(90 days)
The CareCompanion Patient Station is intended to be used in conjunction with the CareCompanion Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.
The CareCompanion Patient Station is used upon prescription of an authorized healthcare provider by patients where regular monitoring of vital signs information is indicated. The information is collected from the CareCompanion Patient Station and transmitted over standard telephone lines to a health care professional.
The device does not send any real-time alarms. The device a diagnostic aid. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
The CareCompanion System consists of two components: a transportable Patient Station installed typically in a patient's home; and the Nurse Station, installed in a healthcare provider or professional caregiver's office. The two components communicate with each other through modems over standard telephone lines and transmit real-time video, audio and data between them.
The real-time video and audio communications allow the patient and the caregiver to view and speak with each other.
With existing legally marketed vital signs measurement devices integrated with the Patient Station, the Patient Station is designed to monitor the patient's blood pressure, pulse rate, blood glucose level, weight and/or heart, lung and bowel sounds, and transmit this data to the Nurse Station. The data is displayed to the caregiver operating the Nurse Station and also automatically recorded in a patient information database. The heart, lunq and bowel sounds may be listened to by the caregiver using a set of headphones supplied with the system.
Vital signs measurement devices integrated in the CareCompanion are FDA approved devices and are used for the same purposes for which they received 510(k) approval. The Patient Station may be configured for use with one to four devices.
The Nurse Station consists of two sub-components, the Nurse Station PC, which is a standard PC with supporting peripherals connected to a videophone, which provides the video conferencing functions for the Nurse Station. The Nurse Station PC may also operate as a standalone device for patient data management and record keeping functions.
This document describes the CareCompanion Tele Homecare System, which facilitates remote monitoring of patient vital signs. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or provide specific numerical device performance metrics like sensitivity, specificity, accuracy, or correlation coefficients. Instead, it focuses on functional equivalence and passing relevant standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Equivalence | Testing was performed with each vital signs measurement device to show that they operate equivalently when integrated with CareCompanion as when operated as independent devices. The CareCompanion and its predicate systems have the same general use to provide the capability for health care professionals to monitor the vitals signs of some of their patients from remote locations. The main functional differences between the CareCompanion and its predicates (higher resolution images for wound care in predicates, ISDN/DSL/Internet communication in one predicate) are "not significant with regard to performance or safety of the vital signs data monitoring and collection functions." |
| Compliance with Standards | The CareCompanion Patient Station and the CareCompanion Nurse Station have been subjected to performance testing to applicable mechanical, electrical and environmental standards. |
| Safety and Effectiveness | The results of the test indicate that the device is substantially equivalent to its predicate devices and does not raise any new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). The testing described is general "functional performance" and "performance testing to applicable mechanical, electrical and environmental standards." It implies integration testing with existing FDA-approved vital signs devices rather than a clinical trial with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for a test set. The focus is on the device's functional performance in relaying data from already approved vital signs devices, rather than on the diagnostic accuracy of the CareCompanion itself based on expert assessment of patient data.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. This is consistent with the lack of details on a test set involving human interpretation or clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this document. The device is a "Tele Homecare System," not a diagnostic imaging or interpretation aid that would typically be evaluated with MRMC studies. The primary goal was to demonstrate substantial equivalence for vital signs data transmission, not a direct comparison of human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, a "standalone" evaluation was part of the testing. The "functional performance" testing confirms that the integrated vital signs measurement devices "operate equivalently when integrated with CareCompanion as when operated as independent devices." This implies testing the CareCompanion's ability to accurately transmit the data generated by the vital signs devices themselves, in a standalone capacity for data transfer, before a human at the Nurse Station interprets it.
7. The Type of Ground Truth Used
The ground truth implicitly used for the functional performance testing of the CareCompanion's data transmission capabilities would be the readings directly provided by the legally marketed and FDA-approved vital signs measurement devices themselves when operated independently. The testing aimed to confirm that the CareCompanion accurately transmits these established readings.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. Given that the device is a data transmission system for pre-existing FDA-approved vital signs monitors, it likely does not involve machine learning or AI models that would require a distinct training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied for machine learning, the establishment of ground truth for a training set is not applicable here. The "ground truth" for the overall system's function comes from the validated outputs of the integrated, standalone vital signs monitors.
