(138 days)
Not Found
No
The description explicitly states it is a "rules-based expert software system," which is a traditional programming approach, not AI/ML.
No
The CoagCare system is a software accessory that facilitates the management of warfarin anticoagulation therapy. While it provides recommendations for warfarin doses and testing schedules, it does not directly perform any physical or biological therapeutic action on the patient. It acts as a management tool and communication facilitator between patient and caregiver, rather than a device that delivers therapy itself.
No
The CoagCare system manages anticoagulation therapy based on INR values, but it does not measure or diagnose. It is an accessory to devices that measure INR, which are the diagnostic devices.
Yes
The device is described as a "software accessory" and an "interactive, internet-based (web-based), rules-based expert software system." The description focuses entirely on the software components (Patient Interface and Caregiver Interface) and their functionalities, without mentioning any associated hardware that is part of the device itself (it is an accessory to separate INR devices).
Based on the provided information, the CoagCare Anticoagulation Management System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The system's intended use is for the management of patients undergoing warfarin therapy, using INR values obtained from separate prescription home-use prothrombin time devices. It facilitates remote clinical management and provides dosage recommendations and testing schedules.
- Device Description: The system is described as a software accessory to the INR devices. It processes data (INR values, symptoms) provided by the patient and caregiver and applies rules to generate recommendations. It does not perform any diagnostic testing itself.
- Role of the INR Device: The crucial diagnostic step – measuring the INR – is performed by a separate, accessory device. The CoagCare system uses the results of this diagnostic test.
- Comparison to Predicate Device: The predicate device, the Diacare® Monitoring System (K882001), is also described as a system for managing anticoagulation therapy, not a device that performs the diagnostic test itself.
In summary, the CoagCare system is a clinical decision support and management tool that utilizes data from an IVD (the home-use prothrombin time device) but does not perform the in vitro diagnostic test itself.
N/A
Intended Use / Indications for Use
The CoagCare Anticoagulation Management System (CoagCare®) is an interactive, internet-based (web-based), rules-based expert software system for the long-term management of patients undergoing warfarin anticoagulation therapy. The system is an accessory to prescription home-use prothrombin time devices that measure International Normalized Ratios (INRs), and it facilitates remote clinical management between patient and caregiver.
Product codes
KQG
Device Description
The CoagCare system is a software accessory to prescription-home use prothrombin time (INR) devices for effective anticoagulation management with warfarin. System Overview: The system consists of two components, the CoagCare Patient Interface and the CoagCare Caregiver Interface, both of which are accessed through an internet browser. The interface provides a structured therapeutic regimen developed for the individual patient. It prompts the patient for INR values, symptoms, and other disease related data, and provides the patient with recommended doses of warfarin and an INR testing schedule that can be adjusted based on parameters specified by the patient's caregiver. The patient is given recommendations for warfarin doses for each day until the next time of required INR testing. In cases of marked abnormal INR readings or disease signs or symptoms suggestive of over-treatment, the Patient Interface instructs the patient to contact his/her healthcare provider for further instructions.
The second component of the CoagCare system is the Caregiver Interface. The caregiver monitoring the patient's anticoagulant therapy accesses the Caregiver Interface at least daily. The Caregiver Interface is programmed to automatically identify patient problems such as patients who report thromboembolic or hemorrhagic symptoms, failure to check their INR on a prescribed day, etc. The Caregiver Interface prioritizes problems requiring the caregiver's attention. Once patients have checked their INRs and transmitted their results, if the caregiver agrees with the warfarin dosing instructions provided by the patient interface, no further interventions are required for that day. Patients with markedly abnormal results or recurrent problems are prioritized for caregiver intervention, whereas stable patients are listed with their results, eliminating the need for direct patient contact by the caregiver. The Caregiver Interface also allows the caregiver to override therapeutic instructions provided by the Patient Interface, or send a text message to the patient through the Patient interface. (For more emergent issues, the patient can be contacted directly by the caregiver by telephone.)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
rules-based expert software system
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription-home use
Caregiver may be a physician, nurse, pharmacist or licensed professional.
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)
The CoagCare Anticoagulation Management System was evaluated in comprehensive clinical studies at three sites. Fifty-eight patients at Duke University Medical Center and 22 patients at the University of New Mexico Medical Center, and 20 patients from a private practice in Miami who had been on warfarin for at least six months were recruited for the study. Patients at the Duke and New Mexico sites were switched to home INR monitoring and followed with the CoagCare system for six months. Patients in the Miami site remained on the system from 3 to 4 months. The overall INRs of all patients averaged 62.5% time in therapeutic range (TTR) prior to the start of CoagCare. This value increased to 73.5% TTR during the study, an 11% and statistically significant improvement ( p=. 008). The site e ffect w as n on-significant ( p=. 87), suggesting that the improvement in TTR was not statistically distinguishable across the sites. The increase in TTR seen with the CoagCare system could reasonably interpreted to reflect a clinically important improvement. Caregivers at all 3 sites reported that it took between 15 and 25 minutes a day to manage between 20 and 58 patients. Due to the automation provided by CoagCare, managing 48 patients with CoagCare did not take much more time than managing 20. Between 92% and 100% of all patients reported that they preferred home management with CoagCare to traditional point-of-care treatment, that they felt that they were being monitored more closely with CoagCare and that their INRs were in better control with home management.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Time in therapeutic range (TTR)
Prior to CoagCare: 62.5% TTR
During CoagCare study: 73.5% TTR
Improvement: 11% (p=0.008)
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
§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument 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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Image /page/0/Picture/0 description: The image shows contact information for a business. The address is 3804 Sweeten Creek Rd. in Chapel Hill, NC 27514. The phone number is (919)419-7228 and the fax number is (919) 419-9088.
