N2000 BASE STATION, N2001 NURSE STATION

K012801 · Neptec Design Group, Ltd. · DXN · Nov 14, 2001 · Cardiovascular

Device Facts

• Record ID: K012801
• Device Name: N2000 BASE STATION, N2001 NURSE STATION
• Applicant: Neptec Design Group, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The N2000 Base 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 oxygen saturation, blood glucose level, temperature, weight, and heart, lung and bowel sounds. The information is collected upon request of the healthcare provider. The N2000 Base Station is intended to be used in conjunction with the N2001 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 not intended to be used for diagnostic purposes. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care or emergency intervention.

Device Story

HomeCare Information Network System (HINS) facilitates remote patient monitoring; consists of N2000 Base Station (patient home) and N2001 Nurse Station (provider office). System integrates FDA-cleared vital signs measurement devices (up to five) to collect blood pressure, pulse, O2 saturation, glucose, temperature, weight, and heart/lung/bowel sounds. Components communicate via modems over standard telephone lines; enables two-way video/audio communication. Data transmitted to N2001 Nurse Station for display and automatic recording in patient database. Operated by patients at home and healthcare professionals at clinical sites. System provides no real-time alarms; not for diagnostic use. Clinical judgment required for interpretation. Benefits include remote access to patient vitals, reducing need for in-person visits.

Clinical Evidence

Bench testing only. Performance testing validated functional performance of HINS and confirmed integrated vital signs measurement devices operated as independent devices. Compliance with IEC 601-1, CAN/CSA-C22.2, UL 2601-1, and FCC Part 15, Subpart C demonstrated.

Technological Characteristics

System comprises N2000 Base Station and N2001 Nurse Station PC. Connectivity via standard telephone lines using modems. Integrates external FDA-cleared vital signs measurement devices. Standards compliance: IEC 601-1, CAN/CSA-C22.2, UL 2601-1, FCC Part 15 Subpart C. No specific software algorithm class or material specifications provided.

Indications for Use

Indicated for patients requiring regular monitoring of vital signs (blood pressure, pulse, O2 saturation, blood glucose, temperature, weight, heart/lung/bowel sounds) via prescription. Contraindicated for patients requiring direct medical supervision or emergency intervention.

Regulatory Classification

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.

Predicate Devices

• Electronic HouseCall System (K000237)
• Cybercare, Inc. (K981533)
• A & D Engineering, Inc. Sure Monitor (K982481)
• Andromed, Inc. Stethos Electronic Stethoscope (K001306)

Submission Summary (Full Text)

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NOV 1 4 2001 K012801

## 510(k) Summary

### Submitter

Neptec Design Group Ltd. 302 Legget Drive Kanata, Ontario Canada K2K 1Y5

#### Contacts

John Schneider Neptec Design Group Ltd. Tel: [phone] Fax: [phone]

or

Charles H. Kyper Kyper & Associates Chapel Hill, NC Tel: [phone] Fax: [phone]

### Date Prepared

August 20, 2001

## Device Information

| Trade Name: | N2000 Base Station / N2001 Nurse Station |
|----------------------|--------------------------------------------------------------|
| Common Name: | Tele Homecare System |
| Classification Name: | Radiofrequency Physiological Signal Transmitter and Receiver |

## Device Description

The HomeCare Information Network System (HINS) consists of two components: a The Homeoale Information installed typically in a patient's home; and the N2001 transportable Nation Dato Claim in the 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 With existing legally mankeled than signed to monitor the patient's blood N2000 Base Statual, the N2000 Blace Station, blood glucose level, temperature, weight pressure, pulse fate, blood oxygen saturalism smit this data to the N2001 Nurse Station.
and/or heart, lung and bowel sounds, and transmit this data to the N200 and also is displayed to the caregiver operating the N2001 News Station and also line data is ulsplayed to the odiografion database. The heart, lung and bowel automatically recorded in a patient information callades from the supplied with the system.

Vital signs measurement devices integrated in the HINS are FDA approved devices and Vital signs measurement devices integration in the received 510(k) approval. The N2000 may be configured for use with one to five devices.

The N2001 Nurse Station consists of two sub-components, the N2001 Nurse Station PC, The N2001 Nulse Glation bonuptoring peripherals connected to the N2000 Base which is a Standad i O with Supporting functions for the Nurse Station. The Station, which provides the video operate as a standalone device for patient data management and record keeping functions.

## Substantial Equivalence

The Neptec Homecare Information Network System (HINS) is substantially quivalent to The Nepleo I romoon over the Electronic HouseCall System (#K000237) by to following products of closens (#K981533) by American Telecare, Inc. In Oybercare, Inc., and the Are Sure Monitor (#K982481) by A & D Engineering, Inc. and the Stethos ™ Electronic Stethoscope (#K001306) by Andromed, Inc. may be used with the system to provide the vital signs monitoring functions.

