BD BACTECTM Standard Anaerobic/F culture vials (prereduced enriched Soybean-Casein Digest broth with CO2) are for anaerobic blood cultures. Principal use is with the BD BACTEC fluorescent series instruments for the qualitative culture and recovery of anaerobic microorganisms from blood.

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 document describes the BD BACTEC™ Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (modified device) and its substantial equivalence to the predicate device (glass vial). The studies performed are analytical and focus on the performance of the culture medium and vial characteristics.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for each test. Instead, it indicates that the modified device should perform "equivalently" or show "no relevant difference" compared to the predicate device. For the purpose of this table, "Acceptance Criteria" are inferred from the study conclusions.

Performance Metric	Acceptance Criteria (Inferred)	Reported Device Performance
Instrument Time to Detection	No relevant difference from the predicate device	Wilcoxon estimated median TTD difference for 443 positive paired sets is -0.500 hours (30 minutes), favoring the modified device. Conclusion: Effect of differences on TTD was minimal; modified device performs equivalently to the predicate device.
Percent Recovery	Recovery equivalent between modified and predicate devices	528 paired sets evaluated; 504 paired sets positive in both at 10-100 CFU inoculum. McNemar p-value could not be calculated as neither device showed exclusive detection. Conclusion: Recovery was equivalent.
Microbial Detection Limit	No statistically significant difference in recovery compared to the predicate device	312 paired sets inoculated: 191 grew in both, 36 in predicate only, 39 in modified only, 46 in neither. McNemar chi-square analysis: p=0.8174. Conclusion: No statistically significant difference in recovery.
False Positive Rate	No false positive bottles for the modified device	240 paired sets (40 from each of 3 lots) inoculated with fresh human blood at varying levels. All expected to be instrument-negative. Conclusion: No false positive bottles observed for the modified device with blood volumes (2, 4, 6, 8, and 10mL).
False Negative Rate	No statistically significant difference in recovery compared to the predicate device	70 paired sets end of protocol negative evaluated for false negative rate. 36 modified device only instrument negatives, 39 predicate device only instrument negatives. 1 false negative observed in the predicate device. McNemar chi-square analysis: p=1.00. Conclusion: No statistically significant difference in recovery.
Reproducibility (Lot-to-Lot)	No relevant difference in time to detection across lots	No relevant difference in time to detection observed between lot comparisons.

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

The document describes analytical studies. The "test set" in this context refers to the samples used in these analytical performance studies.

Instrument Time to Detection: 443 paired sets
Percent Recovery: 528 paired sets
Microbial Detection Limit: 312 paired sets
False Positive Rate: 240 paired sets (40 from each of 3 lots)
False Negative Rate: 70 paired sets

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of these analytical studies (e.g., inoculation with specific CFU levels), they are inherently prospective and controlled laboratory experiments. The origin of the human blood used for the false positive rate study is not specified beyond "fresh human blood."

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

This information is not provided in the document. The studies are analytical performance comparisons of a microbial growth medium, not diagnostic accuracy studies that rely on expert interpretation of results. The "ground truth" for these studies is typically defined by microbial culture techniques (e.g., presence/absence of growth, colony counts) rather than expert consensus on images or clinical classifications.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. These analytical studies focus on the objective measurement of microbial growth and detection by the instrument.

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 information is not applicable. The device (BD BACTEC™ Standard Anaerobic/F Culture Vials) is a culture medium used with an automated instrument (BD BACTEC fluorescent series instruments) for detecting microbial growth in blood. It is not an AI-powered diagnostic device or an imaging device that involves human readers interpreting results with or without AI assistance. Therefore, an MRMC comparative effectiveness study involving human readers and AI is outside the scope of this device.

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

This information is not applicable in the context of an "algorithm only" device. The device itself is a culture vial (medium) that is used with an instrument. The instrument's algorithms detect growth. The studies evaluate the performance of the vial and medium in conjunction with the instrument, not an isolated algorithm. The "standalone" performance is essentially what the analytical studies describe – the ability of the combined system to detect growth.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for these analytical studies is based on microbiological culture and laboratory methods.

Presence/absence of microbial growth: Confirmed by standard microbiological techniques (e.g., subculture to agar plates, colony identification).
Time to detection (TTD): Objectively measured by the BACTEC instrument.
Colony-forming units (CFU): Used to prepare inoculum levels for certain studies.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context presented. The document describes an analytical performance comparison study for a modified device against a predicate device. It does not mention any machine learning or AI components that would require a distinct "training set" in the conventional sense. The instrument's algorithms are assumed to be pre-existing and validated.

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

This information is not provided and is not applicable for the reasons stated in point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.

August 8, 2016

Public Health Service

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

BECTON DICKINSON ASHANTI BROWN REGULATORY SPECIALIST 7 LOVETON CIRCLE, MC 694 SPARKS MD 21152

Re: K161306

Trade/Device Name: BD BACTEC™ Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial growth monitor Regulatory Class: I Product Code: MDB Dated: May 9, 2016 Received: May 10, 2016

Dear Ms. Brown:

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 Parts 801 and 809); medical device reporting (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.

