(73 days)
No
The description focuses on traditional pulse oximetry technology using light absorption and does not mention any AI/ML components or algorithms.
No.
The device is for monitoring physiological parameters (SpO2 and pulse rate), not for treating a disease or condition.
Yes
The device is indicated for "continuously noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are physiological parameters used to assess a patient's health status, thereby aiding in diagnosis and management.
No
The device description clearly outlines physical components like LEDs, a photodiode detector, silicone rubber cushions, and a patient cable with a connector. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states that the Nasal Alar SpO2 Sensor is a non-invasive device that monitors functional oxygen saturation and pulse rate from the nasal ala. This is a measurement taken directly from the patient's body, not from a sample.
- Lack of Sample Analysis: There is no mention of collecting or analyzing any biological samples. The device uses light to measure physiological parameters directly.
Therefore, the device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / 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 (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.
Product codes
DOA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal ala
Indicated Patient Age Range
at least 4 years and older
Intended User / Care Setting
variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision.
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)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy (ARMS): 70-100% +/- 3%
BPM: 30-240 bpm +/- 3 bpm
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a single snake winding around it.
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
1
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 (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" (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 (800) 638-2041 or (301) 796-7100 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
2
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 ( Select one or both, as applicable ) | |
|---|---|
| ---------------------------------------------------------- | -- |
XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| Date Prepared: | 25-Jul-17 |
|---|---|
| Xhale, Inc. | |
| 3630 SW 47th Ave, Suite 100 | |
| Gainesville, FL 32608 | |
| Phone: (352) 371-8488 | |
| Fax: (352) 375-3133 | |
| Official Contact: | Jeffrey Hoebelheinrich |
| Director of Quality and Regulatory Affairs | |
| Proprietary or Trade Name: | Nasal Alar SpO2 Sensor |
| Common/Usual Name: | Oximeter (Accessory - sensor) |
| Classification Name: | Oximeter |
| Product Classification – DQA | |
| 21 CFR 870.2700 | |
| 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.
4
| Attribute | Xhale
Assurance™ Alar / Nasal
SpO2 Sensor
510(k) K143216 | Proposed Xhale
Nasal Alar SpO2 Sensor | Differences |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Indications for Use | The Assurance™ Alar / Nasal
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 ≥30 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. | 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. | Changed minimum
patient age to 4 years
and older and weight
to ≥15 kg |
| Environments of use | variety of healthcare
environments where compatible
pulse oximetry monitors are
indicated for use, under
professional supervision | variety of healthcare
environments where compatible
pulse oximetry monitors are
indicated for use, under
professional supervision. | Identical |
| Patient population | adult and pediatric patients
(weighing ≥30 kg) | adult and pediatric patients (at
least 4 years and older and
weighing ≥15 kg ) | Changed minimum
patient age to 4 years
and older and weight
to ≥15 kg |
| Single patient use | Yes | Yes | Identical |
| 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 | Identical |
| LEDS | Red (~660 nm) and IR (~880
nm) | Red (~660 nm) and IR (~880
nm) | Identical |
| Detector | Photodiode | Photodiode | Identical |
| Connector | 9 pin DB-9 style | 9 pin DB-9 style | Identical |
5
| Attribute | Xhale
Assurance™ Alar / Nasal
SpO2 Sensor
510(k) K143216 | Proposed Xhale
Nasal Alar SpO2 Sensor | Differences |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Performance Testing - Clinical and Non-clinical | | | |
| Patient Contact
Materials
Classification | Materials in the gas pathway
External Communicating
Tissue
Prolonged duration
Materials in direct patient
contact
Surface Contact
Mucosal
Prolonged duration | Materials in the gas pathway
External Communicating
Tissue
Prolonged duration
Materials in direct patient
contact
Surface Contact
Mucosal
Prolonged duration | Identical |
| SpO2 Accuracy
(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
Storage and Operating
Temperature and humidity
Fluid ingress | Mechanical strength
Storage and Operating
Temperature and humidity
Fluid ingress | Identical |
| Pulse rate accuracy | Yes | Yes | Identical |
| Inter-device
reliability and
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.
6
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.