(9 days)
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.
The Allegiance SupraShield Express™ Sterilization Wrap is composed of a "SMS Sandwich type" - Spun Bonded) fabric.
The Allegiance Healthcare Corporation's SupraShield Express™ Sterilization Wrap undergone testing to ensure its safety and effectiveness. The summary of safety and effectiveness outlines the following:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (skin sensitization, intracutaneous reactivity, cytotoxicity) | Material was subjected to and passed skin sensitization, intracutaneous reactivity, and cytotoxicity testing. |
| Physical and Performance Testing (including sterilization performance) | All physical and performance testing was completed. The product is in compliance with established standards and deemed acceptable for its intended use. |
| Substantial Equivalence to Predicate Device (Convertors® Sterilization Wrap) | The Allegiance SupraShield™ Express™ Sterilization Wrap is substantially equivalent in: intended use, material composition, and performance attributes. |
2. Sample Size and Data Provenance
The document does not explicitly state the sample sizes used for the test set or the specific data provenance (e.g., country of origin, retrospective/prospective). It only mentions that the "material used in the composition of this sterilization wrap was evaluated and tested."
3. Number of Experts and Qualifications for Ground Truth
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set.
4. Adjudication Method
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information about a multi-reader multi-case (MRMC) comparative effectiveness study is provided in the document. Therefore, no effect size of human reader improvement with AI assistance can be reported.
6. Standalone (Algorithm Only) Performance Study
This device is a physical product (sterilization wrap), not an algorithm or AI-based system. Therefore, a standalone (algorithm only) performance study is not applicable.
7. Type of Ground Truth Used
The ground truth for the performance of the sterilization wrap was established through compliance with established standards and physical and performance testing, including sterilization performance tooling. It also relied on demonstrating substantial equivalence to an existing predicate device (Convertors® Sterilization Wrap), implying that the predicate device's established safety and effectiveness served as a benchmark.
8. Sample Size for Training Set
As this is a physical medical device and not an AI/ML product, the concept of a "training set" in the context of machine learning is not applicable here.
9. How Ground Truth for Training Set Was Established
Similarly, as this is not an AI/ML product, there is no "training set" and therefore no ground truth established for it in that context. The "training" for this device would refer to its manufacturing process and quality control to meet the performance specifications.
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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
(847) 578-3636
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: 847 785.2461
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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: 847-785-2461
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.
(Please do not WRITE BELOW THIS LINE - Continue on another PAGE)
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 ✗
§ 880.6850 Sterilization wrap.
(a)
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.(b)
Classification. Class II (performance standards).