For use as an internal or external chemical indicator to monitor exposure to steam sterilization conditions for: 121°C (250°F) @ 30 minutes in gravity steam sterilizer cycles or @ 134℃ (273ºF) for 4 minutes in gravity or vacuum assisted steam sterilizer cycles.

Device Description

The INDISTRIP Green Process Indicator for sterilization consists of a metal free indicator ink printed onto white vellum. The indicator changes color from yellow to black when exposed to steam sterilization conditions. Unprocessed indiryclife to stable for atleast 6 months when stored at 30℃ or less. The postprocessed indicator color is stable for at least 6 months after exposurer to steam sterilization conditions for: 121°C (250°F) @ 30 minutes in gravity steam sterilizer cycles or @ 134°C (273°F) for 4 minutes in gravity or vacuum assisted steam sterilize cycles of. The indicator does not respond to dry heat or ethylene oxide.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Indistrip Green device based on the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Indistrip Green (Based on AAMI ANSI ISO 11140-1:2005 Class 1 Process Indicators)

Test Environment	Test Time	Test Temperature	Expected vs. Observed Performance	Acceptance Criterion	Reported Performance (Indistrip Green)
Saturated Steam	3.0 min ± 5 s	121 °C (+3/0 °C)	No change or markedly different	No change or a change that is markedly different from the visible color change as specified by the manufacturer	Pass
Saturated Steam	10.0 min ± 5 s	121 °C (+3/0 °C)	Visible color change	Visible color change as specified by the manufacturer	Pass
Saturated Steam	0.5 min ± 5 s	134 °C (+3/0 °C)	No change or markedly different	No change or a change that is markedly different from the visible color change as specified by the manufacturer	Pass
Saturated Steam	2.0 min ± 5 s	134 °C (+3/0 °C)	Visible color change	Visible color change as specified by the manufacturer	Pass
Dry Heat	30 min ± 1 s	140 °C (+2/0 °C)	No change or markedly different	No change or a change that is markedly different from the visible color change as specified by the manufacturer	Pass

Note: The device's specified visible color change is from yellow to black.

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

The provided document describes physical/chemical testing of the indicator, not a clinical study involving human patients or data in the traditional sense. Therefore, terms like "test set" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable in the same way they would be for a diagnostic imaging device.

Test Set Description: The testing involved subjecting the Indistrip Green indicators to specific controlled conditions (temperature, time, environment) as outlined in the AAMI ANSI ISO 11140-1:2005 standard for Class 1 process indicators.
Sample Size: The document does not explicitly state the number of individual Indistrip Green indicators tested for each condition. It reports "Pass" for each test, implying that a sufficient number was tested to demonstrate consistency and compliance.
Data Provenance: The data is physical/chemical performance data generated under controlled laboratory conditions, likely at the manufacturer's facility or a certified testing lab. No country of origin for patient data is relevant here. The study is prospective in the sense that the tests were conducted specifically to evaluate the performance of this device.

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

This metric is not applicable to the evaluation of a chemical process indicator. Ground truth in this context is established by physical/chemical properties and adherence to recognized industry standards (AAMI ANSI ISO 11140-1:2005), not by expert consensus on interpretations of images or patient outcomes. The expected color change (yellow to black) upon sufficient exposure to sterilization conditions is a deterministic outcome.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the evaluation of a chemical indicator's color change under controlled conditions does not involve expert adjudication methods like 2+1 or 3+1. The observable color change (or lack thereof) against a predefined specification is the determinant of performance.

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

No. An MRMC comparative effectiveness study is designed for evaluating the impact of a device (e.g., AI in medical imaging) on human reader performance, typically in diagnostic tasks. This is not relevant for a chemical process indicator.

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

The device itself is a standalone chemical indicator; it functions without human-in-the-loop interaction for its primary purpose of changing color. The "performance data" presented is a standalone evaluation of the device's ability to undergo the specified color change under various conditions. There's no "algorithm" in the sense of software processing or interpretation; the indicator's chemical reaction is its "performance."

7. The Type of Ground Truth Used

The ground truth used is based on pre-defined physical/chemical performance specifications and industry standards. Specifically, the device claims to meet the requirements defined in AAMI ANSI ISO 11140-1:2005 for Class 1 Process Indicators. The "ground truth" for each test condition is whether the indicator exhibited the expected color change (or lack thereof) as defined by these standards when exposed to particular temperature and time parameters in a saturated steam or dry heat environment.

8. The Sample Size for the Training Set

Not applicable. Chemical process indicators do not typically involve "training sets" in the context of machine learning or AI. The device's performance is driven by its inherent chemical composition, which is designed and manufactured to react in a specific way.

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

Not applicable, as there is no training set for this device. The chemical formulation and manufacturing process are designed to meet the specified performance characteristics directly.

Summary

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510(k) Summary Statement (as required by 807.92 (c))

Date of Submission: Submitter:

January 14, 2011 Robert Gavrick President Indilab, Inc. 10367 Franklin Avenue Franklin Park, IL 60131 Phone: (847) 928-1050 Fax: (847) 928-1052 MAY - 6 2011

Establishment Registration NO: 1450962

Official Contact:

Mark Espenscheid Business Unit Director / Quality Indilab, Inc. 10367 Franklin Avenue Franklin Park, IL 60131 Phone: (847) 928-1050 Fax: (847) 928-1052

Trade Name:

Indistrip Green

Common Name:

Process Indicator for Steam Sterilization

Device Classification:

Device indicator, physical/chemical sterilization process

Regulation Description Sterilization process indicator.

