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

Device Description

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

AI/ML Overview

Here's an analysis of the acceptance criteria and study proving device efficacy, drawn from the provided 510(k) Premarket Notification for the BacT/ALERT SA (Plastic) Culture Bottle:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document focuses on demonstrating substantial equivalence rather than explicit quantitative acceptance criteria as might be seen for a novel device. The primary "acceptance criterion" is functional equivalence in detecting microorganisms and equivalent detection times compared to the predicate device.

Acceptance Criteria Category	Specific Criteria (Implicitly Derived)	Reported Device Performance (BacT/ALERT SA Plastic)
Microorganism Recovery	Equivalent recovery of a panel of medically relevant microorganisms.	"The BacT/ALERT SA Plastic Culture Bottle was substantially equivalent to the BacT/ALERT SA Glass Culture Bottle based on recovery of low levels of the 23 microorganisms included in the study." This implies that the recovery rates of the 23 tested organisms were comparable to the predicate device.
Detection Time	Equivalent time to detection of microorganisms.	"Detection times were equivalent in both bottles." This indicates that the new plastic bottle did not significantly delay or accelerate the detection of microbial growth compared to the glass bottle.
Intended Use	Device must be suitable for the same intended use as the predicate (qualitative detection of aerobic microorganisms in blood and sterile body fluids).	"Same" as the predicate device (BacT/ALERT SA Glass Culture Bottle). The plastic bottle is intended for the same purpose, confirming this aspect of equivalence.
Technological Equivalence	Device must utilize the same core detection technology (reflectance with CO2 color change sensor).	"Same" technology: Reflectance, color change based on CO2 production, emulsion sensor with Xylenol Blue in Silicone Emulsion. This criterion was met by design.

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

Sample Size: "Seeded studies were performed on 23 organisms diluted in human blood and inoculated into the BacT/ALERT SA Plastic Culture bottle and the BacT/ALERT SA Glass Culture bottle."
- While 23 organisms were tested, the number of individual samples (bottles) per organism and per bottle type is not explicitly stated. It's implied there were multiple replicates for each organism to assess recovery and detection time. Given it's a seed study, this usually means a controlled number of organisms were inoculated into a controlled number of samples for each condition.
Data Provenance: The study used human blood as the sample matrix. The specific country of origin for the blood or where the study was conducted is not stated in the provided text. The study design (seeded studies) means it was a prospective experimental study conducted under controlled laboratory conditions, not a retrospective analysis of clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of study does not typically involve human experts establishing "ground truth" in the same way an imaging AI study would. The "ground truth" here is the known presence and type of seeded organisms. The detection and identification of these organisms would likely be performed by trained laboratory personnel using standard microbiological methods, rather than clinical experts providing diagnoses.
No information is provided regarding the number or qualifications of any experts involved in assessing the results, other than implicit assumption of qualified laboratory personnel.

4. Adjudication Method for the Test Set

None applicable in the context of this type of microbiological assay. Adjudication methods like 2+1 or 3+1 are typically used for subjective clinical assessments or image interpretations where multiple experts provide independent reads that need to be resolved. In this seeded study, the outcome (growth/no growth, time to detection, organism identity) is objectively determined by the instrument and subsequent laboratory confirmation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC study was not done. This type of study is designed to assess the performance of diagnostic devices or AI algorithms in the hands of multiple human readers, often comparing performance with and without assistance from the device. The BacT/ALERT system is a standalone diagnostic instrument for microbial detection, not an AI-assisted tool for human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this was a standalone performance study. The BacT/ALERT system (both glass and plastic bottles) is designed to operate autonomously, detecting microbial growth and alerting the user. The study compared the performance of the new plastic bottle (as part of the BacT/ALERT system) and the predicate glass bottle directly, without human intervention in the detection process itself. The "algorithm" here is the instrument's detection mechanism for CO2 production.

7. Type of Ground Truth Used

The ground truth was established by known seeding of specific microorganisms at controlled concentrations. This is a form of controlled experimental ground truth, where the input (what organisms are present in what amount) is precisely defined by the study design. Subsequent identification of recovered organisms would typically be confirmed by standard microbiological identification methods after the instrument detected growth.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this type of device. The BacT/ALERT system is a pre-calibrated instrument that detects a physiological change (CO2 production indicating microbial metabolism). It does not use machine learning algorithms that require a training set to "learn" patterns. Therefore, no training set was used.

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

As no training set was used, this question is not applicable.

Summary

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K020931

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

Submitter's Telephone:

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

Submitter's Contact:

Ron Sanyal Ron Sangal

Date 510(k) Summary Prepared: March 21, 2002

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 SA Culture Bottle

Common or Usual Name: BacT/ALERT SA 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 SA Glass Culture Bottle
A description of the device. (a)(4)
Device Description: The BacT/ALERT SA Plastic Culture Bottle was developed for the same intended use as the current BacT/ALERT SA 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 SA Bottle.

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

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

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510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT SA (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 SA Plastic Culture Bottle utilizes the same detection technology as the BacT/ALERT SA Glass Culture Bottle. The similarities and/or differences with marketed device are listed in Table (a) (6) 1.

FEATURES	BACT/ALERT SA PLASTICCULTURE BOTTLE	BACT/ALERT SA GLASSCULTURE BOTTLE(K993423)
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 SiliconeEmulsion
Growth ofmicroorganisms	Same	Same
Instrument Used	BacT/ALERT Microbial DetectionSystems	BacT/ALERT MicrobialDetection 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 SA (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 SA Plastic Culture bottle and the BacT/ALERT SA 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 SA Plastic Culture Bottle was substantially equivalent to the BacT/ALERT SA 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 logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or other bird.

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

Re:

K020931 Trade/Device Name: BacT/ALERT® SA Culture Bottles Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial Growth Monitor Regulatory Class: Class I Product Code: MDB Dated: March 21, 2002 Received: March 22, 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/cdrh/dsma/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 1 of 1

ﻧ 10(k) Number (If known):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

BacT/ALERT SA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for the recovery and detection of aerobic 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
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Division of Clinical Laboratory Devices

510(k) Number	K020931
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Prescription Use (Per 21 CFR 801.109)
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Over-The-Counter Use
	(Optional Format 1-2-96)

018

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.