(195 days)
Not Found
No
The device description and performance studies focus on traditional pulse oximetry technology using light absorption and do not mention any AI/ML components or algorithms.
No
The device is a sensor used for continuous noninvasive monitoring of functional arterial oxygen saturation and pulse rate. It measures physiological parameters but does not provide therapy or treatment.
Yes
The device is indicated for continuous noninvasive monitoring of functional arterial oxygen saturation and pulse rate, which are physiological parameters used to assess a patient's health status. Monitoring these parameters can aid in the diagnosis or management of various conditions.
No
The device description clearly outlines physical components like LEDs, a photodiode detector, silicone rubber cushions, and a patient cable with a DB-9 connector, indicating it is a hardware device with optical and electrical components, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Assurance™ Alar Sensor Function: The Assurance™ Alar Sensor is a pulse oximetry sensor that measures oxygen saturation and pulse rate directly from the patient's body (in vivo) by using light absorption. It does not analyze samples taken from the body.
Therefore, based on the provided information, the Assurance™ Alar Sensor is a non-invasive medical device used for physiological monitoring, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
74 DQA, 74 DSA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal alar region - the fleshy region at the side of the nose
Indicated Patient Age Range
Adult and pediatric patients (weighing >30kg).
Intended User / Care Setting
Under professional supervision, in a variety of healthcare environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Hypoxia Performance Testing:
- Study Type: Controlled desaturation testing
- Sample Size: 12 healthy volunteer subjects of varying age, gender, ethnicity and skin tone.
- Key Results: Statistical analysis of 552 evenly distributed data pairs, yielded a device accuracy (Arms) of 1.84% over the range 70-100% SaO2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- SpO2 Accuracy: 70-100%: ± 2%
- Pulse Rate Accuracy: 30-250 bpm: ± 3 bpm
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
(via Assurance Biosense, Inc - a wholly owned subsidiary)
701 Hebron Avenue
Glastonbury, CT 06033
Phone: (860) 616-1610
Fax: (352) 375-3133 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | David Rich
Sr. Vice President
Phone: (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 - K991823
Nellcor OxiMax-Fast Adhesive Forehead Sensor - K021089
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.
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
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)
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 of
Operation | Spectrophotometric measurement of
functional arterial Oxygen saturation
by transmissive mode Pulse Oximetry | Spectrophotometric measurement of
functional arterial Oxygen saturation
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
Location | SpO2 Accuracy
(ARMS) | Pulse Rate Accuracy |
|--------------------------------------------------------------------------------------|---------|-----------------------|--------------------------------------------------|---------------------|
| Assurance™ Alar Sensor | - | Nose | 70-100%: ± 2% | 30-250 bpm: ± 3 bpm |
| Nellcor N-395 System:
Oxisensor D-25
Oxisensor R-15
Dura Y & Ear clip D-YSE | K991823 | Finger
Nose
Ear | 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
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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
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
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