(64 days)
BacT/ALERT SA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for the recovery and detection of aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
The BacT/ALERT SA Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Aerobic 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 SA Bottle.
Here's a breakdown of the acceptance criteria and the study details for the BacT/ALERT SA Culture Bottle, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit numerical acceptance criteria for a new mode of operation. The primary "acceptance criteria" can be inferred as "recovery of low levels of 23 microorganisms and equivalent detection times" compared to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Recovery of low levels of 23 microorganisms from human blood | Equivalent to the BacT/Alert Standard Aerobic Culture Bottle |
| Equivalent detection times compared to predicate device | Equivalent to the BacT/Alert Standard Aerobic Culture Bottle |
2. Sample Size and Data Provenance
- Sample Size for Test Set: Seeds studies were performed on 23 organisms. The document doesn't specify the number of individual tests or bottles used per organism, but refers to "seeded studies."
- Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is from Organon Teknika Corporation in Durham, North Carolina, USA, suggesting the study was likely conducted in the US.
- Retrospective or Prospective: The description "Seeded studies were performed" indicates a prospective study design where the researchers inoculated samples under controlled conditions.
3. Number, Qualifications, and Adjudication of Experts for Ground Truth
This type of device (microbial culture bottle) does not typically involve human experts for establishing ground truth in the same way an imaging AI device would. The "ground truth" is determined by the objective growth and detection of microorganisms, which is inherent to the function of the culture bottles themselves.
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
- Adjudication Method: Not applicable.
4. MRMC Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is not relevant for a microbial culture bottle, as it does not involve human readers interpreting output.
5. Standalone Performance
- Was a standalone (algorithm only without human-in-the-loop performance) study done? Yes, in essence. The comparison between the new device and the predicate device is a standalone performance comparison, where the "performance" is the ability of the bottle (and the associated instrument) to detect microbial growth. There is no human involved in the detection process itself; the instrument continuously monitors and flags growth.
6. Type of Ground Truth Used
- Ground Truth: The ground truth for this device is the actual growth of the seeded microorganisms within the culture bottle. This is an objective biological outcome. The success of the device is its ability to accurately detect this growth.
7. Sample Size for Training Set
- The document does not specify a separate training set or details on how the training data was collected. For this type of device, which is a physical consumable for microbial detection rather than a machine learning algorithm, the concept of a "training set" for an AI model is not applicable. The development would involve optimizing the medium and sensor through laboratory testing, likely a continuous process rather than a distinct "training set" as understood in AI/ML contexts.
8. How Ground Truth for Training Set Was Established
- As a training set (in the AI/ML sense) is not applicable here, the method of establishing ground truth for it is also not applicable. The design and validation of the device components (e.g., culture medium, sensor) would have relied on standard microbiological techniques to confirm microbial growth and detection capabilities during product development.
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DEC I 5 1999
510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SA 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: 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:
- 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 SA Culture Bottle
Common or Usual Name: BacT/ALERT SA 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 Standard Aerobic Culture Bottle -
A description of the device. (a)(4)
Device Description: The BacT/ALERT SA Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Aerobic 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 SA Bottle.
(a)(5) A statement of the intended use of the device.
Device Intended Use: The BacT/ALERT SA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic microorganisms ( bacteria and fungi) from blood and other normally sterile body fluids.
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510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SA Culture Bottle
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- A summary of the technological characteristics of the new device in comparison to those of (a)(6) the predicate device.
The BacT/ALERT SA Culture Bottle utilizes the same detection technology as the BacT/ALERT Standard Aerobic Culture Bottle.
| FEATURES | BACT/ALERT SA CULTURE BOTTLE | BACT/ALERT STANDARDAEROBIC CULTUREBOTTLE |
|---|---|---|
| Technology | Reflectance | Reflectance |
| Color change based onCO2 production | YES | YES |
| Sensor | Emulsion | Disc |
| Indicator material | Yes, Same as Standard AerobicBottle | Yes |
| Growth ofmicroorganisms | Yes, Equivalent to StandardAerobic Bottle | Yes |
| Instrument Used | BacT/ALERT Microbial Detection Systems | BacT/ALERT MicrobialDetection Systems |
| Sample Source | Blood, Body Fluids | Blood, Body Fluids |
| Target Population | Adult | Adult |
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510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SA 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 SA bottle and the BacT/Alert Standard Aerobic 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 SA culture bottle was substantially equivalent to the BacT/Alert Standard Culture Bottle based on recovery of low levels of the 23 microorganisms included in the study. Detection times were equivalent in both bottles.
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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 image of a human face in profile, with three wavy lines representing the hair and neck. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Public Health Service
DEC 1 5 1999
Food and Drug Administration 1390 Piccard Drive Rockville, MD 20850
Ms. Rebecca A. Rivas Regulatory Affairs Administrator Organon Teknika Corporation 100 Akzo Avenue Durham, North Carolina 27712
K993423 Re: Trade Name: BacT/ALERT SA Culture Bottle Regulatory Class: I Product Code: MDB Dated: October 11, 1999 Received: October 12, 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): _1993423
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
BacT/ALERT SA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for the recovery and detection of aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Clinical Laboratory Devices
| 510(k) Number | K993423 |
|---|---|
| --------------- | --------- |
| Prescription Use | X |
|---|---|
| ------------------ | --- |
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Prescription Use (Per 21 CFR 801.109)
§ 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.