(214 days)
Winner® Self Seal Sterilization Pouch 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.
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 Winner® Self Seal Sterilization Pouch has the identical intended use and indication for use as the predicate devices, as well as, similar labeling.
The provided text describes a 510(k) submission for the Winner® Self Seal Sterilization Pouch, focusing on demonstrating substantial equivalence to predicate devices. It outlines the intended use, device description, and studies conducted to support the claim. However, the document does not contain the specific details required to complete your request in the format of a typical AI/ML medical device performance study.
Here's an analysis based on the available information:
This is NOT an AI/ML device. The submission is for a physical medical product (sterilization pouch), not a software algorithm or an AI-powered diagnostic tool. Therefore, many of the requested criteria related to AI/ML device performance studies (e.g., sample size for training set, number of experts for ground truth establishment, MRMC studies, standalone algorithm performance, AI vs. human improvement) are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes material and performance characteristics that were tested to establish substantial equivalence. These act as "acceptance criteria" for the physical properties of the pouch.
| Acceptance Criteria (Measured Characteristics) | Reported Device Performance (Summary) |
|---|---|
| Medical grade paper conformity to recognized material standards (pressure drop vs. flow and filtration efficiency) | Confirmed (tested for non-sterile, steam, and EtO sterilized finished devices) |
| Film characteristics (thickness, tensile strength, elongation) | Confirmed (tested for non-sterile, steam, and EtO sterilized finished devices) |
| Seal strength | Confirmed (tested for finished devices) |
| Package burst | Confirmed (tested for finished devices) |
| Dye migration | Confirmed (tested for finished devices) |
| Temperature distribution (for steam and EtO sterilization) | Confirmed (tested for finished devices) |
| Steam sterilization of biological indicators | Confirmed (tested for finished devices) |
| Ethylene Oxide sterilization of biological indicators | Confirmed (tested for finished devices) |
| Ability to maintain sterility until used (Implied) | Confirmed (Intended Use states this capability) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of pouches or samples tested for each characteristic. It only states that testing was performed on "non-sterile, steam sterilized and ethylene oxide sterilized finished devices."
- Data Provenance: The testing was presumably conducted by the manufacturer, Winner Industries Co., LTD, based in Shenzhen, China, or by a contracted lab. The document does not explicitly state the country of origin of the data beyond the manufacturer's location. The studies are prospective in the sense that they were conducted specifically to demonstrate the performance of the Winner® Self Seal Sterilization Pouch for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not directly applicable to a physical product's material and performance testing. The "ground truth" here is established by standardized testing methods and material specifications. For example, "seal strength" has a defined measurement and acceptance range, not an expert opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The testing involves objective measurements against established standards, not interpretation or adjudication by experts.
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, as this is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" is based on standardized engineering and material science specifications and performance test methods relevant to sterilization packaging. For instance:
- ASTM standards for material properties (e.g., tensile strength, elongation).
- ISO or AAMI standards for package integrity (e.g., seal strength, burst testing).
- Biological indicator results demonstrating sterilization efficacy.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.
Conclusion:
The provided document describes a regulatory submission for a physical medical device (sterilization pouch) and details the physical and performance characteristics that were tested to demonstrate substantial equivalence to predicate devices. It clearly demonstrates the device meets the necessary "acceptance criteria" by showing conformity to recognized material standards and successful performance in various tests related to its intended use (sterilization and maintenance of sterility). However, the requested information format is largely geared towards AI/ML device studies, which do not apply to this product.
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Image /page/0/Picture/0 description: The image shows a logo with the word "Winner" in a stylized font. Above the "i" in "Winner" is a small circle. Below the word "Winner" is the phrase "WIN-WIN PARTNER" in a smaller, sans-serif font. The text is slightly curved.
WINNER MEDICAL (USA), II
1900-H PROFORMA AVE. ONTARIO, CA. 91761 TEL: 909-947-9612 FAX: 909-947-9613
DEC 1 3 2005
510K SUMMARY
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: K051242
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- Submitter's Identification:
Winner Industries Co., LTD Winner Industrial Park,Bulong RD., Longhua, Shenzhen Shenzhen China 518109 Telephone: 86-755-28138888 Facsimile: 86-755-28134588
- Submitter's Identification:
U.S. Agent: Winner Medical USA, Inc. 1900-H Proforma Ave. Ontario, California 92861 Telephone: 909-947-9612 Facsimile: 909-947-9613
Contact Person: Ming Xie, Vice President
Date of Summary: 5-6-05
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- Device Name: Winner® Self Seal Sterilization Pouch
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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: Winner® Self Seal Sterilization Pouches are 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 Winner® Self Seal Sterilization Pouch has the identical intended use and indication for use as the predicate devices, as well as, similar labeling. Substantial equivalent to the predicate device was established by testing 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). This information has been included with this submission.
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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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes, possibly representing health, people, and services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC I 3 2005
Dr. Ming Xie Vice President Winner Medical USA, Incorporated 1900-H Proforma Avenue Ontario. California 91761
Re: K051242
Trade/Device Name: Winner® Self Seal Sterilization Pouch Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: October 24, 2005 Received: October 31, 2005
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 Federal Register.
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Page 2 - Dr. Xie
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. or the For of 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 requirents as bet formic 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), nlease 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 (301) 443-6597 or at its Internet address http://www.fda.gov/edrh/industry/support/index.html.
Sincerely vours,
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
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Indications for Use
510(k) Number (if known): K051242
Device Name: Winner® Self Seal Sterilization Pouch
Indications For Use:
Winner® Self Seal Sterilization Pouch 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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).