Who is the manufacturer of VERABAND?

Arbor Medical Innovations, LLC filed the 510(k) submission for VERABAND (K233987).

What is the FDA product code for VERABAND?

LEL. It is classified under 21 CFR 882.5050 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for VERABAND?

510(k) clearance (submission type: Traditional).

What are the predicate devices for VERABAND?

MotionWatch (K132764); ActiTrainer (K080545).

Who can help prepare an FDA 510(k) submission like VERABAND?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VERABAND

K233987 · Arbor Medical Innovations, LLC · LEL · Jun 17, 2024 · Neurology

Device Facts

Record ID	K233987
Device Name	VERABAND
Applicant	Arbor Medical Innovations, LLC
Product Code	LEL · Neurology
Decision Date	Jun 17, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5050
Device Class	Class 2

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.

Device Story

VERABAND™ is a compact, wrist-worn, battery-operated wearable device for monitoring physical activity. It utilizes a 3-axis MEMS accelerometer to capture motion data during daily living and sleep. Data is timestamped and stored in non-volatile memory for later retrieval and post-processing. The device is worn by the patient; no user interaction is required during operation. Healthcare providers download the stored data to analyze physical motion based on acceleration magnitude and timestamps. The output provides quantifiable activity metrics, which assist clinicians in physiological monitoring. The device is not intended for diagnostic use.

Clinical Evidence

No clinical studies were required. Substantial equivalence is supported by non-clinical bench testing, including accelerometer accuracy/precision, battery life, usability/simulated use, and performance comparison against the predicate device. A scatter plot demonstrated a high correlation (R-squared = 0.991) between the subject device and the predicate for activity output metrics.

Technological Characteristics

Wrist-worn device; medical-grade polycarbonate housing; TPE wrist band. 3-axis MEMS accelerometer; +/- 2g dynamic range; 1.6 Hz sampling rate (down-sampled to 1 Hz). 4 MB non-volatile memory. Silver-oxide coin cell battery. IP57 ingress protection. Biocompatibility per ISO 10993-1, -5, -10, -23. Software developed per IEC 62304. Electrical safety per IEC 60601-1, 60601-1-11; EMC per IEC 60601-1-2.

Indications for Use

Indicated for patients requiring monitoring of limb or body movements during daily living and sleep for up to 30 days. Not intended for diagnostic purposes.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

MotionWatch (K132764)
ActiTrainer (K080545)

Related Devices

K181077 — ActiGraph CentrePoint Insight Watch · Actigraph · May 24, 2018
K231532 — ActiGraph LEAP activity monitor (ActiGraph LEAP) · Actigraph, LLC · Jun 23, 2023
K983533 — ACTIWATCH · Mini-Mitter Co., Inc. · Mar 23, 1999
K080545 — ACTITRAINER · Actigraph, LLC · Jul 24, 2008
K132764 — MOTION WATCH AND PRO-DIARY · Camntech, Ltd. · Jan 21, 2014

Submission Summary (Full Text)

{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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 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. 2. 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. 2. Measure battery consumption of devices. 3. 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- 22. | 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.