The BD BACTEC™ Plus Anaerobic/F medium is used in a qualitative procedure for the anaerobic culture and recovery of microorganisms (bacteria) from blood. The principal use of this medium is with the BD BACTEC fluorescent series instruments.

Device Description

The sample to be tested is inoculated into one or more vials which are inserted into the BD BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO2 present. A positive reading indicates the presumptive presence of viable microorganisms in the vial. Detection is limited to microorganisms that will grow in a particular type of medium.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "BD BACTEC Plus Anaerobic/F (plastic)" medium. This device is an anaerobic blood culture medium used with BD BACTEC fluorescent series instruments for the qualitative culture and recovery of microorganisms from blood. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, the "BD BACTEC Plus Anaerobic/F" medium (glass bottle).

The acceptance criteria for this type of device are primarily tied to demonstrating equivalent performance to a legally marketed predicate device across several analytical performance metrics. The study described is a series of analytical studies comparing the new plastic bottle device to the predicate glass bottle device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are not explicitly stated as numerical targets in a table format within the document. Instead, the studies aim to demonstrate "equivalent performance" or that differences are "minimal" or "detectable but favoring the new device" compared to the predicate. The performance is reported in terms of comparison to the predicate device.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (BD BACTEC Plus Anaerobic/F (plastic) vs. Predicate)
Instrument Time to Detection (TTD)	Minimal difference in median TTD compared to predicate.	Median TTD difference of 4.62 minutes, favoring the new device. Minimal effect of differences.
Percent Recovery	Equivalent or improved recovery compared to predicate.	Significant difference favoring the new device, detecting 12 more vials than the predicate.
False Positive Rate	No false positives within recommended usage range of blood volumes.	No false positive bottles observed within the recommended usage range (3 to 10 mL).
False Negative Rate	Equivalent or improved false negative rate compared to predicate.	2 false negative results observed in the new device vs. 14 in the predicate device.
Antimicrobial Neutralization Capability	Equivalent positive detection rate in the presence of antimicrobials compared to predicate.	New device detected positive 86 times (95.56%) vs. predicate 87 times (96.67%). Demonstrated equivalent performance.
Reproducibility	Acceptable reproducibility across lots in TTD and recovery.	Statistical difference in TTD observed between lots, but marginal (mean/median difference < 1 hour).

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

Instrument Time to Detection: 442 paired sets.
Percent Recovery: 528 paired sets evaluated, 442 paired sets positive in both devices.
False Positive Rate: 240 paired sets (80 bottles from each of 3 lots).
False Negative Rate: 146 paired sets evaluated. 30 sets where only predicate detected, 67 sets where only new device detected.
Antimicrobial Neutralization Capability: 90 paired sets of medium.
Reproducibility: Not explicitly stated as a separate sample size, but likely part of the studies above or a dedicated internal study.

Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a diagnostic device, the studies are typically conducted internally by the manufacturer (Becton, Dickinson and Company, located in Sparks, MD, USA) and would be prospective analytical studies. The blood used in the False Positive Rate study is specified as "fresh human blood."

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

This type of device, a microbial growth monitor, relies on objective measurements (e.g., CO2 detection via fluorescence, terminal subculture results) rather than subjective expert interpretation of images or clinical findings. Therefore, the concept of "experts establishing ground truth" in the manner of radiologists reading images is not directly applicable.

Ground Truth Establishment: The ground truth for positive/negative growth, or false positive/negative, is established by the instrument's detection algorithm, and in cases of non-detection, by terminal subculture (a microbiological laboratory procedure).

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used when there is subjective human interpretation involved to resolve disagreements. As mentioned above, the ground truth for this device's performance is based on objective instrument readings and laboratory subculture results. Therefore, no human adjudication method is described or applicable.

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

This is not an AI-based diagnostic imaging device. It is a microbial growth monitor. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

The device itself is essentially "standalone" in its primary function as a microbial growth monitor. The BD BACTEC fluorescent series instruments perform the detection automatically based on their internal algorithms to monitor CO2 production. Human intervention would involve technicians loading samples, interpreting instrument flags, and performing confirmatory tests (like subcultures) for non-detecting or potentially false-negative bottles. The performance metrics reported (TTD, recovery, false positive/negative rates) directly reflect the algorithm's performance within the instrument system, without human "reading" of the sensor.

