(155 days)
MotionWatch (K132764)
No. The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on data capture and storage without mentioning any AI-driven analysis on the device itself.
No
The device is described as an "activity monitor designed for documenting physical movement" and is intended to "monitor the activity associated with movement during sleep." Its analysis capabilities are for "quantifiable analysis of physical motion." There is no mention of treating or preventing any condition.
No
The device is an activity monitor that collects physical movement data for analysis of circadian rhythms and activity. It is not described as providing a diagnosis or diagnostic information.
No
The device is not a software-only medical device because the device description explicitly states it includes a "wearable biosensor (PW010)" which is a hardware component. Additionally, the performance studies include "Bench testing with the biosensor" and "EMC testing per IEC 60601-1-2", "Wireless coexistence testing per ANSI C63.27", "Radiated Spurious Emissions testing per 47 CFR 15.247", and "Electrical Safety testing per IEC 60601-1 and IEC 60601-1-11 safety standards", all of which apply to hardware.
No.
Reasoning: The device monitors physical movement/activity, which is a physiological parameter, not an in vitro diagnostic measurement (analysis of specimens from the human body).
N/A
Intended Use / Indications for Use
DCM is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.
The device is intended to monitor the activity associated with movement during sleep.
DCM can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
Product codes
LEL
Device Description
DCM is a wrist-worn wearable device intended to continuously record high resolution digital acceleration data associated with a patient's physical movement.
In practice, a healthcare professional or researcher can prescribe the device to collect physiological data from patients during sleep and in applications where quantifiable analysis of physical motion is desirable.
The device is set up to collect data by the healthcare professional then placed on the subject's wrist. The device is designed to be worn during normal activities and/or during sleep over a period of days to weeks. The patient does not need to interact with the device to control data collection.
The data stored on the device can be transmitted to the cloud for storage, and made accessible to healthcare professionals or researchers for further analysis. Downloaded data can be post-processed based on the timestamp and magnitude of acceleration along each axis.
The DCM system comprises a system of components:
- wearable biosensor (PW010)
- off the shelf mobile device (PW030) running the DCM mobile app (PW400)
- cloud-based data storage and data processing (PW100) (back-end)
- investigator dashboard (PW500) accessed through a web browser (front-end)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
Adult
Intended User / Care Setting
Healthcare professional or researcher prescribes and sets up the device, patient wears the device. Data is accessible to healthcare professionals or researchers.
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)
The 510(k) summary of the primary predicate device does not include detailed information on testing that would allow for comparison. However, other biofeedback devices such as MotionWatch (K132764) include testing information similar to the table below that summarizes tests performed to establish the safety and effectiveness of DCM.
Bench testing:
- System shall measure acceleration with accuracy of 5% or better (at 1g), in 3 orthogonal directions with sensitivity to at least 0.005g. Result: PASS.
- System shall capture sensor data with timing accuracy within ±10 seconds per hour. Result: PASS.
- In case of connectivity issues, data is stored on the device until it can be transferred. Result: PASS.
Usability:
- Usability complies with the requirements of IEC 62366-1 in relation to safety. Result: PASS.
Packaging:
- Testing to confirm that the packaging design and construction is suitable to protect the system components during exposure to typical shipping stresses and rough handling. Result: PASS.
EMC:
- EMC testing per IEC 60601-1-2 and 47 CFR Part 15 Subpart B. Result: PASS.
Wireless Coexistence:
- Wireless coexistence testing per ANSI C63.27. Result: PASS.
Radio Frequency:
- Radiated Spurious Emissions testing per 47 CFR 15.247. Result: PASS.
Electrical Safety:
- Testing to verify applicable clauses of IEC 60601-1 and IEC 60601-1-11 safety standards. Result: PASS.
Software verification and validation:
- Software developed and tested per IEC 62304. Result: PASS.
Clinical Testing:
DCM did not require clinical studies to support substantial equivalence to the predicate device.
Non-clinical and human factors testing results indicate that the device meets user needs and that it is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Actigraph LEAP (K231532)
Reference Device(s)
MotionWatch (K132764)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.
FDA 510(k) Clearance Letter - DCM (PW-DCM)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov
April 16, 2025
PneumoWave, Ltd
Stuart Kelly
Director of Engineering & Chief Technical Officer
Suites 3 and 4, Second Floor, Maxim 3
Maxim Office Park, Parklands Avenue
Eurocentral, ML1 4WQ
United Kingdom
Re: K243513
Trade/Device Name: DCM (PW-DCM)
Regulation Number: 21 CFR 882.5050
Regulation Name: Biofeedback Device
Regulatory Class: Class II
Product Code: LEL
Dated: March 14, 2025
Received: March 17, 2025
Dear Stuart Kelly:
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.
