NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER

K080255 · Nonin Medical, Inc. · DQA · May 23, 2008 · Cardiovascular

Device Facts

• Record ID: K080255
• Device Name: NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: May 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nonin® Model 7500 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, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused.

Device Story

Portable tabletop pulse oximeter; measures functional arterial oxygen saturation (SpO2) and pulse rate. Inputs: optical signals via compatible sensors (e.g., 8000Q2 Ear Clip). Processing: digital signal analysis to derive SpO2 and pulse rate. Outputs: LED display of SpO2, pulse rate, alarm limits, and volume settings. Used in clinical settings for continuous or spot-check monitoring. Features: audible/visual alarms for saturation/pulse/perfusion, low battery alerts, sensor fault detection, and patient security mode. Powered by AC adapter or internal rechargeable NiMH battery. Assists clinicians in patient status assessment and monitoring.

Clinical Evidence

Bench and clinical testing performed to validate the Model 7500 with the 8000Q2 Ear Clip sensor. Testing demonstrated compliance with ISO 9919:2005 (accuracy of operating data) and IEC 60601-1:1998/ISO 10993-1:2003 (biocompatibility).

Technological Characteristics

Tabletop digital pulse oximeter; LED display; powered by 12 VDC AC adapter or 7.2V NiMH rechargeable battery. Connectivity includes real-time data outputs. Biocompatibility per ISO 10993-1:2003. Accuracy per ISO 9919:2005.

Indications for Use

Indicated for adult, pediatric, infant, and neonatal patients requiring spot-check or continuous monitoring of SpO2 and pulse rate. Suitable for patients with motion or non-motion conditions and varying perfusion levels.

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 Model 7500 Digital Pulse Oximeter (K071285)

Submission Summary (Full Text)

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K080255

## 510(k) Summary

MAY 23 2008 Nonin Medical, Inc. Submitter: Lori M. Roth Contact Person: Clinical/Regulatory Specialist Nonin Medical, Inc. 13700 18t Ave. North Plymouth, MN 55441-5443 January 31, 2008 Date Prepared: Model 7500 Digital Pulse Oximeter Trade Name: Classification Name: Class II, 21 CFR 870.2700 and Number: 74 DQA Product Code: Nonin's Model 7500 Digital Pulse Oximeter Predicate Device(s): manufactured by Nonin Medical, Inc., cleared by the FDA under K071285 on 7/12/07. The Nonin® Model 7500 Digital Pulse Oximeter is Device Description: 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, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. The Model 7500 display uses light-emitting diodes (LED) components to present patient's SpO2 and pulse rate values, as well as alarm limit and volume settings. The Model 7500 can be powered internally with a 12 VDC 1.5A AC adapter or with an integral sealed 7.2-volt rechargeable NiMH battery pack. The Model 7500 includes adjustable audible and visual pulse rate, oxygen saturation, and perfusion alarms. It also includes a variety of advanced features, including low battery alarms, sensor fault, user defined defaults, real-time data outputs, and patient security mode.

Model 7500/8000Q2 Sensor Special 510(K): Premarket Notification Confidential

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| Intended Use: | The Nonin® Model 7500 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, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional and Safety Testing: | Nonin's Model 7500 Pulse Oximeter and 8000Q2 Ear Clip sensor have successfully undergone both bench and clinical testing in order to demonstrate that it meets the requirements of ISO 9919:2005 Clause 50 Accuracy of Operating Data, Clause 102 section 102.2 Labeling, and IEC 60601- 1:1998 (ISO 10993-1:2003) Clause 48 Biocompatibility. |
| Conclusion: | The addition of Model 8000Q2 Ear Clip Sensor when used with Nonin's Model 7500 does not raise any new concerns regarding accuracy or risks when used in combination. |

:

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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 stylized eagle-like symbol with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2008

Ms. Lori M. Roth Clinical Regulatory Specialist Nonin Medical, Incorporated 13700 1st Avenue North Plymouth, Minnesota 55441-5443

Re: K080255

Trade/Device Name: Nonin Medical, Inc. Model 7500 Regulation Number: 21CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 23, 2008 Received: April 24, 2008

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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## Page 2 - Ms. Roth

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 (OS) 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.

Suzie Y. Michaels.

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 (if known) | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Nonin Medical, Inc. Model 7500 |
| Indications for Use | The Nonin ^® Model 7500 Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO ₂ ) and pulse rate of adult, pediatric, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K080255