(63 days)
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No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on automated growth and detection using nucleic acid probes.
No
Explanation: The device is an automated system for culturing and detecting mycobacteria, which is a diagnostic function, not a therapeutic one. It identifies the presence of pathogens but does not treat the condition.
Yes
The device is described as an "automated system for the growth and detection of mycobacteria from human specimens," which directly indicates its use in identifying a disease-causing agent, thus serving a diagnostic purpose.
No
The description clearly states it is an "automated system for the growth and detection of mycobacteria," implying hardware components for incubation and detection, not just software.
Based on the provided information, the ESP Culture System II - Myco is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is for the "growth and detection of mycobacteria from human specimens". This involves testing samples taken from the human body (in vitro) to diagnose or provide information about a disease or condition (mycobacterial infection).
- Specimens: The use of "human specimens" is a key characteristic of IVDs.
- Detection: The system is designed to "detect" the presence of mycobacteria, which is a diagnostic function.
Therefore, the description clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ESP Culture System II - Myco is an automated system for the growth and detection of -mycobacteria from human specimens, including the use of nucleic acid probes for the direct confirmation of positive ESP - myco bottles.
Product codes
MDB
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
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Key Metrics
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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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§ 866.2560 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
1997
Image /page/0/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 2098 Gaither Road, Rockville MD 20850. The text is black and the background is white.
Marianne R. Plaunt, Ph.D. Research Manager AUG - I AccuMed International, Inc. - 29299 Clemens Road, Suite 1-K Westlake, Ohio 44145
Re: K972756 Trade Name: ESP™ Culture System II - Myco/modification Regulatory Class: I Product Code: MDB Dated: May 16, 1997 Received: May 30, 1997
Dear Dr. Plaunt:
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 to 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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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510(k) Number (if Known): Device Name: ESP Culture System II - Myco
Indications For Use:
The ESP Culture System II - Myco is an automated system for the growth and detection of -mycobacteria from human specimens, including the use of nucleic acid probes for the direct confirmation of positive ESP - myco bottles.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Khatme Alverly for Cickon Pontes
(Division Sign-Off)
Division of Clinical Laboratory Devices 510(k) Number ..