A chemical indicator for monitoring all cycles within the STERIS® V-PRO™ 60 (Flexible, Lumen & The VH2O2 Indicators are intended to be used by health care providers with Non-lumen). sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.

Device Description

The SPSmedical VH2O2 External Indicators are single use process indicators, intended for use in verifying exposure to all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX, NX, STERIS® V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and Sterilucent™ PSD-85 sterilizers. For purposes of this submission testing has been performed to validate the SPSmedical VH2O2 External Indicators for use in the Steris® V-PRO® 60 sterilizer.

Indicators will identify if an item has seen vaporized hydrogen peroxide during the Steris® V-PRO® 60 sterilization processes by changing from a pink to a blue signal color. They provide a visual indication to help distinguish between processed and unprocessed items.

Physical Properties: The SPSmedical VH2O2 External Indicators consist of two (2) devices, an indicator label and an indicator card. These devices have minor physical differences. The label has an adhesive backing while the card does not. They use the same manufacturing process and are printed on the same substrate.

Technical Characteristics: The chemical indicator ink utilized on the SPSmedical VH2O2 External Indicators has been formulated to meet the performance requirements ANSVAAMI/ISO 11140-1 for Process Indicators.

Functional Characteristics: The SPSmedical VH2O2 External Indicators are designed to monitor sterilization cycles in low temperature vaporized hydrogen peroxide sterilizers. They are a reliable tool used for the monitoring of vaporized hydrogen peroxide sterilization processes and provide a visual indication that hydrogen peroxide (H2O2), an essential ingredient in the vaporized hydrogen peroxide sterilization process has been introduced into the sterilizer's chamber. Indicators will identify if an item has seen H2O2 during the sterilization process. Indicators change from an initial color of pink to a final signal color of blue.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SPSmedical VH2O2 External Indicators:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SPSmedical VH2O2 External Indicators are primarily focused on their color change performance and adherence to standards.

Acceptance Criteria	Reported Device Performance
Intended Use	Equivalent to predicate (Process Indicator)
Indications for Use	Chemical indicator for monitoring all cycles within the STERIS® V-PRO™ 60 (Flexible, Lumen & Non-lumen) to distinguish between processed and unprocessed units. Colors other than blue (e.g., yellow/green) indicate a process failure.
Endpoint Color	Signal Color of Blue (Equivalent to predicate)
Indicator Agent	H2O2 Indicator Ink (Equivalent to predicate)
Sterilization Method	Vaporized Hydrogen Peroxide (Equivalent to predicate)
Device Materials	Synthetic Substrate (Equivalent to predicate)
Performance - ISO 11140-1 (Complete Reaction Cycle)	Indicators turn to a complete reaction color of blue (Equivalent to predicate)
Performance - ISO 11140-1 (Incomplete Reaction Cycle)	Indicators do not turn blue and are markedly different than the color achieved under the complete reaction cycle testing (Equivalent to predicate)
Biocompatibility	Non-toxic (Equivalent to predicate), made with nontoxic inks and substrates, safe for human contact, and disposable in general waste.
Non-clinical Performance - Steris® V-PRO® 60 (Flexible, Lumen & Non-Lumen cycles)	Turns blue in a half cycle under worst-case conditions. Confirmed via simulated use testing using three lots of product at or beyond their real-time shelf-life, with end-of-shelf-life sterilant and a fully loaded chamber. All testing performed in triplicate in lumen and flexible cycles of the Steris® V-PRO® 60 sterilizer.
Shelf-life	Up to 2 years from the date of manufacture. Post-processing indicator stability verified to maintain color change results for a minimum of six months.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Three (3) lots of product were used for the simulated use testing. These lots were "at or beyond their real time shelf life expiration of twenty four (24) months."
Data Provenance: The simulated use testing was performed "at Steris® by Steris® technicians." This implies the data originated from the manufacturer of the sterilizer (STERIS®), which is a U.S.-based company. The data is prospective, generated specifically for this submission to validate the device's performance with the new sterilizer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts: The document states that the simulated use testing was performed "by Steris® technicians." It does not specify the number of individual technicians involved.
Qualifications of Experts: The qualifications are broadly stated as "Steris® technicians." No specific details are provided regarding their professional certifications, years of experience, or specialization.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "Steris® technicians" performed the testing and observed the color change. The acceptance was based on the indicators turning blue.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a chemical indicator, not an AI-powered diagnostic tool, so such a study would not be applicable. The performance is assessed by a direct pass/fail observation of color change.

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

This refers to a non-AI device. The "standalone performance" is the indicator's ability to change color correctly when exposed to H2O2. This was directly assessed in the simulated use testing by observing the color change.

