The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray or container to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles: 250°F/121°C, 30 minutes Gravity 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS): 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 3 minutes Gravity 270°F/132°C, 10 minutes Gravity 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Gravity 275°F/135°C, 10 minutes Gravity

Stated values (as determined in a steam resistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 1.5 minutes at 135°C

Device Description

The Getinge Assured MI Steam Migrating Integrator is a single use device to monitor steam sterilization cycles. The integrating indicator is designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray or container to function as an independent monitor of critical parameters for sterilization cycles. During steam sterilization, the integrating indicator pellet will migrate into the PASS zone when sterilization conditions have been met.

A paper wick and a steam sensitive chemical pellet containing blue colored dye. A pellet is held within a pocket located at one end of an aluminum foil base. The foil base is adhered to label material that has been bonded with a film. During steam sterilization, the integrating indicator pellet will migrate into the PASS zone when the specified critical parameters of steam sterilization have been met.

AI/ML Overview

The provided text describes the Getinge Assured MI Steam Migrating Integrator, a chemical indicator used to monitor steam sterilization cycles. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Methodology	Pre-Determined Acceptance Criteria	Reported Device Performance
Steam Resistometer (BIER vessel) Testing (Pass/Fail at Stated Value)	Pass result at the stated value for each temperature claimed: - 30 Minutes at 121°C - 3.3 minutes at 132°C - 1.5 minutes at 135°C	PASS
Steam Resistometer (BIER vessel) Testing (Pass/Fail at Reduced Time)	Failing Result at 15% less time of SV for each temperature claimed	PASS
Steam Resistometer (BIER vessel) Testing (Pass/Fail at Reduced Temperature)	Failing Result at 1°C less for each temperature claimed	PASS
Hospital Steam Sterilizer Testing	100% samples passing under passing conditions for each cycle 100% samples failing under failing conditions for each cycle	PASS
Dry Heat Testing	Failing result when exposed to dry heat alone for 30 minutes (±1 minute) at 140°C (±2°C)	PASS
Side-by-side testing of biological indicator and integrator in steam resistometer	The integrator does not reach its endpoint before the biological indicator is inactivated	PASS
Offset/Transference	The indicator agent shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the sterilization cycles for which it is designed	PASS

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

The provided document does not specify the exact sample size for the test set (number of integrators used in each test). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

However, for "Hospital Steam Sterilizer Testing," it mentions "an actual sterilization cycle used in a health care facility," which implies real-world, prospective testing. The resistometer testing would typically be conducted in a laboratory setting.

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

This information is not provided in the document. The ground truth for chemical indicators like this is typically established by the physical and chemical parameters of the sterilization cycle itself (achieving specific temperature, time, and steam conditions), and comparing the indicator's response to these measured parameters or to a biological indicator. There is no mention of human experts establishing ground truth in the context of interpreting the indicator's performance.

4. Adjudication Method for the Test Set

This information is not applicable or provided for this type of device. The determination of "PASS" or "FAIL" for the chemical integrator is based on the physical migration of the pellet into a "PASS" zone, which is a direct, observable, and objective outcome. There is no mention of human adjudication in interpreting the results of the performance tests.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices or imaging analysis where human readers interpret output. The Getinge Assured MI Steam Migrating Integrator is a chemical indicator that provides a direct visual result (pellet migration to "PASS" zone), not an output that requires human interpretation in the same way as an imaging study. There is no AI component involved.

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

This question is not applicable as the device is a chemical indicator, not an algorithm. Its performance is inherent in its physical and chemical properties and its interaction with the sterilization parameters, not through an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for testing the Getinge Assured MI Steam Migrating Integrator is based on:

Physical and chemical parameters of the sterilization cycle: Measured temperature, time, and steam conditions in a controlled setting (steam resistometer).
Comparison to a biological indicator (BI): For the side-by-side testing, the performance of the chemical integrator is compared against a biological indicator, which is considered the gold standard for verifying sterilization efficacy. The ground truth is that sterilization conditions must be sufficient to inactivate the biological indicator.

8. The sample size for the training set

This information is not applicable as there is no "training set" for a chemical indicator. Chemical indicators are designed and manufactured based on established chemical and physical principles, not through machine learning or algorithm training.

