(73 days)
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.
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.
Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets those criteria, according to your defined points.
Device: Nasal Alar SpO2 Sensor (Premarket Notification K171423 for Xhale, Inc.)
Purpose of this 510(k): Expansion of indications to change patient population from a weight of >30 kg to at least 4 years and older and weighing >15 kg. The sensor itself is unchanged from the predicate device (K143216).
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance acceptance criteria are inferred from the predicate device's performance, as the device itself is unchanged and the study is focused on the expanded patient population.
| Acceptance Criteria (from predicate) | Reported Device Performance (for new patient population) |
|---|---|
| SpO2 Accuracy (ARMS): 70-100% ± 3% | Within ARMS specification of ± 3% for the range of 70-100% |
| Pulse Rate (BPM): 30-240 bpm ± 3 bpm | No specific study data provided for BPM; stated as "not changed" from predicate, implying performance is identical. |
| IEC 60601-1 (Electrical Safety): Yes | Yes (Identical to predicate) |
| IEC 60601-1-2 (EMC): Yes | Yes (Identical to predicate) |
| ISO 80601-2-61 (Pulse Oximetry Standards): | Yes (Identical to predicate for mechanical strength, storage/operating temp/humidity, fluid ingress) |
| Mechanical strength: Yes | Yes (Identical) |
| Storage and Operating Temperature and Humidity: Yes | Yes (Identical) |
| Fluid ingress: Yes | Yes (Identical) |
| Pulse rate accuracy: Yes | Yes (Identical) |
| Inter-device reliability and accuracy: Yes | Yes (Identical) |
| Biocompatibility (ISO 10993-1): Materials passed for prolonged duration, mucosal contact, external communicating tissue | Materials are identical and previously tested/accepted under K122996. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of volunteer subjects, but the study type is a "controlled desaturation study with healthy volunteers."
- Data Provenance: The study was a "controlled desaturation study," which is typically prospective clinical data. No country of origin is specified, but given the FDA submission, it's highly likely to be conducted in the USA or follow international standards accepted by the FDA. It is a prospective clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable for this type of device and study. The ground truth for SpO2 accuracy in desaturation studies is established by simultaneous arterial blood gas measurements, not expert human readers/reviewers.
4. Adjudication Method for the Test Set
- Not applicable. The ground truth (arterial blood gas measurements) does not require expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI systems where human interpretation is a key component to be improved. This device is a sensor measuring a physiological parameter.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Yes, performance was effectively assessed in a "standalone" manner, as the device's accuracy was compared against the objective reference standard (arterial blood gas measurements) in the desaturation study. This is an algorithm-only performance assessment in the context of a pulse oximeter sensor.
7. The Type of Ground Truth Used
- Objective Physiological Measurement: The ground truth for SpO2 accuracy was established through a "controlled desaturation study" which, by standard practice in pulse oximetry validation (e.g., as per ISO 80601-2-61), involves simultaneously measuring arterial blood gas (ABG) values (specifically co-oximetry for actual functional oxygen saturation in blood samples) alongside the device's SpO2 readings as subjects' oxygen levels are lowered.
8. The Sample Size for the Training Set
- Not applicable. This is a 510(k) submission for a physical sensor, not an AI/ML algorithm that requires a "training set" in the computational sense. The device itself (the sensor) is unchanged from the predicate. The "study" here is a clinical validation study rather than a machine learning training/testing paradigm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of an AI/ML algorithm here.
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Public Health Service
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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
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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
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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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| Date Prepared: | 25-Jul-17 |
|---|---|
| Xhale, Inc.3630 SW 47th Ave, Suite 100Gainesville, FL 32608Phone: (352) 371-8488Fax: (352) 375-3133 | |
| Official Contact: | Jeffrey HoebelheinrichDirector of Quality and Regulatory Affairs |
| Proprietary or Trade Name: | Nasal Alar SpO2 Sensor |
| Common/Usual Name: | Oximeter (Accessory - sensor) |
| Classification Name: | OximeterProduct Classification – DQA21 CFR 870.2700Class 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.
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| Attribute | XhaleAssurance™ Alar / NasalSpO2 Sensor510(k) K143216 | Proposed XhaleNasal Alar SpO2 Sensor | Differences |
|---|---|---|---|
| Indications for Use | The Assurance™ Alar / NasalSpO2 Sensor is indicated forsingle patient use forcontinuously noninvasivemonitoring of functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate from thenasal ala of adult and pediatricpatients (weighing ≥30 kg), whoare well or poorly perfused. Thesensor can be used in a varietyof healthcare environmentswhere compatible pulseoximetry monitors are indicatedfor use, under professionalsupervision. | The Nasal Alar SpO2 Sensor isindicated for single patient usefor continuously noninvasivemonitoring of functional oxygensaturation of arterial hemoglobin(SpO2) and pulse rate from thenasal ala of adult and pediatricpatients (at least 4 years andolder and weighing ≥15 kg ),who are well or poorly perfused.The sensor can be used in avariety of healthcareenvironments where compatiblepulse oximetry monitors areindicated for use, underprofessional supervision. | Changed minimumpatient age to 4 yearsand older and weightto ≥15 kg |
| Environments of use | variety of healthcareenvironments where compatiblepulse oximetry monitors areindicated for use, underprofessional supervision | variety of healthcareenvironments where compatiblepulse oximetry monitors areindicated for use, underprofessional supervision. | Identical |
| Patient population | adult and pediatric patients(weighing ≥30 kg) | adult and pediatric patients (atleast 4 years and older andweighing ≥15 kg ) | Changed minimumpatient age to 4 yearsand older and weightto ≥15 kg |
| Single patient use | Yes | Yes | Identical |
| Principle ofOperation | Spectrophotometricmeasurement of functionalarterial oxygen saturation bytransmissive mode pulseoximetry | Spectrophotometricmeasurement of functionalarterial oxygen saturation bytransmissive mode pulseoximetry | Identical |
| LEDS | Red (~660 nm) and IR (~880nm) | Red (~660 nm) and IR (~880nm) | Identical |
| Detector | Photodiode | Photodiode | Identical |
| Connector | 9 pin DB-9 style | 9 pin DB-9 style | Identical |
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| Attribute | XhaleAssurance™ Alar / NasalSpO2 Sensor510(k) K143216 | Proposed XhaleNasal Alar SpO2 Sensor | Differences |
|---|---|---|---|
| Performance Testing - Clinical and Non-clinical | |||
| Patient ContactMaterialsClassification | Materials in the gas pathwayExternal CommunicatingTissueProlonged durationMaterials in direct patientcontactSurface ContactMucosalProlonged duration | Materials in the gas pathwayExternal CommunicatingTissueProlonged durationMaterials in direct patientcontactSurface ContactMucosalProlonged 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 strengthStorage and OperatingTemperature and humidityFluid ingress | Mechanical strengthStorage and OperatingTemperature and humidityFluid ingress | Identical |
| Pulse rate accuracy | Yes | Yes | Identical |
| Inter-devicereliability andaccuracy | 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.
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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.
§ 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).