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).

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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Huxley SANSA Home Sleep Apnea Test (SANSA HSAT), based solely on the provided text:

1. Table of acceptance criteria and the reported device performance:

Performance Metric	Acceptance Criteria (Predicate Device)	Reported Device Performance (SANSA HSAT)
Heart Rate Accuracy	30-300 bpm ± the greater of ±10% or ±5 bpm	Arms ≤ 3 bpm (range 30-250 bpm)
SpO2 Accuracy (70-100%)	Arms ≤ 3%	Arms ≤ 3%
Aid to Diagnosis of Moderate to Severe OSA (AHI≥15): Sensitivity	90%	88.2% (95% Cl: 81.3, 93.2)
Aid to Diagnosis of Moderate to Severe OSA (AHI≥15): Specificity	98%	87.3% (95% Cl: 82.1, 91.5)
SpO2 Average Root Mean Square Error (Agrms)	≤ 3.5% (for reflectance technology)	2.4% (Overall)
Sleep/Wake Classification: Sensitivity (Sleep)	(Not explicitly stated in reported predicate performance)	95% (95% Cl: 95, 95)
Sleep/Wake Classification: Specificity (Sleep)	(Not explicitly stated in reported predicate performance)	63% (95% CI: 62, 64)

Note: The table combines the "Performance" section for the predicate and subject devices from the Device Comparison table (page 7) and the "Clinical Performance Data" section for additional reported performance values (page 12). For Sleep/Wake classification, no direct "acceptance criteria" based on the predicate were provided in the document.

2. Sample size used for the test set and the data provenance:

SpO2 Accuracy Test Set: The number of subjects is not explicitly stated, but the test was conducted on "healthy subjects" (page 12).
Comparison to PSG (Moderate to Severe SDB Diagnosis Test Set):
- Sample Size: n = 533
- Data Provenance: Prospective multi-center clinical study in the United States (page 12).
Sleep/Wake Classification Validation Test Set:
- Sample Size: n = 340 (ITD - likely "Intention To Diagnose")
- Data Provenance: Not explicitly stated beyond being "gold standard scored PSG data" (page 12).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not explicitly provided in the text. The ground truth for the comparison to PSG study is stated as "gold standard polysomnography (PSG)" (page 12), and for SpO2, it's "arterial blood gas samples" (page 12). While PSG scoring generally involves experts (e.g., sleep specialists, polysomnographic technologists), the number and specific qualifications of these experts are not detailed in this document.

4. Adjudication method for the test set:

This information is not explicitly provided in the text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not explicitly described. The study focused on the standalone diagnostic performance of the SANSA device compared to PSG. The predicate device's diagnostic performance is noted as being based on "manual scoring of data by HCP" (Healthcare Professional), while the subject device "utilizes an autoscored algorithm with no overread and correction." This suggests a comparison of the AI-driven auto-scoring performance to a human-scored gold standard, but not a study of human readers improving with AI assistance.

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

Yes, a standalone performance study was done. The "Comparison to PSG" study (n=533) directly evaluates the diagnostic performance of the SANSA device's algorithm for moderate to severe SDB, stating it "utilizes an autoscored algorithm with no overread and correction" (page 7) and yielded specific sensitivity and specificity values. The Sleep/Wake classification also reports algorithm-only performance.

7. The type of ground truth used:

For SpO2 Accuracy: Arterial blood gas samples (page 12).
For comparison to PSG (SDB diagnosis) and Sleep/Wake classification: Gold standard polysomnography (PSG) data (page 12).

8. The sample size for the training set:

For the Sansa device AI-based Sleep/Wake classification algorithm: 101 subjects (page 12).
For other algorithms (e.g., AHI calculation): This information is not explicitly provided.

9. How the ground truth for the training set was established:

For the Sansa device AI-based Sleep/Wake classification algorithm: The algorithm was "trained on 101 subjects and validated against the validation dataset (n=340 ITD) taken from gold standard scored PSG data" (page 12). This implies the ground truth for the training set was also established using "gold standard scored PSG data."
For other algorithms: This information is not explicitly provided.

Summary

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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.

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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.

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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

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Indications for Use

510(k) Number (if known) K240285

Device Name Huxley SANSA Home Sleep Apnea Test (1000-00)

Indications for Use (Describe)

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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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

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. ↑

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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

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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).

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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.