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

This information is not applicable as there is no training set.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

May 21, 2020

SteriTec Products MFG Co Inc Jonathan Rutigliano Director, Regulatory Affairs 74 Inverness Drive East Englewood, Colorado 80112

Re: K200252

Trade/Device Name: Getinge Assured MI Steam Migrating Integrator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: February 21, 2020 Received: February 24, 2020

Dear Jonathan Rutigliano:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

CAPT Elizabeth Claverie, MS Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K200252

Device Name Getinge Assured MI Steam Migrating Integrator

Indications for Use (Describe)

Stated values (as determined in a steam resistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 1.5 minutes at 135°C

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary

Manufacturing Facility SteriTec Products Manufacturing CO INC 74 Inverness Drive East Englewood, CO 80112 Ph: 303-660-4201

Contact: Jonathan Rutigliano Director, Regulatory Affairs Ph: 303-660-4201 e-mail: Jon.Rutigliano@Getinge.com

Submission Date: May 16, 2020

1. Device Name

Trade Name:	Getinge Assured MI Steam Migrating Integrator
Device Classification:	Class II
Common/Usual Name:	Indicator, physical/chemical sterilization process
Classification Name:	Indicator, physical/chemical sterilization process (21 CFR 880.2800, JOJ)

2. Predicate Device

Steris Steam Integrating Indicator (K152630). Steris Corporation

3. Description of Device

4. Indications For Use:

{5}------------------------------------------------

be placed in each pack, pouch, tray or container to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

250°F/121°C, 30 minutes Gravity 270°F/132°C. 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 3 minutes Gravity 270°F/132°C, 10 minutes Gravity

275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Gravity 275°F/135°C, 10 minutes Gravity

Stated values (as determined in a steam resistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 1.5 minutes at 135°C

5. Technological Characteristics

The chart below compares the technological characteristics to that of the predicate device:

Feature	PREDICATE	510(k) Filing	COMPARISON
---------	-----------	---------------	------------

{6}------------------------------------------------

Intended Use			Similar
The integrating indicator isdesigned to chemically react overtime with the critical parametersof steam sterilization cycleswithin a specified tolerance. Theintegrating indicator strip isintended to be placed in eachpack, pouch, container, tray orother containment device tofunction as an independentmonitor of critical parameters forthe following sterilization cycles:	Steam Sterilization Cycles:• 250°F/121°C- 30 minGravity• 270°F/132°C- 4 minutesDynamic Air Removal• 270°F/132°C- 15minutes Gravity• 275°F/135°C- 3 minutesDynamic Air Removal• 275°F/135°C- 10minutes Gravity	The Getinge Assured MI SteamMigrating Integrator strip is aninternal pack integrating indicatordesigned to react to critical processparameters of a steam sterilizationcycle within a stated tolerance. Theintegrating indicator is intended tobe placed in each pack, pouch, trayor container to function as anindependent monitor of criticalparameters for the followingsterilization cycles:
	Steam Sterilization Cycles(IUSS):• 270°F/132°C- 4 minutesDynamic Air Removal• 270°F/132°C- 3 minutesGravity• 270°F/132°C- 10minutes Gravity• 275°F/135°C- 3 minutesdynamic air removal• 275°F/135°C- 3 minutesGravity• 275°F/135°C- 10minutes Gravity	Steam Sterilization Cycles:• 250°F/121°C, 30minutes Gravity• 270°F/132°C, 4minutes DynamicAir Removal• 270°F/132°C, 15minutes Gravity• 275°F/135°C, 3 minutesDynamic Air Removal• 275°F/135°C, 10minutes Gravity
		Steam Sterilization Cycles (IUSS):• 270°F/132°C, 4 minutesDynamic Air Removal• 270°F/132°C, 3 minutesGravity• 270°F/132°C, 10minutes Gravity• 275°F/135°C, 3 minutesDynamic Air Removal• 275°F/135°C, 3 minutesGravity• 275°F/135°C, 10minutes Gravity
DeviceDesign	Backing material with embossedcavity containing temperaturesensitive chemical and coloringdye, wicking strip, covered withlaminated paper containinglabeling and windows.	A paper wick and a steamsensitive chemical pelletcontaining blue colored dye. Apellet is held within a pocketlocated at one end of an aluminumfoil base. The foil base is adheredto label material that has beenbonded with a film. During steamsterilization, the integratingindicator pellet will migrate intothe PASS zone when the specifiedcritical parameters of steamsterilization have been met.	Similar
Sterilizationmethods andcycles	Steam Sterilization Cycles:250°F/121°C- 30 minGravity 270°F/132°C- 4 minutesDynamic Air Removal 270°F/132°C- 15minutes Gravity 275°F/135°C- 3 minutesDynamic Air Removal 275°F/135°C- 10minutes Gravity Steam Sterilization Cycles(IUSS): 270°F/132°C- 4 minutesDynamic Air Removal 270°F/132°C- 3 minutesGravity 270°F/132°C- 10minutes Gravity 275°F/135°C- 3 minutesdynamic air removal 275°F/135°C- 3 minutesGravity 275°F/135°C- 10minutes Gravity	Steam Sterilization Cycles:250°F/121°C, 30minutes Gravity 270°F/132°C, 4minutes DynamicAir Removal 270°F/132°C, 15minutes Gravity 275°F/135°C, 3 minutesDynamic Air Removal 275°F/135°C, 10minutes Gravity Steam Sterilization Cycles (IUSS): 270°F/132°C, 4 minutesDynamic Air Removal 270°F/132°C, 3 minutesGravity IUSS 270°F/132°C, 10minutes Gravity IUSS 275°F/135°C, 3 minutesDynamic Air Removal 275°F/135°C, 3 minutesGravity 275°F/135°C, 10minutes Gravity	Same
IndicatorAgent	Proprietary	Proprietary	Same
EndpointSpecifications	The endpoint is determined bymigration of the steam sensitivedye to an area marked ACCEPT(OK) on the indicator. Endpoint isreached at the stated value (SV)for each claimed temperature.Endpoint is not reached at thestated value – 15% time and/or1°C.	The endpoint is determined bymigration of the steam sensitivedye to an area marked PASS on theindicator. Endpoint is reached atthe stated value (SV) for eachclaimed temperature. Endpoint isnot reached at the stated value –15% time and/or 1°C.	Same
EndpointStability	6months	6months	Same
Shelf Life	5 Years	5 Years	Same

