Terragene Bionova® SCBI (BT220, BT221, BT222, BT223) is a self-contained biological indicator inoculated with viable 10f Geobacillus stearothermophilus bacterial spores and is intended for monitoring the effication processes. Oneach Terragene Bionova® SCB is a chemical process indicator that changes color from pink to brown when exposed to steam.

Terragene Bionova® PCD (PCD220-C. PCD222-C. PCD222-C. PCD222-2) provides a defined challenge resistance against the claimed cycles shown below and also demonstrated resistance equivalence to the AAMI/ANSI 16 towel pack. The device provides routine monitoring and sterilizer qualification testing steam sterilization processes.

Terragene Bionova® IC10/20FR Reader Incubates at 60 ℃ and reads the Terragene Bionova® SCBI (BT220, BT221, BT222, and BT223) for fluorescent results at 30 minutes (BT221, BT222), and 3 hours (BT220)

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA, along with an "Indications for Use" statement. It primarily concerns the regulatory approval of sterilization process indicators and an associated incubator. It does not contain information about a study that proves the device meets acceptance criteria in the context of an AI/human performance study as typically understood.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves device performance for an AI-based medical device. The document is about a different type of medical device (sterilization indicators) and does not describe performance metrics in the way you've requested (e.g., sensitivity, specificity, F1-score, effect size for human readers with AI assistance, etc.).

There is no mention of:

A test set with a specific sample size or data provenance.
Experts used to establish ground truth.
Adjudication methods.
MRMC comparative effectiveness studies.
Standalone algorithm performance.
Training set details.
Ground truth used for training.

The "Indications for Use" section does provide performance characteristics related to the sterilization process indicators, such as incubation temperatures and read times for fluorescent results, and pH color change times. However, these are device specifications and not acceptance criteria in the context of an AI performance study with ground truth and expert reviews.

If you are looking for an example of a 510(k) summary (which usually includes performance data for medical devices), this document does not contain that level of detail for performance metrics.

Summary

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

November 2, 2017

Terragene Sa % Raymond Kelly Consultant Licensale Inc 68 Southwoods Ter Southbury, Connecticut 06488

Re: K163646

Trade/Device Name: Terragene Bionova® SCBI (BT220, BT221, BT222, BT223), Terragene Bionova® PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova ® IC10/20FR Reader Incubator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: October 26, 2017 Received: October 31, 2017

Dear Raymond Kelly:

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.

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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 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 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tara A. Ryan -S

for

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications forUse

510(k) Number (if known) K163646

Device Name

Terragene Bionova® SCBI (BT220, BT221, BT222, BT223), Terragene Bionova® PCD (PCD220-C, PCD222-C, PCD222-2), and Terragene Bionova ® IC10/20FR Reader Incubator

Indications for Use (Describe)

Models	121°C	132°C	135°C
Gravity Displacement
BT220, BT222, PCD220-C, PCD220-2, PCD222-C,PCD222-2	30 minutes	15 minutes,25 minutes	10 minutes
BT221, BT223	NA	3 minutes,10 minutes	3 minutes,10 minutes
Dynamic Air Removal (Vacuum Assist)
BT220, BT222, PCD220-C, PCD220-2, PCD222-C,PCD222-2	NA	4 minutes	3 minutes
Models	Fluorescence Read Time		pH Color Change
BT221, BT222, PCD222-C, PCD222-2	1 hour		48 Hours
BT223	30 minutes		48 Hours
BT220, PCD220-C, PCD220-2	3 hours		48 Hours

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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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).