(182 days)
The Vis-U-All Heat-Seal Pouch and Tubing have been qualified by STERIS Corporation as suitable for use by health care providers to enclose and seal other medical devices to be sterilized in the AMSCO V-Pro 1 Low Temperature Sterilizer. The system is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
The proposed Vis-U-All Heat Seal Pouch is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider by the AMSCO® V-PRO 1 Low Temperature Sterilization System. The purpose of this submission is to demonstrate the Vis-U-All Heat Seal Pouch is qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilizer. The 510(k) number for the AMSCO® V-PRO 1 Low Temperature Sterilizer is K062297 cleared on October 4, 2007.
The provided document is a 510(k) premarket notification for a medical device (Vis-U-All Heat Seal Pouch and Tubing), which is a sterilization wrap. It discusses the device's substantial equivalence to predicate devices and its intended use. However, it does not include detailed information on specific acceptance criteria and a study proving those criteria were met in the format requested.
The document states: "Performance testing of the Vis-U-All Heat Seal Pouch and Tubing demonstrated that the proposed pouch is qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilizer and is as safe, as effective, and performs the same as the predicate device." This is a general statement of compliance, not a detailed breakdown of acceptance criteria and performance data.
Therefore, I cannot fulfill your request for the specific table and study details (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types and establishment for training sets) because this information is not present in the provided text.
Based on the information given, I can only report that:
- Acceptance Criteria (Implied): The device must be "qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilizer" and demonstrate it is "as safe, as effective, and performs the same as the predicate device."
- Reported Device Performance: The device "demonstrated that the proposed pouch is qualified for use" and "is as safe, as effective, and performs the same as the predicate device."
All other requested details (sample sizes, expert qualifications, etc.) are not available in this document.
{0}------------------------------------------------
Device Name 1.
| Device Name | OCT 16 200 | |
|---|---|---|
| Trade Name: | Vis-U-All Heat Seal Pouch and Tubing | |
| Common/usual Name: | Sterilization pouch | |
| Classification Name: | Sterilization wrap (21 CFR 880.6850 Product Code KCT). |
2. Predicate Devices
3. Description of Device
The proposed Vis-U-All Heat Seal Pouch is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider by the AMSCO® V-PRO 1 Low Temperature Sterilization System. The purpose of this submission is to demonstrate the Vis-U-All Heat Seal Pouch is qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilizer. The 510(k) number for the AMSCO® V-PRO 1 Low Temperature Sterilizer is K062297 cleared on October 4, 2007.
4. Intended Use
The Vis-U-All Heat-Seal Pouch and Tubing have been qualified by STERIS Corporation as suitable for use by health care providers to enclose and seal other medical devices to be sterilized in the AMSCO® V-PRO 1 Low Temperature Sterilizer. The system is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
5. Description of Safety and Substantial Equivalence
The Vis-U-All Heat Seal Pouch and Tubing object of this Premarket submission are substantially equivalent to the STERRAD Sterilization Pouch (K951295) which is also suitable for use in Vapor Hydroxide Sterilization System. The materials of composition for the Vis-U-All Heat Seal Pouch and Tubing have not changed in their composition from the predicate, K771032. The plastic film (polymylar) thickness has changed to 2.0mil. The device has no chemical indicators.
{1}------------------------------------------------
Performance testing of the Vis-U-All Heat Seal Pouch and Tubing demonstrated that the proposed pouch is qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilizer and is as safe, as effective, and performs the same as the predicate device.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized graphic of three human figures, represented by flowing lines, symbolizing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 16 2007
Mr. John R. Scoville Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060-1834
Re: K071087
Trade/Device Name: Vis-U-All Heat Seal Pouch and Tubing Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: September 12, 2007 Received: September 13, 2007
Dear Mr. Scoville:
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 -Mr. Scoville
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 your 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
K071087 510(k) Number (if known):
Device Name: Vis-U-All Heat Seal Pouch and Tubing
Indications For Use:
The Vis-U-All Heat-Seal Pouch and Tubing have been qualified by STERIS Corporation as suitable for use by health care providers to enclose and seal other medical devices to be sterilized in the AMSCO V-Pro 1 Low Temperature Sterilizer. The system is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ X_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule A. Mingle Ko
lion of Anesthesiology, General Hospital, Ascion Control, Dental Devices
umber. K071087
Confidential
§ 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).