Nasal Alar SpO2 Sensor

K171423 · Xhale, Inc. · DQA · Jul 27, 2017 · Cardiovascular

Device Facts

• Record ID: K171423
• Device Name: Nasal Alar SpO2 Sensor
• Applicant: Xhale, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jul 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nasal Alar SpO2 Sensor is indicated for single patient use for continuously noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients (at least 4 years and older and weighing >15 kg), who are well or poorly perfused. The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision.

Device Story

Disposable, single-patient-use pulse oximetry sensor; attaches to nasal alar region via soft silicone rubber cushions. Uses red (660 nm) and IR (890 nm) LEDs and a silicon photodiode to measure light absorption by arterial blood. Connects via DB-9 cable to compatible pulse oximetry monitors. Operates by spectrophotometric measurement of functional arterial oxygen saturation. Used in clinical environments under professional supervision. Output displayed on compatible monitor; assists clinicians in assessing patient oxygenation status; enables continuous monitoring in patients with poor perfusion.

Clinical Evidence

Controlled desaturation study performed on healthy volunteers per ISO 80601-2-61 across 8 oximetry platforms. Results confirmed SpO2 accuracy within ARMS specification of ±3% for the 70-100% range under steady-state/non-motion conditions. Anthropometric data supported device fit for the expanded pediatric weight range (>15 kg).

Technological Characteristics

Disposable nasal alar sensor; soft silicone rubber cushions for retention; red (660 nm) and IR (890 nm) LEDs; silicon photodiode detector; DB-9 connector. Complies with IEC 60601-1, IEC 60601-1-2 (EMC), and ISO 80601-2-61. Materials tested per ISO 10993-1.

Indications for Use

Indicated for continuous noninvasive monitoring of functional SpO2 and pulse rate in adult and pediatric patients (≥4 years old, >15 kg) who are well or poorly perfused. Used in healthcare environments under professional supervision.

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

• Xhale Assurance™ Alar / Nasal SpO2 sensor (K143216)

Reference Devices

• Xhale Assurance™ Alar / Nasal SpO2 (K122996)

Submission Summary (Full Text)

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Public Health Service

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July 27, 2017

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

% Paul Dryden Consultant ProMedic, LLC 24301 Woodsage Dr. Bonita Springs, Florida 34134

Re: K171423

Xhale, Inc.

Trade/Device Name: Nasal Alar SpO2 Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: May 11, 2017 Received: May 15, 2017

Dear Paul Dryden:

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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (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.

# Mark S. Fellman -S

for

Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

# K171423

Device Name

# Nasal Alar SpO2 Sensor

Indications for Use (Describe)

The Nasal Alar SpO2 Sensor is indicated for single patient use for continuously noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients (at least 4 years and older and weighing >15 kg), who are well or poorly The sensor can be used in a variety of healthcare environments where compatible pulse perfused. oximetry monitors are indicated for use, under professional supervision.

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|----------------------------------------------------------|--|
|----------------------------------------------------------|--|

XX Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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| Date Prepared: | 25-Jul-17 |
|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Xhale, Inc.<br>3630 SW 47th Ave, Suite 100<br>Gainesville, FL 32608<br>Phone: [phone]<br>Fax: [phone] | |
| Official Contact: | Jeffrey Hoebelheinrich<br>Director of Quality and Regulatory Affairs |
| Proprietary or Trade Name: | Nasal Alar SpO2 Sensor |
| Common/Usual Name: | Oximeter (Accessory - sensor) |
| Classification Name: | Oximeter<br>Product Classification – DQA<br>21 CFR 870.2700<br>Class II |
| Predicate Device: | K143216 - Xhale Assurance™ Alar / Nasal SpO2 sensor |

#### Device Description:

Xhale is seeking an expansion of indications to change patient population from a weight of >30 kg to at least 4 years and older and >15 kg.

The Nasal Alar SpO2 Sensor itself is unchanged and identical to that submitted in K143216.

