Terragene Chemdye® Bowie-Dick Test Pack (BD125X/1), Bowie-Dick Test Card (BD8948X/1) and Bowie-Dick Test Sheet (BDA4/1) are designed for testing air removal efficiency for cycles of 132ºC for 3.5 minutes in dynamicair-removal steam sterilizers.

Device Description

Not Found

AI/ML Overview

This document is a marketing authorization letter for a device and therefore does not contain the detailed information necessary to answer some of the questions. Specifically, it does not include information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

However, based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

This information is not available in the provided document. The document is an FDA clearance letter, which confirms substantial equivalence but does not detail the specific performance metrics or acceptance criteria used in the underlying studies.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not available in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not available in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not available in the provided document.

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:

This information is not available in the provided document. The device, Terragene Chemdye® Bowie-Dick Test Pack, Bowie-Dick Test Card, and Bowie-Dick Test Sheet, are chemical indicators for sterilization processes, not an AI-powered diagnostic tool that would typically involve human readers.

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

This information is not applicable/not available for this type of device. The devices are chemical indicators that change color to show air removal efficiency, and their performance is inherently standalone in their function (i.e., they indicate a condition without human interpretation of an algorithm's output).

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

This information is not available in the provided document. For Bowie-Dick tests, the "ground truth" would typically be established based on standardized test procedures and expected color changes under validated sterilization conditions.

8. The sample size for the training set:

This information is not applicable/not available in the provided document. The devices are chemical indicators, not machine learning algorithms that require a "training set."

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

This information is not applicable/not available for this type of device.

Summary

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June 30, 2020

Terragene SA c/o.Raymond Kelly, Consultant Licensale Inc 3422 Leonard Ln. New Smyrna Beach FL 32168 USA

Re: K200272

Trade/Device Name: Terragene Chemdye® BD125X/1 Bowie-Dick Test Pack, Terragene Chemdye® BD8948X/1 Bowie-Dick Test Card and Terragene Chemdye® BDA4/1 Bowie-Dick Test Sheet. Regulation Number: 21 CFR 880.2800 Regulation Name: Indicator, Physical/Chemical Sterilization Process Regulatory Class: Class II Product Code: JOJ Dated: Mav 29, 2020

Dear Raymond Kelly:

Received: June 01, 2020

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

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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 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 (OS) 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,

Christopher K. Dugard, M.S. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K200272

Device Name

Terragene Chemdye® BD125X/1 Bowie-Dick, Terragene Chemdye® BD8948X/1 Bowie-Dick Test Card and Terragene Chemdye® BDA4/1 Bowie-Dick Test Sheet.

Indications for Use (Describe)

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

	Production Use (Part 21 CFR 601 Subpart D)
	Study Tier Control Use (21 CFR 601 Subpart G)

__ 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.

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

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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).