ULTRAVIEW DM3 MONITOR

K093802 · Zoe Medical, Inc. · DXN · Apr 9, 2010 · Cardiovascular

Device Facts

• Record ID: K093802
• Device Name: ULTRAVIEW DM3 MONITOR
• Applicant: Zoe Medical, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.

Device Story

Portable patient monitor for spot check and continuous monitoring of NIBP, SpO2, pulse rate, and temperature. Used by clinicians and qualified medical personnel in clinical settings. Device processes physiological signals to provide real-time vital sign data and alarms. Output displayed for clinician review to support patient assessment and clinical decision-making. Benefits include timely monitoring of patient status and alerting to abnormal vital sign trends.

Clinical Evidence

Clinical performance testing was performed according to ISO 9919:2005 to demonstrate the safety and effectiveness of the oximetry feature. No other clinical data provided; other performance categories (software, electrical safety, EMC, bench testing) were verified through non-clinical testing.

Technological Characteristics

Portable patient monitor. Parameters: NIBP, SpO2, pulse rate, temperature. Connectivity: Not specified. Software: Verified and validated per internal processes. Sterilization: Not applicable (non-sterile).

Indications for Use

Indicated for adult and pediatric patients requiring monitoring, recording, and alarming of vital signs including SpO2, pulse rate, NIBP, and temperature. For use by healthcare professionals.

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

• Spacelabs Healthcare / élance Vital Signs Monitoring System (K090556)
• Cardinal Health / Model 2082 Temp Plus III Thermometer (K955846)

Submission Summary (Full Text)

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## Submitter

Zoe Medical Incorporated 460 Boston Street Topsfield, MA 01983-1223

Contact Name: James Chickering Contact Title: Regulatory Affairs Manager Phone: [phone] X37 Fax: [phone]

Date Prepared: December 4, 2009

#### Trade Name

Ultraview DM3 Monitor

#### Common Name

Patient Physiological Monitor (with alarms)

#### Classification Name

Non-invasive Blood Pressure Measurement System

#### Classification Regulation

21 CFR 870.1130

#### Product Code

DXN

## Substantially Equivalent Devices

| Ultraview DM3 Monitor | Predicate 510(k)<br>Number | Predicate Manufacturer / Model |
|---------------------------------------|----------------------------|-----------------------------------------------------------------|
| Non-invasive Blood Pressure component | K090556 | Spacelabs Healthcare /<br>élance Vital Signs Monitoring System |
| Pulse Oximetry component | K090556 | Spacelabs Healthcare /<br>élance. Vital Signs Monitoring System |
| Temperature component | K955846 | Cardinal Health /<br>Model 2082 Temp Plus III Thermometer |

## Device Description

The Ultraview DM3 Monitor is a portable patient monitor intended to be used by clinicians and medical qualified personnel for spot check and continuous monitoring of non-invasive blood pressure (NIBP), pulse oximetry (SpO2), and temperature.

APR - 9 2010

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# Technology Comparison

The Ultraview DM3 Monitor utilizes the same or similar technology for each parameter as utilized by the predicate devices.

## Intended Use

The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs.

The Ultraview DM3 Monitor is intended for monitoring, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.

## Performance Testing

| Category | Testing Summary |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization Validation | The Ultraview DM3 Monitor is not sterilized or sterilizable, and<br>therefore this section does not apply to the monitor itself. |
| Shelf Life Testing | The Ultraview DM3 Monitor is not sterilized or sterilizable, and<br>therefore this section does not apply to the monitor itself. |
| Biocompatibility Testing | The Ultraview DM3 Monitor has no patient contact materials, and<br>therefore this section does not apply to the monitor itself. |
| Software Testing | Software for the Ultraview DM3 Monitor was designed and<br>developed according to Zoe Medical's software development<br>process, and was verified and validated. Test results indicated that<br>the Ultraview DM3 Monitor complies with its predetermined<br>specification. |
| Electrical Safety | The Ultraview DM3 Monitor was tested for patient safety in<br>accordance with applicable standards. Test results indicated that the<br>Ultraview DM3 Monitor complies with its predetermined specification. |
| Electromagnetic Compatibility<br>Testing | The Ultraview DM3 Monitor was tested for EMC in accordance with<br>applicable standards. Test results indicated that the Ultraview DM3<br>Monitor complies with its predetermined specification. |
| Performance Testing - Bench | The Ultraview DM3 Monitor was tested in accordance with internal<br>requirements and procedures, and test results indicated that the<br>device complies with the predetermined requirements. This testing<br>includes performance and functional, environmental, and shipping<br>and transportation testing. |
| Performance Testing - Animal | Animal performance testing was not performed and is not necessary<br>to demonstrate safety and effectiveness of the Ultraview DM3<br>Monitor. |
| Performance Testing - Clinical | Clinical performance testing was performed according to ISO<br>9919:2005 to demonstrate safety and effectiveness of the oximetry<br>feature of the Ultraview DM3 Monitor. |

## Conclusion

Based upon a comparison of devices and performance testing results, the Ultraview DM3 Monitor is substantially equivalent to the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

APR - 9 2010

Zoe Medical c/o Mr. James Chickering Regulatory Affairs Manager 460 Boston St. Topsfield, MA 01983

Re: K093802

Trade/Devicc Name: Ultraview DM3 Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN, DQA Dated: March 29, 2010 Received: April 06, 2010

Dear Mr. Chickering:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. James Chickering

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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: K093802

Device Name:

## Ultraview DM3 Monitor

Indications for Use:

The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs.

The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.

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

Over-The-Counter Use (Part 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)

| (Division Sign-Off) |
|---------------------|
|---------------------|

Division of Cardiovascular Devices

| 510(k) Number | K093802 |
|---------------|---------|
|---------------|---------|

Zoe Medical, Incorporated