BD BACTECT™ Standard/10 Aerobic/F culture vials (enriched Soybean-Casein Digest broth with CO2) are for aerobic blood cultures. Principal use is with the BD BACTEC fluorescent series instruments for the qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) 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/10 Aerobic/F Culture Vials (plastic version). The device is a culture vial for aerobic blood cultures, intended for use with BD BACTEC fluorescent series instruments for qualitative detection of microorganisms (bacteria and yeast) in blood. The study presented aims to demonstrate that the plastic version of the culture vial is substantially equivalent to the predicate device (glass version).

Here's an analysis of the acceptance criteria and study details based on the provided text, focusing on the comparisons between the modified (plastic) device and the predicate (glass) device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Time to Detection (TTD): No relevant difference from current product (predicate device).	The estimated median TTD difference for 682 positive paired sets was -1.084 hours, favoring the modified device. Conclusion: The modified device meets the acceptance criteria, and the effect of differences between the modified and predicate devices on TTD was minimal; the modified device performs equivalently.
Percent Recovery: Equivalent between devices.	984 paired sets evaluated. 948 were positive in both. 4 grew in predicate only, 9 grew in modified only. McNemar chi-square analysis: 0.2673, indicating no relevant difference.
Microbial Detection Limit: No relevant difference between devices.	360 paired sets tested. 207 grew in both. 37 grew in predicate only, 48 grew in modified only. McNemar chi-square analysis: 0.2781, indicating no relevant difference.
False Positive Rate: No false positives in the modified device, or statistically insignificant difference from predicate.	240 paired sets evaluated. No false positives in the modified device. One anomaly (a false positive) observed in the predicate device (positive at 16.98 hours without organism). A statistical analysis could not be performed due to insufficient failures in the test (only one failure in predicate and none in modified). Implicitly, the modified device met this better than the predicate.
False Negative Rate: No statistically significant difference in recovery between devices.	91 paired sets were instrument negative. 41 modified devices and 57 predicate devices were instrument negative. Terminal subculture of instrument negatives identified 34 false negatives total. 18 were in the predicate device, 16 in the modified device. McNemar chi-square analysis (p=0.8638) indicates no statistically significant difference in recovery between the modified and predicate devices.
Reproducibility: No statistical difference across lots in TTD and recovery.	The modified device was evaluated for reproducibility across lots. No statistical difference in time to detection and recovery was observed between lot comparisons.

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

The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It describes analytical studies comparing the modified device to a predicate device.

Instrument Time to Detection: 682 paired sets recovered organisms in both devices.
Percent Recovery: 984 paired sets.
Microbial Detection Limit: 360 paired sets.
False Positive Rate: 240 paired sets (comprised of 40 bottles from each of 3 lots).
False Negative Rate: 91 paired sets that were instrument negative.

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

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth. The studies described are laboratory-based comparisons of detection capabilities, not evaluations of human interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method involving human interpretation. The "ground truth" (or reference standard) in these studies appears to be based on whether microorganisms were successfully grown and detected, or confirmed by terminal subculture in the case of false negatives.

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 MRMC comparative effectiveness study was done. This device is a culture vial designed for automated detection by an instrument, not an AI-assisted diagnostic tool that requires human reader interpretation.

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

The performance described in the document is effectively "standalone" in terms of the device's ability to detect microbial growth. The BD BACTEC fluorescent series instruments are automated systems that detect increases in CO2 produced by microorganisms. The studies evaluate the performance of the modified culture vial within this automated system, essentially demonstrating the algorithm (instrument's detection mechanism) only performance as it relates to the culture media. There is no human intervention in the detection process itself once the vials are loaded into the instrument.

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

The ground truth for the analytical studies appears to be based on:

Presence of microbial growth: Confirmed by instrument detection and/or terminal subculture for definitive growth determination.
Known inoculum levels: For studies like Microbial Detection Limit and implied for Time to Detection and Percent Recovery, predefined organism concentrations are used to challenge the system.

8. The Sample Size for the Training Set

The document does not mention any "training set." The studies described are analytical performance evaluations of a medical device, not a machine learning model that requires a training phase.

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

Not applicable, as there is no mention of a training set or machine learning model.

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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them. The logo is black and white.

