Hoggan Scientific® microFET2™

K162412 · Hoggan Scientific, LLC · LBB · Mar 9, 2017 · Orthopedic

Device Facts

• Record ID: K162412
• Device Name: Hoggan Scientific® microFET2™
• Applicant: Hoggan Scientific, LLC
• Product Code: LBB · Orthopedic
• Decision Date: Mar 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1240
• Device Class: Class 2

Intended Use

The microFET2™ System is a dynamometer device for performing muscle tests to quantitatively measure muscle weakness caused by injury or for sports medicine applications, as well as measure general muscle strength. The device is used to record and convey an individual's ability to resist force for a specific muscle group being tested.

Device Story

MicroFET2 is a handheld, battery-operated digital dynamometer; utilizes resistance-based strain gauge (load cell) to measure force applied by patient during muscle testing. Device captures analog force signals; microprocessor converts signals to digital, calibrated data; displays results on LCD or transmits via Bluetooth to optional clinical/data collection software. Used by clinicians in clinical settings to assess muscle strength/weakness in head, neck, limbs, and digits. Ergonomic design allows ambidextrous use; includes elastic strap for stabilization. Clinicians use objective measurements to evaluate patient progress, guide rehabilitation, and inform clinical decision-making regarding injury recovery or sports performance.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing confirmed device met pre-determined acceptance criteria for electrical safety (IEC 60601-1), EMC (IEC 60601-1-2, CISPR 11, FCC Part 15B), and biocompatibility (referencing K860226).

Technological Characteristics

Handheld dynamometer; resistance-based strain gauge (load cell) sensing; 3.7V Lithium-Ion battery; wireless RF/Bluetooth connectivity; LCD display. Complies with IEC 60601-1, IEC 60601-1-2, CISPR 11, and FCC Part 15B. Class II ME, Type B applied part. No sterilization required.

Indications for Use

Indicated for individuals recovering from physical injury or for sports medicine applications requiring quantitative measurement of muscle strength and weakness.

Regulatory Classification

Identification

An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.

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 subject to the limitations in § 886.9.

Predicate Devices

• Ametek, Inc., Dynamometer, Model Chatillon FCE and MSC series (K042889)

Reference Devices

• Hoggan reference device (K860226)

Submission Summary (Full Text)

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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 consists of the department's name encircling a symbol. The symbol features a stylized representation of three 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

March 9, 2017

Hoggan Scientific, LLC Spencer Walker Director Regulatory Affairs 3653 West 1987 South Bld. # 7 Salt Lake City, Utah 84104

Re: K162412

Trade/Device Name: MicroFET2™ System Regulation Number: 21 CFR 888.1240 Regulation Name: AC-Powered Dynamometer Regulatory Class: Class II Product Code: LBB Dated: February 17, 2017 Received: February 27, 2017

Dear Mr. Walker:

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# 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) K162412

Device Name Hoggan Scientific® microFET2TM

#### Indications for Use (Describe)

The microFET2™ System is a dynamometer device for performing muscle tests to quantitatively measure muscle weakness caused by injury or for sports medicine applications, as well as measure general muscle strength. The device is used to record and convey an individual's ability to resist force for a specific muscle group being tested.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(k) Summary

| Submitter: | Hoggan Scientific, LLC |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Spencer Walker, MSc - Director Regulatory Affairs<br>3653 West 1987 South Bld. # 7<br>Salt Lake City, UT 84104<br>[phone] |
| Date Prepared: | August 23, 2016 |
| Trade Name: | microFET2™ |
| Classification Name: | Dynamometer<br>21 CFR §888.1240, Product Code LBB, Class II |
| Predicate Device(s): | • K042889- Ametek, Inc., Dynamometer, Model Chatillon<br>FCE and MSC series; |

## Device Description:

The microFET2™ is an ergonomically designed hand-held, battery operated, digital muscle tester. Which is an accurate, portable Force Evaluation Testing (FET) dynamometer, designed specifically for taking objective, reliable, and quantifiable muscle testing measurements, and is used to record a person's ability to resist force for a specific muscle or muscle group being tested.

The device's ergonomic design allows for its use ambidextrously, depending on stabilization requirements, by being held in either hand using an elastic strap for convenience and comfort. The size and weight of the device allows the examiner/tester to use the same procedures and methods of muscle testing techniques without causing injury to the clinician or patient.

## Indications for Use:

The microFET2TM system is a dynamometer device for performing muscle tests to quantitatively measure muscle weakness caused by injury, or for sports medicine applications, as well as measure general muscle strength. The device is used to record and convey an individual's ability to resist force for a specific muscle group being tested.