The Nasal Alar SpO2 Sensor is a disposable, single patient use Pulse Oximetry sensor designed to attach to the patient's nasal alar region - the fleshy region at the side of the nose. Skin contact and adhesive free sensor retention is via soft silicone rubber cushions encapsulating the optical components. The Nasal Alar SpO2 Sensor with its associated patient cable terminates in a DB-9 connector compatible with monitors employing Nellcor SpO2 technology.

The sensor utilizes red and IR LED light sources of 660 nm and 890 nm respectively along with a silicon photodiode detector to detect changes in oxygen saturation in the blood. Since oxygen saturated blood absorbs different amounts of light at each wavelength (red and infrared) as compared with unsaturated blood, the amount of light absorbed at each wavelength by the blood in each pulse can be used to calculate oxygen saturation.

# Indications for Use:

The Nasal Alar SpO2 Sensor is indicated for single patient use for continuously noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpQ2) and pulse rate from the nasal ala of adult and pediatric patients (at least 4 years and older and weighing >15 kg), who are well or poorly perfused. The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision.

# Comparison to Predicate

The following table compares the predicate.

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| Attribute | Xhale<br>Assurance™ Alar / Nasal<br>SpO2 Sensor<br>510(k) K143216 | Proposed Xhale<br>Nasal Alar SpO2 Sensor | Differences |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Indications for Use | The Assurance™ Alar / Nasal<br>SpO2 Sensor is indicated for<br>single patient use for<br>continuously noninvasive<br>monitoring of functional oxygen<br>saturation of arterial hemoglobin<br>(SpO2) and pulse rate from the<br>nasal ala of adult and pediatric<br>patients (weighing ≥30 kg), who<br>are well or poorly perfused. The<br>sensor can be used in a variety<br>of healthcare environments<br>where compatible pulse<br>oximetry monitors are indicated<br>for use, under professional<br>supervision. | The Nasal Alar SpO2 Sensor is<br>indicated for single patient use<br>for continuously noninvasive<br>monitoring of functional oxygen<br>saturation of arterial hemoglobin<br>(SpO2) and pulse rate from the<br>nasal ala of adult and pediatric<br>patients (at least 4 years and<br>older and weighing ≥15 kg ),<br>who are well or poorly perfused.<br>The sensor can be used in a<br>variety of healthcare<br>environments where compatible<br>pulse oximetry monitors are<br>indicated for use, under<br>professional supervision. | Changed minimum<br>patient age to 4 years<br>and older and weight<br>to ≥15 kg |
| Environments of use | variety of healthcare<br>environments where compatible<br>pulse oximetry monitors are<br>indicated for use, under<br>professional supervision | variety of healthcare<br>environments where compatible<br>pulse oximetry monitors are<br>indicated for use, under<br>professional supervision. | Identical |
| Patient population | adult and pediatric patients<br>(weighing ≥30 kg) | adult and pediatric patients (at<br>least 4 years and older and<br>weighing ≥15 kg ) | Changed minimum<br>patient age to 4 years<br>and older and weight<br>to ≥15 kg |
| Single patient use | Yes | Yes | Identical |
| Principle of<br>Operation | Spectrophotometric<br>measurement of functional<br>arterial oxygen saturation by<br>transmissive mode pulse<br>oximetry | Spectrophotometric<br>measurement of functional<br>arterial oxygen saturation by<br>transmissive mode pulse<br>oximetry | Identical |
| LEDS | Red (~660 nm) and IR (~880<br>nm) | Red (~660 nm) and IR (~880<br>nm) | Identical |
| Detector | Photodiode | Photodiode | Identical |
| Connector | 9 pin DB-9 style | 9 pin DB-9 style | Identical |

