The Green Card Bowie-Dick Test is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 270°F (132°C) and 273°F (134°C) for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.

Device Description

The Green Card Bowie-Dick Test is designed specifically for daily monitoring of pre-vacuum steam sterilizers to detect the presence of residual air as recommended by ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. The Green Card Bowie-Dick Test is a 3.5" X 1.91" card with the indicator ink printed on one side. Both sides of the card are laminated with a polyester film and an identification/record label is placed on the back side. The Green Card Bowie-Dick Test duplicates the resistance of a Bowie-Dick towel pack as described in ANSI/AAMI ST8 Hospital Steam Sterilizers.

The Green Card Bowie-Dick Test indicator areas will uniformly change color from purple to green when a passing Bowie-Dick test is performed. If a significant amount of air is present inside the sterilizer chamber during the sterilization cycle, it will be detected by the Green Card and displayed as a purple area on the indicator card, whereas the remainder of the indicator will have turned green. The non-uniform color change demonstrates the presence of air that would have created a 2°C temperature depression in a standard cloth Bowie-Dick pack.

AI/ML Overview

The provided text describes the Green Card Bowie-Dick Test (BD115), a sterilization process indicator. The study detailed is a non-clinical performance test to verify the device meets applicable standards for Class 2 indicators for Bowie and Dick-type air removal tests.

Here's the breakdown of the acceptance criteria and study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Testing (of 3 manufactured lots)	Pre-Determined Acceptance Criteria	Results
Uniform Color Change (Pass Test) - ANSI/AAMI/ISO 11140-5 Annex B	The Standard Test Pack must demonstrate no greater than a 0.5°C difference between the inside of the Standard Test Pack and the drain temperature and shall remain so for the duration of the exposure time exclusive of a 15-second equilibration time. This should be demonstrated with a thermocouple graph. The SteriTec Green Card Bowie-Dick Test Card indicator cards must demonstrate a uniform color change to green.	PASS
Non-Uniform Color Change (Fail Test) - ANSI/AAMI/ISO 11140-5 Annex F	The Standard Test Pack must demonstrate a 2°C (+1°/-0°C) temperature difference between the towel pack and the drain temperatures for the last one minute of the three and a half minute sterilization cycle. This should be demonstrated with a thermocouple graph. The SteriTec Green Card Bowie-Dick Test Card indicator cards must demonstrate a non-uniform color change with a purple area in the center and the rest of the indicator green.	PASS
Dry Heat Testing - ANSI/AAMI/ISO 11140-5 Annex C	The SteriTec Green Card Bowie-Dick Test Card shall show either no change or a change that is markedly different from the change occurring after exposure to a steam sterilization process.	PASS
Color Density Test - ANSI/AAMI/ISO 11140-5 Annex A	Difference in color density between the substrate and indicator should be not less than 0.3.	PASS
Indicator Color Stability	Verify that the Green Card Indicator sample end color has not changed to any other color and has remained green after 18 months or longer from steam sterilization exposure. Verify that the Green Card Indicator sample fail point color has not changed to any other color and has remained purple in center of card after 18 months or longer from steam sterilization exposure.	PASS
Shelf-Life Stability	The following tests will be performed at 24 months of shelf life or longer: ● The pass cycle samples shall exhibit complete color change to green. ● The fail cycle samples shall exhibit incomplete color change. This presents as a purple spot in the center of the test card.	PASS

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

Sample Size: The testing was conducted on 3 manufactured lots of the Green Card Bowie-Dick Test.
Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a physical device, it's highly likely to be prospective testing conducted by the manufacturer (SteriTec Products, Inc., located in Englewood, CO, USA).

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

This information is not provided in the document. The ground truth for this type of device (a chemical indicator for sterilization) is established through physical measurements of temperature and air presence in a controlled sterilization environment, not through expert interpretation of images. The criteria refer to thermocouple graphs for temperature verification.

4. Adjudication Method for the Test Set:

Not applicable or not specified. The performance of this device is assessed against objective physical and chemical changes (color change, temperature differences) based on defined ANSI/AAMI/ISO standards, rather than subjective human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is not relevant for this device. An MRMC study is typically performed for AI/image analysis systems where human readers interpret medical images, and the AI assists in that interpretation. The Green Card Bowie-Dick Test is a chemical indicator that provides a direct visual result.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, effectively. The performance testing described is for the device itself to objectively meet specific physical and chemical criteria. The "algorithm" here is the chemical reaction of the indicator. The acceptance criteria are based on whether the indicator changes color as expected under specific sterilization conditions, without human interpretation influencing the measurement of those conditions (e.g., thermocouple readings). The visual interpretation of the color change by a human is the final step, but the "performance" of the device in demonstrating the condition is intrinsic to the device itself.

