(192 days)
No
The device description and performance studies focus on basic digital measurement, data display, and wireless transmission, with no mention of AI or ML algorithms for analysis or interpretation.
No
A therapeutic device is used to treat or alleviate a medical condition. This device is described as a dynamometer used for measuring muscle strength and weakness, which is a diagnostic or assessment tool, not a treatment.
Yes
The device is described as measuring "muscle weakness caused by injury" and is used to "quantitatively measure muscle weakness," indicating its role in identifying and assessing a medical condition.
No
The device description explicitly states it is a "hand-held, battery operated, digital muscle tester" and mentions hardware components like a load cell and LCD display. While it includes optional software, the core device is a physical dynamometer.
Based on the provided information, the microFET2™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to measure muscle strength and weakness by applying force and recording resistance. This is a physical measurement of a physiological function, not an analysis of biological samples (like blood, urine, or tissue) outside of the body.
- Device Description: The device is a hand-held dynamometer that measures force. It does not interact with or analyze biological specimens.
- 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.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The microFET2™ does not fit this description.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LBB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head, Neck, Shoulders, Arms, Elbows, Wrists, Hands, Fingers, Hips, Legs, Knees, Ankles, Feet, Toes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
- IEC 60601-1-2 Medical Device (2014)
- CISPR 11 Emissions Class B (2009), A1(2010)
- FCC Part 15B Radiated Emissions Conducted Emissions
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.1240 AC-powered dynamometer.
(a)
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.(b)
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.
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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
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Submitter: | Hoggan Scientific, LLC |
|---|---|
| Contact Person: | Spencer Walker, MSc - Director Regulatory Affairs |
| 3653 West 1987 South Bld. # 7 | |
| Salt Lake City, UT 84104 | |
| (801) 581-5080 | |
| Date Prepared: | August 23, 2016 |
| Trade Name: | microFET2™ |
| Classification Name: | Dynamometer |
| 21 CFR §888.1240, Product Code LBB, Class II | |
| Predicate Device(s): | • K042889- Ametek, Inc., Dynamometer, Model Chatillon |
| 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.
4
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 | ||
| Component | Subject Device – K162412 | Predicate - K042889 - Ametek |
| (Chatillon FCE & MSC) | ||
| Device Name | microFET2™ | MSC Series Digital Muscle Strength |
| Comparator, Chatillon/Ametek | ||
| Intended Use | The microFET2™ is a dynamometer | |
| diagnostic device used for | ||
| quantitatively evaluating muscle | ||
| strength | The Chatillon FCE and MSC series | |
| dynamometers are diagnostic devices | ||
| used for quantitatively evaluating | ||
| muscle strength | ||
| Indications | ||
| for 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 or muscle | ||
| group being tested. | The intended use of the Chatillon FCE | |
| and MSC series dynamometers is for | ||
| performing manual muscle testing to | ||
| measure muscle strength. The target | ||
| population for this product is individuals | ||
| recovering from physical injury or for | ||
| sports medicine applications | ||
| Classification | AC-Powered Dynamometer | |
| 21CFR 888.1240 | ||
| Product Code: LBB | ||
| Class II | AC-Powered Dynamometer | |
| 21CFR 888.1240 | ||
| Product Code: LBB | ||
| Class II | ||
| Prescription | ||
| (Rx Only) | Yes | Yes |
| Anatomical | ||
| site | Head, Neck, Shoulders, Arms, Elbows, | |
| Wrists, Hands, Fingers, Hips, Legs, | ||
| Knees, Ankles, Feet, Toes | Head, Neck, Shoulders, Arms, Elbows, | |
| Wrists, Hands, Fingers, Hips, Legs, | ||
| Knees, Ankles, Feet, Toes | ||
| Measurement | 0.8 Ibf Minimum - 300 Ibf Maximum | |
| With 0.1 lbf resolution | 100 lbf Maximum with 0.01 Ibf | |
| resolution | ||
| 200 Ibf Maximum with 0.02 Ibf | ||
| resolution | ||
| 500 Ibf Maximum with 0.05 Ibf | ||
| resolution | ||
| Unit of | ||
| Measurement | Displays force as Ibf, Kgf, N | Displays force as Ibf, Kgf, N, gf, ozf |
| Power Supply | Battery Powered - May not to be | |
| operated while attached to charger. | Battery Powered - May be operated | |
| while attached to a charger | ||
| Battery | 3.7 V Lithium-Ion Battery | |
| 90 hours continuous use (non-wireless mode) | ||
| 6 hours continuous use (wireless mode) | 4.8V Nickel Metal Hydride Battery | |
| 30 hours continuous use | ||
| Human | ||
| factors | Handheld | |
| • |