(125 days)
Surgical drapes made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination. These are provided non-sterile to kit packers, who then may sterilize the drape as part of a kit.
Various types of surgical drapes
The provided text is a 510(k) Premarket Notification for "Surgical Drapes." This document is focused on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving device performance against such criteria.
The 510(k) pathway for medical devices largely relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device (one that was on the market before May 28, 1976, or has been reclassified). This process typically involves comparing the new device's technological characteristics and indications for use to those of the predicate device. Performance data, if included, is often used to support the claim of substantial equivalence rather than to meet specific, quantitatively defined "acceptance criteria" through a comprehensive clinical study.
Therefore, the requested information elements related to acceptance criteria, specific device performance metrics, sample sizes, ground truth, expert involvement, and comparative effectiveness studies are not applicable to this document. The document describes the device, its intended use, and compares it to a predicate device (Webster Enterprises – K864899) to demonstrate substantial equivalence, focusing on similarities in features and materials rather than statistical performance against predefined acceptance criteria.
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Premarket Notification 510(k) Section 5 -- 510(k) Summary
<061422 Austin Medical
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 22-May-06
SEP 2 5 2006
| Austin Medical, Inc.1578 Prairie RoadEnterprise, FL 32725 | Tel – (407) 549-5643Fax – (828) 586-1093 |
|---|---|
| Official Contact: | Tim Hutto, Owner |
| Proprietary or Trade Name: | Surgical Drapes |
| Common/Usual Name: | Surgical Drapes |
| Classification Name: | Surgical drapes |
| Device: | Various types of surgical drapes |
| Predicate Devices: | Webster Enterprises – K864899 |
Austin Medical offers a series of non-sterile surgical drapes for various surgical procedure applications, i.e., table covers, OB/GYN, General Surgery, Orthopedic, ENT and ENNT, Drape Sheets, Cystoscopy, Craniotomy, Angiography, Fluid Pouches, Instrument Covers, U Drapes, Minor procedure drapes, and pediatric drapes.
| Indications for Use: | |
|---|---|
| Indicated Use -- | Non-sterile surgical drapes made from natural and syntheticmaterials intended to be used by medical professionals asprotective coverings, such as a patient covering to isolate a sitefor surgical incision from contamination. These are providednon-sterile to kit packers, who then may sterilize the drape aspart of a kit. |
| Patient Population -- | Any individual |
| Environment of Use -- | Physician office, hospital, sub-acute institutions |
| Contraindications -- | None |
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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 22-May-06
Device Attributes:
| Features | PredicateWebster - K864899 | AustinProposed |
|---|---|---|
| Indications for use | Surgical drapes made from natural andsynthetic materials intended to be used bymedical professionals as protective coverings,such as a patient covering to isolate a site forsurgical incision from contamination | Same |
| Environment of Use | Physician offices, Hospital, Sub-acuteInstitutions | Same |
| Patient Population | No limitations | Same |
| Contraindications | None | None |
| Sterility | Non-sterileSterile | Non-sterile |
| Configurations | Many | Many |
| Absorbency | Absorbent and non-absorbent | Same |
| Materials in patientcontact | Micro-embossed LDPE, Clear LDPE,Sontara, non-woven, Airtex, Polyfoam,Medical grade tape, liners | Identical |
| Disposable | Yes | Yes |
Differences Between Other Legally Marketed Predicate Devices
The Austin Medical surgical drapes are viewed as substantially equivalent to the following predicate device. Webster, K864899.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, serif font. The words are evenly spaced and the text is centered.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EP 2 5 2006
Austin Medical, Incorporated Mr. Paul E. Dryden President ProMedic, Incorporated 3460 Pointe Creek Court # 102 Bonita Springs, Florida 34134-2015
Re: K061422
Trade/Device Name: Surgical Drapes Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKK Dated: September 14, 2006 Received: September 15, 2006
Dear Mr. Dryden:
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. Dryden
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notifioation" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
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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4 Indications for Use Statement
Page 1 of 1
koby 22 (To be assigned) 510(k) Number:
Device Name:
Surgical Drapes. Various disposable, non-sterile surgical drapes (Table covers, OB/GYN, General Surgery, Orthopedic, ENT and ENNT, Drape Sheets, Cystoscopy, Craniotomy, Anglogiaphy, Flaid Poaches, and Instrument Covers)
Indications for Use:
Surgical drapes made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination. These are provided non-sterile to kit packers, who then may sterilize the drape as part of a kit.
Prescription Use
(Part 21 CFR 801 Subpart D)
or
Over-the-counter use 7 (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shila A. Murphy, 40
n of Anesthesiology, General Hospital, n Control, Dental Devices
Number: K011422
§ 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.