(119 days)
The Busse Surgical Drape is intended for external use only and is used is as a protective patient covering, such as to isolate a site of surgical incisions from it a vacu is a a provided steries using ethylene oxide.
Surgical drapes are intended to provide protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.
The document describes a 510(k) premarket notification for the Busse Surgical Drape. The stated goal is to demonstrate substantial equivalence to a predicate device (3M Company, Drapes, K031287). The acceptance criteria and the study performed are focused on the safety and material compatibility of the new device.
There is no mention of an algorithm or AI in this document, as it pertains to a physical medical device (surgical drapes). Therefore, many of the requested points related to AI performance metrics (e.g., effect size of human readers with AI, standalone algorithm performance, training set details) are not applicable.
Here's an analysis of the provided information concerning acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance and Evidence |
|---|---|
| Biocompatibility and Safety for Intended Use | All materials used in the fabrication were evaluated through biological qualification safety tests. Materials met testing requirements. |
| Equivalence in Design, Material, and Intended Use to Predicate | "The surgical drapes are generally identical to 3M Surgical Drapes in design, material & intended use." (This is a claim of equivalence rather than a specific performance metric, but it forms the basis of the 510(k) submission.) |
| Compliance with specific biocompatibility tests | Performed and met requirements for: - Kligman Maximization Test - Intracutaneous Injection Test - Systemic Injection Test - Rabbit Pyrogen Test |
2. Sample size used for the test set and the data provenance
The document specifies biocompatibility tests were performed on the materials used in the surgical drapes. Regarding "sample size used for the test set," this would refer to the number of samples of the material tested in each biological assay, or the number of animals used for the in vivo tests. However, the document does not explicitly state the number of samples or animals for these tests.
The data provenance is internal to Busse Hospital Disposables, as they commissioned or performed these tests. It is a prospective evaluation of their device materials. The country of origin of the data is not specified but is implicitly the United States given the FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the context of biocompatibility testing for a physical device. Ground truth for these types of tests is established by standardized laboratory protocols and scientific interpretation of results (e.g., observation of reactions in animal models, or cell culture changes), not by expert consensus in the way medical image analysis or clinical diagnosis might be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Biocompatibility tests have predefined endpoints and interpretation criteria, and do not typically involve an adjudication process by multiple experts for results.
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 medical device (surgical drape), not an AI/CAD system for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (surgical drape), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility testing, the "ground truth" is derived from standardized biological testing protocols and laboratory observations/measurements. For example:
- Kligman Maximization Test: Assesses skin sensitization. Ground truth would be the presence/absence and severity of allergic reactions in test subjects.
- Intracutaneous Injection Test: Assesses local tissue reaction. Ground truth would be the presence/absence and severity of erythema/edema.
- Systemic Injection Test: Assesses systemic toxicity. Ground truth would be observations of general toxicity signs/symptoms.
- Rabbit Pyrogen Test: Detects pyrogens. Ground truth would be the presence or absence of a fever response in rabbits.
These are objective, biologically defined endpoints.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
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Image /page/0/Picture/0 description: The image shows the logo for "busse Hospital Disposables". The word "busse" is in a bold, sans-serif font, with the letters closely spaced together. Below the word "busse" is the phrase "Hospital Disposables" in a smaller, sans-serif font. The logo is simple and modern, and the use of bold font makes it easily recognizable.
DEC 0 9 2008
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:
August 6, 2008
Surgical Drapes
Surgical Drapes
Busse Surgical Drapes
Product Trade Name:
Common Name:
Classification Name:
Predicate Device:
Device Description:
Class II, 21 CFR 878.4370, Product code KKX
3M Company, Drapes, K031287
Surgical drapes are intended to provide protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.
Intended Use:
A Surgical Drape is a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination.
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Image /page/1/Picture/0 description: The image shows the logo for "busse Hospital Disposables". The word "busse" is in a stylized font where the letters are thick and have vertical lines running through them. Below the word "busse" is the phrase "Hospital Disposables" in a smaller, simpler font. The logo is black and white.
Technological Characteristics/Substantial Equivalence:
The surgical drapes are generally identical to 3M Surgical Drapes in design, material & intended use.
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:
-
- Kligman Maximization Test
-
- Intracutaneous Injection Test
-
- Systemic Injection Test
-
- Rabbit Pyrogen Test
These materials have met the testing requirements and were found to be acceptable for the intended use.
Conclusion:
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 generally 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.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, rendered in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 9 2008
Mr. Muhamad Ansari Director of Regulatory Affairs Busse Hospital Disposables, Incorporated 75 Arkay Drive Hauppauge, New York 11788
Re: K082297
Trade/Device Name: Busse Surgical Drape I Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: November 13, 2008 Received: November 18, 2008
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 (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 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 vours.
Snyte Y. Michael Davis
Chiu S. Lin, Ph. D Division 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): ____________________________________________________________________________________________________________________________________________________ K082297
Device Name: Busse Surgical Drape I
Indication for Use: The Busse Surgical Drape is intended for external use only and is used is as a protective patient covering, such as to isolate a site of surgical incisions from it a vacu is a a provided steries using ethylene oxide.
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 W. Murphy, MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K082297
§ 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.