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 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 used for diagnostic purposes and is not intended by any automated ECG analysis system or algorithm.

AI/ML Overview

This document (K244027) is a Special 510(k) submission for the SANSA HSAT device, focusing on adding cellular capability. This type of submission is used when a modification to an already cleared device does not significantly change its safety or effectiveness or its indications for use. Therefore, the information provided primarily concerns the equivalence of the modified device to its predicate (which is its own previous version, K240285).

The document states that there are no changes to the Indications for Use, physical hardware, principles of operation, device offerings, manufacturing process, or device packaging as part of the cellular update. This means that the core performance characteristics related to sleep apnea detection and physiological measurements have already been established and cleared with the predicate device.

Given this context, the document does not contain a new, comprehensive clinical study proving the device meets new acceptance criteria for its core function (sleep apnea detection). Instead, it focuses on non-clinical testing to demonstrate that the addition of cellular capability does not negatively impact the device's original performance and introduces no new safety or effectiveness concerns.

Therefore, many of the requested points regarding acceptance criteria and clinical study details for the sleep apnea detection function are not included in this specific Special 510(k) document, as they were addressed in the original clearance (K240285). The performance claims for the device (e.g., Sensitivity, Specificity for OSA) are listed as "Identical" to the predicate, meaning these were established in the predicate's clearance.

However, I can extract the information related to the changes made and the testing performed for this specific submission (K244027):

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For the specific change (cellular capability), the document does not present a table of new clinical acceptance criteria. Instead, it asserts that the performance remains "Identical" to the predicate, and non-clinical testing verifies that the cellular addition does not degrade this performance.

The "Performance" criteria listed under the "Device Comparison" table are for the main function of the device (sleep apnea detection and physiological measurements), which are stated to be identical to the predicate. These are not new acceptance criteria for the cellular update, but rather the previously established performance of the base device.

Performance Metric (from Predicate)	Acceptance Criteria (from Predicate)	Reported Device Performance (for Subject Device)
Heart Rate	Rms ≤ 3 bpm (range 30-250 bpm)	Rms ≤ 3 bpm (range 30-250 bpm) (Identical)
SpO2	Rms ≤ 3% (range 70-100%)	Rms ≤ 3% (range 70-100%) (Identical)
Aid to Diagnosis of Moderate to Severe OSA (AHI ≥ 15) Sensitivity	88.2%	88.2% (Identical)
Aid to Diagnosis of Moderate to Severe OSA (AHI ≥ 15) Specificity	87.3%	87.3% (Identical)

For the cellular capability itself, the acceptance is implicitly based on:

Successful wireless data transfer via Cellular (LTE-M).
No regression in existing functionality.
Maintenance of data integrity during upload.
Meeting cybersecurity requirements.
Compliance with wireless testing standards (FCC 47 CFR Part 15, Part 24, Part 27, Part 2).

2. Sample Size Used for the Test Set and Data Provenance

This Special 510(k) primarily relies on non-clinical testing for the cellular capability. Therefore, there is no "test set" in the sense of a patient cohort for a clinical study.

Test Set (for the cellular update): Not applicable in terms of patient data. The testing involved software testing, cybersecurity testing, and wireless testing. The sample size for these types of tests would be in terms of test cases, configurations, and test environments, not patient data.
Data Provenance: Not applicable for the cellular update. The statement "Identical" for performance refers to the original data from the predicate device's clearance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable for this Special 510(k) submission, as no new clinical study requiring ground truth establishment by experts for sleep apnea diagnosis was performed for the cellular update. The "Identical" performance refers to the ground truth established for the predicate device.

4. Adjudication Method for the Test Set

Not applicable for this Special 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This submission is for a modification (cellular capability) to an existing device, not a new AI-assisted diagnostic tool requiring a human-in-the-loop MRMC study. The "device performance" listed is for the standalone device, not in assistance with human readers in a comparative setting.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, the performance metrics (Sensitivity, Specificity for OSA, Heart Rate, SpO2 accuracy) listed in the "Device Comparison" table represent the standalone performance of the SANSA HSAT device's algorithms, without human intervention in the interpretation of these core metrics. These metrics are stated to be "Identical" to the predicate, implying this standalone performance was established during the predicate's clearance.

7. The Type of Ground Truth Used

For the core function of sleep apnea evaluation (sAHI, etc.), the document does not explicitly state the ground truth used. However, for sleep apnea diagnostics, the common ground truth is Polysomnography (PSG) scored by board-certified sleep technologists and interpreted by board-certified sleep physicians. Since the device aids in the evaluation of sleep-related breathing disorders, it's highly likely that full PSG served as the ground truth for the predicate device's performance validation. This document does not provide details of the ground truth for the predicate.

8. The Sample Size for the Training Set

The document does not provide information on the training set sample size. This would have been part of the original K240285 submission, as this document focuses only on changes related to cellular connectivity.

9. How the Ground Truth for the Training Set was Established

The document does not provide information on how the ground truth for the training set was established. This would have been part of the original K240285 submission.

Summary

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January 28, 2025

Huxley Medical % Grace Powers Founder/ Principal Consultant Powers Regulatory Consulting 2451 Cumberland Parkway SE Suite 3740 Atlanta, Georgia 30339

Re: K244027

Trade/Device Name: SANSA HSAT Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing frequency monitor Regulatory Class: Class II Product Code: MNR Dated: December 29, 2024 Received: December 30, 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/cdrh/cfdocs/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.

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.

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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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

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.

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

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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,

Rachana Visaria -S

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K244027

Device Name SANSA HSAT

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.

