(60 days)
Not Found
No
The summary describes a diagnostic test cartridge and instrument for measuring heparin response, focusing on functional performance and comparison to a predicate device. There is no mention of AI, ML, or related concepts.
No.
The device is described as an "in vitro diagnostic test" intended for determining individual responses to heparinization in whole blood, not for treating a condition or disease.
Yes
Explanation: The "Device Description" explicitly states, "The Heparin Dose Response (HDR) cartridge is an in vitro diagnostic test."
No
The device description explicitly states it is a "cartridge" and is used "in the HMS or HMS Plus instruments," indicating it is a physical component and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Device Description" section explicitly states: "The Heparin Dose Response (HDR) cartridge is an in vitro diagnostic test."
- Intended Use: The "Intended Use / Indications for Use" section describes the device as "intended for determining in vitro individual responses to heparinization using whole blood". The phrase "in vitro" is a key indicator of an IVD, meaning it's used to test samples outside of the body.
- Sample Type: The device uses "whole blood", which is a biological sample commonly used in in vitro diagnostic testing.
- Purpose: The purpose is to determine "individual responses to heparinization", which is a diagnostic assessment related to a patient's physiological response to a medication.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The heparin dose response cartridge is intended for determining in vitro individual responses to heparinization using whole blood on the HMS or HMS Plus instruments.
Product codes (comma separated list FDA assigned to the subject device)
JOX
Device Description
The Heparin Dose Response (HDR) cartridge is an in vitro diagnostic test. The HDR cartridge uses fresh whole blood for determining in vitro individual responses to heparinization based on a target activated clotting time (ACT). The cartridge is for use in the HMS or HMS Plus (Hemostasis Management System) instruments.
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
Not Found
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)
Functional testing such as stability, accuracy and precision were used to establish the performance characteristic of the modifications of this device from the previously marketed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.5680 Automated heparin analyzer.
(a)
Identification. An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.(b)
Classification. Class II (special controls).
0
OCl 1 - 2004
510(k) Summary
Date Prepared: August 19, 2004
Submitter:
Medtronic Perfusion Systems 7611 Northland Boulevard Brooklyn Park, MN 55428
Contact Person: Dawn M. Stenstrom Principal Regulatory Affairs Specialist Phone: (763) 391-9604 Fax: (763) 391-9603
Device Name and Classification:
| Trade Name: | Heparin Dose Response Cartridge |
|---|---|
| Common Name: | Analyzer, Heparin, Automated |
| Classification: | Class II |
| Predicate Devices: | Hepcon® HMS Coagulation System and its Associated |
| Cartridges and Controls | |
| K894317 |
Device Description
The Heparin Dose Response (HDR) cartridge is an in vitro diagnostic test. The HDR cartridge uses fresh whole blood for determining in vitro individual responses to heparinization based on a target activated clotting time (ACT). The cartridge is for use in the HMS or HMS Plus (Hemostasis Management System) instruments.
Indication for Use
The heparin dose response cartridge is intended for determining in vitro individual responses to heparinization using whole blood on the HMS or HMS Plus instruments.
Comparison to Predicate Device
The predicate device is the currently marketed HDR cartridge. The currently marketed HDR cartridge has the same indications for use and is the same in all aspects to the modified cartridge with exception of the source of heparin.
Summary of Performance Data
Functional testing such as stability, accuracy and precision were used to establish the performance characteristic of the modifications of this device from the previously marketed device.
Conclusion
Medtronic has demonstrated that the HDR cartridge is substantially equivalent to the predicate device based upon design, test results, and indications for use.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized design featuring three abstract shapes that resemble human figures or waves, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 - 2004
Ms. Dawn M. Stenstrom Principal Regulatory Affairs Specialist Medtronic Perfusion Systems 7611 Northland Drive N Minneapolis, MN 55428-1088
Re: K042070
Trade/Device Name: Heparin Dose Response Cartridge Regulation Number: 21 CFR § 864.5680 Regulation Name: Automated Heparin Analyzer Regulatory Class: II Product Code: JOX Dated: September 16, 2004 Received: September 17, 2004
Dear Ms. Stenstrom:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
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Page 2
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Robert L. Becker, Jr.
Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K042070
Device Name:
Heparin Dose Response Cartridge
Indications for Use:
The heparin dose response cartridge is intended for determining in vitro individual responses to heparinization using whole blood on the HMS or HMS Plus instruments.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Djagnostic Devices (OIVD)
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042070
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