(427 days)
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No
The document describes a functional electrical stimulator that triggers based on gait cycle, but there is no mention of AI or ML in the device description, intended use, or performance studies. The software is described as "MODERATE" level of concern, which is typical for devices without complex AI/ML algorithms.
Yes
The device is intended to address a medical condition (lack of ankle dorsiflexion), improve gait, and provides medical benefits like prevention of disuse atrophy and muscle re-education through electrical stimulation.
No
Explanation: The device is described as an electrical stimulator used to address foot drop by stimulating muscles and nerves, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a battery-operated electrical stimulator that attaches to the leg and consists of a Patient Kit with physical components and a Clinician System which includes software. The performance studies also detail testing on physical components like the Cuff, Functional Stimulation Unit, and Remote Control, as well as electrical safety and biocompatibility testing. While software is part of the system, it is not the sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The XFT-2001D Foot Drop System is an external electrical stimulator that applies electrical impulses to the leg to improve gait. It does not analyze any samples taken from the body.
- Intended Use: The intended use clearly describes a therapeutic function (addressing lack of ankle dorsiflexion) and not a diagnostic one.
- Device Description: The description details a physical device that attaches to the leg and stimulates nerves and muscles, which is consistent with a therapeutic device, not an IVD.
Therefore, based on the provided information, the XFT-2001D Foot Drop System is a therapeutic medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
XFT-2001D Foot Drop System is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of walking, the XFT-2001D electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Stimulation (FES) may include prevention/retardation of disuse attophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.
Product codes (comma separated list FDA assigned to the subject device)
GZI
Device Description
Nerve and Muscle Stimulator (Foot Drop System) is a battery-operated, electrical stimulator that can be used for functional electrical stimulation (FES).
Nerve and Muscle Stimulator (Foot Drop System) is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, Nerve and Muscle Stimulator (Foot Drop System) stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle. The Nerve and Muscle Stimulator (Foot Drop System) consists of the Patient Kit and the Clinician Kit. The Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System includes the Medical Records Management Software.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Limb
Indicated Patient Age Range
Adult
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical safety and EMC testing were conducted on the XFT-2001D (clinical kit), consisting of a Cuff, a Functional Stimulation Unit, and a Remote Control.
The device complies with IEC 60601-1-2:2014: Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests. IEC 60601-1:2005 (Third Edition)+CORR.1:2006+CORR.2:2007+A1:2012 Consolidated version Medical electrical equipment -Part 1: General requirements for basic safety and essential performance.
IEC 60601-2-10:2012 Medical electrical equipment -Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
Biocompatibility: The electrode pads are the mainly body contacting parts. Electrode pads, as accessories of the device, are adopted the Self-adhesive Electrode manufactured by Top Rank Health Care Equipment Co., Ltd and have been cleared by FDA in November 22, 2013 as K132588.The electrode pads is considered skin contacting for a duration of less than 24 hours.
The biocompatibility evaluation for the XFT-2001D cuff was conducted in accordance with ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity and ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization.
Software Verification and Validation: The software for this device was considered as a "MODERATE" level of concern, the software failure or design flaw prior to mitigation may lead to an error in the intensity or timing of stimulation that could result in minor injury such as skin irritation to the patient. And software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 30, 2017
Shenzhen XFT Medical Limited Mrs. Jiang Xiaoying Manager RM 203, BLD1, 14 Jinhui Road, New District Shenzhen, Guangdong CN
Re: K162718
Trade/Device Name: Foot Drop System, Model 2001-D Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI Dated: October 27, 2017 Received: October 31, 2017
Dear Mrs. Xiaoying:
We have reviewed vour 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
1
801); medical device reporting of medical device-related 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Vivek J. Pinto -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) K162718
Device Name Foot Drop System (Model XFT-2001D)
Indications for Use (Describe)
XFT-2001D Foot Drop System is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of walking, the XFT-2001D electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Stimulation (FES) may include prevention/retardation of disuse attophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.
| 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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3
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | November 30, 2017 |
|---|---|
| Submitter: | Shenzhen XFT Medical Limited |
| Room203, Building 1, Biomedicine Innovations Industrial Park, | |
| #14 Jinhui Road, Pingshan New District, Shenzhen, China | |
| Contact Person: | Mrs. Jiang Xiaoying |
Co xfthr3@xft.cn Tel: +86-(0) 755-29888818
Device: Trade Name: Foot Drop System
Model: XFT-2001D series
External Neuromuscular Functional Stimulator Classification Names:
Product Code: GZI Regulation Number: 21 CFR 882.5810 Device Class: Class II Submission Purpose: New Device Predicate Device(s): K123972
4
- Nerve and Muscle Stimulator (Foot Drop System) is a battery-operated, Device
Description: electrical stimulator that can be used for functional electrical stimulation (FES).
