(270 days)
No
The device description and performance studies focus on the physical properties of the pouch and the performance of the chemical indicators, with no mention of AI or ML.
No.
This device is a sterilization pouch intended to enclose other medical devices for sterilization and maintain their sterility, not to treat or diagnose a disease or condition in a patient.
No
Explanation: The device, a sterilization pouch with process indicators, is designed to ensure the sterility of medical devices and to confirm exposure to sterilization processes (steam or EtO). It does not diagnose any medical condition, nor does it provide information about the presence or absence of a disease. Its function is to facilitate and verify a sterilization process, not to diagnose.
No
The device is a physical sterilization pouch made of paper and plastic film with adhesive and process indicators. It is a hardware medical device, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to enclose medical devices for sterilization and maintain their sterility. It also includes process indicators to show exposure to sterilization. This is a function related to the preparation and storage of medical devices, not the examination of specimens derived from the human body.
- Device Description: The description focuses on the physical properties of the pouch materials and how they function in the sterilization process.
- Lack of IVD Characteristics: There is no mention of analyzing human specimens (blood, urine, tissue, etc.), detecting diseases, conditions, or states of health, or providing information for diagnosis, monitoring, or treatment decisions based on such analysis.
The device is clearly intended for use in the sterilization process of other medical devices within a healthcare setting.
N/A
Intended Use / 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 medical 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.
Product codes
FRG
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. The Sterilization Pouch with indicators has the identical intended use, components, and manufacturing methods as our previous Self Seal Sterilization Pouch.
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
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).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 "Wimer" in a stylized font. Below "Wimer" is the phrase "WIN-WIN PARTNER" in a sans-serif font. The text is curved, giving it a dynamic appearance. The logo is black and white.
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
-
- Device Name: Sterilization Pouch with indicators
-
- Classification Name: Pack, Sterilization Wrapper, Bag and Accessories (21 CFR 880.6850).
-
- Predicate Device:
1
-
- 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.
-
- 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".
2
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.
3
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
4
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