MPM SYSTEM

K041854 · Aerotel Medical Systems, Ltd. · DXN · Oct 6, 2004 · Cardiovascular

Device Facts

• Record ID: K041854
• Device Name: MPM SYSTEM
• Applicant: Aerotel Medical Systems, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Aerotel MPM SYSTEM is intended to be used with home patient monitoring devices (blood pressure, digital scale, blood glucose level, respiratory peak flow, pulse oximetry) to send the measured data to a central station via modem by telephone, where reports can be generated for the physician and reports can be received over the Internet by physicians and patients.

Device Story

MPM System acts as a modem-based interface for home patient monitoring; connects to cleared measurement devices (blood pressure, scale, glucose, peak flow, pulse oximetry); transmits physiological data via telephone modem to a central station; central station software processes data to generate reports; reports accessible to physicians and patients via the Internet; enables remote patient monitoring; facilitates clinical decision-making by providing timely access to home-measured health parameters.

Clinical Evidence

Bench testing only; no clinical data provided. System validated with compatible measuring units; software extensively validated.

Technological Characteristics

Modem-based data transmission system; interfaces with external home monitoring devices; central station software for data management and report generation; internet connectivity for report distribution; no new technology utilized.

Indications for Use

Indicated for patients using home monitoring devices (blood pressure, digital scale, blood glucose, respiratory peak flow, pulse oximetry) who require transmission of measured data to a central station for report generation and internet-based review by physicians and patients.

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

• Cybernet Medical Medstar (K020534)
• Aerotel BPTEL/MPM (K983717)
• Aerotel TeleCliniQ (K021447)
• Aerotel MPMP-Net (K030825)

Submission Summary (Full Text)

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

# OCT 6 - 2004

Image /page/0/Picture/3 description: The image shows the alphanumeric string "K041854" in a bold, sans-serif font. Below this string, there is another string "P 1/2" written in a smaller, less defined font. The overall impression is that of a label or identifier, possibly from a document or inventory system.

### Aerotel Medical Systems (1998) Ltd. 510(k) Submission BP-Tel Trans-Telephonic Blood Pressure Measurement System

#### 510(k) Summary

#### (1) Submitter Information

Name: Aerotel Medical Systems (1998) Ltd.

Address:

5 Hazoref Street 58858 Holon Israel

Telephone Number: 972-3-559-6111

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone [phone] Fax [phone]

Date Prepared: June 3, 2004

(2) Name of Device

Trade Name: MPM System Common Name: Device for transmitting measurement parameters from the home and receiving them at a central station with Internet Access. Classification name: Telephone electrocardiograph transmitter and receiver.

(3) Equivalent legally-marketed devices.

- 1. Cybernet Medical Medstar, K020534
- 2. Aerotel BPTEL/MPM, K983717
- 3. Aerotel TeleCliniQ, K021447
- 4. Aerotel MPMP-Net, K030825

(4) Description

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

1) 2-1 2-

The system comprises a modem-like device that connects to various cleared measurement devices and a ntral station program that keeps the records of the patients, and makes the reports available ... the internet.

## (5) Intended Use

The Aerotel MPM SYSTEM is intended to be used with home patient monitoring devices (b)ood pressure, digital scale, blood glucose level, respiratory peak flow, pulse oximetry) to send the measured data to a central station via modem by telephone, where reports can be generated for the physician and reports can be received over the Internet by physicians and patients.

(6) Performance Data

#### (a) Non-clinical tests

The system has been tested with all of the compatible measuring units and has satisfactorily passed the tests. The software has been extensively validated.

#### (b) Clinical tests

Clinical tests are not necessary because the device does not use new technology/

(c) Conclusions

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

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare. The caduceus is composed of three parallel lines that curve and flow together.

OCT 6 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aerotel Medical Systems, Ltd. c/o George H. Myers, Sc.D. Medsys, Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604

Re: K041854

Trade Name: MPM System Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: July 7, 2004 Received: July 8, 2004

Dear Dr. Myers:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device 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 encrosule) to regally manatis and the Medical Device American by to de Ford. Four conninered phor to they 2011-03-12) in accordance with the provisions of the Federal Food, DNIg, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic 710 (710) that as not some of in the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general controls pro reserving 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 rr your device to such additional controls. Existing major regulations affecting your device can may be subject to back adders and Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

Page 2 - George H. Myers, Sc.D.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA S Issualice of a subside on the requirements of the Act
that FDA has made a determination that your device complies with of acception. Your must that FDA has made a dolorimiation administered by other Federal agencies. You must or any Federal statutes and regulations daminding, but not limited to: registration and listing (21) comply with an the Act 3 requirements, merceans, and manufacturing practice requirements as set CFK Part 807); labeling (21 CFR Part 800); good manat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 81 CFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (overlees) (over device as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in 10 I his letter will anow you to ocgin marketing your and equivalence of your device to a legally premarket notification: "The FDA inding of bactualized on 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 advice for your ac 11 594-4648. Also, please note the regulation entitled, and Colliact the Office of Complanou at (501) 37 - 7 - 7 - 7 - 7 807.97). You may obtain " Misoranding of Icierchee to premanter is thirds. In the Act from the Division of Small
other general information on your responsibilities under the Act from the 1990 Call o other general information on your respense Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Blimmimo for

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

Enclosure

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

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Indications for Use Form

Device Name: MPM System

Indications for Usc:

The Aerotel MPM SYSTEM is indicated when patients use with home patient monitoring devices (blood pressure, digital scale, blood glucose level, respiratory peak flow, pulse oximetry) and wish to send the measured data to a central station via modem by telephone, where reports can be generated for the physician and reports can be received over the Internet by physicians and patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

**Prescription Use**
Use

(Per 21 CFR 810.109)

O

Over-the-Counter

(Optional Format 1-2-96)

Blumuma

lon Slanof Cardlovascular Devices 510fk] Number