drapes describe d in this submission are one piece, single use, designed to provide an absorbent sterile barrier & protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.

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Image /page/1/Picture/0 description: The image shows the word "busse" in a stylized font, with the words "Hospital Disposables" underneath. Below that, the words "Intended Use:" are written, with a line underneath. The text is in black and white.

A Surgical Drape is a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using ethylene oxide.

Technological Characteristics:

The subject device has the same Technological Characteristics as a legally marketed predicate device

Summary of Testing:

All materials used in the fabrication of the surgical drapes were evaluated through biological qualification safety tests.

The biocompatibility tests performed were;

1. Kligman Maximization Test
1. Intracutaneous Injection Test
1. Systemic Injection Test
Rabbit Pyrogen Test ধ

、

1. L929 Mem Elution Test
  These materials have met the testing requirements and were found to be acceptable for the intended use.

The above statements are accurate representations of the device Busse intents to market. Based on all the testing and comparison Busse believes the subject device is substantially equivalent to the predicate device. All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted.

Conclusion:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Muhamad Ansari Director of Regulatory Affairs Busse Hospital Disposables P.O. Box 11067 75 Arkay Drive Hauppauge, NY 11788

FEB 2 6 2009

Re: K083424

Trade/Device Name: Busse Surgical Drape II Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: February 6, 2009 Received: February 11, 2009

Dear Mr. Ansari:

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. Ansari

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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Anthony V. Morton for

Ginette Y. Michaud, M.D. Acting 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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Indications for Use Statement

510(k) Number (if known): K083424

Device Name: Busse Surgical Drape II

Indication for Use: The Busse Surgical Drape is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide. There are various models of drapes: Non-woven drapes, Tissue Drape, & SMS Drapes with round, oval & square fenestration shapes.

Prescription Use (Per 21 CFR 801Subpart D) AND/OR

Over-The-Counter Use X (Per 21 CFR 801Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule N. Murphy, R
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K083424

Additional information requested on 1/5/09 - K083424 Page 2

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.