ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085

K122996 · Xhale · DQA · Apr 10, 2013 · Cardiovascular

Device Facts

• Record ID: K122996
• Device Name: ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085
• Applicant: Xhale
• Product Code: DQA · Cardiovascular
• Decision Date: Apr 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Assurance Alar 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

Assurance Alar Sensor is a disposable, single-patient-use pulse oximetry sensor. It attaches to the nasal alar region using soft silicone rubber cushions for retention. The device utilizes red (660 nm) and infrared (890 nm) LED light sources and a silicon photodiode detector to measure light absorption changes in blood during each pulse. It connects via a DB-9 cable to compatible pulse oximetry monitors (e.g., Nellcor N-395). The monitor processes these signals to calculate and display SpO2 and pulse rate. Used in clinical settings under professional supervision, the device provides continuous monitoring to assist clinicians in assessing patient oxygenation status, potentially benefiting patients by enabling timely intervention for desaturation events.

Clinical Evidence

Controlled desaturation study performed per ISO/IEC 80601-2-61 on 12 healthy volunteers (varying age, gender, ethnicity, skin tone). Sensors connected to Nellcor N-395 monitors. Reference values obtained via indwelling arterial catheter and Co-oximeter. Analysis of 552 data pairs yielded an accuracy (ARMS) of 1.84% over the 70-100% SaO2 range.

Technological Characteristics

Transmissive pulse oximetry sensor; red (660 nm) and IR (890 nm) LEDs; silicon photodiode detector; silicone rubber skin contact material; DB-9 connector; disposable; single-patient use; compatible with Nellcor OxiSensor II technology monitors; tested per ISO 10993-1 (biocompatibility), IEC 60601-1-2 (EMC), and ISO 80601-2-61 (safety/performance).

Indications for Use

Indicated for continuous noninvasive monitoring of functional arterial oxygen saturation and pulse rate in adult and pediatric patients weighing >30kg. Suitable for 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

• Nellcor N-395 Pulse Oximeter System (K991823)
• Nellcor OxiMax-Fast Adhesive Forehead Sensor (K021089)
• Masimo E1 Ear Sensor (K121912)

Submission Summary (Full Text)

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Ki2296

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Image /page/0/Picture/2 description: The image shows the logo for Xhale, a company that focuses on breathing new life into medicine. The logo features a stylized "X" symbol on the left, followed by the company name "Xhale" in bold, black letters. Below the name is the tagline "Breathing New Life into Medicine" in a smaller font.

# 510(k) SUMMARY

APR 1 0 2013

| Submitter | Xhale, Inc.<br>(via Assurance Biosense, Inc - a wholly owned subsidiary)<br>701 Hebron Avenue<br>Glastonbury, CT 06033<br>Phone: [phone]<br>Fax: [phone] |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | David Rich<br>Sr. Vice President<br>Phone: [phone] |
| Date Prepared | Feb 4, 2013 |
| Trade Name | Assurance™ Alar Sensor |
| Regulation (Common) Name | Pulse Oximeter Sensor |
| Classification | Class II, 21CFR 870.2700, 21CFR 870.2900 |
| Product Code | 74 DQA, 74 DSA |
| Predicate Device(s) | Nellcor N-395 Pulse Oximeter System - K991823<br>Nellcor OxiMax-Fast Adhesive Forehead Sensor - K021089<br>Masimo E1 Ear Sensor - K121912 |

### Device Description

The Assurance™ Alar 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 Assurance™ Alar Sensor with its associated patient cable, terminates in a DB-9 connector compatible with monitors employing Nellcor OxiSensor II SpO2 technology such as the Nellcor N-395.

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.

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Image /page/1/Picture/1 description: The image shows the logo for Xhale. The logo consists of a stylized symbol to the left of the word "Xhale" in a bold, sans-serif font. Below the word "Xhale" is the tagline "Breathing New Life into Medicine" in a smaller font. The symbol to the left of the word "Xhale" is a geometric shape that resembles a stylized "X" or a four-way intersection.

# Indications for Use

The Assurance™ Alar Sensor is indicated for single patient use for continuous noninvasive monitoring of functional arterial oxygen saturation and pulse rate from the nasal alar of adult and pediatric patients, (weighing >30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision.