7. The Type of Ground Truth Used

The ground truth for the test set was the actual exposure to the specified vaporized hydrogen peroxide sterilization process within the Steris® V-PRO™ 60 sterilizer, under "half cycle with end of shelf life sterilant with a fully loaded chamber" and observation of the expected color change (pink to blue).

8. The Sample Size for the Training Set

This device does not involve an AI algorithm, so there is no "training set." The performance is based on the inherent chemical properties of the indicator and its physical design.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this chemical indicator.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 9, 2015

Crosstex SPSmedical Division Mr. Michael Nolan Research and Development Coordinator 6789 West Henrietta Road Rush, NY 14543

Re: K143520

Trade/Device Name: SPSmedical VH2O2 External Indicators Regulation Number: 21 CFR 880.2800(b) Regulation Name: Physical/chemical sterilization process indicator Regulatory Class: II Product Code: JOJ Dated: May 8, 2015 Received: May 12, 2015

Dear Mr. Nolan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Mr. Nolan

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); 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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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) K143520

Device Name SPSmedical VH2O2 External Indicators

Indications for Use (Describe)

CATALOG NUMBER GPL-2000R 5093

PRODUCT NAME Indicator Label Indicator Card

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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SUBMITTER INFORMATION

SPSmedical Supply Corp.a division of Crosstex International		Contact:	Michael G. NolanResearch and Development Coordinator
6789 West Henrietta Road		Phone:	(800) 722-1529 x 120
Rush, NY 14543 U.S.A.		Fax:	(585) 359-0167
Date of Summary:	May 26, 2015

DEVICE NAME AND CLASSIFICATION

Device Trade Name:	SPSmedical VH2O2 External Indicators
Common Name:	Vaporized Hydrogen Peroxide Chemical Indicators
Classification Name:	Physical/chemical sterilization process indicator 21 CFR § 880.2800(b)
Review Panel:	General Hospital
Product Code:	JOJ
Device Class:	II

PREDICATE DEVICE:

SPSmedical VH2O2 Indicators K140566.

DEVICE DESCRIPTION:

INTENDED USE:

The SPSmedical VH3O2 External Indicators are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed items. Indicators change to a signal color of blue after exposure to vapor hydrogen peroxide.

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BIOCOMPATIBILITY

SPSmedical VH2O2 External Indicators are manufactured using nontoxic inks and substrates that will not alter the chemical composition of the products being sterilized and are safe for human contact. SPSmedical VH2O2 External Indicators can be disposed in general waste receptacles.

STORAGE CONDITIONS:

Store the SPSmedical VH2O2 External Indicators in a cool, dry place (15-30°C), and away from any alkaline chemicals, acids and sources of light.

NON-CLINICAL TESTING:

Since the SPSmedical VH2O2 External Indicators are a legally market device only the new Steris® V-PRO® 60 sterilization cycles were validated for use through simulated use testing. Three (3) lots of product were used which were all at or beyond their real time shelf life expiration of twenty four (24) months.

Simulated Use Testing: Consisted of verifying SPSmedical VH2O2 External Indicators turned blue in a half cycle with end of shelf life sterilant with a fully loaded chamber at Steris® by Steris® technicians. All testing was performed in triplicate in lumen and flexible cycles of the Steris® V-PRO® 60 sterilizer.

Shelf Life: When properly stored the SPSmedical VH2O2 External Indicators maintain a shelf life of up to two (2) years from the date of manufacture. The expiration date is located on every pack. Post processing indicator stability has been verified to maintain color change results for a minimum of six (6) months when properly stored.

All other concerns with the SPSmedical VH2O2 External Indicators have been previously validated. There have been no changes to the product since the predicate filing under K140566.

COMPONENTS:

Indicators are composed of commercially existing materials of synthetic paper or label stock (e.g. Tyvek ", polypropylene, polystyrene etc ... ). The indicator ink is a nontoxic sterilization indicator ink that changes from an initial color of pink to a blue signal color when exposed to the stated vaporized hydrogen peroxide sterilization process described within this submission.

SUBSTANTIAL EQUIVALENCE DISCUSSION:

The predicate and subject devices are the exact same device. The predicate and subject devices are substantially equivalent in terms of their intended use, functional and technical characteristics within the vaporized hydrogen peroxide sterilization processes described within this submission.

PREDICATE I.D.

