Who is the manufacturer of VOLMED OPERATION DRAPE?

Medal Intl. Sales Co., LLC filed the 510(k) submission for VOLMED OPERATION DRAPE (K955872).

What is the FDA product code for VOLMED OPERATION DRAPE?

KKX. It is classified under 21 CFR 878.4370 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for VOLMED OPERATION DRAPE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for VOLMED OPERATION DRAPE?

Steri-Drape® Surgical Incise Drapes (pre-1976).

Who can help prepare an FDA 510(k) submission like VOLMED OPERATION DRAPE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VOLMED OPERATION DRAPE

K955872 · Medal Intl. Sales Co., LLC · KKX · Mar 12, 1996 · General, Plastic Surgery

Device Facts

Record ID	K955872
Device Name	VOLMED OPERATION DRAPE
Applicant	Medal Intl. Sales Co., LLC
Product Code	KKX · General, Plastic Surgery
Decision Date	Mar 12, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4370
Device Class	Class 2

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).

Indications for Use

Indicated for use as a protective patient covering during surgical procedures to isolate the surgical incision site from microbial and other contamination.

Regulatory Classification

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)

Related Devices

K101688 — EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 · Exact Medical Manufacturing, Inc. · Sep 20, 2010
K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX · Foshan Nanhai Plus Medical Co, Ltd. · Jun 24, 2015
K141324 — HONGYU DISPOSABLE SURGICAL DRAPES · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · Apr 14, 2015
K082297 — BUSSE SURGICAL DRAPE · Busse Hospital Disposables, Inc. · Dec 9, 2008
K062480 — JOYKEY SURGICAL DRAPES (STERILE) · Joykey Industryial , Ltd. · Mar 5, 2007

Submission Summary (Full Text)

{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).