(308 days)
Not Found
No
The summary describes a sterilization wrap and its physical properties and intended use, with no mention of AI or ML technology.
No
The device is a sterilization wrap used to maintain the sterility of other medical devices, not to prevent, diagnose, or treat a disease or condition.
No
The device is a sterilization wrap used to enclose other medical devices for sterilization and maintain sterility, not to diagnose a condition or disease.
No
The device description clearly states it is composed of a wet formed non-woven cellulose fiber with acrylic binders, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to enclose another medical device for sterilization and maintain sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description details the material composition and single-use nature of the wrap. There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic tests.
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
Therefore, the Bioshield® Express™ Sterilization Wrap is a medical device used in the sterilization process, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Allegiance BioShield® Express™ Sterilization Wrap is a single-use, non-sterile device. It is 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 prevacuum steam sterilization processes.
The Bioshield® 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 prevacuum steam sterilization processes.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
The Allegiance BioShield® Express™ Sterilization Wrap is composed of a wet formed non-woven cellulose fiber with acrylic binders. The Allegiance BioShield® Express™ Sterilization Wrap is a single-use, non-sterile device.
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 sterilization wrap was evaluated and tested as required in ISO Standard 10993 Part 1. The material was subjected to skin sensitization, intracutaneous reactivity and cytotoxicity testing. Physical and performance testing was completed including sterilization performance testing. This product is in compliance with established standards, where applicable, and is deemed acceptable 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
AUG. 5.1999 3:41PM
P.3/5 NO. OSA
K9837/9
AUG 25 -
legiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085 847.473.1500 FAX: 847.785.2461
ATTACHMENT F
SUMMARY OF SAFETY AND EFFECTIVENESS
Manufacturer:
Regulatory Affairs Contact
Telephone:
Date Summary Prepared:
Product Trade Name:
Common Name:
Classification:
Predicate Device: (K770933)
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
October 16, 1998
Allegiance BjoShield® Express™ Sterilization Wrap
CSR Wrap or Sterilization Wrap
Sterilization Wrap
Allegiance BioShield® Sterilization Wrap
The Allegiance BioShield® Express™ Sterilization Wrap is composed of a wet formed non-woven cellulose fiber with acrylic binders.
The Allegiance BioShield® Express™ Sterilization Wrap is a single-use, non-sterile device. It is 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 prevacuum steam sterilization processes.
1
Image /page/1/Picture/2 description: The image shows the word "Allegiance" in a stylized, bold, black font. To the left of the word is a graphic of a plus sign made up of small squares. The word is slightly slanted to the right, giving it a dynamic appearance.
Allegiance Healthcare Corporation
1500 Waukegan Road McGaw Park, IL 60085 847.473.1500 FAX: 847.785.2461
ATTACHMENT F Page 2 of 2
Substantial Equivalence:
The Allegiance Allegiance BioShield® Express™ Sterilization Wrap is substantially equivalent to the Dextex II Sterilization Wrap and the Kimguard™ Sterilization in that the:
- intended use is the same
- performance attributes are the same
The Allegiance BioShield® Express™ Sterilization Wrap is substantially equivalent to the Allegiance BjoShield® Sterilization Wrap in that the:
- intended use is the same
- material composition is the same
- performance attributes are the same
The material used in the composition of this sterilization wrap was evaluated and tested as required in ISO Standard 10993 Part 1. The material was subjected to skin sensitization, intracutaneous reactivity and cytotoxicity testing. Physical and performance testing was completed including sterilization performance testing. This product is in compliance with established standards, where applicable, and is deemed acceptable for its intended use.
Summary of Testing:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 25 1999
Patricia Sharpe-Gregg Ms. Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building MP-WM McGaw Park, Illinois 60085
Re : K983719
...
BioShield® Express™ Sterilization Wrap Trade Name: Requlatory Class: II Product Code: FRG Dated: July 15, 1999 Received: July 16, 1999
Dear Ms. Sharpe-Gregg:
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 legally marketed predicate 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
3
Page 2 - Ms. Sharpe-Gregg
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 (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" (21CFR 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.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timo y A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
.
.•.
:
Allegiance
Alleglance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 USA 847-473-1500 FAX: 847-785-2461
510(k) Notification Express Sterlilzation Wrap V. Mueller Business Unit Page 1 of 1
| 510(k) Number (if known): | Unknown K983719 |
|---|---|
| Device Name: | Bioshield® Express™ Sterilization Wrap |
| Indications For Use: | The Bioshield® 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 prevacuum steam 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) | |
|---|---|
| Over-The Counter Use | |
| (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K983719 |