Trade Name:	SPSmedical VH2O2 Indicators
Model No.:	GPS-250R	Indicator Strip
	GPS-250Y	Indicator Strip
	GPL-2000R	Indicator Label
	GPL-2000Y	Indicator Label
	HT-048	Indicator Tape
	HT-036	Indicator Tape
	5093	Indicator Card

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Submitter/holder:	SPSmedical Supply Corp.a division of Crosstex International6789 West Henrietta RoadRush, NY 14543 U.S.A.Phone: (585) 359-0130Fax: (585) 359-0167
510(k) No:	K140566

COMPARISON OF INDICATIONS FOR USE (IFU):

Predicate IFU-A chemical indicator for monitoring all cycles within the STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO™ 1, V-PRO™ 1 Plus (Lumen & Non-lumen), V-PRO® maX (Flexible, Lumen & Non-lumen) and Sterilucent" PSD-85 (Lumen & Non-lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.

Subject IFU-A chemical indicator for monitoring all cycles within the STERIS® V-PRO® 60 (Flexible, Lumen & Non-lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.

CATALOG NUMBER	PRODUCT NAME
GPL-2000R	Indicator Label
5093	Indicator Card

Discussion—The Predicate Device and the Subject Device have the same IFU with the exception of cycles other than the cycles which are the principle of this 510(k) remain on the Subject IFU.

DESIGN DIFFERENCES PREDICATE VS. SUBJECT DEVICE:

The predicate and subject devices are the exact same device. The subject device seeks the Indication for Use within the Steris® V-PRO® 60.

SUBSTANTIAL EQUIVALENCE CONCLUSIONS

The subject device has the same intended use, technical characteristics and functional characteristics as the predicate device. Both provide a visual indication that the indicator has been exposed to the vaporized hydrogen peroxide sterilization process. Both are made of the exact same materials and exact same manufacturing processes. The non-clinical testing has been performed by and directed by Steris® Corporation and found to meet predetermined acceptance criteria.

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SUBSTANTIAL EQUIVALENCE COMPARISON TABLE

ELEMENT	SUBJECT DEVICE(K143520)	PREDICATE(K140566)
Intended Use	Equivalent	Process Indicator
Indications for Use	A chemicalindicator formonitoring all cycles within theSTERIS® V-PRO™ 60 (Flexible,Lumen & Non-lumen).TheVH2O2 Indicators are intended tobe used by health care providerswith sterilizationwraps,containers, cassettes, or pouches todistinguish between processed andunprocessed units. Colors otherthan blue such as yellow/greenshould be treated as a processfailure.Catalog Number Product NameGPL-2000R Indicator Label5093 Indicator Card	A chemical indicator formonitoring all cycles within theSTERRAD® 100S (Standard &Long), 200, 100NX (Standard,Flex & Express), NX (Standard& Advanced), STERIS® V-PRO™ 1, V-PRO™ 1 Plus(Lumen & Non-lumen), V-PRO® maX (Flexible, Lumen &Non-lumen) and SterilucentPSD-85 (Lumen & Non-lumen).The VH2O2 Indicators areintended to be used by healthcare providers with sterilizationwraps, containers, cassettes, orpouches to distinguish betweenprocessed and unprocessedunits. Colors other than bluesuch as yellow/green should betreated as a process failure.
Device Design	Card, Label	Strip, Label, Tape, Card etc.
Endpoint Color	Equivalent	Signal Color of Blue
Indicator Agent	Equivalent	H2O2 Indicator Ink
Sterilization Method	Equivalent	Vaporized Hydrogen Peroxide
Device Materials	Equivalent	Synthetic Substrate
Performance-ISO 11140-1Complete reaction cycle	Equivalent	Indicators turn to a completereaction color of blue
Performance-ISO 11140-1Incomplete reaction cycle	Equivalent	Indicators do not turn blue andare markedly different than thecolor achieved under thecomplete reaction cycle testing.
Biocompatibility	Equivalent	Non-toxic
Non-clinical Performance-Steris® V-PRO® 60(Flexible, Lumen & Non-Lumen cycles)	Equivalent	Turns blue in a half cycle underworst case conditions.
Shelf-life	Equivalent	Up to 2 years

CONCLUSION:

Since the predicate device and the subject device are the exact same device, they have the same intended use, the same functional and technical characteristics; they are comprised of the same materials and performance. Non-clinical testing performed at Steris® by Steris® technicians in the Steris® V-PRO® 60 documents that based on the results from the nonclinical testing performed there are no concerns with the safety or effectiveness of the SPSmedical VH2O2 External Indicators. Based on these facts and the nonclinical tests performed the subject device is as safe, as effective, and performs as well as the predicate device [SPSmedical Hydrogen Peroxide Chemical Indicators (K140566)].

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).