(86 days)
BD BACTEC Peds Plus™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 (mainly bacteria and yeast) from pediatric and non-pediatric blood specimens which are generally less than 3 mL in volume.
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's fluorescence measurement is detected at regular intervals to determine the change in CO2 present in the system. A positive reading indicates the presumptive presence of viable microorganisms in the vial. BD BACTEC Peds Plus™F culture vial detection is limited to microorganisms that will grow in a particular type of medium.
The document describes the analytical performance criteria and the study conducted for the BD BACTEC™ Peds Plus™/F Culture Vials.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (BD BACTEC Peds Plus/F Plastic Vial vs. Glass Vial) |
|---|---|---|
| Instrument Time to Detection (TTD) | Median TTD difference < 10% between test and control devices. | Wilcoxon estimated median TTD difference was approximately 30 minutes, favoring the test device. This is < 10% and deemed not clinically relevant. |
| Percent Recovery | No significant difference in percent recovery between test and control devices. | Both test and control devices were positive in all 492 paired sets (10-100 CFU). No difference was observed from the control. |
| Microbial Detection Limit | No statistically significant difference in recovery between test and control devices. | McNemar chi-square analysis showed no statistically significant difference in recovery (p=0.644) between test and control devices. |
| False Negative Rate | No false negatives observed. | No false negatives observed in either the control or test device. |
| Antimicrobial Neutralization | No statistically significant difference in recovery between test and control devices when evaluating antimicrobial neutralization. | Recovery was the same in the test and control devices, indicating no statistically significant difference. |
2. Sample Size Used for the Test Set and Data Provenance:
- Instrument Time to Detection: 672 paired sets evaluated. 596 paired sets were positive in both devices.
- Percent Recovery: 492 paired sets (from the 672, specifically with 10-100 CFU) evaluated.
- Microbial Detection Limit: 180 paired sets (from the 672, specifically with 0-1, 1-10 CFU) evaluated.
- Antimicrobial Neutralization: Representative drug of its class was evaluated at the MIC level for selected strains. (Specific sample size for this part of the study is not explicitly stated as a number of paired sets, but focuses on the number of strains and drug class).
The data provenance is not explicitly stated regarding country of origin or whether it's retrospective or prospective. However, such studies for regulatory submissions are typically prospective, controlled laboratory studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The study described is an analytical performance study comparing two medical devices (plastic vial vs. glass vial) in a laboratory setting, not a clinical study involving human patients where expert readers would establish ground truth for diagnostic interpretations. Therefore, this information is not applicable to the provided text. The "ground truth" here refers to whether microorganisms grew and were detected as per the gold standard laboratory methods.
4. Adjudication Method for the Test Set:
Not applicable. This was an analytical performance study, not a clinical study requiring adjudication of expert 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:
Not applicable. This is not an AI-based device, nor a diagnostic imaging device typically evaluated with MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a culture vial used with an instrument (BD BACTEC fluorescent series instrument) for automated detection of microbial growth. The performance described is "standalone" from human interpretation in the sense that the instrument provides the detection results. There is no "human-in-the-loop" AI algorithm being evaluated.
7. The Type of Ground Truth Used:
The ground truth used for this analytical performance study is the actual growth and detection of microorganisms in the culture vials, confirmed by laboratory methods (i.e., whether growth occurred and was detected by the instrument, and confirmed by potentially subcultures or other microbiological techniques if discrepancies arose, though the document doesn't detail this level of confirmation). The study design compares the performance of a new plastic vial with an existing glass vial (control).