Sponsor:	Huxley Medical, Inc.1465 Northside Dr NW Ste 217Atlanta, GA, 30318info@huxleymed.com
Submission Contact:	Grace Powers, MS, MBA, RACFounder/Principal ConsultantPowers Regulatory Consultinggrace@powersregulatory.com
Submission Date:	December 27, 2024
Subject Device:	Trade Name: SANSA HSATCommon Name: Ventilatory Effort RecorderClassification Name: Breathing FrequencyMonitor Regulation: 21 CFR §868.2375Regulatory Classification: Class 2Product Code: MNR
Predicate Device:	SANSA HSAT (K240285)

Device Description

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hours per study. The ECG channel is used for diagnostic purposes and is not intended by any automated ECG analysis system or algorithm.

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).

Comparison between Subject and Predicate Device

The purpose of this Special 510(k) submission is to activate the cellular capability of the SANSA HSAT (subject device). This is a change to the manufacturer's (Huxley Medical) own previously cleared device (K240285). There is no change to the Indications for Use, physical hardware of the device, principles of operation, device offerings, manufacturing process or device packaging as part of the cellular update.

An overview comparison of the SANSA HSAT (subject device) to the predicate device is presented in the table below.

DeviceComparison	Predicate Device:SANSA HSAT (K240285)	Subject Device:SANSA HSAT	Comparison
Manufacturer	Huxley Medical, Inc.	Huxley Medical, Inc.	Identical
FDA ProductCode	MNR	MNR	Identical
Regulation	868.2375	868.2375	Identical
Classification	II	II	Identical
ClassificationName	Ventilatory Effort Recorder	Ventilatory Effort Recorder	Identical
AdvisoryCommittee	Anesthesiology	Anesthesiology	Identical
PrescriptionUse?	Yes	Yes	Identical
Indications forUse	The Huxley Home Sleep ApneaTest (SANSATM) is a wearabledevice intended for use in therecording, analysis, and storage ofbiophysical parameters to aid inthe evaluation of sleep-relatedbreathing disorders of adultssuspected of sleep apnea. Thedevice is intended for the clinicaland home use setting under thedirection of a HealthcareProfessional (HCP).	The Huxley Home Sleep ApneaTest (SANSATM Cellular) is awearable device intended for usein the recording, analysis, andstorage of biophysical parametersto aid in the evaluation of sleep-related breathing disorders ofadults suspected of sleepapnea. The device is intended forthe clinical and home use settingunder the direction of a HealthcareProfessional (HCP).	Identical
TargetPopulation	Adults (22 years age and older)	Adults (22 years age and older)	Identical
Intended UseEnvironment	Clinics and Home Use	Clinics and Home Use	Identical
DevicePlacement forData Collection	Chest sensor	Chest sensor	Identical
Device Sensors	Chest SensorAccelerometerECG	Chest SensorAccelerometerECG	Identical
	Reflectance Photo-plethysmography	Reflectance Photo-plethysmography
Channels	OximetryHeart rateChest movementSnoringBody positionRespiratory effortActigraphySleep stage (Sleep/Wake)ECG (Reference channel only)	OximetryHeart rateChest movementSnoringBody positionRespiratory effortActigraphySleep stage (Sleep/Wake)ECG (Reference channel only)	Identical
AnalysisOutputs	sAHIBody Position Discrete StatesHeart RateTotal Sleep TimeSpO2	sAHIBody Position Discrete StatesHeart RateTotal Sleep TimeSpO2	Identical
Performance	Heart Rate: Arms ≤ 3 bpm (range30-250 bpm)SpO2 Arms ≤ 3% (range 70-100%)Aid to Diagnosis of Moderate toSevere OSA (AHI≥15): Sensitivity88.2%, Specificity 87.3%	Heart Rate: Arms ≤ 3 bpm (range30-250 bpm)SpO2 Arms ≤ 3% (range 70-100%)Aid to Diagnosis of Moderate toSevere OSA (AHI≥15): Sensitivity88.2%, Specificity 87.3%	Identical
Data Collectionand Transfer	Patient data is physicallytransferred via USB after studyconclusion.	Patient data is wirelesslytransferred via Cellular (LTE-M) atthe conclusion of the study. In theevent of no connectivity or failedtransfer,patient data is physicallytransferred via USB after studyconclusion.	Similar — Cellularconnectivityaddition does notimpact use, safety,or effectiveness ofthe device.
RecordingCapacity	Approx. 10 hours per study. 2nights of study maximum.	Approx. 10 hours per study. 2nights of study maximum.	Identical
Energy Source	Rechargeable Lithium PolymerBattery	Rechargeable Lithium PolymerBattery	Identical
AnalysisSoftware	Analysis performed off therecording device, on a compatible	Analysis performed off therecording device, on a compatible	Identical

Table 1: Device Comparison

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Non-Clinical Performance Data

The following non-clinical testing was conducted to support device changes:

Software Unit & Integration Testing to test firmware, and Software Verification Testing at the system . level to verify the end-to-end functionality. This testing verified the additional features, ensuring that no regression occurred, and that the data integrity was not altered in the upload process
- Testing was conducted in accordance with IEC 62304, Medical device software Software life O 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 Controls Verify the additional cybersecurity controls added to mitigate ● cybersecurity risks in cellular upload.
- Cybersecurity Testing in accordance with "Guidance for Industry and Food and Drug O Administration Staff: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" issued September 27, 2023.
. Wireless Testing per FCC 47 CFR Part 15 Conducted and Radiated emissions, Part 24 and Part 27 Spurious Emissions, and SAR Testing per FCC 47 CFR Part 2.
- No coexistence testing was conducted as it was not required in accordance with AAMI TIR 69, O given the negligible risk tier of the device.

Conclusion

The SANSA HSAT is substantially equivalent to the legally marketed predicate device as demonstrated by the identical indications for use, performance data, and similar technologies, and therefore 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).