(90 days)
Not Found
No
The device description and performance studies focus on chemical detection and incubation, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is used for the qualitative culture and recovery of anaerobic microorganisms from blood, indicating it is an in vitro diagnostic device for disease detection, not for treating a condition.
Yes
Explanation: The device is used for the qualitative culture and recovery of anaerobic microorganisms from blood, with a positive reading indicating the presumptive presence of viable microorganisms. This process helps identify the cause of infection, which is a diagnostic purpose.
No
The device description clearly outlines a physical instrument (BD BACTEC fluorescent series instrument) that interacts with physical vials containing a chemical sensor. The summary describes hardware components and their function, not just software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "qualitative culture and recovery of anaerobic microorganisms from blood." 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 details how the device interacts with the sample (inoculation into vials) and how it detects the presence of microorganisms (chemical sensor detecting CO2 produced by growth). This process is performed in vitro (outside the body).
- Anatomical Site: The specified anatomical site is "blood," which is a biological sample.
The device fits the definition of an IVD as it is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood
Indicated Patient Age Range
Not Found
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
Instrument time to Detection:
Study type: Comparison of modified device to predicate device.
Sample size: 443 paired sets.
Key results: Wilcoxon estimated median TTD difference of -0.500 hours (30 minutes) favoring the modified device. The modified device performs equivalently to the predicate device.
Percent Recovery:
Study type: Comparison of modified device to predicate device.
Sample size: 528 paired sets evaluated, 504 paired sets positive in both devices at inoculum level 10-100CFU.
Key results: Recovery was equivalent between the modified and predicate devices. McNemar p-value could not be calculated as neither device showed detection exclusively.
Microbial Detection Limit:
Study type: Comparison of modified device to predicate device.
Sample size: 312 paired sets inoculated; 191 grew and detected in both devices.
Key results: McNemar chi-square analysis showed no statistically significant difference in recovery (p=0.8174) between the modified and predicate devices.
False Positive Rate:
Study type: Comparison of modified device to predicate device.
Sample size: 240 paired sets (40 paired sets from each of 3 lots).
Key results: No false positive bottles observed for the modified device with blood volumes (2, 4, 6, 8, and 10mL).
False Negative Rate:
Study type: Comparison of modified device to predicate device.
Sample size: 70 paired sets.
Key results: One false negative observation, found in the predicate device. McNemar chi-square analysis showed no statistically significant difference in recovery (p=1.00) between the modified and predicate devices.
Reproducibility:
Study type: Evaluation across lots.
Key results: No relevant difference in time to detection observed between lot comparisons.
Key Metrics
For Microbial Detection Limit: p=0.8174
For False Negative Rate: p=1.00
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/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.
1
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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
| ------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
|---|
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)
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.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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
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.
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.