The V-PROTM Sterilization Tray is used to contain reusable medical devices for sterilization in the Amsco® V-PRO™ 1 Low Temperature Sterilizer and to maintain sterility of properly processed medical devices during normal handling and storage until they are removed for use. The trays must be wrapped with a legally marketed, FDA cleared sterilization wrap for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer prior to placing in the Sterilizer.

The V-PRO "M Sterilization Tray can be used with V-PRO "10 Instrument Organizers to allow stabilization of various cylindrical medical devices during processing. The medical device organizers attach to the V-PROTM Sterilization Tray bottom and stabilize cylindrical medical instruments.

Device Description

The V-PRO™ Sterilization Tray is available in various sizes, 10''x 10" x 21" to accommodate the loads to be processed. The tray contains two handles that remain internalized during wrapping/processing and a lid with two clamping mechanisms for securing to the tray. There are numerous 0.01" diameter holes in the lid and tray for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally marketed, FDA cleared sterilization wrap for use in the Amsco® V-PROTM 1 Low Temperature Sterilizer to maintain sterility of the devices.

The tray can contain medical device organizers to allow stabilization of various cylindrical medical devices during processing. Each organizer consists of a device holding element and lock base that attach to the V-PRO™ Sterilization Tray. The sizes for the device holding element range from a 5 mm diameter and 6 mm stem height to a 19 mm diameter and 25 mm stem height. For attachment to the tray, each device holding element is positioned over one of the numerous holes at the inner tray surface and pushed into a lock base located at the respective tray hole on the outer tray surface. A minimum of two, aligned organizers should be used for each device requiring stabilization. Once the device is placed into the organizers, it is secured by each organizer's twist lock.

AI/ML Overview

This document is a 510(k) summary for the V-PRO™ Sterilization Tray and Instrument Organizers, which is a medical device intended to hold, transport, and store sterilized medical devices. It is a premarket notification to the FDA, and it focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a detailed study with acceptance criteria and device performance in the way one might expect for a novel therapeutic or diagnostic device.

Therefore, the requested information, specifically regarding acceptance criteria and a study proving the device meets those criteria in detail, including sample sizes, expert qualifications, and specific adjudication methods, is not explicitly provided in this 510(k) summary.

However, I can extract the information that is implicitly or explicitly stated about the device's performance and the general nature of its qualification.

Summary of Device Qualification (based on the provided text):

The V-PRO™ Sterilization Tray (and instrument organizers) underwent qualification testing to support its suitability for use in the Amsco® V-PRO™ 1 Low Temperature Sterilization System. The goal was to demonstrate that it is safe and effective and has the same intended use and characteristics as its predicate devices.

The performance specifications mentioned are:

Demonstrate sterilization of devices when wrapped.
Material compatibility with various healthcare processing chemistries and Vaprox HC Sterilant.
Cleaning efficacy.
Inability to emit harmful substances after processing.

Missing Information:

Specific numerical acceptance criteria for "sterilization of devices," "cleaning efficacy," or "inability to emit harmful substances."
Detailed study protocols, blinding, sample sizes for specific tests, data provenance for these tests, or expert involvement in establishing ground truth.
No Multi-Reader Multi-Case (MRMC) or standalone algorithm performance studies are applicable as this is a physical medical device, not an AI/software device.

Here's the best I can construct based on the provided text, acknowledging the significant gaps in the requested details for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Performance Specifications / Requirements)	Reported Device Performance
Sterilization Efficacy: Demonstrate sterilization of devices when wrapped	Device qualified by STERIS Corporation for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer has been shown to be safe and effective.
Material Compatibility: Compatibility with various healthcare processing chemistries and Vaprox HC Sterilant.	Device qualified by STERIS Corporation for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer has been shown to be safe and effective.
Cleaning Efficacy: Efficacy in cleaning.	Device qualified by STERIS Corporation for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer has been shown to be safe and effective.
Substance Emission: Inability to emit harmful substances after processing.	Device qualified by STERIS Corporation for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer has been shown to be safe and effective.
Substantial Equivalence: Same intended use and characteristics as predicate devices.	The FDA completed its review and determined the device is substantially equivalent to legally marketed predicate devices.

Study Information (Based on interpretation of a 510(k) submission for a physical device, which typically relies on internal testing and comparison to predicates):

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document mentions "qualification testing data," but does not detail the number of units or cycles tested.
Data Provenance: The testing was "performed by STERIS Corporation." This indicates proprietary in-house testing. Country of origin of the data is implicitly USA, where STERIS Corporation is located. The nature of testing would be prospective, as it's qualification testing for a new product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified in this type of submission. Ground truth for sterilization efficacy, material compatibility, and cleaning efficacy would typically be established through validated internal laboratory protocols, rather than expert human review of a "test set" in the diagnostic sense.

4. Adjudication method for the test set

Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 typically refer to expert review for diagnostic AI studies. For physical device qualification, results are determined by objective measurements against established standards.

5. 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 is a physical sterilization tray and instrument organizer, not an AI or diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance specifications would be based on objective laboratory measurements and validated test methods according to relevant industry standards (e.g., for sterilization, material compatibility, cleaning). For example, demonstrating "sterilization of devices" would involve sterility testing (e.g., absence of microbial growth) after sterilization cycles.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model. There is no "training set."

9. How the ground truth for the training set was established

Not applicable. As above, no training set. The "ground truth" for demonstrating the device works as intended would be through established scientific and engineering principles applied in controlled laboratory settings for device performance testing.