AUG 1 6 2005
This summary of 510(k) safety and effectiveness information is befing submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is K050821.
| 807.92 (a)(1): Name: | Zycare, Inc. |
|---|---|
| Address: | 3804 Sweeten Creek Road |
| Chapel Hill, NC 27514 | |
| Phone: | (919) 419-7228 |
| Contact: | Mr. Steve D. Holdaway, MBA |
807.92 (a)(2): Device Name -- trade name and common name, and classification
| Trade name: | CoagCare® Anticoagulation Management System
(CoagCare®) |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Software accessory to prescription-home use
prothrombin time (INR) devices for effective
anticoagulation management with warfarin |
| Classification: | CoagCare® is considered an unclassified accessory to
INR test systems; INR test systems are regulated
under 21 CFR 864.7750, Class II: 81 GJS.
The device regulation for a "calculator/data
processing module for clinical use" (21 CFR
862.2100) exempts such Class I devices from 510(k)
requirements. This regulation is not entirely
applicable, however, since the exemption only applies
to data processors for clinical laboratory use, and not
home use or use in clinic settings. |
1
807.92 (a)(3): Identification of the legally marketed predicate device
The CoagCare® Anticoagulation Management System is substantially equivalent to the Diacare® Monitoring System, K882001, cleared October 18, 1988; the Diacare system was cleared for the clinical management of diabetes mellitus.
807.92 (a)(4): Device Description
The CoagCare system is a software accessory to prescription-home use prothrombin time (INR) devices for effective anticoagulation management with warfarin. System Overview: The system consists of two components, the CoagCare Patient Interface and the CoagCare Caregiver Interface, both of which are accessed through an internet browser. The interface provides a structured therapeutic regimen developed for the individual patient. It prompts the patient for INR values, symptoms, and other disease related data, and provides the patient with recommended doses of warfarin and an INR testing schedule that can be adjusted based on parameters specified by the patient's caregiver. The patient is given recommendations for warfarin doses for each day until the next time of required INR testing. In cases of marked abnormal INR readings or disease signs or symptoms suggestive of over-treatment, the Patient Interface instructs the patient to contact his/her healthcare provider for further instructions.
The second component of the CoagCare system is the Caregiver Interface. The caregiver monitoring the patient's anticoagulant therapy accesses the Caregiver Interface at least daily. The Caregiver Interface is programmed to automatically identify patient problems such as patients who report thromboembolic or hemorrhagic symptoms, failure to check their INR on a prescribed day, etc. The Caregiver Interface prioritizes problems requiring the caregiver's attention. Once patients have checked their INRs and transmitted their results, if the caregiver agrees with the warfarin dosing instructions provided by the patient interface, no further interventions are required for that day. Patients with markedly abnormal results or recurrent problems are prioritized for caregiver intervention, whereas stable patients are listed with their results, eliminating the need for direct patient contact by the caregiver. The Caregiver Interface also allows the caregiver to override therapeutic instructions provided by the Patient Interface, or send a text message to the patient through the Patient interface. (For more emergent issues, the patient can be contacted directly by the caregiver by telephone.)
2
807.92 (a)(5): Intended use
The CoagCare Anticoagulation Management System (CoagCare) is an interactive internet-based (web-based) software system for the long-term management of patients undergoing warfarin anticoagulation therapy. The system is an accessory to prescription home-use prothrombin time devices that measure International Normalized Ratios (INRs), and it facilitates remote clinical management between patient and caregiver.
