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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Predicate / Standard)	Reported Device Performance (Assurance™ Alar Sensor)
SpO2 Accuracy (ARMS)	70-100%: ± 2% (Nellcor N-395 System & Dura Y & Ear clip D-YSE) / 70-100%: ± 2.5% (Masimo E1 Ear Sensor)	70-100%: ± 2%
Pulse Rate Accuracy	30-250 bpm: ± 3 bpm (All Predicate Devices)	30-250 bpm: ± 3 bpm
Biocompatibility	Meets ISO 10993-1, 10993-5, 10993-10 Pass/Fail Criteria	Met applicable requirements (Pass)
Electromagnetic Compatibility	Meets IEC 60601-1-2 standards (CISPR 11, IEC 61000-4-2, 4-3, 4-6)	Met requirements
Electrical Safety (Fluid Ingress)	Meets IEC 60601-1 Clause 11.6 & ISO 80601-2-61 (IPX1)	Met IPX1 requirements
Surface Temperature	Skin temperature under the device not exceeding 41°C (ISO 80601-2-61 Clause 201.11 and ANNEX BB)	Did not exceed 38°C (Pass)
Pulse Rate Accuracy (low signal)	Within ± 3 bpm using SpO2 simulator at minimum perfusion	Measured pulse rate within ± 3bpm
Inter-device Reliability and Accuracy	Deviation ≤2% SpO2 and ≤1 bpm (relative to simulated)	Deviation ≤2% SpO2 and ≤1 bpm
Mechanical (Drop Test)	Meets IEC 60601-1 clause 15.3.4.1 for hand-held ME equipment	Passed without damage and satisfied requirements
Storage Temperature and Humidity	-40°C to +70°C, 15% to 95% RH (non-condensing)	Not affected
Operating Temperature and Humidity	-5°C to +40°C, 15% to 95% RH (non-condensing)	Not affected

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Clinical Testing (Hypoxia Performance): 12 healthy volunteer subjects.
Data Provenance: The study was a "Controlled desaturation testing," which implies a prospective, controlled clinical study. The country of origin of the data is not explicitly stated, but the context of an FDA submission suggests it was likely performed in the US or under standards accepted by the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document mentions "Reference blood samples were drawn from an indwelling arterial catheter and analyzed on a Co-oximeter." This indicates that the ground truth for SpO2 was established through laboratory analysis by a Co-oximeter, which is a highly accurate method for blood gas analysis, rather than expert interpretation of images or other subjective assessments. Therefore, the concept of a "number of experts" for ground truth as might apply to image-based diagnostics is not directly applicable here.

4. Adjudication Method for the Test Set

Not applicable as the ground truth was established by direct measurement with a Co-oximeter on blood samples, not through expert consensus or interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or indicated. This type of study is more common for diagnostic imaging AI, where human readers interpret cases with and without AI assistance. This submission focuses on a sensor's accuracy compared to a gold standard.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the hypoxia performance testing describes a standalone evaluation of the device. The sensor was connected to monitors, and the SpO2 values were recorded. The statistical analysis of the data pairs yielded the device's accuracy (Arms) independently, without human interpretation influencing the primary SpO2 measurement recorded by the device.

7. The Type of Ground Truth Used

The type of ground truth used for SpO2 accuracy was outcomes data/reference standard measurement obtained from Co-oximeter analysis of arterial blood samples (SaO2).

8. The Sample Size for the Training Set

The document does not report a separate training set size for the Assurance™ Alar Sensor. This device is a pulse oximeter sensor, which typically relies on established biophysical principles and calibration during manufacturing rather than machine learning algorithms that require extensive training data in the same way an AI diagnostic tool would. The accuracy is likely inherent to its design and calibration, not learned from a dataset.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set for a machine learning algorithm is mentioned. The device's operation is based on spectrophotometric principles, not a learned model from a training set.

Summary

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

Ki2296

Page 1 of 6

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.(via Assurance Biosense, Inc - a wholly owned subsidiary)701 Hebron AvenueGlastonbury, CT 06033Phone: (860) 616-1610Fax: (352) 375-3133
Contact Person	David RichSr. Vice PresidentPhone: (860) 616-1610
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 - K991823Nellcor OxiMax-Fast Adhesive Forehead Sensor - K021089Masimo E1 Ear Sensor - K121912

Device Description

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.

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

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

Predicate Device(s) Comparison

Intended Use and Indications for Use

Attribute	Assurance™ Alar Sensor	Predicate Device (K121912)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

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

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)Masimo E1 Ear Sensor
Principle ofOperation	Spectrophotometric measurement offunctional arterial Oxygen saturationby transmissive mode Pulse Oximetry	Spectrophotometric measurement offunctional arterial Oxygen saturationby 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)	SensorLocation	SpO2 Accuracy(ARMS)	Pulse Rate Accuracy
Assurance™ Alar Sensor	-	Nose	70-100%: ± 2%	30-250 bpm: ± 3 bpm
Nellcor N-395 System:Oxisensor D-25Oxisensor R-15Dura Y & Ear clip D-YSE	K991823	FingerNoseEar	70-100%: ±2%80-100%: ± 3.5%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

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

Page 4 of 6

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.

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

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.

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

Page 6 of 6

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.

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

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wings, representing health, hope, and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

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

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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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

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

Page 1 of 1

4.1

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).