(165 days)
Yes
The device description explicitly states that the cloud-based algorithm "utilizes a combination of signal processing and Al/ML components" and later mentions an "Al based Sleep/Wake classification algorithm".
No
The device is intended to aid in the evaluation and diagnosis of sleep-related breathing disorders, not to treat them.
Yes
The device is intended to aid in the evaluation and diagnosis of sleep-related breathing disorders, as indicated by phrases like "aid in the evaluation of sleep-related breathing disorders" and "aid to diagnose moderate to severe SDB."
No
The device description explicitly states that the SANSA device contains hardware components: a reflective PPG sensor, a single-lead ECG sensor, and a 3-axis accelerometer. While it utilizes software for analysis, it is not solely software.
Based on the provided information, the Huxley Home Sleep Apnea Test (SANSA) is not an In Vitro Diagnostic (IVD) device.
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 detect diseases, conditions, or infections. The tests are performed outside of the body (in vitro).
- SANSA's Function: The SANSA device is a wearable device that collects biophysical parameters directly from the body (in vivo) using sensors like PPG, ECG, and accelerometer. It does not analyze samples taken from the body.
- Intended Use: The intended use is to aid in the evaluation of sleep-related breathing disorders by recording and storing biophysical parameters. This is a physiological measurement and analysis, not an in vitro test.
While the device uses algorithms and processes data to provide information for diagnosis, the fundamental method of data collection is from the body itself, not from a sample taken from the body.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section explicitly states 'Not Found'.
Intended Use / Indications for Use
The Huxley Home Sleep Apnea Test (SANSA) is a wearable device intended for use in the recording, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for the clinical and home use setting under the direction of a Healthcare Professional (HCP).
Product codes
MNR
Device Description
The Huxley Home Sleep Apnea Test (SANSA™) is a wearable device intended for use in the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for clinical and home use setting under the direction of a Healthcare Professional (HCP). The system is prescription use only.
The SANSA HSAT collects multiple physiological signals using a single wearable patch worn on the chest. The SANSA device contains a reflective PPG sensor, a single-lead ECG sensor, and a 3-axis accelerometer. The signals from these sensors are passed into a cloud-based algorithm which utilizes a combination of signal processing and AI/ML components to compute time-series data for clinician review and summary metrics for report output. The device outputs the following time-series channels: Oximetry, Heart Rate, Chest Movement, Snoring, Body Position, Respiratory Effort, Actigraphy, Sleep staging (Sleep/Wake), and ECG (reference channel only). The following summary metrics are calculated: sansa-Apnea Hypopnea Index (sAHI) and Total Sleep Time (TST).
Recorded data are uploaded to a software portal where physiological tracings are made available for review and event editing by a qualified healthcare professional. The device is intended to be worn for 10 hours per study. The ECG channel is intended to be used as a reference channel and is not intended to be used for diagnostic purposes and is not intended by any automated ECG analysis system or algorithm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
The signals from these sensors are passed into a cloud-based algorithm which utilizes a combination of signal processing and AI/ML components to compute time-series data for clinician review and summary metrics for report output.
The Sansa device AI based Sleep/Wake classification algorithm was trained on 101 subjects and validated against the validation dataset (n=340 ITD) taken from gold standard scored PSG data.
Input Imaging Modality
Not Found
Anatomical Site
Chest
Indicated Patient Age Range
Adults (22 years age and older)
Intended User / Care Setting
Healthcare Professional (HCP) / Clinical and Home Use
Description of the training set, sample size, data source, and annotation protocol
The Sansa device AI based Sleep/Wake classification algorithm was trained on 101 subjects. Data source: gold standard scored PSG data. Annotation protocol: Not Found.
Description of the test set, sample size, data source, and annotation protocol
The Sansa device AI based Sleep/Wake classification algorithm was validated against the validation dataset (n=340 ITD). Data source: gold standard scored PSG data. Annotation protocol: Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
SpO2 Accuracy: The Sansa device's SpO2 measurements were compared to arterial blood gas samples in healthy subjects over the range of 70-100% oxygen saturation. The average root mean square error (Agws) met the required specifications of ≤ 3.5% for reflectance technology.