Summary

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2007 0CT

K070769

510(k) Summary For V-PRO™ Sterilization Tray and Instrument Organizers

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459

Contact:

Patrick J. McCullagh, Ph.D. Vice President Global Quality Systems Engineering & Regulatory Affairs Telephone:(440) 392-7601 Fax No: (440) 392-8963

March 20, 2007 Submission Date:

STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600

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1. Device Name

Trade Name:	V-PROTM Sterilization Tray and InstrumentOrganizers.
Common/usual Name:	Sterilization Trays, Cassettes and other Accessories.
Classification Name:	General Hospital and Personal Use Devices(21 CFR 880.6850).
Product Code:	KCT

2. Predicate Devices

The V-PRO 114 Sterilization Tray is substantially equivalent to legally marketed existing devices as indicated in Table 5-1

DeviceName	Conmed LinvatecInstrumentSterilization Tray	OlympusSterilization Trays	AptimaxInstrumentTray
K#	K052992	K033222	K013003
SE Date	10/16/06	08/02/04	08/28/02

Table 5-1. V-PROTM 136 Tray Predicate Devices information

STERIS Corporation performed qualification testing to support the suitability of the V-PRO™ Sterilization Tray in the Amsco® V-PROM 1 Low Temperature Sterilization System (K062297). The qualification testing data is included in this submission.

The V-PRO 100 Sterilization Tray as well as the predicate devices are intended to hold, transport and store sterilized medical devices. They are supplied in a variety of sizes and configurations to accommodate various medical instruments. The design and material composition of the V-PROTT Sterilization Tray and the indicated predicate devices allow diffusion of the sterilant around the contents when used with approved sterilization wrap.

Description of Device 3.

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for use in the Amsco® V-PROTM 1 Low Temperature Sterilizer to maintain sterility of the devices.

4. Intended Use

The V-PRO110 Sterilization Tray is used to contain reusable medical devices for sterilization in the Amsco® V-PRO™ 1 Low Temperature Sterilizer and to maintain sterility of properly processed medical devices during normal handling and storage until they are removed for use. The trays must be wrapped with a legally marketed, FDA cleared sterilization wrap for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer prior to placing in the Sterilizer.

Tables 5-2 and 5-3 list the trays and instrument organizers included in this submission.

Tray Type(inches)	Recommended MaxLoad (lbs)*	Recommended MaximumInstrument Organizers
21 x 10	9.13	20
17 x 10	6.47	20
14 x 10	5.16	16
10 x 10	4.48	10

Table 5-2. V-PRO™ Sterilization Tray available sizes for use in the Amsco® V-PROTM 1 Low Temperature Sterilizer.

Includes weight of the tray

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Diameter (mm)	Stem Height (mm)
5	6
	13
	25
9	6
	13
	25
11	6
	13
	25
14	6
	13
	25
17	6
	13
	25
19	6
	13
	25

Table 5-3. V-PROTM Instrument Organizers for use with the
		V-PRO™ Sterilization Tray

ട. Description of Safety and Substantial Equivalence

The V-PROTN Sterilization Tray qualified by STERIS Corporation for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer as a medical device has been shown to be safe and effective.

This device qualified by STERIS Corporation for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer has the same intended use and characteristics, including the availability of different sizes as the predicate devices. Refer to Section 12 for detailed information regarding Substantial Equivalence.

Performance Specifications and Design Requirements 6.

The V-PRO 110 Sterilization Tray must demonstrate sterilization of devices when wrapped, material compatibility with the various healthcare processing chemistries and Vaprox HC Sterilant, cleaning efficacy, and the inability to emit harmful substances after processing.

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Image /page/4/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 & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its body. The eagle's wings are suggested by curved lines, and the profiles are stacked vertically, creating a sense of depth and unity.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jack Scoville Fellow Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060-1834

OCT 5 2007

Re: K070769

Trade/Device Name: V-PRO™ Sterilization Tray and Instrument Organizers Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: September 7, 2007 Received: September 10, 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.

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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 complics 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 (OS) 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.

Clare

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): K070769

Device Name: V-PROTM Sterilization Tray and Instrument Organizers.

Indications For Use:

The V-PROTM Sterilization Tray is used to contain devices for sterilization in the Amsco® V-PROTM 1 Low Temperature Sterilizer and to maintain sterility of properly processed medical devices during normal handling and storage until they are removed for use. The trays must be wrapped with a legally marketed, FDA cleared sterilization wrap for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer prior to placing in the Sterilizer.

The V-PROTM Sterilization Tray can be used with V-PRO™ Instrument Organizers to allow stabilization of various cylindrical medical devices during processing. The Instrument Organizers attach to the V-PROTM Sterilization Tray bottom and stabilize cylindrical medical instruments.

Tables 1 and 2 list the trays and instrument organizers included in this submission.

Table 1. V-PRO™ Sterilization Tray available sizes for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer.

Tray Type(inches)	Recommended MaxLoad (lbs)*	Recommended MaximumInstrument Organizers
21 x 10	9.13	20
17 x 10	6.47	20
14 x 10	5.16	16
10 x 10	4.48	10

Includes weight of the tray

I able 2. V-PRO™ Instrument Organizers for use with the V-PRO™ Sterilization Tray
-----------------------------------------------------------------------------------	--	--	--	--	--	--

Diameter (mm)	Stem Height (mm)
5	6
5	13
5	25
9	6
9	13
9	25
11	6
11	13
11	25

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION V-PRO™ Sterilization Tray and Instrument Organizers.

Diameter (mm)	Stem Height (mm)
14	6
	13
	25
17	6
	13
	25
19	6
	13
	25

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)

Clurs gCJ.fr 88 m.

(Tivision Sign-Off) Livision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: 070769

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).