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If you desire specific advice for your device on our labeling regulations (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" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Steven R. Gitterman -S

for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
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4. Indications for Use Statement

510(k) Number (if known)

Device Name

BD BACTECTM Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial

Indications for Use (Describe)

Type of Use (Select one or both, as applicable) 区Prescription Use (Part 21 CFR 801 Subpart D) □Over-The Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED

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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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FORM FDA 3881 (8/14) Services (301) 443-6740

Page 1 of 1 EF

PSC Publishing

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5. 510(k) Summary

BD BACTEC™ Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial

Summary Preparation Date:

5/9/2016

Submitted by: Ashanti C. Brown

BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

Contact: Ashanti C. Brown Regulatory Specialist

Tel: 410-316-4766 Fax: 410-316-4188 Email: ashanti.brown@bd.com

Proprietary Names:

BD BACTEC™ Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial

Common Names:

Anaerobic blood culture medium

Regulatory Information

Classification: 21 CFR§866.2560, Class I

Product Code(s): MDB

Predicate Device BD BACTEC Standard Anaerobic/F Culture Vials (K915796)

Device Establishment

Becton Dickinson Caribe Ltd. Vicks Drive Lot #6 Cayey, PR 00737 Registration Number: 2647876

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Intended Use

Device Description

Device Comparison

The BD BACTEC Standard Anaerobic/F Culture Vials (plastic) - modified device, differs from the BD BACTEC Standard Anaerobic/F Culture Vials (glass) - predicate device, in the following ways:

The medium in the modified 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 modified 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 O differences in bottle geometry (thickness and shape) compared to the glass bottle.
. The indicator and red dye concentrations in the modified device have been increased to yield signals that are equivalent to the glass bottle.
- O The bromocresol purple indicator (BCP) in the modified device's sensor has been increased from a ratio of 1.8 mg per gram of sensor in the predicate device to a ratio of 6.5 mg per gram of sensor in the modified device.
- The radglo red dye in the modified device's sensor has been increased from a ratio of 1.9 O mg per gram of sensor in the predicate device to a ratio of 4.0 mg per gram of sensor in the modified 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 modified 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.

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O The modified device's sensor contains 13 mg per bottle of the adhesion promoter 3glycidoxypropyl trimethoxysilane (GOP). This is not used in the predicate device.
The modified device bottle weighs 20.9g compared to the predicate device bottle weight of 113g, .
The modified device measures 5.0 inches high compared to the predicate device height of 5.6 inches.

BD BACTEC Standard Anaerobic/F Culture Vials (plastic) - modified device, is similar to the BD BACTEC Standard Anaerobic/F Culture Vials (glass) - predicate device in the following ways:

. Both the modified and predicate devices are used for the qualitative anaerobic culture and recovery of microorganisms from human blood.
Both devices are intended to be used with the BD BACTEC fluorescent-series of blood culture . instruments.
The BD BACTEC fluorescent-series of blood 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.
. Both devices are incubated at 35° C (± 1.5° C) for a period of up to 120 hours.
. Both devices incorporate a sensor that detects increases in CO2 within the bottle as a result of organism growth.
. Both devices require a sample volume of 3.0-7.0 mL of blood.
Both devices utilize the same formulation of enriched soybean casein digest broth as the growth . medium.

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Analytical Studies

Instrument time to Detection

A total of 443 paired sets were positive in both the modified and predicate devices. The Wilcoxon estimated median TTD difference for the 443 positive sets is -0.500 hours (30 minutes), favoring the modified device. The data indicates that the effect of differences between the modified and predicate devices on TTD under these test conditions was minimal and that the modified device performs equivalently to the predicate device. The modified device meets the acceptance criteria of "No relevant difference from the predicate device."

Percent Recovery

Recovery was equivalent between the modified and predicate devices. A total of 528paired sets were evaluated in the Percent Recovery comparison. Of those, 504 paired sets were positive in both the modified and predicate devices at inoculum level 10-100CFU. The McNemar p-value for this data could not be calculated given that neither device showed detection exclusively.

Microbial Detection Limit

A total of 312 paired sets were inoculated, of this group 191 grew and detected in both the modified and predicate devices. Thirty-six cultures grew and detected in the predicate device only. Thirty -nine cultures grew and detected in the modified device only. There were forty -six paired sets that were not detected in either the modified or predicate devices. The McNemar chi-square analysis of the data indicates that there was no statistically significant difference in recovery (p=0.8174) between the modified and predicate devices.

False Positive Rate

A total of 240 paired sets were used to execute this study. The 240 paired sets were comprised of 40 paired sets 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. Each bottle is expected to be instrument-negative following the complete protocol (120 hours). There were no false positive bottles for the modified device observed with blood volumes (2, 4, 6, 8, and 10mL).

False Negative Rate

A total of 70 paired sets were end of protocol negative in the modified and predicate devices and were evaluated for the determination of the False Negative Rate. There were 36 modified device only instrument negative bottles evaluated by terminal subculture and 39 predicate device only instrument negatives evaluated by terminal subculture . There was a total of 1 false negative observation. The 1 false negative was found in the predicate device. The McNemar chi-square analysis of the data indicates that there was no statistically significant difference in recovery (p=1.00) between the modified and predicate devices.

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Reproducibility

The modified device was evaluated for reproducibility across lots in terms of time to detection and recovery. There was no relevant difference in time to detection observed between lot comparisons.

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.