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# Comparative Analysis:

The microFET2™ is comparable to the predicate device in intended use, fundamental scientific technology, design, principles of operation and functional performance evaluations. The microFET2™ system has been fully assessed within the Hoggan Scientific Risk Management and Design Controls systems. All necessary verification steps met pre-determined acceptance criteria to confirm safety and effectiveness.

| Technology Comparison of microFET2™ with Predicate Device: | | |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Component | Subject Device – K162412 | Predicate - K042889 - Ametek<br>(Chatillon FCE & MSC) |
| Device Name | microFET2™ | MSC Series Digital Muscle Strength<br>Comparator, Chatillon/Ametek |
| Intended Use | The microFET2™ is a dynamometer<br>diagnostic device used for<br>quantitatively evaluating muscle<br>strength | The Chatillon FCE and MSC series<br>dynamometers are diagnostic devices<br>used for quantitatively evaluating<br>muscle strength |
| Indications<br>for use | The microFET2™ system is a<br>dynamometer device for performing<br>muscle tests to quantitatively measure<br>muscle weakness caused by injury or<br>for sports medicine applications, as well<br>as measure general muscle strength.<br>The device is used to record and<br>convey an individual's ability to resist<br>force for a specific muscle or muscle<br>group being tested. | The intended use of the Chatillon FCE<br>and MSC series dynamometers is for<br>performing manual muscle testing to<br>measure muscle strength. The target<br>population for this product is individuals<br>recovering from physical injury or for<br>sports medicine applications |
| Classification | AC-Powered Dynamometer<br>21CFR 888.1240<br>Product Code: LBB<br>Class II | AC-Powered Dynamometer<br>21CFR 888.1240<br>Product Code: LBB<br>Class II |
| Prescription<br>(Rx Only) | Yes | Yes |
| Anatomical<br>site | Head, Neck, Shoulders, Arms, Elbows,<br>Wrists, Hands, Fingers, Hips, Legs,<br>Knees, Ankles, Feet, Toes | Head, Neck, Shoulders, Arms, Elbows,<br>Wrists, Hands, Fingers, Hips, Legs,<br>Knees, Ankles, Feet, Toes |
| Measurement | 0.8 Ibf Minimum - 300 Ibf Maximum<br>With 0.1 lbf resolution | 100 lbf Maximum with 0.01 Ibf<br>resolution<br>200 Ibf Maximum with 0.02 Ibf<br>resolution<br>500 Ibf Maximum with 0.05 Ibf<br>resolution |
| Unit of<br>Measurement | Displays force as Ibf, Kgf, N | Displays force as Ibf, Kgf, N, gf, ozf |
| Power Supply | Battery Powered - May not to be<br>operated while attached to charger. | Battery Powered - May be operated<br>while attached to a charger |
| Battery | 3.7 V Lithium-Ion Battery<br>90 hours continuous use (non-wireless mode)<br>6 hours continuous use (wireless mode) | 4.8V Nickel Metal Hydride Battery<br>30 hours continuous use |
| Human<br>factors | Handheld<br>• <1 lb.<br>• Two small LCD displays<br>• Two switches for user interaction<br>• Wireless RF<br>• Bluetooth data transfer | Handheld<br>• 1.5 lb.<br>• Single large LCD display<br>• Navigation Keys for user interaction with menu |
| Fundamental<br>Scientific<br>Technology | Resistance based strain gauge (Load Cell) with microprocessor to convert analog signal to digital, calibrated data | Resistance based strain gauge (Load Cell) with microprocessor to convert analog signal to digital, calibrated data |
| Sterilization | None | None |
| Radiation<br>safety: | IEC 60417-5140 (Non-ionizing Radiation)<br>IEC 61000-4-8 Power Frequency (50/60Hz) Magnetic Field<br>IEC 61000-4-3 RF Radiated Fields Immunity<br>IEC 61000-4-2 Electrostatic Discharge<br>CISPR 11 Group1 Class B | BS EN 61010-1:2001 Safety<br>Requirement for Electrical Equipment<br>BS EN 50081-1:1992 EMC Generic Emissions Standard<br>BS EN 50082-1:1992 EMC Generic Immunity Standard |
| Applied Part<br>Class (per<br>IEC 60601-2-<br>18; (2009)) | Class II ME<br>Type B | Class II ME<br>Type B |

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# Functional/Safety Testing:

The following functional tests were performed. All data met pre-determined acceptance criteria.

- . Biocompatibility – The microFET2™ materials are the same as those from the Hoggan reference device per K860226. A new warning was added to the Instructions for Use manual advising the user to use the foam portion of the device over clothing.
- Electrical Safety and Electromagnetic Compatibility (EMC) The electrical . safety and EMC series of test demonstrates the safety and compatibility of the electrical and EMC characteristics of the microFET2™. The microFET2™ was tested to the requirements of the following industry standards:
- IEC 60601-1 Medical Device Electrical Safety (2012) o
- IEC 60601-1-2 Medical Device (2014) o
- CISPR 11 Emissions Class B (2009), A1(2010) o
- FCC Part 15B Radiated Emissions Conducted Emissions o

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- Software The microFET2™ system uses firmware to control the handheld . device:
- Battery usage, load cell force conversion to LCD display screens . and Bluetooth wireless capabilities

The optional Clinical Software may be used to wirelessly record patient testing results and record keeping.

The optional FET Data Collection Software may be used to plot the data on a computer monitor in real time.

The microFET2™ firmware/software level of concern have been determined to be minor, and are deemed to not result in harm to the patient or misdiagnosis of the patient condition when the device is used by a medical professional.

## Conclusion:

The microFET2™ is substantially equivalent to the cited predicate device. Additionally, the microFET2™ met all acceptance criteria to confirm safety and effectiveness.