7. The Type of Ground Truth Used

The ground truth used primarily consists of:

Instrument-detected positivity/negativity: Based on the BD BACTEC fluorescent series instrument's chemical sensor and detection algorithms for CO2 production.
Terminal Subculture: For vials that did not detect positive by the instrument, a terminal subculture was performed to definitively determine if viable microorganisms were present (e.g., to confirm false negatives). This is a standard microbiological laboratory method.
Controlled Inoculation: For studies like False Positive Rate and Antimicrobial Neutralization Capability, the ground truth is established by the known inoculation of organisms and/or antimicrobials.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" in the context of machine learning or AI. This is a traditional medical device (a culture medium in a plastic bottle) with an associated instrument that uses a pre-defined algorithm for detection. The development of the medium and the instrument's algorithm would have involved internal validation and optimization, but the term "training set" doesn't apply in the typical AI/ML sense.

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

As mentioned above, the concept of a "training set" for AI/ML does not apply directly to this device. The development and optimization of the BACTEC instrument's detection algorithm and the culture medium formulation would have been based on established microbiological principles, internal research and development studies, and performance data from prior versions of the device, rather than a distinct "training set" with ground truth established for supervised learning.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

BECTON, DICKINSON AND COMPANY PAUL SWIFT ASSOCIATE MANAGER, REGULATORY AFFAIRS 7 LOVETON CIR., MC 694 SPARKS MD 21152

Re: K141810

Trade/Device Name: BD BACTEC Plus Anaerobic/F (plastic) Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial growth monitor Regulatory Class: I Product Code: MDB Dated: November 5, 2014 Received: November 6, 2014

Dear Mr. Swift:

This letter corrects our substantially equivalent letter of December 10, 2014.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and 809); medical device reporting

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(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809] ), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K141810 Device Name

BD BACTECTM Plus Anaerobic/F (plastic)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

D Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

SUBMITTED BY:	BECTON, DICKINSON AND COMPANY7 LOVETON CIRCLESPARKS, MD 21152Phone: 410-316-4905Fax: 410-316-4188
CONTACT NAME:	Paul Swift, RAC Associate Manager, Regulatory Affairs
DATE PREPARED:	October 30, 2014 (revised March 8, 2016)
DEVICE TRADE NAME:	BD BACTECTM Plus Anaerobic/F (plastic)
DEVICE COMMON NAME:	Anaerobic blood culture medium
DEVICE CLASSIFICATION:	21 CFR §866.2560, Class I
PREDICATE DEVICE:	BD BACTEC Plus Anaerobic/F medium (K954925)

INTENDED USE:

The BD BACTEC Plus Anaerobic/F medium is used in a qualitative procedure for the anaerobic culture and recovery of microorganisms (bacteria) from blood. The principal use of this medium is with the BD BACTEC fluorescent series instruments.

DEVICE DESCRIPTION:

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DEVICE COMPARISON: The BD BACTEC Plus Anaerobic/F (plastic) medium differs from the BD BACTEC Plus Anaerobic/F (glass) medium in the following ways:

The medium in the new device is contained in a multilayer polycarbonate/nylon/polycarbonate plastic bottle; whereas, the medium in the predicate device is contained in a glass bottle.
The new device contains 2.6 g of sensor per bottle; whereas, the predicate device contains □ 1.75 g of sensor per bottle.
- The volume of sensor has been adjusted for the plastic bottle to accommodate for о differences in bottle geometry (thickness and shape) compared to the glass bottle.
□ The indicator and red dye concentrations in the new device have been increased to yield signals that are equivalent to the glass bottle.

o The bromocresol purple indicator (BCP) in the new device's sensor has been increased from a ratio of 1 mg per gram of sensor in the predicate device to a ratio of 2.5 mg per gram of sensor in the new device.

O The radglo red dye in the new device's sensor has been increased from a ratio of 1.09 mg per gram of sensor in the predicate device to a ratio of

1.54 mg per gram of sensor in the new device.

