(40 days)
The BacT/ALERT MP culture 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.
The BacT/ALERT MP culture bottle was developed for the same intended use as the current BacT/ALERT MP Process Bottle (glass), when used in conjunction with the MB/BacT Reconstitution Fluid (for use with sterile specimens) or with MB BacT Antibiotic Supplement (for use with digesteddecontaminated clinical specimens) is a selective growth medium for the in vitro culture recovery of mycobacteria organisms commonly encountered in body fluids other than blood and from digested-decontaminated clinical specimens. 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 bottle.
Here's an analysis of the provided text regarding the acceptance criteria and study for the bioMérieux BacT/ALERT MP Culture Bottle:
This submission is for a substantial equivalence determination for a new device (plastic bottle) compared to an existing predicate device (glass bottle) for the same intended use. Therefore, the "acceptance criteria" and "device performance" are primarily focused on demonstrating equivalence in performance.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical "acceptance criteria" in a typical sense (e.g., "sensitivity must be >X%"). Instead, the performance assessment is based on demonstrating substantial equivalence to the predicate device. The primary performance metric mentioned is related to recovery and detection times of mycobacterial organisms.
| Acceptance Criterion (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Equivalent recovery of mycobacterial organisms | Recovery of the 12 mycobacterial organisms was substantially equivalent. |
| Equivalent detection times for mycobacterial organisms | Detection times were substantially equivalent in both bottles. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The study was performed on 12 organisms. It's important to note this refers to the types of organisms, not necessarily the number of individual tests or specimens. The document doesn't specify how many replicates or specimens were used for each of the 12 organisms.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective clinical data. It describes "seeded studies," which typically implies laboratory-controlled experiments rather than clinical patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study described is a "seeded study" which involves inoculating known organisms. The "ground truth" for the presence of the organisms is inherent in the experimental design (i.e., the organisms were intentionally BSL inoculated). Therefore, expert review to establish ground truth from unknown samples is not relevant for this type of test.
4. Adjudication Method for the Test Set
Not applicable. As described above, this was a seeded study with known organisms. There was no need for adjudication of results by multiple experts as the presence of the target organism was controlled experimentally.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a diagnostic culture bottle for detecting microbial growth, not an imaging or interpretation device that would involve human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, this was effectively a standalone performance study of the device. The "algorithm" here is the chemical detection system within the bottle and the instrument (MB/BacT or BacT/ALERT 3D) that monitors it. The study compared the performance of the new plastic bottle against the predicate glass bottle directly on their ability to detect microbial growth, without human interpretation as part of the primary outcome measure.
7. The Type of Ground Truth Used
The ground truth used was spiking/seeding with known organisms. In a seeded study, the presence and identity of the microorganisms are precisely controlled by the researchers who introduce them into the test samples.
8. The Sample Size for the Training Set
Not applicable. This device is a diagnostic culture medium and detection system, not a machine learning or AI model that requires a "training set" in the computational sense. The "training" of the device is inherent in its design and manufacturing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of this device technology.
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Premarket Notific bioMerieux, Inc. BacT/ALERT MP Culture Bottles (plastic)
JUL 1 4 2003
510(k) Summary
(a)(1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Submitter's Address: | 100 Rodolphe Street,Durham, North Carolina 27712 |
| Submitter's Telephone: | (919)-620-2968 |
| Submitter's Contact: | Jocelyn Jennings, RAC |
| Date 510(k) Summary prepared: | May 29, 2003 |
- (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 MP Culture Bottle |
|---|---|
| Common or Usual Name: | BacT/ALERT MP 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 MP Glass Process Bottle
(a)(4) A description of the device
Device Description: The BacT/ALERT MP culture bottle was developed for the same intended use as the current BacT/ALERT MP Process Bottle (glass), when used in conjunction with the MB/BacT Reconstitution Fluid (for use with sterile specimens) or with MB BacT Antibiotic Supplement (for use with digesteddecontaminated clinical specimens) is a selective growth medium for the in vitro culture recovery of mycobacteria organisms commonly encountered in body fluids other than blood and from digested-decontaminated clinical specimens. 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 bottle.
CONFIDENTIAL
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(a)(5) A statement of the intended use of the device
Device Intended Use: The BacT/ALERT MP culture 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.
(a)(6) A summary of the technological characteristics of the new device in comparison to those of the predicate device
The BacT/ALERT MP Plastic Culture Bottle utilizes the same detection technology as the BacT/ALERT MP Glass Process Bottle. The similarities and/or differences with marketed device are listed in Table (a)(6) 1.
| FEATURES | BACT/ALERT MPPLASTIC CULTUREBOTTLE | BACT/ALERT MPGLASS PROCESSBOTTLE (K993576) |
|---|---|---|
| Intended Use | Same | Same |
| Culture BottleMaterial | Plastic | Glass |
| Product Code | MDB | MDB |
| Technology | Reflectance | Reflectance |
| Color change based onCO2 production | Yes | Yes |
| Sensor | Emulsion | Emulsion |
| Indicator Material | Xylenol Blue inSilicone Emulsion | Xylenol Blue inSilicone Emulsion |
| Growth ofmicroorganisms | Same | Same |
| Instrument Used | MB/BacTMycobacterialDetection System andBacT/ALERT 3DSystems | MB/BacTMycobacterialDetection System andBacT/ALERT 3DSystems |
| Sample source | Body fluids anddigested-decontaminated clinicalspecimens | Body fluids anddigested-decontaminated clinicalspecimens |
| Target Population | Adult | Adult |
CONFIDENTIAL
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(b)(1) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the 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 Plastic Culture Bottle and the BacT/ALERT MP Glass Process Bottle.
(b)(2) 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 Plastic Culture Bottle was substantially equivalent to the BacT/ALERT MP Glass Process Bottle based on recovery of the 12 mycobacterial organisms included in the study. Detection times were substantially equivalent in both bottles.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." surrounding a stylized symbol. The symbol is composed of three curved lines that resemble a human figure with outstretched arms.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 4 2003
Jocelyn Jennings, RAC Senior Regulatory Affairs Specialist Biomerieux, Inc. 100 Rodolphe Street Durham, NC 27712
Re: K031737
Trade/Device Name: BacT/ALERT MP Culture Bottle Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial Growth Monitor Regulatory Class: Class I Product Code: MDB Dated: June 3, 2003 Received: June 9, 2003
Dear Ms. Jennings:
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 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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Page 2 -
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT VI.
510(k) Number (if known): K 031737
Device Name: BacT/ALERT MP Culture Bottle
Indications For Use:
The BacT/ALERT MP culture 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use V
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Fuddie Mc. Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K03 1737
CONFIDENTIAL
§ 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.