SUPRASHIELD EXPRESS STERILIZATION WRAP

K990300 · Allegiance Healthcare Corp. · FRG · Feb 10, 1999 · General Hospital

Device Facts

• Record ID: K990300
• Device Name: SUPRASHIELD EXPRESS STERILIZATION WRAP
• Applicant: Allegiance Healthcare Corp.
• Product Code: FRG · General Hospital
• Decision Date: Feb 10, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The SupraShield® Express™ Sterilization Wrap is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. This wrap is intended for use in steam or ethylene oxide (EO) sterilization processes.

Device Story

SupraShield Express Sterilization Wrap is a non-sterile, SMS (Spun-Bonded/Melt-Blown/Spun-Bonded) sandwich-type fabric wrap. Used in clinical settings by healthcare providers to enclose medical devices prior to sterilization. The wrap allows penetration of steam or ethylene oxide (EO) sterilants while maintaining a sterile barrier for the enclosed device until the point of use. It functions as a protective packaging system to ensure the sterility of surgical instruments and other medical equipment.

Clinical Evidence

Bench testing only. The device underwent biocompatibility testing including skin sensitization, intracutaneous reactivity, and cytotoxicity testing per ISO Standard 10993. Physical and performance testing, including sterilization performance, was completed to demonstrate compliance with established standards.

Technological Characteristics

SMS (Spun-Bonded/Melt-Blown/Spun-Bonded) fabric sterilization wrap. Designed for steam and ethylene oxide (EO) sterilization. Biocompatibility testing conducted per ISO 10993.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices requiring sterilization via steam or ethylene oxide (EO) processes and to maintain sterility of the enclosed devices until use.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• Convertors® Sterilization Wrap (K921243)

Submission Summary (Full Text)

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# 1-16 99

### llegiance

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085 847.473.1500 AX: 847.785.2461

### ATTACHMENT E

## SUMMARY OF SAFETY AND EFFECTIVENESS

Manufacturer:

Regulatory Affairs Contact

Telephone:

Date Summary Prepared:

Product Trade Name:

Common Name:

Classification:

Predicate Device: (K921243)

Description:

Intended Use:

Allegiance Healthcare Corporation V. Mueller Business Unit 1435 Lake Cook Road Deerfield, IL 60015

Patricia Sharpe-Gregg 1500 Waukegan Road McGaw Park, Illinois 60085

[phone]

January 27, 1999

SupraShield Express™ Sterilization Wrap

CSR Wrap or Sterilization Wrap

Sterilization Wrap

Convertors® Sterilization Wrap

The Allegiance SupraShield Express™ Sterilization The Allegiance Ouplation of a "SMS Sandwich type Wrap is composed of a "Olds Same" - Spun Bonded) fabric.

The Allegiance SupraShield Express™ Sterilization The Allegianoo Guse, non-sterile device. It is Wrap is a single about of enclose another medical intended to be asse to be sterilized by a healthcare device that is to be seeing allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. It is stemity of the encloses steam and ethylene oxide (EO) sterilization processes.

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### Allequance Allegiance Healthcare Corporation
Allegiance Bead

1500 Waukegan Road McGaw Park, IL 00085 847.473.1500 FAX: [phone]

Substantial Equivalence:

The Allegiance Allegiance SupraShield™ Express™
Chemical Marc is cubstantially equivalent to the The Allegiance Allegiance SubraShleid - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Sterilization Wrap is substan language in that the:
Convertors Sterilization Wrap in the same flors Stenlization is the same

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

Summary of Testing:

The material used in the composition of this The material used in the Composition .
sterilization wrap was evaluated and tested as sterilization wrap was evaluation and 1. The required in The required in I required in ISO Standard 10500 consitization, material was material was subjected to skir scholicity testing.
intracutaneous reactivity and cytotoxicity testing. intracutaneous reactivity and cyclosics.completed
Physical and performance testing was completed
Physical and performance testing . This Physical and performance testing was on . This including sterilization performance tooling of the standards,
product is in compliance with established standards,
the states and in deemed in deemed acceptable for its product is in compliance with establiers where applicable for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that resembles three stylized waves or lines, which is a common symbol associated with HHS.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 1999

Ms. Patricia Sharpe-Gregg MB. Factre Healthcare Corporation 1500 Waukegan Road William Merz Building 60085 McGaw Park, Illinois

K990300 Re : Suprashield Express Sterilization Wrap Trade Name: Regulatory Class: II FRG Product Code: Dated: January 27, 1999 Received: February 1, 1999

#### Dear Ms. Sharpe-Gregg

We have reviewed your Section 510 (k) notification of intent to We have reviewed your section 31%, "howe have determined the market the device relered above than a maications for device is substantially equivalence (rose marketed in interstate
use stated in the enclosure) to devices marketed in interest use stated in the encrosure, so the enactment date of the commerce prior co may 26, 1978, or to devices that have been Medical Device Amendments, or to devices sims of the Pederal Food, Drug, and Cosmetic Act (Act). You may, therefore, Food, Drug, and Cosmetic Acc (ine, eneral controls provisions
market the device, subject to the general and of the Act The general controls provisions of the Act of the Act. of the Act. The general conual registration, listing of Include requirementBeturing 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 (Special Controls) of Crabb additional controls. Existing major be subject to such addition device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A rederal Requiralions, ficte ar, ration assumes compliance with the Good Manufacturing Practice for Medical Devices: General the Good Manufacturing Fraat 820) and that, through periodic (GMP) regulation (2) crk rare ouve Administration (PDA) will verify such assumptions. Failure to comply with the GMP vertify such assumpcions. regulatory action. In addition, FDA regulation may resure in regulated] accerning your device in the Federal Register. Please note: this response to your the rederal negible on submission does not affect any prematiet notification Bannder sections 531 through 542 of

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Page 2 - Ms. Sharpe-Gregg

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 requlation (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.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directdr 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 Healthcare Corporation**
1500 Waukegan Road
McGaw Park, Mlinois 60085 USA
847-473-1500
FAX: [phone]

clal 510(k) Device Modification: SupraShield® Express Sterilization Wrap V. Muellor Businoss Unit

Page 1 of 1

0(k) Number (if known):

Unknown

Device Name:

SupraShield® Express™ Sterilization Wrap

Indications For Use:

The SupraShield® Express™ Sterilization Wrap is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

This wrap is intended for use in steam or ethylene oxide (EO) sterilization processes.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Lù or lin
(Division Sign-Off)
Division of Dental, Infection Control
and Gene
Over-The Counter Use ✗