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 Systems (nonshaking detection systems) and the BacT/Alert Microbial Detection Systems (shaking detection systems).

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 acceptance criteria and study for the MB/BacT™ Blood Culture Bottle:

This document focuses on establishing substantial equivalence for an expanded indication of an existing device (MB/BacT™ Blood Culture Bottle) in a new system (BacT/Alert Microbial Detection System). As such, the "acceptance criteria" are implied by the comparison to a predicate device, rather than explicit numerical thresholds.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission seeking substantial equivalence for an expanded indication rather than a de novo approval, the "acceptance criteria" are framed by comparison to the predicate device, the BACTEC 13A Blood Bottle. The primary goal is to demonstrate comparable performance. The document does not explicitly state numerical acceptance criteria, but rather a qualitative assessment of "comparable" or "favorable" performance.

Acceptance Criteria (Implied by Comparison to Predicate)	Reported Device Performance (MB/BacT™ Blood Culture Bottle)
Recovery and detection of Mycobacteria in blood comparable to predicate device.	"yielded test results, both in clinical studies and in-house studies, comparable to that seen with the predicate device, the Bactec 13A Blood Culture Bottle."
Favorable growth performance of Mycobacterial isolates.	"Overall, favorable growth performance was achieved with the cultures."
Overall organism isolation rate comparable to predicate.	From 491 paired bottles: 41 organisms isolated by both; 7 by MB/BacT™ alone; 2 by Bactec 13A alone. (Indicates competitive, if not slightly superior, isolation).

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

Test Set Sample Size:
- Clinical Studies: 491 paired bottles.
- Nonclinical/In-house Studies (Mycobacterial Isolates): 20 mycobacterial isolates representing 10 different species, each tested at two inoculum levels (1 x 10² and 1 x 10³ CFU).
Data Provenance: The document does not explicitly state the country of origin for the clinical data. It generally refers to "clinical studies" and "in-house studies." Given the submitter's address (Durham, North Carolina, USA), it is highly probable the in-house studies were conducted in the US. The clinical studies are not specified as retrospective or prospective; however, "studies were carried out" implies prospective data collection for the comparison.

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth in the clinical or nonclinical studies. For blood culture systems, the "ground truth" for organism isolation and identification is typically established by standard microbiology laboratory procedures, which would involve trained microbiologists, but this is not detailed in the provided text.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set results. The comparison seems to be based on direct laboratory findings from the two different culture systems.

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

This is not applicable to this device. This device is an in-vitro diagnostic (IVD) blood culture bottle, not an imaging or diagnostic device requiring human interpretation of visual data where reader variability would be a primary concern. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor would it typically be relevant for this type of IVD.

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

This is implicitly a standalone study in terms of the device performance. The MB/BacT™ Blood Culture Bottle is used in conjunction with the BacT/Alert Microbial Detection System. The system automatically detects microbial growth. While laboratory personnel retrieve positive bottles and perform subsequent identification, the "performance" discussed here relates to the ability of the bottle/system combination to detect mycobacteria. There is no "human-in-the-loop" performance component that would modify the detection algorithm itself. The comparison is between two automated detection systems (MB/BacT™ on BacT/Alert vs. BACTEC 13A).

7. Type of Ground Truth Used

The ground truth used for both the clinical and nonclinical studies appears to be based on microbial isolation and identification.

In nonclinical studies: Known mycobacterial isolates at specific inoculum levels were used to assess "growth performance."
In clinical studies: Organisms "isolated by both" or "isolated by... alone" implies standard microbiological culture and identification methods as the ground truth for presence/absence of mycobacteria in the blood samples.

8. Sample Size for the Training Set

The document does not provide information regarding a "training set." The studies described are performance evaluation studies, comparing the new device's performance to a predicate. This type of 510(k) submission generally relies on demonstrating equivalence through direct comparison rather than an AI/machine learning model that would require distinct training and test sets.

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

As no "training set" is mentioned in the context of an AI/machine learning model, this information is not applicable and therefore not provided in the document.

