MB/BacT Blood Culture Bottles in combination with the MB/BacT Enrichment Fluid are specifically designed for the cultivation of Mycobacterium sp. commonly isolated from blood when used in conjunction with the MB/BacT Mycobacterial Detection System.

Device Description

MB/BacT Blood Culture Bottles are specifically designed for the cultivation of Mycobacterium sp. Commonly isolated from blood.

AI/ML Overview

Here's an analysis of the provided text regarding the MB/BacT™ Blood Culture Bottle's acceptance criteria and supporting study:

The document is a 510(k) Premarket Notification for the MB/BacT™ Blood Culture Bottle, which is designed for the recovery and detection of Mycobacteria from blood. The device is being compared to the predicate device, the BACTEC 13A Blood Bottle (K863191).

Acceptance Criteria and Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a pass/fail format. Instead, it focuses on demonstrating substantial equivalence to the predicate device. The performance is gauged by whether the MB/BacT bottles yield comparable results to the BACTEC 13A.

Here's a table summarizing the reported device performance in relation to the predicate device:

Aspect	Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (MB/BacT™ Blood Culture Bottle)
Intended Use	To be equivalent to the predicate device for recovery and detection of Mycobacteria from blood.	Same intended use: recovery and detection of Mycobacteria from blood.
Specimen Source	To be equivalent to the predicate device in handling blood specimens.	Blood
Sample Volume	To be equivalent to the predicate device's sample volume.	5 mls.
Microbial Growth	Favorable growth performance for mycobacterial isolates comparable to the predicate device.	Non-clinical: Favorable growth performance achieved with 20 mycobacterial isolates (10 species) at 1x10² and 1x10¹ CFU. Clinical: 55 organisms isolated by both bottles, 9 isolated by MB/BacT only, 2 isolated by BacTec 13A only. This demonstrates comparable or potentially superior isolation rates for MB/BacT for some organisms.
Safety and Effectiveness	To be as safe and effective as the legally marketed predicate device.	Conclusions state the device is as safe, as effective, and performed as well or better than the legally marketed device, based on comparable test results in clinical and in-house studies.

Study Details

2. Sample size used for the test set and the data provenance:

Non-clinical (In-house) Test Set: 20 mycobacterial isolates representing 10 different species.
Clinical Test Set: 238 paired bottles.
Data Provenance: Not explicitly stated, but the submission is from the United States (Organon Teknika Corporation, Durham, North Carolina). Given the nature of a 510(k) submission, it would typically involve prospective or retrospective data collected under a controlled study protocol. The phrase "Two clinical studies were carried out" suggests a prospective design for the clinical evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not specify the number of experts used or their qualifications for establishing ground truth. The determination of "organism isolation" would typically be performed by trained laboratory personnel, but no explicit details on expert involvement are provided.

4. Adjudication method for the test set:

The document does not describe an explicit adjudication method. The outcome is presented as isolated organisms by either device or both. It implies that the presence of a Mycobacteria species would be confirmed by standard laboratory identification methods once detected by either bottle, but no specific adjudication process for discrepancies is detailed.

5. 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:

No. This device is a blood culture bottle for detecting microbial growth, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, in essence. The performance of the MB/BacT™ Blood Culture Bottle (which operates using a colorimetric sensor to monitor CO₂ production) is inherently standalone in its detection mechanism. The study directly compares the detection capability of this bottle technology to the predicate BACTEC 13A technology, without explicitly involving varying human interpretations of the growth signals from the device itself. The "organism isolation" is the direct output of the bottle's function.

7. The type of ground truth used:

Microbial Growth/Identification: The ground truth is the actual isolation and identification of Mycobacterium sp. from the blood samples. This would typically be confirmed by subsequent laboratory procedures (e.g., staining, culturing on specific media, biochemical tests, or molecular methods) after a "positive" signal from the blood culture bottle.

8. The sample size for the training set:

The document does not mention a separate training set. This type of device (a diagnostic culture medium) doesn't typically involve a "training set" in the machine learning sense. Its performance is evaluated based on its ability to support microbial growth and detect metabolic byproducts.

9. How the ground truth for the training set was established:

As no training set is mentioned in the context of machine learning, this question is not applicable. The device's mechanism of action (colorimetric detection of CO2) is based on established biological principles, not on
learned patterns from a training dataset.

