(182 days)
The VERABAND™ is a compact, lightweight, body-worn activity monitoring device designed to document physical movement associated with applications in physiological monitoring. The device is intended to monitor limb or body movements during daily living and sleep for a limited time interval (up to 30- days).
The VERABAND™ can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. VERABAND™ is not intended for diagnostic purposes.
The VERABANDTM is a compact, wrist-worn battery-operated wearable device intended for collecting a patient's motion data for assessing patient activity. VERABANDTM is intended to acquire and store data while being worn during normal activities and/or during sleep. The device consists of a wearable band with compact housing for battery-powered on-board electronics with an accelerometer. The recorded activity data is timestamped and stored in non- volatile memory for later retrieval. Downloaded VERABANDTM data can be post-processed based on the timestamp and magnitude of acceleration for reporting.
Here's a breakdown of the acceptance criteria and study information for the Veraband™ device based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accelerometer Accuracy and Precision | - Accelerometer shall meet full-range accuracy requirement.- Accelerometer shall meet static calibration point accuracy requirement.- Accelerometer shall meet repeatability and reproducibility requirement. | Pass |
| Activation Trigger | - Device shall activate at the required light level.- Device shall not activate while in the packaging. | Pass |
| Device Donning/Doffing | Device shall be able to survive the required donning and doffing. | Pass |
| Device Band Separation and Elongation Forces | - Device shall meet force requirements for elongation.- Device shall meet force requirements for separation. | Pass |
| Battery Life for Duration of Use | Device shall meet the battery life requirements for Expected Device Life. | Pass |
| User Cleaning | Device shall maintain function after a required minimum number of cleanings. | Pass |
| Device Sampling Rate and Full-Scale Dynamic Range | Device shall have a sampling rate and full-scale dynamic range that meets the requirements. | Pass |
| Device Frequency Response | Device shall be within the requirement of the predicate's bandwidth. | Pass |
| VERABAND™ Intended Use | Device shall meet repeatability and reproducibility requirements for activity levels. | Pass |
| VERABAND™ Report Generation Comparison | Device output metrics shall meet the predicate comparison requirements. | Pass |
| Usability | Device shall meet the related usability requirement survey scores. | Pass |
| Packaging Testing | Device shall maintain function per requirements after shipping. | Pass |
| EMC | Device shall meet the related EMC requirements. | Pass |
| Electrical Basic Safety | Device shall meet the related electrical basic safety requirements. | Pass |
| Biocompatibility Testing | Device shall meet the related biocompatibility requirements. | Pass |
| Firmware Verification and Validation Testing | Device shall meet the related Firmware requirements. | Pass |
| Software Verification and Validation Testing | Device shall meet the related Software requirements. | Pass |
2. Sample Size and Data Provenance (for test set, if applicable)
The document primarily describes non-clinical engineering and performance testing. It does not explicitly state a "test set" in the context of clinical data. For the "VERABAND™ intended use" test, it states "Simulated users wearing the device perform activities at different intensities of motion and wear compliance times." While it implies subjects, no specific sample size is provided. The data is non-clinical/simulated.
3. Number of Experts for Ground Truth and Qualifications (for test set, if applicable)
Not applicable, as the provided data focuses on non-clinical and simulated testing for performance validation rather than expert-derived ground truth for a test set of patient data.
4. Adjudication Method (for test set, if applicable)
Not applicable. The reported tests are primarily objective engineering and performance validations against predefined criteria, not subjective human evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "The VERABAND™ did not require clinical studies to support substantial equivalence to the primary predicate device." Therefore, no MRMC study was conducted or reported.
6. Standalone (Algorithm Only) Performance Study
Yes, the majority of the reported testing falls under standalone performance. The "non-clinical testing summary" details various tests (e.g., accelerometer accuracy, battery life, sampling rate, frequency response, report generation comparison) that evaluate the device's technical functionality and performance in isolation or in comparison to a predicate device's output, without human-in-the-loop performance measurement.
