(427 days)
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.
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.
The provided text is a 510(k) summary for the XFT-2001D Foot Drop System, which seeks to demonstrate substantial equivalence to a predicate device (WalkAide, K123972). This document primarily details a comparison of the proposed and predicate devices' technical specifications and outlines the performance testing conducted to support safety and effectiveness. It does not present a study with specific acceptance criteria and reported device performance in the context of clinical efficacy or accuracy metrics for AI/ML-driven devices.
The "Performance Data" section (Page 10) focuses on regulatory compliance testing rather than clinical study results. It mentions:
- EMC and Electrical safety: Compliance with IEC 60601-1-2:2014, IEC 60601-1:2005, and IEC 60601-2-10:2012. These are standards for the basic safety and essential performance of medical electrical equipment, including electromagnetic disturbances and specific requirements for nerve and muscle stimulators.
- Biocompatibility: Evaluation of electrode pads (K132588) per ISO 10993-5:2009 (in vitro cytotoxicity) and ISO 10993-10:2010 (irritation and skin sensitization).
- Software Verification and Validation: Conducted for a "MODERATE" level of concern software, following FDA guidance for software in medical devices.
Therefore, many of the requested elements for a deep dive into AI/ML study specifics (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not present in this document.
However, I can still extract information based on the type of "acceptance criteria" and "study" described in the document, which are regulatory compliance focused.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
For this device, the "acceptance criteria" are compliance with established international standards for medical electrical equipment and software. The "reported device performance" indicates that the device met these standards.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard/Guidance) | Reported Device Performance |
|---|---|---|
| EMC and Electrical Safety | IEC 60601-1-2:2014 (Electromagnetic disturbances) | Device complies with the standard. |
| IEC 60601-1:2005 (Basic safety and essential performance) | Device complies with the standard. | |
| IEC 60601-2-10:2012 (Nerve and muscle stimulators) | Device complies with the standard. | |
| Biocompatibility | ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Evaluation conducted according to the standard. |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Evaluation conducted according to the standard. | |
| Software V&V | FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (for "MODERATE" level of concern software) | Software verification and validation testing were conducted and documentation provided as recommended. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes compliance testing for electrical safety, EMC, biocompatibility, and software V&V, which typically involve laboratory tests on devices and materials, not clinical "test sets" with patient data in the way an AI/ML diagnostic device would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable for the type of testing described (regulatory compliance for an external functional electrical stimulator). Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or outcomes, which are not part of this submission's performance data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the type of testing described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not done. This type of study is relevant for AI-assisted diagnostic or interpretive devices. The XFT-2001D is an external functional electrical stimulator, not an interpretive AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm (in the context of AI/ML) was not done. The software V&V was conducted for the device's operational software at a "MODERATE" level of concern, indicating its impact on device function rather than a diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the specific performance data presented (EMC, electrical safety, biocompatibility, software V&V), the "ground truth" is defined by the standards themselves. For example, a device's electrical leakage current measurement must be below a certain threshold specified in IEC 60601-1. There isn't "ground truth" derived from patient outcomes or expert consensus in the way it's understood for AI/ML diagnostic tools.
8. The sample size for the training set
This information is not applicable as the device is not an AI/ML-driven diagnostic or predictive model in the context of the provided document. The software mentioned is for the device's operational control, not for "training" algorithms.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" in the context of an AI/ML model for this device's submission.
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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
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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
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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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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 LimitedRoom203, 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
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- 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.
