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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vis-U-All Self Seal Pouch:

This document is a 510(k) premarket notification for a sterilization pouch, which is a low-risk device. As such, it does not involve AI or complex software, and therefore, many of the requested categories (like sample size for test set, number of experts, MRMC studies, training set details) are not applicable or not provided in this type of regulatory submission. The assessment focuses on the physical and functional performance of the pouch itself in the context of sterilization.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Material Composition	Not explicitly stated as a numerical criterion, but implies conformity to predicate device materials. The plastic film thickness has changed to 2.0 mil.	Materials of composition have not changed from the predicate (K771032), except for the plastic film thickness which is now 2.0 mil.
Sterilization Efficacy	Pouch must be "qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilization System"	Pouch demonstrated qualification for use in the AMSCO® V-PRO 1 Low Temperature Sterilization System.
Sterility Maintenance	Pouch must be able to "maintain sterility of the enclosed device until used."	Performance testing demonstrated the pouch is "as safe, as effective, and performs the same as the predicate device" in maintaining sterility.
Overall Performance	Must be "as safe, as effective, and performs the same as the predicate device"	Performance testing demonstrated the proposed pouch meets this criterion.

Study Details

Given the nature of the device (sterilization pouch) and the type of regulatory submission (510(k) premarket notification), this is not a study involving AI or human interpretation of medical images. Instead, it relies on performance testing of the physical product.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated in the provided text. This type of information would typically be detailed in the full test reports referenced in the submission, but not in this summary.
- Data Provenance: Not explicitly stated. The company, STERIS, Corporation, is based in Mentor, Ohio, USA, which implies the testing likely occurred in the USA or through US-based labs, but this is an inference. The data would be prospective, as it involves testing the newly designed pouch.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable in the context of this device. Ground truth is established through physical and microbiological testing (e.g., sterility testing, barrier integrity testing) conforming to established standards for sterilization pouches, not through expert human interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, typically in medical imaging or diagnostic contexts. Here, device performance is objectively measured.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is not an AI-powered diagnostic tool, and therefore, an MRMC study is irrelevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on performance standards and objective measurements demonstrating:
  - Sterilization efficacy: The ability of the pouch to allow sterilant penetration and kill microorganisms when processed in the AMSCO® V-PRO 1 Low Temperature Sterilization System. This is often verified using biological indicators (BIs) or chemical indicators (CIs) in challenge tests (though the device itself has no CIs).
  - Sterility maintenance: The barrier integrity of the pouch in preventing microbial recontamination post-sterilization, often assessed through microbial challenge tests and physical performance tests (e.g., seal strength, burst strength, material integrity after sterilization cycles).
  - Material compatibility: Ensuring the materials withstand the sterilization process without degradation that would compromise integrity.
The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

Summary

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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

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.

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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.

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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:

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

Page 1 of 1

Confidential

Regulation Number and Section

§ 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).