Comparison to PSG: Sansa clinical performance was compared to the gold standard polysomnography (PSG) in a prospective multi-center clinical study in the United States (n = 533). Clinically acceptable performance between Sansa and PSG was demonstrated across all diagnostic conditions. The results of the study support that Sansa is sufficiently accurate as an aid to diagnose moderate to severe SDB. The study was demographically representative of patients with SDB across age, sex, race, ethnicity, BMI, and skin tone.
The Sansa device AI based Sleep/Wake classification algorithm was trained on 101 subjects and validated against the validation dataset (n=340 ITD) taken from gold standard scored PSG data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Aid to Diagnosis of Moderate to Severe OSA (AHI≥15): Sensitivity 88.2%, Specificity 87.3%
Sleep/Wake classification: Sensitivity (Sleep): 95% Cl: 95, 95) and Specificity (Sleep): 63% (95% CI: 62, 64)
Predicate Device(s)
Reference Device(s)
K220095, K212153, K203343, K183559
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
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July 15, 2024
Huxley Medical % Grace Powers Founder/ Principal Consultant Powers Regulatory Consulting 2451 Cumberland Parkway SE Suite 3740 Atlanta, Georgia 30339
Re: K240285
Trade/Device Name: Huxley SANSA Home Sleep Apnea Test (1000-00) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: June 11, 2024 Received: June 11, 2024
Dear Grace Powers:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song -S
for
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known) K240285
Device Name Huxley SANSA Home Sleep Apnea Test (1000-00)
Indications for Use (Describe)
The Huxley Home Sleep Apnea Test (SANSA) is a wearable device intended for use in the recording, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for the clinical and home use setting under the direction of a Healthcare Professional (HCP).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/2 description: The image shows the logo for Huxley Medical. The logo is in a sans-serif font and is a light gray color. The word "HUXLEY" is on the top line, and the word "MEDICAL" is on the bottom line. The letters are stylized, with the "X" being formed by two intersecting lines and the "Y" having a small "TM" symbol next to it.
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Huxley Medical Traditional 510(k) premarket notification.
-
Huxley Medical, Inc. Sponsor: 1465 Northside Dr NW Ste 217 Atlanta, GA, 30318 info@huxleymed.com Grace Powers, MS, MBA, RAC Submission Contact: Founder/Principal Consultant Powers Regulatory Consulting
June 11, 2024 Submission Date: -
Trade Name: Huxley SANSA Home Sleep Apnea Test Subject Device: (1000-00) Common Name: Ventilatory Effort Recorder Classification Name: Breathing Frequency Monitor Regulation: 21 CFR §868.2375 Regulatory Classification: Class 2 Product Code: MNR Predicate Device:
grace@powersregulatory.com -
Reference Devices: ANNE Sleep (K220095) BioBeat Platform, BB-613WP Patch (K212153) Wesper Lab (K203343) WatchPAT ONE (K183559)
Device Description
The Huxley Home Sleep Apnea Test (SANSA™) is a wearable device intended for use in the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for clinical and home use setting under the direction of a Healthcare Professional (HCP). The system is prescription use only.
The SANSA HSAT collects multiple physiological signals using a single wearable patch worn on the chest. The SANSA device contains a reflective PPG sensor, a single-lead ECG sensor, and a 3-axis accelerometer. The signals from these sensors are passed into a cloud-based algorithm which utilizes a combination of signal processing and Al/ML components to compute time-series data for clinician review and summary metrics for report output. The device outputs the following time-series channels: Oximetry, Heart Rate, Chest Movement, Snoring, Body Position, Respiratory Effort, Actigraphy, Sleep staging (Sleep/Wake), and ECG (reference channel only). The following summary metrics are calculated: sansa-Apnea Hypopnea Index (sAHI) and Total Sleep Time (TST).
Recorded data are uploaded to a software portal where physiological tracings are made available for be used for diagnostic purposes and is not intended by any automated ECG analysis system or algorithm. ↑
5
review and event editing by a qualified healthcare professional. The device is intended to be worn for 10 hours per study. The ECG channel is intended to be used as a reference channel and is not intended to
6
Intended Use/Indications for Use
The Huxley Home Sleep Apnea Test (SANSA™) is a wearable device intended for use in the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for the clinical and home use setting under the direction of a Healthcare Professional (HCP).