Nerve and Muscle Stimulator (Foot Drop System) is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, Nerve and Muscle Stimulator (Foot Drop System) stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle. The Nerve and Muscle Stimulator (Foot Drop System) consists of the Patient Kit and the Clinician Kit. The Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System includes the Medical Records Management Software.
- Intended Use: XFT-2001D Foot Drop System is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of walking, the XFT-2001D electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.
- Technology: Proposed device and predicate device use a small electrical signal to stimulate the nerves in the leg, causing the muscles contract and produce a movement that can help walking. The most common use of FES is as a treatment for foot drop where disruptions in the nerve pathways between the legs and brain which means the front of your foot cannot be lifted to the correct angle when walking.
The Foot Drop System employs the same fundamental scientific technology as its predicate devices.
5
Basis for Technological characteristics, features, specifications, materials and Substantial intended uses of the new device are substantially equivalent to the Equivalence: quoted predicated device. The parameters such as waveform, frequency, pulse width, output current and voltage, although not exactly identical to this particular predicate, do not raise any new questions of safety or effectiveness. Applicable performance and safety testing was performed to verify technological and functional characteristics including any design modification. The differences that exist between the devices are insignificant in terms of safety and effectiveness.
The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness.
Table 1 Comparison between XFT-2001D and the predicate device
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| Specification | Predicate Device | Proposed device |
|---|---|---|
| K number | K123972 | K162718 |
| Device name | WalkAide | XFT-2001D |
| Manufacturer | Innovative Neurotronics, Inc. | Shenzhen XFT Medical Limited |
| Intended Use/ Indications for | ||
| Use | The Innovative Neurotronics WalkAide | |
| System is intended to address the lack of | ||
| ankle dorsiflexion in patients who have | ||
| sustained damage to upper motor | ||
| neurons or pathways to the spinal cord. | ||
| During the swing phase of gait, the | ||
| WalkAide electrically stimulates the | ||
| appropriate muscles that cause ankle | ||
| dorsiflexion and may thus improve the | ||
| patient's gait. Medical benefits of | ||
| Functional Electrical Stimulation (FES) | ||
| may include prevention/retardation of | ||
| disuse atrophy, increased local blood | ||
| flow, muscle re-education, and | ||
| maintained or increased joint range of | ||
| motion. | XFT-2001D Foot Drop System is | |
| intended to address the lack of ankle | ||
| dorsiflexion in patients who have | ||
| sustained damage to upper motor | ||
| neurons or pathways to the spinal | ||
| cord. During the swing phase of | ||
| walking, the XFT-2001D electrically | ||
| stimulates the appropriate muscles | ||
| that cause ankle dorsiflexion and may | ||
| thus improve the individual's gait. | ||
| Medical benefits of Functional | ||
| Electrical Stimulation (FES) may include | ||
| prevention/retardation of disuse | ||
| atrophy, increased local blood flow, | ||
| muscle re-education, and maintained | ||
| or increased joint range of motion. | ||
| Contraindications | Do not use on persons with implanted | |
| demand type cardiac pacemakers or | ||
| defibrillators. | Do not use on persons with implanted | |
| demand type cardiac pacemakers or | ||
| defibrillators | ||
