CONVERTORS DRAPE MATERIAL

K964125 · Allegiance Healthcare Corp. · KKX · Dec 23, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K964125
• Device Name: CONVERTORS DRAPE MATERIAL
• Applicant: Allegiance Healthcare Corp.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Dec 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The Convertors® Drapes and Leggings are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

Device Story

Convertors® Drapes and Leggings function as sterile barriers; composed of nonwoven polyester fibers adhesively laminated to 1.25 mil embossed polyethylene film. Used in clinical/surgical settings to isolate incision sites from contaminants. Protects patients by preventing microbial transfer; aids clinicians in maintaining sterile fields. No active components; passive barrier technology.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1 (cytotoxicity, sensitization, irritation/intracutaneous reactivity). Physical performance testing included hydrostatic head, impact penetration, synthetic blood penetration (ASTM 1670-1995), Phi X174 viral penetration (ASTM 1671-1995), Trapezoid Tear, Grab Tensile, Mullen Burst, Basis Weight, and flammability (Class 2).

Technological Characteristics

Nonwoven adhesively bonded polyester fibers laminated to 1.25 mil embossed blended polyethylene film. Passive barrier device. Flammability Class 2. Tested per ASTM 1670-1995 and ASTM 1671-1995.

Indications for Use

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

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

• Convertors® Drape Materials

Submission Summary (Full Text)

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DEC 23 1996

Allegiance

Allegiance Healthcare Corporation
1500 Waukegan Road
McGaw Park, Illinois 60085-6787
847.473.1500
FAX: [phone]

K964125

## XII. **SMDA REQUIREMENTS**

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
### Convertors® Drapes and Leggings

**Manufacturer:**
Allegiance Healthcare Corporation
Convertors® Operations
One Butterfield Trail
El Paso, Texas 79906

**Regulatory Affairs Contact:**
Sharon Robbins
Allegiance Healthcare Corporation
1500 Waukegan Road MPK
McGaw Park, IL 60085

**Telephone:** [phone]

**Date Summary Prepared:** September, 1996

**Common Name:** Convertors® Drapes and Leggings

**Classification:** Class II per 21CFR § 878.4370

**Predicate Device:** Convertors® Drape Materials

**Description:**
These drapes and leggings will be composed of a nonwoven fabric adhesively laminated to a synthetic polymer film. The nonwoven contains adhesively bonded polyester fibers. The film is a 1.25 mil finely embossed blended polyethylene construction.

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DEC 20 '96 08:50AM 344-345.2460
P.4/4

# Allegiance

Allegiance Healthcare Corporation
1500 Waukegan Road
McGaw Park, Illinois 60085-6787
847.473.1500
FAX: [phone]

## XII. **SMDA REQUIREMENTS** (continued)

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
**Convertors® Drapes and Leggings**

**Intended Use:**
The Convertors® Drapes and Leggings are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

**Substantial Equivalence:**
The Convertors® Drapes and Leggings are substantially equivalent to the Convertors® legging drape materials in that:
- the intended use is the same
- the performance attributes are similar

**Summary of testing:**
All materials used in the fabrication of this Convertors® drapes and leggings were evaluated through biological qualification safety tests as outlined in in ISO 10993 Part-1 “Biological Evaluation of Medical Devices”. The biocompatibility tests performed were cytotoxicity, sensitization, and irritation/intracutaneous reactivity. These materials also met the requirements of hydrostatic head, impact penetration, synthetic blood penetration (ASTM 1670-1995), Phi X174 (ASTM 1671-1995) Trapazoid Tear, Grab Tensile, Mullen Burst, Basis Weight, and flammability, Class 2. These materials have met the requirements of the identified tests and were found to be acceptable for the intended use.

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