(21 days)
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No
The document describes a blood culture medium and its use with an instrument, focusing on microbial growth and detection, with no mention of AI or ML.
No
This device is a diagnostic tool used to detect microorganisms in blood cultures, not to treat a condition. Its purpose is to identify the presence of bacteria and yeast for diagnosis, not therapy.
No
This device is a blood culture medium used to grow and recover microorganisms from blood samples, which is a step in identifying the presence of infection. It does not provide a diagnosis itself, but rather aids in the detection and isolation of pathogens for further diagnostic testing.
No
The device is a blood culture medium, which is a physical substance used for growing microorganisms. It is explicitly described as a "bacterial growth medium" and is used in conjunction with physical instruments (BD BACTEC Fluorescent Series Instruments). This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for a "qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood." This is a diagnostic test performed in vitro (outside the body) on a biological sample (blood) to identify the presence of microorganisms.
- Device Description: The description reinforces this by stating it's a "bacterial growth medium intended for use in the qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) from human blood." It's used in conjunction with an instrument to monitor clinical blood specimens for the presence of microorganisms, which is a diagnostic activity.
- Anatomical Site: The anatomical site is "blood," which is a biological sample used for diagnostic testing.
The information provided aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BD BACTEC Plus Aerobic/F Blood Culture medium is used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principle use of this medium is with BD BACTEC Fluorescent Series Instruments.
Product codes
MDB
Device Description
BD BACTEC Plus Aerobic/F Blood Culture medium is a bacterial growth medium intended for use in the qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) from human blood. It has been design for blood volumes of three (3) to ten (10) milliliters and is used specifically with the BD BACTEC Fluorescent Series Instruments in monitoring of clinical blood specimens for the presence of microorganisms.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
blood
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Included in this Special 510(k), are the Hazard Analysis and the associated validations and verifications conducted to address individual hazards/risks identified for this modification. The Hazard Analysis did not identify any changes that raised new issues with safety and effectiveness. The parameters listed below were evaluated in internal studies conducted by BD Diagnostic Systems according to appropriate Design Control procedures. The modified BD BACTEC Plus Aerobic/F Blood Culture medium met all current product claims for performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Medium Sensitivity/Specificity: Overall medium performance for the modified formulation is equivalent to the current formulation
- False Positive Rate: False positive rate for the modified formulation is equivalent to the current formulation
- False Negative Rate: False negative rate for the modified formulation is equivalent to the current formulation
- Instrument Compatibility: The modified formulation can be used in any BD BACTEC Fluorescent Series Instrument
Predicate Device(s)
BD BACTECTM Plus Aerobic/F Blood Culture Medium (K921133)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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K0r352)2
Confidential
Page 1 of 1
510(k) SUMMARY
DEC 2 4 2008
| SUBMITTED BY: | BECTON, DICKINSON AND COMPANY
7 LOVETON CIRCLE
SPARKS, MD 21152
Phone: 410-316-4099
Fax: 410-316-4041 |
|------------------------|-------------------------------------------------------------------------------------------------------------------|
| CONTACT NAME: | Dennis Mertz, Sr. Manager, Regulatory Affairs |
| DATE PREPARED: | November 26, 2008 |
| DEVICE TRADE NAME: | BD BACTEC™ Plus Aerobic/F Blood Culture
Medium |
| DEVICE COMMON NAME: | Microbial Growth Monitor |
| DEVICE CLASSIFICATION: | 21 CFR § 866.2560 Class I |
| PREDICATE DEVICES: | BD BACTEC™ Plus Aerobic/F Blood Culture
Medium (K921133) |
INTENDED USE:
BD BACTEC Plus Aerobic/F Blood Culture medium is used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principle use of this medium is with BD BACTEC Fluorescent Series Instruments.
DEVICE DESCRIPTION:
BD BACTEC Plus Aerobic/F Blood Culture medium is a bacterial growth medium intended for use in the qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) from human blood. It has been design for blood volumes of three (3) to ten (10) milliliters and is used specifically with the BD BACTEC Fluorescent Series Instruments in monitoring of clinical blood specimens for the presence of microorganisms.