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"
Page 2
K243513 - Stuart Kelly Page 2
(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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K243513 - Stuart Kelly Page 3
Sincerely,
Jay R. Gupta -S
Jay Gupta
Assistant Director
DHT5A: Division of Neurosurgical,
Neurointerventional, and
Neurodiagnostic Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K243513
Device Name
DCM (PW-DCM)
Indications for Use (Describe)
DCM is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.
The device is intended to monitor the activity associated with movement during sleep.
DCM can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
DCM is indicated for monitoring of adult patients only.
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:
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Page 5
510(k) Summary
March 14, 2025
Submitter Information:
PneumoWave Limited
Suites 3 and 4,
Second Floor, Maxim 3
Maxim Office Park
Parklands Ave
Eurocentral ML1 4WQ
United Kingdom
Contact:
Stuart Kelly
Director of Engineering and CTO
+44 (0)7505 710 276
Device Information:
Proprietary Name: DCM
Common Name: Movement Assessment Device
Classification Name: Biofeedback Device
Classification Codes: LEL
Regulation Number: 21 CFR §882.5050
Predicate Devices:
Actigraph LEAP (K231532)
Actigraph, LLC
Indications for Use:
DCM is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.
The device is intended to monitor the activity associated with movement during sleep.
DCM can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
Page 6
DCM 510(k) Summary March 2025 2 of 7
DCM is indicated for monitoring of adult patients only.
Device Description:
DCM is a wrist-worn wearable device intended to continuously record high resolution digital acceleration data associated with a patient's physical movement.
In practice, a healthcare professional or researcher can prescribe the device to collect physiological data from patients during sleep and in applications where quantifiable analysis of physical motion is desirable.
The device is set up to collect data by the healthcare professional then placed on the subject's wrist. The device is designed to be worn during normal activities and/or during sleep over a period of days to weeks. The patient does not need to interact with the device to control data collection.
The data stored on the device can be transmitted to the cloud for storage, and made accessible to healthcare professionals or researchers for further analysis. Downloaded data can be post-processed based on the timestamp and magnitude of acceleration along each axis.
The DCM system comprises a system of components:
- wearable biosensor (PW010)
- off the shelf mobile device (PW030) running the DCM mobile app (PW400)
- cloud-based data storage and data processing (PW100) (back-end)
- investigator dashboard (PW500) accessed through a web browser (front-end)
Comparison to the Predicate:
The table below compares the DCM device to the Actigraph LEAP (K231532).
Page 7
DCM 510(k) Summary March 2025 3 of 7
| Subject Device: DCM | Predicate: Actigraph Leap (K231532) | Comments | |
|---|---|---|---|
| Indications for use | DCM is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. |
The device is intended to monitor the activity associated with movement during sleep.
DCM can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
DCM is indicated for monitoring of adult patients only. | The ActiGraph LEAP™ is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.
The device is intended to monitor the activity associated with movement during sleep.
The ActiGraph LEAP™ can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable. | Equivalent |
| Intended patient population | Adult | Adult | Equivalent
Not intended for paediatric use |
| Prescription or OTC | Prescription | Prescription | Equivalent |
| Classification & Product code | 882.5050, LEL | 882.5050, LEL | Equivalent |
| Where device is worn (anatomical site) | Wrist | Wrist | Equivalent |
| What the device measures | Physical activity | Physical activity | Equivalent |
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DCM 510(k) Summary March 2025 4 of 7
| Subject Device: DCM | Predicate: Actigraph Leap (K231532) | Comments | |
|---|---|---|---|
| Use during rest/motion | During motion and at rest | During motion and at rest | Equivalent |
| Spot checking / continuous measurement | Continuous measurement | Continuous measurement | Equivalent |
| Real time monitoring / retrospective evaluation | Retrospective | Retrospective | Equivalent |
| Operating principle | Measurement of linear accelerations in 3-axes associated with the patient's physical movement. | Measurement of linear accelerations in 3-axes associated with the patient's physical movement. | Equivalent |
| Biosensor sensor type | Triaxial MEMS accelerometer | Triaxial MEMS accelerometer | Equivalent |
| Biosensor sensitivity/resolution | 0.061mg/LSB | 3 mg/LSB | Equivalent: Similar range |
| Biosensor dynamic range | +/-2 g | +/-8 g | Equivalent: Similar range |
| Biosensor frequency | 12.5Hz | 32-256Hz | Equivalent: Similar range |
| Battery | Lithium coin-cell battery [CR2032] | Lithium rechargeable battery, max 4.2V | Equivalent: Both lithium batteries |
| Mounting components | Biosensor is mounted on an EKG electrode (Vermed A10005SG (Nissha Medical) or Skintact FS-40 (Leonhard Lang GmbH) which can be placed directly on the wrist, or attached to a wrist strap | Armband/strap | Equivalent: Biosensor can be mounted in the same way as predicate. |
