(9 days)
Not Found
No
The device is a sterilization wrap, a physical material, and the description focuses on its composition and performance in sterilization processes. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
Explanation: The device is a sterilization wrap used to maintain sterility of medical devices, not to treat a medical condition or disease.
No
The device is a sterilization wrap used to maintain sterility of another medical device. It does not perform any diagnostic function.
No
The device description clearly states it is a "SMS Sandwich type" fabric, indicating a physical material, not software.
Based on the provided text, the SupraShield® Express™ Sterilization Wrap is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to enclose another medical device for sterilization and maintain its sterility. This is a function related to the preparation and storage of medical devices, not the examination of specimens derived from the human body.
- Device Description: The description focuses on the material composition of the wrap, which is consistent with a packaging or barrier material.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or treatment.
- Using reagents or assays.
Therefore, the SupraShield® Express™ Sterilization Wrap falls under the category of a medical device used in the sterilization process, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Allegiance SupraShield Express™ Sterilization 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
The Allegiance SupraShield Express™ Sterilization The Allegiance Ouplation of a "SMS Sandwich type Wrap is composed of a "Olds Same" - Spun Bonded) fabric.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
(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.
1
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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2
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
3
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
4
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 ✗