DIGITAL PULSE OXIMETER, MODEL 7500FO

K071415 · Nonin Medical, Inc. · DQA · Aug 8, 2007 · Cardiovascular

Device Facts

• Record ID: K071415
• Device Name: DIGITAL PULSE OXIMETER, MODEL 7500FO
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nonin® Model 7500FO Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. Testing was performed in MR conditional environments at 1.5T and 3T. It is indicated for spot-checking and / or continuous monitoring of patients who are well or poorly perfused.

Device Story

Portable, tabletop pulse oximeter; designed for MR environments (1.5T and 3T). Uses fiber optic sensors/cables containing no conductive components to measure SpO2 and pulse rate. Device processes optical signals to calculate saturation and pulse; displays values via LED; provides audible/visual alarms for SpO2, pulse rate, and perfusion. Powered by AC adapter or internal rechargeable NiMH battery. Used by clinicians in clinical settings; provides real-time monitoring data to assist in patient assessment and clinical decision-making during MR procedures. Benefits include safe, continuous patient monitoring without interference from or to the MR environment.

Clinical Evidence

Device underwent both bench and clinical testing to demonstrate functional features and substantial equivalence to the predicate. Specific metrics not provided in summary.

Technological Characteristics

Tabletop pulse oximeter; fiber optic sensing technology; non-conductive sensor/cable components for MR compatibility. Powered by 12 VDC AC adapter or 7.2V NiMH rechargeable battery. LED display for SpO2, pulse rate, and alarm status. MR conditional at 1.5T and 3T.

Indications for Use

Indicated for adult, pediatric, and infant patients, including those well or poorly perfused, for spot-checking or continuous monitoring of SpO2 and pulse rate in MR environments (1.5T and 3T).

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

• Model 8604FO Pulse Oximeter and Fiber Optic Sensor (K910001)

Submission Summary (Full Text)

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# SECTION 2. SUMMARY AND CERTIFICATION fight 1 of 2

## A.

| Submitter: | Nonin Medical, Inc. | |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Lori M. Roth<br>Clinical/Regulatory Specialist<br>Nonin Medical, Inc.<br>13700 1st Ave. North<br>Plymouth, MN 55441-5443 | AUG - 8 2007 |
| Date Prepared: | May 18, 2007 | |
| Trade Name: | Model 7500FO Digital Pulse Oximeter | |
| Classification Name:<br>and Number: | Class II, 21 CFR 870.2700 | |
| Product Code: | DQA | |
| Predicate Device(s): | Nonin's Model 7500FO is substantially equivalent to the<br>Model 8604FO Pulse Oximeter and Fiber Optic Sensor<br>manufactured by Nonin Medical, Inc. that was cleared by<br>the FDA under K910001 on 7/1/91. | |
| Device Description: | The Nonin® Model 7500FO Digital Pulse Oximeter is a<br>portable, tabletop device indicated for use in measuring,<br>displaying, and recording functional oxygen saturation of<br>arterial hemoglobin (SpO2) and pulse rate of adult,<br>pediatric, and infant patients in an MR environment.<br>Testing was performed in MR conditional environments at<br>1.5T and 3T. It is indicated for spot-checking and / or<br>continuous monitoring of patients who are well or poorly<br>perfused.<br><br>The Model 7500FO display uses light-emitting diodes<br>(LED) components to present patient's SpO2 and pulse rate<br>values, as well as alarm limit and volume settings. The<br>Model 7500FO can be powered externally with a 12 VDC<br>1.5A AC adapter or with an integral sealed 7.2-volt<br>rechargeable NiMH battery pack.<br><br>The Model 7500FO includes adjustable audible and visual<br>pulse rate, oxygen saturation, and perfusion alarms. It also includes a variety of advanced features, including low | |

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K071415

page 1 of 2

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| | battery alarms, sensor alarm, user defined defaults, real-<br>time data outputs, and patient security mode.<br>Nonin's fiber optic sensors and cables contain no<br>conductive components, they can safely be placed on the<br>patient's finger while inside an MR (magnetic resonance)<br>environment. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Nonin® Model 7500FO Digital Pulse Oximeter is a<br>portable, tabletop device indicated for use in measuring,<br>displaying, and recording functional oxygen saturation of<br>arterial hemoglobin (SpO2) and pulse rate of adult,<br>pediatric, and infant patients in an MR environment.<br>Testing was performed in MR conditional environments at<br>1.5T and 3T. It is indicated for spot-checking and / or<br>continuous monitoring of patients who are well or poorly<br>perfused. |
| Functional and<br>Safety Testing: | Nonin's Model 7500FO Pulse Oximeter and fiber optic<br>sensor have successfully undergone both bench and clinical<br>testing in order to demonstrate that it has appropriate<br>functional features and is substantially equivalent to the<br>predicate device. |
| Conclusion: | Nonin's Model 7500FO is substantially equivalent to the<br>Model 8604FO Pulse Oximeter manufactured by Nonin<br>Medical, Inc. and cleared by the FDA under K910001 on<br>7/01/91. |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circle around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG = 8 2007

Ms. Lori M. Roth Clinical Regulatory Specialist Nonin Medical, Incorporated 13700 15t Avenue North Plymouth, Minnesota 55441-5443

Re: K071415

Trade/Device Name: Model 7500FO Digital Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 18, 2007 Received: May 21, 2007

Dear Ms. Roth:

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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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 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/industry/support/index.html.

Sincerely vours.

Chiu Lin, Ph.D.

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

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# Indications for Use Statement

| 510(K) Number: | K071415 |
|----------------|---------|
|----------------|---------|

Device Name:

### Model 7500FO Digital Pulse Oximeter

#### Indications for Use:

The Nonin® Model 7500FO Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. Testing was performed in MR conditional environments at 1.5T and 3T. It is indicated for spot-checking and / or continuous monitoring of patients who are well or poorly perfused.

~~

ision Sign-Off) (uchnar B.C.) Civision of Anesthesiology, General Hospital, Infection Control, Dental Devices (10(k) Number:

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Nonin Medical Inc.