(29 days)
Not Found
Yes
The device description explicitly states that the cloud-based algorithm "utilizes a combination of signal processing and AI/ML components".
No.
The device is intended to aid in the evaluation and diagnosis of sleep-related breathing disorders by recording and storing biophysical parameters, not to treat them.
Yes
The device's intended use is to aid in the evaluation of sleep-related breathing disorders, it records and analyzes biophysical parameters, and outputs metrics like Apnea Hypopnea Index (AHI) for clinician review, all of which are characteristic of a diagnostic device.
No
The device description explicitly states it is a "wearable device" that "collects multiple physiological signals using a single wearable patch worn on the chest." It also details the inclusion of hardware components like a "reflective PPG sensor, a single-lead ECG sensor, and a 3-axis accelerometer." This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Huxley Home Sleep Apnea Test (SANSA) is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The SANSA device is a wearable device that collects physiological signals directly from the patient's body (chest). It does not analyze samples like blood, urine, or tissue.
- The intended use and device description clearly state it's a wearable device for recording and storing biophysical parameters. This aligns with a diagnostic device that measures physiological signals, not an IVD that analyzes biological samples.
- The device description details sensors for PPG, ECG, and accelerometer. These are all used for measuring physiological responses, not for analyzing biological specimens.
Therefore, the SANSA device falls under the category of a diagnostic device that measures physiological parameters, rather than an In Vitro Diagnostic device.
No
The input text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" is marked as "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 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.
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 setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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%
Predicate Device(s)
SANSA HSAT (K240285)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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
3
Indications for Use
510(k) Number (if known) K244027
Device Name SANSA HSAT
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) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/2 description: The image shows the logo for Huxley Medical. The logo is in a light gray color and features the word "HUXLEY" in a stylized font. Below the word "HUXLEY" is the word "MEDICAL" in a smaller, sans-serif font. The "TM" symbol is located to the right of the letter "Y" in "HUXLEY".
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 217
Atlanta, GA, 30318
info@huxleymed.com |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Contact: | Grace Powers, MS, MBA, RAC
Founder/Principal Consultant
Powers Regulatory Consulting
grace@powersregulatory.com |
| Submission Date: | December 27, 2024 |
| Subject Device: | Trade Name: SANSA HSAT
Common Name: Ventilatory Effort Recorder
Classification Name: Breathing Frequency
Monitor Regulation: 21 CFR §868.2375
Regulatory Classification: Class 2
Product Code: MNR |
| Predicate Device: | SANSA HSAT (K240285) |
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
5
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.
| Device
Comparison | Predicate Device:
SANSA HSAT (K240285) | Subject Device:
SANSA HSAT | Comparison |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Huxley Medical, Inc. | Huxley Medical, Inc. | Identical |
| FDA Product
Code | MNR | MNR | Identical |
| Regulation | 868.2375 | 868.2375 | Identical |
| Classification | II | II | Identical |
| Classification
Name | Ventilatory Effort Recorder | Ventilatory Effort Recorder | Identical |
| Advisory
Committee | Anesthesiology | Anesthesiology | Identical |
| Prescription
Use? | Yes | Yes | Identical |
| Indications for
Use | The Huxley Home Sleep Apnea
Test (SANSATM) 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). | The Huxley Home Sleep Apnea
Test (SANSATM Cellular) 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). | Identical |
| Target
Population | Adults (22 years age and older) | Adults (22 years age and older) | Identical |
| Intended Use
Environment | Clinics and Home Use | Clinics and Home Use | Identical |
| Device
Placement for
Data Collection | Chest sensor | Chest sensor | Identical |
| Device Sensors | Chest Sensor
Accelerometer
ECG | Chest Sensor
Accelerometer
ECG | Identical |
| | Reflectance Photo-
plethysmography | Reflectance Photo-
plethysmography | |
| 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
Respiratory effort
Actigraphy
Sleep stage (Sleep/Wake)
ECG (Reference channel only) | Identical |
| Analysis
Outputs | sAHI
Body Position Discrete States
Heart Rate
Total Sleep Time
SpO2 | sAHI
Body Position Discrete States
Heart Rate
Total Sleep Time
SpO2 | Identical |
| 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% | 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% | Identical |
| Data Collection
and Transfer | Patient data is physically
transferred via USB after study
conclusion. | Patient data is wirelessly
transferred via Cellular (LTE-M) at
the conclusion of the study. In the
event of no connectivity or failed
transfer,
patient data is physically
transferred via USB after study
conclusion. | Similar — Cellular
connectivity
addition does not
impact use, safety,
or effectiveness of
the device. |
| Recording
Capacity | Approx. 10 hours per study. 2
nights of study maximum. | Approx. 10 hours per study. 2
nights of study maximum. | Identical |
| Energy Source | Rechargeable Lithium Polymer
Battery | Rechargeable Lithium Polymer
Battery | Identical |
| Analysis
Software | Analysis performed off the
recording device, on a compatible | Analysis performed off the
recording device, on a compatible | Identical |
Table 1: Device Comparison
6
7
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.