Assurance Alar / Nasal SpO2 Sensor

K143216 · Xhale, Inc. · DQA · Mar 17, 2015 · Cardiovascular

Device Facts

• Record ID: K143216
• Device Name: Assurance Alar / Nasal SpO2 Sensor
• Applicant: Xhale, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Assurance™ 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 (weighing > 30kg), 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 pulse oximetry sensor; attaches to nasal ala using soft silicone rubber cushions. Inputs: red (660 nm) and infrared (880 nm) light transmitted through tissue; detected by silicon photodiode. Principle: spectrophotometric measurement of light absorption by oxygenated vs. deoxygenated blood. Output: SpO2 and pulse rate data transmitted via DB-9 connector to compatible pulse oximetry monitors. Used in clinical healthcare environments under professional supervision. Healthcare providers view output on monitor screen to assess patient oxygenation status and heart rate; aids in clinical decision-making regarding respiratory support or patient stability. Benefits: provides continuous, noninvasive monitoring for patients where traditional finger sensors may be unsuitable or poorly perfused.

Clinical Evidence

Controlled desaturation study conducted on healthy volunteers per ISO 80601-2-61. Performance evaluated across 8 different oximetry platforms. Primary endpoint: SpO2 accuracy (ARMS) in the 70-100% range under steady-state/non-motion conditions. Results showed ARMS values ranging from 1.5 to 2.2 across platforms, meeting the specification of ≤ 3%.

Technological Characteristics

Disposable nasal/alar sensor; silicone rubber cushions; red (660 nm) and IR (880 nm) LEDs; silicon photodiode detector. Connects via DB-9 connector. Complies with IEC 60601-1, IEC 60601-1-2 (EMC), and ISO 80601-2-61 (mechanical strength, fluid ingress, temperature). Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for single patient use for continuous noninvasive monitoring of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate in adult and pediatric patients weighing > 30kg, including well or poorly perfused patients, 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™ Aral SpO2 sensor (K122996)
• Nellcor OxiMax sensors (K060576)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

March 17, 2015

Xhale Inc. c/o Mr. Paul Dryden Regulatory Consultant 3630 SW 47th Avenue, Suite 100 Gainesville, FL 32608

Re: K143216

Trade/Device Name: Assurance™ Alar / Nasal SpO2 Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: February 12, 2015 Received: February 13, 2015

### Dear Mr. 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.

{1}------------------------------------------------

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 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/Resourcesfor You/Industry/default.htm. 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 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K143216

Device Name

# Assurance™ Nasal / Alar SpO2 Sensor

#### Indications for Use (Describe)

The Assurance™ 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 (weighing > 30kg), 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.

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

XX Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

{3}------------------------------------------------

### 510(k) Summary Page 1 of 6

| Date Prepared: | 16-Mar-15 |
|----------------------------|---------------------------------------------|
| | Xhale, Inc. |
| | 3630 SW 47th Ave, Suite 100 |
| | Gainesville, FL 32608 |
| | Phone: [phone] |
| | Fax: [phone] |
| Official Contact: | Jeffrey Hoebelheinrich |
| | Director of Quality and Regulatory Affairs |
| Proprietary or Trade Name: | Assurance™ Alar / Nasal SpO2 Sensor |
| Common/Usual Name: | Oximeter (Accessory – sensor) |
| Classification Name: | Oximeter |
| | Product Classification – DQA |
| | 21 CFR 870.2700 |
| | Class II |
| Predicate Devices: | K122996 – Xhale Assurance™ Aral SpO2 sensor |
| | K060576- Nellcor OxiMax sensors |

### Device Description:

The Alar / Nasal 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 Alar / Nasal 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 880 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 Assurance™ Nasal / Alar SpO2 Sensor is indicated for single patient use for continuously noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate from the nasal ala of adult and pediatric patients (weighing > 30kg), 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 Predicates

The following table compares the predicates.

