(77 days)
Not Found
No
The document describes a sterilization pouch and does not mention any AI or ML components or functionalities.
No
This device is a sterilization containment pouch, not a device used for therapy. Its purpose is to maintain sterility of medical devices, not to treat a condition or provide therapy.
No
Explanation: The provided text describes a sterilization pouch used to contain medical devices during the sterilization process and maintain their sterility afterward. It does not mention any function related to diagnosing diseases or conditions.
No
The device description clearly states it is a physical pouch made of Tyvek and plastic film, which are hardware components.
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 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 disease or other conditions.
- Device Description: The device is a sterilization containment pouch. This is a physical barrier for maintaining sterility, not a reagent, instrument, or system intended for use in the in vitro examination of specimens derived from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening
The device's function is purely related to the sterilization and storage of medical devices used in healthcare settings.
N/A
Intended Use / Indications for Use
The Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System has 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 Sterilization System. The Vis -U-All Low Temperature Tyvck Sterilization Pouch for V-PRO 1 Sterilization 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.
Indications For Use:
The Vis-U-All Low Temperature Tyvek Sterilization Pouches are sterilization containment pouches for use by the health care providers to enclose medical devices to be sterilized in the Amsco V-PRO 1 Low Temperature Sterilization System. The pouches maintain the sterility of the enclosed device during normal handling and storage until the pouch is opened and the medical device is removed for use.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The proposed Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in the Amsco V-PRO 1 Low Temperature Sterilization System. The proposed pouch is available as either a self seal pouch, a heat seal pouch, or heat seal tubing.
The purpose of this submission is to demonstrate the Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System is safe and effective for double pouching.
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 providers
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)
Testing of the Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System demonstrated that the proposed pouches and tubing are safe and effective when double-pouched.
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 handwritten string of characters. The characters appear to be "K90371". The handwriting is somewhat stylized, making the characters slightly difficult to read, but the overall form is clear.
Image /page/0/Picture/11 description: The image shows the STERIS logo. The word "STERIS" is in all caps and in a serif font. Below the word is a graphic of several horizontal lines that are curved to resemble waves.
MAY
- 1 2009 510(k) Summary For Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
John Robert (Jack) Scoville. Fellow, Regulatory Affairs Telephone:(440) 392-7330 Fax No: (440) 357-9198
Summary Date:
February 12, 2009
STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600
1
1. Device Name
| Trade Name: | Vis-U-All Low Temperature Tyvek Sterilization
Pouch for V-PRO 1 Sterilization System |
|----------------------|-----------------------------------------------------------------------------------------|
| Common/usual Name: | Sterilization pouch |
| Classification Name: | Sterilization wrap (21 CFR 880.6850 Product Code
KCT). |
2. Predicate Device
3. Description of Device
The proposed Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in the Amsco V-PRO 1 Low Temperature Sterilization System. The proposed pouch is available as either a self seal pouch, a heat seal pouch, or heat seal tubing.
The purpose of this submission is to demonstrate the Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System is safe and effective for double pouching.
4. Intended Use
The Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System has 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 Sterilization System. The Vis -U-All Low Temperature Tyvck Sterilization Pouch for V-PRO 1 Sterilization 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.
2
5. Description of Safety and Substantial Equivalence
The device models are identical to the cleared predicate dcvices K070765 and K071087.
Testing of the Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System demonstrated that the proposed pouches and tubing are safe and effective when double-pouched.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
MAY - 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 -
Mr. John Robert Scoville, Jr. Fellow, Regulatory Affairs Steris Corporation 5960 Heisley Road Mentor, Ohio 44060
Re: K090371
Trade/Device Name: Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization System
Regulation Number: 21 CFR 880.6850
Regulation Name: Sterilization Wrap
Regulatory Class: II
Product Code: KCT
Dated: March 31, 2009
Received: April 1, 2009
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 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.
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.
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Page 2- Mr. Scoville
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Susan Bunon
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K090371
Device Name: Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System
Indications For Use:
The Vis-U-All Low Temperature Tyvek Sterilization Pouches are sterilization containment pouches for use by the health care providers to enclose medical devices to be sterilized in the Amsco V-PRO 1 Low Temperature Sterilization System. The pouches maintain the sterility of the enclosed device during normal handling and storage until the pouch is opened and the medical device is removed for use.
| Type | Size | Type | Size |
|---|---|---|---|
| Pouch, Self | |||
| Seal and | |||
| Heat Seal, | |||
| Tyvek | 3" x 7" | Tubing, Heat | |
| Seal, Tyvek | 3" x 100' | ||
| 4" x 9" | 4" x 100' | ||
| 4" x 12" | 6" x 100' | ||
| 4'" x 22" | 9" x 100' | ||
| 6" x 10" | 14" x 100' | ||
| 8" x 12" | |||
| 10" x 15" | |||
| 12" x 18" |
Over-The-Counter Use _ Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule A Murphy MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: