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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Neptec CareCompanion system.

Based on the provided text, the Acceptance Criteria and the Study that proves the device meets them are primarily focused on Substantial Equivalence to a predicate device, specifically regarding the addition of a pulse oximeter. There's limited information on standalone performance metrics for each vital sign, rather the testing emphasizes functional equivalence.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Functional Equivalence	Operate equivalently when integrated with CareCompanion as when operated as independent devices (for each vital signs measurement device).	Testing was performed for each vital signs measurement device to show that they operate equivalently.	This is a high-level statement without specific numerical performance metrics (e.g., accuracy, precision) for each vital sign.
Pulse Oximeter Conformance	Conformance with manufacturer's specifications.	The pulse oximeter was tested to verify conformance with manufacturer's specifications.	Similar to functional equivalence, this confirms adherence to existing specs but doesn't provide the specs themselves.
Mechanical Standards	Adherence to applicable mechanical standards.	CareCompanion Patient Station and Nurse Station subjected to performance testing to applicable mechanical standards.	Confirms testing, but not specific standard names or results.
Electrical Standards	Adherence to applicable electrical standards.	CareCompanion Patient Station and Nurse Station subjected to performance testing to applicable electrical standards.	Confirms testing, but not specific standard names or results.
Environmental Standards	Adherence to applicable environmental standards.	CareCompanion Patient Station and Nurse Station subjected to performance testing to applicable environmental standards.	Confirms testing, but not specific standard names or results.
Safety and Effectiveness	Does not raise any new questions of safety or effectiveness compared to the predicate device.	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.	This is the ultimate conclusion of the substantial equivalence pathway.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify the sample size for any of the performance tests. It states "Testing was performed" and "The pulse oximeter was tested."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing appears to be internal validation by the manufacturer, rather than a clinical study.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The document describes functional testing against existing specifications and predicate devices, not the establishment of ground truth by human experts for a diagnostic or interpretive task.
Adjudication Method for the Test Set:
- Not applicable. The testing described focuses on functional performance and conformance to specifications, not on inter-rater agreement for a diagnostic outcome.
If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-assisted diagnostic device, but rather a telemedicine system for vital signs collection and communication. Therefore, an MRMC study is not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The core of the "Performance Testing" section describes standalone testing of the integrated vital signs measurement devices (e.g., "show that they operate equivalently when integrated with CareCompanion as when operated as independent devices") and the pulse oximeter against its manufacturer's specifications. This can be considered a form of standalone performance assessment for the individual measurement components within the system. The system itself is explicitly designed to be human-in-the-loop, with a "caregiver operating the Nurse Station" and clinical judgment required.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance testing cited appears to be:
  - Manufacturer's specifications: For the pulse oximeter.
  - Performance of independent devices: For the other integrated vital signs measurement devices. The equivalence to these "independent devices" is the reference.
  - Applicable mechanical, electrical, and environmental standards: For general system performance.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that would require a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "neptec" in a bold, sans-serif font. To the right of the word is a geometric design composed of several cubes. The cubes are arranged in a way that creates a sense of depth and dimension. The overall design is simple and modern.

MAY 2 9 2003

Image /page/0/Picture/2 description: The image shows a document with the text "K022274 page 1 of 3" written at the top. Below the text is a logo with the text "ISO 9001 Registered" inside of it. The logo is a diamond shape with a square inside of it. The text is centered inside of the square.

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

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.

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

{2}------------------------------------------------

K022274
page 3 of 3

heart. Jung and bowel sounds. The information is collected upon request and direction of the healthcare provider.

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:

(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

Regulation Number and Section

§ 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).