THE BACT/ALERT 3D MICROBIAL DETECTION SESTEM WITH EXPRECTION OR MICORACTERIA IN IS USED IN QUALITATIVE PROCEDURES FOR GROWTH AND DETECTION OF MICOBACTERIA IN CLINICAL SPECIMENS OTHER THAN BLOOD.

Device Description

BacT/Alert 3D System with expanded Mycobacteria indication is used in the qualitative procedures for growth and detection of Mycobacteria in clinical specimens other than blood.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance for BacT/Alert 3D with Mycobacteria Indication

Based on the provided 510(k) summary (K981736) for the BacT/Alert 3D System with expanded Mycobacteria Indication, the device aims to demonstrate substantial equivalence to the legally marketed MB/BacT Mycobacteria Culture System. The acceptance criteria are implicitly defined by the demonstration of comparable performance to the predicate device in several key aspects.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion is "substantial equivalence" to the MB/BacT Mycobacteria Culture System. This is evaluated through a comparison of performance characteristics.

Acceptance Criterion	Reported Device Performance (BacT/Alert 3D)
Intended Use	Growth and detection of Mycobacteria in Clinical Specimens other than blood. (Identical to predicate)
Media	Utilizes MB/BacT Process bottles (K954468), Culture Media with suitable nutritional conditions to recover mycobacterial species. Containing Middlebrook 7H9 Broth, Pancreatic Digest of Casein, Bovine Serum Albumin, Catalase, Purified Water. (Identical to predicate)
Bottle Blocks	Sealed for spill control. (Identical to predicate)
Air Circulation	Shuts off when door is open. (Functionally equivalent to predicate's "shuts off when drawer is open")
Determination for	High enough amount of acceleration of CO2 production, High enough amount of long-term growth, and high enough total change (delta) in the growth curve. (Identical detection algorithms as predicate)
Clinical Performance	22 isolates were positive on both the BacT/Alert 3D and the MB/BacT. 14 isolates were positive on BacT/Alert 3D only. 8 isolates were positive on MB/BacT only. (The BacT/Alert 3D yielded test results comparable to that seen with the predicate device.)
Non-clinical Performance (Time to Detection)	Analysis of times to detection showed no significant effect of detection system for either high (10^6 CFU/ml) or low (10^2 CFU/ml) inoculum levels when compared to the MB/BacT system.

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

Non-clinical Seeded Study:
- Sample Size: 10 organisms were tested. For low inoculum (10^2 CFU/ml), 6 bottles per organism were used (3 for current MB/BacT, 3 for BacT 3D), totaling 60 bottles. For high inoculum (10^6 CFU/ml), 2 bottles per organism were used (1 for current MB/BacT, 1 for BacT 3D), totaling 20 bottles.
- Data Provenance: In-house (Organon Teknika Corporation). Prospective.
Clinical Study:
- Sample Size: A total of 311 isolates were cultured from clinical specimens.
- Data Provenance: Clinical specimens. Retrospective or prospective is not explicitly stated, but "cultured from clinical specimens" generally implies real-world, likely retrospective collection, although a prospective collection of new specimens is also possible. The country of origin is not specified.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for either the non-clinical or clinical studies.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. For the clinical study, the results appear to be a direct comparison of positivity between the two systems, implying that a definitive "ground truth" might have been established prior to culturing, or that the systems were being compared against each other as equivalent methods.

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

No. This device is an automated microbial detection system, not a diagnostic imaging device typically evaluated with MRMC studies. The "readers" are the instruments themselves performing automated detection.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes. Both the non-clinical seeded study and the clinical study evaluated the performance of the BacT/Alert 3D system as a standalone algorithm/instrument, comparing its detection capabilities directly against the predicate device. There is no mention of human-in-the-loop performance in the context of aiding human interpretations.

7. The Type of Ground Truth Used

Non-clinical Seeded Study: The ground truth was based on the known inoculation of specific organisms at defined concentrations (10^6 and 10^2 CFU/ml). The "truth" of an organism being present and viable was established by the experimental design.
Clinical Study: The ground truth appears to be based on the comparative positivity between the BacT/Alert 3D and the MB/BacT Mycobacteria Culture System. While ideal ground truth for mycobacterial infection might come from further identification methods or clinical diagnosis, the study focuses on the agreement and discrepancies between the two culture systems in detecting something positive for mycobacteria. The document states "22 isolates were positive on both... 14 isolates were found to be positive on the BacT/Alert 3D only. 8 additional isolates were found to be positive on the MB/BacT only." This suggests the ground truth was the presence of a positive culture result according to each system's established criteria.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set. Given the 1998 submission date and the nature of the device (an automated microbial growth monitor, not a complex AI model requiring extensive neural network training in the modern sense), it is highly probable that the "algorithm" refers to pre-programmed detection logic based on CO2 production, growth curves, and delta changes, which would typically be developed and validated rather than "trained" on a large dataset in the way contemporary machine learning models are. The seeded and clinical studies serve as verification and validation (V&V) of the pre-established algorithms.

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

As no separate "training set" is described for algorithm development in the provided text, this question is not applicable. The algorithms for positivity determination (CO2 acceleration, long-term growth, total change in growth curve) are stated to be the same as the predicate device, implying they were already established and validated by the predicate device's prior regulatory submissions and development.

Summary

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JUL 2 4 1998

510(k) PREMARKET NOTIFICATION BACT/ALERT 3D SYSTEM EXPANDED INDICATION FOR MYCOBACTERIA

K981736

510(K) SUMMARY 16.0

A 510(k) Summary follows for the BacT/Alert 3D with Mycobacteria Indication described in this submission.

