(258 days)
Not Found
No
The description focuses on basic activity monitoring and statistical reporting, with no mention of AI/ML terms or complex analytical methods that would typically indicate their use. The comparison to a predicate device also suggests a similar, non-AI/ML based technology.
No
The device is used for monitoring and analysis of physiological data, not for treating or mitigating a disease or condition.
No
Explanation: The device is described as an activity monitor that measures, records, and scores movements. While it generates a report for a care provider containing statistical information about movements, its primary function is monitoring and data collection, not diagnosing a specific condition. The intended use is for "physiological monitoring" and to "analyze limb activity associated with movement during sleep," which points to tracking and assessing, rather than diagnosing.
No
The device description explicitly states that ActiSpec® consists of "a pair of toe bands containing firmware within the toe band housing" and that these toe bands are "small, battery-operated activity monitor[s] worn on the big (great) toe." This indicates the presence of physical hardware components (toe bands, housing, battery, accelerometer) in addition to the software/firmware.
Based on the provided information, the ActiSpec® device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This includes things like blood, urine, tissue, etc.
- ActiSpec® is a wearable device that measures physical activity on the human body. It uses an accelerometer to detect movement.
The device's function is to monitor and record physical activity, not to analyze biological samples for diagnostic purposes. While the data collected might be used by a care provider to inform a diagnosis or treatment plan, the device itself is not performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
ActiSpec® is a small limb worn activity monitor designed for documents associated with applications in physiological monitoring. The device intended use is to analyze limb activity associated with movement during sleep. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.
Product codes (comma separated list FDA assigned to the subject device)
ISD
Device Description
ActiSpec® consists of a pair of toe bands containing firmware within the toe band housing, and an offline data download, scoring, and report generation tool. The ActiSpec® toe band is a small, battery-operated activity monitor worn on the big (great) toe. ActiSpec® typically is packaged as a pair of toe bands, one for each big toe.
ActiSpec® measures, records, and scores movements caused by the contraction of the tibialis anterior muscle responsible for movement of the big toe and dorsiflexion of the ankle and foot. These movements are detected by the accelerometer.
The intention is for the patient to wear the toe bands only while sleeping for five (5) consecutive nights. After the fifth night, the patient returns the toe bands to Sleep Modus and a report is generated for the care provider.
The generated report contains statistical information regarding the movements of the patient each night including a graph showing those movements. The report is in the form of a PDF document emailed to the care provider.
ActiSpec® has a 2-year shelf life in addition to a 120-hour active data collection period. Device activation occurs upon removal of the toe bands from the light-proof packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Big (great) toe
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Testing has been performed to demonstrate that the ActiSpec® meets the predetermined specifications. In addition, a bench comparison was performed between ActiSpec® and the predicate ActiTrainer device. Comparison testing demonstrates that the event recording capabilities of the devices are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5360 Measuring exercise equipment.
(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2015
Sleep Modus, Inc. c/o Diane Rutherford Submissions Manager Ken Block Consulting 1201 Richardson Drive Suite 280 Richardson, Texas 75080-4403
Re: K143512
Trade/Device Name: ActiSpec Activity Monitor Regulation Number: 21 CFR 890.5360 Regulation Name: Measuring Exercise Equipment Regulatory Class: Class II Product Code: ISD Dated: July 30, 2015 Received: July 31, 2015
Dear Ms. Rutherford:
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 (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. 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143512
Device Name ActiSpec Activity Monitor
Indications for Use (Describe)
ActiSpec® is a small limb worn activity monitor designed for documents associated with applications in physiological monitoring. The device intended use is to analyze limb activity associated with movement during sleep. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.
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
| Submitter: | Sleep Modus, Inc.
1201 Richardson Drive, Suite 280-B
Richardson, TX 75080 | | | | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|--------------------------------------------------|--|--|
| Contact Person: | Sleep Modus, Inc.
Mr. Stanford P. Hudson
President
1201 Richardson Drive, Suite 280-B
Richardson, TX 75080
TEL: 214-405-4055
sphudson@sleepmodus.com | | | | |
| Date Prepared: | December 10, 2014 (revised August 17, 2015) | | | | |
| Trade Name: | ActiSpec® Activity Monitor | | | | |
| Common Name: | Activity Recording Device | | | | |
| Primary
Classification Name: | Measuring exercise equipment | | | | |
| Product Code: | ISD | Class 2 | 890.5360 | | |
| Predicate Devices: | K080545
K040554 | ActiTrainer
ActiGraph | ActiGraph, LLC
Manufacturing Technology, Inc. | | |
| Device Description: | ActiSpec® consists of a pair of toe bands containing firmware within the toe band
housing, and an offline data download, scoring, and report generation tool. The
ActiSpec® toe band is a small, battery-operated activity monitor worn on the big
(great) toe. ActiSpec® typically is packaged as a pair of toe bands, one for each big
toe.
