(223 days)
Not Found
No
The device description and performance studies focus on chemical sensing and fluorescence detection, with no mention of AI or ML.
No.
This device is designed for the qualitative culture and recovery of microorganisms from blood, primarily for diagnostic purposes, not for treating a disease or condition.
Yes
Explanation: The device is used to detect the presence of microorganisms in blood cultures, indicating an infection, which is a diagnostic purpose.
No
The device description clearly outlines a physical culture vial and an instrument that interacts with the vial to detect microbial growth. This involves hardware components (vials, instrument, sensor) and is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) from blood." This is a diagnostic purpose, aiming to identify the presence of microorganisms in a biological sample (blood).
- Device Description: The description explains how the device works by detecting CO2 produced by microbial growth in a sample. This process is performed in vitro (outside the body) on a biological specimen.
- Anatomical Site: The sample is taken from "blood," which is a biological specimen.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
BD BACTECTM 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.
Product codes (comma separated list FDA assigned to the subject device)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 twenty-three paired sets that were not detected in either the modified or predicate devices. The McNemar chi-square 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 were 34 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
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,
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 Administration | ||
| Indications for Use | Expiration Date: January 31, 2017 | |
| See PRA Statement below. | ||
| 510(k) Number (if known) | ||
| K161810 | ||
| Device Name | ||
| BD BACTECT™ Standard/10 Aerobic/F Culture Vials | ||
| Soybean-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 for | ||
| the 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. | ||
| The burden time for this collection of information is estimated to average 79 hours per response, including | ||
| the time to review instructions, search existing data sources, gather and maintain the data needed and | ||
| complete and review the collection of information. Send comments regarding this burden estimate or any | ||
| other aspect of this information collection, including suggestions for reducing this burden, to: | ||
| Department of Health and Human | ||
| Services Food and Drug Administration | ||
| Office of Chief Information Officer | ||
| Paperwork Reduction Act (PRA) | ||
| Staff PRAStaff@fda.hhs.gov | ||
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection | ||
| of 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
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/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.
7
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.