(50 days)
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No
The document describes a reusable surgical drape made of synthetic materials, focusing on its physical properties, durability, and sterilization process. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device, ComPel Surgical Drapes, is intended to cover patients or working surfaces during surgical procedures to isolate a site of surgical incision from microbial and other contamination. It does not provide any therapeutic effect or treatment.
No
This device, ComPel Surgical Drapes, is intended to cover patients or surfaces to prevent contamination during surgical procedures. Its function is protective, not diagnostic.
No
The device description clearly indicates it is a physical product (surgical drapes made of fabric) and 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 to cover patients or working surfaces during surgical procedures to isolate the surgical site from contamination. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a surgical drape made of synthetic materials. Its function is described in terms of its physical properties (barrier performance, strength, durability) and its ability to be sterilized. There is no mention of it being used to analyze samples or provide diagnostic information.
- Performance Studies: The performance studies listed focus on physical properties, barrier function, toxicity, and durability. There are no studies related to analyzing biological samples or providing diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
ComPel Surgical Drapes are intended to cover patients or working surfaces during surgical procedures. ComPel Surgical Drapes and Covers are made of synthetic materials intended to be used as protective other of Dargious such as to isolate a site of surgical incision from microbial and other contamination.
ComPel Surgical Drapes will function as a surgical drape when processed according to instructions. Com of Dargical Drapes are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical drapes that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
Product codes
KKX
Device Description
All base fabrics used in the construction of ComPel Surgical Drapes are made from 100% polyester, knitted or woven into fabric and then dyed. WrapPel and ComPel fabrics are fluorocarbon treated, XTR fabric is silicone coated, COMBOsafe fabric is laminated with a urethane film and Zorwik is treated to be hydrophilic.
ComPel Surgical Drapes will function as a surgical drape when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical drapes that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care facilities and/or contract sterilization/laundry companies.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The tests that have been successfully completed include: Flammability 16 CFR Part 1610. a. Barrier Performance b. Suter Hydrostatic Testing AATCC #127-1989 i, Mullens Hydrostatic Testing ASTM D751-95 Procedure A ii. Strength ASTM #D-1682-87 & ASTM #D-3786-87 C. Lint EDANA 220.0-96 d. Toxicity Cytotoxicity MEM Elution (MG023) e. Acute Systemic Toxicity (ISO 10993) Primary Skin Irritation (ISO 10993)) f. Sterilization Product sold non-sterilized using prevacuum steam cycles. Durability through 75 processing (wash, dry and sterilization). Colorfastness to Commercial Laundering - AATCC #61-1993(4A).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 a black and white emblem. The emblem is in the shape of a shield with a thick black border. Inside the shield are the letters 'S' and 'C' intertwined, also in black. The 'S' is in the foreground, partially overlapping the 'C'.
STANDARD TEXTILE
OCT 1 1 2001
012807
510(k) Summary
This summary of 510(k) safety and effectiveness is being supplied in accordance with the Safe Medical Device Act of 1990 and 21 C.F.R.
807.92(a)
| 1. | Standard Textile Co., Inc.
One Knollcrest Drive
Cincinnati, Ohio 45237 | Contact Person: Brad Bushman
(513) 761-9255 Ext. 455
Summary Prepared on 6/29/01 |
|----|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| 2. | Device Name: | ComPel Surgical Drapes and Covers, non-sterile (75X reusable) |
| | Common/Usual Name: | Non-sterile Surgical Drapes and Covers |
| | Classification Name: | Fenestrated Surgical Drapes/Covers
Non-fenestrated Surgical Drapes/Covers
Regulation #878.4370 |
| 3. | Predicate Device: | ComPel Surgical Drapes #K923811 |
-
All base fabrics used in the construction of ComPel Surgical Drapes are made from 100% polyester, 4. knitted or woven into fabric and then dyed. WrapPel and ComPel fabrics are fluorocarbon treated, XTR fabric is silicone coated, COMBOsafe fabric is laminated with a urethane film and Zorwik is treated to be hydrophilic.
ComPel Surgical Drapes will function as a surgical drape when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical drapes that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies. -
ComPel Surgical Drapes are intended to be used on patients or surfaces where protection from liquid ર. migration is needed. The location and level of liquid protection as well as the size and location of a fenestration is defined by the surgical staff. The liquid barrier properties will inhibit the migration of liquids across its surface.
There are no critical differences in the use of this product from currently marketed ComPel Surgical Drapes (K923811) except for the use of the COMBOsafe fabric. ComPel Surgical Drapes have demonstrated that they will perform as intended when used as labeled. -
The tests that have been successfully completed include: 6.
- Flammability 16 CFR Part 1610. a.
- Barrier Performance b.
·
- Suter Hydrostatic Testing AATCC #127-1989 i,
- Mullens Hydrostatic Testing ASTM D751-95 Procedure A ii.
- Strength ASTM #D-1682-87 & ASTM #D-3786-87 C.
- Lint EDANA 220.0-96 d.
- Toxicity Cytotoxicity MEM Elution (MG023) e. Acute Systemic Toxicity (ISO 10993)
- Primary Skin Irritation (ISO 10993)) f.
- Sterilization Product sold non-sterilized using prevacuum steam cycles. ದ್ದು
- h. Durability through 75 processing (wash, dry and sterilization).
- i. Colorfastness to Commercial Laundering - AATCC #61-1993(4A).
To the best of my knowledge, all data and information in the 510(k) are truthful and accurate, and that no material fact has been omitted.
Bradley
Bradley J. Bushman
... Page 56.
VORI D HEADQUARTE
ONE KNOLLCREST D CINCINNATI OHIO
1
Image /page/1/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" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 1 2001
Mr. Bradley J. Bushman Director, Technical Resources Standard Textile Company, Incorporated One Knollcrest Drive Cincinnati, Ohio 45237
Re: K012807
Trade/Device Name:ComPel Surgical Drapes Regulation Number: 878.4370 Regulation Name: Nonsterile Surgical Drapes and Covers Regulatory Class: II Product Code: KKX Dated: September 14, 2001 Received: September 18, 2001
Dear Mr. Bushman:
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.
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.
2
Page 2 - Mr. Bushman
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ti. A. Uhtomskii
Tin Directo: Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K012807 510(k) NUMBER:
ComPel Surgical Drapes DEVICE NAME:
INDICATIONS FOR USE:
ComPel Surgical Drapes are intended to cover patients or working surfaces during surgical procedures. ComPel Surgical Drapes and Covers are made of synthetic materials intended to be used as protective other of Dargious such as to isolate a site of surgical incision from microbial and other contamination.
ComPel Surgical Drapes will function as a surgical drape when processed according to instructions. Com of Dargical Drapes are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical drapes that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number.
Over-The-Counter-Use (Optional Format 1)