K Number
K200272
Device Name
Terragene Chemdye
Manufacturer
Date Cleared
2020-06-30

(147 days)

Product Code
Regulation Number
880.2800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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
More Information

Not Found

Not Found

No
The document describes a chemical indicator for steam sterilization and contains no mention of AI or ML technology.

No
This device is designed for testing the efficiency of steam sterilizers, not for directly treating or diagnosing medical conditions in patients. It is a quality control tool for medical equipment.

No

Explanation: The device tests the efficiency of steam sterilizers, which are used to sterilize medical equipment, not to diagnose a medical condition in a patient.

No

The device is a physical test pack, card, or sheet used in steam sterilizers, not a software application.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to test the air removal efficiency of steam sterilizers. This is a quality control test for a sterilization process, not a test performed on a biological sample (like blood, urine, or tissue) to diagnose a disease or condition in a patient.
  • Device Description: While the description is "Not Found," the intended use clearly points away from an IVD.
  • Anatomical Site / Patient Age Range: These are listed as "Not Applicable," which is consistent with a device used for equipment testing rather than patient diagnosis.
  • Intended User / Care Setting: While listed as "Over-The-Counter Use," this likely refers to the accessibility of the product for purchase and use in a healthcare setting (like a clinic or hospital) for equipment testing, not for direct patient use or diagnosis by a layperson.

IVDs are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device does not fit that description.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

JOJ

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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)

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.

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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