7
K240285 - 510(k) Summary
An overview comparison of the SANSA HSAT (subject device) to the predicate and reference devices is presented in the table below.
| Device
Comparison | Subject Device: SANSA
HSAT - K240285 | Predicate Device: ANNE Sleep
K220095 | Reference Device
(listed for specific
technical
characteristics) | Comparison |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Huxley Medical, Inc. | Sibel, Inc. | N/A | N/A |
| FDA Product
Code | MNR | MNR | N/A | Identical |
| Regulation | 868.2375 | 868.2375 | N/A | Identical |
| Classification | II | II | N/A | Identical |
| Classification
Name | Ventilatory Effort Recorder | Ventilatory Effort Recorder | N/A | Identical |
| Advisory
Committee | Anesthesiology | Anesthesiology | N/A | Identical |
| Prescription
Use? | Yes | Yes | N/A | Identical |
| Indications for
Use | The SANSA Home Sleep
Apnea Test (SANSA HSAT) is
a wearable device intended
for use in the recording,
analysis, and storage of
biophysical parameters to
aid in the evaluation of
sleep-related breathing
disorders of adults
suspected of sleep apnea.
The device is intended for
the clinical and/or home use
setting under the direction
of a Healthcare Professional
(HCP). | Anne Sleep is a wearable
sensor system intended for use
in the collection, analysis,
display, and storage of
physiological parameters to aid
in the evaluation of sleep-
related breathing disorders of
adult patients suspected of
sleep apnea. The device is
intended for use in the clinical
and home setting under the
direction and interpretation by
a Healthcare Professional
(HCP). | N/A | Similar- The subject and
predicate device have similar
indications for use. Both are used
to aid in the evaluation of sleep-
related breathing disorders. |
| Device
Comparison | Subject Device: SANSA
HSAT - K240285 | Predicate Device: ANNE Sleep
K220095 | Reference Device
(listed for specific
technical characteristics) | Comparison |
| Target
Population | Adults (22 years age and
older) | 22 years age and older | N/A | Identical |
| Intended Use
Environment | Clinics and Home Use | Recording in the home
environment with the report and
interpretation performed in the
clinical setting. | N/A | Similar- The subject and predicate
devices are both able to be used
at home. The subject device can
also be used in the
clinical setting. Both the device's
data are interpreted by clinicians. |
| Device
Placement for
Data Collection | Chest sensor | Chest and finger sensors | BioBeat platform,
BB-613WP Patch
K212153: Chest
Sensor | Similar- Devices utilize chest
sensors. Chest placement to
collect oximetry is supported
by the reference device. |
| Device Sensors | Chest Sensor
Accelerometer ECG
Reflectance Photo-
plethysmography | Limb sensor Chest sensor
Accelerometer ECG
Photo- plethysmography | BioBeat platform,
BB-613WP Patch
K212153:
Reflectance Photo-
plethysmography | Similar- The subject and predicate
device both use accelerometer,
ECG, and
photoplethysmography (PPG)
sensors. |
| Channels | Oximetry Heart rate
Chest movement
Snoring
Body position
Respiratory effort
Actigraphy
Sleep stage
(Sleep/Wake) ECG
(Reference channel
only) | Oximetry Heart rate
Chest movement
Snoring
Body position Pulse rate
Peripheral arterial tonometry
(PAT) | Wesper (K203343)
relevant channel:
Respiratory Effort
WatchPAT One
(K183559) relevant
channel:
Actigraphy
Sleep stage
(Sleep/Wake) | Substantially equivalent:
Each of the channels from the
subject device is provided by the
predicate and / or reference
devices. |
| Device
Comparison | Subject Device: SANSA
HSAT - K240285 | Predicate Device: ANNE Sleep
K220095 | Reference Device
(listed for specific
technical
characteristics) | Comparison |
| Analysis
Outputs | sAHI
Body Position Discrete
States
Heart Rate
Total Sleep Time SpO2 | Sibel-AHI (based on manual
scoring of data by HCP) Body
Position Discrete States Heart
Rate
Total Sleep Time SpO2 | N/A | Substantially equivalent:
The subject device provides
similar analysis to the predicate
device. |
| Performance | Heart Rate: Arms ≤ 3
bpm (range 30-250
bpm)
SpO2: Arms ≤ 3% (range
70-100%)
Aid to Diagnosis of
Moderate to Severe
OSA (AHI≥15):
Sensitivity 88.2%,
Specificity
87.3% | Pulse Rate: 30-300 bpm ± 3 bpm
Heart Rate: 30-300 bpm ± the
greater of ±10% or ±5 bpm
SpO2: Arms ≤ 3% (range 70-
100%)
Aid to Diagnosis of Moderate to
Severe OSA (AHI≥15): Sensitivity
90%, Specificity 98% | BioBeat platform,
BB-613WP Patch
K212153: Arms HR:
±3%, HR Range: 40-
250 bpm | Substantially equivalent: The
subject device provides similar
performance to the predicate
device.