7. Type of Ground Truth Used:

The ground truth is established through objective physical measurements in controlled sterilization environments, specifically:
- Temperature measurements using thermocouples within a "Standard Test Pack" and at the drain, to verify specific temperature differences (e.g., no greater than 0.5°C difference for pass, 2°C or greater for fail).
- Defined steam sterilization cycles (e.g., 270°F/132°C and 273°F/134°C for 3.5 minutes).
- Absence or presence of residual air engineered into the test conditions.
- Direct observation of color change (uniform green for pass, non-uniform with purple for fail) and color density as per ANSI/AAMI/ISO standards.

8. Sample Size for the Training Set:

Not applicable/Not specified. This is a physical chemical indicator, not an AI/machine learning algorithm that requires a "training set" in the computational sense. Its performance is inherent to its material composition and design, which is validated through a test set of manufactured lots.

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

Not applicable. As explained above, there is no "training set" for this device in the context of an AI/ML algorithm. The device's inherent chemical and physical properties are designed to react to specific sterilization conditions, and its performance is validated against established industry standards for those reactions, not "trained" on data.

Summary

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February 20, 2025

SteriTec Products, Inc. (a Getinge Company) % Barb Smith Principal Regulatory Affairs Specialist Getinge 75 Barbour Pond Wayne, New Jersey 07470

Re: K250172

Trade/Device Name: Green Card Bowie-Dick Test (BD115) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: January 17, 2025 Received: January 21, 2025

Dear Barb Smith:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Christopher K. Dugard -S

Christopher K. Dugard, M.S. Division Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K250172

Device Name

Green Card Bowie-Dick Test (BD115)

Indications for Use (Describe)

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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SteriTec Products, Inc. 74 Inverness Drive East Englewood, CO 80112 (303) 660-4201

510(k) Summary for the Green Card Bowie-Dick Test

Page 1 of 5

510(k) Summary K250172

Date Prepared: February 17, 2025

Applicant Information

SteriTec Products Manufacturing CO INC (a Getinge Group company) 74 Inverness Drive East Englewood, CO 80112 U.S. Ph: 303-660-4201

Contact: Barb Smith Principal Requlatory Affairs Specialist Ph: 585-370-6101 e-mail: barb.smith@getinge.com

1. Device Name

Trade Name:	Green Card Bowie-Dick Test (BD115)
Device Classification:	Class II
Common/Usual Name:	Indicator, physical/chemical sterilization process
Classification Name:	Indicator, physical/chemical sterilization process (21 CFR 880.2800, JOJ)

1. Predicate Device
  SteriTec Bowie-Dick Mini Pak (K024293). SteriTec Products, Manufacturing Co. Inc.

3. Description of Device

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510(k) Summary for the Green Card Bowie-Dick Test

displayed as a purple area on the indicator card, whereas the remainder of the indicator will have turned green. The non-uniform color change demonstrates the presence of air that would have created a 2°C temperature depression in a standard cloth Bowie-Dick pack.

4. Intended Use/Indications for Use:

The Green Card Bowie-Dick Test Card is designed to detect the presence of residual air in prevacuum steam sterilizers operating at 270°F (132°C) and 273°F (134°C) for 3.5 minutes.

The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met, and no air is present. If enough air is present to create a 2°C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.

5. Technological Characteristics

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

Feature	Predicate Device	Subject/Modified Device	Comparison
	SteriTec Bowie-Dick Mini Pak(K024293)	Green Card Bowie-Dick Test
IntendedUse/Indicationsfor Use	SteriTec Bowie-Dick Mini Pak isdesigned to detect the presenceof residual air in pre-vacuumsteam sterilizers operating at 132°C for 3.5 minutes.The indicator will demonstrate auniform color change from purpleto green when the propersterilization conditions are met,and no air is present. If enoughair is present to create a 2° C orgreater temperature difference ina standard Bowie-Dick test towelpack, the indicator willdemonstrate a non-uniform colorchange.	The Green Card Bowie-Dick TestCard is designed to detect thepresence of residual air in pre-vacuum steam sterilizersoperating at 270°F (132°C) and273°F (134°C) for 3.5 minutes.The indicator will demonstrate auniform color change from purpleto green when the propersterilization conditions are met,and no air is present. If enoughair is present to create a 2°C orgreater temperature difference ina standard Bowie-Dick test towelpack, the indicator willdemonstrate a non-uniform colorchange.	The Intended Use of themodified device is the sameas the predicate.This submission proposesthe monitoring of anadditional exposuretemperature and time to theIndications for Use of:• 134°C 3.5 minutesIn addition, the name waschanged from Bowie-DickMini Pak to Green CardBowie-Dick Test.
DeviceDesign	Card measuring 3.5"x1.85" withindicator ink printed on one sideand laminated with a polyesterfilm on both sides.Identification/record label is onthe back side opposite theindicator side.Indicator area will turn uniformlyfrom purple to green when a	Card measuring 3.5"x1.91" withindicator ink printed on one sideand laminated with a polyesterfilm on both sides.Identification/record label is onthe back side opposite theindicator side.Indicator area will turn uniformlyfrom purple to green when a	Minor change in carddimension.
successful Bowie-Dick test isperformed. If a significant amountof air is present in the sterilizerchamber during the test, theindicator will have a non-uniformcolor change with purple stillpresent.The card is placed inside a holderassembly prior to placement inthe sterilizer. The holder is openon both sides allowing theunrestricted flow of steam and airremoval around the card. Theholder acts as a weight to keepthe indicator card from blowingaround during the test. The holderdoes not have any functionalityregarding the test itself.	successful Bowie-Dick test isperformed. If a significant amountof air is present in the sterilizerchamber during the test, theindicator will have a non-uniformcolor change with purple stillpresent.The card is placed inside a holderassembly prior to placement inthe sterilizer. The holder is openon both sides allowing theunrestricted flow of steam and airremoval around the card. Theholder acts as a weight to keepthe indicator card from blowingaround during the test. The holderdoes not have any functionalityregarding the test itself.
Sterilizationmethodsand cycles	Steam sterilizer Bowie-Dick test132°C 3.5 minutes	Steam sterilizer Bowie-Dick test132°C 3.5 minutes and 134°C 3.5minutes	This submission proposesthe monitoring of additionalexposure temperature andtime to the Indications forUse of:• 134°C 3.5 minutes
IndicatorAgent	Proprietary	Proprietary	Same
ColorChange	The indicator area will changefrom purple to green whenexposed to steam sterilizationcycle with acceptable vacuumcycles.	The indicator area will changefrom purple to green whenexposed to steam sterilizationcycle with acceptable vacuumcycles.	Same
Interpretation	If no significant amount ofresidual air is present, theindicator will show a uniformgreen color change. If theindicator shows a purple color inthe center, this indicates thepresence of residual air.	If no significant amount ofresidual air is present, theindicator will show a uniformgreen color change. If theindicator shows a purple color inthe center, this indicates thepresence of residual air.	Same
Shelf Life	2 Years	2 Years	Same

