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

Device Description

The BacT/ALERT SV Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Aerobic 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 SV Bottle.

AI/ML Overview

The provided text describes the 510(k) Premarket Notification for the BacT/ALERT SV Culture Bottle. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the BacT/ALERT SV Culture Bottle was substantial equivalence to its predicate device, the BacT/Alert Standard Aerobic Culture Bottle. This was primarily assessed based on the ability to recover equivalent levels of microorganisms and comparable detection times.

Acceptance Criteria	Reported Device Performance (BacT/ALERT SV Culture Bottle)
Recovery of low levels of microorganisms	Equivalent to the BacT/Alert Standard Aerobic Culture Bottle for 23 tested microorganisms.
Detection times	Equivalent to the BacT/Alert Standard Aerobic Culture Bottle.
Intended Use	Same as the predicate device: enhanced recovery and detection of aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
Technological Characteristics	Utilizes the same detection technology (reflectance) as the predicate, with minor changes like sensor type (emulsion vs. disc) but same indicator material. Performance in terms of growth of microorganisms is equivalent.

It's important to note that the document emphasizes the equivalence to a legally marketed predicate device rather than defining numerical targets for sensitivity, specificity, or time to detection. The acceptance criteria are implicitly met if the new device performs "as well or better than" the predicate.

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

Sample Size:
- 23 organisms were used for the seeded studies.
- For each organism, the study involved a dilution in human blood inoculated into both the BacT/ALERT SV bottle and the BacT/Alert Standard Aerobic bottle. The exact number of samples (bottles) per organism per dilution is not specified, but it implies multiple samples for each of the 23 organisms to assess "recovery of low levels" and "detection times."
Data Provenance: The organism studies were conducted using "human blood." The country of origin is not specified, but it's likely within the USA, given the FDA submission. The study type was non-clinical testing, specifically seeded studies, meaning known organisms were introduced into samples. This is a form of prospective, controlled laboratory testing.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth. For seeded studies, the "ground truth" is inherently known by the experiment design (i.e., the specific organisms and their concentrations that are deliberately introduced). Therefore, external experts to establish ground truth are typically not required in such studies. Laboratory personnel with expertise in microbiology and instrument operation would have conducted the tests and interpreted the raw detection results.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for interpreting ambiguous results, often with human interpretation (e.g., radiology images). In this context of automated microbial detection using seeded samples, the assessment of "detection" is generally clear-cut based on the instrument's output. Therefore, an explicit adjudication method as described for interpretive tasks is not applicable or mentioned. The "detection times" and "recovery" would be objectively measured by the BacT/ALERT Microbial Detection Systems.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for devices that involve human interpretation (e.g., AI-assisted diagnosis in imaging). This device is an automated in vitro diagnostic instrument for microbial detection, where the direct output is from the instrument rather than a human interpretation.

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

This device is a standalone device in terms of its detection capability. The BacT/ALERT SV Culture Bottle, in conjunction with the BacT/ALERT Microbial Detection Instruments, performs the detection autonomously. Human involvement is in sample preparation, loading, and interpreting the instrument's objective detection signal (e.g., positive or negative for growth, and time to detection). The performance described in the document (recovery and detection times) is the standalone performance of the combined bottle and instrument system.

7. The Type of Ground Truth Used

The ground truth used was known microbial presence and concentration established through seeded studies. Specific organisms were diluted in human blood and intentionally inoculated into the culture bottles, allowing for a direct comparison of the device's ability to detect these known organisms against the predicate device.

8. The Sample Size for the Training Set

The document does not mention a training set because this submission is for a device that relies on a well-established detection technology (reflectance) rather than a novel algorithm requiring extensive data-driven training (like machine learning models). The technology of the new device is stated to be the same as the predicate, with minor physical differences in the sensor. The studies described are validation/verification studies, not training.

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

As no training set is mentioned or implied, the question of how its ground truth was established is not applicable.

Summary

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K994343

FR 1 0 2000

510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SV 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: December 22, 1999

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 SV Culture Bottle

Common or Usual Name: BacT/ALERT SV Culture Bottle

Classification Name: Microbial Growth Monitor

An identification of the legally marketed device to which the submitter claims substantial (a)(3) equivalence;
Device Equivalent to: BacT/Alert Standard Aerobic Culture Bottle
A description of the device. (a)(4)
Device Description: The BacT/ALERT SV Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Aerobic 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 SV Bottle.

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

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

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

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

The BacT/ALERT SV Culture Bottle utilizes the same detection technology as the BacT/ALERT Standard Aerobic Culture Bottle.

FEATURES	BACT/ALERT SV CULTURE BOTTLE	BACT/ALERT STANDARDAEROBIC CULTUREBOTTLE
Technology	Reflectance	Reflectance
Color change based onCO2 production	YES	YES
Sensor	Emulsion	Disc
Indicator material	Yes, Same as Standard AerobicBottle	Yes
Growth ofmicroorganisms	Yes, Equivalent to StandardAerobic 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 SV Culture Bottle

(b)1) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the 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 23 organisms diluted in human blood and inoculated into the BacT/ALERT SV bottle and the BacT/Alert Standard Aerobic 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 SV culture bottle was substantially equivalent to the BacT/Alert Standard Culture Bottle based on recovery of low levels of the 23 microorganisms included in the study. Detection times were equivalent in both bottles.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is composed of three curved lines that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 0 2000

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

Re: K994343 Trade Name: BacT/ALERT SV Culture Bottle Regulatory Class: I Product Code: MDB Dated: December 22, 1999 Received: December 23, 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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

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" (21CFR 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/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 SV Culture Bottle

Page ਰੀ

510(k) Number (If known):

BacT/ALERT SV Culture Bottle

Device Name:

Indications For Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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	Wordy Dubow
	(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K994343

Prescription Use	Y	OR	Over-The-Counter Use
(Per 21 CFR 801.109)			(Optional Format 1

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.