(270 days)
Winner® Self Seal Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam 121°C for 15 minutes or greater than or equal to 600 mg/l of ethylene oxide (EtO) for 1 hour at 55° C and 70%RH. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The process indicators on the pouches are intended to demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices.
These pouches are manufactured from a medical grade paper and plastic film that are heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Sterilization Pouch with indicators has the identical intended use, components, and manufacturing methods as our previous Self Seal Sterilization Pouch.
The provided text is a 510(k) summary for the "Winner® Self Seal Sterilization Pouch with Steam and Ethylene Oxide Process Indicators." This type of document is for medical device approval and focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria for a new, innovative AI/software device.
Therefore, much of the requested information (like sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance of an algorithm, etc.) is not applicable or available in this document because it describes a physical sterilization pouch, not a software or AI-driven diagnostic device.
Here's an analysis based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "The process indicators meet the performance requirements of ANSI/AAMI ST60:1996 standard entitled "Sterilization of health care products - Chemical indicators -Part 1: General requirements"." However, the specific quantitative acceptance criteria defined within ANSI/AAMI ST60:1996 and the detailed reported device performance against those criteria are not provided in this summary. Instead, a general statement of compliance is made.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Standards (Paper) | Conforms to recognized material standards (details not specified) |
| Material Standards (Film) | Conforms to recognized material standards (details not specified) |
| Physical Testing (Paper) | Pressure drop vs. flow, filtration efficiency from non-sterile, steam sterilized, and EtO sterilized devices (details not specified) |
| Physical Testing (Film) | Thickness, tensile strength, and elongation from non-sterile, steam sterilized, and EtO sterilized devices (details not specified) |
| Finished Device Performance | Seal strength, package burst, dye migration, temperature distribution for steam and EtO sterilization, steam and EtO sterilization of biological indicators (details not specified) |
| Process Indicators | Meets the performance requirements of ANSI/AAMI ST60:1996 standard entitled "Sterilization of health care products - Chemical indicators -Part 1: General requirements." (Specific quantitative criteria and measured performance not detailed) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "physical testing of the medical grade paper... and film... as well as, performance of these finished devices." The number of units tested is not specified.
- Data Provenance: The testing was conducted as part of the submission process, likely by the manufacturer (Winner Industries Co., LTD & Winner Medical USA, Inc.). The country of origin of the data is not specified beyond where the company is based (Shenzhen, China, and Pomona, CA, USA). The testing is prospective in nature, as it relates to evaluating the newly manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a physical sterilization pouch, not an AI/software diagnostic device requiring expert interpretation for ground truth. Performance is assessed against physical and chemical standards.
4. Adjudication method for the test set:
This information is not applicable for the same reasons as above.
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:
This is not applicable. The device is not an AI product and does not involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's performance is based on established material standards (e.g., medical grade paper and plastic film standards) and performance standards (e.g., ANSI/AAMI ST60:1996 for chemical indicators). It also involves demonstrating the ability to maintain sterility and allow sterilization, which would be verified through microbiology (sterilization of biological indicators) and physical integrity testing.
8. The sample size for the training set:
This is not applicable as the device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable for the same reasons as above.
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WINNER MEDICAL (USA
1037 WALNUT AVE. POMONA, CA. 91766 TEL: 909-465-0598 FAX: 909-465-0729
510K SUMMARY
JUN - 8 2007
This summary of 510K safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510K number is:
-
- Submitter's Identification:
Winner Industries Co., LTD & Winner Medical USA, Inc. Winner Industrial Park, Bulong RD., Longhua, Shenzhen Shenzhen China 518109 Telephone: 86-755-28138888 Facsimile: 86-755-28134588
- Submitter's Identification:
U.S. Agent for Winner Industries Co., LTD: Winner Medical USA, Inc. 1037 Walnut Ave. Pomona, California 91766 Telephone: 909-465-0598 Facsimile: 909-465-0729
Contact Person: Ming Xie, Vice President
Date of Summary: 9-4-06
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- Device Name: Sterilization Pouch with indicators
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- Classification Name: Pack, Sterilization Wrapper, Bag and Accessories (21 CFR 880.6850).
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- Predicate Device:
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- Intended Use: Sterilization Pouch with indicators is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam 121°C for 15 minutes or ethylene oxide (EtO). It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
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- Device Description/ Comparison: These pouches are manufactured from a medical grade paper and plastic film that are heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Sterilization Pouch with indicators has the identical intended use, components, and manufacturing methods as our previous Self Seal Sterilization Pouch. Substantial equivalent to the predicate device was established by physical testing of the medical grade paper (pressure drop vs. flow and filtration efficiency) and film (thickness, tensile strength and elongation) from non-sterile, steam sterilized and ethylene oxide sterilized finished devices, as well as, performance of these finished devices (seal strength, package burst, dye migration, temperature distribution for steam and ethylene oxide sterilization, steam and ethylene oxide sterilization of biological indicators). The process indicators meet the performance requirements of ANSI/AAMI ST60:1996 standard entitled "Sterilization of health care products - Chemical indicators -Part 1: General requirements".
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract design of an eagle, which is a common symbol of the United States.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 8 2007
Winner Industries Company, Limited C/O Ming Xie, Ph.D. Vice President Winner Medical (USA), Incorporated 1037 Walnut Avenue Pomona, California 91766
Re: K062704
Trade/Device Name: Winner® Self Seal Sterilization Pouch with Steam and Ethylene Oxide Process Indicators Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: May 15, 2007 Received: May 17, 2007
Dear Dr. Xie:
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 Eederal Register.
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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. 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ove
Chiu Lin, Ph.D. 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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Indications for Use
K062704 510(k) Number (if known):
Winner® Self Seal Sterilization Pouch with Steam and Ethylene Oxide Device Name: Process Indicators Indications For Use:
Winner® Self Seal Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam 121°C for 15 minutes or greater than or equal to 600 mg/l of ethylene oxide (EtO) for 1 hour at 55° C and 70%RH. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The process indicators on the pouches are intended to demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
X Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OND)
Shule A. Murphy, MD
Page 1 of
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K062714
§ 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).