7. Type of Ground Truth Used
For the non-clinical tests, the ground truth was based on:
- Established engineering specifications and requirements (e.g., full-range accuracy, required light level, expected device life, minimum number of cleanings, sampling rate, full-scale dynamic range, predicate's bandwidth, repeatability and reproducibility for activity levels, predicate comparison requirements for output metrics).
- Recognized consensus standards (e.g., IEC, ISO, ASTM).
- Simulated motions and user activities.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. The device is described as an activity monitoring device with an accelerometer to acquire and store data, which is then post-processed. It doesn't appear to be an AI/ML-driven diagnostic device that would typically involve a training set for model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" for an AI/ML model. The device's operation relies on sensor data acquisition and processing based on established algorithms and engineering principles, not on a trained machine learning model.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
June 17, 2024
Arbor Medical Innovations, LLC % Kay Fuller President & Principal Regulatory & Clinical Affairs Consultant Medical Device Regulatory Solutions, LLC 230 Collingwood Dr., Suite 260 Ann Arbor, Michigan 48103
Re: K233987
Trade/Device Name: Veraband™M Regulation Number: 21 CFR 882.5050 Regulation Name: Biofeedback Device Regulatory Class: Class II Product Code: LEL, ISD Dated: May 10, 2024 Received: May 13, 2024
Dear Kay Fuller:
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 (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"
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(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 OS 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 (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.
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 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.
Patrick Antkowiak -S
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical,
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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
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Indications for Use
510(k) Number (if known) K233987
Device Name VERABAND
Indications for Use (Describe)
The VERABAND™ is a compact, lightweight, body-worn activity monitoring device designed to document physical movement associated with applications in physiological monitoring. The device is intended to monitor limb or body movements during daily living and sleep for a limited time interval (up to 30- days).
The VERABAND™ can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. VERABAND™ is not intended for diagnostic purposes.
| 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
Arbor Medical Innovations, LLC
VERABAND™
June 11, 2024
The following summary is provided pursuant to Section 513 (l) (3) (A) of the Federal Food Drug and Cosmetic Act:
1. GENERAL INFORMATION
| Submitter Information: | Arbor Medical Innovations, LLC168 S. Industrial Drive,Saline, MI 48176 |
|---|---|
| Contact Information: | Kay Fuller, RACPresident & Principal Regulatory & Clinical Research ConsultantMedical Device Regulatory Solutions, LLC734-846-7852 |
| 2. DEVICE INFORMATION | |
| Device Name: | VERABANDTM |
| Proprietary Name: | VERABANDTM |
| Common Name: | Movement/Sleep Assessment Device (actigraphy) |
| Classification Name: | Biofeedback Device (Primary)Measuring Exercise Equipment |
| Classification Code: | LEL / ISD |
| Regulation Number: | 21 CFR §882.5050 (Primary) / 21 CFR 890.5360 |
| 3. PREDICATE DEVICE(S) | Arbor Medical Innovation's VERABANDTM is similar to the primary predicatedevice K132764 cleared for US commercialization on 1/21/2014 and predicatedevice K080545 cleared for US commercialization on 7/24/2008. |
| 4. DEVICE DESCRIPTION | The VERABANDTM is a compact, wrist-worn battery-operated wearabledevice intended for collecting a patient's motion data for assessing patientactivity. VERABANDTM is intended to acquire and store data while being wornduring normal activities and/or during sleep. The device consists of a wearableband with compact housing for battery-powered on-board electronics with anaccelerometer. The recorded activity data is timestamped and stored in non-volatile memory for later retrieval. Downloaded VERABANDTM data can bepost-processed based on the timestamp and magnitude of acceleration forreporting. |
| 5. INDICATIONS FOR USE | The VERABANDTM is a compact, lightweight, body-worn activity monitoringdevice designed to document physical movement associated withapplications in physiological monitoring. The device is intended to monitorlimb or body movements during daily living and sleep for a limited timeinterval (up to 30-days). The VERABANDTM can be used to assess activity inany instance where quantifiable analysis of physical motion is desired. |
VERABAND™ is not intended for diagnostic purposes.
