The BacT/ALERT MP Process Bottle is designed for use with the MB/BacT and the The DacT/ALERT 3D Mycobacteria Detection Systems, for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens.

Device Description

The BacT/ALERT MP Process Bottle was developed for the same intended use as the current MB/BacT Process Bottle, provide suitable nutritional and environmental conditions for mycobacterial organisms commonly encountered in body fluids. An inoculated bottle is placed into the MB/ BacT Detection Instrument or the BacT/ALERT 3D Instrument where it is incubated and continuously monitored for the presence of mycobacteria that will grow in the BacT/ALERT MP Process Bottle.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BacT/ALERT MP Process Bottle, based on the provided K993576 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly state numerical acceptance criteria (e.g., "sensitivity must be > X"). Instead, the acceptance criterion is implied as substantial equivalence to the predicate device (MB/BacT Process Bottles) in terms of recovery and detection times for mycobacterial organisms.

Acceptance Criterion (Implied)	Reported Device Performance
Substantial equivalence in recovery of mycobacterial organisms.	The BacT/ALERT MP Process Bottle showed equivalent recovery for 12 organisms.
Substantial equivalence in detection times for mycobacterial organisms.	Detection times were substantially equivalent in both bottles.

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

Sample Size (Test Set): 12 organisms were used. The document does not specify the number of replicate bottles per organism or the total number of individual tests performed.
Data Provenance: The document does not specify the country of origin. The studies appear to be prospective seeded studies as organisms were inoculated into bottles for testing.

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

The document does not mention the use of experts to establish ground truth for the seeded studies. For seeded studies in microbiology, the "ground truth" is typically the known presence and identity of the inoculated organism.

4. Adjudication Method for the Test Set

Not applicable. The study involved a direct comparison of the new device's performance against a predicate device using known inoculated organisms (ground truth). There was no mention of human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a microbial growth monitor, and performance is based on automated detection by instrumentation, not human reader interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The device's performance (recovery and detection time) was evaluated directly by the BacT/ALERT 3D System or MB/BacT Mycobacterial Detection Systems after inoculation and incubation, without human intervention for result interpretation.

7. The Type of Ground Truth Used

The ground truth used was the known inoculation of specific mycobacterial organisms into the test bottles. This provides a definitive "positive" control for the presence of the target organisms.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. The studies described are performance validation tests for the physical bottle. If there was any internal algorithm development for the detection systems themselves, that information is not provided in this 510(k) summary. The 12 organisms tested were part of the test set to demonstrate equivalence.

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

As no specific training set is mentioned for an algorithm, this question is not directly applicable. For the performance studies described, the ground truth was inherently established by the controlled inoculation of known organisms.

Summary

{0}------------------------------------------------

K993576

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: October 20, 1999

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 MP Process Bottle

Common or Usual Name: BacT/ALERT MP Process 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: MB/BacT Process Bottles
A description of the device. (a)(4)
Device Description: The BacT/ALERT MP Process Bottle was developed for the same intended use as the current MB/BacT Process Bottle, provide suitable nutritional and environmental conditions for mycobacterial organisms commonly encountered in body fluids. An inoculated bottle is placed into the MB/ BacT Detection Instrument or the BacT/ALERT 3D Instrument where it is incubated and continuously monitored for the presence of mycobacteria that will grow in the BacT/ALERT MP Process Bottle.
(a)(5) A statement of the intended use of the device.
Device Intended Use: The BacT/ALERT MP Process Bottle is designed for use with the MB/BacT and the BacT/ALERT 3D Mycobacteria Detection Systems, for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens.

{1}------------------------------------------------

A summary of the technological characteristics of the new device in comparison to those of (a)(6) the predicate device. The BacT/ALERT MP Process Bottle utilizes the same detection technology as the MB/BacT/ Culture Bottle.

FEATURES	BACT/ALERT MP PROCESS BOTTLE	MB/BACT PROCESSBOTTLE
Technology	Reflectance	Reflectance
Color change based onCO2 production	Yes	Yes
Sensor	Emulsion	Disc
Indicator material	Yes, Same as MB/BacT ProcessBottle	Yes
Growth ofmicroorganisms	Yes, Equivalent to MB/BacTProcess Bottle	Yes
Instrument Used	MB/BacT Mycobacterial DetectionSystems or BacT/ALERT 3D System	MB/BacT MycobacterialDetection Systems orBacT/ALERT 3D System
Sample Source	Body Fluids	Body Fluids
Target Population	Adult	Adult

{2}------------------------------------------------

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 12 organisms and inoculated into the BacT/ALERT MP Process Bottle and the MB/BacT Process Bottle.

(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 MP Process Bottle was substantially equivalent to the MB/BacT Process Bottle based on recovery of the 12 mycobacterial organisms included in the study. Detection times were substantially equivalent in both bottles.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 4 1999

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

K993576 Re: Trade Name: BacT/ALERT MP Process Bottle Regulatory Class: I Product Code: MDB Dated: October 20, 1999 Received: October 21, 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.

{4}------------------------------------------------

Page 2

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

{5}------------------------------------------------

Page
of

510(k) Number (If known):	K993576
Device Name:	BacT/ALERT MP Process Bottle

Indications For Usa:

decontaminated clinical specimens.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubris

inical Laboratory Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

(Optional Format 1-2-98)

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.