807.92 (a)(6): Technological Similarities and Differences to Predicate
The following chart describes similarities and differences between the CoagCare system and the Diacare system (the predicate).
| CHARACTERISTIC | CoagCare | Diacare (K882001) |
|---|---|---|
| Intended Use | Software (web-based) system used | |
| in the patient's home for the | ||
| management and monitoring of | ||
| INR levels and dosing | ||
| recommendations in patients being | ||
| treated with anticoagulation | ||
| therapy (warfarin); automates | ||
| supervision of patients | Hardware/software system used in | |
| the patient's home for the | ||
| management and monitoring of | ||
| glucose and insulin levels in | ||
| patients being treated for diabetes; | ||
| automates supervision of patients | ||
| System Functions | Screens the data for problems, | |
| prioritizes patient records for | ||
| physician review, monitors | ||
| implementation of a home | ||
| medication dosing algorithm; | ||
| physician can manage patients | ||
| remotely | Screens the data for problems, | |
| prioritizes patient records for | ||
| physician review, monitors | ||
| implementation of a home | ||
| medication dosing algorithm; | ||
| physician can manage patients | ||
| remotely | ||
| Route of Information Transfer | Secure internet web-site with | |
| dedicated servers | Direct server dial-in |
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| CHARACTERISTIC | CoagCare | Diacare (K882001) |
|---|---|---|
| Data Output | Printable reports | Printable reports |
| Patient Identification | Secured through passwords and | |
| secure website | Hardware based, meter connected | |
| to phone line by patient | ||
| Safety Features | Requires tight professional | |
| oversight in the event of | ||
| unexpected results or symptoms | Requires tight professional | |
| oversight in the event of | ||
| unexpected results or symptoms | ||
| Testing Environment | Home use with professional | |
| oversight | Home use with professional | |
| oversight | ||
| System Components | Proprietary internet-enabled | |
| software, patient interface and care | ||
| giver interface | Proprietary software, patient | |
| interface and care giver interface | ||
| Risk to Patient | Minimal, system will enforce | |
| contact with health care | ||
| professional in the event of | ||
| unexpected results/symptoms | Minimal, system will enforce | |
| contact with health care | ||
| professional in the event of | ||
| unexpected results/symptoms | ||
| Required IVD Component | Requires INR meter to obtain | |
| clinical INR results | Requires glucose meter to obtain | |
| clinical glucose results | ||
| Management Decision | Systems utilizes published and | |
| generally accepted algorithms to | ||
| adjust medication doses and make | ||
| treatment decisions | Systems utilizes published and | |
| generally accepted algorithms to | ||
| adjust medication doses and make | ||
| treatment decisions |
The differences between the two data management systems do not raise new issues of safety and effectiveness.
807.92 (b)(1): Brief Description of Non-clinical data
Non-clinical studies are not relevant to software accessories.
: .
4
807.92 (b)(2): Brief Description of Clinical Data
The CoagCare Anticoagulation Management System was evaluated in comprehensive clinical studies at three sites. Fifty-eight patients at Duke University Medical Center and 22 patients at the University of New Mexico Medical Center, and 20 patients from a private practice in Miami who had been on warfarin for at least six months were recruited for the study. Patients at the Duke and New Mexico sites were switched to home INR monitoring and followed with the CoagCare system for six months. Patients in the Miami site remained on the system from 3 to 4 months. The overall INRs of all patients averaged 62.5% time in therapeutic range (TTR) prior to the start of CoagCare. This value increased to 73.5% TTR during the study, an 11% and statistically significant improvement ( p=. 008). The site e ffect w as n on-significant ( p=. 87), suggesting that the improvement in TTR was not statistically distinguishable across the sites. The increase in TTR seen with the CoagCare system could reasonably interpreted to reflect a clinically important improvement. Caregivers at all 3 sites reported that it took between 15 and 25 minutes a day to manage between 20 and 58 patients. Due to the automation provided by CoagCare, managing 48 patients with CoagCare did not take much more time than managing 20. Between 92% and 100% of all patients reported that they preferred home management with CoagCare to traditional point-of-care treatment, that they felt that they were being monitored more closely with CoagCare and that their INRs were in better control with home management.
807.92 (b)(3): Conclusions from Clinical Testing
In summary, we have demonstrated that patients and caregivers can successfully use the CoagCare system to produce improved outcomes and a high degree of patient satisfaction. The studies show that the CoagCare system is safe and effective for intended use.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference of the circle.
Public Health Service
AUG 1 6 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Steven D. Holdaway, MBA Chief Executive Officer ZyCare, Inc. 3804 Sweeten Creek Road Chapel Hill, NC 27514
Re: K050821
Trade/Device Name: CoagCare Anticoagulation Management System (CoagCare®) Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation instrument Regulatory Class: Class II Product Code: KQG Dated: July 25, 2005 Received: July 26, 2005
Dear Mr. Holdaway:
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 (240) 276-0484. 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/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, PA Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
March 29, 2005
STATEMENT OF INTENDED USE
K050821 510(k) Number (if Known):
Device Name: CoagCare Anticoagulation Management System (CoagCare®)
Indications for Use:
The CoagCare Anticoagulation Management System (CoagCare®) is an interactive, internet-based (web-based), rules-based expert software system for the long-term management of patients undergoing warfarin anticoagulation therapy. The system is an accessory to prescription home-use prothrombin time devices that measure International Normalized Ratios (INRs), and it facilitates remote clinical management between patient A caregiver may be a physician, nurse, pharmacist or licensed and caregiver. professional.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division/Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050821
Page 8 of 1 Section 1- Statutory Requirements