ActiSpec® measures, records, and scores movements caused by the contraction of
the tibialis anterior muscle responsible for movement of the big toe and dorsiflexion
of the ankle and foot. These movements are detected by the accelerometer.
The intention is for the patient to wear the toe bands only while sleeping for five (5)
consecutive nights. After the fifth night, the patient returns the toe bands to Sleep
Modus and a report is generated for the care provider.
The generated report contains statistical information regarding the movements of the
patient each night including a graph showing those movements. The report is in the
form of a PDF document emailed to the care provider.
ActiSpec® has a 2-year shelf life in addition to a 120-hour active data collection
period. Device activation occurs upon removal of the toe bands from the light-proof
packaging. | | | | |
| Statement of
Intended Use: | ActiSpec® is a small limb worn activity monitor designed for documenting physical
movements associated with applications in physiological monitoring. The device's
intended use is to analyze limb activity associated with movement during sleep. The
unit can also be used to assess activity in any instance where quantifiable analysis of
physical motion is desirable. | | | | |
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Image /page/4/Picture/0 description: The image shows the logo for Sleep Modus. The logo consists of a blue circle with a white waveform inside, followed by the text "sleep MODUS" in blue. The text is in a sans-serif font, with "sleep" in lowercase and "MODUS" in uppercase.
Summary of Technological Characteristics: ActiSpec® utilizes an accelerometer to monitor the occurrence of motion. The firmware utilizes a specified time base which defines an epoch. The firmware accepts notifications from the accelerometer of changes in acceleration that exceed a specified threshold. If a notification occurs within an epoch, then the firmware marks that epoch location to indicate the movement within onboard non-volatile memory. Otherwise, it marks the location to indicate that no movement occurred within that epoch. As described previously, ActiSpec® measures, records, and scores movements caused by the contraction of the tibialis anterior muscle
The accelerometer is configured to notify firmware if the slope of acceleration exceeds the threshold. The accelerometer, as configured by firmware, has an effective sample rate of 10Hz and draws minimal current during non-sampling periods which enables the ActiSpec® device to achieve the 120-hour active time without requiring firmware to continually extract samples from the chip.
The ActiSpec® toe band and battery are disposable with the accelerometer, microcontroller, non-volatile memory, and optical activation circuit being re-usable (recyclable) electronics.
When compared to the predicate devices, all share the same indications for use, are battery operated wearable activity recording devices, feature offline scoring and data processing, share the same device category, nature of body contact and duration of contact, and are non-sterile.
A few minor differences do exist between the proposed ActiSpec and the predicate devices. Most of these differences are driven by ActiSpec® being designed to be worn on the big toe while the ActiTrainer is worn on the wrist or foot and ActiGraph is worn on the wrist, ankle, or waist. Because the ActiSpec® is worn on the toe, the device is smaller and lighter. Also, the ActiSpec is to be used for one recording cycle and is worn only during sleep, so the requirements on the battery, memory, and recording time are less than that of the predicates which are typically worn for 24 hours a day for seven consecutive days.
The ActiSpec shares the same acceleration sensitivity with the predicate ActiTrainer but utilizes a fixed acceleration threshold of 0.1g while the ActiTrainer allows the user to define the movement threshold. The ActiSpec has an epoch period of 0.5 seconds, which is the minimum duration of candidate movements according to standard scoring of periodic limb (foot) movements during sleep. The ActiTrainer allows for an epoch to be a minimum of 1.0 seconds to a maximum of 4 minutes. In spite of these differences, comparison testing demonstrates that the event recording capabilities of the devices are substantially equivalent.
Testing has been performed to demonstrate that the ActiSpec® meets the Summary of Non-Clinical Data: predetermined specifications. In addition, a bench comparison was performed between ActiSpec® and the predicate ActiTrainer device. Test Data:
Sleep Modus, Inc. considers the ActiSpec® to be substantially equivalent to the Conclusion: predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.