| Do not place the electrodes in the | ||
| carotid sinus region (throat). | Do not place the electrodes in the | |
| carotid Sinus region (throat). | ||
| Laryngeal or pharyngeal spasms placed | ||
| across the throat or in the mouth. | Laryngeal or pharyngeal spasms may | |
| occur when the electrodes are placed | ||
| across the throat or in the mouth. | ||
| Do not place the electrodes over | ||
| malignant tumors. | Do not place the electrodes over | |
| malignant tumors. | ||
| Do not place the electrodes over areas in | ||
| which symptoms of existing thrombosis | ||
| are present. | Do not place the electrodes over areas | |
| in which symptoms of existing | ||
| thrombosis are present. | ||
| Do not use if person has a history of | ||
| seizure disorder. | Do not use if person has a history of | |
| seizure disorder. | ||
| Patient Population | Adult | Adult |
| Power Source(s) | 1.5 AA Battery (not rechargeable) | DC3.7V, 400mAh, rechargeable lithium |
| battery (Stim Unit & Remote control) | ||
| Patient Leakage Current | -Normal condition: 0.5mA | -Normal condition: 0.5mA |
| Specification | Predicate Device | Proposed Device |
| Number of Output Modes | 2 modes: gait mode and training | |
| mode | 2 modes: gait mode and training | |
| mode | ||
| Number of Output Channels | 1 | 1 |
| Regulated Current or | ||
| Regulated Voltage | Voltage | Current |
| Software/Firmware/Microproc | ||
| essor | Microprocessor | Microprocessor |
| Auto Overload Trip? | No | No |
| Auto No-Load Trip? | No | Yes |
| Auto Shut Off? | No | Yes |
| Patient Override Control? | Yes | Yes |
| Indicator Display | ||
| On/Off Status? | Yes | Yes |
| Low Battery? | ||
| Voltage/Current Level? | Yes | Yes |
| Timer Range (minutes) | 30 minutes | 20 minutes |
| ON Time (seconds) | 1-5 sec in 1 sec steps | 1-5 sec in 0.5 sec steps |
| OFF Time (seconds) | 1-10 sec in 1 sec steps | 2-10 sec in 1 sec steps |
| Net Charge (µC per pulse) | 16.7-33Hz | 16.7-33Hz |
| 25-300 microseconds | 100-300 μS | |
| Frequency (Pulses per second) | Pules width adjustable in following | |
| discrete steps: | ||
| 25/50/100/150/200/250/300μS | Pules width adjustable in following | |
| discrete | ||
| steps:100/150/200/250/300uS | ||
| Pulse width | 25-300 microseconds | 100-300 μS |
| Pules width adjustable in following | ||
| discrete steps: | ||
| 25/50/100/150/200/250/300μS | Pules width adjustable in following | |
| discrete steps: | ||
| 100/150/200/250/300uS | ||
| 41.2µC @ 500 ohm | 27.0μC @ 500 ohm | |
| Max Phase Charge(μC) | 28µC @ 1K ohm | 27.0µC @ 1K ohm |
| Max Current Density, | ||
| (mA/cm²) | 1.8mA/cm² (500 ohm) | 0.7mA/cm² (500 ohm) |
| Maximum Power Density, | ||
| (W/cm²) | 0.0128W/cm² (500 ohm) | 0.005W/cm² (500 ohm) |
| Specification | Predicate Device | Proposed Device |
| Max Output Voltage | unknown@ 500 ohm | 45V @ 500 ohm |
| 121V@ 1 K ohm | 90V @ 1 K ohm | |
| unknown @ 2 K ohm | 156V @ 2 K ohm | |
| unknown @ 10 K ohm | 158V@ 10 K ohm | |
| Max Output Current | 20.7mA rms@ 500 ohm | 14mA rms@ 500 ohm |
| unknown @ 2 K ohm | 11mA rms@ 2 K ohm | |
| unknown @ 10 K ohm | 2.2mA rms@10 K ohm | |
| Burst Mode | ||
| -Pulses per burst | Burst length and PPS dependent | Burst length and PPS dependent |
| -Bursts per second | Depends on ON and OFF times | Depends on ON and OFF times |
| -Burst duration | ||
| (seconds) | ||
| -Duty Cycle [Line (b) x Line (c)] | 1 to 5 sec in 1 sec steps Depends on | |
| ON and OFF times | 1 to 5 sec in 1 sec steps Depends on | |
| ON and OFF times | ||
| Stimulation Trigger Source | Tilt Sensor or Foot Sensor | Tilt Sensor |
| Anatomical Sites | Limb | Limb |
| Shipping and storage | Temp: -20 °C to 60 °C | |
| Relative Humidity: 95% max, non- | ||
| condensing | temp: -20°C to 55°C Relative | |
| Humidity |