REGIONAL OXIMETER

K102715 · Nonin Medical, Inc. · MUD · Dec 17, 2010 · Cardiovascular

Device Facts

• Record ID: K102715
• Device Name: REGIONAL OXIMETER
• Applicant: Nonin Medical, Inc.
• Product Code: MUD · Cardiovascular
• Decision Date: Dec 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Model 7600 Regional Oximeter System: Nonin's non-invasive Model 7600 4-Channel Regional Oximeter System is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments. Model 8004CA Regional Sensor: The 8004CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8004CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, longterm care and mobile environments. Model 8000CA Regional Oximeter Sensor: The 8000CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8000CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, longterm care and mobile environments.

Device Story

System monitors mixed arterial/venous blood oxygen levels via non-invasive near-infrared spectroscopy (NIRS). Comprised of disposable sensors (8004CA/8000CA), patient oximetry device (pod), and 4-channel display unit. Sensors emit light (700-900 nm) and measure returning light via photodiodes; pod calculates absorption values and rSO2 saturation. Display unit provides real-time numeric data and trend lines with audio/visual alarms. Bluetooth module enables data output. Used by clinicians in hospital/mobile environments to monitor regional oxygenation; output aids clinical decision-making regarding patient perfusion and oxygen status.

Clinical Evidence

The device underwent extensive performance, electromagnetic, safety, and clinical testing. No specific clinical trial metrics (e.g., sensitivity, specificity) are detailed in the provided summary, but testing confirmed substantial equivalence to predicate devices.

Technological Characteristics

NIRS-based regional oximeter; sensors measure light absorption at 700-900 nm. System includes disposable sensors, patient oximetry pod, and 4-channel display unit. Battery-backed, mains-powered. Connectivity via Bluetooth. Software-controlled signal processing.

Indications for Use

Indicated for adult and pediatric patients >40 kg requiring spot-check or continuous monitoring of regional hemoglobin oxygen saturation (rSO2) in clinical settings including OR, recovery, critical care, ER, long-term care, and mobile environments.

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 Medical, Model 7600 Regional Oximeter System (K090807)
• CAS Medical, Fore-Sight® Cerebral Oximeter MC-2000 (K091452)
• Somanetics Corporation, INVOS® Model 5100B Adult/Pediatric Cerebral Oximeter (K051274)

Submission Summary (Full Text)

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K102715

## SECTION 2. SUMMARY AND CERTIFICATION

.

| DEC | | 2010 |
|-----|--|------|
|-----|--|------|

| A. 510(k) Summary | DEC 17 2010 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Nonin Medical, Inc. |
| Contact Person: | Lori M. Mitchell RN, BSN<br>Clinical/Regulatory Specialist<br>Nonin Medical, Inc.<br>13700 1st Ave. North<br>Plymouth, MN 55441-5443 |
| Date Prepared: | September 17, 2010 |
| Trade Name: | Model 7600 Regional Oximeter with Equanox™<br>Technology and Bluetooth® Wireless Technology and<br>compatible Regional Sensors (Models 8004CA and<br>8000CA) |
| Classification Name:<br>and Number: | Class II, 21 CFR 870.2700 |
| Product Code: | MUD |
| Predicate Device(s): | Nonin's Model 7600 4-Channel Regional Oximeter with<br>Equanox™ Technology and Bluetooth® Wireless<br>Technology and compatible Regional Sensors (Models<br>8004CA and 8000CA) are substantially equivalent to the<br>Nonin Medical, Model 7600 Regional Oximeter System<br>(K090807), CAS Medical, Fore-Sight® Cerebral Oximeter<br>MC-2000 (K091452), Somanetics Corporation, INVOS®<br>Model 5100B Adult/Pediatric Cerebral Oximeter<br>(K051274). |
| Device Description: | Nonin's® Model 7600 4-Channel Regional Oximeter<br>System with Equanox™ Technology and Bluetooth®<br>Wireless Technology and compatible sensors (8004CA,<br>8000CA) continuously monitor and record the mixed<br>arterial/venous blood oxygen levels through non-invasive<br>near-infrared spectroscopy sensors.<br>The system is comprised of three subsystems; sensor,<br>patient oximetry device (pod) and 4-channel display unit. |

Nonin Medical Inc.