{4}------------------------------------------------

# 510(k) Summary

| Attribute | Xhale<br>Alar SpO2 sensor<br>K122996 | Nellcor<br>OxiMax Sensors<br>K060576 | Proposed Xhale<br>Alar / Nasal SpO2 Sensor |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Assurance™ Alar SpO2 Sensor is<br>indicated for single patient use for<br>continuously noninvasive monitoring of<br>functional oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse rate from<br>the nasal ala of adult and pediatric<br>patients (weighing > 30kg), who are well<br>or poorly perfused. The sensor can be<br>used in a variety of healthcare<br>environments where compatible pulse<br>oximetry monitors are indicated for use,<br>under professional supervision. | Indicated for single patient use for<br>continuously noninvasive monitoring of<br>functional oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse rate.<br><br>Neonate, pediatric, and adult who are<br>well or poorly perfused, in hospitals,<br>hospital-type facilities, intra-hospital<br>transport, and home environments. | The Assurance™ Nasal / Alar SpO2 Sensor<br>is indicated for single patient use for<br>continuously noninvasive monitoring of<br>functional oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse rate from the<br>nasal ala of adult and pediatric patients<br>(weighing > 30kg), who are well<br>or poorly perfused. The sensor can be<br>used in a variety of healthcare<br>environments where compatible pulse<br>oximetry monitors are indicated for use,<br>under professional supervision. |
| Environments of use | variety of healthcare environments<br>where compatible pulse oximetry<br>monitors are indicated for use, under<br>professional supervision | hospitals, hospital-type facilities,<br>intra-hospital transport, and home<br>environments | variety of healthcare environments where<br>compatible pulse oximetry monitors are<br>indicated for use, under professional<br>supervision |
| Patient population | adult and pediatric patients (weighing ><br>30kg) | Neonate, pediatric, and adult | adult and pediatric patients (weighing ><br>30kg) |
| Single patient use | Yes | Yes | Yes |
| Technology, Features and Specifications | | | |
| Principle of Operation | Spectrophotometric measurement of<br>functional arterial oxygen saturation by<br>transmissive mode pulse oximetry | Spectrophotometric measurement of<br>functional arterial oxygen saturation by<br>transmissive mode pulse oximetry | Spectrophotometric measurement of<br>functional arterial oxygen saturation by<br>transmissive mode pulse oximetry |
| LEDS | Red (~660 nm) and IR (~880 nm) | Red (~660 nm) and IR (~880 nm) | Red (~660 nm) and IR (~880 nm) |
| Detector | Photodiode | Photodiode | Photodiode |
| Connector | 9 pin DB-9 style | 9 pin DB-9 style | 9 pin DB-9 style |

{5}------------------------------------------------

# 510(k) Summary

| Attribute | Xhale<br>Alar SpO2 sensor<br>K122996 | Nellcor<br>OxiMax Sensors<br>K060576 | Proposed Xhale<br>Alar / Nasal SpO2 Sensor |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing - Clinical and Non-clinical | | | |
| Patient Contact Materials<br>Classification | Materials in the gas pathway<br>External Communicating<br>Tissue<br>Prolonged duration<br><br>Materials in direct patient 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 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 contact<br>Surface Contact<br>Mucosal<br>Prolonged duration |
| SpO2 Accuracy ( $A_{RMS}$ )* | 70-100% ± 2% | 70-100% ± 2% | 70-100% ± 3% |
| BPM | 30-250 bpm ± 3 bpm | 20-250 bpm ± 3 bpm | 30-240 bpm ± 3 bpm |
| IEC 60601-1 | Yes | - | Yes |
| IEC 60601-1-2 | EMC | - | EMC |
| ISO 80601-2-61 | Mechanical strength<br>Storage and Operating Temperature and<br>humidity<br>Fluid ingress | - | Mechanical strength<br>Storage and Operating Temperature<br>and humidity<br>Fluid ingress |
| Pulse rate accuracy | Yes | - | Yes |
| Inter-device reliability and<br>accuracy | Yes | - | Yes |

{6}------------------------------------------------

## 510(k) Summary Page 4 of 6 16-Mar-15

## Substantial Equivalence Discussion

The table above compares the key features of the proposed Assurance™ Alar / Nasal SpO2 Sensor as compared to the predicate Xhale Assurance™ Alar SpO2 Sensor (K122996) and the predicate Nellcor OxiMax Sensor (K060576).

