The SPSmedical H2O2 Chemical Indicators are indicated for use as process indicators for all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro 1, V-Pro 1 Plus and V-Pro maX sterilizers. They 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.

Device Description

SPSmedical Vaporized Hydrogen Peroxide (HzOn) Chemical Indicators are process indicators which are cleared for use in verifying exposure to vapor hydrogen peroxide in the STERRAD® 100S, 200, 100NX, NX, STERIS® V-Pro lumen and non lumen sterilization processes. Testing has been performed which validates the SPSmedical Vaporized Hydrogen Peroxide (H2O2) Chemical Indicators for use in the STERIS® V-Pro flexible sterilization cycle and the STERIS® V-Pro maX sterilizer.

Indicators will identify if an item has seen H2O2 during the STERIS® V-Pro flexible sterilization process by changing to a Blue signal color. They provide a visual indication to help distinguish between processed and unprocessed items.

AI/ML Overview

The provided text describes a 510(k) summary for the SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators. The information focuses on the device's similarity to a predicate device and its intended use, rather than a detailed study with specific acceptance criteria and performance metrics typically seen in AI/software device submissions. Therefore, a direct response to some of the requested points is not possible given the nature of the document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as would be expected for a sophisticated AI/software device. Instead, it states that:

"All lots of SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators gave acceptable results for all test performed."

This implies that the indicators successfully changed color as expected when exposed to vaporized hydrogen peroxide and did not change color when not exposed, or when exposed to conditions that should not trigger a change. The acceptance is qualitative (color change) rather than quantitative (e.g., sensitivity, specificity, AUC).

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

The document states:

"Multiple lots of indicators with various levels of shelf life were included in testing."

However, it does not specify an exact sample size for the test set or the number of indicators from each lot.
The data provenance is not explicitly mentioned as "country of origin," but the testing was performed to AAMI/ANSVISO 11140:2005 requirements and in simulated use in the STERIS® V-Pro maX sterilizer. It can be inferred that the testing occurred in a controlled lab environment associated with the device manufacturer, SPSmedical Supply Corp. in Rush, NY, U.S.A. The study is prospective in the sense that controlled experiments were conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts

This information is not applicable to this type of device. The "ground truth" for a chemical indicator is a visible color change, which is a direct physical reaction, not an interpretation requiring expert human judgment (like a radiologist reading an image).

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. There is no ambiguous result that would require adjudication by multiple experts. The color change is a clear binary outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not applicable. This is a physical chemical indicator, not an AI or software device that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this product.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable. The device is a physical chemical indicator, not an algorithm. Its performance is inherently "standalone" in that it physically reacts to the presence of vaporized hydrogen peroxide; human observation is required to interpret the color change, but there is no "algorithm" or "computer" involved in its core function.

7. The Type of Ground Truth Used

The ground truth used is the direct physical exposure to vaporized hydrogen peroxide under controlled conditions and the expected visual color change of the indicator. For example, indicators exposed to a validated sterilization cycle should change color to "Blue," while unexposed indicators or those exposed to inadequate cycles should not.

8. The Sample Size for the Training Set

This information is not applicable. As a physical chemical indicator, there is no "training set" in the context of machine learning or AI. The indicators are manufactured to a specific chemical formulation, and their performance is verified through testing, not trained through data.

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

This information is not applicable for the same reason as point 8.

Summary

{0}------------------------------------------------

510(k) Summary of Safety and Effectiveness

APR 1 5 2011 K110152

510k No.:

Submitter:

. SPSmedical Supply Corp. 6789 West Henrietta Road Rush, NY 14543 U.S.A. Phone: (585)-359-0130 Fax: (585)-359-0167
Establishment FDA Registration No.: 1319130 .
January 14th, 2011 Date Summary was Prepared .
Gary J. Socola . Printed name of person submitting for 510(k)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------>OCD Sare ડ Signature of person submitting for 510(k)
Vice President, Scientific Affairs ● Title of person submitting for 510(k)

Device Name and Classification

Trade Name:	SPSmedical Vaporized Hydrogen PeroxideChemical Indicators
Classification Name:	Sterilization Process Chemical Indicator
Common Name:	Vaporized Hydrogen Peroxide Chemical Indicators
Device Classification:	General Hospital - Class II, Regulation Number 880.2800
Product Code:	80JOJ
Predicate Device:	SPSmedical Vaporized Hydrogen Peroxide ChemicalIndicators (K030680 and K090650)

{1}------------------------------------------------

Device Description:

Intended Use:

The SPSmedical Vaporized Hydrogen Peroxide (H2O2) Chemical Indicators are process indicators used to verify exposure to the STERIS® V-Pro maX flexible sterilization process. They 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.

Statement of Similarity to the Legally Marketed Predicate Device:

Have the same intended use ●
Have the same device design ●
Incorporate the same technical characteristics ●
Incorporate the same materials .
. Have the same endpoint color change
Have the same shelf life �
Have the same storage conditions .
Packaged using the same materials and processes .

Non-Clinical Testing:

Verification and validation tests were performed as a result of a Failure Mode and Effects Analysis (FMEA) assessment.

Various testing, including testing to AAMI/ANSVISO 11140:2005 requirements for indicators being run in vaporized hydrogen peroxide sterilization processes was performed. Testing also included simulated use in the STERIS® V-Pro maX vaporized hydrogen peroxide flexible sterilization cycle. Multiple lots of indicators with various levels of shelf life were included in testing.

All lots of SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators gave acceptable results for all test performed.

Conclusion:

For all the foregoing reasons, SPSmedical believes that the SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators are safe and effective when used for routine monitoring of STERIS® V-Pro maX sterilizer running a vaporized hydrogen peroxide flexible sterilization cycle and can be safely marketed in the United States.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a staff entwined by two snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WQ66-G609 Silver Spring, MD 20993-0002

Mr. Gary J. Socola Vice President, Scientific Affairs SPSmedical Supply, Corporation 6789 West Henrietta Road Rush, New York 14543

APR 1 5 2011

Re: K110152

Trade/Device Name: SPSmedical H2O2 Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: January 14, 2011 Received: January 19, 2011

Dear Mr. Socola:

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.

{3}------------------------------------------------

Page 2- Mr. Socola

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucmm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 CDRF1'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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS for USE STATEMENT

SPSmedical Supply Corp. Applicant:

510(k) Number (if known):

Device Name: SPSmedical H2O2 Chemical Indicator

Indications For Use:

Catalog Number	Product Name
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

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 OF NEEDED)

urrence of CDRH, Office of Device Evaluation (ODE)

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

Page __ of ___________________________________________________________________________________________________________________________________________________________________

510(k) Number: K110152

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).