(46 days)
The BacT/ALERT PF Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.
The BacT/ALERT PF Culture Bottle provides a sensitive method for detection of microorganisms when only a small volume of blood is available. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT PF Culture Bottle.
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Acceptance Criteria and Study for BacT/ALERT PF Culture Bottle
The provided documentation details the submission for a 510(k) premarket notification for the BacT/ALERT PF Culture Bottle, claiming substantial equivalence to the BacT/ALERT Pedi-BacT Culture Bottle. The study primarily focuses on demonstrating that the new device performs equivalently to the predicate device in terms of microbial recovery.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Implied Acceptance Criteria) | Reported Device Performance (BacT/ALERT PF Culture Bottle) | Predicate Device Performance (BacT/ALERT Pedi-BacT Culture Bottle) |
|---|---|---|
| Recovery of low levels of microorganisms | Equivalent recovery | Baseline for comparison |
| Detection of 23 specific microorganisms | Equivalent detection | Baseline for comparison |
Note: The document doesn't explicitly state quantitative acceptance criteria or specific numerical performance targets for the new device. Instead, the criterion is implied to be "equivalence" to the predicate device for microbial recovery and detection.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The "test set" consists of 23 organisms. For each organism, two concentrations were seeded into bottles of both the BacT/ALERT PF and Pedi-BacT Culture Bottles. This means a total of 23 organisms * 2 concentrations * 2 bottle types = 92 bottles were tested as a minimum, although the phrasing "utilizing 23 organisms seeded into BacT/ALERT PF and Pedi-BacT Culture Bottles" suggests a larger total number of bottles, as each organism at each concentration would need multiple replicates of each bottle type for statistical validity. However, the exact number of replicates is not specified.
- Data Provenance: The study was described as "In-house seeded studies." This indicates the data was generated within the submitter's (Organon Teknika Corporation) laboratory. The country of origin is not explicitly stated, but the company address is Durham, North Carolina, USA. The study design is an experimental, controlled study rather than retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The ground truth (presence or absence of microbial growth and detection) would have been established by direct observation and monitoring using the BacT/ALERT systems themselves or through standard microbiological culturing techniques to confirm growth.
4. Adjudication Method for the Test Set
No adjudication method is described. As the "ground truth" is determined by the objective operation of the instruments detecting microbial growth, expert adjudication (like in image interpretation studies) is not applicable here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was conducted or mentioned. This type of study is more relevant for diagnostic devices that involve human interpretation (e.g., radiology images) rather than automated microbial detection systems. Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "In-house seeded studies" evaluated the performance of the BacT/ALERT PF Culture Bottle (algorithm/device only) in detecting microorganisms, comparing it directly to the predicate device. This was a direct assessment of the device's capability without human intervention in the detection process.
7. Type of Ground Truth Used
The ground truth used was the known presence and concentration of specific microorganisms (23 different organisms seeded at two specified concentrations: <100 CFU/bottle and <10 CFU/bottle). The gold standard for confirming growth would be standard microbiological techniques for culture confirmation.
8. Sample Size for the Training Set
The document does not mention a "training set." This device is not described as utilizing machine learning or AI that would require a separate training set. It relies on established reflectance technology to detect CO2 production. The "seeded studies" described are for performance validation rather than training.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for this device, information on how its ground truth was established is not applicable or provided.
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510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT PF Culture Bottle 510(k) Summary
The submitter's name, address, telephone number, a contact person, and the date (a)(1) the 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:
- (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 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 (a)(3) substantial equivalence:
Device Equivalent to: BacT/ALERT Pedi-BacT Culture Bottle
(a)(4) A description of the device.
The BacT/ALERT PF Culture Bottle provides a sensitive Device Description: method for detection of microorganisms when only a small volume of blood is available. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT PF Culture Bottle.
(a)(5) A statement of the intended use of the device.
Device Intended Use: The BacT/ALERT PF Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.
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510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT PF Culture Bottle
A summary of the technological characteristics of the new device in comparison to (a)(6) those of the predicate device.
The BacT/ALERT PF Culture Bottle utilizes the same detection technology as the BacT/Alert Pedi-BacT Culture Bottle.
| FEATURES | BACT/ALERT PF CULTURE BOTTLE | BACT/ALERT PEDI-BACT CULTURE BOTTLE |
|---|---|---|
| Technology | Reflectance | Reflectance |
| Color change based on CO2 production | YES | YES |
| Sensor | Emulsion | Disc |
| Indicator material | Yes, Same as Pedi-BacT Bottle | Yes |
| Growth of microorganisms | Yes, Equivalent to Pedi-BacT Bottle | Yes |
| Instrument Used | BacT/ALERT Microbial Detection Systems | BacT/ALERT Microbial Detection Systems |
| Sample Source | Blood | Blood |
| Target Population | Pediatric | Pediatric |
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:
In-house seeded studies were performed utilizing 23 organisms seeded into BacT/ALERT PF and Pedi-BacT Culture Bottles. Two concentrations of organisms were seeded one at <100 CFU/bottle and the other at <10 CFU/bottle.
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510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT PF Culture Bottle
(b)3) The conclusions drawn from the nonclinical 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).
BacT/ALERT PF is substantially equivalent to Pedi-BacT Culture Bottles based on recovery of low levels of 23 microorganisms included in this study. The BacT/ALERT PF Culture Bottle has the same intended use and utilizes the same detection methodology as the current Pedi-BacT/Alert Culture Bottle. The BacT/ALERT PF Culture Bottle is a modified version of the current Pedi-BacT Culture Bottle.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, positioned inside a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the perimeter of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 3 1999
Ms. Rebecca A. Rivas Regulatory Affairs Administrator Organon Teknika Corporation 100 Akzo Avenue Durham, North Carolina 27712
Re: K992401 Trade Name: BacT/ALERT PF Culture Bottle Regulatory Class: I Product Code: MDB Dated: July 16, 1999 Received: July 19, 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 (OS) 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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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 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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510(k) Number (If known): BacT/ALERT PF Culture Bottle Device Nama:
Indications For Use:
The BacT/ALERT PF Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_k 993401
Prescription Use V (Per 21 CFR 801. 909) ರಸ
Over-The Counter Use
(Optional Format 1-2-98)
§ 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.