(77 days)
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.
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 provided text describes a medical device submission (510(k)) for a sterilization pouch and focuses on its substantial equivalence to predicate devices, rather than an AI-powered diagnostic device. Therefore, the typical elements of acceptance criteria and studies (like sample size for test sets, expert qualifications, and MRMC studies) for an AI device are not applicable here.
However, I can extract the relevant information from the document related to the device's performance and the study performed, framed as closely as possible to your request.
Here's an interpretation based on the provided text:
Acceptance Criteria and Study for Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System
Since this is a sterilization pouch and not an AI device, the "acceptance criteria" revolve around its ability to perform its function (maintaining sterility, allowing sterilization) and demonstrate substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| Functionality/Intended Use | Suitable for enclosing and sealing medical devices. | Demonstrated suitable for use by healthcare providers to enclose and seal other medical devices. (Page 2) |
| Designed to maintain sterility of properly processed medical devices. | Designed to maintain sterility during normal handling and storage until opened. (Page 2) | |
| Effective for sterilization by Amsco V-PRO 1 Low Temperature Sterilization System. | Qualified by STERIS Corporation as suitable for use in the Amsco V-PRO 1 Low Temperature Sterilization System. (Page 2) | |
| Safety and effectiveness when double-pouched. | Testing demonstrated that the proposed pouches and tubing are safe and effective when double-pouched. (Page 3) | |
| Substantial Equivalence | Identical to cleared predicate devices. | Device models are identical to the cleared predicate devices K070765 and K071087. (Page 3) |
2. Sample Size and Data Provenance (for the "Study" as described)
- Test Set Description: The document refers to "Testing" but does not specify a separate "test set" in the context of a dataset for an algorithm. Rather, it refers to testing of the physical device.
- Sample Size: Not explicitly stated as a number of Pouches/Tubing tested. The document says "Testing of the Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System demonstrated...".
- Data Provenance: Not applicable in the context of country of origin for a data set. The testing would have been conducted by STERIS Corporation, likely at their facilities in the USA.
- Retrospective/Prospective: Not applicable. This refers to physical product testing.
3. Number of Experts and Qualifications (for establishing "ground truth")
- Ground Truth Establishment: The "ground truth" here pertains to the physical performance of the sterilization pouch. The document does not specify a number of experts or their qualifications for establishing this "ground truth" in terms of clinical interpretation. The "ground truth" is based on established engineering and sterilization efficacy standards that STERIS would have followed during their testing.
4. Adjudication Method
- Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies in expert opinions on data, which isn't the type of "study" described for this physical device.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC study was not done. This type of study is for evaluating the performance of diagnostic devices (often AI-assisted) with human readers, which is not relevant for a sterilization pouch.
6. Standalone Performance Study (Algorithm Only)
- Standalone Study: No, this is not an AI algorithm. Therefore, a standalone performance study in that context is not applicable. The closest equivalent would be the performance testing of the device itself (the pouch) to ensure it meets specifications.
7. Type of Ground Truth Used
- Ground Truth Type: Not explicitly stated, but for this type of device, the "ground truth" would be established through:
- Engineering specifications and standards: Relating to material properties, seal integrity, and permeability for sterilization agents.
- Sterilization efficacy testing: Demonstrating that the pouch allows the sterilization process to occur effectively and maintains sterility afterwards. This would likely involve microbiological challenge tests.
- Comparison to predicate devices: Verifying that the new device performs identically or equivalently to legally marketed predicate devices.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Training Set Ground Truth: Not applicable, as there is no training set for an AI model.
In summary, the provided document describes a 510(k) submission for a physical medical device (a sterilization pouch), not an AI-powered diagnostic tool. Therefore, many of the questions regarding AI-specific study methodologies are not applicable. The "study" here refers to the testing conducted by the manufacturer to demonstrate the device's safety, effectiveness, and substantial equivalence to predicate devices for its intended use, particularly for "double-pouching."
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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
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1. Device Name
| Trade Name: | Vis-U-All Low Temperature Tyvek SterilizationPouch for V-PRO 1 Sterilization System |
|---|---|
| Common/usual Name: | Sterilization pouch |
| Classification Name: | Sterilization wrap (21 CFR 880.6850 Product CodeKCT). |
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.
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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.
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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
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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, SelfSeal andHeat Seal,Tyvek | 3" x 7" | Tubing, HeatSeal, 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:
§ 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).