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510(k) PREMARKET NOTIFICATION BACT/ALERT 3D SYSTEM EXPANDED INDICATION FOR MYCOBACTERIA

510(k) Summary

The submitter's name, address, telephone number, a contact person, and the date the summary (a)(1) was prepared;

Submitter's Name: Organon Teknika Corporation

Organon Teknika Corporation Submitter's Address: 100 Akzo Avenue Durham, North Carolina 27712

Submitter's Telephone: (919) 620-2288

Submitter's Contact: Rebecca Rivas

Date 510(k) Summary Prepared: May 15, 1998

The name of the device, including the trade or proprietary name if applicable, the common or (a)(2) usual name, and the classification name, if known;
Trade or Proprietary Name: BacT/Alert 3D

Common or Usual Name: BacT/Alert 3D

Classification Name: Microbial Growth Monitor

(a)(3) An identification of the legally marketed device to which the submitter claims substantial equivalence;
Device Equivalent to: MB/BacT Mycobacteria Culture System

A description of the device. (a)(4)

Device Description: BacT/Alert 3D System with expanded Mycobacteria indication is used in the qualitative procedures for growth and detection of Mycobacteria in clinical specimens other than blood.

A statement of the intended use of the device. (a)(5)
Device Intended Use: Used in qualitative procedures for growth and detection of Mycobacteria in clinical specimens other than blood.

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510(k) PREMARKET NOTIFICATION BACT/ALERT 3D SYSTEM EXPANDED INDICATION FOR MYCOBACTERIA

predicate device.
Intended Use	Growth and detection ofMycobacteria in ClinicalSpecimens other thanblood.	Growth and detection ofMycobacteria in ClinicalSpecimens other than blood.
Media	MB/BacT Process bottles(K954468),Culture Mediawith suitable nutritionalconditions to recovermycobacterial species.Containing Middlebrook7H9 Broth, PancreaticDigest of Casein, BovineSerum Albumin,Catalase,Purified Water.	MB/BacT Processbottles(K954468),CultureMedia with suitablenutritional conditions torecover mycobacterial species.Containing Middlebrook 7H9Broth, Pancreatic Digest ofCasein, Bovine SerumAlbumin,Catalase, PurifiedWater.
Bottle Blocks	Sealed for spill control	Sealed for spill control
Air Circulation	Shuts off when door is open	Shuts off when drawer is open
Determinationfor positivity	High enough amount ofacceleration of CO2production, High enoughamount of long-termgrowth, and high enoughtotal change (delta) in thegrowth curve.	High enough amount ofacceleration of CO2production, High enoughamount of long-term growth,and high enough total change(delta) in the growth curve.
	MB/BacT MycobacteriaSystem	BacT/Alert 3D withMycobacteria Indication

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

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510(k) PREMARKET NOTIFICATION BACT/ALERT 3D SYSTEM EXPANDED INDICATION FOR MYCOBACTERIA

A brief discussion of the nonclinical tests submitted, referenced, or relied on in the Premarket (b)1) 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 in-house for 10 organisms at inoculum levels of 106 (high) and 102 (low) CFU/ml. Individual strains of each organism at the low inoculum level were inoculated into six bottles each. Three bottles were loaded into the current MB/BacT system, and three were loaded into the BacT 3D instrument. Individual strains of each organism at the high inoculum level were inoculated into two bottles each. One bottle was loaded into the current MB/BacT system, and one bottle was loaded into the BacT 3D Times to detection (in days) for each bottle were used to perform analysis for substantial instrument. equivalence between the two systems. Analysis of the times to detection showed no significant effect of detection system for either the high or low inoculum level.

A brief discussion of the clinical tests submitted, referenced, or relied on in the Premarket b)(2) notification submission for a determination of substantial equivalency.

A total of 311 isolates were cultured from clinical specimens on both the BacT/Alert 3D and the MB/BacT Mycobacteria Culture System. 22 isolates were positive on both the BacT/Alert 3D and the MB/BacT. An additional 14 isolates were found to be positive on the Bac 7/Alert 3D only. 8 additional isolates were found to be positive on the MB/BacT only.

(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).

Organon Teknika's BacT/Alert 3D System with mycobacteria indication utilizes the same culture media bottles and detection algorithms as the currently marketed predicate device the MB/Bacteria Culture System.

Both systems are equivalent in the following respects:

1. They both have the same intended use: For use in qualitative procedures for growth and detection of mycobacteria in clinical specimens other than blood.
1. They both utilize the same culture media bottles and detection methodology.
The BacT/Alert 3D vielded test results comparable to that seen with the predicate device the 3. MB/BacT Mycobacteria Culture System.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

The 2 1 1898

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Rebecca Rivas Requlatory Affairs Administrator Organon Teknika Corporation 100 Akzo Avenue Durham, North Carolina 27712

K981736 Re: Trade Name: BacT/Alert 3D with Mycobacteria Indication Requlatory Class: I Product Code: MDB Dated: June 24,1998 Received: June 25, 1998

Dear Ms. Rivas:

or regulations.

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 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 The general controls provisions of provisions of the Act. the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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

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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 requlation entitled, "Misbranding by reference to premarket notification" Other general information on your (21 CFR 807.97). responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/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

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10(k) Number (If known):

Device Name: BACT/ALERT 3D WITH MYCOBACTERIA INDICATION

Indications For Use:

THE BACT/ALERT 3D MICROBIAL DETECTION SESTEM WITH EXPRECTION OR MICORACTERIA IN IS USED IN QUALITATIVE PROCEDURES FOR GROWTH AND DETECTION OF MICOBACTERIA IN CLINICAL SPECIMENS OTHER THAN BLOOD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981736

Prescription Use (Per 21 CFR 801.109)

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.