(182 days)
Not Found
No
The description focuses on basic data acquisition and storage from an accelerometer, with post-processing based on timestamp and magnitude. There is no mention of AI/ML algorithms for data analysis or interpretation.
No.
The device is described as an activity monitoring device used to document physical movement and assess activity. It is explicitly stated that it is "not intended for diagnostic purposes." Its function is data collection for quantifiable analysis of motion, not for therapy.
No
The section "Intended Use / Indications for Use" explicitly states: "VERABAND™ is not intended for diagnostic purposes."
No
The device description explicitly states it consists of a wearable band with compact housing for battery-powered on-board electronics with an accelerometer, indicating it includes hardware components.
Based on the provided information, the VERABAND™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is "not intended for diagnostic purposes." IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The VERABAND™ monitors physical movement.
- Device Description: The device description focuses on collecting motion data from the body, not analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
The VERABAND™ is an activity monitoring device used for physiological monitoring and assessing physical motion.
N/A
Intended Use / Indications for Use
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.
Product codes
LEL, ISD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limb or body
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: Non-clinical testing, Usability & Simulated Use Testing.
Sample Size: Not specified for all tests, but includes testing on devices.
Standalone Performance: Not explicitly stated as standalone performance, but various tests were conducted on the VERABAND™ itself.
Key Results: All performance testing met predefined acceptance criteria. The device consistently produced results according to its predefined user needs and intended use. Performance output metrics showed a strong correlation (R-squared value of 0.991) between the subject device (VB) and the predicate device (MW). Usability results demonstrated fulfillment of user needs and intended use requirements, with all predetermined acceptance criteria met.
Key Metrics
Accelerometer Accuracy and Precision: Pass
Activation trigger: Pass
Device donning/doffing: Pass
Device band separation and band elongation forces: Pass
Battery life for duration of use: Pass
User cleaning: Pass
Device Sampling Rate and Full-Scale Dynamic Range: Pass
Device Frequency Response: Pass
VERABAND™ intended use: Pass (repeatability and reproducibility for activity levels)
VERABAND™ Report Generation Comparison: Pass (output metrics meet predicate comparison requirements)
Usability: Pass (related usability requirement survey scores)
Packaging Testing: Pass
EMC: Pass
Electrical Basic Safety: Pass
Biocompatibility Testing: Pass
Firmware Verification and Validation Testing: Pass
Software Verification and Validation Testing: Pass
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
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"
1
(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,
2
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
3
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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4
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, LLC
168 S. Industrial Drive,
Saline, MI 48176 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Kay Fuller, RAC
President & Principal Regulatory & Clinical Research Consultant
Medical Device Regulatory Solutions, LLC
734-846-7852 |
| 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 predicate
device K132764 cleared for US commercialization on 1/21/2014 and predicate
device K080545 cleared for US commercialization on 7/24/2008. |
| 4. DEVICE DESCRIPTION | 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. |
| 5. INDICATIONS FOR USE | The VERABANDTM 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 VERABANDTM can be used to assess activity in
any instance where quantifiable analysis of physical motion is desired. |
VERABAND™ is not intended for diagnostic purposes.
5
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 Device
K233987
VERABAND™ | Primary Predicate
K132764
MotionWatch | Secondary Predicate
K080545
ActiTrainer |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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 MotionWatch and PRO-Diary are
compact, lightweight, body-worn activity
monitoring devices that may be used to
document physical movement
associated with applications in
physiological monitoring. The devices
are intended to monitor limb or body
movements during daily living and sleep.
The MotionWatch and PRO-Diary can
be used to assess activity in any
instance where quantifiable analysis of
physical motion is desired.
