(119 days)
No
The 510(k) summary describes a standard surgical drape and does not mention any AI or ML capabilities. The performance studies focus on material biocompatibility, not algorithmic performance.
No.
The document describes the device as a protective patient covering used to isolate surgical incision sites from contamination, which falls under general hospital supplies rather than a therapeutic intervention.
No
The device is a surgical drape, which is a protective patient covering used to isolate a site of surgical incisions. It does not provide information about a patient's health status or condition.
No
The device description clearly states it is a physical surgical drape made of materials that undergo biocompatibility testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "external use only" as a "protective patient covering" during surgery. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces its function as providing "protection from microbial and other contamination."
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the biocompatibility and safety of the materials, which is relevant for a medical device used externally, but not for an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical drape does not fit that description.
N/A
Intended Use / Indications for Use
A Surgical Drape is a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination.
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.
Product codes
KKX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- Rabbit Pyrogen Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
l
1
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.
2
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.
3
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
4
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