DeviceComparison	Subject Device: SANSAHSAT - K240285	Predicate Device: ANNE SleepK220095	Reference Device(listed for specifictechnicalcharacteristics)	Comparison
Manufacturer	Huxley Medical, Inc.	Sibel, Inc.	N/A	N/A
FDA ProductCode	MNR	MNR	N/A	Identical
Regulation	868.2375	868.2375	N/A	Identical
Classification	II	II	N/A	Identical
ClassificationName	Ventilatory Effort Recorder	Ventilatory Effort Recorder	N/A	Identical
AdvisoryCommittee	Anesthesiology	Anesthesiology	N/A	Identical
PrescriptionUse?	Yes	Yes	N/A	Identical
Indications forUse	The SANSA Home SleepApnea Test (SANSA HSAT) isa wearable device intendedfor use in the recording,analysis, and storage ofbiophysical parameters toaid in the evaluation ofsleep-related breathingdisorders of adultssuspected of sleep apnea.The device is intended forthe clinical and/or home usesetting under the directionof a Healthcare Professional(HCP).	Anne Sleep is a wearablesensor system intended for usein the collection, analysis,display, and storage ofphysiological parameters to aidin the evaluation of sleep-related breathing disorders ofadult patients suspected ofsleep apnea. The device isintended for use in the clinicaland home setting under thedirection and interpretation bya Healthcare Professional(HCP).	N/A	Similar- The subject andpredicate device have similarindications for use. Both are usedto aid in the evaluation of sleep-related breathing disorders.
DeviceComparison	Subject Device: SANSAHSAT - K240285	Predicate Device: ANNE SleepK220095	Reference Device(listed for specifictechnical characteristics)	Comparison
TargetPopulation	Adults (22 years age andolder)	22 years age and older	N/A	Identical
Intended UseEnvironment	Clinics and Home Use	Recording in the homeenvironment with the report andinterpretation performed in theclinical setting.	N/A	Similar- The subject and predicatedevices are both able to be usedat home. The subject device canalso be used in theclinical setting. Both the device'sdata are interpreted by clinicians.
DevicePlacement forData Collection	Chest sensor	Chest and finger sensors	BioBeat platform,BB-613WP PatchK212153: ChestSensor	Similar- Devices utilize chestsensors. Chest placement tocollect oximetry is supportedby the reference device.
Device Sensors	Chest SensorAccelerometer ECGReflectance Photo-plethysmography	Limb sensor Chest sensorAccelerometer ECGPhoto- plethysmography	BioBeat platform,BB-613WP PatchK212153:Reflectance Photo-plethysmography	Similar- The subject and predicatedevice both use accelerometer,ECG, andphotoplethysmography (PPG)sensors.
Channels	Oximetry Heart rateChest movementSnoringBody positionRespiratory effortActigraphySleep stage(Sleep/Wake) ECG(Reference channelonly)	Oximetry Heart rateChest movementSnoringBody position Pulse ratePeripheral arterial tonometry(PAT)	Wesper (K203343)relevant channel:Respiratory EffortWatchPAT One(K183559) relevantchannel:ActigraphySleep stage(Sleep/Wake)	Substantially equivalent:Each of the channels from thesubject device is provided by thepredicate and / or referencedevices.
DeviceComparison	Subject Device: SANSAHSAT - K240285	Predicate Device: ANNE SleepK220095	Reference Device(listed for specifictechnicalcharacteristics)	Comparison
AnalysisOutputs	sAHIBody Position DiscreteStatesHeart RateTotal Sleep Time SpO2	Sibel-AHI (based on manualscoring of data by HCP) BodyPosition Discrete States HeartRateTotal Sleep Time SpO2	N/A	Substantially equivalent:The subject device providessimilar analysis to the predicatedevice.
Performance	Heart Rate: Arms ≤ 3bpm (range 30-250bpm)SpO2: Arms ≤ 3% (range70-100%)Aid to Diagnosis ofModerate to SevereOSA (AHI≥15):Sensitivity 88.2%,Specificity87.3%	Pulse Rate: 30-300 bpm ± 3 bpmHeart Rate: 30-300 bpm ± thegreater of ±10% or ±5 bpmSpO2: Arms ≤ 3% (range 70-100%)Aid to Diagnosis of Moderate toSevere OSA (AHI≥15): Sensitivity90%, Specificity 98%	BioBeat platform,BB-613WP PatchK212153: Arms HR:±3%, HR Range: 40-250 bpm	Substantially equivalent: Thesubject device provides similarperformance to the predicatedevice.The subject device does notreport Pulse Rate.The predicate device diagnosticperformance is between manualscoring by HCP of Sibel and PSGdata, whereas the subject deviceutilizes an autoscored algorithmwith no overread and correction.Similar diagnostic performance isachieved with comparable HSATdevices utilizing autoscorealgorithms.

Table 1: Device Comparison

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Traditional 510(k) — Huxley SANSA Home Sleep Apnea Test (1000-00)

K240285 - 510(k) Summary

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Traditional 510(k) — Huxley SANSA Home Sleep Apnea Test (1000-00)

K240285 - 510(k) Summary

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K240285 - 510(k) Summary

DeviceComparison	Subject Device: SANSAHSAT- K240285	Predicate Device: ANNE SleepK220095	Reference Device(listed for specifictechnicalcharacteristics)	Comparison
Data Collectionand Transfer	Patient data isphysically transferredvia USB after studyconclusion.	Patient data is wirelesslytransferred via Bluetooth fromthe sensors to a mobile phone.Data is then wirelesslytransferred from the phone tothe cloud when connected tothe internet.	N/A	Similar:The subject device and predicatedevice both transfer patient datafrom the device to a cloud-basedsoftware platform for analysis.The subject device utilizes wireddata transfer, whereas thepredicate device utilizes wirelesstransfer, but this difference doesnot impact safety or effectiveness.
RecordingCapacity	Approx. 10 hours perstudy. 2 nights of studymaximum.	36 hours of continuous use	WatchPAT One(K183559): Approx.10 hours	Substantially equivalent:The subject device and predicatedevice can both operate over afull night of sleep. Durationdifferences do not influencesafety or effectiveness.
Energy Source	Rechargeable LithiumPolymer Battery	Rechargeable Lithium PolymerBattery	N/A	Identical
AnalysisSoftware	Analysis performed offthe recording device,on a compatible cloud-based softwareplatform.	Analysis performed off therecording device, on acompatible cloud-basedsoftware 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).

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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.

Regulation Number and Section

§ 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).