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. This is the same intended use as a previously cleared for the Busse Surgical Drape II, K083424.

Device Description

The Laminated Non-Woven 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) submission for "Busse Surgical Drapes III." The primary focus of this document is to demonstrate substantial equivalence to a predicate device, "Busse Surgical Drapes II (K083424)," not to provide a detailed study proving the device meets new, objective performance criteria in the way AI/ML medical devices often do.

Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this 510(k) submission for a traditional medical device (surgical drapes).

However, I can extract the relevant information regarding acceptance criteria and the "study" that demonstrates compliance based on the document's content.

Here's a breakdown:

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

Acceptance Criteria / Test Performed	Reported Device Performance
Biocompatibility Testing:	The materials met the testing requirements and were found acceptable for the intended use.
1. Kligman Maximization Test	Acceptable
2. Intracutaneous Injection Test	Acceptable
3. Systemic Injection Test	Acceptable
4. Rabbit Pyrogen Test	Acceptable
5. L929 Mem Elution Test	Acceptable
Technological Characteristics Equivalence:	The subject device has the same Technological Characteristics as the legally marketed predicate device (Busse Surgical Drapes II, K083424).
Intended Use Equivalence:	The intended use is the same as the predicate device (Busse Surgical Drape II, K083424): to isolate a site of surgical incisions from microbial and other contamination.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided document. Biocompatibility tests typically use a small number of animal subjects or cell cultures, but the exact count is not given.
Data Provenance: Not specified. The tests are standard biological qualification safety tests, generally performed in specialized labs. Whether these were conducted in the US or elsewhere is not stated. The data would be prospective for these specific tests on the device materials.

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)

Not applicable. This is a traditional medical device (surgical drape), not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the material tests would be the established safety thresholds and methodologies for biocompatibility, as defined by international standards (e.g., ISO 10993). The interpretation of these results is done by qualified toxicologists/biocompatibility specialists, but specific numbers and qualifications are not provided in this summary.

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

Not applicable. As this is not an AI/ML device involving human interpretation of results, there is no adjudication method in the context 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 a traditional medical device; therefore, no MRMC study, human readers, or AI assistance is involved.

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

Not applicable. This is a traditional medical device; therefore, no algorithm or "standalone" performance is relevant.

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

The "ground truth" for the reported tests is established through pre-defined scientific methods and acceptance criteria for biocompatibility testing. These criteria are based on established toxicology and material science principles, typically referenced in standards like ISO 10993. The test results (e.g., cell viability, irritation response) are compared against these predetermined thresholds.

8. The sample size for the training set

Not applicable. This is a traditional medical device; there is no "training set" in the context of an AI/ML algorithm.

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

Not applicable. As there is no training set, this question is not relevant.

Summary

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K092212

Image /page/0/Picture/1 description: The image shows the date "OCT - 9 2009". The text is in a simple, sans-serif font and is horizontally aligned. The date is likely extracted from a document or photograph, indicating the date of creation or recording.

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

Date Summary Prepared:

July 15, 2009

Product Trade Name:

Busse Surgical Drapes III

Busse Surgical Drapes II, K083424

Common Name:

Busse Surgical Drapes III

Classification Name: Surgical Drapes III Class II, 21 CFR 878.4370, Product code KKX

Predicate Device:

Device Description:

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K092212

Intended Use:	A Surgical Drape is a protective patient covering,such as to isolate a site of surgical incisions frommicrobial and other contamination. They areprovided sterile using ethylene oxide.
Technological Characteristics:	The subject device has the same TechnologicalCharacteristics as a legally marketed predicatedevice
Summary of Testing:	All materials used in the fabrication of the surgicaldrapes were evaluated through biologicalqualification safety tests.The biocompatibility tests performed were:1. Kligman Maximization Test2. Intracutaneous Injection Test3. Systemic Injection Test4. Rabbit Pyrogen Test5. L929 Mem Elution TestThese materials have met the testing requirementsand were found to be acceptable for the intendeduse.
Conclusion:	The above statements are accurate representationsof the device Busse intents to market. Based on allthe testing and comparison Busse believes thesubject device is substantially equivalent to thepredicate device. All data and informationsubmitted in this premarket notification is truthfuland accurate and no material fact has been omitted.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

Mr. Muhamad Ansari Director of Regulatory Affairs Busse Hospital Disposables, Incorporated 75 Arkay Drive Hauppauge, New York 11788

T - 9 2009

Re: K092212

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: September 10, 2009 Received: September 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Anthony O. water for
Susan Buckner, D.D.S., M.S.

usan Runner, D.D.S., M.A. 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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INDICATION FOR USE STATEMENT

510(k) Number (if known):

Device Name: Busse Surgical Drape III

Indication for Use:

687 – Sterile Blue Laminated Non-Woven 22 x 25 Drape with 2 ¼" Fenestration and Adhesive Patch

686 - Sterile Blue Laminated Non-Woven 22 x 25 Drape

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)

Shale Murphy
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K192212

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.