## Discussion of Differences:

The differences between the proposed Alar / Nasal SpO- Sensor and the predicate Alar Sensor (K122996):

- · The Alar / Nasal SpO2 Sensor has 1 (one) wire connecting the sensor to the DB-9 connector.
- The predicate device had a separate AB-N Adaptor Cable that was necessary to o connect to a DB-9 port.
- The proposed Alar / Nasal SpO2 Sensor removed the need for the additional o adaptor by direct connection of the sensor assembly to the cable with a DB-9 connector.
- The proposed Alar / Nasal SpO2 Sensor has a PCB with embedded software that is ● directly connected to the DB-9 connector.
- This allows the sensor to communicate with the compatible pulse oximetry o equipment and display the SpO2 and heart rate data on the screen.
- Pulse Rate Accuracy - Testing was performed for the accuracy of pulse rate over the range from 30-240 bpm using a SpO2 simulator the results were identical pulse rate accuracy within + 3 bpm over the tested range. We tested 30-240 bpm when the predicate Alar (K122996) was tested at 30-250 bpm. This test method difference is not significant as long as it is disclosed in the labeling and is equivalent to the predicate K122996 - Xhale Assurance™ Alar SpO2 sensor.

Discussion - These differences can be viewed as substantially equivalent and do not raise any new safety or effectiveness concerns when compared to the predicate K122996 - Xhale Assurance™ Alar SpO2 sensor.

In summary one can conclude that substantial equivalence is met based upon the following:

Indications for Use – The indications for use are identical for the proposed device when compared to the predicate - K122996 - Xhale Assurance™ Alar SpO2 sensor. Discussion - Each device is indicated for use as a pulse oximeter sensor.

Technology and construction - The technology is identical to the predicate K122996 - Xhale Assurance™ Alar SpO2 sensor. The basic design, fabrication, constructions and materials are identical to the predicate K122996 - Xhale Assurance™ Alar SpO2 sensor. Discussion - The basic design, fabrication, constructions and materials are identical to the predicate K122996 - Xhale Assurance™ Alar SpO2 sensor.

Patient Population - The patient population is identical to the predicate K122996 - Xhale Assurance™ Alar SpO2 sensor.

Discussion - The patient population is identical - predicate and adults > 30kg.

{7}------------------------------------------------

## 510(k) Summary Page 5 of 6 16-Mar-15

Environment of Use - The environments of use are identical to the predicate K122996 - Xhale Assurance™ Alar SpO2 sensor. Discussion - Both devices are used in the identical settings.

### Non-Clinical Testing Summary -

Pulse Rate Accuracy - Testing was performed for the accuracy of pulse rate over the range from 30-240 bpm using a SpO2 simulator the results were identical pulse rate accuracy within + 3 bpm over the tested range.

Discussion - The Pulse Rate Accuracy is equivalent to the predicate K122996 - Xhale Assurance™ Alar SpO2 sensor.

Inter-device reliability and accuracy - Testing of the sensor across a range of test conditions and the testing showed the pulse rate to be within + 3 bpm over the range.

Discussion - The inter-device reliability and accuracy is identical to the predicates K122996 -Xhale Assurance™ Alar SpO2 sensor and K060576 - Nellcor OxiMax sensor.

Skin Temperature - Per ISO 80601-2-61 the maximum temperature limit is 41°C. Testing showed that corrected for 35°C the proposed sensor did not exceed this limit. Results ranged from 34.3 to 39.1℃.

Discussion - The results are substantially equivalent to the predicates s K122996 – Xhale Assurance™ Alar SpO2 sensor and K060576 - Nellcor OxiMax 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 predicate K122996 - Xhale Assurance™M Alar 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%

Discussion - The clinical testing demonstrated that the performance is substantially equivalent to the predicates K122996 - Xhale Assurance™ Alar SpO2 sensor and K060576 - Nellcor OxiMax sensor. ISO 80601-2-61 allows for an ARMS range of up to + 3% across the range of 70-100%.

| Xhale Assurance A1x sensor with<br>model tested | Arms SpO2<br>70-100% |
|-------------------------------------------------|----------------------|
| Nellcor N-600x | 1.8 (257 pts) |
| Philips Intellivue A04 | 1.5 (257 pts) |
| Nellcor N-595 | 2.1 (258 pts) |
| Philips Intellivue A02 | 2.2 (258 pts) |
| Nellcor N-395 | 1.7 (266 pts) |
| Philips Intellivue A01 | 1.7 (264 pts) |
| DataScope Passport 2 | 1.7 (279 pts) |
| GE Dash 3000 | 2.2 (279 pts) |

{8}------------------------------------------------

# 510(k) Summary Page 6 of 6 16-Mar-15

# 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.