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| Attribute | Xhale<br>Assurance™ Alar / Nasal<br>SpO2 Sensor<br>510(k) K143216 | Proposed Xhale<br>Nasal Alar SpO2 Sensor | Differences |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Performance Testing - Clinical and Non-clinical | | | |
| Patient Contact<br>Materials<br>Classification | Materials in the gas pathway<br>External Communicating<br>Tissue<br>Prolonged duration<br><br>Materials in direct patient<br>contact<br>Surface Contact<br>Mucosal<br>Prolonged duration | Materials in the gas pathway<br>External Communicating<br>Tissue<br>Prolonged duration<br><br>Materials in direct patient<br>contact<br>Surface Contact<br>Mucosal<br>Prolonged duration | Identical |
| SpO2 Accuracy<br>(ARMS)* | 70-100% $\u00b1$ 3%* | 70-100% $\u00b1$ 3%* | Identical |
| BPM | 30-240 bpm $\u00b1$ 3 bpm | 30-240 bpm $\u00b1$ 3 bpm | Identical |
| IEC 60601-1 | Yes | Yes | Identical |
| IEC 60601-1-2 | EMC | EMC | Identical |
| ISO 80601-2-61 | Mechanical strength<br>Storage and Operating<br>Temperature and humidity<br>Fluid ingress | Mechanical strength<br>Storage and Operating<br>Temperature and humidity<br>Fluid ingress | Identical |
| Pulse rate accuracy | Yes | Yes | Identical |
| Inter-device<br>reliability and<br>accuracy | Yes | Yes | Identical |

# Substantial Equivalence Discussion

The table above compares the key features of the proposed Nasal Alar SpO2 Sensor as compared to the predicate Xhale Assurance™ Alar / Nasal SpO2 Sensor (K143216). In summary one can conclude that substantial equivalence is met based upon the following:

Indications for Use – The indications for use are similar for the proposed device when compared to the predicate - K143216 - Xhale Assurance™ Alar / Nasal SpO2 sensor. Discussion - Each device is indicated for use as a pulse oximeter sensor. The proposed change is for patient population and not for use as a pulse oximeter sensor. It is noted that the devices to which the sensors are attached have been cleared for use with the proposed patient population.

Technology and construction - The technology is identical to the predicates K143216- Xhale Assurance™ Alar / Nasal SpO2 sensor. The basic design, fabrication, constructions and materials are identical to the predicate K143216 - Xhale Assurance™ Alar / Nasal SpO2 sensor. Discussion - The basic design, fabrication, constructions and materials are identical to the predicate K143216 - Xhale Assurance™ Alar / Nasal SpO2 sensor.

Patient Population - The patient population is similar to the predicate K143216 - Xhale Assurance™ Alar / Nasal SpO2 sensor.

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Discussion - The patient population has been reduced from >30 kg to at least 4 years and older and weighing >15 kg. The reduction in patient weight does not impact clinical performance of the device. Please see Clinical Testing section for support of change in patient population.

Environment of Use - The environments of use are identical to the predicate K143216 - Xhale Assurance™ Alar / Nasal SpO2 sensor. Discussion - Both devices are used in the identical settings.

# Non-Clinical Testing Summary -

Pulse Rate Accuracy, Inter-device reliability and accuracy, Skin Temperature - These specifications have not changed.

Discussion - The performance is identical to the predicate device, K143216 - Xhale Assurance™ Alar / Nasal SpO2 sensor.

Materials – The materials were tested per ISO 10993-1 for the submission K122996 and we have not changed the materials.

Discussion - The materials are identical to the reference K122996 - Xhale Assurance™ A1ar / Nasal SpO2.

### Clinical Testing

We performed a controlled desaturation study with healthy volunteers per ISO 80601-2-61 and the results across the 8 oximetry platforms showed that the SpO2 was within ARMs specification of 3 under steady state / non-motion conditions for the range of 70-100%.

We reviewed published anthropometric data to also support the fit of the subject device in the nostril. The data supported weight as a predictor of morphologic measurements. This data plus the acceptance of adult hypoxemic testing for patient as young as 4 years old were used to determine the new population.

Discussion - The clinical testing demonstrated that the performance is substantially equivalent to the predicate K143216 - Xhale Assurance™ Alar / Nasal SpO2 sensor. ISO 80601-2-61 allows for an ARMS range of up to + 3% across the range of 70-100%. As the subject device is placed at the nasal alar, we included a weight limitation.

# Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.