BacT/Alert Culture Bottles are used with the BacT/Alert Microbial Detection System in qualitative procedures for recovery and detection of aerobic and anaerobic microorganisms from blood and other body fluids.

Device Description

The BacT/Alert® Culture Bottles contain media and an internal sensor that detects CO2 as an indicator of microbial growth when used in connection with the BacT/Alert® Microbial Detection System.

AI/ML Overview

The provided documents are a 510(k) summary and FDA clearance letter for the BacT/Alert Culture Bottles. This device is a microbial growth monitor used for the recovery and detection of aerobic and anaerobic microorganisms from blood and other body fluids.

Based on the information provided, the submission focuses on demonstrating substantial equivalence to traditional culture methodology, rather than setting specific quantitative acceptance criteria for the device's performance. The document describes the type of testing performed and the conclusions drawn, but it does not detail specific acceptance criteria or provide the raw performance data from a study that would "prove" the device meets such criteria in a quantitative sense as typically seen for AI/ML devices with metrics like sensitivity and specificity.

Therefore, for aspects related to specific quantitative acceptance criteria, sample sizes, expert involvement, and ground truth methodologies, the information is largely absent or not applicable in the context of this 510(k) submission which primarily relies on equivalence to an established method.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Intended Use Equivalence: Recovery and detection of aerobic and anaerobic microorganisms from body fluids.	BacT/Alert® Culture Bottles are used for "recovery and detection of aerobic and anaerobic microorganisms from blood and other body fluids," which is "the same intended use" as traditional culture methodology.
Methodology Equivalence: In-vitro diagnostic test systems based on microbial growth in media.	Both BacT/Alert® Culture Bottles and conventional methods are "in-vitro diagnostic test systems which are based on microbial growth in media."
Result Comparability: Yield test results comparable to conventional culture methodology.	"Organon Teknika's BacT/Alert® Culture Bottles yield test results comparable to that seen with conventional culture methodology."
Overall Performance Equivalence: Safe, effective, and performs as well or better than the legally marketed predicate device.	"BacT/Alert® Culture Bottles perform equivalent to conventional culture methodology."

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

The document states, "Testing was performed to establish the performance characteristics of the new device including comparison to traditional culture methodology." However, no specific sample size for the test set is provided.

Data Provenance: Not explicitly stated, but clinical testing was performed for comparison. The context implies it would be retrospective or prospective clinical samples as part of a comparative study against standard methods. There is no mention of country of origin.

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

Not Applicable / Not Provided: This type of information is typically relevant for studies using expert consensus for ground truth, especially in image analysis or diagnostic interpretation by human readers. For a microbial growth detection system, the "ground truth" would likely be established through confirmed microbial culture results (e.g., Gram stain, subculture, identification), rather than expert interpretation of a specific output from the device, and then compared to the BacT/Alert's detection. The document does not specify the method or process for establishing ground truth for the comparison methodology.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided: Adjudication methods (like 2+1, 3+1) are typically used when multiple human readers interpret results and their disagreements need to be resolved to establish ground truth or a consensus reading. In this case, the device detects microbial growth, and the comparison is to "traditional culture methodology." The "ground truth" for the traditional method would be based on established laboratory procedures for culture and identification, not on adjudication of human interpretations of the BacT/Alert output.

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

No, not explicitly stated or implied. An MRMC study is designed to assess the diagnostic performance of multiple readers on multiple cases and is common in imaging studies involving human interpretation. This submission describes a device that automates a detection process and compares its results to traditional laboratory methods, not to human readers interpreting raw data from the device.

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

Yes, implicitly. The BacT/Alert® Culture Bottles with the BacT/Alert® Microbial Detection System likely operate in a standalone manner for detecting microbial growth (i.e., the system flags positive results based on CO2 detection). The "performance characteristics" established for the device would represent this standalone performance, although the document doesn't explicitly use the term "standalone performance." The comparison is between the device's output and the output of conventional culture methodology.

7. The Type of Ground Truth Used

The ground truth for comparison was "conventional culture methodology." This implies that other established laboratory tests and procedures (e.g., subculturing, Gram staining, biochemical identification) were used to confirm the presence and nature of microorganisms in samples, which then served as the reference standard against which the BacT/Alert system's detection capability was evaluated.

8. The Sample Size for the Training Set

Not Applicable / Not Provided: This device is a detection system for microbial growth, not an AI/ML device that requires a training set in the typical sense (i.e., for learning patterns from data to make predictions or classifications). Its function is based on a chemical-mechanical principle (CO2 detection via a sensor), not an algorithm trained on a dataset.

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

Not Applicable / Not Provided: As noted above, this device is not described as an AI/ML system that utilizes a training set in the conventional manner.

Summary

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NOV 17, 1997

510(K) Summary BacT/Alert® Culture Bottles

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:

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: BacT/Alert® Culture Bottle

Common or Usual Name: Culture Bottles

Classification Name: Microbial Growth Monitor

An identification of the legally marketed device to which the submitter claims (a)(3) substantial equivalence;

Device Equivalent to: Traditional Culture Methodology

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

Device Description: The BacT/Alert® Culture Bottles contain media and an internal sensor that detects CO2 as an indicator of microbial growth when used in connection with the BacT/Alert® Microbial Detection System.

A statement of the intended use of the device. (8)(5)

BacT/Alert® Culture Bottles are used with BacT/Alert® Device Intended Use: Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and anaerobic microorganisms from blood and other body fluids.

A summary of the technological characteristics of the new device in comparison to (a)(6) those of the predicate device.
The BacT/Alert® culture Bottles contain media and an internal sensor that detects CO2 as an indicator of microbial growth when used in connection with the BacT/Alert® Microbial Detection System.

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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.

Testing was performed to establish the performance characteristics of the new device including comparison to traditional culture methodology.

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).

Organon Teknika's BacT/Alert® Culture Bottles are used with the BacT/Alert® Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and anaerobic microorganisms from blood and other body fluids. It is substantially equivalent to conventional culture methodologies for detection of microorganisms from blood (K903505) and other body fluids.

The assays are equivalent in the following respects:

1. They have the same intended use: recovery and detection of aerobic and anaerobic microorganisms from body fluids.
1. They are both in-vitro diagnostic test systems which are based on microbial growth in media.
1. Organon Teknika's BacT/Alert® Culture Bottles yield test results comparable to that seen with conventional culture methodology.

The data contained in this submission shows that BacT/Alert® Culture Bottles perform equivalent to conventional culture methodology and based on this information we hereby submit this premarket notification in accordance with section 510(k).

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 17 1997

Ms. Rebecca A. Rivas Requaltory Affairs Orqanon Teknika Corporation 100 Akzo Avenue Durham, North Carolina 27712

Re : K973305 BacT/Alert Blood Culture Bottles for body fluids Trade Name: III Requlatory Class: Tier: I Product Code: MDB Dated: Auqust 28, 1997 Received: September 3, 1997

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 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 You provisions of the Federal Food, Druq, and Cosmetic Act (Act). 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 requirement, 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 Reqister. 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 Butman

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 BacT/Alert® Culture Bottle

510(k) Number (If known): K973305

Device Name: BacT/Alert Culture Bottles (expanded indications)

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arian Cooper

sion Sign-Off Division of Clinical Laboratory Devices K9 510(k) Number

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.