Additionally, the PRO-Diary has a built-
in score pad that allows the wearer to
subjectively assign and enter responses
to pre-programmed questions. The
score pad can be used as a substitute or
in addition to the traditional written
patient diary in conjunction with activity
monitoring. | The ActiTrainer 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
ActiTrainer can be used to
analyze circadian rhythms and
assess activity in any instance
where quantifiable analysis of
physical motion is desirable. |
| Device General
Description | Compact, wearable, battery operated
physical activity data recorder | Compact, wearable, battery operated
physical activity data recorder with
integrated score pad. | Wearable, battery operated
physical activity data recorder |
| Size and Visual
Appearance and Physical
description of recorder | Plastic molded wrist style band -maximum
36mm x 20mm x 10mm | Plastic molded wristwatch style casing
with 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, biocompatible
material | 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 battery
Rechargeable via USB |
| Battery Life | 90 days, pre-wear; Sufficient battery life for
the post-use return | 6 months | N/A-rechargeable |
| Accelerator Type | Microelectromechanical system (MEMS)-
based integrated circuit -3 axis | Microelectromechanical system
(MEMS)- based integrated circuit -3
axis | Microelectromechanical system
(MEMS)-based integrated circuit
- 2 axis |
| Activity Channels (# of
Axis of Orientation) | 3 | 1, 2 or 3 | 2 |
| Accelerometer Dynamic
Range | +/- 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 Sampling
Rate | 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 ANSI
AAMI ISO 10993-5:2009/(R)2014,
ISO 10993-10 4th Ed. 2021-11 and
ISO 10993-23 1st Ed.2021-01 | Standard nylon wrist band.in contact
with intact skin surface. | Nylon & Velcro® (wrist band) |
| Human Factors | Worn on wrist like a wristwatch; No user
interaction is required | Worn on wrist like a wristwatch; No
user interaction is required | Worn on wrist (optional chest
strap); Some user interaction is
required |
| 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 |
6
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 |
| Accelerometer | |||
| Accuracy and | |||
| Precision | Using a static and dynamic testing, a range of accelerations | ||
| are applied to the device. | The accelerometer of the device shall meet the full | ||
| range accuracy requirement. | |||
| The accelerometer of the device shall meet the static | |||
| calibration point accuracy requirement. | |||
| The accelerometer shall meet the repeatability and | |||
| reproducibility requirement. | Pass | ||
| Activation trigger | Devices are packaged and opened in different light level | ||
| environments and activation of the device evaluated. | The device shall activate at the required light level. | ||
| The device shall meet the requirement to not activate | |||
| while in the packaging. | Pass | ||
| Device donning/doffing, | The device band is stretched to simulate donning and doffing | ||
| multiple times a day and evaluated for damage, | The device shall be able to survive the required | ||
| donning and doffing. | Pass | ||
| Device band separation | |||
| and band elongation | |||
| forces | 1. The device band is stretched to a specified elongation and | ||
| the force is evaluated. |
- The band is stretched to failure. | The device shall meet the force requirements for 1.
elongation and 2. separation. | Pass |
| Battery life for duration
of use | 1. Measure PCB Power Consumption at worst-case
temperatures and calculate battery capacity. - Measure battery consumption of devices.
- Evaluate function after different time storage periods | The device shall meet the battery life requirements
for Expected Device Life. | Pass |
| User cleaning | The device is repeatably cleaned per the IFU and evaluated
for function. | The device shall maintain function after a required
minimum number of cleanings. | Pass |
| Device Sampling
Rate and Full-Scale
Dynamic Range | Human accelerometer data is statistically analyzed to confirm
the sampling rate and dynamic full-scale range is
acceptable for the intended use. | The device shall have a sampling rate and full-scale
dynamic range that meets the requirements. | Pass |
| Device
Frequency
Response | Simulated accelerations are applied to the device and a
predicate over a range of frequencies. | The device shall be within the requirement of the
predicate's bandwidth | Pass |
| VERABAND™
intended use | Simulated users wearing the device perform activities at
different intensities of motion and wear compliance times. The
data is downloaded and analyzed. | The device shall meet repeatability and
reproducibility requirements for activity levels. | Pass |
| VERABAND™
Report Generation
Comparison | Generate simulated motions on VERABAND™ and predicate
device. Perform data analysis and compare report outputs. | The device output metrics shall meet the predicate
comparison requirements. | Pass |
| Usability | Users shall wear the device for a fixed time period and respond
to a usability survey and the survey results are analyzed. | The device shall meet the related usability
requirement survey scores. | Pass |
| Packaging Testing | Packaging transportation simulation testing per ASTM D4169- -
| Device shall maintain function per requirements
after 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 basic
safety requirements. | Pass |
| Biocompatibility Testing | Testing per ISO 109993-1. | The device shall meet the related biocompatibility
requirements. | Pass |
| Firmware
Verification and
Validation Testing | Firmware developed and tested per IEC 62304. | The device shall meet the related Firmware
requirements. | Pass |
| Software Verification
and Validation Testing | Software developed and tested per IEC 62304. | The device shall meet the related Software
requirements. | Pass |
7
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 3.2 | |
| 2020-08 Consolidated Version | Medical electrical equipment - Part 1: General requirements for basic safety and essential | |
| performance | ||
| 19-36 | IEC 60601-1-2 Edition 4.1 2020-09 | |
| Consolidated Version | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential | |
| performance - 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 essential
performance - Collateral Standard: Requirements for medical electrical equipment and
medical 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 ISO
10993-1: 2018 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management 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
8
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.