SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)

K151305 · Nonin Medical, Inc. · MUD · Aug 27, 2015 · Cardiovascular

Device Facts

• Record ID: K151305
• Device Name: SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)
• Applicant: Nonin Medical, Inc.
• Product Code: MUD · Cardiovascular
• Decision Date: Aug 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Model 8203CA The Model 8203CA 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 or pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8203CA 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. Model 8204CA The Model 8204CA 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 8204CA 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.

Device Story

Single-patient use, non-sterile, disposable regional oximetry sensors; used with Nonin Model X-100 or Model 7600 oximetry systems. Sensors utilize optical technology to measure regional hemoglobin oxygen saturation (rSO2) in blood underneath the sensor. Model 8203CA provides trend monitoring; Model 8204CA provides absolute real-time monitoring. Used in OR, surgical recovery, critical care, ER, long-term care, and mobile environments. Operated by clinicians to monitor patient oxygenation status; output displayed on compatible oximetry system monitors. Data assists clinicians in assessing tissue perfusion and oxygenation, potentially guiding clinical interventions to improve patient outcomes.

Clinical Evidence

No new clinical testing performed. Substantial equivalence supported by bench testing (electrical safety, EMC, mechanical durability, biocompatibility) and reliance on clinical data previously provided for predicate devices (K102715) due to unchanged critical sensor optics technology.

Technological Characteristics

Disposable, non-sterile regional oximetry sensors. Biocompatible materials (ISO 10993-1). Optical sensing principle. Compatible with Nonin X-100 and 7600 systems. Standards compliance: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, ISO 14155, ASTM D-4169, ISTA 2A.

Indications for Use

Indicated for adult and pediatric patients > 88 lbs (40 kg) requiring monitoring of regional hemoglobin oxygen saturation (rSO2). Model 8203CA for trend monitoring; Model 8204CA for absolute real-time monitoring.

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 SenSmart Model 8003CA Regional Oximetry Sensor (K102715)
• Nonin SenSmart Model 8004CA Regional Oximetry Sensor (K102715)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES · USA

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

Nonin Medical Inc. Laura Lind Sr. Regulatory Affairs Specialist 13700 1st Avenue North Plymouth, Minnesota 55441

Re: K151305

Trade/Device Name: SenSmart Model 8203CA Regional Oximetry Sensor, SenSmart Model 8204CA Regional Oximetry Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: July 30, 2015 Received: July 31, 2015

Dear Laura Lind:

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.

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

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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 of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mitchell Stein

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known) K151305 - Page 1 of 1

#### Device Name

SenSmart™ Model 8203CA Regional Oximetry Sensor SenSmart™ Model 8204CA Regional Oximetry Sensor

# Indications for Use (Describe)

#### Model 8203CA

The Model 8203CA 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 or pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8203CA sensor without baseline reestablishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.

#### Model 8204CA

The Model 8204CA 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 8204CA 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.

Type of Use (Select one or both, as applicable)

| <div> <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 12px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 5. "510(k) Summary" as required by section 807.92(c)

| Submitter: | Nonin Medical, Inc.<br>13700 1st Ave. North<br>Plymouth, MN 55441-5443 |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone:<br>Fax: | 763-553-9968<br>763-553-7807 |
| Contact Person: | Laura Lind<br>Senior Regulatory Affairs Specialist |
| Date Prepared: | May 15, 2015 |
| Trade Names: | SenSmart™ Model 8203CA Regional Oximetry Sensor<br>SenSmart™ Model 8204CA Regional Oximetry Sensor |
| Common Name:<br>Classification Name:<br>Regulation Number: | Regional oximetry sensor<br>Oximeter, Tissue Saturation<br>Class II, 21 CFR 870.2700 (Oximeter) |
| Product Code, Panel: | MUD, Cardiovascular |
| Predicate Device(s): | The Nonin SenSmart Model 8203CA and Model 8204CA Regional<br>Oximetry Sensors are predicated on the Nonin SenSmart Model<br>8003CA and Model 8004CA Regional Oximetry Sensors cleared<br>under K102715 (December 17, 2010.) |
| Device Description: | The SenSmart Model 8203CA Regional Oximetry Sensor (Model<br>8203CA) and SenSmart Model 8204CA Regional Oximetry<br>Sensor (Model 8204CA) are single-patient use, non-sterile<br>disposable regional (tissue saturation) sensors intended for use<br>with the Nonin Medical Model X-100 SenSmart Regional Oximetry<br>System (Model X-100). The proposed devices are also compatible<br>with the Nonin Model 7600 Regional Oximeter (Model 7600). |
| Intended Use: | Model 8203CA<br>The Model 8203CA single-patient use, non-sterile, disposable<br>sensor is intended for use as an adjunct monitor of trends in<br>regional hemoglobin oxygen saturation of blood underneath the<br>sensor of adult or pediatric patients weighing greater than 88<br>pounds (40 kilograms). The sensor may be repositioned or<br>replaced with another 8203CA sensor without baseline re-<br>establishment. It is intended for use in environments including the<br>operating room, surgical recovery, critical care, emergency room,<br>long-term care, and mobile environments. |

