(79 days)
No
The device description and intended use are for a physical surgical drape, and there is no mention of AI or ML technology in the provided text.
No
The Busse Surgical Drape is intended to be used as a protective patient covering to isolate a site of surgical incisions from microbial and other contamination. It does not provide any therapeutic effect.
No
Explanation: The device is a surgical drape intended to provide a sterile barrier and protection from contamination during surgery. It does not perform any diagnostic function.
No
The device is a physical surgical drape made of laminated non-woven material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination." This describes a physical barrier used during surgery, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical characteristics of the drape (material, size, fenestration, adhesive) and its function as a sterile barrier.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on biocompatibility and safety, which are relevant for a surgical device, but not for an IVD.
Therefore, this device falls under the category of a surgical drape, which is a medical device but not an In Vitro Diagnostic device.
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. They are provided sterile using ethylene oxide.
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. The Drapes included in this submission are the following:
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
Product codes
KKX
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.
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
- L929 Mem Elution Test
These materials have met the testing requirements and were found to be acceptable for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Busse Surgical Drapes II, K083424
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
l
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:
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.
1
K092212
| Intended Use: | 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:
- Kligman Maximization Test
- Intracutaneous Injection Test
- Systemic Injection Test
- Rabbit Pyrogen Test
- L929 Mem Elution 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 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. |
2
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.
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); 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
4
INDICATION FOR USE STATEMENT
510(k) Number (if known):
Device Name: Busse Surgical Drape III
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. This is the same intended use as a previously cleared for the Busse Surgical Drape II, K083424. The Drapes included in this submission are the following:
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