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

Device Description

The BacT/ALERT FA Culture Bottle was developed for the same intended use as the current BacT/Alert FAN Aerobic 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 Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT FA Bottle.

AI/ML Overview

The provided text describes the acceptance criteria and a study for the BacT/ALERT FA Culture Bottle. Here's a breakdown of the requested information:

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

Acceptance Criteria	Reported Device Performance
Equivalent recovery of microorganisms	"BacT/ALERT FA culture bottle was substantially equivalent to the BacT/Alert FAN Culture Bottle based on recovery of low levels of the 23 microorganisms included in the study."
Equivalent detection times	"Detection times in the test bottle were equivalent in both bottles."

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

Sample Size: 23 organisms (strains) were diluted in human blood. The exact number of individual samples (e.g., individual blood aliquots) or runs per organism is not specified but it involved inoculating these diluted organisms into both the BacT/ALERT FA bottle and the BacT/Alert FAN bottle.
Data Provenance: The text does not specify the country of origin of the human blood or where the study was conducted. It also does not explicitly state if it was retrospective or prospective, but the description ("Seeded studies were performed...") implies a prospective, controlled laboratory study.

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)

The ground truth was established through "Seeded studies" where specific organisms were inoculated into blood samples. This is a direct, experimental ground truth, meaning the presence and identity of the microorganisms were known by design. Therefore, no external experts were needed to establish the ground truth for the presence of the inoculated organisms.

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

Not applicable. The ground truth was experimentally determined by seeding the samples with known microorganisms, not by expert review requiring adjudication.

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

No. This study is for a medical device (culture bottle), not an AI algorithm, and does not involve human readers interpreting results in a comparative effectiveness study. The comparison is between two culture bottle technologies.

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

Yes, in a sense. The study evaluated the performance of the BacT/ALERT FA Culture Bottle as a standalone component with an automated detection system (BacT/ALERT Microbial Detection Instruments). The performance assessed was the ability of the bottle to support growth and allow for timely detection of microorganisms, without direct human interpretation influencing the detection itself.

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

The ground truth used was experimental ground truth through "seeded studies." Known microorganisms were intentionally introduced into the samples.

8. The sample size for the training set

The document does not mention a training set. This is a study for a medical device (culture bottle), not a machine learning model, so the concept of a training set is not applicable in the context described.

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

Not applicable, as no training set is mentioned or relevant to this type of device study.

Summary

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SEP 3 1999

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:

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

Common or Usual Name: BacT/ALERT FA 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 Aerobic Culture Bottle
A description of the device. (a)(4)
Device Description: The BacT/ALERT FA Culture Bottle was developed for the same intended use as the current BacT/Alert FAN Aerobic 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 Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT FA Bottle.

(a)(5) A statement of the intended use of the device.

Device Intended Use: The BacT/ALERT FA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms ( bacteria and fungi) from blood and other normally sterile body fluids.

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

The BacT/ALERT FA Culture Bottle utilizes the same detection technology as the BacT/ALERT FAN Aerobic Culture Bottle.

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

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 23 organisms diluted in human blood and inoculated into the BacT/ALERT FA bottle and the BacT/Alert FAN bottle.

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(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 FA culture bottle was substantially equivalent to the BacT/Alert FAN Culture Bottle based on recovery of low levels of the 23 microorganisms included in the study. Detection times in the test bottle were equivalent in both bottles.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP --------------------------------------------------------------------------------------------------------------------------------------------------------------------------3 1999

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

Re: K992400 Trade Name: BacT/ALERT FA Culture Bottle Regulatory Class: I Product Code: MDB Dated: July 16, 1999 Received: July 19, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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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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 your 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 Sutman

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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Page _ of _

510(k) Number (If known):	____________________________________________________________________________________________________________________________________________________
Device Name:	BacT/ALERT FA Culture Bottle

Indications For Usa:

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

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

Concumence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois

Division Sign Off) Division of Clinical Laboratory Devices 510(k) Number_K99 2400

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use

(Optional Format 1-2-95)

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.