VITALCAREGIVING SYSTEM

K051544 · Advanced Monitoring Caregiving, Inc. · DXH · Oct 7, 2005 · Cardiovascular

Device Facts

• Record ID: K051544
• Device Name: VITALCAREGIVING SYSTEM
• Applicant: Advanced Monitoring Caregiving, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Oct 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Advanced Monitored Care ("AMC") AMC System is intended to be used in conjunction with home patient measuring devices to send the measured parameters from a patient's home to a central computer via an intermediary organization, where reports can be generated for the physician and data can be reviewed over the Internet by physicians and patients.

Device Story

AMC System acts as a central data repository and reporting platform for home medical measurements. It receives data from cleared home measurement devices via intermediary organizations; stores data in patient files; generates reports including diagrams, data sheets, histograms, and scatter diagrams. System has no direct interface with patients or their measuring devices. Physicians and patients access data via internet using secure, password-protected accounts. System performs no diagnosis; provides historical data review to assist physician clinical decision-making. Benefits include remote access to longitudinal patient data for chronic disease management.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including extensive software validation and compatibility testing with intermediary organization interfaces. The device uses the same technology as predicate devices.

Technological Characteristics

Central station software system for data aggregation and reporting. Connectivity via internet/web browser. Secure password-protected access. Data input received from intermediary organizations. No direct patient interface. Software-based reporting (diagrams, histograms, scatter plots).

Indications for Use

Indicated for chronically-ill patients requiring periodic measurement of medical parameters via home monitoring devices connected to a central station for report generation and web-based review by authorized personnel. Not for real-time monitoring.

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Predicate Devices

• Aerotel MPM (K041854)
• RemoteNurse (K041308)
• Cybernet Medstar (K020534)

Submission Summary (Full Text)

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# Page A1 OCT 7 - 2005

## Advanced Monitored Caregiving Inc. 510(k) submission AMC System Overview and Product Description June 3, 2005

### 510(k) summary

### 1. Submitter Information

Name: Advanced Monitored Caregiving Inc.

Address:

1729 E. 12th St Brooklyn NY 11229

Telephone Number: 718-645-2273 Fax Number : 718-998-9247

Contact person:

Dr. George Myers Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Tel.: [phone] Fax: [phone]

Date prepared: June 3, 2005

### 2. Name of Device

Trade Name: AMC System

Common Name: Central station for home medical parameters measurement devices and transtelephonic digital transmission system

Classification name: Telephone Electrocardiographic transmitter and receiver (870.2920/74DXH)

#### 3. Equivalent legally- marketed devices:

Aerotel MPM, K041854 RemoteNurse, K041308 Cybernet Medstar K020534

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## 4. Description

The AMC System receives data from cleared home measurement devices via an intermediary organization, stores the information in databases, and produces reports for patients and physicians that can be viewed on the Internet by means of secure transmission methods. The AMC system has no direct interface with patients or patients' measuring devices.

The AMC system performs no diagnosis. It stores the received data in the patient's file as received from intermediate organizations, and generates reports in the form of diagrams, data sheets, histograms and scatter diagrams (where applicable).

The AMC system allows the patient and his doctor to access the patient's data via the Internet by use of secured password-protected access codes. These codes (User name and password) are assigned by the AMC system ..

### 5. Intended Use

The Advanced Monitored Care ("AMC") AMC System is intended to be used in conjunction with home patient measuring devices to send the measured parameters from a patient's home to a central computer via an intermediary organization, where reports can be generated for the physician and data can be reviewed over the Internet by physicians and patients.

#### 6. Performance Data

#### Non – clinical tests

The software for this product has undergone extensive validation testing. The interfaces with the intermediary organizations are all tested for compatibility.

### Clinical tests

The AMC system uses the same technology as the predicate devices, and thus no clinical tests are required. All home measurement devices are FDA-cleared..

### 7. Conclusion

The AMC System monitoring system is equivalent in safety and efficacy to the legally-marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 - 2005

Advanced Monitoring Caregiving Inc. c/o Mr. George Myers Medsys, Inc. 377 Route 17S Hasbrouck Heights, NJ 070604

Re: K051544

Trade Name: Vital Caregiving System Regulation Number: 21 CFR 870.2920 Regulation Name: Transmitters and Receivers, Electrocardiograph. Telephone Regulatory Class: Class II Product Code: DXH Dated: September 09, 2005 Received: September 12, 2005

## Dear Mr. Myers:

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. George Myers

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that i Dr o resuarted essour device complies with other requirements of the Act that I DA has made a dolorized administered by other Federal agencies. You must or any I cuchares and roganizents, including, but not limited to: registration and listing Comply with and rice b requirements, as a manufacturing practice requirements as scl (21 CFR Part 807), laboring (21 CFR Part 820); and if applicable. the electronic forth in the quality bytvelles (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro risions (Seeting your device as described in your Section 510(k) I mis icher will anow you to begin mainenes , .
premarket notification. The FDA finding of substantial equivalence of your device to a legally premative notineation. The sure 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 If you desire specific advised at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. IMhoranum of reference to your responsibilities under the Act may be obtained from the Other general mionnation on your mernational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ashley B. Bovair

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K051544 510(k) Number (if known):

Indications for Use Form

Device Name: AMC System

Indications for Use:

The AMC SYSTEM is indicated when a physician wants to periodically measure data of chronically-ill home r nt reason it me monitoring devices connected via wired or wireless facilities to a central station, where parts can be generated and viewed via a Web browser by authorized personnel (e.g. physicians, care givers, and patients). The system is not intended to provide real-time data or real-time monitoring.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Adule Boan

**510(k) Number** K051544