8. The Sample Size for the Training Set:
Not applicable. This device is a culture vial, not an AI algorithm that requires a training set. The study focuses on evaluating the analytical performance of the device itself.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
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March 16, 2018
Becton Dickinson and Company Ashanti Brown Regulatory Affairs Specialist 7 Loveton Circle MC:694 Sparks, Maryland 21152
Re: K173873
Trade/Device Name: BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial growth monitor Regulatory Class: Class I Product Code: MDB Dated: December 19, 2017 Received: December 20, 2017
Dear Ashanti 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
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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.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ribhi Shawar -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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Indications for Use
510(k) Number (if known) K173873
Device Name
BD BACTEC™ Peds Plus™/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial
Indications for Use (Describe)
BD BACTEC Peds Plus™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 (mainly bacteria and yeast) from pediatric and non-pediatric blood specimens which are generally less than 3 mL in volume.
| 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) |
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510(k) Summary BD BACTEC™ Peds Plus™/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial Summary Preparation Date:
12/11/2017
Submitted by:
BD Diagnostic Systems Becton Dickinson and Company 7 LOVETON CIRCLE SPARKS, MD 21152
Contact:
Ashanti Brown Regulatory Affairs Specialist
Tel: 410-316-4766 Fax: 410-316-4188 Email: ashanti.brown@bd.com
Proprietary Names:
For the media: BD BACTEC™ Peds Plus™/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial
Common Names:
For the instrument: BD BACTECTM Instrument System For the media: BD BACTEC™ Peds Plus™/F (in Plastic)
Regulatory Information
Regulation section: 21 CFR §866.2560
Classification: Class I
Product Code(s): MDB
Predicate Device
BD BACTEC™ Peds Plus™/F Culture Vials Sovbean-Casein Digest Broth with Resins (K954927)
Device Establishment
Becton Dickinson Caribe Ltd. Vicks Drive Lot #6 Cavev. PR 00737 Registration Number: 2647876
Performance Standards
No performance standards have been developed under Section 514 of the Food, Drug and Cosmetic Act.
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Intended Use of Predicate
BD BACTEC Peds Plus™/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 (mainly bacteria and yeast) from pediatric and other blood specimens which are generally less than 3 mL in volume.
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's fluorescence measurement is detected at regular intervals to determine the change in CO2 present in the system. A positive reading indicates the presumptive presence of viable microorganisms in the vial. BD BACTEC Peds Plus™F culture vial detection is limited to microorganisms that will grow in a particular type of medium.
Analytical Performance
The Analytical Performance inclusive of the antimicrobial neutralization capability study demonstrate substantial equivalence of the test device (plastic) to the control device (glass) when inoculated with 3mL of blood at 0-1, 1-10, and 10-100 CFU; supporting the amendment of the blood volumes listed in the package insert, amending blood volumes on vial labeling, updating language surrounding the Haemophilus species, and removing the Fluconazole limitation listed in current package insert.
Summary of Analytical Performance
Instrument Time to Detection
A total of 672 paired sets were evaluated. Of these, 596 paired sets were positive in both the test and control devices. The Wilcoxon estimated median TTD difference for the 596 positive sets was approximately 30 minutes, favoring the test device. There is a statistically detectable difference in the TTD in the test device compared to control device. This median difference in TTD is <10% and is therefore determined not clinically relevant.
Percent Recovery
Of the 672 paired sets evaluated in the Instrument Time to Detection comparison, 492 paired sets (10-100 CFU) were evaluated for Percent Recovery. Both the test and control devices were positive in all of the 492 paired sets. McNemar p-value could not be calculated because there are no recovery failures in the control or test devices. There was no difference from the control.
Microbial Detection Limit
Of the 672 paired sets evaluated in the Instrument Time to Detection comparison a total of 180 paired sets (0-1, 1-10 CFU) were evaluated for microbial detection limit. Of these, 104 grew and detected in both the test and control devices. Twenty three were positive in the control device only. Nineteen were positive in the test device only. There were thirty-four paired sets that were negative in both the test and control devices. The McNemar chi-square analysis of the data indicates that there was no statistically significant difference in recovery (p=0.644) between the test and control devices.
1 The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determinal equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
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False Negative Rate
There were no false negatives observed in either the control or test device.
Antimicrobial Neutralization
One drug representative of its class was evaluated at the MIC level for the selected strains to demonstrate equivalent performance of the test device to the control device. There was no statistically significant difference in recovery between the test and control devices observed during this evaluation; because recovery was the same in the test and control devices p-value could not be determined.
§ 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.