(214 days)
Not Found
No
The device description and performance studies focus on material properties and sterilization efficacy, with no mention of AI or ML.
No
The device is a sterilization pouch used to enclose other medical devices for sterilization and to maintain their sterility. It does not actively treat or diagnose a disease or condition.
No
The device is a sterilization pouch used to maintain the sterility of other medical devices. It does not diagnose any condition or disease.
No
The device is a physical sterilization pouch made of paper and plastic film, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose other medical devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions using samples from the human body.
- Device Description: The description focuses on the materials and construction of a pouch for sterilization, not on reagents, instruments, or software used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Winner® Self Seal Sterilization Pouch falls under the category of a medical device used for sterilization and storage, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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:
1
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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.
-
- 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.
2
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.
3
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
4
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)