## Predicate Device(s) Comparison

Intended Use and Indications for Use

| Attribute | Assurance™ Alar Sensor | Predicate Device (K121912)<br>Masimo E1 Ear Sensor |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Continuous noninvasive monitoring of functional arterial oxygen saturation and pulse rate. | Same |
| Indications for Use | The Assurance™ Alar Sensor is indicated for single patient use for continuous noninvasive monitoring of functional arterial oxygen saturation and pulse rate from the nasal alar of adult and pediatric patients, (weighing >30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision. | The Masimo El Ear Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients, (weighing > 30kg), who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments. |
| Patient Population | Adults, Peds >66 lbs. / 30 kg. | Adults, Peds >66 lbs. / 30 kg. |
| Duration of Use | Single patient, multi-use | Single patient, multi-use |

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Image /page/2/Picture/1 description: The image shows the logo for Xhale, a company that is "Breathing New Life into Medicine". The logo consists of a stylized "X" shape on the left, followed by the word "Xhale" in bold, black letters. Below the company name is the tagline, "Breathing New Life into Medicine".

## Technology & Materials

| Attributes | Assurance™ Alar Sensor | Predicate Device (K121912)<br>Masimo E1 Ear Sensor |
|---------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Principle of<br>Operation | Spectrophotometric measurement of<br>functional arterial Oxygen saturation<br>by transmissive mode Pulse Oximetry | Spectrophotometric measurement of<br>functional arterial Oxygen saturation<br>by transmissive mode Pulse Oximetry |
| Reusable/Disposable | Disposable, Single Patient Use | Disposable, Single Patient Use |
| LEDs | Red (~660 nm) and IR (~880 nm) | Red (~660 nm) and IR (~880 nm) |
| LED drive | 2 wire, anti-parallel | 2 wire, anti-parallel |
| Detector | photodiode | photodiode |
| Connector | 9 pin DB-9 style | 9 pin DB-9 style |
| Skin Contact | Silicone rubber | Silicone rubber |

## Performance & Accuracy

| Device | 510(k) | Sensor<br>Location | SpO2 Accuracy<br>(ARMS) | Pulse Rate Accuracy |
|--------------------------------------------------------------------------------------|---------|-----------------------|--------------------------------------------------|---------------------|
| Assurance™ Alar Sensor | - | Nose | 70-100%: ± 2% | 30-250 bpm: ± 3 bpm |
| Nellcor N-395 System:<br>Oxisensor D-25<br>Oxisensor R-15<br>Dura Y & Ear clip D-YSE | K991823 | Finger<br>Nose<br>Ear | 70-100%: ±2%<br>80-100%: ± 3.5%<br>70-100%: ± 2% | 30-250 bpm: ± 3 bpm |
| Nellcor OxiMax Forehead | K021089 | Forehead | 70-100%: ±2% | 30-250 bpm: ± 3 bpm |
| Masimo E1 Ear Sensor | K121912 | Ear | 70-100%: ±2.5% | 30-250 bpm: ± 3 bpm |

The Assurance ™ Alar Sensor has been compared to the predicate device(s) and is viewed as substantially equivalent because:

- The intended use and indications for use are the same ●
- . The principles of operation, optical components and materials are the same
- . The performance and accuracy is the same or better

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Image /page/3/Picture/1 description: The image shows the logo for Xhale. The logo consists of a stylized "X" symbol to the left of the word "Xhale" in bold, black letters. Below the word "Xhale" is the tagline "Breathing New Life into Medicine" in a smaller font.

### Nonclinical Testing Summary

The following testing of the Assurance™ Alar Sensor was performed in accordance with the requirements of the design control regulations and established quality assurance procedures.

#### Biocompatibility of materials

Materials were evaluated per ISO 10993-1. The sensor is a surface device where materials have direct or incidental skin contact for less than 29 days.

- Surface Communicating, Skin, Prolonged duration .
- o. Cytotoxicity (tested per ISO 10993-5)
- Sensitization (tested per ISO 10093-10) o
- Irritation (tested per ISO 10993-10) o
- Pass / fail criteria was met for each respective ISO 10993 test .

Discussion: All materials were tested according to ISO 10093-1 for the intended use level of patient contact and duration and found to meet the applicable requirements.

#### Electromagnetic Compatibility

The device was tested per IEC 60601-1-2.

- . Emissions Testing
- o CISPR 11: Radiated Electromagnetic Emissions (2004)
- . Immunity Testing
- IEC 61000-4-2: Electrostatic Discharge Immunity (2001) O
- IEC 61000-4-3: Radiated Electromagnetic Field Immunity (2006) o
- o IEC 61000-4-6: Radio-Frequency Common Mode Immunity

Discussion: The device met the requirements of IEC 60601-1-2 relevant to the device. The tests conformed to the requirements set forth in ISO 80601-2-61, Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.

#### Electrical Safety Testing

Fluid Ingress / Spill Resistance

- The device was tested per ISO 80601-2-61 requirement of IEC 60601-1 Clause 11.6. . overflow, spillage, leakage, ingress of water or particulate matter requirements.
Discussion: The device mects IPX1 requirements.

