STABIL-O-GRAPH

K041313 · I.E.M. GmbH · DXN · Jun 18, 2004 · Cardiovascular

Device Facts

• Record ID: K041313
• Device Name: STABIL-O-GRAPH
• Applicant: I.E.M. GmbH
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Stabil-O-Graph Blood Pressure Monitor is intended to be used by adults at home to measure blood pressure (systolic and diastolic) and pulse rate from the upper arm.

Device Story

Stabil-O-Graph is a fully automatic table-top blood pressure monitor for home use. Device utilizes an inflatable upper arm cuff to measure blood pressure and pulse rate via the oscillometric principle. Operated by the patient, the device automatically processes pressure oscillations to determine systolic and diastolic values. Output is displayed for the user to monitor their cardiovascular metrics. Device provides a non-invasive method for routine blood pressure tracking, assisting patients in managing their health status.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarity to the predicate device.

Technological Characteristics

Fully automatic table-top device; oscillometric measurement principle; inflatable upper arm cuff; dimensions/materials similar to predicate; non-invasive blood pressure measurement system.

Indications for Use

Indicated for adults for home monitoring of systolic/diastolic blood pressure and pulse rate via upper arm cuff (circumference 24-42 cm).

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

• OMRON, Model HEM-711 (773AC) (K021862)

Submission Summary (Full Text)

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JUN 1 8 2004

MTC

Media Trade Corporation

K 04/13/3
page 1 of 2

11820 Red Hibiscus Drive - Bonita Springs, FL 34135 Tel [phone] -- Fax [phone] E-mail: [e-mail] Web: www.mediatradecorp.com

## 510(k) Summary

| Submitter's Name: | Guenter Ginsberg<br>Media Trade Corporation |
|--------------------|-----------------------------------------------------------------------------------------------------------------------|
| Address: | 11820 Red Hibiscus Drive<br>Bonita Springs, FL 34135 |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Contact: | Guenter Ginsberg |
| Date of Summary: | May 7, 2004 |
| Trade Name: | Stabil-O-Graph, Blood Pressure Monitor |
| Classification: | Noninvasive Blood Pressure Measurement System<br>Product Code: DXN<br>Regulation Number: 21 CFR 870.1130<br>Class: II |
| Predicate Devices: | OMRON, Model HEM-711 (773AC)<br>K 021862 (Predicate) |

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K041313
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| Page -2- (510k Summary) | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | The Stabil-O-Graph Blood Pressure Monitor is a<br>fully automatic table model device that measures<br>blood pressure in a human being by means of an<br>inflatable cuff on the upper arm. It employs the<br>method of the "Oscillometric Principle". |
| Intended Use: | The Stabil-O-Graph Blood Pressure Monitor is<br>intended to be used by adults at home to measure<br>blood pressure (systolic and diastolic) and pulse rate<br>from the upper arm. |
| Technological Characteristics: | The Stabil-O-Graph Blood Pressure Monitor has<br>the same general design and performance<br>characteristics as the predicate devices from<br>Omron. The main difference is the physical size,<br>shape and weight.<br>The Stabil-O-Graph Blood Pressure Monitor has<br>the same intended use, general design and<br>incorporates similar materials and components,<br>hence should therefore raise no new questions of<br>safety and effectiveness.<br>This submitter concludes that the Stabil-O-Graph<br>Blood Pressure Monitor is therefore substantially<br>equivalent to the predicate device from Omron. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 2004

I.E.M. GMBH c/o Mr. Guenter Ginsberg Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, FL 34135

Re: K041313

Trade Name: I.E.M. Stabil-O-Graph Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: May 07, 2004 Received: May 17, 2004

Dear Mr. Ginsberg:

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 for assessment 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 may or subject to vacan would 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.Guenter Ginsberg

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualited on a substitution with other requirements of the Act
that FDA has made a determination that your device also concepcies. You must that FDA has made a delefinination in your deress by other Federal agencies. You must
or any Federal statutes and regulations administered by other to registration and list or any Federal statules and regulations administers, but not limited to: registration and listing (21 l comply with all the Act STEQuiltents, menames warmacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end if emplicable, the electronic CFR Part 807); labeling (21 CFR Fatl ovi ); good manatasaan.g
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Sections 95 % = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = This letter will anow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, p premarket notification. The FDA imaling of substance 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 CFR Part 801), please
rs the regulation in 161 1161 at 11 1616 at has note the rogulation entitle If you desire specific advice for your ac [phone]. Also, please note the regulation entitled, conlact the Office of Comphalled at (50 ) et St 807.97). You may obtain " Misbranding by relefence to prematic its time ander the Act from the Division of Small other general information on your responsion.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at the themators attrack Manifiacturers, International and Consulter Pressow.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

urna R. lochner

(JA 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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K0413i3

Page / of /

510(k) NUMBER (IF KNOWN) : K04/3/3/3

DEVICE NAME: I.E.M.Stabil-O-Graph

INDICATIONS FOR USE:

The I.E.M. Stabil-O-Graph is intended to be used by adults at home to monitor Blood Pressure (systolic and diastolic) and pulse rate from the upper arm with arm circumference ranging from 9.4 inches to 16.5 inches (24 cm to 42 cm).

Prescription Use (Per 21 CFR 801.109) ાર

Over - The - Counter - Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dmna R Vochner
(Division Sign-Off)

Division of Cigh-Oil)
Division of Cardiovascular Devices

510(k) Number K041313