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

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

Acceptance Criteria and Device Performance

The acceptance criteria for the BacT/ALERT FA Plastic Culture Bottle are implicitly defined by its substantial equivalence to the predicate device, the BacT/ALERT FA Glass Culture Bottle. The study aimed to demonstrate that the new device performs "as well or better" than the predicate and that "Detection times were equivalent in both bottles." While explicit numerical acceptance criteria are not provided (e.g., "detection time must be within X% of the predicate"), the overall performance target was parity or superiority.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent recovery of low levels of microorganisms	"Recovery of low levels of the 23 microorganisms included in the study" was shown to be equivalent.
Equivalent detection times for microorganisms	"Detection times were equivalent in both bottles."
Suitable for detection of aerobic and facultative anaerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids	The study included 23 organisms, demonstrating this capability.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: The study involved "23 organisms." The text doesn't specify the number of individual tests or inoculations per organism, but refers to "low levels" of these organisms, implying multiple tests or replicates to assess recovery and detection times.
- Data Provenance: The study used "human blood" for diluting the organisms. The country of origin for the data is not specified. It was a prospective study conducted specifically for this 510(k) submission to demonstrate performance characteristics of the new device relative to the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The ground truth for bacterial growth and detection in culture bottles is typically established by laboratory methods, such as visual confirmation of growth, subculture, and identification, rather than expert interpretation of images or signals that require human consensus. The "ground truth" here is the actual presence and growth of the inoculated microorganisms.
Adjudication method for the test set:
- This is not applicable and not provided. The study involves direct measurement of microbial growth and detection times, not a diagnostic interpretation or subjective assessment that would require an adjudication process.
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:
- This is not applicable and not provided. This device is an automated microbial detection system, not an AI-assisted diagnostic tool that involves human readers interpreting results.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The study compared the performance of the new BacT/ALERT FA Plastic Culture Bottle with the predicate BacT/ALERT FA Glass Culture Bottle, both of which are used with the automated BacT/ALERT Microbial Detection Systems. The system itself operates in a standalone manner to detect microbial growth. The "algorithm" here refers to the detection mechanism of the instrument when monitoring the bottles.
The type of ground truth used:
- The ground truth was the actual presence and growth of specific, known microorganisms at "low levels" in human blood. This is equivalent to known positive controls or spiked samples where the microbial content is precisely controlled and confirmed through standard microbiological techniques.
The sample size for the training set:
- The text does not mention a training set. This product is a physical culture bottle intended for use with a pre-existing detection system (BacT/ALERT Microbial Detection Instruments). The study described is a performance validation study for the new bottle material, not a development or training phase for a new algorithm.
How the ground truth for the training set was established:
- This is not applicable as no training set is mentioned or implied for this type of device submission.

Summary

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APR 1 7 2002

K020813

510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT FA (Plastic) 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:

bioMérieux, Inc.

Submitter's Address:

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

Submitter's Telephone:

Submitter's Contact:

Ron Sanyal

March 8, 2002 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 FA Glass Culture Bottle
A description of the device. (a)(4)
Device Description: The BacT/ALERT FA Plastic Culture Bottle was developed for the same intended use as the current BacT/ALERT FA 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 FA Bottle.

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

Device Intended Use: 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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510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT FA (Plastic) Culture Bottle

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

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

FEATURES	BACT/ALERT FA PLASTIC CULTURE BOTTLE	BACT/ALERT FA GLASS CULTURE BOTTLE (K992400)
Intended Use	Same	Same
Culture Bottle Material	Plastic	Glass
Product Code	MDB	MDB
Technology	Reflectance	Reflectance
Color change based on CO2 production	YES	YES
Sensor	Emulsion	Emulsion
Indicator material	Xylenol Blue in Silicone Emulsion	Xylenol Blue in Silicone Emulsion
Growth of microorganisms	Same	Same
Instrument Used	BacT/ALERT Microbial Detection Systems	BacT/ALERT Microbial Detection Systems
Sample Source	Blood, Body Fluids	Blood, Body Fluids
Target Population	Adult	Adult

TABLE (a) (6) 1.

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510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT FA (Plastic) 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 23 organisms diluted in human blood and inoculated into the BacT/ALERT FA Plastic Culture bottle and the BacT/ALERT FA Glass Culture bottle.

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

The BacT/ALERT FA Plastic Culture Bottle was substantially equivalent to the BacT/ALERT FA Glass Culture Bottle based on recovery of low levels of the 23 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. The eagle's wings are represented by the profiles, creating a sense of unity and human connection.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

APR 1 7 2002

Re: K020813

Trade/Device Name: BacT/ALERT® FA 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 wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of the 10 May 20, 1977, in ecordance with the provisions of the Federal Food, Drug, devices mat nave occh roomstile in quire approval of a premarket approval application (PMA). and Cosmeter For (110) and the device, subject to the general controls provisions of the Act. The I ou may, therefore, maines of the Act include requirements for annual registration, listing of general controls pro resuring practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classined too as controls. Existing major regulations affecting your device can may oe subject to basil adales and 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 I touse of actived 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 or any I vactar banates and securements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fat 60775 morems (21 (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 ) 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/cdrh/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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510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT FN (Plastic) Culture Bottle

Page 1 of 1:

510(k) Number (If known):	K020813
	BacT/ALERT® FA Culture Bottle

Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sigr
Division of C	atory Devices
510(k) Number	K020813
Prescription Use	✓
(Per 21 CFR 801.109)	OR
	Over-The-Counter Use
	(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.