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6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The VERABAND™ fundamental technological characteristics are similar to those of the predicate devices as described herein, and as described in the following table:
| Parameter | Subject DeviceK233987VERABAND™ | Primary PredicateK132764MotionWatch | Secondary PredicateK080545ActiTrainer |
|---|---|---|---|
| Intended Use | The VERABAND™ is a compact, lightweight,body-worn activity monitoring devicedesigned to document physical movementassociated with applications in physiologicalmonitoring. The device is intended to monitorlimb or body movements during daily livingand sleep for a limited time interval (up to 30-days).The VERABAND™ can be used to assessactivity in any instance where quantifiableanalysis of physical motion is desired.VERABAND™ is not intended for diagnosticpurposes. | The MotionWatch and PRO-Diary arecompact, lightweight, body-worn activitymonitoring devices that may be used todocument physical movementassociated with applications inphysiological monitoring. The devicesare intended to monitor limb or bodymovements during daily living and sleep.The MotionWatch and PRO-Diary canbe used to assess activity in anyinstance where quantifiable analysis ofphysical motion is desired.Additionally, the PRO-Diary has a built-in score pad that allows the wearer tosubjectively assign and enter responsesto pre-programmed questions. Thescore pad can be used as a substitute orin addition to the traditional writtenpatient diary in conjunction with activitymonitoring. | The ActiTrainer is a small wornactivity monitor designed fordocumenting physical movementassociated with applications inphysiological monitoring. Thedevice is intended to monitor theactivity associated withmovement during sleep. TheActiTrainer can be used toanalyze circadian rhythms andassess activity in any instancewhere quantifiable analysis ofphysical motion is desirable. |
| Device GeneralDescription | Compact, wearable, battery operatedphysical activity data recorder | Compact, wearable, battery operatedphysical activity data recorder withintegrated score pad. | Wearable, battery operatedphysical activity data recorder |
| Size and VisualAppearance and Physicaldescription of recorder | Plastic molded wrist style band -maximum36mm x 20mm x 10mm | Plastic molded wristwatch style casingwith detachable band.Size 36 x 28.2 x 9.4 (excluding band) | Wrist band (chest strap option)8.5cm x3.4cm x1.6 cm |
| Weight in gms | 5 grams, Maximum | 9.1 grams | 51 grams |
| Casing Materials | Medical Grade Polycarbonate, biocompatiblematerial | ABS blend | Polycarbonate |
| Wrist band Materials | Thermoplastic elastomer (TPE),biocompatible material | ABS blend | Nylon & Velcro® (wrist band) |
| Power Source | Silver-Oxide battery (coin cell) | 3.0 volt coin cell battery type CR2032(1 each, user-replaceable | Lithium-Ion batteryRechargeable via USB |
| Battery Life | 90 days, pre-wear; Sufficient battery life forthe post-use return | 6 months | N/A-rechargeable |
| Accelerator Type | Microelectromechanical system (MEMS)-based integrated circuit -3 axis | Microelectromechanical system(MEMS)- based integrated circuit -3axis | Microelectromechanical system(MEMS)-based integrated circuit- 2 axis |
| Activity Channels (# ofAxis of Orientation) | 3 | 1, 2 or 3 | 2 |
| Accelerometer DynamicRange | +/- 2 g | +/- 8g | +/- 5g |
| Accelerometer Sensitivity | $1.0$ milli-g (±3%) per Least Significant Bit | 12 Bits (A/D Conversion) | 4 milli-g Least Significant Bit |
| Accelerometer SamplingRate | 1.6 Hz down sampled to 1 Hz | 50 Hz (Raw Sampling Rate) | 30 Hz, Analog method |
| Firmware | Embedded C | Not Known | Embedded C |
| Memory | 4 MB | 512kBytes | 1024 KB |
| Recording time | 28 days | 182 Days @ 60s epoch | 14 days |
| Water Resistance(Ingress Protection) | IP57 | IPX7 | IP21 (condensation) |
| Sterility | None Required | None Required | None Required |
| Biocompatibility(Wrist Band Materials) | Biocompatible: skin contact (intact skin),prolonged > 24hrs to ≤30 days per ANSIAAMI ISO 10993-5:2009/(R)2014,ISO 10993-10 4th Ed. 2021-11 andISO 10993-23 1st Ed.2021-01 | Standard nylon wrist band.in contactwith intact skin surface. | Nylon & Velcro® (wrist band) |
| Human Factors | Worn on wrist like a wristwatch; No userinteraction is required | Worn on wrist like a wristwatch; Nouser interaction is required | Worn on wrist (optional cheststrap); Some user interaction isrequired |
| Storage Temp | -20 to 60°C @ 0-93%RH | -25°C to 70°C | -10°C to 50°C |
| Operating Temp | -20°C to 40°C @ 0-93%RH | -25°C to 70°C | -10°C to 50°C |
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7. NON-CLINICAL TESTING SUMMARY
Non-clinical testing was performed on VERABAND™ to validate performance and support a SE determination to the predicate. The following design control, risk management and quality assurance methodologies were utilized to develop VERBAND™:
- Risk Analysis .
