(82 days)
The Fit2Walk Monofilament Sensory Screening Tool is intended to determine whether a person with diabetes has the presence of an adequate level of protective sensation in their feet as indicated by having enough tactile sensitivity in order to perceive 10 grams of force against the skin of their feet.
It is indicated for use by adult Diabetic patients on a periodic basis to evaluate changes in sensory perception in the feet due to Diabetic peripheral sensory neuropathy. This device is not to be considered a replacement for routine sensory evaluation by a health care provider.
Monofilaments are devices that contain a small strand of filament attached to a handle. When placed upon the skin, they apply a certain amount of pressure before the filament bends or buckles. The point at which the filament bends or buckles is rated in grams of force. Monofilaments are primarily used to check for a certain level of sensation present in the skin in different parts of the body. The ten gram monofilament has been widely accepted by the medical community to evaluate the level of sensation in the skin of the feet for evaluating severe diabetic peripheral sensory neuropathy or LOPS (loss of protective sensation) of the feet.
The provided text describes the "Fit2Walk Monofilament Sensory Screening Tool" and its substantial equivalence to a predicate device. It references a study to support its performance.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for the Fit2Walk device in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to a predicate device ("Medical Monofilament Sensory Testing Filament") and references a study that supports the concept of self-administered monofilament testing for diabetic foot risk.
The key performance aspect for monofilaments is the force they apply and their ability to determine sensation.
| Feature | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Fit2Walk Monofilament Sensory Screening Tool) |
|---|---|---|
| Intended Use | Determine protective sensation in feet for diabetic patients (perceive 10 grams of force). | Same as predicate, with emphasis on self-administration and periodic evaluation. |
| Filament material | Polyester | Polyester |
| Semmes-Weinstein number (firmness) | 5.07 | 5.07 |
| Force Range | 10 gram (Range 8.5-11.5) | 10 gram (Range 8.5-11.5) |
| Availability | Available to medical practitioners. | Initially online, potentially retail stores, indicating OTC use. |
The study cited ("Evaluation of a Self-Administered Sensory Testing Tool...") aims to demonstrate the inter-rater reliability between patient and provider sensory evaluations using a monofilament, which is a performance characteristic relevant to the Fit2Walk's intended use as an over-the-counter device. However, specific numerical performance data (like agreement rates or statistical measures of reliability) from that study directly linked to the Fit2Walk device are not provided in this submission summary. The summary only mentions "a paper describes a study concerning the use of a self-administered sensory testing tool...and determine the inter-rater reliability between patient and provider sensory evaluations."
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary references a study, but does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature) of the study cited (Birke and Rolfsen, 1998). We only know it was published in "Diabetes Care, Vol. 21, Number 1, January 1998."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not specified in the provided document. The summary only mentions "inter-rater reliability between patient and provider sensory evaluations," implying that healthcare providers were involved in establishing a comparison, but their number and qualifications are not detailed.
4. Adjudication Method
Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The study referenced focuses on the reliability of patient self-assessment versus provider assessment, not AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The Fit2Walk Monofilament is a physical device, not an algorithm. Its "performance" relates to its physical properties (force applied) and the user's ability to interpret sensation.
7. Type of Ground Truth Used
Based on the description of the referenced study ("inter-rater reliability between patient and provider sensory evaluations"), the "ground truth" for comparison would likely be the assessment by a healthcare provider using a monofilament. This is a form of expert assessment.
8. Sample Size for the Training Set
Not applicable/Not specified. The Fit2Walk is a physical device, not an AI model requiring a training set. The study referenced would have involved a patient cohort, but it's not a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not specified. As there is no AI or machine learning component, the concept of a training set and its ground truth establishment is not relevant to this device submission.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2015
Medical Monofilament Manufacturing % Susan Hamann Consultant Alvamed 21 Phillip Ave Burlington, Massachusetts 01803
Re: K143068
Trade/Device Name: Fit2Walk Monofilament Sensory Screening Tool Regulation Number: 21 CFR 882.1500 Regulation Name: Esthesiometer Regulatory Class: Class I Product Code: GXB Dated: October 22, 2014 Received: October 31, 2014
Dear Ms. Hamann,
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. Iisting 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
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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 yours,
Felipe Aquel -S
Carlos L. Peña, PhD, MS for 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) K143068
Device Name
Fit2Walk Monofilament Sensory Screening Tool
Indications for Use (Describe)
The Fit2Walk Monofilament Sensory Screening Tool is intended to determine whether a person with diabetes has the presence of an adequate level of protective sensation in their feet as indicated by having enough tactile sensitivity in order to perceive 10 grams of force against the skin of their feet.