The concentrations used in the plastic bottle accommodate for differences in overall O sensor volume per bottle.

| A clear, inert adhesion promoter has been added to the new device's sensor to ensure adhesion of the sensor to the polycarbonate surface of the plastic bottle. The glass surface of the predicate device does not require an adhesion promoter.
- The new device's sensor contains 13 mg per bottle of the adhesion promoter O 3-glycidoxypropyl trimethoxysilane (GOP). This is not used in the predicate device.
| The new bottle weighs 20.9g compared to the predicate device bottle weight of 113g.
The new device measures 5.0 inches high compared to the predicate device height of 5.6 inches.
The new device contains 30 mL of soybean casein digest broth; whereas, the predicate device contains 25 mL of soybean casein digest broth.

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The BD BACTEC Plus Anaerobic/F (plastic) medium is similar to the BD BACTEC Plus Anaerobic/F (glass) medium in the following ways:

□ Both the new and predicate devices are used for the qualitative anaerobic culture and recovery of microorganisms from human blood. fluorescent-series of blood culture instruments. culture instruments apply the same incubation and agitation parameters to both devices. The BD BACTEC fluorescent-series of blood culture instruments apply the same growth and detection algorithms to both devices. hours. of organism growth. □ Both devices require a sample volume of 3 - 10 mL of blood. []Both devices incorporate resins for the adsorption of antimicrobials that may be present in clinical samples. □ Both devices utilize the same formulation of enriched soybean casein digest broth as the growth medium.

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SUMMARY OF PERFORMANCE DATA

Analytical Studies:

Instrument Time to Detection

A total of 442 paired sets were positive in both the new and predicate devices. The median TTD difference between the paired positive sets was 4.62 minutes, favoring the new device. The data indicate that the effect of differences between the new and predicate devices on TTD under these test conditions was minimal and that the new device performs equivalently to the predicate device.

Percent Recovery

There was a significant difference in recovery between the BD BACTEC Plus Anaerobic/F blood culture medium contained in plastic bottles and the predicate device contained in glass bottles, favoring the new device contained in plastic vials. A total of 528 paired sets were evaluated in the Percent Recovery comparison. Of those, 442 paired sets were positive in both the new and predicate devices. The data indicate that the effect of differences between the new and predicate devices on percent recovery under these test conditions was detectable, with the new device detecting 12 more vials than the predicate device.

False Positive Rate

A total of 240 paired sets were used to execute this study. The 240 paired sets were comprised of 80 bottles from each of 3 lots. The paired sets were inoculated with fresh human blood at varying levels as specified by the test protocol and entered into the BACTEC blood culture instrument. It was expected that each bottle would be instrument-negative following the complete protocol (120 hours). There were no false positive bottles of the new device observed within the recommended usage range of blood volumes (3 to 10 mL).

False Negative Rate

A total of 146 paired sets were evaluated for the determination of the False Negative Rate of the new device. Additionally, there were 30 sets where only the predicate device detected and 67 sets where the new device only detected. All vials that did not detect were evaluated for false negativity via terminal subculture. Of these, sixteen (16) were false negative bottles (i.e., instrument-negative, subculture positive). Fourteen (14) false negative results were observed in the predicate device contained in the glass bottle. Two

(2) false negative results were observed in the modified device contained in the plastic bottle.

Antimicrobial Neutralization Capability

Eleven drugs representative of their classes were evaluated at the MIC level of selected strains to demonstrate equivalent performance of the new device to the predicate device. A total of 90 paired sets of medium were tested. The predicate device detected positive 87 times (96.67%) and the new device detected positive 86 times (95.56%). The drugs evaluated were: Ciprofloxacin, Cefazolin, Cefotaxime, Cefoxitin, Clindamycin, Gentamicin, Meropenem, Metronidazole, Piperacillin/Tazobactam and Vancomycin.

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Reproducibility

The new device was evaluated for reproducibility across lots in terms of time to detection and recovery. There was a statistical difference in time to detection observed between a lot comparison; however differences were marginal with the mean and median difference being less than 1 hour.

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.