Summary

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KG8372

510(k) Premarket Notification Organon Teknika Corporation MB/BacT™ Blood Culture Bottle Expanded Indication for use in the BacT/Alert Microbial Detection Systems

16.0 510(k) SUMMARY

A 510(k) Summary follows for the MB/BacT™ Blood Culture Bottle expanded indication for use in the BacT/Alert Microbial Detection System product described in this submission.

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510(k) Premarket Notification Organon Teknika Corporation MB/BacT™ Blood Culture Bottle Expanded Indication for use in the BacT/Alert Microbial Detection Systems 510(k) Summary

The submitter's name, address, telephone number, a contact person, and the date (a)(1) the 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: 10/22/98

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: Mycobacteria 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 for the cultivation of Mycobacterium sp. Commonly isolated from blood.

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

Device Intended Use: Recovery and detection of Mycobacteria from blood.

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

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510(k) Premarket Notification Organon Teknika Corporation Expanded Indication for use in the BacT'M Blood Culture Bottle

Expanded Indication for use in the BacT/Alert Microbial Detection Systems

Expanded Indication for use in the Bac1/Alert Microbial Detection Systems
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	3-5 mls.	5 mls.
Technology	Colorimetric sensor and reflectancevalues are used to monitorproduction of CO₂ dissolved inculture media.	Radiometric technique, $^{14}$ CO₂produced by Mycobacteria fromthe metabolism of $^{14}$ C-labeledsubstance is measured.
Storage	Culture Bottles - 15°C - 30°CEnrichment Fluid - 2°C - 8°C	Culture Bottles - 2°C - 25°CEnrichment Fluid - 2°C - 25°C
Components	Culture Bottle and EnrichmentFluid	Culture Bottle and EnrichmentFluid
Controls	Certificate of Analysis provided , labmay test new lots if desired withATCC#25291 and ATCC#13950recommended days to positiveprovided in package insert.	Quality Control Certificates provided.

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510(k) Premarket Notification Organon Teknika Corporation MB/BacT™ Blood Culture Bottle Expanded Indication for use in the BacT/Alert Microbial Detection Systems

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 shaking conditions for two theoretical levels of inocula, 1 x 102 and 1 x 10' 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 vielding a total of 491 paired bottles. The studies compared growth of Mycobacteria sp. from blood between the MB/Blood Culture Bottle tested in a BacT/Alert Microbial Detection System (shaking environment) and the Bactec 13A. Out of the 491 paired bottles, 41 organisms were isolated by both the MB/Blood Bottle and the Bactec bottle. Seven (7) organisms were isolated by the MB/BacT Blood Bottle alone and 2 organisms were isolated by the Bactec 13A bottle alone.

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:

1. They have the same intended use: the recovery and detection of Mycobacteria in blood.
They are both in-vitro diagnostic test systems which are based on microbial growth in 2. media.
1. Organon Teknika's MB/BacT Blood Culture Bottle when used on the BacT/Alert Microbial Detection System (shaking environment) vielded test results, both in clinical 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 3 1999

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

K983772 Re: Trade Name: MB/BacT Blood Culture Bottle Regulatory Class: I Product Code: MDB Dated: October 23, 1998 Received: October 26, 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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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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510(k) Premarket Notification Organon Teknika Corporation MB/BacT™ Blood Culture Bottle Expanded Indication for use in the BacT/Alert Microbial Detection Systems

Page	of
510(k) Number (If known):
Device Name:	MB/BacT Blood Culture Bottle Expanded Indication for use on BacT/Alert Microbial Detection Systems
Indications For Use:
	MB/BacT Blood Culture Bottles in combination with the MB/BacT Enrichment Fluid are specifically designed for the cultivation of

hment Fluid are specifical Mycobacterium sp. commonly isolated from blood when used in conjunction with the MB/BacT Mycobacterial Detection Systems (nonshaking detection systems) and the BacT/Alert Microbial Detection Systems (shaking detection systems).

(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	K98 3772

Prescription Use_ (Per 21 CFR 801.109) OR

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.