(158 days)
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 Ethylene Oxide and Gravity Steam Sterilization processes.
The Allegiance BioShield® Express™ Sterilization Wrap is composed of a wet formed non-woven cellulose fiber with acrylic binders.
This submission describes the Allegiance BioShield® Express™ Heavy & Super Duty Sterilization Wrap. The document provided is a 510(k) Premarket Notification, which is a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on demonstrating equivalence rather than comprehensive clinical studies with acceptance criteria as one would find for a novel device.
The provided text does not contain the specific information required to complete all sections of your request, particularly regarding detailed acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for training data. This type of information is typically part of a comprehensive clinical study report, which is not fully described in this 510(k) summary.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria or performance metrics in a table. Instead, it relies on demonstrating equivalence to predicate devices and adherence to an ISO standard.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended use is the same as the predicate device. | Intent of this device is the same as the predicate (K983719) and the Kimguard™ Sterilization Wrap; to enclose a medical device for sterilization and maintain sterility. |
| Performance attributes are the same as the predicate device. | "Performance attributes are the same" as the predicate device BioShield® Express™ Sterilization Wrap and the Kimguard™ Sterilization Wrap. |
| Material composition is the same as the predicate device. | "Material composition is the same" as the predicate BioShield® Express™ Sterilization Wrap. |
| Compliance with ISO Standard 10993 Part 1 for biocompatibility. | Material was "evaluated and tested as required in ISO Standard 10993 Part 1." |
| Biological safety (skin sensitization, intracutaneous reactivity, cytotoxicity). | Material was "subjected to skin sensitization, intracutaneous reactivity and cytotoxicity testing." |
| Physical and performance testing, including sterilization performance. | "Physical and performance testing was completed including sterilization performance testing." |
| Acceptable for use with Ethylene Oxide and Gravity Steam sterilization processes. | Intended for use in "Ethylene Oxide and Gravity Steam Sterilization processes." |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document states "Physical and performance testing was completed," but no details on the number of units or tests are provided.
- Data Provenance: Not specified. Given it's a 510(k) in the US, the testing would typically be conducted to meet US regulatory requirements, but the origin of the data (e.g., country where tests were run) is not detailed. It is retrospective in the sense that the testing was completed prior to the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable and not provided. The ground truth for this device is established through laboratory testing against established physical, chemical, and biological standards (e.g., ISO 10993, sterilization efficacy). There are no "experts" in the sense of clinical reviewers establishing ground truth for individual cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation by multiple human readers (e.g., radiologists for medical images). This device is a sterilization wrap, and its performance is assessed through laboratory tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical product (sterilization wrap), not an AI or imaging diagnostic device. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or an AI device. The "standalone performance" would refer to the physical and biological performance of the wrap itself, which was tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance is based on:
- Established standards: Compliance with ISO Standard 10993 Part 1 for biocompatibility.
- Laboratory test results: Objective measurements from physical (e.g., strength, porosity), chemical, and biological tests (e.g., cytotoxicity, sterilization efficacy validations).
- Predicate device performance: The performance of the predicate device serves as a benchmark for equivalence.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/machine learning device that requires a "training set."
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Allegiance Healthcare Corporation
510(k) Premarket Notification: Allegiance BioShield® Express™ Heavy & Super Duty Sterilization Wrap
APR 2 1 2000 V. Mueller Business Unit
93871
ATTACHMENT F
Summary of Safety & Effectiveness
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Image /page/1/Picture/0 description: The image shows the word "Allegiance" in a stylized font. To the left of the word is a symbol that looks like a plus sign made up of small dots. The word "Allegiance" is in bold, black letters. The font is slightly italicized.
Allegiance Healthcare Corporation
1500 Waukegan Road McGaw Park, IL 60085 847.473.1500 FAX: 847.785.2461
Image /page/1/Picture/3 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The string reads 'K993871'.
ATTACHMENT F
SUMMARY OF SAFETY AND EFFECTIVENESS
| Manufacturer: | Allegiance Healthcare CorporationV. Mueller Business Unit1430 Waukegan RoadMcGaw Park, IL 60085 |
|---|---|
| Regulatory Affairs Contact | Patricia Sharpe-Gregg1500 Waukegan RoadMcGaw Park, Illinois 60085 |
| Telephone: | (847) 578-3636 |
| Date Summary Prepared: | November 11, 1999 |
| Product Trade Name: | Allegiance BioShield® Express™ Heavy Duty &Super Duty Sterilization Wrap |
| Common Name: | CSR Wrap or Sterilization Wrap |
| Classification: | Sterilization Wrap |
| Predicate Device:(K983719) | Allegiance BioShield® Express™ Sterilization Wrap |
| Description: | The Allegiance BioShield® Express™ SterilizationWrap is composed of a wet formed non-wovencellulose fiber with acrylic binders. |
| Intended Use: | The Allegiance BioShield® Express™ SterilizationWrap is a single-use, non-sterile device. It isintended to be used to enclose another medicaldevice that is to be sterilized by a healthcareprovider. It is intended to allow sterilization of theenclosed medical device and also to maintain sterilityof the enclosed device until used. This wrap isintended for use in Ethylene Oxide and GravitySteam Sterilization processes. |
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Image /page/2/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a graphic of a plus sign made up of small dots. The word is in black and the background is white.
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 Kimguard™ Sterilization in that the: - intended use is the same - performance attributes are the same The Allegiance BioShield® Express™ Heavy Duty & Super Duty Sterilization Wrap is substantially equivalent to the Allegiance BioShield® Express™ Sterilization Wrap in that the: - material composition is the same - performance attributes are the same Summary of Testing: 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
use.
applicable, and is deemed acceptable for its intended
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2000
Ms. Patricia Sharpe-Gregg Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building MPWM McGaw Park, Illinois 60085-6787
Re: K993871 Trade Name: Bioshield® Express™ Heavy & Super Duty Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: March 13, 2000 Received: March 14, 2000
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 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 The general controls provisions of the Act 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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Ms. Sharpe-Gregg
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 regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberrood in your 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) 594-4690. 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
y A. Ulat Directbr 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, Illinois 60085 USA
847-473-1500
FAX: 847-785-2461
510(k) Notification BioShield Express Heavy & Super Duty Sterilization Wrap Addition of Ethylene Oxide & Gravity Steam Indications For Use V. Mueller Business Unit Page 1 of 1
510(k) Number (if known):
Unknown
Device Name:
Indications For Use:
Bioshield® Express™ Heavy & Super Duty Sterilization Wrap
The Bioshield® Express™ Heavy Duty & Super Duty 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 Ethylene Oxide and Gravity 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 X
ivision Sign-Off Division of Dental, Infectio 510(k) Numbe
§ 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).