- . Requirements Review
- Design Reviews .
- Unit Level Testing (Verification) .
- Electrical/EMC Safety & V&V Testing .
- Performance Testing (Validation) .
- Usability & Simulated Use Testing (Validation)
- System compatibility with software for data download/collection/reporting ●
| VERABAND™ Non-Clinical Testing Summary Table | |||
|---|---|---|---|
| Test | Test Method Summary | Pass/ Fail Criteria | Results |
| AccelerometerAccuracy andPrecision | Using a static and dynamic testing, a range of accelerationsare applied to the device. | The accelerometer of the device shall meet the fullrange accuracy requirement.The accelerometer of the device shall meet the staticcalibration point accuracy requirement.The accelerometer shall meet the repeatability andreproducibility requirement. | Pass |
| Activation trigger | Devices are packaged and opened in different light levelenvironments and activation of the device evaluated. | The device shall activate at the required light level.The device shall meet the requirement to not activatewhile in the packaging. | Pass |
| Device donning/doffing, | The device band is stretched to simulate donning and doffingmultiple times a day and evaluated for damage, | The device shall be able to survive the requireddonning and doffing. | Pass |
| Device band separationand band elongationforces | 1. The device band is stretched to a specified elongation andthe force is evaluated.2. The band is stretched to failure. | The device shall meet the force requirements for 1.elongation and 2. separation. | Pass |
| Battery life for durationof use | 1. Measure PCB Power Consumption at worst-casetemperatures and calculate battery capacity.2. Measure battery consumption of devices.3. Evaluate function after different time storage periods | The device shall meet the battery life requirementsfor Expected Device Life. | Pass |
| User cleaning | The device is repeatably cleaned per the IFU and evaluatedfor function. | The device shall maintain function after a requiredminimum number of cleanings. | Pass |
| Device SamplingRate and Full-ScaleDynamic Range | Human accelerometer data is statistically analyzed to confirmthe sampling rate and dynamic full-scale range isacceptable for the intended use. | The device shall have a sampling rate and full-scaledynamic range that meets the requirements. | Pass |
| DeviceFrequencyResponse | Simulated accelerations are applied to the device and apredicate over a range of frequencies. | The device shall be within the requirement of thepredicate's bandwidth | Pass |
| VERABAND™intended use | Simulated users wearing the device perform activities atdifferent intensities of motion and wear compliance times. Thedata is downloaded and analyzed. | The device shall meet repeatability andreproducibility requirements for activity levels. | Pass |
| VERABAND™Report GenerationComparison | Generate simulated motions on VERABAND™ and predicatedevice. Perform data analysis and compare report outputs. | The device output metrics shall meet the predicatecomparison requirements. | Pass |
| Usability | Users shall wear the device for a fixed time period and respondto a usability survey and the survey results are analyzed. | The device shall meet the related usabilityrequirement survey scores. | Pass |
| Packaging Testing | Packaging transportation simulation testing per ASTM D4169-22. | Device shall maintain function per requirementsafter shipping. | Pass |
| EMC | EMC Testing per IEC 60601-1-2. | The device shall meet the related EMC requirements | Pass |
| Electrical Basic Safety | Testing per IEC 60601- and IEC 60601-1-11. | The device shall meet the related electrical basicsafety requirements. | Pass |
| Biocompatibility Testing | Testing per ISO 109993-1. | The device shall meet the related biocompatibilityrequirements. | Pass |
| FirmwareVerification andValidation Testing | Firmware developed and tested per IEC 62304. | The device shall meet the related Firmwarerequirements. | Pass |
| Software Verificationand Validation Testing | Software developed and tested per IEC 62304. | The device shall meet the related Softwarerequirements. | Pass |
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Figure 1, below, provides a graphical summary of the performance output metrics for the subject device and the predicate.