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Image /page/4/Picture/1 description: The image shows the logo for Xhale. The logo consists of a square-shaped symbol on the left and the word "Xhale" in bold, black letters on the right. Below the word "Xhale" is the tagline "Breathing New Life into Medicine" in a smaller font. The square symbol is made up of curved lines that form an abstract shape.

## Surface Temperature

- The device was tested per ISO 80601-2-61 Clause 201.11 and ANNEX BB: skin . temperature requirements for protection against excessive temperatures.

| Test | Max Temp (Right) (°C) | Max Temp (Left) (°C) |
|------|-----------------------|----------------------|
| 1 | 30.7 | 29.2 |
| 2 | 37.6 | 36.7 |
| 3 | 27.9 | 27.2 |
| 4 | 36.3 | 37.6 |
| 5 | 36.9 | 35.2 |

Discussion: The device passed the test with the skin temperatures under the device not exceeding 38°C, below the max temperature limit of 41°C.

### Pulse Rate accuracy (low signal)

- . The device was tested for accuracy of pulse rate over the range 30-250 bpm using an SpO2 simulator at minimum perfusion settings under conditions of no motion.
Discussion: The device measured the pulse rate to within ± 3bpm over the range.

#### Inter-device Reliability and Accuracy

- . A population of devices was tested under simulated conditions to assess the Interdevice Reliability and Accuracy. The devices were tested over the ranges; 85-99% SpO2 and 40-140 bpm.
Discussion: The deviation between simulated and measured values across the population was ≤2% SpOz and ≤1 bpm. This performance is within the stated accuracies of ±2% SpO2 and ± 3 bpm accordingly.

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Image /page/5/Picture/1 description: The image shows the logo for Xhale, a company that is "Breathing New Life into Medicine". The logo consists of a stylized "X" symbol to the left of the company name. The "X" symbol is made up of thick black lines that form a square shape with curved lines extending from each corner.

## Mechanical and Environmental Testing

#### Drop Test

- The device was tested per ISO 80601-2-61 requirement of IEC 60601-1 clause . 15.3.4.1 drop test requirements for hand-held ME equipment.
Discussion: The device passed the drop test without damage and satisfied the test requirements.

Storage Temperature and Humidity

- The device was tested following storage at the extremes of temperature and humidity: t -40°C to +70°C, 15% to 95% RH (non-condensing).
Discussion: The device was not affected by the ranges of temperature and humidity indicated as storage conditions.

Operating Temperature and Humidity

- . The device function was evaluated over the range of temperature and humidity: -5°C to +40°C, 15% to 95% RH (non-condensing).
Discussion: The device function was not affected over the ranges of temperature and humidity indicated as operating conditions.

#### Clinical Testing Summary

Hypoxia Performance Testing

- Controlled desaturation testing was performed per ISO/IEC 80601-2-61 under . no-motion conditions with 12 healthy volunteer subjects of varying age, gender, ethnicity and skin tone.
- Sensors were connected to Nellcor N-395 monitors representative of "Nellcor . OxiSensor II SpO2 technology". SpO2 values were recorded from the monitors over the range of 70-100% SaO2
- . Reference blood samples were drawn from an indwelling arterial catheter and analyzed on a Co-oximeter.

Discussion: Statistical analysis of 552 evenly distributed data pairs, yielded a device accuracy (Arms) of 1.84% over the range 70-100% SaO2.

### Substantial Equivalence Conclusion

The sponsor has demonstrated through design and feature comparison, performance testing, and controlled desaturation testing, the Assurance™ Alar Sensor is substantially equivalent to the listed predicate devices.

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#### April 10, 2013

Mr. David Rich Senior Vice President Xhale, Incorporated 701 Hebron Avenue GLASTONBURY CT 06033

Re: K122996

Trade/Device Name: Assurance Alar Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA, DSA Dated: March 22, 2013 Received: March 27, 2013

Dear Mr. Rich:

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. Ilsting 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.

Public Health Service

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

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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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/Resourcesfor You/Industry/default.htm.

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

Sincerely yours.

Kwame O. Ulmer for

Anthony D. Watson, B.S., M.S., M.B.A. 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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# Indications for Use

# 510(k) Number (if known): וֹז וֹב רו ברי רב

## Device Name: Assurance Alar Sensor

Indications for use: The Assurance Alar 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.

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lester W. Schultheis 2013.04.08 1

(Division Sign-Off) (Division of Anesthesiology, General H Infection Control, Dental Devices

510(k) Number

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