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MAY 2 2 2002
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510(k) Summary
Submitter
Neptec Design Group Ltd. 302 Legget Drive Kanata, Ontario Canada K2K 1Y5
Contacts
John Schneider Neptec Design Group Ltd. Tel: 613-599-7602 Fax: 613-599-7604
or
Charles H. Kyper Kyper & Associates Chapel Hill, NC Tel: 919-960-0049 Fax: 919-960-0009
Date Prepared
February 18, 2002
Device Information
| Trade Name: | CareCompanion Nurse Station / CareCompanion Patient Station |
|---|---|
| Common Name: | Tele Homecare System |
| Classification Name: | Radiofrequency Physiological Signal Transmitter and Receiver |
Device Description
The CareCompanion System consists of two components: a transportable Patient Station installed typically in a patient's home; and the Nurse Station, installed in a healthcare provider or professional caregiver's office. The two components communicate with each other through modems over standard telephone lines and transmit real-time video, audio and data between them.
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The real-time video and audio communications allow the patient and the caregiver to view and speak with each other.
With existing legally marketed vital signs measurement devices integrated with the Patient Station, the Patient Station is designed to monitor the patient's blood pressure, pulse rate, blood glucose level, weight and/or heart, lung and bowel sounds, and transmit this data to the Nurse Station. The data is displayed to the caregiver operating the Nurse Station and also automatically recorded in a patient information database. The heart, lunq and bowel sounds may be listened to by the caregiver using a set of headphones supplied with the system.
Vital signs measurement devices integrated in the CareCompanion are FDA approved devices and are used for the same purposes for which they received 510(k) approval. The Patient Station may be configured for use with one to four devices.
The Nurse Station consists of two sub-components, the Nurse Station PC, which is a standard PC with supporting peripherals connected to a videophone, which provides the video conferencing functions for the Nurse Station. The Nurse Station PC may also operate as a standalone device for patient data management and record keeping functions.
Substantial Equivalence
The Neptec CareCompanion is substantially equivalent to the following predicate svstems: the N2000 Base Station / N2001 Nurse Station (#K012801) by Neptec Design Group Ltd, the Electronic HouseCall System (#K000237) by Cybercare, Inc., and the Aviva Systems (#K981533) by American Telecare, Inc.
The CareCompanion and its predicate systems have the same general use to provide the capability for health care professionals to monitor the vitals signs of some of their patients from remote locations.
The main functional differences between the systems are that the predicate devices provide the capability to generate higher resolution images allowing heath care professionals to perform a range of assessment functions including wound care. This feature is not an indicated use for the CareCompanion. The Electronic HouseCall System by Cybercare is also capable of communicating over ISDN, DSL or Internet links in addition to standard telephone lines. These differences, however, are not significant with regard to performance or safety of the vital signs data monitoring and collection functions.
Intended Use
The Patient Station is intended to be used upon prescription of an authorized healthcare provider by patients as a means to collect and transmit patient vital signs information over standard telephone lines between the patient, typically at home, and a health care professional at the health care provider's site. The information includes: blood
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pressure, pulse rate, blood glucose level, weight, and heart, lung and bowel sounds. The information is collected upon request and direction of the healthcare provider.
The CareCompanion Patient Station is intended to be used in conjunction with the CareCompanion Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.
The device does not send any real-time alarms. The device a diagnostic aid. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
Performance Testing
Testing was performed to validate the functional performance of the CareCompanion. In particular, testing was performed with each vital signs measurement device to show that they operate equivalently when integrated with CareCompanion as when operated as independent devices.
In addition, the CareCompanion Patient Station and the CareCompanion Nurse Station have been subjected to performance testing to applicable mechanical, electrical and environmental standards.
Conclusion
The results of the test indicate that the device is substantially equivalent to its predicate devices and does not raise any new questions of safety or effectiveness.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2002
Mr. John Schneider HINS Project Manager Neptec Design Group Ltd. 302 Legget Drive Kanata, Ontario Canada K2K 1Y5
Re: K020584
Trade Name: CareCompanion Nurse Station and CareCompanion Patient Station Regulation Name: Noninvasive Blood Pressure Measurement System and Glucose Test System
Regulation Number: 870.1130 and 862.1345 Regulatory Class: Class II (two) Product Code: DXN and CGA Dated: February 18, 2002 Received: February 21, 2002
Dear Mr. Schneider:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -- Mr. John Schneider
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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Douk Tulla
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of
510(k) Number (if known):
Device Name: CareCompanion Nurse Station / CareCompanion Patient Station
Indications For Use:
The CareCompanion Patient Station is intended to be used in conjunction with the CareCompanion Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.
The CareCompanion Patient Station is used upon prescription of an authorized healthcare provider by patients where regular monitoring of vital signs information is indicated. The information is collected from the CareCompanion Patient Station and transmitted over standard telephone lines to a health care professional.
The device does not send any real-time alarms. The device a aid. Clinical iudgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
(Optional Format 3-
10-98)
Division of Cardiovascular & Respiratory Devices
510(k) Number K020584
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).