(36 days)
Not Found
No
The summary describes a culture bottle and a microbial detection system that monitors for growth, but there is no mention of AI or ML in the device description, intended use, or performance studies. The comparison is to a predicate device that is also a culture bottle.
No.
This device is designed for the detection and recovery of microorganisms for diagnostic purposes, not for treating diseases or conditions.
Yes
This device is used for the "recovery and detection of anaerobic microorganisms from blood, and other normally sterile body fluids," which is a diagnostic procedure.
No
The device description clearly states it is a "Plastic Culture Bottle" and is used with "BacT/ALERT Microbial Detection Instruments," indicating it is a physical component and part of a larger hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "qualitative procedures for enhanced recovery and detection of anaerobic microorganisms from blood, and other normally sterile body fluids." 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's used with a "Microbial Detection System" to "monitor for the presence of microorganisms" in inoculated bottles. This is a classic description of an in vitro diagnostic process.
- Anatomical Site: The specified anatomical sites are "Blood, Body Fluids," which are biological samples commonly used in IVD testing.
- Performance Studies: The performance studies involve "seeded studies... diluted in human blood," demonstrating that the device is being evaluated for its ability to detect microorganisms in human samples.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
BacT/ALERT FN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of anaerobic microorganisms from blood and other normally sterile body fluids.
Product codes (comma separated list FDA assigned to the subject device)
MDB
Device Description
The BacT/ALERT FN Plastic Culture Bottle was developed for the same intended use as the current BacT/ALERT FN Glass Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT FN Bottle.
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
Adult
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)
Seeded studies were performed on 9 organisms diluted in human blood and inoculated into the BacT/ALERT FN Plastic Culture bottle and the BacT/ALERT FN Glass Culture bottle. The BacT/ALERT FN Plastic Culture Bottle was substantially equivalent to the BacT/ALERT FN Glass Culture Bottle based on recovery of low levels of the 9 microorganisms included in the study. Detection times were equivalent in both bottles.
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.
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:
bioMérieux, Inc.
Submitter's Address:
100 Rodolphe Street. Durham, North Carolina 27712 (919) 620-2373
Submitter's Telephone:
Submitter's Contact:
Ron Sanyal Ron Sa
Date 510(k) Summary Prepared: March 8, 2002
- (a)(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known;
Trade or Proprietary Name: BacT/ALERT FN Culture Bottle
Common or Usual Name: BacT/ALERT FN Culture Bottle
Classification Name: Microbial Growth Monitor
-
(a)(3) An identification of the legally marketed device to which the submitter claims substantial equivalence;
Device Equivalent to: BacT/Alert FN Glass Culture Bottle -
A description of the device. (a)(4)
Device Description: The BacT/ALERT FN Plastic Culture Bottle was developed for the same intended use as the current BacT/ALERT FN Glass Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT FN Bottle.
A statement of the intended use of the device. (a)(5)
Device Intended Use: BacT/ALERT FN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of anaerobic microorganisms from blood and other normally sterile body fluids.
1
A summary of the technological characteristics of the new device in comparison to those of (a)(6) the predicate device.
The BacT/ALERT FN Plastic Culture Bottle utilizes the same detection technology as the BacT/ALERT FN Glass Culture Bottle. The similarities and/or differences with marketed device are listed in Table (a) (6) 1.
| FEATURES | BACT/ALERT FN PLASTIC
CULTURE BOTTLE | BACT/ALERT FN GLASS
CULTURE BOTTLE
(K992432) |
|-----------------------------------------|-----------------------------------------|----------------------------------------------------|
| Intended Use | Same | Same |
| Culture Bottle Material | Plastic | Glass |
| Product Code | MDB | MDB |
| Technology | Reflectance | Reflectance |
| Color change based on
CO2 production | YES | YES |
| Sensor | Emulsion | Emulsion |
| Indicator material | Xylenol Blue in Silicone Emulsion | Xylenol Blue in Silicone Emulsion |
| Growth of
microorganisms | Same | Same |
| Instrument Used | BacT/ALERT Microbial Detection Systems | BacT/ALERT Microbial
Detection Systems |
| Sample Source | Blood, Body Fluids | Blood, Body Fluids |
| Target Population | Adult | Adult |
TABLE (a)(6).1
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 9 organisms diluted in human blood and inoculated into the BacT/ALERT FN Plastic Culture bottle and the BacT/ALERT FN Glass Culture bottle.
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the (b)3) device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).
The BacT/ALERT FN Plastic Culture Bottle was substantially equivalent to the BacT/ALERT FN Glass Culture Bottle based on recovery of low levels of the 9 microorganisms included in the study. Detection times were equivalent in both bottles.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with its head turned to the left. The eagle is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Ron Sanyal, M. Pharm., CQE, RAC Manager, Regulatory Affairs Biomerieux, Inc. 100 Rodolphe Street Durham, NC 27712
K020815 Re:
Trade/Device Name: BacT/ALERT® FN Culture Bottle Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial Growth Monitor Regulatory Class: Class I Product Code: MDB Dated: March 8, 2002 Received: March 13, 2002
Dear Mr. Sanyal:
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.
APR 1 8 2002
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/odrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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 1 of 1.
| | | 510(k) Number (If known):_____________________________________________________________________________________________________________________________________________________ | KOZO815
Comments of the consisted to the consisted to the consideration of the control of the contribution of the contribution of the contribution of the contribution of the contribu | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | CALL AND |
BacT/ALERT® FN Culture Bottle Device Name:
Indications For Usa:
BacT/ALERT® FN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of anaerobic microorganisms from blood, and other normally sterile body fluids.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concumence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | KD2 0815 |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | |||
| (Optional Format 1-2-96) |