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SteriTec Products, Inc.
74 Inverness Drive East Englewood, CO 80112 (303) 660-4201

510(k) Summary for the Green Card Bowie-Dick Test

Page 3 of 5

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Page 4 of 5

510(k) Summary for the Green Card Bowie-Dick Test

6. Non-Clinical Performance Testing

Performance testing was conducted to verify that the proposed Green Card Bowie-Dick Test meets the applicable portions of ANSI/AAMI/ISO 11140-5 Sterilization of health care products — Chemical indicators Part 5: Class 2 indicators for Bowie and Dick-type air removal tests.

The following table summarizes the performance testing that was completed, with acceptance criteria and results to demonstrate that performance of the Green Card Bowie-Dick Test is as safe and effective as the predicate device. This testing confirms and demonstrates that the proposed device meets the requirements of its pre-determined acceptance criteria in its claimed intended steam sterilization cycles.

Performance Testing of 3manufactured lots of GreenCard Bowie-Dick Test	Pre-Determined Acceptance Criteria	Results
Uniform Color Change (PassTest)-ANSI/AAMI/ISO 111140-5Annex B	The Standard Test Pack must demonstrateno greater than a 0.5° C difference betweenthe inside of the Standard Test Pack and thedrain temperature and shall remain so for theduration of the exposure time exclusive of a15 second equilibration time. This should bedemonstrated with a thermocouple graph.The SteriTec Green Card Bowie-Dick TestCard indicator cards must demonstrate auniform color change to green	PASS
Non-Uniform Color Change (FailTest)- ANSI/AAMI/ISO 11140-5Annex F	The Standard Test Pack must demonstrate a2° C (+1°/-0°C) temperature differencebetween the towel pack and the draintemperatures for the last one minute of thethree and half minute sterilization cycle. Thisshould be demonstrated with a thermocouplegraph.The SteriTec Green Card Bowie-Dick TestCard indicator cards must demonstrate a non-uniform color change with a purple area in thecenter and the rest of the indicator green.	PASS
Dry Heat Testing - ANSI/AAMI/ISO11140-5 Annex C	The SteriTec Green Card Bowie-Dick TestCard shall show either no change or a changethat is markedly different from the changeoccurring after exposure to a steamsterilization process.	PASS
Color Density Test-ANSI/AAMI/ISO 11140-5 Annex A	Difference in color density between thesubstrate and indicator should be not lessthan 0.3.	PASS
Indicator Color Stability	Verify that the Green Card Indicator sampleend color has not changed to any other colorand has remained green after 18 months orlonger from steam sterilization exposure.	PASS

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SteriTec Products, Inc. 74 Inverness Drive East Englewood, CO 80112 (303) 660-4201

510(k) Summary for the Green Card Bowie-Dick Test

Page 5 of 5

	Verify that the Green Card Indicator samplefail point color has not changed to any othercolor and has remained purple in center ofcard after 18 months or longer from steamsterilization exposure.
Shelf-Life Stability	The following tests will be performed at 24months of shelf life or longer.● The pass cycle samples shall exhibitcomplete color change to green.● The fail cycle samples shall exhibitincomplete color change. Thispresents as a purple spot in thecenter of the test card.	PASS

7. Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the subject device in 510(k) submission K250172, the modified Green Card Bowie-Dick Test, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared in K024293, 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).