(206 days)
No
The device is a sterilization pouch and the description focuses on its physical properties and compatibility with a specific sterilization system, with no mention of AI/ML.
No
The device is a sterilization containment pouch, not a device used for treating or diagnosing a medical condition.
No
Explanation: The device is a sterilization containment pouch, not a diagnostic tool. Its purpose is to maintain the sterility of other medical devices, not to diagnose medical conditions.
No
The device is a physical sterilization pouch made of Tyvek and plastic film, clearly described as a hardware component for containing medical devices during sterilization.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for sterilizing medical devices and maintaining their sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The description focuses on the physical characteristics of the pouch and its compatibility with a specific sterilization system. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The text does not contain any terms or concepts typically associated with IVD devices, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Diagnostic purposes
- Clinical chemistry, microbiology, immunology, etc.
The device is clearly described as a sterilization containment pouch for medical devices.
N/A
Intended Use / Indications for Use
The Vis-U-All Self Seal Pouch is a sterilization containment pouch designed for devices to be sterilized by the AMSCO® V-PRO 1 Low Temperature Sterilization System. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
Product codes
KCT
Device Description
The proposed Vis-U-All Self 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. It permits sealing of the pouch without need of heat-sealing equipment. The purpose of this submission is to demonstrate the Vis-U-All Self 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.
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 care 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)
Performance testing of the Vis-U-All Self Seal Pouch 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
1. Device Name
| Trade Name: | Vis-U-All Self Seal Pouch |
|---|---|
| Common/usual Name: | Sterilization pouch |
| Classification Name: | Sterilization wrap (21 CFR 880.6850 Product Code KCT). |
2. Predicate Device
- Surgicot Pouches, Peel Open, Breathable (K771032) .
- Surgipeel Self Seal Packaging System (K820302) .
3. Description of Device
The proposed Vis-U-All Self 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. It permits sealing of the pouch without need of heat-sealing equipment. The purpose of this submission is to demonstrate the Vis-U-All Self 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.
ব. Intended Use
The Vis-U-All Self Seal Pouch is a sterilization containment pouch designed for devices to be sterilized by the health care provider by the AMSCO® V-PRO 1 Low Temperature Sterilization System. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
5. Description of Safety and Substantial Equivalence
The materials of composition for the Vis-U-All Self Seal Pouch 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.
Performance testing of the Vis-U-All Self Seal Pouch 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.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings outstretched, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 2 2007
Patrick J. McCullagh, Ph.D. Vice President STERIS, Corporation 5960 Heisley Road Mentor, Ohio 44060-1834
Re: K070765
Trade/Device Name: Vis-U-All Self Seal Pouch Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: September 12, 2007 Received: September 13, 2007
Dear Dr. McCullagh:
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.
2
Page 2 - Dr. McCullagh
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
510(k) Number (if known): K070765
Device Name:
Vis-U-All Self Seal Pouch
Indications For Use:
The Vis-U-All Self Seal Pouch is a sterilization containment pouch designed for devices to be sterilized by the AMSCO V-Pro 1 Low Temperature Sterilization System. 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 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. Murphy, AD
(Division Sign-Off)
Division of Anesthesiology General Hospital Infection Control, Dental Devices
510(k) Number: K070765
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Confidential