It is indicated for use by adult Diabetic patients on a periodic basis to evaluate changes in sensory perception in the feet due to Diabetic peripheral sensory neuropathy. This device is not to be considered a replacement for routine sensory evaluation by a health care provider.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows a stylized letter "M" with an arc above it. The "M" is bold and black, and the arc is a thin black line. The arc is centered above the "M" and curves upwards. The image is simple and graphic, with a focus on the letter "M".
MEDICAL MONOFILAMENT MANUFACTURING
121-2 CAMELOT DRIVE, PLYMOUTH, MA, USA 02360
P: 508.746.7877
F: 508.746.540
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
January 6, 2015
Name of Submitter:
Medical Monofilament Manufacturing 121 Camelot Drive Plymouth, MA 02360
Phone: 508-746-7877 Fax: 508-746-5409
Corresponding Official: Michelle Hardiman CEO
Device Proprietary Name: Fit2Walk Monofilament Sensory Screening Tool
Common Name: Sensory Screening Tool
Classification Name: Esthesiometer (21 CFR 882.1500, Product Code GXB)
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Substantial Equivalence:
The Fit2Walk Monofilament Sensory Screening Tool is substantially equivalent to the following device that is currently legally marketed: Medical Monofilament Sensory Testing Filament.
Device Description:
Monofilaments are devices that contain a small strand of filament attached to a handle. When placed upon the skin, they apply a certain amount of pressure before the filament bends or buckles. The point at which the filament bends or buckles is rated in grams of force. Monofilaments are primarily used to check for a certain level of sensation present in the skin in different parts of the body. The ten gram monofilament has been widely accepted by the medical community to evaluate the level of sensation in the skin of the feet for evaluating severe diabetic peripheral sensory neuropathy or LOPS (loss of protective sensation) of the feet.
Intended Use/Indications for Use:
The Fit2Walk Monofilament Sensory Screening Tool is intended to be used to determine whether a person with diabetes has the presence of an adequate level of protective sensation in their feet as indicated by having enough tactile sensitivity in order to perceive 10 grams of force against the skin of their feet.
It is indicated for use by adult Diabetic patients on a periodic basis to evaluate changes in sensory perception in the feet due to Diabetic peripheral sensory neuropathy. This device is not to be considered a replacement for routine sensory evaluation by a health care provider.
| Feature | Fit2Walk MonofilamentSensory Screening Tool | Medical Monofilament SensoryTesting Filament. |
|---|---|---|
| Intended Use | The Fit2Walk MonofilamentSensory Screening Tool isintended to be used todetermine whether a personwith diabetes has the presenceof an adequate level ofprotective sensation in theirfeet as indicated by havingenough tactile sensitivity inorder to perceive 10 grams offorce against the skin of theirfeet.It is indicated for use by adultDiabetic patients on a periodic | The Medical Monofilament SensoryTesting Filament is intended to beused by medical personnel todetermine whether a person withdiabetes has the presence of anadequate level of protectivesensation in their feet as indicatedby having enough tactile sensitivityin order to perceive 10 grams offorce against the skin of their feet. |
Comparison of Features for the Fit2Walk Monofilament Sensory Screening Tool and the Medical Monofilament Sensory Testing Monofilament.
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| basis to evaluate changes insensory perception in the feetdue to Diabetic peripheralsensory neuropathy. Thisdevice is not to be considered areplacement for routinesensory evaluation by a health | ||
|---|---|---|
| care provider. | ||
| Filament material | Polyester | Polyester |
| Semmes-Weinstein number(firmness) | 5.07 | 5.07 |
| Force Range | 10 gram (Range 8.5-11.5) | 10 gram (Range 8.5-11.5) |
| Availability | The Fit2Walk kit will initiallybe available online, but mayalso be available at retailstores in the future. | Available to medicalpractitioners online atwww.medicalmonofilament.com |
Performance Data:
Included in this submission is a report from Diabetes Care, Vol. 21, Number 1, January 1998, "Evaluation of a Self-Administered Sensory Testing Tool to Identify Patients at Risk of Diabetes-Related Foot Problems" written by James A Birke and Robert Rolfsen. The paper describes a study concerning the use of a self-administered sensory testing tool designed to identify individuals at risk for diabetes-related foot problems and determine the inter-rater reliability between patient and provider sensory evaluations.
Conclusion:
The Fit2Walk Monofilament Sensory Screening Tool is substantially equivalent to the Medical Monofilament Sensory Testing Filament.
§ 882.1500 Esthesiometer.
Link to an amendment published at 90 FR 55989, Dec. 4, 2025. (a)
Identification. An esthesiometer is a mechanical device which usually consists of a single rod or fiber which is held in the fingers of the physician or other examiner and which is used to determine whether a patient has tactile sensitivity.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.