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Image /page/4/Picture/0 description: The image shows the logo for Nonin. The logo consists of an orange geometric shape on the left and the word "NONIN" in blue on the right. The geometric shape is made up of several squares that are nested inside each other. The word "NONIN" is written in a sans-serif font, and the letters are all capitalized.

Image /page/4/Picture/1 description: The image shows three parallelograms of different colors. The first parallelogram is orange, the second is blue, and the third is gray. The parallelograms are arranged side by side.

## Model 8204CA

The Model 8204CA 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 8204CA 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.

Testing: The Nonin Model 8203CA and Model 8204CA sensors are supported by safety, electromagnetic compatibility, device performance, and clinical testing to ensure appropriate functionality and to demonstrate substantial equivalence to the predicate devices. The devices were tested with the Model X-100 system.

## Functional and Safety Testing:

The results of the testing demonstrate equivalency with the predicate devices and compliance to recognized standards. Table 1 summarizes test results for the proposed devices, which met the relevant requirements of the applicable recognized standards.

#### Table 1

| Test | Reference | Result |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------|
| Electrical Safety | IEC 60601-1 | Pass |
| Temperature and Humidity | IEC 60601-1<br>EN 1789 | Pass |
| Atmospheric Pressure (Altitude) | IEC 60601-1 | Pass |
| Electromagnetic Immunity and<br>Emissions | IEC 60601-1-2 | Pass |
| Performance | ISO 80601-2-61<br>IEC 60601-1<br>IEC 60601-1-6; IEC 60601-1-12<br>IEC 62304<br>ANSI/AAMI EC13<br>ISO 14155-1; ISO 14155-2 | Pass |
| Ingress Protection | ISO 80601-2-61 | Pass |
| Diaphoretic related ingress | Internal performance<br>characterization | Pass |
| Mechanical Durability | IEC 60601-1<br>ISO 80601-2-61<br>ISTA 2A<br>ASTM D-4169 | Pass |
| Biocompatibility | ISO 10993-1 | Biocompatible |

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| | rSO2 Accuracy testing: the critical sensor optics technology of<br>the proposed devices remains unchanged from the predicate<br>devices. rSO2 accuracy is demonstrated through detailed device<br>comparison, analysis and testing. |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Clinical testing: the critical sensor optics technology of the<br>proposed devices remains unchanged from the predicate devices.<br>Thus prior clinical testing provided in K102715 is applicable for the<br>proposed Model 8203CA and Model 8204CA sensors. |
| | Testing conclusion: the proposed Model 8203CA and Model<br>8204CA sensors meet all acceptance criteria. Based on test<br>results, analysis and comparison to the legally marketed<br>predicates, the Model 8203CA and Model 8204CA sensors<br>perform equivalently to the predicate sensors for their intended<br>use. |
| Summary of<br>Substantial<br>Equivalence: | The Model 8203CA and Model 8204CA sensors have the<br>following similarities to the predicate devices:<br>Identical indications for use Identical intended use environments Identical patient population Same primary mode of operation Identical critical sensor optics technology Used with the same systems in same manner Perform equivalently to the same specifications Similar construction and materials |
| Conclusion: | No new questions of safety and effectiveness were raised. Based<br>on the results of the above referenced testing, the same critical<br>optics technology, results from safety and performance testing<br>and analysis, and risk management assessment, Nonin Medical<br>has determined that the proposed SenSmart Model 8203CA<br>Regional Oximetry Sensor and SenSmart Model 8204CA<br>Regional Oximetry Sensor are substantially equivalent to the<br>predicate Nonin SenSmart Model 8003CA Regional Oximetry<br>Sensor and SenSmart Model 8004CA Regional Oximetry Sensor |

and the proposed devices are safe for their intended use.

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