(86 days)
No
The summary describes a chemical sensor and fluorescence measurement for detecting CO2, which is a standard biological detection method, not AI/ML. There is no mention of AI, ML, or related concepts in the document.
No.
This device is designed to detect the presence of microorganisms in blood samples for diagnostic purposes and does not provide therapeutic treatment.
Yes
The device qualitatively cultures and recovers microorganisms from blood specimens, and a positive reading indicates the presumptive presence of viable microorganisms, which are clear diagnostic purposes.
No
The device description clearly outlines physical components (vials, chemical sensor) and their interaction with an instrument for detection, indicating it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the vials are for "qualitative culture and recovery of aerobic microorganisms (mainly bacteria and yeast) from pediatric and non-pediatric blood specimens." This involves testing a sample taken from the human body (blood) to provide information about a person's health status (presence of microorganisms).
- Device Description: The description explains that the device is used to detect the presence of microorganisms in a sample inoculated into the vial. This is a diagnostic process performed in vitro (outside the body).
- Anatomical Site: The device is used with "Blood specimens," which are samples taken from the human body for diagnostic purposes.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
MDB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and non-pediatric
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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. This median difference in TTD is
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 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.