The BacT/ALERT FN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of anaerobic microorganisms from blood and other normally sterile body fluids.

Device Description

The BacT/ALERT FN Culture Bottle was developed for the same intended use as the current BacT/Alert FAN Anaerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instrument where it is incubated and continously monitored for the presence of microorganisms that will grow in the BacT/ALERT FN Culture Bottle.

AI/ML Overview

Here's an analysis of the provided text to extract the requested information regarding the acceptance criteria and the study that proves the device meets them:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Recovery of anaerobic organisms from human blood	Equivalent to the predicate device (BacT/Alert FAN Anaerobic Culture Bottle)
Time to detection of anaerobic organisms	Equivalent to the predicate device (BacT/Alert FAN Anaerobic Culture Bottle)

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated, but the study involved "low levels of eleven anaerobic organisms diluted in human blood." The number of samples (bottles) per organism or per blood sample is not provided.
Data Provenance: The data was generated through "seeded studies" using "human blood." The country of origin is not specified, but the submission is to the FDA in the USA. Given this, it's a prospective study conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a diagnostic tool for microbial growth. The "ground truth" for the test set would be the confirmed presence and identity of the seeded anaerobic organisms, which is determined by standard microbiological culture and identification methods, not expert reader consensus.

4. Adjudication method for the test set

Not applicable. As described above, the ground truth for microbial growth detection is based on the inherent biology and laboratory confirmation of the seeded organisms, not expert adjudication of images or diagnoses.

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

Not applicable. This device is a fully automated microbial detection system, not an AI-assisted diagnostic tool that aids human readers.

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

Yes, a standalone study was performed. The BacT/ALERT FN Culture Bottle, in conjunction with the BacT/ALERT Microbial Detection Instrument, operates automatically to detect microbial growth. The study compared the performance of this system (BacT/ALERT FN Culture Bottle + Instrument) directly against the predicate device's system (BacT/Alert FAN Anaerobic Culture Bottle + Instrument).

7. The type of ground truth used

The ground truth was established by seeding known anaerobic organisms into human blood at "low levels" and then measuring their recovery and time to detection. This is essentially a controlled laboratory setup where the presence and type of microorganism are known beforehand.

8. The sample size for the training set

Not applicable. This document describes a new iteration of an existing diagnostic culture bottle, not a machine learning algorithm that requires a training set in the conventional sense. The "training" for the device would have been its design and development based on established microbiological principles.

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

Not applicable. See point 8.

Summary

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SEP 2 4 1999

510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT FN Culture Bottle

510(k) Summary

The submitter's name, address, telephone number, a contact person, and the date the (a)(1) summary was prepared;

Submitter's Name: Organon Teknika Corporation

Submitter's Address: 100 Akzo Avenue Durham, North Carolina 27712

Submitter's Telephone: (919) 620-2288

Submitter's Contact: Rebecca A. Rivas

Date 510(k) Summary Prepared: July 19, 1999

(a)(2) ( The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known;
Trade or Proprietary Name: BacT/ALERT FN Culture Bottle

Common or Usual Name: BacT/ALERT FN Culture Bottle

Classification Name: Microbial Growth Monitor

An identification of the legally marketed device to which the submitter claims substantial (a)(3) equivalence;
Device Equivalent to: BacT/Alert FAN Anaerobic Culture Bottle

(a)(4) A description of the device.

The BacT/ALERT FN Culture Bottle was developed for the same Device Description: intended use as the current BacT/Alert FAN Anaerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instrument where it is incubated and continously monitored for the presence of microorganisms that will grow in the BacT/ALERT FN Culture Bottle.

(a)(5) A statement of the intended use of the device.
Device Intended Use: The BacT/ALERT FN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of anaerobic microorganisms from blood and other normally sterile body fluids.

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(a)(6) A summary of the technological characteristics of the new device in comparison to those of the predicate device.

The BacT/ALERT FN Culture Bottle utilizes the same detection technology as the BacT/ALERT FAN Anaerobic Culture Bottle.

FEATURES	BACT/ALERT FN CULTURE BOTTLE	BACT/ALERT FANANAEROBIC CULTUREBOTTLE
Technology	Reflectance	Reflectance
Color change based onCO₂ production	YES	YES
Sensor	Emulsion	Disc
Indicator material	Yes, Same as FAN AnaerobicBottle	Yes
Growth ofmicroorganisms	Yes, Equivalent to FAN AnaerobicBottle	Yes
Instrument Used	BacT/ALERT Microbial Detection Systems	BacT/ALERT MicrobialDetection Systems
Sample Source	Blood, Body Fluids	Blood, Body Fluids
Target Population	Adult	Adult

1998

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510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT FN Culture Bottle

A brief discussion of the nonclinical tests submitted, referenced, or relied on in the (b)1) premarket notification submission for a determination of substantial equivalency.

Testing was performed to establish the performance characteristics of the new device including:

Seeded studies were performed on eleven anaerobic organisms diluted in human blood. The inoculums were seeded into the BacT/ALERT FN Culture Bottle and the BacT/Alert FAN Anaerobic Culture Bottle. Recovery of the seeded organisms were compared between the two culture bottles.

(b)3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).

The BacT/ALERT FN Culture Bottle has the same intended use and uses the same detection methodology as the predicate device, the current BacT/Alert FAN Anaerobic Culture Bottle. BacT/ALERT FN Culture Bottle was found to be substantially equivalent to the BacT/Alert FAN Anaerobic Culture Bottle based on recovery of low levels of eleven anaerobic organisms. Times to detection were also equivalent between both the BacT/ALERT FN Culture Bottle and the predicate device, the current BacT/Alert FAN Anaerobic Culture Bottle.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

SEP 2 4 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rebecca A. Rivas Regulatory Affairs Administrator Organon Teknika Corporation 100 Akzo Avenue Durham, North Carolina 27712

Re: K992432 Trade Name: BacT/ALERT FN Culture Bottle Regulatory Class: I Product Code: MDB Dated: July 20, 1999 Received: July 21, 1999

Dear Ms. Rivas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT FN Culture Bottle

Page	__________ of __________
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510(k) Number (If known):	K992432
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BacT/ALERT FN Culture Bottle

Device Name:

Indications For Usa:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubose

ical Laboratory Devices Division of C 510(k) Number

Prescription Use (Per 21 CFR 801.109)

ଠାର

Over-The-Counter Use

(Optional Format 1-2-98)

Regulation Number and Section

§ 866.2560 Microbial growth monitor.

(a)
Identification. A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.