REMOTE CARE

K050234 · E.Care Solutions, Inc. · HGM · Aug 25, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K050234
• Device Name: REMOTE CARE
• Applicant: E.Care Solutions, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Aug 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

Remote Care is intended to be used only with the Analogic Fetalgard Lite to assist in the transmission and graphical display of maternal abdominal contractions and fetal heart rate. Remote Care receives the strip data from the monitoring system via a modem or the CareStation video phone. This strip data is then transmitted to the Remote Care web site for viewing by the health care provider. Remote Care does not provide real-time capabilities or alerts. The device is intended for use to communicate strip data which can be used to aid in assessing the well being of the fetus in the final trimester of pregnancy. Healthcare professionals must apply clinical judgment and experience to assess the data transmitted. The device is not intended as a replacement for professional medical care. It should not be used for patients requiring emergency intervention.

Device Story

Remote Care is a web-based patient management application; functions as an accessory to Analogic FETALGARD Lite monitor. Receives physiological strip data (maternal contractions, fetal heart rate) via modem or CareStation video phone; transmits data to secure web repository. Provides graphical or PDF strip file display for healthcare providers in hospitals, clinics, or patient homes. No real-time capabilities or alerts; requires clinical judgment for assessment. Benefits include remote access to fetal monitoring data, multi-user support, and centralized database management. Operates as an enterprise solution with role-based security.

Clinical Evidence

Bench testing only. Functional compliance to specifications and performance comparison to the predicate device were conducted.

Technological Characteristics

Web-based application; Microsoft SQL Server database; connectivity via modem or video phone. Displays data as graphic or PDF strip files. Multi-user access with role-based security management. Accessory to Analogic FETALGARD Lite monitor.

Indications for Use

Indicated for use in the final trimester of pregnancy to assist in the transmission and graphical display of maternal abdominal contractions and fetal heart rate for assessment of fetal well-being. Not for patients requiring emergency intervention.

Regulatory Classification

Identification

A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.

Predicate Devices

• Analogic FETALGARD Lite (K002503)

Submission Summary (Full Text)

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

## AUG 2 5 2005

K050234

# APPENDIX A: SUMMARY AND CERTIFICATION

## A. 510(K) SUMMARY

### Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the summary for the Remote Care by e.Care Solutions.

| SUBMITTER'S NAME: | e.Care Solutions |
|---------------------|---------------------------------------------------|
| ADDRESS: | 1345 Wilmington Island Road<br>Savannah, GA 31410 |
| CONTACT PERSON: | Constance G. Bundy |
| TELEPHONE NUMBER: | 763-574-1976 |
| FAX NUMBER: | 763-571-2437 |
| DATE OF SUBMISSION: | 31 January 2005 |

#### Identification of device 1.

Proprietary Name: Remote Care Common Name: Perinatal Monitoring System Accessory Classification Status: Class II per regulations 884.2740, Perinatal Monitoring System and Accessories Product Codes: HGM

#### 2. Equivalent devices

e. Care Solutions believes the Remote Care is substantially equivalent to Analogic FETALGARD Lite™ by Analogic Corporation, 510(k) # K002503.

#### Description of the Device 3.

Remote Care is an internet database application and repository for the storage and archival of patient information with their physiological data that relates to the Remote Care OB customers' prenatal experience. "Remote Care" receives data from the Analogic FETALGARD Lite™ and makes the data available to the medical professional through the World Wide Web.

#### Intended use 4.

"Remote Care" is a patient management web based application device for use with the Analogic FETALGARD Lite™ to record and graphically display maternal abdominal contractions and the fetal heart rate by means of a display in the format of a graphic or PDF strip file. The data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy (Non-Stress Test). This device is for trained medical personnel located in hospitals, clinics, doctor's offices and in the patient's home.

{1}------------------------------------------------

#### Indications for Use న్.

Remote Care is intended to be used only with the Analogic FETALGARD Lite™ to assist in the transmission and graphical display of maternal abdominal contractions and fetal heart rate. Remote Care receives the strip data from the monitoring system via a modem or the CareStation video phone. This strip data is then transmitted to the Remote Care web site for viewing by the health care provider.

