(54 days)
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No
The summary describes a culture bottle and an instrument that monitors for microbial growth, with no mention of AI or ML technologies.
No.
The device is designed for the detection and recovery of mycobacteria for diagnostic purposes, not for treating a disease or condition.
Yes
The device is designed for the "recovery and detection of mycobacteria" from clinical specimens, indicating its use in identifying the presence of a pathological agent, which is a diagnostic function.
No
The device description clearly states it is a "Process Bottle" which is a physical container designed to provide nutritional and environmental conditions for mycobacterial growth. It is used in conjunction with detection instruments, indicating it is a hardware component of a larger system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens." This involves testing samples taken from the human body to provide information about a person's health.
- Device Description: The description further clarifies that it provides "suitable nutritional and environmental conditions for mycobacterial organisms commonly encountered in body fluids" and is "continuously monitored for the presence of mycobacteria." This describes a process of analyzing a biological sample to identify a specific organism.
- Performance Studies: The performance studies involve "Seeded studies were performed on 12 organisms and inoculated into the BacT/ALERT MP Process Bottle and the MB/BacT Process Bottle." This demonstrates testing the device's ability to detect specific organisms in a controlled setting, which is characteristic of IVD testing.
- Predicate Device: The mention of a "Predicate Device(s)" which is the "MB/BacT Process Bottles" further supports its classification as an IVD, as predicate devices are typically other legally marketed IVDs.
All these points 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
The BacT/ALERT MP Process Bottle is designed for use with the MB/BacT and the BacT/ALERT 3D Mycobacteria Detection Systems, for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens.
Product codes
MDB
Device Description
The BacT/ALERT MP Process Bottle was developed for the same intended use as the current MB/BacT Process Bottle, provide suitable nutritional and environmental conditions for mycobacterial organisms commonly encountered in body fluids. An inoculated bottle is placed into the MB/ BacT Detection Instrument or the BacT/ALERT 3D Instrument where it is incubated and continuously monitored for the presence of mycobacteria that will grow in the BacT/ALERT MP Process Bottle.
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
Body Fluids
Indicated Patient Age Range
Adult
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
Testing was performed to establish the performance characteristics of the new device including: Seeded studies were performed on 12 organisms and inoculated into the BacT/ALERT MP Process Bottle and the MB/BacT Process Bottle.
Summary of Performance Studies
The BacT/ALERT MP Process Bottle was substantially equivalent to the MB/BacT Process Bottle based on recovery of the 12 mycobacterial organisms included in the study. Detection times were substantially equivalent in both bottles.
Key Metrics
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Predicate Device(s)
MB/BacT Process Bottles
Reference Device(s)
Not Found
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.
0
510(k) Summary
- The submitter's name, address, telephone number, a contact person, and the date the (a)(1) summary was prepared;
Submitter's Name: Organon Teknika Corporation
Submitter's Address: 100 Akzo Avenue Durham, North Carolina 27712 Submitter's Telephone: (919) 620-2288
Submitter's Contact: Rebecca A. Rivas
Date 510(k) Summary Prepared: October 20, 1999
- The name of the device, including the trade or proprietary name if applicable, the common (a)(2) or usual name, and the classification name, if known;
Trade or Proprietary Name: BacT/ALERT MP Process Bottle
Common or Usual Name: BacT/ALERT MP Process Bottle
Classification Name: Microbial Growth Monitor
-
An identification of the legally marketed device to which the submitter claims substantial (a)(3) equivalence;
Device Equivalent to: MB/BacT Process Bottles -
A description of the device. (a)(4)
Device Description: The BacT/ALERT MP Process Bottle was developed for the same intended use as the current MB/BacT Process Bottle, provide suitable nutritional and environmental conditions for mycobacterial organisms commonly encountered in body fluids. An inoculated bottle is placed into the MB/ BacT Detection Instrument or the BacT/ALERT 3D Instrument where it is incubated and continuously monitored for the presence of mycobacteria that will grow in the BacT/ALERT MP Process Bottle. -
(a)(5) A statement of the intended use of the device.
Device Intended Use: The BacT/ALERT MP Process Bottle is designed for use with the MB/BacT and the BacT/ALERT 3D Mycobacteria Detection Systems, for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens.
1
- A summary of the technological characteristics of the new device in comparison to those of (a)(6) the predicate device. The BacT/ALERT MP Process Bottle utilizes the same detection technology as the MB/BacT/ Culture Bottle.
| FEATURES | BACT/ALERT MP PROCESS BOTTLE | MB/BACT PROCESS
BOTTLE |
|-----------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------|
| Technology | Reflectance | Reflectance |
| Color change based on
CO2 production | Yes | Yes |
| Sensor | Emulsion | Disc |
| Indicator material | Yes, Same as MB/BacT Process
Bottle | Yes |
| Growth of
microorganisms | Yes, Equivalent to MB/BacT
Process Bottle | Yes |
| Instrument Used | MB/BacT Mycobacterial Detection
Systems or BacT/ALERT 3D System | MB/BacT Mycobacterial
Detection Systems or
BacT/ALERT 3D System |
| Sample Source | Body Fluids | Body Fluids |
| Target Population | Adult | Adult |
2
A brief discussion of the nonclinical tests submitted, referenced, or relied on in the (b)1) premarket notification submission for a determination of substantial equivalency.
Testing was performed to establish the performance characteristics of the new device including:
Seeded studies were performed on 12 organisms and inoculated into the BacT/ALERT MP Process Bottle and the MB/BacT Process Bottle.
(b)3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).
The BacT/ALERT MP Process Bottle was substantially equivalent to the MB/BacT Process Bottle based on recovery of the 12 mycobacterial organisms included in the study. Detection times were substantially equivalent in both bottles.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 4 1999
Ms. Rebecca A. Rivas Regulatory Affairs Administrator Organon Teknika Corporation 100 Akzo Avenue Durham, North Carolina 27712
K993576 Re: Trade Name: BacT/ALERT MP Process Bottle Regulatory Class: I Product Code: MDB Dated: October 20, 1999 Received: October 21, 1999
Dear Ms. Rivas:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Page | |
|---|---|
| of |
| 510(k) Number (If known): | K993576 |
|---|---|
| Device Name: | BacT/ALERT MP Process Bottle |
Indications For Usa:
The BacT/ALERT MP Process Bottle is designed for use with the MB/BacT and the The DacT/ALERT 3D Mycobacteria Detection Systems, for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-
decontaminated clinical specimens.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubris
inical Laboratory Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-98)