(318 days)
No
The description focuses on basic data transmission, video/audio communication, and data display/recording, with no mention of AI/ML algorithms for analysis or interpretation.
No
Explanation: The device is described as aiding in the communication and monitoring of vital signs, not directly treating a condition or restoring health. It is explicitly stated that "The device is not intended as a substitute for medical care" and "Clinical judgement and experience are required to check and interpret the information transmitted."
No
The device collects and transmits vital signs data and facilitates communication, but it explicitly states that clinical judgment and experience are required to "check and interpret the information transmitted," and that the device "is not intended as a substitute for medical care." Furthermore, it "does not send any real-time alarms," indicating it does not perform automated analysis or diagnosis.
No
The device description explicitly states the system consists of two components, a Patient Station and a Nurse Station, which include hardware like vital signs measurement devices, modems, a standard PC, and a videophone. The performance studies also mention testing of mechanical, electrical, and environmental standards, indicating hardware components are part of the device.
Based on the provided text, the CareCompanion Patient Station is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- CareCompanion Function: The CareCompanion system focuses on monitoring vital signs (blood pressure, pulse rate, blood glucose, weight, blood oxygen saturation, heart/lung/bowel sounds) and providing two-way communication between the patient and healthcare professional. It collects data directly from the patient or integrated vital signs devices, not from analyzing biological specimens.
- Intended Use: The intended use clearly states it's for providing communication and transmitting vital signs information for monitoring, not for analyzing biological samples.
Therefore, the CareCompanion Patient Station falls under the category of a medical device used for patient monitoring and communication, not an IVD.
N/A
Intended Use / 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 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)
DRG
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.
Using 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, blood oxygen saturation level 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, lung and bowel sounds may be listened to by the caregiver using a set of headphones supplied with the system.
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
healthcare provider, professional caregiver, patient
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. The pulse oximeter was tested to verify comformance with manufacturer's specifications.
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 device 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.
K002690, K982776, K970763, K983576, K990522
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
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
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MAY 2 9 2003
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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
Date Prepared
July 5, 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
Tel .: (613) 599-7602 Fax: (613) 599-7604
1
K022274
page 2 of 3
The real-time video and audio communications allow the patient and the caregiver to view and speak with each other.
Using 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, blood oxygen saturation level 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, lung and bowel sounds may be listened to by the caregiver using a set of headphones supplied with the system.
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 with the addition of the pulse oximeter is substantially equivalent to the predicate Neptec CareCompanion (#K020584) that has previously been approved by the FDA.
The CareCompanion and its predicate have the same general use to provide the capability for health care professionals to monitor the vitals signs of their patients from remote locations.
The main difference between the systems is the addition of a pulse oximeter for the collection of blood oxygen saturation data.
The pulse oximeter is substantially equivalent to the following FDA approved devices:
- Nonin Palmsat Pulse Oximeter Model 2500 (#K002690) by Nonin Medical, Inc. .
- 9303 Neonatal/Adult Vital Signs Monitor (#K982776) by CAS Medical Systems, Inc. .
- Escort II Modular Telemetry System (#K970763) by Medical Data Electronics, Inc. .
- DR180-R/Oxy Holter and Pulse Oximetry Recorder (#K983576) by Northeast . Monitoring, Inc.
- Digital EEG and Sleep Acquisition System (#K990522) by La Mont Medical. Inc. .
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 pressure, pulse rate, blood glucose level, weight, blood oxygen saturation level and
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K022274
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heart. Jung 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 is a diagnostic 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.
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. The pulse oximeter was tested to verify comformance with manufacturer's specifications.
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 device and does not raise any new questions of safety or effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, ribbon-like appearance. Encircling the profile image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 2003
Neptec Design Group, Ltd. c/o Mr. John Schneider HINS Project Manager 302 Legget Drive Kanata, Ontario Canada K2K 1Y5
Re: K022274
Trade Name: Carecompanion patient station & nurse station Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II (two) Product Code: DRG Dated: March 6, 2003 Received: March 10, 2003
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.
4
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), please contact the Office of Compliance at (301) 594-4646. 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,
R. Zeller M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K02274
Page 1 of 1
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 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Only
10-98)
(Optional Format 3-
V. Oellette