Page v of vii
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DEVICE COMPARISON:
The modified BD BACTEC Plus Aerobic/F Blood Culture medium differs from the current legally marketed BD BACTEC Plus Aerobic/F Blood Culture medium in the following ways:
- The modified BD BACTEC Plus Aerobic/F Blood Culture medium . contains 30mL of broth whereas the current BD BACTEC Plus Aerobic/F Blood Culture medium contains 25mL of broth.
- The modified BD BACTEC Plus Aerobic/F Blood Culture medium . contains the addition of antioxidants and vitamins to stabilize the nutrients in the media during the manufacturing process whereas the current BD BACTEC Plus Aerobic/F Blood Culture medium does not contain these ingredients.
- The modified BD BACTEC Plus Aerobic/F Blood Culture medium . contains an increase in the glucose (dextrose) and a reduction in the concentration of sucrose in order to enhance the nutritional content of the medium whereas the current BD BACTEC Plus Aerobic/F Blood Culture medium has a lower concentration of glucose but a higher concentration of sucrose.
- An algorithm modification will be made for processing late protocol . (>35 hours) growth that will be incorporated into the BACTEC Fluorescent Series instruments to compliment the formulation changes to the medium. Both the modified and current BD BACTEC Plus Aerobic/F Blood Culture medium will utilize this modified algorithm.
SUBSTANTIAL EQUIVALENCE
The modified BD BACTEC Plus Aerobic/F Blood Culture medium is substantially equivalent' to the current legally marketed device, BD BACTEC Plus Aerobic/F Blood Culture medium. Modifications made to the BD BACTEC Plus Aerobic/F Blood Culture medium did not change the intended use of the device or the fundamental scientific technology.
| Modification | Potential Impact of Modification |
|---|---|
| Reagent Modifications | Stability of aerobic environment over |
| shelf life | |
| Increase medium volume | Blood to broth ratio |
| Algorithm modification | Time to detection for slow growing |
| yeast |
Modifications to the BACTEC Plus Aerobic/F medium are as follows:
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Included in this Special 510(k), are the Hazard Analysis and the associated validations and verifications conducted to address individual hazards/risks identified for this modification. The Hazard Analysis did not identify any changes that raised new issues with safety and effectiveness. The parameters listed below were evaluated in internal studies conducted by BD Diagnostic Systems according to appropriate Design Control procedures. The modified BD BACTEC Plus Aerobic/F Blood Culture medium met all current product claims for performance.
| Parameter | Result |
|---|---|
| Medium Sensitivity/Specificity | Overall medium performance for the |
| modified formulation is equivalent to | |
| the current formulation | |
| False Positive Rate | False positive rate for the modified |
| formulation is equivalent to the current | |
| formulation | |
| False Negative Rate | False negative rate for the modified |
| formulation is equivalent to the current | |
| formulation | |
| Instrument Compatibility | The modified formulation can be used |
| in any BD BACTEC Fluorescent | |
| Series Instrument |
"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 premarket approval or reclassification. A determination of substantial 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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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Mr. Dennis Mertz Regulatory Affairs Specialist BD Diagnostic System Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
DEC 2 4 2008
Re: K083572
Trade/Device Name: BD BACTECTM Plus Aerobic/F Blood Culture Medium Regulation Number: 21 CFR & 866.2660 Regulation Name: Microbial Growth Monitor Regulatory Class: I Product Code: MDB Dated: December 2, 2008 Received: December 3, 2008
Dear Mr. Mertz:
We have reviewed your Section 510(k) prematket 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sally attaym
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Confidential
INDICATION FOR USE
510(k) Number (if known): K083572
Device Name: BD BACTEC Plus Aerobic/F Blood Culture medium
Indication For Use:
BD BACTEC Plus Aerobic/F blood Culture medium is used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principle use of this medium is with BD BACTEC Fluorescent Series Instruments.
Prescription Use X (21 CFR Part 801 Subpart D) Subpart C)
And/Or
Over the Counter Use (21 CFR Part 801
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Vell attor
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 083572