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

Device Description

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

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the BacT/ALERT SN (Plastic) Culture Bottle, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

The provided document describes a substantial equivalence submission, which means the new device (BacT/ALERT SN Plastic Culture Bottle) is compared to a legally marketed predicate device (BacT/ALERT SN Glass Culture Bottle). The acceptance criteria are implicitly defined by demonstrating equivalent performance to the predicate device.

Table 1: Acceptance Criteria and Reported Device Performance

Performance Metric/Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (BacT/ALERT SN Plastic Culture Bottle)
Microorganism Recovery	Equivalent recovery of low levels of 9 test microorganisms to the predicate device.	"Recovery of low levels of the 9 microorganisms included in the study" was equivalent to the predicate device.
Detection Times	Equivalent detection times to the predicate device.	"Detection times were equivalent in both bottles."

Study Information

The type of study conducted is a comparative performance study against the predicate device.

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

Sample Size: The document states "Seeded studies were performed on 9 organisms." This indicates that nine specific microorganisms were tested. The number of replicates or individual tests per organism is not specified in this summary.
Data Provenance: The study involved "human blood," indicating the biological matrix used. The origin country of the human blood or where the study was conducted is not specified. The study is by nature prospective, as it involves direct experimentation with the new device.

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

This type of study (microbial growth and detection) typically relies on laboratory-based microbiological techniques as the ground truth, rather than expert interpretation of images or clinical data. Therefore, no external experts were explicitly mentioned for establishing ground truth as one might see in imaging studies. The "ground truth" for positive growth and detection times would be determined by the instrument's (BacT/ALERT Microbial Detection Systems) readings and potentially confirmed by standard microbiological methods (e.g., subculturing). The qualifications of the laboratory personnel performing these tests are not specified.

4. Adjudication Method:

None explicitly mentioned or applicable in the context of this performance study. The device's automated detection system and established microbiological methods would determine the outcome directly.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and aims to measure the impact of AI assistance on human performance. This submission is for an automated microbial detection system, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance Study:

Yes, implicitly. The study directly measures the performance of the BacT/ALERT SN Plastic Culture Bottle in conjunction with the BacT/ALERT Microbial Detection System. Since the system (including the bottle) provides an automated output (detection of microbial growth), this can be considered a standalone performance assessment of the device and its associated technology without human intervention in the detection process itself.

7. Type of Ground Truth Used:

The ground truth is based on direct microbiological observation/culturing and instrumental detection. The "ground truth" for microorganism recovery and detection times is established by the known inoculation of specific organisms and the automated detection by the BacT/ALERT Microbial Detection System, which is a well-established technology for this purpose.

8. Sample Size for the Training Set:

Not applicable/not specified. This document describes a performance validation study for a device, not the development or training of a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML model development.

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

Not applicable. As there is no training set for an AI/ML algorithm described, this question is not relevant to the provided documentation.

Summary

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APR 2 6 2002

K021123

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

Submitter's Contact:

100 Rodolphe Street, Durham, North Carolina 27712

(919) 620-2373 Ron Sanyal Ron

April 4, 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 SN Culture Bottle

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

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

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

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

FEATURES	BACT/ALERT SN PLASTICCULTURE BOTTLE	BACT/ALERT SN GLASSCULTURE BOTTLE(K993421)
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 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 SN (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 9 organisms diluted in human blood and inoculated into the BacT/ALERT SN Plastic Culture bottle and the BacT/ALERT SN Glass Culture bottle.

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

The BacT/ALERT SN Plastic Culture Bottle was substantially equivalent to the BacT/ALERT SN The Dactive 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles an abstract caduceus or a stylized representation of human figures.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K021123

Trade/Device Name: BacT/ALERT® SN Culture Bottle Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial Growth Monitor Regulatory Class: Class I Product Code: MDB Dated: April 4, 2002 Received: April 8, 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 10 rate exaction 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.

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 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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510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT SN (Plastic) Culture Bottle

Page 1 of 1

510(k) Number (if known):__

BacT/ALERT® SN 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)

Freddie L. Poole

(Division Sign-Off) (DMsion Sign-Olir)
Division of Clinical Laboratory Devices 12021123 510(k) Number.

Prescription Use (Per 21 CFR 801.109) ાર

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Formal 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.