CONVERTORS SMS DRAPES

K970554 · Allegiance Healthcare Corp. · KKX · May 27, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970554
• Device Name: CONVERTORS SMS DRAPES
• Applicant: Allegiance Healthcare Corp.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: May 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The Convertors® SMS Drapes and Accessories 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® SMS Drapes and Accessories are protective patient coverings used in surgical settings to isolate incision sites from microbial contamination. The device consists of a trilaminate Spunbond/Meltblown/Spunbond (SMS) polyolefin nonwoven fabric with an adhesively laminated reinforcement fabric around the fenestration. The drape acts as a physical barrier to prevent the transfer of microorganisms, body fluids, and particulate matter between the patient and the surgical environment. It is intended for use by healthcare professionals in clinical or surgical environments. The device provides a sterile barrier to reduce the risk of surgical site infections, thereby benefiting the patient by maintaining a sterile field during invasive procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, and irritation/intracutaneous reactivity. Physical testing included hydrostatic head, impact penetration, alcohol repellency, Elmendorf tear, and grab tensile strength. Flammability testing was also conducted. All materials met the requirements of the identified tests.

Technological Characteristics

Trilaminate Spunbond/Meltblown/Spunbond (SMS) polyolefin nonwoven fabric; adhesively laminated reinforcement fabric around fenestration. Physical properties evaluated via hydrostatic head, impact penetration, alcohol repellency, Elmendorf tear, and grab tensile tests. Biocompatibility evaluated per ISO 10993-1.

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

• Kimberly-Clark Evolution III Drapes

Submission Summary (Full Text)

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MAY 27 1997

Allegiance

K970554

Allegiance Healthcare Corporation

1500 Waukegan Road

McGaw Park, Illinois 60085-6787

847.473.1500

FAX: [phone]

## XII. SMDA REQUIREMENTS

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## Convertors® SMS Drapes and Accessories

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: January, 1997

Common Name: Convertors® SMS Drapes and Accessories

Classification: Class II per 21CFR § 878.4370

Predicate Device: Kimberly-Clark Evolution III Drapes

Description: These drapes will be composed of a trilaminate Spunbond/Meltblown/Spunbond Polyolefin nonwoven fabric with an adhesively laminated reinforcement fabric around the fenestration.

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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® SMS Drapes and Accessories**

### Intended Use:
The Convertors® SMS Drapes and Accessories 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® Drape material is substantially equivalent to the Kimberly-Clark SMS (Evolution III) drapes:

- the intended use is the same
- the performance attributes are similar

### Summary of testing:
All materials used in the fabrication of this Convertors® drape materials were evaluated through biological qualification safety tests as outlined in the ISO 10993 Part-1 “Biological Evaluation of Medical Devices”. The biocompatibility tests performed were cytotoxicity, sensitization, and irritation/ intracutaneous reactivity. Flammability testing was performed. The physical tests performed on the SMS material were hydrostatic head, impact penetration, alcohol repellency, elmendorf tear and grab tensile. These materials have met the requirements of the identified tests and were found to be acceptable for the intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 27 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Sharon Robbins
Regulatory Affairs Manager
Allegiance Healthcare Corporation
1500 Waukegan Road
McGaw Park, Illinois 60085-6787

Re: K970554
Trade Name: Convertors SMS Drapes
Regulatory Class: II
Product Code: KKX
Dated: April 1, 1997
Received: April 29, 1997

Dear Ms. Robbins:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Robbins

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Allegiance

Allegiance Healthcare Corporation

1500 Waukegan Road

McGaw Park, Illinois 60085-6787

847.473.1500

FAX: [phone]

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510(k) Number (if known): Unknown K970554

Device Name: Convertors® SMS Drapes and Accessories

Indications For Use: The Convertors® SMS Drapes and Accessories are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☐ or Over-The-Counter Use ☑
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K970554