EVISION DATA MANAGEMENT SOFTWARE

K092678 · Nonin Medical, Inc. · DQA · Oct 1, 2009 · Cardiovascular

Device Facts

• Record ID: K092678
• Device Name: EVISION DATA MANAGEMENT SOFTWARE
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 1, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

eVISION® Data Management Software (eVISION) is an optional accessory for use with Nonin's Model 7600 Regional Oximeter System. It is intended for use by healthcare professionals when 1) transferring data from the Model 7600 to a computer in order to maintain individual records of regional oximetry data, 2) reviewing data according to user-selected parameters, and 3) generating reports.

Device Story

eVISION Data Management Software is an accessory for the Model 7600 Regional Oximeter System; it functions as a data management tool for personal computers. The software receives regional oxygen saturation (rSO2) data from the oximeter via a Bluetooth connection. It transforms this input into visual data graphs and summary statistics for clinician review. The software allows clinicians to save patient information and rSO2 data into a library for future retrieval. The clinician is responsible for selecting analysis criteria; the software does not provide diagnoses or treatment recommendations. It is intended for use in clinical settings by healthcare professionals to maintain patient records and facilitate data interpretation.

Clinical Evidence

No clinical data. Bench testing only; software verification and validation were performed to confirm performance, functionality, and features.

Technological Characteristics

Software-based data management application for PC. Connectivity via Bluetooth to Model 7600 Regional Oximeter. Functions include data transfer, storage, graphical display, and report generation. No specific algorithm architecture or hardware materials described.

Indications for Use

Indicated for use by healthcare professionals to manage, review, and report regional oxygen saturation (rSO2) data downloaded from the Nonin Model 7600 Regional Oximeter System.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• Nonin's nVISION Data Management Software (K033307)

Submission Summary (Full Text)

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<092678

# 510(k) Summary

#### Submitter:

Contact Person:

Date Prepared:

Trade Name:

Classification Name: and Number:

Predicate Device(s):

Device Description:

Nonin Medical, Inc.

Lori M. Roth Clinical/Regulatory Specialist Nonin Medical, Inc. 13700 1st Ave. North Plymouth, MN 55441-5443

August 31, 2009

Data Management Software

Class II, 21 CFR 870.2700

Nonin's nVISION Data Management Software (K033307) cleared on 05/06/2004.

eVISION® Data Management Software (eVISION) is an optional accessory for use with the Model 7600 Regional Oximeter System to display and summarize downloaded patient regional oxygen saturation (rSO2) data on a personal computer. Data can be displayed as data graphs and/or statistics for review and interpretation by a clinician. Data is obtained from the Model 7600 via Bluetooth® connection provided by the host computer on which eVISION is installed. The software also allows regional oximetry data and patient information to be saved in a "library" for future retrieval and analysis. The clinicain using eVISION software is solely responsible for selecting the analysis criteria used to calculate summary statistics included in the reports. eVISION® software is an adjunct system requiring clinician interpretation of results; it does not suggest a course of treatment or generate a diagnosis.

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Intended Use:

eVISION® Data Management Software (eVISION) is an optional accessory for use with Nonin's Model 7600 Regional Oximeter System. It is intended for use by healthcare professionals when 1) transferring data from the Model 7600 to a computer in order to maintain individual records of regional oximetry data, 2) reviewing data according to user-selected parameters, and 3) generating reports.

#### Functional and Safety Testing:

The Risk Management process is used to assess the safety of the device; no new risks were identified with the modification to the eVISION Data Management Software. Software Verification and Validation was completed to verify the performance, functionality, and features of eVISION.

### Conclusion:

This submission demonstrates that the modified eVISION Data Management Software is substantially equivalent to Nonin's nVISION Data Management Software (K033307) cleared on 05/06/2004.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol associated with medicine and healthcare.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Nonin Medical, Inc. c/o Ms. Lori M. Roth 13700 1st Ave. North, Plymouth, Minnesota 55441-5443

OCT -1 2009

Re: K092678

Trade/Device Name: eVISION Data Management Software Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: August 31, 2009 Received: September 1, 2009

Dear Ms. Lori:

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 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.

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.

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Ms. Lori M. Roth

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CcntersOffices/CDRH/CDRHOffices/ucm115809.htm 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Malvina B. Eydelman, M.D Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

(092678

510(k) Number (if known)

Device Name

Nonin Medical, Inc. eVISION® Data Management Software

### Indications for Use:

eVISION® Data Management Software (eVISION) is an optional accessory for use with Nonin's Model 7600 Regional Oximeter System. It is intended for use by healthcare professionals when 1) transferring data from the Model 7600 to a computer in order to maintain individual records of regional oximetry data, 2) reviewing data according to userselected parameters, and 3) generating reports.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Zen.

510(k) Number .

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K092678