The subject device does not
report Pulse Rate.
The predicate device diagnostic
performance is between manual
scoring by HCP of Sibel and PSG
data, whereas the subject device
utilizes an autoscored algorithm
with no overread and correction.
Similar diagnostic performance is
achieved with comparable HSAT
devices utilizing autoscore
algorithms. |
Table 1: Device Comparison
8
Traditional 510(k) — Huxley SANSA Home Sleep Apnea Test (1000-00)
K240285 - 510(k) Summary
9
Traditional 510(k) — Huxley SANSA Home Sleep Apnea Test (1000-00)
K240285 - 510(k) Summary
10
K240285 - 510(k) Summary
| Device
Comparison | Subject Device: SANSA
HSAT- K240285 | Predicate Device: ANNE Sleep
K220095 | Reference Device
(listed for specific
technical
characteristics) | Comparison |
|---------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Data Collection
and Transfer | Patient data is
physically transferred
via USB after study
conclusion. | Patient data is wirelessly
transferred via Bluetooth from
the sensors to a mobile phone.
Data is then wirelessly
transferred from the phone to
the cloud when connected to
the internet. | N/A | Similar:
The subject device and predicate
device both transfer patient data
from the device to a cloud-based
software platform for analysis.
The subject device utilizes wired
data transfer, whereas the
predicate device utilizes wireless
transfer, but this difference does
not impact safety or effectiveness. |
| Recording
Capacity | Approx. 10 hours per
study. 2 nights of study
maximum. | 36 hours of continuous use | WatchPAT One
(K183559): Approx.
10 hours | Substantially equivalent:
The subject device and predicate
device can both operate over a
full night of sleep. Duration
differences do not influence
safety or effectiveness. |
| Energy Source | Rechargeable Lithium
Polymer Battery | Rechargeable Lithium Polymer
Battery | N/A | Identical |
| Analysis
Software | Analysis performed off
the recording device,
on a compatible cloud-
based software
platform. | Analysis performed off the
recording device, on a
compatible cloud-based
software platform. | N/A | Identical |
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510(k) Summary
Non-Clinical Performance Data
The subject devices was subject to non-clinical performance testing. There are no device-specific guidance documents, special controls document, and/or requirements in a device-specific regulation that are applicable to the subject device.
A list of the non-clinical bench testing is listed below:
- Heart Rate Testing and accuracy per 60601-2-47
- . SPO2 Clinical and SQI Testing
- Body Position Testing
- Snoring Testing
- Actigraphy Testing
- Chest Movement Testing
- Respiratory Effort Testing
- Disposable ECG Electrodes Testing per ANSI/AAMI EC12 (Labeling, Biological Response, Adhesive performance duration of use, Packaging and shelf life, and the following electrical performance tests: AC impedance, DC offset voltage, combined offset instability and internal noise, and bias current tolerance).