The HINS 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 HINS. 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 N2000 Base 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

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health care professional at the health care provider's site. The information includes:
All on the successional band career asturetion, blood ducose level, temperature health care professional at the health care provider a site: " his in earling the level, temperature,
blood pressure, pulse rate, blood oxygen saturation is collected upon re blood pressure, pulse rate, blood oxygen saturation, blood groom of the request
weight, and heart, lung and bowel sounds. The information is collected upon request
and hea welght, anion of the healthcare provider.

The N2000 Base Station is intended to be used in conjunction with the N2001 Nurse The N2000 Base Station is intended to be used in conjuncies with the waters.
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 not intended to be used
in the can on Olici colludgement and experience are required to check and The device does not send any real-time arams. The donce are required to check and
for diagnostic purposes. Clinical judgement and experience as a substitute for for diagnostic purposes. Cilinical Jugeneer and intended as a substitute for
interpret the information transmitted. The device is not intended as a substitute for interpret the information transmitted. The device to not montal and called in the connection in the commend in medioal our emergency intervention.

## Performance Testing

The N2000 Base Station and the N2001 Nurse Station have been subjected to The N2000 Base Station and the N2001 Antiso estarsnee to specifications, and programments, and programm performance testing or vital Signs theasaremonto. Portonial and emissions in compliance with:

- IEC 601-1 .
- CAN/CSA-C22.2 .
- UL 2601-1 .
- FCC Part 15, Subpart C .

Medical Electrical Equipment Medical Electrical Equipment Safety of Medical Electrical Equipment FCC Rules and Regulations

Testing was performed to validate the functional performance of the HINS. In particular, Testing was performed with each vital signs measurement device to show that they testing was performed with each vitar signs meadinent operated as independent devices.

## Conclusion

The results of the test indicate that the device is substantially equivalent to it's predicate The results of the test indicato that the estions of safety or effectiveness.

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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 depiction of an eagle with three wavy lines representing its body and wings. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2001

Mr. John Schneider HINS Project Manager Neptec Design Group Ltd. 302 Legget Drive Kanata, Ontario Canada K2K 1Y5

## Re: K012801

KU12801
Trade Name: N2000 Base Station and N2001 Nurse Station HomeCare Information Network System Regulation Number: 21 CFR 870. 1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 20, 2001 Received: August 21, 2001

Dear Mr. Schneider:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boodor 910(x) pecies is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conniner of the to may 20, 2017 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 r on thay, therefore, mains 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 issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substanted of the requirements of the Act
that FDA has made a determination that your device compilies with other requirements of t that FDA has made a determinations administered by other Federal agencies. You must
or any Federal statutes and regulations adminst but not limited to: registration and lis or any Federal statutes and regulations administered by registration and listing (21
comply with all the Act's requirements, including, but not limited to: reguirements as s comply with all the Act's requirements, including, our sig, requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 801); good manufacturing prisciplingsble, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and If applicati forth in the quality systems (QS) regulation (21 CFR Part 220) and 2 41)
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)
This and the submit and only a TRA ding of substantial equivalence of your devic This letter will allow you to begin marketing your device as your device to a legally
premarket notification. The FDA finding of substantial equivalence of your device and th premarket notification. The FDA finding of substantial equivaliation of 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 CPR Part 801 and If you desire specific advice for your device discussio devices, please contact the Office of
additionally 21 CFR Part 809.10 for in vite dia creations on the promotion and a additionally 21 CFR Part 809.10 for mirro offer questions on the promotion and advertising of
Compliance at [phone]. Additionalines at [phone]. Also, please not Compliance at [phone]. Addition of Compliance at [phone]. Also, please note the your device, please contact the United of Couldnation" (21 CFR Pats 807.97).
regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). regulation entitled, "Misbranding on your responsibilities under the Act may be obtained from the Other general information on your responsional one morner Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at its to Division of Sinan Mamaractarers, for at its Internet address [phone] 058-2017 drh/dsma/dsmamain.html

Sincerely yours,

Doak Tith

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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NOV 1 4 2001

Page 1 of 1

# 510(k) Number (if known): K012801

KO12801

Device Name: N2000 Base Station / N2001 Nurse Station

Indications For Use:

The N2000 Base Station is Intended to be used in conjunctions between the patient The N2000 Base Station is intended to be used in Collunications between the patient and the health care professional.

and the nealth dark profession of an authorized healthere provider. by patients where regular monitoring of vital signs information is indicated.
by patients where regular monitoring of vital signs information is indicated. by patients where regular monitoring of vial Signs information over standard
information is collected from the N2000 Fa information 13 to a health care professional.

The device is not indicated for The device does not send any real-time alarms. Clinical judgement and experience are required to check and diagnostic purposes. interpret the information transmitted. The device is not rater as a substitute for The device is contraindicated for patients requiring direct medical medical care. 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)

(Optional Format 3-10-98)

Prescription Use (Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012801