Image /page/7/Figure/1 description: The image is a scatter plot that shows the relationship between MW (CPM) and VB (ADS). The x-axis represents MW (CPM), and the y-axis represents VB (ADS). The plot shows a positive correlation between the two variables, with an R-squared value of 0.991. There are three vertical dashed lines that separate the plot into three sections labeled Low, Moderate, and Vigorous.
Figure 1. Graphical Summary of VB vs. MW Output Metrics
Basic level software documentation per FDA Guidance "Content of Premarket Submissions for Device Software Functions", issued June 14, 2023 was also included in this premarket notification submission. VERABAND™ was developed in accordance with the company's design control procedures and tested in accordance with the company's verification and validation procedures.
Voluntary Recognized Consensus Standards to which the subject device conforms include:
| FR Rec.Number | Standard ID | Standard Title |
|---|---|---|
| 19-49 | IEC 60601-1 Edition 3.22020-08 Consolidated Version | Medical electrical equipment - Part 1: General requirements for basic safety and essentialperformance |
| 19-36 | IEC 60601-1-2 Edition 4.1 2020-09Consolidated Version | Medical electrical equipment - Part 1-2: General requirements for basic safety and essentialperformance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| 19-38 | IEC 60601-1-11:2015+ A1:2020 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essentialperformance - Collateral Standard: Requirements for medical electrical equipment andmedical electrical systems used in the home healthcare environment |
| 5-125 | ISO 14971:2019 | Medical devices - Applications of risk management to medical devices |
| 2-258 | ANSI AAMI ISO10993-1: 2018 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement process |
| 2-245 | ANSI AAMI ISO 10993-5:2009/(R)2014 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| 2-296 | ISO 10993-10 4th Ed. 2021-11 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization |
| 2-291 | ISO 10993-23 1st Ed.2021-01 | Biological evaluation of medical devices - Part 23: Tests for irritation |
| 13-79 | ANSI AAMI IEC 62304:2006/A1:2016 | Medical device software - Software life cycle processes [Including Amendment 1 (2016)] |
| 14-576 | ASTM D4169-22 | Standard Practice for Performance Testing of Shipping Containers and Systems |
| 5-134 | ISO 15223-1 4th Ed.2021-07 | Medical devices - Symbols to be used with information to be supplied by the manufacturer- Part 1: General requirements |
predefined acceptance criteria for the engineering (non-clinical) All performance testing were met. The results from the non-clinical testing performed on VERABAND™ produced results consistently according to its predefined user needs and intended use.
Arbor Medical Innovations, LLC . ● K233987 510(k) Summary ● June 2024 . Page 4 of 5
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8. CLINICAL TESTING SUMMAR
The VERABAND™ did not require clinical studies to support substantial equivalence to the primary predicate device.
The VERABAND™ non-clinical and clinical usability results demonstrate that the VERABAND™ clinical user needs and intended use requirements were fulfilled and all predetermined acceptance criteria were met.
9. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
The subject device and the primary predicate device are substantially equivalent, with respect to intended use, instructions for use, design features, technological characteristics, manufacturing methods, performance criteria, special controls, and safety and effectiveness. The subject device is substantially equivalent to the primary predicate device (K132764) noted herein.
10. CONCLUSION
The non-clinical and clinical usability results contained herein, demonstrates that VERABAND™ performs according to its intended use. Arbor Medical Innovations considers the VERABAND™ (subject device) to be substantially equivalent to the legally marketed primary predicate device noted herein, and is safe and effective for its labeled intended use.
§ 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.