(63 days)
No
The summary describes a control solution for verifying the performance of a hemostasis management system and its cartridges, with no mention of AI or ML.
No.
This device is described as an "in vitro diagnostic device" intended to "verify the performance of the HMS instrument and the Purple/Black HMS Heparin Assay cartridge." Its purpose is for quality control and performance verification rather than direct therapeutic intervention in a patient.
No
Explanation:
The device is described as a "control" intended to "verify the performance of the HMS instrument and HMS Heparin Assay cartridges." It is used to ensure the proper functioning of a diagnostic system rather than directly diagnosing a condition itself.
No
The device description explicitly states it is an "in vitro diagnostic device" and a "control" intended to verify the performance of an "instrument" and "cartridge." These are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "To verify the performance of the HMS instrument and HMS Heparin Assay cartridges".
Furthermore, the "Device Description" section clearly states: "The Purple/Black Heparin Assay control is an in vitro diagnostic device."
N/A
Intended Use / Indications for Use
To verify the performance of the HMS instrument and HMS Heparin Assay cartridges
Product codes
GGN, JOX, GFT
Device Description
The Purple/Black Heparin Assay control is an in vitro diagnostic device. This control is intended to verify the performance of the HMS instrument and the Purple/Black HMS Heparin Assay cartridge. The cartridge is for use in the HMS Plus (Hemostasis Management System) 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
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
Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device.
Key Metrics
Not Found
Predicate Device(s)
Purple/Black HMS Control, K922031
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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OCT 1 8 2004
510(k) Summary
Date Prepared: | August 13, 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: | Purple/Black Heparin Assay Control |
---|---|
Common Name: | Analyzer, Heparin, Automated |
Classification: | Class II |
Predicate Devices: | Purple/Black HMS Control, K922031 |
Hepcon® HMS Coagulation System and its Associated Cartridges and Controls, K894317
Device Description
The Purple/Black Heparin Assay control is an in vitro diagnostic device. This control is intended to verify the performance of the HMS instrument and the Purple/Black HMS Heparin Assay cartridge. The cartridge is for use in the HMS Plus (Hemostasis Management System) instrument.
Indication for Use
This product is intended to verify the performance of the HMS instrument and HMS Heparin Assay cartridges.
Comparison to Predicate Device
The predicate devices are the currently marketed Purple/Black HMS control and the other colored HMS controls. The currently marketed Purple/Black control has the same indications for use and is the same in all aspects to the modified control with exception of the source of heparin.
Summary of Performance Data
Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device.
Conclusion
Medtronic has demonstrated that the Purple/Black Heparin Assay control is substantially equivalent to the predicate devices based upon design, test results, and indications for use.
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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 stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three lines forming the wings and a base that resembles a staff with entwined snakes. The overall design is simple and monochromatic.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Dawn M. Stenstrom Principal Regulatory Affairs Specialist Medtronic Perfusion Systems 7611 Northland Drive N Minneapolis, MN 55428-1088
OCT 1 8 2004
K042206 Re:
Trade/Device Name: Purple/Black Heparin Assay Control Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: GGN, JOX, GFT Dated: September 28, 2004 Received: September 29, 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 for associated in the encreatment 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 he 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 nredicate device results in a classification for your device and thus, permits your device to proceed to the market.
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If you desire specific information about the application of labeling requirements to your device, of to If you desire specific information as advertising of your device, please contact the Office of In of questions on the promotion and Safety at (301) 594-3084. Also, please note the VITO Diagnostic Dovice Draiaaten and manager and premarket notification" (21CFR Part 807.97). regulation entitled, "Misolanding by reiseous on your responsibilities under the Act from the You may outlif only 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
4042206 510(k) Number (if known):
Device Name:
Purple/Black Heparin Assay Control
Indications for Use:
To verify the performance of the HMS instrument and HMS Heparin Assay cartridges
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 Diagnostic Devices (OIVD)
Arzeline Bautista
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) KD42206