(90 days)
Not Found
No
The description focuses on basic communication and data transmission, with no mention of AI/ML algorithms for analysis or interpretation. The document explicitly states that clinical judgment is required to interpret the data.
No.
The device is a communication and monitoring tool that facilitates data transmission and video/audio interaction, but it explicitly states that it "is not intended as a substitute for medical care" and is a "diagnostic aid" that requires "clinical judgement and experience to check and interpret the information transmitted." It does not directly provide therapy.
No
Explanation: The "Intended Use" section explicitly states, "The device a diagnostic aid." (Note: This appears to be a typo and likely meant "The device is a diagnostic aid."). However, the device description clarifies its role is to collect and transmit vital signs data from existing, FDA-approved vital signs measurement devices, not to perform independent diagnostic analysis. It facilitates communication and data transfer, and relies on clinical judgment for interpretation. The phrase in the "Intended Use" section is contradicted by the overall description of its function as a communication and data transfer system for information already gathered by other FDA-approved diagnostic tools.
No
The device description explicitly states the system consists of two components, a transportable Patient Station and a Nurse Station, which include hardware like modems, a PC, peripherals, and a videophone. It also integrates with existing vital signs measurement devices.
Based on the provided text, the CareCompanion Patient Station is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- CareCompanion Function: The CareCompanion Patient Station's primary function is to facilitate two-way communication (video, audio, data) between a patient and a healthcare professional and to transmit vital signs data collected from existing, legally marketed vital signs measurement devices.
- Nature of Data: The data collected and transmitted (blood pressure, pulse rate, blood glucose level, weight, heart/lung/bowel sounds) are physiological measurements taken from the patient, not tests performed on samples taken from the patient.
- No Mention of Sample Analysis: The description does not mention any analysis of biological samples.
The device acts as a communication and data transmission system for vital signs information, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DXN, CGA
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.
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.
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
Authorized healthcare provider / typically in a patient's home and a healthcare provider's site (office)
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)
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.
Key Results: 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.
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
§ 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).
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Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically "KO2O584". The characters are written in a bold, sans-serif font, and they appear to be handwritten or stylized. The sequence consists of two letters, "K" and "O", followed by the numbers "2", "0", "5", "8", and "4".
MAY 2 2 2002
Image /page/0/Picture/2 description: The image shows the word "neptec" in a stylized, sans-serif font. To the right of the word is a geometric design composed of three stacked cubes. The cubes are arranged in a way that creates a sense of depth and dimension. The overall design is simple yet modern.
pl / 3
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.
1
1
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
2
2
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.
ന
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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