Regulation Medical Specialty General Hospital

Review Panel General Hospital

Product Code JOJ

Submission Type 510(k)

Regulation Number 880.2800

Device Class 2

Total Product Life Cycle (TPLC) TPLC Product Code Report GMP Exempt? No

Predicate Device: Indistrip 400S; 510(k) No. K875193

Section 5 - 510(k) Summary Statement Page 2 of 5 Revision Date 04/28/2011

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Indications for Use:

Consensus Standards: Utilized as part of our Statement of Conformity

Recognition Number: 14-195 Product Area: Sterility

Title of Standard: Sterilization of health care products - Chemical indicators - Part 1: General requirements, 2ed (Revision of ANSI/AAMI ST60:1996)

Reference Number: 11140-1:2005 Publication Date: 09/08/2009

Standards Development Organization: AAMI ANSI ISO

Device Description:

The indicator does not respond to dry heat or ethylene oxide. The process requirements, in comparison to the predicate device are presented in Table 5-11

Section 5 – 510(k) Summary Statement Page 3 of 5 Revision Date 04/28/2011

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Comparison with Predicate Device (Table 5-TI):

ItemName	Predicate Device	Subject Device
Indistrip (K875193)	Indistrip Green
Intended Use	For use as an internal orexternal chemical indicatorto monitor exposure tosteam sterilizationconditions for 121-141°C(250 - 285°F) gravity andvacuum assisted steamsterilizer cycles.	For use as an internal orexternal chemical indicatorto monitor exposure tosteam sterilizationconditions for: 121°C(250°F) @ 30 minutes ingravity steam sterilizercycles or @ 134°C (273°F)for 4 minutes in gravity orvacuum assisted steamsterilizer cycles.
Material	Lead Based Ink Printedonto White Vellum	Organic Based Ink, MetalFree, Printed onto WhiteVellum
Color Change	Off-White/tan to Black	Yellow to Black
Sterilization Method	Steam	Steam
Color Change Timing	8 minutes 250°F3 minutes 273°F	8 minutes 250°F3 minutes 273°F
Size	9/16" x 4"	9/16" x 4"
Precautions	Do not use the Indistrip tomonitor dry heat, ethyleneoxide, or other lowtemperature sterilizationprocesses	Do not use the IndistripGreen to monitor dry heat,ethylene oxide, or otherlow temperaturesterilization processes
General Instructions	Utilize on and/or in eachpack to be steamsterilized. Processaccording to establishedprocedures. Afterprocessing remove theindicator and observe thecolor change. If theindicator bar is not black,inadequate exposure isindicated. Return forprocessing.	Utilize on and/or in eachpack to be steamsterilized. Processaccording to establishedprocedures. Afterprocessing remove theindicator and observe thecolor change. If theindicator bar is not black,inadequate exposure isindicated. Return forprocessing.

Section 5 – 510(k) Summary Statement Page 4 of 5 Revision Date 04/28/2011

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Performance Data:

TestEnvironment	Test Time	Test Temperature	No Change or achange that ismarkedly differentfrom the visible colorchange as specifiedby the manufacturer	Visible colorchange asspecified by themanufacturer	IndistripResults	IndistripGreenResults
SaturatedSteam	3.0 min ± 5 s	121 °C (+3/0 °C)	Acceptable result	Unacceptableresult	Pass	Pass
SaturatedSteam	10.0 min ± 5 s	121 °C (+3/0 °C)	Unacceptable result	Acceptable result	Pass	Pass
SaturatedSteam	0.5 min ± 5 s	134 °C (+3/0 °C)	Acceptable result	Unacceptableresult	Pass	Pass
SaturatedSteam	2.0 min ± 5 s	134 °C (+3/0 °C)	Unacceptable result	Acceptable result	Pass	Pass
Dry Heat	30 min ± 1 s	140 °C (+2/0 °C)	Acceptable result	Unacceptableresult	Pass	Pass

Meats the requirements defined in 11140-1:2005 (AAMI ANSI ISO) Class 1 Table 5-TII Test Performance Characteristics Class 1 Process Indicators

Conclusion:

The Indistrip Green, Heavy Metal free Steam Sterilization indicator is in accordance with 21 CFR 807 has the same intended use, provides substantially equivalent process color change timing, and color change stability as the Indistrip steam sterilization predicate device 510(k) K875193. The main difference is the indistrip
the Indistrin Groon, Product Cards IND (1933) The main difference is that the Indistrip Green, Product Code INDA00G indicator ink is developed with a metal free organic indicator as compared to the standard lead based steam indicator utilized in the Indistrip 400S steam indicator strip. The two devices are substantially equivalent.

Section 5 – 510(k) Summary Statement Page 5 of 5 Revision Date 04/28/2011

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

MAY - 6 2011

Mr. Mark Espenscheid Director of Quality Indilab, Incorporated 10367 Franklin Avenue Franklin Park, Illinois 60131

Re: K110369

Trade/Device Name: Indistrip Green Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: January 15, 2011 Received: February 8, 2011

Dear Mr. Espenscheid:

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. Espenscheid

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 (OS) regulation (2) 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 /ucm115809.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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

dams

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

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Section 4 - Indications for Use Statement.

510(k) Number (if known): N/A

Device Name: Indistrip Green

Indications for Use:

For use as an internal or external chemical indicator to monitor exposure to steam sterilization conditions for: 121℃ (250°F) @ 30 minutes in gravity steam sterilizer cycles or @ 134℃ (273ºF) for 4 minutes in gravity or vacuum assisted steam sterilizer cycles.

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 ANTOHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabetk B. Clamin-Will

Page 1 of 1

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

:10(k) Number: K110369

Section 4 - Indications for Use Statement Page 2 of 2 Revision 04-28-2011

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).