{7}------------------------------------------------

{8}------------------------------------------------

6. Performance Testing

Performance testing was conducted to verity that the proposed Getinge Assured MI Steam Migrating Integrator meets the requirements for integrating indicators in accordance with the Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators for integrating indicators as well as ANSI/AAMI/ISO 11140-1:2014. The following table summarizes the performance testing that was completed, with acceptance criteria and the results demonstrate that the Getinge Assured MI Steam Migrating Integrator met the requirements of the pre-determined acceptance criteria in its claimed intended steam sterilization cycles.

Test Methodology	Purpose	Pre-DeterminedAcceptanceCriteria	Results
Steam Resistometer (BIERvessel) Testing	To test the pass/fail criteria foreach critical cycle parameterand provide the pass/fail resultsto show how the chemicalintegrator reacts to all thecritical parameters in thesterilization cycle for which it isintended according toANSI/AAMI/ISO 11140-1:2014Sterilization of health careproducts - Chemical indicatorsPart 1: General requirementsand Premarket Notification[510(k)] Submissions forChemical Indicators - Guidancefor Industry and FDA Staff.	Pass result at the statedvalue for each temperatureclaimed:- 30 Minutes at 121°C- 3.3 minutes at132°C- 1.5 minutes at135°C	PASS
		Failing Result at 15% lesstime of SV for eachtemperature claimed	PASS
Steam Resistometer (BIERvessel) Testing	To evaluate one parameterat a time in a resistometerwhile holding the otherparameters constantaccording to PremarketNotification [510(k)]Submissions for ChemicalIndicators - Guidance forIndustry and FDA Staff	Failing Result at 1°Cless for eachtemperature claimed	PASS
Hospital SteamSterilizer Testing	To demonstrate pass/failresults from an actualsterilization cycle used in ahealth care facility according toPremarket Notification [510(k)]Submissions for ChemicalIndicators - Guidance forIndustry and FDA Staff	100% samples passingunder passing conditionsfor each cycle100% samples failingunder failing conditionsfor eachcycle	PASS
Dry Heat Testing	To demonstrate that theintegrator does not changecolor following a dry heat cycleaccording to ANSI/AAMI/ISO11140-1:2014 Sterilization ofhealth care products - Chemicalindicators - Part 1: Generalrequirements and PremarketNotification [510(k)]Submissions for ChemicalIndicators - Guidance forIndustry and FDA Staff	Failing result whenexposed to dry heat alonefor30 minutes (±1 minute) at140°C (±2°C)	PASS
Side-by-side testing ofthe biological indicatorand integrator in steamresistometer	To demonstrate that thechemical integrator parallelsthe performance of anappropriate biologicalindicator. The results of thisstudy should demonstratethat the integrator does notreach its endpoint before thebiological indicator isinactivated, as specified inPremarket Notification[510(k)] Submissions forChemical Indicators -Guidance for Industry andFDA Staff	The integrator does notreach its endpoint beforethe biological indicator isinactivated	PASS
Offset/Transference	To demonstrate the indicatoragent does not bleed or offset tosubstrate which it is appliedaccording to ANSI/AAMI/ISO11140-1:2014 Sterilization ofhealth care products - Chemicalindicators - Part 1: Generalrequirements.	The indicator agent shallnot offset or bleed,penetrate the substrate towhich it is applied, ormaterials in which it is incontact before, during orafter the sterilizationcycles for which it isdesigned	PASS

{9}------------------------------------------------

7. Conclusion

Based on the results from the performance testing as required in Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators for integrating indicators as well as ANSI/AAMI/ISO 11140- 1:2014, the proposed device is as safe, as effective and performs as well as or better than the legally marketed device (K152630), Class II Indicator, physical/chemical sterilization process (21 CFR 880.2800), JOJ.

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).