(354 days)
A sterilization container system 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 container system is intended to be used in STERRAD® 50, STERRAD® 100 and STERRAD® 100S, ethylene oxide and pre-vacuum sterilization processes.
The Allegiance Genesis™ STERRAD® Compatible Reusable Sterilization Container System is a reusable device which features an assortment of container designs and sizes, and inner basket and platform types.
The provided text describes the "Genesis™ STERRAD® Compatible Reusable Sterilization Container System" and its substantial equivalence to a predicate device, focusing on its intended use and performance in sterilization. However, the document does not contain specific acceptance criteria values in a table, detailed device performance metrics with numerical values, or descriptions of a study structured to prove a device meets those criteria with a specified sample size.
Therefore, I cannot fully complete the requested table or answer all questions as the specific data is not present in the provided text.
Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Criteria (Not explicitly stated with values) | Reported Device Performance (Summary) |
|---|---|---|
| Sterilization Performance (STERRAD®) | Ensure sterilization of enclosed medical devices | "All acceptance criteria were met." |
| Sterilization Performance (Ethylene Oxide) | Ensure sterilization of enclosed medical devices | "All acceptance criteria were met." |
| Sterilization Performance (Pre-vacuum) | Ensure sterilization of enclosed medical devices | "All acceptance criteria were met." |
| Shelf Life Sterility (30-day) | Maintain sterility of enclosed devices | "Results demonstrate that this product is in compliance with established standards, and is deemed acceptable for its intended use." |
| Shelf Life Sterility (180-day) | Maintain sterility of enclosed devices | "Results demonstrate that this product is in compliance with established standards, and is deemed acceptable for its intended use." |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document states "Sterilization Performance studies were conducted" and "Thirty-Day and One Hundred Eighty-Day Event Related Shelf Life Sterility tests were conducted," but does not provide the number of units or tests performed.
- Data provenance: Not explicitly stated (e.g., country of origin). The testing was conducted for the manufacturer, Allegiance Healthcare Corporation, a US-based company. The studies were likely performed domestically or at a contracted US-based laboratory. The document implies these were prospective studies conducted for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. The document only states that "all acceptance criteria were met" and "results demonstrate that this product is in compliance." It does not describe any expert adjudication process.
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:
- No MRMC comparative effectiveness study was done or mentioned. This device is a sterilization container, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable. The device is a physical sterilization container, not an algorithm or AI. The performance discussed is the physical ability of the container to facilitate sterilization and maintain sterility.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for sterilization performance and sterility maintenance would typically be established through laboratory testing using biological indicators, chemical indicators, and sterility testing according to established standards (e.g., AAMI, ISO). This would not necessarily involve expert consensus in the same way a diagnostic imaging study would, but rather adherence to validated scientific methods.
8. The sample size for the training set:
- Not applicable. This device does not involve a training set as it is not an AI or machine learning model.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
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AUG 2 0 2002
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Genesis™ STERRAD® Compatible Reusable Sterilization Container System
Manufacturer:
.. .
Regulatory Affairs Contact
Telephone:
Date Summary Prepared:
Product Trade Name:
Common Name:
Classification:
Predicate Device: (K991023)
Description:
Allegiance Healthcare Corporation V. Mueller Business Unit 1430 Waukegan Road McGaw Park, IL 60085
Lance Marconi 1500 Waukegan Road McGaw Park, Illinois 60085
(847) 578-3312
August 30, 2001
Genesis™ STERRAD® Compatible Reusable Sterilization Container System
Sterilization Container
Sterilization Wrap
SteriTite perforated base rigid reusable sterilization container system
The Allegiance Genesis™ STERRAD® Compatible Reusable Sterilization Container System is a reusable device which features an assortment of container designs and sizes, and inner basket and platform types.
Allegiance Healthcare Corporation Genesis™ STERRAD Compatible Reusable Sterilization Container System V. Mueller Business Unit
198
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Intended Use:
A sterilization container system, 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 container system is intended to be used in STERRAD®, ethylene oxide and pre-vacuum sterilization processes.
The Allegiance Genesis™ STERRAD® Compatible Reusable Sterilization Container System is substantially equivalent to the SteriTite perforated base rigid reusable sterilization container system with SCF02-polypropylene non-woven disposable filter by Case Medical, Inc in that the:
- Intended use is the same ●
- . Performance attributes are the same
Sterilization Performance studies were conducted for the Genesis™ STERRAD® Compatible Reusable Sterilization Container System and all acceptance criteria were met.
Thirty-Day and One Hundred Eighty-Day Event Related Shelf Life Sterility tests were conducted. Results demonstrate that this product is in compliance with established standards, and is deemed acceptable for its intended use.
Allegiance Healthcare Corporation Genesis™ STERRAD® Compatible Reusable Sterilization Container System V. Mueller Business Unit
Summary of Testing:
Substantial Equivalence:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 0 2002
Mr. Lance Marconi Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road McGraw Park, Illinois 60085
Re: K012931
Trade/Device Name: GenesisTM STERRAD® Compatible Reusable Sterilization Container System Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: June 5, 2002 Received: June 7, 2002
Dear Mr. Marconi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Mr. Marconi
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Puare
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K012931 |
|---|---|
| Device Name: | Genesis™ STERRAD® Compatible Reusable Sterilization Container System |
| Indications For Use: | A sterilization container system 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 container system is intended to be used in STERRAD® 50, STERRAD® 100 and STERRAD® 100S, ethylene oxide and pre-vacuum sterilization processes. |
| Model Number: | Model Description: |
|---|---|
| CD1-4ST | Bottom, Half-Length, Perforated, 4", Lid, Half-Length |
| CD1-5ST | Bottom, Half-Length, Perforated, 5", Lid, Half-Length |
| CD1-6ST | Bottom, Half-Length, Perforated, 6", Lid, Half-Length |
| CD2-4ST | Bottom, Mid-Length, Perforated, 4", Lid, Mid-Length |
| CD2-5ST | Bottom, Mid-Length, Perforated, 5", Lid, Mid-Length |
| CD2-6ST | Bottom, Mid-Length, Perforated, 6", Lid, Mid-Length |
| CD3-4ST | Bottom, Full-Length, Perforated, 4", Lid, Full-Length |
| CD3-5ST | Bottom, Full-Length, Perforated, 5", Lid, Full-Length |
| CD3-6ST | Bottom, Full-Length, Perforated, 6", Lid, Full-Length |
| CD0-3ST | Bottom, Mini, Perforated, 3", Lid, Mini |
| CD0-4ST | Bottom, Quarter-Length, Perforated, 4", Lid, Quarter-Length |
| CD4-3ST | Bottom, Small Shallow, Perforated, 3", Lid, Small |
| CD4-5ST | Bottom, Small, Perforated, 5-1/2", Lid, Small |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | or | Over-The Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | ||
| (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 6 | ||
| 510(k) Number: | K012931 |
§ 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).