(69 days)
No
The document describes a mechanical and software-controlled electronic quality control device for a hemostasis management instrument. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The device's function is described as checking specific mechanical and functional aspects of the instrument, not performing complex data analysis or learning.
No
The device is described as an "electronic quality control" and is used to verify the proper functioning of instruments, not to directly treat patients or affect body structure/function.
No
The device is described as an "Electronic Quality Control" used to perform quality control of instruments, not to diagnose a patient's medical condition. It verifies the operating condition of laboratory instruments.
No
The device description explicitly states it is an "interactive mechanical and software controlled verification cartridge" and an "electronic control," indicating it includes hardware components in addition to software.
Based on the provided text, the HEPtrac Electronic Quality Control is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the HEPtrac is a "verification cartridge for use with instruments that utilize the Hepcon Hemostasis Management cartridges." Its purpose is to "provide a means for performing quality control of the instruments." It is designed to check the instrument's operating condition, not to perform a diagnostic test on a patient sample.
- Device Description: The description reinforces this by stating it's an "electronic control" designed to "minimize the use of liquid based controls by providing the operator a means to determine the operating condition of the instrument."
- Lack of Patient Sample Testing: There is no mention of the device interacting with or analyzing patient samples (blood, urine, etc.) to provide diagnostic information about a patient's health.
- Focus on Instrument Performance: The performance studies described focus on verifying the HEPtrac's ability to check the instrument's functions (flag release force, reagent delivery, etc.).
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The HEPtrac's function is to ensure the instrument is working correctly, which is a crucial part of the IVD process, but the HEPtrac itself is a quality control tool for the instrument, not the diagnostic test itself.
N/A
Intended Use / Indications for Use
The HEPtrac Electronic Quality Control, manufactured by Medtronic Blood Management, is an interactive mechanical and software controlled verification cartridge for use with instruments that utilize the Hepcon Hemostasis Management cartridges. The purpose of the HEPtrac is to provide a means for performing quality control of the instruments in the clinical testing environment.
Product codes
JPA
Device Description
The HEPtrac is an electronic control that has been developed to assist users of the Hepcon Hemostasis Management (HMS) Instrument (K894317) and associated cartridges and controls (K894317), to perform control testing as required under 42CFR493.1253. Sec. ( c ) "for all automated coagulation testing systems, the laboratory must include two levels control each eight hours of operation and each time a change in reagents occurs". The HEPtrac, electronic quality control is designed to minimize the use of liquid based controls by providing the operator a means to determine the operating condition of the instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical testing environment.
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
Laboratory testing was done to confirm the devices performance in relation to the predicate device.
Performance testing was done to verify the HEPtrac's ability to check the condition of the HMS instrument for the following functions:
-
- Flag release force
-
- Reagent delivery
-
- Flag lift wire height
-
- Flag sensors
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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K98181815
JUL 30 1998
510(k) SUMMARY
| Submitted by: | Medtronic Blood Management
18501 E. Plaza Drive
Parker, Colorado 80134 | |
|-------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------|
| Manufacturing Facility: | Medtronic Blood Management
18501 E. Plaza Drive
Parker, Colorado 80134 | |
| Submitted Device: | Trade Name:
Common Name: | HEPtrac Electronic Quality Control
Electronic Quality Control |
Device Classification: Class II
21 CFR § 864.5425 "A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays." The HEPtrac is a Electronic Control for such a device.
- Product Description: The HEPtrac is an electronic control that has been developed to assist users of the Hepcon Hemostasis Management (HMS) Instrument (K894317) and associated cartridges and controls (K894317), to perform control testing as required under 42CFR493.1253. Sec. ( c ) "for all automated coagulation testing systems, the laboratory must include two levels control each eight hours of operation and each time a change in reagents occurs". The HEPtrac, electronic quality control is designed to minimize the use of liquid based controls by providing the operator a means to determine the operating condition of the instrument.
- Intended Use: The HEPtrac Electronic Quality Control, manufactured by Medtronic Blood Management, is an interactive mechanical and software controlled verification cartridge for use with instruments that utilize the Hepcon Hemostasis Management cartridges. The purpose of the HEPtrac is to provide a means for performing quality control of the instruments in the clinical testing environment.
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Performance Standards:
Per section 514 of the Food, Drug and Cosmetic Act, there are no specific performance standards for this device.
Statement of substantial equivilance-
The HEPtrac electonic control for the HMS instrument is very similar to the ACTtrac electronic control for the ACT instrument in the following areas; intended use, operation, and function. The HEPtrac and the ACTtrac are both used to asses the operating condition of automated coagulation timers. The HEPtrac has been designed to function with a six channel instrument rather than the predicate device that was design to function in a two channel device.
A summary of the essential features between the ACTtrac (predicate device) and HEPtrac is contained in Table 1.1
Table 1.1 Comparison between the ACTtrac and HEPtrac Electronic Quality Control tests
| Predicate device | ||
|---|---|---|
| ACTtrac | HEPtrac | |
| Control Test Type | Electronic | Electronic |
| Number of channels | 2 | 6 |
| Reagent delivery check | yes | yes |
| Flag Sensor check | yes | yes |
| Clot detection | yes | yes |
| Flag release test | no | yes |
From Table 1.1 it can be seen that the two types of devices share the same basic features for testing automated coagulation timers. The primary difference between these two devices lies in the model number of coagulation timer it is designed to test.
Testing:
Laboratory testing was done to confirm the devices performance in relation to the predicate device.
Performance testing was done to verify the HEPtrac's ability to check the condition of the HMS instrument for the following functions:
-
- Flag release force
-
- Reagent delivery
-
- Flag lift wire height
-
- Flag sensors
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a stylized eagle emblem. The eagle is depicted with three human profiles incorporated into its design, symbolizing the department's focus on people's health and well-being.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 30 1998
Karl Steineck . Regulatory Affairs Specialist Medtronic Blood Management 18501 E. Plaza Drive Parker, Colorado 80134-9061
Re : K981815 HEPtrac Requlatory Class: II Product Code: JPA Dated: May 20, 1998 Received: May 22, 1998
Dear Mr. Steineck:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 In addition, FDA may publish further announcements action. 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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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 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 qeneral 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Aitman
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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INTENDED USE STATEMENT
510(k) Number (if known): K981815
Device Name: HEPtrac Electronic Quality Control
Indications For Use:
The HEPtrac Electronic Quality Control, manufactured by Medtronic Blood Management, is an interactive mechanical and software controlled verification cartridge for use with instruments that utilize the Hepcon Hemostasis Management cartridges. The purpose of the HEPtrac is to provide a means for performing quality control of the instruments in the clinical testing environment.
(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. K981815
Prescriptive Use ✓
OR
Over-the-Counter Use _