Model 7600 4-Channel Regional Oximeter System Traditional 510(K): Premarket Notification

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The sensor allows light absorption measurements at various wavelengths in the near-infrared spectrum (approximately 700 to 900 nanometers). The sensor is approximately 1.5 by 3 inches.

The sensors plug into the patient oximetry device (pod) which controls the light emitted from the sensor LEDs and measures the light returning to the sensor photodiodes. From these measurements, the pod determines specific absorption values and calculates the mixed arterial/venous oxygen saturation values. The pods then communicate the regional oxygen saturation readings and other data to the display unit.

The 4-channel display unit displays absolute real-time regional hemoglobin oxygen saturation (rSO2) numeric data and trend lines. It is a battery-backed, mains powered device equipped with audio and visual alarm indicators. Real-time data and playback output is accomplished through a Bluetooth transceiver module.

Model 7600 4-Channel Regional Oximeter System:

Nonin's non-invasive Model 7600 4-Channel Regional Oximeter System is intended for use as an absolute realtime adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (>40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

## Model 8004CA Regional Sensor:

The 8004CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8004CA sensor without baseline re-establishment. It is intended for use in environments including the operating

# Intended Use:

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room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

Model 8000CA Regional Sensor:

The 8000CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8000CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

## Functional and Safety Testing:

Nonin's Model 7600 4-Channel Regional Oximeter with Equanox™ Technology and Bluetooth® Wireless Technology and compatible Regional Sensors (Models 8004CA and 8000CA) have successfully undergone extensive performance, electromagnetic, safety, clinical, environmental, and software testing to ensure that it has appropriate functional features and is substantially equivalent to the predicate devices.

Conclusion: Nonin's Model 7600 4-Channel Regional Oximeter with Equanox™ Technology and Bluetooth® Wireless Technology and compatible Regional Sensors (Models 8004CA and 8000CA) are substantially equivalent to the Nonin Medical, Model 7600 Regional Oximeter System (K090807), CAS Medical, Fore-Sight® Cerebral Oximeter MC-2000 (K091452), Somanetics Corporation, INVOS® Model 5100B Adult/Pediatric Cerebral Oximeter (K051274).

Nonin Medical Inc.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

DEC 1 7 2010

Re: K102715

Trade/Device Name: Nonin Medical, Inc. Model 7600 4-Channel Regional Oximeter. With Equanox " Technology and Bluetooth Wireless Technology and Compatible Regional Sensors (Models 8004CA and 80000CA) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: MUD Dated: September 17, 2010 Received: September 20, 2010

Dear Ms. Mitchell:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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## Page 2- Ms. Mitchell

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

um d. Rosas
for

Anthony D. Watson, B.S., M.S., M.B.A. 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

102715

510(K) Number:

Device Name:

Nonin Medical, Inc. Model 7600 4-Channel Regional Oximeter with Equanox™ Technology and Bluetooth® Wireless Technology and compatible Regional Sensors (Models 8004CA and 8000CA)

Indications for Use:

### Model 7600 Regional Oximeter System:

Nonin's non-invasive Model 7600 4-Channel Regional Oximeter System is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

### Model 8004CA Regional Sensor:

The 8004CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8004CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, longterm care and mobile environments.

### Model 8000CA Regional Oximeter Sensor:

The 8000CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8000CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, longterm care and mobile environments.

| Prescription Use | _X_ |
|-----------------------------|-------------------|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR 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 Evanianos (RBB) ov. General Hospital |
|--------------------|------------------------------------------------------------------------------------------------------------------|
| Nonin Medical Inc. | Infection Control, Dental Devices<br>Model 7600 4-Channel Regional Oximeter System Traditional 510(K): Premarket |
| | Notification<br>510/k) Number: .<br>3 |
| | |