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

February 9, 2017

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

Re: K161810

Trade/Device Name: BD BACTEC Standard/10 Aerobic/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: January 16, 2017 Received: January 18, 2017

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,

Ribhi Shawar -A

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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Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES		Form Approved: OMB No. 0910-0120
Food and Drug AdministrationIndications for Use		Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)
K161810
Device Name
BD BACTECT™ Standard/10 Aerobic/F Culture VialsSoybean-Casein Digest Broth in a Plastic Vial
Indications for Use (Describe)
BD BACTECT™ Standard/10 Aerobic/F culture vials (enriched Soybean-Casein Digest broth with CO2)are for aerobic blood cultures. Principal use is with the BD BACTEC fluorescent series instruments forthe qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) from blood.
Type of Use (Select one or both, as applicable)
☑Prescription Use (Part 21 CFR 801 Subpart D) □Over-The Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collectionof information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)	Page 1 of 1	PSC Publishing
Services (301) 443-6740	EF

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510(k) Summary

BD BACTEC™ Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial

Summary Preparation Date:

6/30/2016

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/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial

Common Names:

Aerobic blood culture medium

Regulatory Information

Classification: 21 CFR§866.2560, Class I

Product Code(s): MDB

Predicate Device BD BACTECTM Standard/10 Aerobic/F Culture Vial (K954921)

Device Establishment

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

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Intended Use

BD BACTEC™ Standard/10 Aerobic/F culture vials (enriched Soybean-Casein Digest broth with CO2) are for aerobic blood cultures. Principal use is with the BD BACTEC fluorescent series instruments for the qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) from blood.

Device Description

Device Comparison

The BD BACTEC Standard/10 Aerobic/F Culture Vials (plastic) differs from the BD BACTEC Standard/10 Aerobic/F Culture Vials (glass) 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 o accommodate for 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 O ratio of 1.09 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 O overall 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.
- The modified device's sensor contains 13 mg per bottle of the adhesion O promoter 3-glycidoxypropyl trimethoxysilane (GOP). This is not used in the predicate device.

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. The modified 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/10 Aerobic/F Culture Vials (plastic) is similar to the BD BACTEC Standard/10 Aerobic/F Culture Vials (plastic) in the following ways:

. Both the modified and predicate devices are used for the qualitative Aerobic 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 3.0-10.0 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 682 paired sets recovered organisms in both the modified and predicate devices. The estimated median TTD difference for the 682 positive sets is -1.084 hour, favoring the modified device. The modified device meets the acceptance criteria of "No relevant difference from current product." The data indicate 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.

Percent Recovery

Recovery was equivalent between the modified and predicate devices. A total of 984 paired sets were evaluated in the Percent Recovery comparison. Of those, 948 paired sets were positive in both the modified and predicate devices at inoculum level 10-100CFU. Four cultures grew and detected in the predicate device only. Nine cultures grew and detected in the modified device only. There were twentythree paired sets that were not detected in either the modified or predicate devices. The McNemar chisquare analysis of 0.2673 indicates no relevant difference between devices.

Microbial Detection Limit

A total of 360 paired sets were tested; 207 of the inoculated cultures grew and detected in both the modified and predicate devices. Thirty-seven cultures grew and detected in the predicate device only. Forty-eight cultures grew and detected in the modified device only. There were sixty-eight paired sets that were not detected in either the modified or predicate devices. The McNemar chi-square analysis of 0.2781 indicates no relevant difference 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 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 positives in the modified device. There was one anomaly observed in the predicate device. This device was positive in the BACTEC FX instrument at 16.98 hours. The vials utilized in this study are inoculated with fresh blood, no organisms were added to the vial found to be false positive had an organism present due to contamination during the inoculation process. A statistical analysis could not be performed due insufficient failures within the test.

False Negative Rate

A total of 91 paired sets were instrument negative. Additionally, there were 41 modified devices and 57 predicate devices that were instrument negative. All of the instrument negatives were evaluated by terminal subculture. There were34 false negatives (instrument negative subculture positive). Of the 34 false negatives 18 were observed in the predicate device and 16 were observed in the modified device. The McNemar chi-square analysis of the data indicates that there was no statistically significant difference in recovery (p=0.8638) 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 statistical difference in time to detection and recovery 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.