← Product Code [KKX](/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX) · K053495 # EQUIPMENT SLUSH DRAPE (K053495) _Advance Medical Designs, Inc. · KKX · Mar 16, 2006 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KKX/K053495 ## Device Facts - **Applicant:** Advance Medical Designs, Inc. - **Product Code:** [KKX](/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX.md) - **Decision Date:** Mar 16, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4370 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use Advance Medical Designs equipment drapes are used to cover a variety of surgical and non-surgical equipment in various clinical settings. It is to be used in general and Endoscopic surgery for use with saline. ## Device Story Equipment slush drape; polyurethane film; sterile barrier pouch. Used to cover surgical/non-surgical equipment in clinical settings; specifically general and endoscopic surgery involving saline. Protects equipment from contamination. Operated by surgical staff. ## Clinical Evidence Bench testing only. Material tested to ASTM F 1671 for viral penetration and 16 CFR Part 1610 for flammability. ## Technological Characteristics Polyurethane film; sterile barrier pouch. Tested to ASTM F 1671 (viral penetration) and 16 CFR Part 1610 (flammability). ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - MicroTek Equipment Drapes ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ATTACHMENT 2 K053495 16 ... # Substantial Equivalence 510(k) Summary ## Advance Medical Designs, Inc Equipment Slush Drape To Whom It May Concern: Date: 02/27/2006 Submitter/ Contact Name and Address William Slevin Advance Medical Designs, Inc. 1241 Atlanta Industrial Drive Marietta, GA 30066 Tel: (770) 422-3125 Trade Name: Advance Medical Designs, Inc Equipment Slush Drape Classification Name: Drape, Surgical Common/ Usual Name: Equipment Slush Drape Predicate Legally Marketed Device: MicroTek Equipment Drapes Intended Use: Advance Medical Designs equipment drapes are used to cover a variety of surgical and non-surgical equipment in various clinical settings. It is to be used in general and Endoscopic surgery for use with saline. Description of the Device: The Advance Medical Designs, Inc Equipment Drapes consist of polyurethane film that is cut and configured to specification. Packaged in a pouch to act as a sterile barrier. These equipment drapes are equivalent to other equipment drapes currently being marketed for the same intended use {1}------------------------------------------------ : ### Performance The material used in this product has been tested to ASTM Mcthod F 1671 for Viral Penetration and to 16 CFR Part 1610 for Flammability. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA". The symbol in the center consists of three curved lines that appear to be stylized representations of a human figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 16 2008 Mr. William Slevin Ouality Assurance Regulatory Affairs Advance Medical Designs, Incorporated 1241 Atlanta Industrial Drive Marietta, Georgia 30066 Re: K053495 Trade/Device Name: Equipment Slush Drape Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: March 10, 2006 Received: March 13, 2006 Dear Mr. Slevin: 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 Eederal Register. {3}------------------------------------------------ #### Page 2 -- Mr. Slevin 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 notification" (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 yours, Cluts Chin Lin, Ph.D. 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 {4}------------------------------------------------ # Indications for Use ### 510(k) Number (if known): 长 053495 Device Name: Slush Drape Indications For Use: Advance Medical Designs Slush Drapes are equipment covers used to cover a variety of surgical and non surgical equipment in various clinical settings. It is to be used in General and Endoscopic surgery for use with Saline. Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | Page 1 of 1 | |--------------------------------------------------------|-------------| | Division of Anesthesiology, General Hospital, | | | Infection Control, Dental Devices | | | 510(k) Number: | K053495 | ... ... .. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KKX/K053495](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KKX/K053495) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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