NVISION DATA MANAGEMENT SOFTWARE

K033307 · Nonin Medical, Inc. · DQA · May 6, 2004 · Cardiovascular

Device Facts

• Record ID: K033307
• Device Name: NVISION DATA MANAGEMENT SOFTWARE
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: May 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

nVISION® Data Management Software (nVISION) is an optional accessory for compatible Nonin oximeters with memory playback. nVISION® software is indicated for use with the following Nonin oximeters: 9700, 3100, 9600, 2120, 2500, 8500, 8600, 8800, and 9840. It is intended for use by healthcare professionals when (1) transferring data from pulse oximeters to computers in order to maintain individual records of pulse oximetry data, (2) reviewing that data according to user-selected parameters, and (3) generating reports.

Device Story

nVISION Data Management Software functions as an accessory for Nonin pulse oximeters with memory playback. It runs on a personal computer to download, store, and display oximetry data. Healthcare professionals use the software to review data based on user-selected parameters and generate reports for clinical interpretation. The software does not provide automated diagnoses or treatment suggestions; it serves as an adjunct tool for record-keeping and data visualization. The clinician remains responsible for all data analysis and clinical decision-making.

Clinical Evidence

Bench testing only. Representative software samples underwent performance testing to demonstrate appropriate functional characteristics.

Technological Characteristics

PC-based software for data management and graphical display of pulse oximetry data. Compatible with specific Nonin oximeter models (9700, 3100, 9600, 2120, 2500, 8500, 8600, 8800, 9840).

Indications for Use

Indicated for use by healthcare professionals to manage pulse oximetry data from compatible Nonin oximeters (models 9700, 3100, 9600, 2120, 2500, 8500, 8600, 8800, 9840).

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

• Respironics' Profox Software (K001708)
• Nellcor's Score Software (K961450)

Submission Summary (Full Text)

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

# MAY - 6 2004

.

KA33307

## SECTION 2. Summary and Certification

#### A. 510(K) Summary

-----

| Submitter: | Nonin Medical, Inc. |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John R. Dalpee<br>Director of Regulatory Affairs<br>Nonin Medical, Inc.<br>2605 Fernbrook Lane N.<br>Plymouth, MN 55447<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | 10 October, 03 |
| Trade Name: | nVISION® Data Management Software (K033307). Class II, 21<br>CRF 870.2700. |
| Classification Name<br>And Number: | Pulse Oximeter Data Management Software |
| Product Code: | DQA |
| Predicate Devices: | nVISION® Data Management Software is substantially equivalent<br>to Respironics' Profox Software (K001708) and Nellcor's Score<br>Software (K961450). |
| Device Description: | nVISION® Data Management Software (nVISION) is an optional<br>accessory for compatible Nonin oximeters with memory playback.<br>nVISION® software is indicated for use with the following Nonin<br>oximeters: 9700, 3100, 9600, 2120, 2500, 8500, 8600, 8800, and<br>9840. nVISION® software runs on a personal computer and<br>provides a graphical display of downloaded oximetry data for<br>review and interpretation by a clinician. This software also allows<br>oximetry data and patient information to be saved in a "library" for<br>future retrieval and analysis. The healthcare professional using<br>nVISION® software is solely responsible for selecting the analysis<br>criteria used to calculate summary statistics included in the reports.<br>nVISION® software is an adjunct system requiring human<br>interpretation of results; it does not suggest a course of treatment or<br>generate a diagnosis. |

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

| Intended Use: | nVISION® Data Management Software (nVISION) is an optional<br>accessory for compatible Nonin oximeters with memory playback.<br>nVISION® software is indicated for use with the following Nonin<br>oximeters: 9700, 3100, 9600, 2120, 2500, 8500, 8600, 8800, and<br>9840. It is intended for use by healthcare professionals when (1)<br>transferring data from pulse oximeters to computers in order to<br>maintain individual records of pulse oximetry data, (2) reviewing<br>that data according to user-selected parameters, and (3) generating<br>reports. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional and<br>Safety Testing: | Representative samples of nVISION® software successfully<br>underwent performance testing to demonstrate appropriate<br>functional characteristics. |
| Conclusion: | nVISION® Data Management Software is substantially equivalent<br>to Respironics' Profox Software (K001708) and Nellcor's Score<br>Software (K961450).<br><br>This conclusion is based on the fact that nVISION® software is<br>equivalent to the predicate devices in terms of functional design,<br>indications for use, principles of operation, software platform, and<br>hardware requirements. |

:

:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

--(

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

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a bird or a stylized human figure.

MAY - 6 2004

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

John R. Dalpee Director of Regulatory Affairs Nonin Medical, Incoporated 2605 Fernbrook Lane, North Minneapolis, MN 55447-4755

Re: K033307

Trade/Device Name: nVision Data Management Software Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: March 12, 2004 Received: March 15, 2004

Dear Mr. Dalpee:

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.

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); good manufacturing practice requirements as set forth in the quality

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

Page 2 - John R. Dalpee

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Office of Compliance at [phone]. 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Qul

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications For Use Page

510(K) Number : 033307

Device Name: nVISION® Data Management Software

## Indications for Use:

nVISION® Data Management Software (nVISION) is an optional accessory for compatible Nonin oximeters with memory playback. nVISION Is Indicated for use with the following Nonin oximeters: 9700, 3100, 9600, 2120, 2500, 8500, 8600, 8800, and 9840. It is intended for use by healthcare professionals when (1) transferring data from pulse oximeters to computers in order to maintain Individual records of pulse oximetry data, (2) reviewing that data according to user-selected parameters, and (3) generating reports.

Prescription Use
(Part 21 CFR 801 Subpart D)

And/Or

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cain Taylor

(Division Sigh-Off) Division of Anesthealology, General Hospital, Infection Control, Dental Devices

510(k) Number: