The BacT/ALERT SN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for recovery and detection of anaerobic microorganisms (bacteria) from blood and other normally sterile body fluids.

Device Description

The BacT/ALERT SN Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Anaerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT SN Bottle.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BacT/ALERT SN Culture Bottle, based on the provided text:

Acceptance Criteria and Device Performance

The core of the acceptance criteria for the BacT/ALERT SN Culture Bottle revolved around demonstrating substantial equivalence to its predicate device, the BacT/Alert Standard Anaerobic Culture Bottle. This was primarily assessed by comparing the recovery and detection times of various microorganisms.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (BacT/ALERT SN)
Microorganism Recovery	Equivalent recovery of low levels of 11 specific microorganisms	Demonstrated equivalent recovery of low levels of the 11 microorganisms included in the study compared to the predicate device.
Detection Times	Comparable detection times for the 11 specific microorganisms	Detection times were comparable in both bottles (BacT/ALERT SN and predicate).
Technological Equivalence	Same detection technology	Utilizes the same reflectance technology.
Color Change Mechanism	Color change based on CO2 production	Yes, exhibits color change based on CO2 production.
Indicator Material	Same indicator material as predicate	Yes, uses the same indicator material.
Instrument Compatibility	Compatibility with BacT/ALERT Microbial Detection Systems	Compatible with BacT/ALERT Microbial Detection Systems.
Sample Source	Intended for blood and body fluids	Processes blood and body fluids.
Target Population	Intended for adult population	Intended for the adult population.

Study Details

This document describes a 510(k) Premarket Notification, which typically relies on demonstrating substantial equivalence rather than a full-scale clinical trial with acceptance criteria defined by specific clinical endpoints like sensitivity or specificity percentages. The study performed here is a comparative non-clinical study.

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

Sample Size: "Seeded studies were performed on 11 organisms diluted in human blood and inoculated into the BacT/ALERT SN bottle and the BacT/Alert Standard Anaerobic bottle." The exact number of replicates or individual test instances for each organism is not specified.
Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA, suggesting the study was likely conducted in the U.S. or by a company with operations there.
- Retrospective or Prospective: The description "Seeded studies were performed" implies a prospective experimental design, where samples were created and tested specifically for the study.

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

This type of study (comparative performance of culture bottles) does not typically involve human experts establishing a "ground truth" in the same way an imaging AI algorithm might. The ground truth in this context is the confirmed presence and growth rate of the seeded microorganisms, which is measured by the BacT/ALERT system itself. The expertise would lie in the microbiological techniques used for organism preparation, inoculation, and confirmation, rather than diagnostic interpretation. The document does not specify the number or qualifications of these microbiological experts.

4. Adjudication method for the test set:

No adjudication method is described, as the "outcome" is a direct measurement by the BacT/ALERT instrument (detection of growth and time to detection). The comparison is between the new device and the predicate device's performance, not human interpretations.

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 was a non-clinical, in-vitro diagnostic (IVD) device study comparing the performance of two culture bottles. MRMC studies are typically used for imaging AI algorithms where human interpretation is a key component.

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

Yes, effectively. The BacT/ALERT system (both with the new SN bottle and the predicate bottle) operates as an automated, standalone system for detecting microbial growth. The study assessed the performance of the new bottle within this automated context. There isn't a "human-in-the-loop" for interpreting the primary outcome of microbial growth detection; the instrument provides a positive/negative result and a time to detection.

7. The type of ground truth used:

The ground truth was established by seeded microorganisms of known species and concentrations, diluted in human blood. The expected outcome was the growth of these specific microorganisms. The "truth" is the fact of microbial presence and their growth characteristics.

8. The sample size for the training set:

This document does not describe a training set. This is not an AI/machine learning device that requires a training set. It's a medical device (culture bottle) that undergoes performance testing.

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

As there is no training set for this device, this question is not applicable.

Summary

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K993421

DEC I 4 1999

510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SN Culture Bottle

510(k) Summary

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 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 (a)(2) or usual name, and the classification name, if known;
Trade or Proprietary Name: BacT/ALERT SN Culture Bottle

Common or Usual Name: BacT/ALERT SN Culture Bottle

Classification Name: Microbial Growth Monitor

(a)(3) An identification of the legally marketed device to which the submitter claims substantial equivalence;
Device Equivalent to: BacT/Alert Standard Anaerobic Culture Bottle
A description of the device. (a)(4)
Device Description: The BacT/ALERT SN Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Anaerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT SN Bottle.

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

Device Intended Use: The BacT/ALERT SN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for recovery and detection of anaerobic microorganisms ( bacteria) from blood and other normally sterile body fluids.

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510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SN Culture Bottle

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

The BacT/ALERT SN Culture Bottle utilizes the same detection technology as the BacT/ALERT Standard Anaerobic Culture Bottle.

FEATURES	BACT/ALERT SN CULTURE BOTTLE	BACT/ALERT STANDARDANAEROBIC CULTUREBOTTLE
Technology	Reflectance	Reflectance
Color change based on CO2 production	Yes	Yes
Sensor	Emulsion	Disc
Indicator material	Yes, Same as Standard Anaerobic Bottle	Yes
Growth of microorganisms	Yes, Equivalent to Standard Anaerobic Bottle	Yes
Instrument Used	BacT/ALERT Microbial Detection Systems	BacT/ALERT MicrobialDetection Systems
Sample Source	Blood, Body Fluids	Blood, Body Fluids
Target Population	Adult	Adult

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510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SN 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:

Seeded studies were performed on 11 organisms diluted in human blood and inoculated into the BacT/ALERT SN bottle and the BacT/Alert Standard Anaerobic bottle.

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

The BacT/ALERT SN culture bottle was substantially equivalent to the BacT/Alert Standard Anaerobic Culture Bottle based on recovery of low levels of the 11 microorganisms included in the study. Detection times were comparable in both bottles.

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Image /page/3/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of a human figure, with three lines forming the head and upper body, and a flowing design below, possibly representing water or movement.

DEC I 4 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K993421 Re: Trade Name: BacT/ALERT SN Culture Bottle Regulatory Class: I Product Code: MDB Dated: October 11, 1999 Received: October 12, 1999

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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510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SN Culture Bottle

Page _ of _

K993421 510(k) Number (If known):

BacT/ALERT SN Culture Bottle

Device Name:

Indications For Usa:

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

Concumence of CDRH, Office of D e Evaluation (ODE)

Woody Dubres

Division of Clinical Laboratory Devices K99342 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

਼ੁਕ

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.