DIGITAL PULSE OXIMETER, MODEL 7500

K071285 · Nonin Medical, Inc. · DQA · Jul 12, 2007 · Cardiovascular

Device Facts

• Record ID: K071285
• Device Name: DIGITAL PULSE OXIMETER, MODEL 7500
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jul 12, 2007
• 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 hemoglobin oxygen saturation (SpO2) and pulse rate. Inputs via compatible sensors; processes signals to derive physiological values; displays data via LED indicators. Used in clinical settings for spot-checking or continuous monitoring; operated by healthcare professionals. Features include adjustable audible/visual alarms for SpO2, pulse rate, and perfusion; sensor fault detection (SPIM); patient security mode; real-time data output. Powered by AC adapter or internal rechargeable NiMH battery. Provides clinicians with real-time physiological data to support monitoring and clinical decision-making for patients across all age groups, including those with perfusion challenges or motion.

Clinical Evidence

Human oxygenation evaluations conducted to confirm conformance to accuracy and precision specifications. Bench testing performed to verify functional design and safety. No specific clinical trial metrics (e.g., sensitivity, specificity) provided in the summary.

Technological Characteristics

Tabletop pulse oximeter; LED display; powered by 12 VDC AC adapter or 7.2V NiMH rechargeable battery. Features sensor fault detection (SPIM), adjustable alarms, and real-time data output. Operates via standard pulse oximetry sensing principles.

Indications for Use

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

• Model 2500A Digital Pulse Oximeter (K050056)

Submission Summary (Full Text)

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K071285

## 510(k) Summary

| Submitter:<br>Contact Person: | Nonin Medical, Inc.<br>Lori M. Roth<br>Clinical/Regulatory Specialist<br>Nonin Medical, Inc.<br>13700 1st Ave. N.<br>Plymouth, MN 55441-5443<br>JUL 12 2007 |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | May 4, 2007 |
| Trade Name: | Model 7500 Digital Pulse Oximeter |
| Classification Name:<br>and Number:<br>Product Code: | Oximeter<br>Class II, 21 CFR 870.2700<br>DQA |
| Predicate Device(s): | The predicate device is the Model 2500A Digital Pulse<br>Oximeter, K050056 cleared on June 21, 2005. |
| Device Description: | The Nonin® Model 7500 Digital Pulse Oximeter is a<br>portable, tabletop device indicated for use in<br>measuring, displaying, and recording functional<br>oxygen saturation of arterial hemoglobin (SpO2) and<br>pulse rate of adult, pediatric, infant, and neonatal<br>patients. It is indicated for spot-checking and / or<br>continuous monitoring of patients during both motion<br>and non-motion conditions, and for patients who are<br>well or poorly perfused. |
| | The Model 7500 display uses light-emitting diodes<br>(LED) components to present patient's SpO2 and<br>pulse rate values, as well as alarm limit and volume<br>settings. The Model 7500 can be powered internally<br>with a 12 VDC 1.5A AC adapter or with an integral<br>sealed 7.2-volt rechargeable NiMH battery pack. |
| | The Model 7500 includes adjustable audible and<br>visual pulse rate, oxygen saturation, and perfusion<br>alarms. It also includes a variety of advanced<br>features, including low battery alarms, sensor fault<br>detection (SPIM), user defined defaults, real-time data<br>outputs, and patient security mode. |

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Confidential

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| 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 (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. |
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| Functional and Safety Testing: | Nonin's Model 7500 Digital Pulse Oximeter has successfully undergone both bench and human testing to support the determination of substantial equivalence. Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications. |
| Conclusion: | Nonin's Model 7500 Digital Pulse Oximeter is substantially equivalent to the predicate device in terms of accuracy, functional design and principles of operation. Performance test results do not raise new questions of safety and effectiveness when compared to the legally marketed device. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL 1 2 2007

Re: K071285

Trade/Device Name: Model 7500 Digital Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 12, 2007 Received: June 13, 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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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 (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 yours.

Sybilte Y. Michie Omd.

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:

Device Name:

Model 7500 Digital Pulse Oximeter

## 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 (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.

Prescription Use X (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)

Senyte Y. Michaelons.

(Division Sign-Off) Division of Anesthesic Infection Control, D

510(k) Number: k071285