BacT/Alert® FAN™ 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.

Device Description

The BacT/Alert® FAN Culture Bottles contain media, an adsorbent 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

Here's a breakdown of the acceptance criteria and the study details for the BacT/Alert™ FAN Culture Bottles, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in a quantitative or pass/fail format for this premarket notification. Instead, it focuses on demonstrating substantial equivalence to traditional culture methodology.

Acceptance Criterion (Implied)	Reported Device Performance
Same Intended Use	Recovery and detection of aerobic and anaerobic microorganisms from body fluids.
Similar Technology Basis	In-vitro diagnostic test systems based on microbial growth in media.
Comparable Test Results	Test results comparable to conventional culture methodology.

2. Sample Size and Data Provenance for the Test Set

Sample Size: The document does not specify a numerical sample size for the test set used in the clinical tests. It generally states that "Testing was performed to establish the performance characteristics."
Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

The document does not provide information on:

The number of experts used to establish ground truth.
The qualifications of any such experts.
The type of ground truth (expert consensus, pathology, outcomes data, etc.).

For this type of device (microbial growth monitor), "ground truth" would typically refer to confirmed culture results from established laboratory methods, but the document doesn't detail how this was established for the comparison.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

Was it done? No. This type of study (MRMC) is typically relevant for interpretative diagnostic devices where human reading is a primary component. The BacT/Alert™ FAN Culture Bottles are automated microbial detection systems.
Effect Size: Not applicable as an MRMC study was not performed.

6. Standalone Performance Study

Was it done? Yes, in essence. The clinical tests performed were to establish the performance characteristics of the new device, including comparison to traditional culture. This comparison serves as a standalone performance assessment against a predicate. The device "detects CO2 as an indicator of microbial growth when used in connection with the BacT/Alert® Microbial Detection System," which implies an automated, standalone detection process once the bottles are inoculated and placed in the system.

7. Type of Ground Truth Used (for Test Set)

The document implicitly suggests that "traditional culture methodology" was used as the reference or ground truth for comparison. This would generally involve established laboratory techniques for isolating, identifying, and culturing microorganisms.

8. Sample Size for the Training Set

The document does not provide information on a training set sample size. For a device like this, which is a culture medium/bottle rather than a machine learning algorithm, the concept of a "training set" in the context of AI/ML is not directly applicable. The device's performance is based on its chemical and biological composition and its interaction with the BacT/Alert system, which would have undergone its own development and validation.

9. How Ground Truth for the Training Set Was Established

As the concept of a "training set" for an AI/ML algorithm is not applicable here, there is no information provided on how ground truth for a training set was established. Device performance is based on its intrinsic design and validation against established microbiological methods.

Summary

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K973325

510(k) Premarket Notification Organon Teknika Corporation BacT/Alert™ FAN Culture Bottles

510(k) Summary BacT/Alert® FAN™ Culture Bottles

DEC - 2 1997

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 A.Rivas

Date 510(k) Summary Prepared:

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® FAN™ 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 substantial (a)(3) equivalence;

Device Equivalent to: Traditional Culture Methodology

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

Device Description: The BacT/Alert® FAN Culture Bottles contain media, an adsorbent 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. (a)(2)

BacT/Alert® FAN™ Culture Bottles are used with the 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.

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510(k) Premarket Notification Organon Teknika Corporation BacT/Alert™ FAN Culture Bottles

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

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.

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

The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device (b)3) 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® FAN 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.

The methods are equivalent in the following respects:

દ

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® FAN Culture Bottles vield test results comparable to that seen with conventional culture methodology.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the eagle in a circular fashion. The logo is black and white.

DEC - 2 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Rebacca A. Rivas Regulatory Specialist Organon Teknika Corp. 100 Akzo Ave. Durham, NC 27712

Re: K973325

Trade Name: Bact/Alert Fan Culture Bottles Regulatory Class: I Product Code: MDB Dated: November 7, 1997 Received: November 10, 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 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 Iegally marketed predicate device results in a classification for your device and thus, permits vour 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 vours.

Steven Autman

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™ FAN Culture Bottles

ਤੋਂ ਤੋਂ k97 5 10(k) Number (il known):_

、Device Name:_ BACT/ALERI FAN Quiture Bottles (expended indications)

ations For Use:

d with the BacT/Alert Hicrobial Dete P/Alert FAN Culture Bottles etion of res for from blood and other body Cluide

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1°° EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NE_JEDI

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use_
(Per 21 CFR 801.109)

Over The-Counts: Use ...

(Optional Formal 1-2-96)

. ... ... ....................................................................................................................................................................

John Ticehurst, Med Offices & Interim chief
(Division Sign-Off)
MICB

Division of Clinical Laboratory Devices 510(k) Number_JC 9

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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.