(28 days)
Not Found
No
The summary describes a culture bottle and a detection system that monitors for microbial growth, but there is no mention of AI or ML being used in the detection or analysis process.
No
This device is a culture bottle used to detect microorganisms in blood, not to treat a condition or disease.
Yes
The device is used to detect the presence of microorganisms (bacteria and yeast) in blood samples, which is a diagnostic procedure for identifying infections.
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 that the BacT/ALERT PF Culture Bottles are used in "qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood." This describes a test performed on a sample taken from the human body (blood) to provide information about a person's health status (presence of microorganisms).
- Device Description: The description further clarifies that the inoculated bottle is placed into an instrument that "monitors for the presence of microorganisms." This is a diagnostic process.
- Anatomical Site: The device is used with "Blood," which is a biological sample.
- Performance Studies: The performance studies involve "seeded studies... diluted in human blood," demonstrating that the device is used to analyze human samples.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the safety and compatibility of any tissue or organ for transplantation.
N/A
Intended Use / Indications for Use
BacT/ALERT® PF Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.
Product codes
MDB
Device Description
The BacT/ALERT PF Plastic Culture Bottle was developed for the same intended use as the current BacT/ALERT PF Glass Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections. 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 PF 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
Pediatric
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
Seeded studies were performed on 23 organisms diluted in human blood and inoculated into the BacT/ALERT PF Plastic Culture bottle and the BacT/ALERT PF Glass Culture bottle. The BacT/ALERT PF Plastic Culture Bottle was substantially equivalent to the BacT/ALERT PF Glass Culture Bottle based on recovery of low levels of the 23 microorganisms included in the study. Detection times were equivalent in both bottles.
Key Metrics
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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.
0
APR 1 8 2002
510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT PF (Plastic) Culture Bottle
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 Sanyal
Date 510(k) Summary Prepared: March 20, 2002
- 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 PF Culture Bottle
Common or Usual Name: BacT/ALERT PF Culture 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: BacT/Alert PF Glass Culture Bottle -
A description of the device. (a)(4)
Device Description: The BacT/ALERT PF Plastic Culture Bottle was developed for the same intended use as the current BacT/ALERT PF Glass Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections. 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 PF Bottle. -
A statement of the intended use of the device. (a)(5)
Device Intended Use: BacT/ALERT® PF Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.
1
510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT PF (Plastic) Culture Bottle
A summary of the technological characteristics of the new device in comparison to those of (a)(6) the predicate device.
The BacT/ALERT PF Plastic Culture Bottle utilizes the same detection technology as the BacT/ALERT PF Glass Culture Bottle. The similarities and/or differences with marketed device are listed in Table (a) (6) 1.
| FEATURES | BACT/ALERT PF PLASTIC CULTURE
BOTTLE | BACT/ALERT PF GLASS
CULTURE BOTTLE |
|-----------------------------------------|-----------------------------------------|-------------------------------------------|
| | | (K992401) |
| 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 | Blood |
| Target Population | Pediatric | Pediatric |
TABLE (a)(6).1
Image /page/1/Picture/5 description: The image contains a close-up of the number "054" in a bold, sans-serif font. The digits are tightly spaced and slightly distorted, giving them a somewhat irregular appearance. The image is black and white, with the numbers appearing in black against a white background.
2
510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT PF (Plastic) Culture Bottle
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 23 organisms diluted in human blood and inoculated into the BacT/ALERT PF Plastic Culture bottle and the BacT/ALERT PF 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 PF Plastic Culture Bottle was substantially equivalent to the BacT/ALERT PF Glass Culture Bottle based on recovery of low levels of the 23 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 logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ron Sanyal, M. Pharm., CQE, RAC Manager, Regulatory Affairs Biomerieux, Inc. 100 Rodolphe Street Durham, NC 27712
APR 1 8 2002
K020923 Re:
Trade/Device Name: BacT/ALERT® PF Culture Bottle Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial Growth Monitor Regulatory Class: Class I Product Code: MDB Dated: March 20, 2002 Received: March 21, 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.
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/cdrh/dsma/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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ની Page
510(k) Number (If known):
. BacT/ALERT PF Culture Bottle
Indications: For Usa:
Device Name:
The BacT/ALERT PF Culture Bottles are used with the BacT/ALERT Microbial The Dact / All Collective procedures for enhanced recovery and detection of Delection Dystems in qualitative procedures (bacteria and yeast) from blood.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
ਾਕ
Over-The Counter Use
(Optional Format 1-2-98)
Freddie L. Lode
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020923