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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 forUse | The Innovative Neurotronics WalkAideSystem is intended to address the lack ofankle dorsiflexion in patients who havesustained damage to upper motorneurons or pathways to the spinal cord.During the swing phase of gait, theWalkAide electrically stimulates theappropriate muscles that cause ankledorsiflexion and may thus improve thepatient's gait. Medical benefits ofFunctional Electrical Stimulation (FES)may include prevention/retardation ofdisuse atrophy, increased local bloodflow, muscle re-education, andmaintained or increased joint range ofmotion. | XFT-2001D Foot Drop System isintended to address the lack of ankledorsiflexion in patients who havesustained damage to upper motorneurons or pathways to the spinalcord. During the swing phase ofwalking, the XFT-2001D electricallystimulates the appropriate musclesthat cause ankle dorsiflexion and maythus improve the individual's gait.Medical benefits of FunctionalElectrical Stimulation (FES) may includeprevention/retardation of disuseatrophy, increased local blood flow,muscle re-education, and maintainedor increased joint range of motion. |
| Contraindications | Do not use on persons with implanteddemand type cardiac pacemakers ordefibrillators. | Do not use on persons with implanteddemand type cardiac pacemakers ordefibrillators |
| Do not place the electrodes in thecarotid sinus region (throat). | Do not place the electrodes in thecarotid Sinus region (throat). | |
| Laryngeal or pharyngeal spasms placedacross the throat or in the mouth. | Laryngeal or pharyngeal spasms mayoccur when the electrodes are placedacross the throat or in the mouth. | |
| Do not place the electrodes overmalignant tumors. | Do not place the electrodes overmalignant tumors. | |
| Do not place the electrodes over areas inwhich symptoms of existing thrombosisare present. | Do not place the electrodes over areasin which symptoms of existingthrombosis are present. | |
| Do not use if person has a history ofseizure disorder. | Do not use if person has a history ofseizure disorder. | |
| Patient Population | Adult | Adult |
| Power Source(s) | 1.5 AA Battery (not rechargeable) | DC3.7V, 400mAh, rechargeable lithiumbattery (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 trainingmode | 2 modes: gait mode and trainingmode |
| Number of Output Channels | 1 | 1 |
| Regulated Current orRegulated Voltage | Voltage | Current |
| Software/Firmware/Microprocessor | 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 followingdiscrete steps:25/50/100/150/200/250/300μS | Pules width adjustable in followingdiscretesteps:100/150/200/250/300uS |
| Pulse width | 25-300 microseconds | 100-300 μS |
| Pules width adjustable in followingdiscrete steps:25/50/100/150/200/250/300μS | Pules width adjustable in followingdiscrete 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 onON and OFF times | 1 to 5 sec in 1 sec steps Depends onON 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 °CRelative Humidity: 95% max, non-condensing | temp: -20°C to 55°C RelativeHumidity< 93%Atmos.: 700-1060hPa |
| Operating Conditions | Temp: 0-40 degrees CAltitude: from -400 to 2,400 meters(- 1300 to 8,000 ft) | temp: -5°C to 40°C RelativeHumidity< 80%Atmos.: 860-1060hPa |
| Relative Humidity: 0 to 95%, non-condensing | ||
| Electrode Size and Shape | 3.175 cm (1.25 inches) diameterRound | 5 cm diameter Round |
| Electrode materials(Basicmechanical element) Materialcontacting skin | Hydrogel and Stainless Steel (SS)316 | Hydrogel /conductive fabric |
| Materials-cuff | fabric | fabric |
| Specification | Predicate Device | Proposed Device |
| MaximumStimulation Period | 3 seconds | 3 seconds |
| Wireless communication | Blue tooth 1.2 | Blue tooth 4.0 |
| Weight | 87.9 g | 43 g |
| Dimensions (in.) [W x H x D] | 826121mm | 737010mm |
| Housing Materials andConstruction | ABS | ABS |
| Waveform | Asymmetrical Biphasic | Asymmetrical Biphasic |
| Shape | rectangular | rectangular |
| Expected Service Life | 5 years | 5 years |
| Compliance with 21CFR 898? | Yes | Yes |
| Compliance with VoluntaryStandards | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 |
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Performance The following performance data were provided in support of the substantial
Data: equivalence determination.
EMC and Electrical safety
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."
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- Shenzhen XFT Medical Limited believes that the XFT-2001D Foot Drop Conclusion: System is as safe and effective, and performs in a substantially equivalent manner to the predicate device. The modifications do not raise any safety or effectiveness issues and meet the applicable requirements of IEC60601-2- 10 "Particular requirements for the safety of nerve and muscle stimulators." and the FDA document "Guidance Document for Powered Muscle Stimulator 510(k)s" June 9, 1999. We conclude that the proposed XFT- 2001D Foot Drop System is substantially equivalent to the WalkAide System (K123972).
§ 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).