Remote Care does not provide real-time capabilities or alerts. The device is intended for use to communicate strip data which can be used to aid in assessing the well being of the fetus in the final trimester of pregnancy. Healthcare professionals must apply clinical judgment and experience to assess the data transmitted. The device is not intended as a replacement for professional medical care. It should not be used for patients requiring emergency intervention.

#### Technological characteristics, comparison to predicate device. 6.

"Remote Care" is an accessory to the Analogic FETALGARD Lite™ by Analogic Corporation and is similar in many respects. Remote Care receives data from the Analogic device and graphically displays the data in similar format to the Analogic device. The primary difference is that "Remote Care" has features for increased security and patient database solution, scalable application and database, and World Wide Web accessibility. Remote Care offers an enterprise solution with a security role management process supporting an organization, department and person.

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

Comparative Table

| | Feature | Remote Care<br>e.Care Solutions | Analogic FETALGARD Lite™<br>Analogic Corporation |
|-----|-------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| 1. | Fetal Monitor | Analogic FETALGARD Lite™ monitor | Analogic FETALGARD Lite™ monitor |
| 2. | Data Receiver | Analogic FETALGARD Lite™ data receiver | Analogic FETALGARD Lite™ data receiver |
| 3. | FHR/URM Rendering | Analogic FETALGARD Lite™ Viewer - Modified For Multi-user access & the Web | Analogic FETALGARD Lite™ Viewer - Client Machine Only & Single User |
| 4. | Input | Analogic FETALGARD Lite™ data receiver and key board entry from the "Remote Care" web user interface | Analogic FETALGARD Lite™ data receiver and key board entry from Analogic FETALGARD Lite™ Viewer client interface |
| 5. | Output | Screen and Adobe PDF file – see Substantial Equivalence “Remote Care” Output submitted with this document | Screen and Paper – see Substantial Equivalence FETALGARD Lite™ Output submitted with this document |
| 6. | Printing | YES | YES |
| 7. | Patient Database | YES – Extensive – Microsoft SQL Server | YES – Limited – Microsoft Access |
| 8. | Reporting | Yes | NO |
| 9. | Multi-User | YES | YES - Limited |
| 10. | WEB Enabled | YES | NO |

#### 7. Discussion of functional testing.

Tests has been conducted and successfully completed, including functional compliance to specifications and performance comparison to the predicate device.

#### 8. Conclusion

Based on performance testing and a comparison to the predicate device, it is the conclusion of e.Care Solutions that the Remote Care is substantially equivalent to devices already on the marked (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three parallel, curved lines resembling a bird in flight. The emblem is black, and the background is white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

e.Care Solutions, Inc. % Ms. Constance G. Bundy Consultant C. G. Bundy Associates, Inc. 6740 Riverview Terrace FRIDLEY MN 55432

Re: K050234

AUG 2 5 2005

Trade/Device Name: Remote Care Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring systems and accessories Regulatory Class: II

Product Code: HGM Dated: July 14, 2005 Received: July 19, 2005

Dear Ms. Bundy:

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 (Premarket Approval), 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.

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.

{4}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mancing of substantial equivalence of your device to a legally premarket notification. The FDA midnig of Sacomman of - pour device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CIFR Part 801), please If you desire spectic advice for your device on but the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation chance, "hisornation on your responsibilities under the Act from the 807.97). You may obtain other general monational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# Indications for Use

### 510(k) Number: K050234

Device Name: Remote Care

### Indications for Use:

Remote Care is intended to be used only with the Analogic Fetalgard Lite to assist in Remote Oarc is intendod to be display of maternal abdominal contractions and fetal the transmission and grapment areply trip data from the monitoring system via a modem or the CareStation video phone. This strip data is then transmitted to the model Care web site for viewing by the health care provider.

Remote Care does not provide real-time capabilities or alerts. The device is intended for use to communicate strip data which can be used to aid in assessing the well being for use to oommanibute of pregnancy. Healthcare professionals must apply of the retus in the timester of passess the data transmitted. The device is not intended as a replacement for professional medical care. It should not be used for patients requiring emergency intervention.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---------------------|--------------------------------------------------------|
| | Nancy C. Brogdon |
| (Division Sign-Off) | |

(I Division of Reproductive, Abdominal, and Radiological Devices ----------