(269 days)
None
Not Found
No
The description explicitly states the use of "standard image processing techniques" and does not mention AI, ML, or related terms.
No
The device is described as a computer-aided optical microscope system used to map cervical cytology preparations for presentation to a cytotechnologist or cytopathologist for diagnostic interpretation, rather than for treatment.
Yes
The system is intended to map cervical cytology preparations for presentation to a cytotechnologist or cytopathologist for diagnostic interpretation, indicating its role in the diagnostic process.
No
The description explicitly states "computer-aided optical microscope system," indicating the device includes hardware components (the optical microscope system) in addition to the software for image processing.
Based on the provided information, the TracCell™ 2000 System is likely an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's used to map cervical cytology preparations (which are biological samples taken from the body) for diagnostic interpretation by a cytotechnologist or cytopathologist. This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Sample Type: It works with "cervical cytology preparations," which are in vitro samples.
- Diagnostic Interpretation: The system is designed to facilitate "diagnostic interpretation" by a trained professional.
While the description doesn't explicitly use the term "IVD," the function and purpose described strongly indicate it falls under this category. It's a tool used in a laboratory setting to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
TracCell™ 2000 System is intended as a computer-aided optical microscope system used to map adequately stained, well-preserved, cervical cytology preparations that have been prepared using a Papanicolaou or Pap-like stained protocol. The mapping of the slide into "presented" and "excluded" areas is performed by segmenting the light-absorbing objects from background material based upon standard image processing techniques for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation.
Product codes
JOY
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
optical microscope
Anatomical Site
cervical
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cytotechnologist or cytopathologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5260 Automated cell-locating device.
(a)
Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized design that resembles an abstract caduceus, a symbol often associated with healthcare.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 8 1997
Mr. John R. Miers Director of Regulatory Affairs ACCUMED INTERNATIONAL, INC. 900 N. Franklin, Suite 401 Chicago, Illinois 60610 ..
Re : K964689/S2 AccuMed International's TracCell™ 2000 Slide Trade Name: Mapping System Regulatory Class: II Product Code: JOY Dated: May 30, 1997 Received: June 2, 1997
Dear Mr. Miers:
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 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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (05) 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.
1
Page 2
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 requlation (21 CFR Part 801 and additionally 809.10 for in xitro 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 Also, please note the regulation entitled, (301) 594-4639. "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 Putman
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
2
Page 1_of_1
510(k) Number (if known):
Device Name: _
TracCell™ 2000 Slide Mapper System_
Indications For Use:
TracCell™ 2000 System is intended as a computer-aided optical microscope system used to map adequately stained, well-preserved, cervical cytology preparations that have been prepared using a Papanicolaou or Pap-like stained protocol. The mapping of the slide into "presented" and "excluded" areas is performed by segmenting the light-absorbing objects from background material based upon standard image processing techniques for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carter E. Madison
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
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