(308 days)
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.
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.
The provided document is a 510(k) Pre-Market Notification for the Allegiance BioShield® Express™ Sterilization Wrap. This type of document is for a medical device that does not use AI/machine learning and therefore, the requested information about acceptance criteria for AI performance, sample sizes for test and training sets, expert qualifications, and MRMC studies is not applicable.
The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on intended use, material composition, and performance attributes.
However, based on the Summary of Safety and Effectiveness and the Summary of Testing sections, I can extract and infer some information regarding the device's performance evaluation against established standards.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of quantitative acceptance criteria with reported numerical performance values in the way one would for an AI model's metrics (e.g., sensitivity, specificity). Instead, it states compliance with established standards and successful completion of tests.
| Performance Attribute / Test Category | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO Standard 10993 Part 1 | Material was evaluated and tested as required in ISO 10993 Part 1. |
| Skin Sensitization | Acceptable non-sensitization response | Subjected to skin sensitization testing. |
| Intracutaneous Reactivity | Acceptable non-reactive response | Subjected to intracutaneous reactivity testing. |
| Cytotoxicity | Acceptable non-cytotoxic response | Subjected to cytotoxicity testing. |
| Physical and Performance | Compliance with established standards for sterilization wrap (e.g., tensile strength, porosity, fluid repellency, microbial barrier properties, etc.) | Physical and performance testing was completed. |
| Sterilization Performance | Ability to allow sterilization and maintain sterility for its intended use in prevacuum steam sterilization processes. | Sterilization performance testing was completed. |
| Overall Compliance | Deemed acceptable for intended use and compliance with applicable established standards. | Product is in compliance with established standards, where applicable, and is deemed acceptable for its intended use. |
Note: The specific numerical acceptance criteria (e.g., "tensile strength X N/mm^2") are not detailed in this summary document but would be part of the detailed test reports submitted to the FDA.
2. Sample Sizes and Data Provenance for Test Set:
Not applicable. This is a physical product and the "test set" refers to samples of the sterilization wrap material subjected to laboratory and performance tests, not a dataset for an algorithm. The source of material is the manufacturer, Allegiance Healthcare Corporation.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. Ground truth for a physical medical device like sterilization wrap is established through recognized laboratory testing standards validated by scientific and engineering principles, not through expert consensus on diagnostic interpretations.
4. Adjudication Method for Test Set:
Not applicable. As described above, performance is evaluated through standardized physical, chemical, and biological tests, not through human adjudication of diagnostic outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study is relevant for diagnostic imaging devices or software where human readers interpret medical images. The BioShield® Express™ Sterilization Wrap is a commodity medical device.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device does not involve an algorithm.
7. Type of Ground Truth Used:
The ground truth for this device's safety and effectiveness relies on:
- Established ISO Standards (e.g., ISO 10993 Part 1 for biocompatibility): These standards define acceptable methodologies and limits for biological evaluation of medical devices.
- Industry-recognized test methods: For physical and performance attributes (e.g., material strength, air permeability, fluid resistance, microbial barrier properties relevant to sterilization wrap).
- Sterilization efficacy studies: Demonstrating the ability of the wrap to allow steam penetration for sterilization and maintain sterility.
8. Sample Size for Training Set & 9. How Ground Truth for Training Set Was Established:
Not applicable. There is no concept of "training set" for a physical medical device. The device's formulation and design are based on established engineering principles for materials science and sterilization technology, not machine learning training.
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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.
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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:
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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:
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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
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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 |
§ 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).