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 Plastic Culture Bottle was developed for the same intended use as the current BacT/ALERT FN Glass 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 FN Bottle.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the BacT/ALERT FN Culture Bottle:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Recovery of microorganisms	Equivalent recovery of low levels of 9 microorganisms compared to predicate.
Detection times	Equivalent detection times compared to predicate.

Note: The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for recovery or detection time. Instead, the study's aim was to demonstrate "substantial equivalence" to the predicate device, meaning performance was expected to be comparable or better. The conclusion states equivalence was achieved.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: 9 organisms. The document doesn't specify the number of individual tests or bottles per organism, but mentions "low levels of the 9 microorganisms."
Data Provenance: Human blood (used for dilution) inoculated into the culture bottles. The origin (country/retrospective/prospective) of the human blood samples is not specified, but the study design ("seeded studies") indicates a controlled, likely prospective, laboratory-based study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. For a microbial growth monitor, the ground truth is typically established by laboratory methods confirming the presence and growth of specific microorganisms, not by human expert interpretation in the same way as, for example, radiology images.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of this device. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective interpretations (e.g., medical image diagnosis). For a microbial growth monitor, the "ground truth" relies on objective lab measurements (e.g., confirmed microbial growth, identification, and quantification).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. The BacT/ALERT FN Culture Bottle is a device for detecting microbial growth, not for interpretation by human readers in the same manner.

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

Yes, the study described is essentially a standalone performance study. The device (BacT/ALERT FN Plastic Culture Bottle) was tested directly for its ability to recover and detect microorganisms, and its performance was compared to a predicate device (BacT/ALERT FN Glass Culture Bottle). There's no indication of a human-in-the-loop component in the primary performance evaluation.

7. The Type of Ground Truth Used

The ground truth used was the confirmed presence and growth of specific microorganisms (9 known organisms) inoculated into blood samples at "low levels." This is a laboratory-established ground truth based on microbiology techniques.

8. The Sample Size for the Training Set

This information is not applicable/provided. The BacT/ALERT FN Culture Bottle is a physical culture medium and detection system, not an AI/machine learning algorithm that requires a training set in the conventional sense. The "development" of the device would involve R&D and testing, but not a "training set" of data for algorithmic learning.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/provided for the reasons stated above (not an AI/ML device requiring a training set).

Summary

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K020815

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:

bioMérieux, Inc.

Submitter's Address:

100 Rodolphe Street. Durham, North Carolina 27712 (919) 620-2373

Submitter's Telephone:

Submitter's Contact:

Ron Sanyal Ron Sa

Date 510(k) Summary Prepared: March 8, 2002

(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

(a)(3) An identification of the legally marketed device to which the submitter claims substantial equivalence;
Device Equivalent to: BacT/Alert FN Glass Culture Bottle
A description of the device. (a)(4)
Device Description: The BacT/ALERT FN Plastic Culture Bottle was developed for the same intended use as the current BacT/ALERT FN Glass 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 FN Bottle.

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

Device Intended Use: 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 summary of the technological characteristics of the new device in comparison to those of (a)(6) the predicate device.

The BacT/ALERT FN Plastic Culture Bottle utilizes the same detection technology as the BacT/ALERT FN Glass Culture Bottle. The similarities and/or differences with marketed device are listed in Table (a) (6) 1.

FEATURES	BACT/ALERT FN PLASTICCULTURE BOTTLE	BACT/ALERT FN GLASSCULTURE BOTTLE(K992432)
Intended Use	Same	Same
Culture Bottle Material	Plastic	Glass
Product Code	MDB	MDB
Technology	Reflectance	Reflectance
Color change based onCO2 production	YES	YES
Sensor	Emulsion	Emulsion
Indicator material	Xylenol Blue in Silicone Emulsion	Xylenol Blue in Silicone Emulsion
Growth ofmicroorganisms	Same	Same
Instrument Used	BacT/ALERT Microbial Detection Systems	BacT/ALERT MicrobialDetection Systems
Sample Source	Blood, Body Fluids	Blood, Body Fluids
Target Population	Adult	Adult

TABLE (a)(6).1

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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 9 organisms diluted in human blood and inoculated into the BacT/ALERT FN Plastic Culture bottle and the BacT/ALERT FN Glass Culture bottle.

The conclusions drawn from the nonclinical and clinical tests that demonstrate that the (b)3) 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 Plastic Culture Bottle was substantially equivalent to the BacT/ALERT FN Glass Culture Bottle based on recovery of low levels of the 9 microorganisms included in the study. Detection times were equivalent in both bottles.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with its head turned to the left. The eagle is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

Ron Sanyal, M. Pharm., CQE, RAC Manager, Regulatory Affairs Biomerieux, Inc. 100 Rodolphe Street Durham, NC 27712

K020815 Re:

Trade/Device Name: BacT/ALERT® FN Culture Bottle Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial Growth Monitor Regulatory Class: Class I Product Code: MDB Dated: March 8, 2002 Received: March 13, 2002

Dear Mr. Sanyal:

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.

APR 1 8 2002

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 -

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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/odrh/dsma/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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Page 1 of 1.

		510(k) Number (If known):_____________________________________________________________________________________________________________________________________________________	KOZO815Comments of the consisted to the consisted to the consideration of the control of the contribution of the contribution of the contribution of the contribution of the contribu	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
				CALL AND

BacT/ALERT® FN Culture Bottle Device Name:

Indications For Usa:

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

Concumence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	KD2 0815

Prescription Use	✓	OR	Over-The-Counter Use
(Per 21 CFR 801.109)
			(Optional Format 1-2-96)

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.