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DCM 510(k) Summary March 2025 5 of 7
| Subject Device: DCM | Predicate: Actigraph Leap (K231532) | Comments | |
|---|---|---|---|
| Skin contacting material | Biosensor: PC/ABS plastic |
EKG Electrode fixation patch: PET foam with acrylate skin adhesive (off the shelf EKG electrode) | Housing: Plastic polyamide (Chendong PA+50%GF CP9021 F60LW BK3027F)
Lens: Hardened glass (Caihong CG01pro+ high aluminosilicate glass)
Strap (band) and buckle: Silicon (Midgold GF2041E) and Plastic polyamide (Chendong PA+50%GF CP9021 F60LW BK3027F)
Bottom case lens: Nylon | Equivalent: All skin contacting materials are biocompatible polymers. |
| Software and firmware | Mobile app is preloaded onto an off the shelf mobile device. The mobile app sends data to the cloud. The health care professional accesses a web-based dashboard for data transfer. | Embedded firmware for microcontroller which does not connect to the internet. Communication software for data transfer. | Equivalent |
| User interface | Mobile app screen shows battery level, functional status and time of day. No data measures or feedback to patient (Health care professionals can access the web-based dashboard). | Device screen shows battery level, functional status, and time of day. No data measures or feedback to patient. | Equivalent |
| Sterility | Supplied non-sterile | Supplied non-sterile | Equivalent |
| Respiratory rate measurement | None | None | Equivalent |
| Apnea claims | None | None | Equivalent |
| Alarms / Alerts | None | None | Equivalent |
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DCM 510(k) Summary March 2025 6 of 7
Summary of Testing
The 510(k) summary of the primary predicate device does not include detailed information on testing that would allow for comparison. However, other biofeedback devices such as MotionWatch (K132764) include testing information similar to the table below that summarizes tests performed to establish the safety and effectiveness of DCM.
| Requirement | Test Method | Pass/Fail Criteria | Result |
|---|---|---|---|
| The system shall measure acceleration with accuracy of 5% or better (at 1g), in 3 orthogonal directions with sensitivity to at least 0.005g | Bench testing with the biosensor in a range of orientations. | Acceleration recorded by the device meets the requirements. |
Accelerometer accuracy to be tested across extended duration data collection runs to confirm that there is no sensor drift. | PASS |
| The system shall capture sensor data with timing accuracy within ±10 seconds per hour | Bench testing with mobile app paired to biosensor for the length of a typical session, timestamps inspected. | Data is transmitted to the cloud and the timestamps are visible and accurate within the requirements when viewed in the Investigator Dashboard. | PASS |
| In case of connectivity issues, data is stored on the device until it can be transferred. | Bench testing with mobile app paired with biosensor, manual interruption and restoration of connectivity, followed by inspection of data. | Data is stored on the biosensor when connection to the mobile device is interrupted and transferred when connection is restored.
Data is stored on the mobile device when connection to the cloud platform is interrupted and transferred when connection is restored. | PASS |
| Usability | Usability complies with the requirements of IEC 62366-1 in relation to safety | Usability activities are conducted according to the IEC 62366-1 process and demonstrates that the usability of the medical device is acceptable with regard to safety | PASS |
Page 11
DCM 510(k) Summary March 2025 7 of 7
| Requirement | Test Method | Pass/Fail Criteria | Result |
|---|---|---|---|
| Packaging | Testing to confirm that the packaging design and construction is suitable to protect the system components during exposure to typical shipping stresses and rough handling. | Device meets visual inspection criteria and passes functional tests following exposure to typical shipping stresses and rough handling | PASS |
| EMC | EMC testing per IEC 60601-1-2 and 47 CFR Part 15 Subpart B. | Device meets requirements for emissions (Class B) and immunity | PASS |
| Wireless Coexistence | Wireless coexistence testing per ANSI C63.27 | No interruption to wireless data connections. | PASS |
| Radio Frequency | Radiated Spurious Emissions testing per 47 CFR 15.247 | Device meets requirements for spurious emissions. | PASS |
| Electrical Safety | Testing to verify applicable clauses of IEC 60601-1 and IEC 60601-1-11 safety standards | Device meets applicable requirements for electrical, mechanical and thermal safety, for healthcare and home use environments. | PASS |
| Software verification and validation | Software developed and tested per IEC 62304 | Software developed and maintained in accordance with the IEC 62304 lifecycle process, and all verification and validation test passed | PASS |
Clinical Testing
DCM did not require clinical studies to support substantial equivalence to the predicate device.
Non-clinical and human factors testing results indicate that the device meets user needs and that it is safe and effective for its intended use.
Conclusions
DCM is substantially equivalent to the predicate device with respect to intended use, design features, technological characteristics, and performance criteria. All predetermined pass/fail criteria were met.