- . Usability Testing (Patients and Healthcare Providers) leveraging the following:
- "Guidance for Industry and Food and Drug Administration Saff: Applying Human Factors and Usability Engineering to Medical Devices" issued February 3, 2016
- . IEC 62366-1, Medical Devices – Part 1: Application of usability engineering to medical devices
- IEC 60601-1-6, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability
- . IEC 60601-1-11, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- . Software Verification testing including unit level and integration Testing in accordance with IEC 62304, Medical device software life cycle processes and "Guidance for Industry and Food and Drug Administration Staff: Content of Premarket Submissions for Device Software Functions" issued June 14, 2023.
- . Cybersecurity Testing in accordance with "Guidance for Industry and Food and Drug Administration Staff: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" issued September 27, 2023.
- . EMC and Electrical Safety Testing per 60601-1, 60601-1-11, 60601-2-47 and 80601-2e I
- . Cleaning, Disinfection and Shelf Life Testing
All non-clinical bench testing passed.
Biocompatibility Testing
The subject and predicate device are considered as surface devices in contact with intact skin per ISO 10993-1. The biocompatibility evaluation was completed and included Cytotoxicity, Sensitization and Intracutaneous Reactivity/Irritation testing. All testing passed.
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Clinical Performance Data
SpO2 Accuracy: The Sansa device's SpO2 measurements were compared to arterial blood gas samples in healthy subjects over the range of 70-100% oxygen saturation according to Section 201.12.1 of ISO 80601-2-61 and Pulse Oximeters-Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, Issued March 2013. The average root mean square error (Agws) met the required specifications of ≤ 3.5% for reflectance technology.
| Subgroup | Category | Arms (70-100%) |
|---|---|---|
| Overall | 2.4 | |
| Fitzpatrick | 1-2 | 2.2 |
| 3-4 | 3.7 | |
| 5-6 | 1.7 | |
| Sex | Male | 2.4 |
| Female | 2.4 |
Comparison to PSG: Sansa clinical performance was compared to the gold standard polysomnography (PSG) in a prospective multi-center clinical study in the United States (n = 533). Clinically acceptable performance between Sansa and PSG was demonstrated across all diagnostic conditions. The results of the study support that Sansa is sufficiently accurate as an aid to diagnose moderate to severe SDB. The study was demographically representative of patients with SDB across age, sex, race, ethnicity, BMI, and skin tone.
The Sansa device yielded the following diagnostic performance to diagnose moderate to severe SDB: Sensitivity of 88.2% (95% Cl: 81.3, 93.2), Specificity of 87.3% (95% Cl: 82.1, 91.5).
Subgroup analysis on race showed the following performance: White: Sensitivity of 88.1% (95% C: 79.2, 94.1) and Specificity of 83.7% (95% Cl: 76.7, 89.3); Black: Sensitivity of 86.8% (95% Cl: 71.9, 95.6) and Specificity of 96.4% (95% Cl: 87.5, 99.6); and All Other Races: Sensitivity of 100% (95% Cl: 47.8, 100) and Specificity of 90.9% (95% Cl: 58.7, 99.8). Subgroup analysis on Fitzpatrick score showed the following performance: 1-4: Sensitivity of 90.4% (95% Cl: 83.5, 95.1) and Specificity of 87.4% (95% Cl: 81.9, 91.8); 5-6: Sensitivity of 66.7% (95% Cl: 34.9, 90.1) and Specificity of 86.4% (95% Cl: 65.1, 97.1). Subgroup analysis on BMI (kg/m2) showed the following performance: ≤30: Sensitivity of 85.7% (95% Cl: 69.7, 95.2) and Specificity of 90.3% (95% Cl: 82.9, 95.2); >30: Sensitivity of 89.1% (95% Cl: 80.9, 94.7) and Specificity of 84.5% (95% CI: 76.4, 90.7).
The Sansa device Al based Sleep/Wake classification algorithm was trained on 101 subjects and validated against the validation dataset (n=340 ITD) taken from gold standard scored PSG data. This validated classification resulted in a performance of Sensitivity (Sleep): 95% Cl: 95, 95) and Specificity (Sleep): 63% (95% CI: 62, 64).
13
510(k) Summary
Conclusion
The SANSA HSAT is substantially equivalent to the legally marketed predicate device as demonstrated by the similar indication for use, similar technologies and performance data, and does not raise different questions of safety and effectiveness.