(719 days)
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No
The provided text describes an automated system for microbial detection and susceptibility testing, focusing on the process and inputs (blood, body fluids, drugs, inoculum sources). There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The description is purely functional and does not suggest any learning or adaptive capabilities.
No
This device is for the detection of microbial growth and susceptibility testing, not for treating or preventing disease.
Yes
This device, the ESP Culture System II, is described as an "automated system for the detection of microbial growth" and for "susceptibility testing of Mycobacterium tuberculosis." These functions are performed to identify pathogens and determine their susceptibility to drugs, which are diagnostic indicators used to guide treatment decisions.
No
The device description explicitly states it is an "automated system" for detecting microbial growth and performing susceptibility testing. This implies the presence of hardware components beyond just software to perform these functions (e.g., incubators, sensors, readers).
Based on the provided information, the ESP Culture System II is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is for the "detection of microbial growth from blood and other normally sterile body fluids, and for the detection of mycobacteria from various sources." It also mentions "susceptibility testing of Mycobacterium tuberculosis." These are all diagnostic tests performed on samples taken from the human body (in vitro).
- Device Description: The device description reiterates the same intended uses, confirming its role in laboratory testing of biological samples.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, treatment, or prevention of disease. The ESP Culture System II clearly fits this definition.
N/A
Intended Use / Indications for Use
The ESP Culture System II is an automated system for the detection of microbial growth from blood and other normally sterile body fluids, and for the detection of mycobacteria from various sources. The system may be used for the susceptibility testing of Mycobacterium tuberculosis with the drugs rifampin (1μg/ml), isoniazid ( 0.1 and 0.4ug/ml), and ethambutol (5 and 8ug/ml) The inoculum source for the susceptibility testing can originate from an ESP Myco seed bottle, or a McFarland No. 1 equivalent cell suspension created from colonies grown on an agar source.
Product codes
MJA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling a stylized image of an eagle or bird. The bird is depicted with three swooping lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 13 1999
Nadine M. Sullivan, Ph.D. Chief Science Officer TREK Diagnostic Systems, Inc. 210 Business Park Drive Sun Prairie, WI 53590
Re: K972772
Trade Name: ESP Culture System II - Myco Susceptibility Testing Regulatory Class: II Product Code: MJA Dated: June 29, 1999 Received: July 1, 1999
Dear Dr. Sullivan:
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 Autman
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 K972772 Device Name: ESP Culture System II
. - --------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Indications For Use:
The ESP Culture System II is an automated system for the detection of microbial growth from blood and other normally sterile body fluids, and for the detection of mycobacteria from various sources. The system may be used for the susceptibility testing of Mycobacterium tuberculosis with the drugs rifampin (1μg/ml), isoniazid ( 0.1 and 0.4ug/ml), and ethambutol (5 and 8ug/ml) The inoculum source for the susceptibility testing can originate from an ESP Myco seed bottle, or a McFarland No. 1 equivalent cell suspension created from colonies grown on an agar source.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
| Woody Dubois | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K972772 |
| Prescription Use X | OR | Over-The Counter Use ______ |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
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