Summary

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KC982263

AUG 1 8 1998

510(k) Premarket Notification Organon Teknika Corporation MB/BacT™ Blood Culture Bottle

510(K) SUMMARY 17.0

A 510(k) Summary follows for the MB/BacT™ Blood Culture Bottle product described in this submission.

.00137

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510(k) Premarket Notification Organon Teknika Corporation MB/BacT™ Blood Culture Bottle

510(k) Summary MDA™Simplastin HTF

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 USA

Submitter's Telephone: (919) 620-2288

Submitter's Contact: Rebecca Rivas

Date 510(k) Summary Prepared:

The name of the device, including the trade or proprietary name if applicable, the (a)(2) common or usual name, and the classification name, if known;

Trade or Proprietary Name: MB/BacT™ Blood Culture Bottle

Common or Usual Name: Mycobacterium Blood Culture Bottle

Classification Name: Microbial Growth Monitor

An identification of the legally marketed device to which the submitter claims (a)(3) substantial equivalence;
BACTEC 13A Blood Bottle - Becton Dickinson & Device Equivalent to: Co.(K863191)

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

Device Description: MB/BacT Blood Culture Bottles are specifically designed forthe cultivation of Mycobacterium sp. Commonly isolated from blood.

(a)(5) A statement of the intended use of the device.
Device Intended Use: Recovery and detection of Mycobacteria from blood.

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510(k) Premarket Notification Organon Teknika Corporation MB/BacT™ Blood Culture Bottle

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

Assay Feature	MB/BacT™ Blood Culture Bottle	BACTEC 13A Blood CultureBottle
Specimen Source	Blood	Blood
Intended Use	Culture and detection of Mycobacteria sp.from blood.	Culture and detection ofmicroorganisms (mainlyMycobacteria) from blood.
Sample Volume	5 mls.	5 mls.
Technology	Colorimetric sensor and reflectancevalues are used to monitor productionof CO₂ dissolved in culture media.	Radiometric technique, 14CO₂produced by Mycobacteria fromthe metabolism of 14C-labeledsubstance is measured.
Storage	Culture Bottles - 15°C - 30°C	Culture Bottles - 2°C - 25°C
	Enrichment Fluid - 2°C - 8°C	Enrichment Fluid - 2° - 25°C
Components	Culture Bottle and Enrichment Fluid	Culture Bottle and EnrichmentFluid
Controls	Certificate of Analysis provided, labmay test new lots if desired withATCC#25291 and ATCC#13950recommended days to positive providedin package insert.	Quality Control Certificates provided.

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510(k) Premarket Notification Organon Teknika Corporation MB/BacT™ Blood 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:

A total of twenty mycobacterial isolates were tested representing ten different species. All isolates were evaluated in non-shaking conditions for two theoretical levels of inocula, 1 x 102 and 1 x 101 CFU, respectively. Overall, favorable growth performance was achieved with the cultures.

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

Two clinical studies were carried out with a total of 238 paired bottles. Blood was inoculated in even volumes of 5 mls. into each bottle pair. The studies compared growth of Mycobacteria sp. from blood between the MB/BacT Blood Culture Bottles and the BacTec 13A Culture Bottle. Out of the 238 paired bottles, 55 organisms were isolated by both bottles. 9 organisms were isolated by MB/BacT bottles only and 2 organisms were isolated by BacTec 13A bottles only.

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

Both the MB/BacT Blood Culture Bottle and the predicate device, the BacTec 13A are equivalent in the following respects:

They have the same intended use: the recovery and detection of Mycobacteria in 1. blood.
1. They are both in-vitro diagnostic test systems which are based on microbial growth in media.
Organon Teknika's MB/BacT Blood Culture Bottle yield test results, both in clinical 3. studies and in-house studies, comparable to that seen with the predicate device the BacTec 13A Blood Culture Bottle.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 8 1998

Rebecca A. Rivas Regulatory Affairs Administrator Organon Teknika Corporation 100 Akzo Avenue Durham, N.C. 27712

Re: K982263

Trade Name: MB/BACT® Blood Culture Bottle Regulatory Class: I Product Code: MDB Dated: June 25, 1998 Received: June 29, 1998

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.

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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 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

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Page	of
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(10(k) Number (If known):

MB/BacT Blood 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)

Woody Dubois

(Division Sign-off)
Division of Clinical Laboratory Devices
510(k) Number K982263

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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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.