← Product Code [KKX](/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX) · K955872 # VOLMED OPERATION DRAPE (K955872) _Medal Intl. Sales Co., LLC · KKX · Mar 12, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KKX/K955872 ## Device Facts - **Applicant:** Medal Intl. Sales Co., LLC - **Product Code:** [KKX](/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX.md) - **Decision Date:** Mar 12, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4370 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use As a protective patient covering during surgical procedures, such as to isolate a site of surgical incision from microbial and other contamination. ## Device Story Volmed Operation Drape; sterile surgical incise drape; transparent polyurethane film coated with acrylic medical-grade adhesive; supported by silicon-coated polyethylene release paper; polyethylene protective film on outer surface. Used in surgical settings to isolate incision sites from contamination. Applied by surgical staff to patient skin prior to incision. Acts as physical bacterial barrier. Benefits patient by reducing risk of surgical site contamination. ## Clinical Evidence Bench testing only. Biocompatibility established via in vitro cytotoxicity, guinea pig subcutaneous implantation, and rabbit dermal irritation tests. Human repeat insult patch test confirmed no irritation or allergic contact dermatitis. Microbial permeability study using S. aureus demonstrated effective bacterial barrier performance. ## Technological Characteristics Transparent polyurethane film; acrylic medical-grade adhesive; silicon-coated polyethylene release paper; polyethylene protective film. Gamma irradiation sterilization. Sizes: 10x10cm to 30x60cm. Class II device (79KKX). ## 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 - Steri-Drape® Surgical Incise Drapes (pre-1976) ## 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} K 955872 # 510 (k) SUMMARY MAR 12 1996 ## I. ADMINISTRATIVE Submitter: Medal International Sales Company, LLC Route 17 Box 283-P Fort Worth, Texas 76126 (817) 244-8977 Contact Person: S. Douglas Pritchett Date of Preparation: December 26, 1995 ## II. DEVICE NAME Proprietary Name: Volmed™ Operation Drape Common Name: Sterile Surgical Incise Drape Classification Name: Sterile Surgical Drape Regulatory Class: Class II Device Product Code: 79KKX ## III. PREDICATE DEVICE Steri-Drape® Surgical Incise Drapes, legally marketed prior to May 28, 1976 by 3M Company. ## IV. DEVICE DESCRIPTION The Volmed Operation Drape is a sterile incise drape composed of a transparent mat polyurethane film coated on one side with an acrylic medical grade adhesive, supported by peelable white, silicon coated, double sided polyethylene protected release paper. The other side of the polyurethane film is protected by a polyethylene film which is removed after application of the drape to the surgical site. Volmed Operations Drapes are supplied in 10 cm x 10 cm, 10 cm x 20 cm, 20 cm x 20 cm, 20 cm x 40 cm and 30 cm x 60 cm sizes in individual packages sterilized by gamma irradiation. The biocompatibility of the device has been established by in vitro cytotoxicity, subcutaneous implantation (guinea pig), and dermal irritation (rabbit) tests. A repeat insult patch test in human volunteers showed that the material does not induce irritation or allergic contact dermatitis. In addition, a microbial permeability study with S. aureus was performed to demonstrate the effective performance of the drape as a bacterial barrier. Premarket Notification: Volmed™ Operation Drape 9 {1} Premarket Notification: Volmed™ Operation Drape 10 ## V. INTENDED USE As a protective patient covering during surgical procedures, such as to isolate a site of surgical incision from microbial and other contamination. ## VI. CONCLUSION The technological characteristics of the Volmed Operation Drape are the same as those of predicate devices, such as the Steri-Drape® Surgical Incise Drape (3M Company). Biocompatibility and performance testing of the Volmed Operation Drape have demonstrated topical safety as well as effective microbial barrier performance. Accordingly, Medal International Sales Company has concluded that the Volmed Operation Drape is safe and effective for its intended use and performs at least as well as legally marketed predicate devices, such as the Steri-Drape® Surgical Incise Drape (3M Company). --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KKX/K955872](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KKX/K955872) **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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