SMDIE DEVICE INTERFACING SYSTEM

K061590 · Siemens Medical Solutions Health Services Corporat · MWI · Jun 21, 2006 · Cardiovascular

Device Facts

• Record ID: K061590
• Device Name: SMDIE DEVICE INTERFACING SYSTEM
• Applicant: Siemens Medical Solutions Health Services Corporat
• Product Code: MWI · Cardiovascular
• Decision Date: Jun 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Indications for Use

The SMDIE Device Interfacing System is indicated for data transfer between standalone physiological monitors that collect noninvasive blood pressure, temperature, and blood oxygenation level through external cuffs and thermometers to external clinical information systems. The SMDIE is also indicated for patient weight transfer between Scale-Tronix 5002 class physician office scales. The SMDIE Device Interfacing System is not intended for continuous vital sign monitoring purposes.

Device Story

SMDIE Device Interfacing System acts as a data bridge between standalone physiological monitors (measuring NIBP, temperature, SpO2) or Scale-Tronix 5002 scales and external clinical information systems. Device uses serial interfaces to collect patient data; translates data into HL7 protocols for transmission to external systems. Used in clinical settings; operated by healthcare staff. Output allows clinicians to view patient vitals and weight within existing information systems, facilitating documentation and clinical decision-making. System is not intended for continuous monitoring.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Software-based device interfacing system. Uses serial interfaces for data acquisition from physiological monitors and scales. Connectivity via HL7 data exchange protocols. Operates as a data retriever and translator for integration with external clinical information systems.

Indications for Use

Indicated for data transfer of noninvasive blood pressure, temperature, blood oxygenation, and patient weight from standalone physiological monitors and Scale-Tronix 5002 scales to external clinical information systems. Not for continuous vital sign monitoring.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• M2367A Device Link System by Agilent Technologies, Inc. (K012094)
• Unity Network ID by General Electric Medical Systems Information Technology (K021454)
• DataCaptor by Capsule Technologie (K032142)
• Integriti Patient Monitor by Alliance Instruments (K980688)
• Centra View Device Link System by ICU Data Systems, Inc. (K033283)

Submission Summary (Full Text)

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JUN 2 1 2006 Siemens Medical Solutions Health Services Corporation Traditional 510(k) Premarket Submission SMDIE Device Interfacing System

### SECTION 5 - 510(k) SUMMARY

| Submission Correspondent:<br>Address: | Emergo Group, Inc.<br>2454 McMullen Booth Road<br>Suite 427<br>Clearwater, FL 33759 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------|
| Phone:<br>Fax:<br>E Mail: | [phone]<br>[phone]<br>[e-mail] |
| Contact: | Mr. Ian Gordon<br>Senior Vice President |
| Submission Sponsor: | Siemens Medical Solutions Health Services Corporation<br>51 Valley Stream Parkway<br>Malvern, PA 19355 |
| Date Prepared: | May 19, 2006 |
| Trade Name: | SMDIE Device Interfacing System |
| Common Name: | Physiological device data retriever and translator |
| Classification: | Monitor, Physiological, Patient (Without Arrhythmia<br>Detection Or Alarms) |
| Regulation #: 870.2300, Class II | Product Code: MWI |

Description: The SMDIE Device Interfacing System Software is intended for use with standalone physiological monitor and Scale-Tronix 5002 scales to transfer data from the physiological monitor and scale to external devices via Health Level Seven data exchange protocols for vitals results and patient information.1

^&quot; Health Level Seven is one of several Ancrican National Standards Institute (ANSI) -accredited Standards Developing Organizations (SDOs) operating in the healtheare arena. Most SDOs produce standards (sometimes of protocols) for a particular healtheare domain such as pharmacy, medical devices, imaging or insurance (claims processing) transactions. Health Level Seven's domain is clinical and administrative data." Source: http://www.hl7.org.

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Serial interfaces between physiological monitors and the SMDIE allow patient weight, non-invasive blood pressure, blood oxygenation level, and temperature to be communicated to the Device Connectivity & User Interface Component.

061590

### List of Classification names and numbers of externally connected devices are as follows:

- Cardiac Monitor 870.2300 .
- Clinical Electronic Thermometer 880.2910 .
- . Oximeter - 870.2700
- Non-Invasive Blood Pressure Measurement System -- 870.1130 .
- Breathing Frequency Monitor 868.2375 ●

The SMDIE Device Interfacing System is indicated for data Intended Use: transfer between standalone physiological monitors that collect noninvasive blood pressure, temperature, and blood oxygenation level through external cuffs and thermometers to external clinical information systems. The SMDIE is also indicated for patient weight transfer between Scale-Tronix 5002 class physician office scales. The SMDIE Device Interfacing System is not intended for continuous vital sign monitoring purposes.

For Prescription Use Only.

#### Predicate Devices:

The SMDIE Device Interfacing System substantially equivalent to the following predicate devices.

M2367A Device Link System by Agilent Technologies, Inc. 510(k) #: K012094 Decision: Substantially Equivalent (SE)

Unity Network ID by General Electric Medical Systems Information Technology 510(k) #: K021454 Decision: Substantially Equivalent (SE)

DataCaptor by Capsule Technologie 510(k) #: K032142 Decision: Substantially Equivalent (SE)

Integriti Patient Monitor by Alliance Instruments 510(k) #: K980688 Decision: Substantially Equivalent (SE)

Centra View Device Link System by ICU Data Systems, Inc. 510(k) #: K033283 Decision: Substantially Equivalent (SE)

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K061590
P 3/3

Siemens Medical Solutions Health Services Corporation Traditional 510(k) Premarket Submission SMDIE Device Interfacing System

## Safety and Effectiveness and Summary and Conclusion Regarding Substantial Equivalence:

By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.

The minor differences between the SMDIE Device Interfacing System and the predicate devices cited do not raise any additional questions regarding safety and effectiveness. Software Testing was performed on the SMDIE Device Interfacing System and was determined to be acceptable.

The device, as designed, is as safe and effective as the predicate device, and the device is determined to be substantially equivalent to the referenced predicate devices.

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Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health and Human Services. The logo features the department's emblem, which is a stylized representation of a human figure. The figure is composed of three abstract shapes that resemble a person's head, torso, and legs. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

JUN 2 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Siemens Medical Solutions Health Services Corporation. c/o Mr. Daniel W. Lehtonen Responsible Third party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd. Unit B7 Twinsburg, OH 44087

Re: K061590

Trade Name: SMDIE Device Interfacing System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm). Regulatory Class: II (two) Product Code: MWI Dated: June 7, 2006 Received: June 8, 2006

Dear Mr. Daniel W. Lethtonen:

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. Daniel W. Lethtonen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be devilode that I Drimination that your device complies with other requirements of the Act that I Dr Hab Intact a and regulations administered by other Federal agencies. You must or any I odolar statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Far 8077, laceming (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. This letter will allow you to begin marketing your device as described in your Section 510(k) I mis loter will anow you to ought inding of substantial equivalence of your device to a legally prematic is notificate device results 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 of Compliance at (240) 276- 0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international 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,

Bffmmimor 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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### INDICATIONS FOR USE

510(k) Number (if known):

# Device Name: SMDIE Device Interfacing System

### Indications for Use:

The SMDIE Device Interfacing System is indicated for data transfer between standalone physiological monitors that collect noninvasive blood pressure, temperature, and blood oxygenation level through external cuffs and thermometers to external clinical information systems. The SMDIE is also indicated for patient weight transfer between Scale-Tronix 5002 class physician office scales. The SMDIE Device Interfacing System is not intended for continuous vital sign monitoring purposes.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

B.Bennumton

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