(302 days)
Not Found
No
The device description mentions a microprocessor and a smartphone app for control and data storage. While it collects tilt angle data and calculates recommended parameters, this functionality is described as calculating based on collected data, not using AI/ML algorithms for learning or adaptation. There is no mention of AI, ML, DNN, or training/test sets, which are common indicators of AI/ML integration in medical devices.
Yes
The device is intended to address the lack of ankle dorsiflexion, improve gait, and provide medical benefits such as prevention/retardation of disuse atrophy, increased local blood flow, muscle reeducation, and maintained or increased joint range of motion, which are all therapeutic purposes.
No
The device is described as a stimulator that provides electrical stimulation to improve gait and muscle function. While it has an "Evaluation Mode" that collects data, this mode is used to calculate recommended parameters for stimulation, not to diagnose a medical condition. Its primary function is therapeutic stimulation, not diagnosis.
No
The device description explicitly states it is a "wearable and DC 3.7V rechargeable lithium battery powered multifunction device, and integrated metal (stainless-steel) electrodes," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Nerve and Muscle Stimulator (Model: XFT-2001EA) is a therapeutic device that applies electrical stimulation to the body to improve muscle function and gait. It does not analyze biological specimens.
- Intended Use: The intended use clearly describes a therapeutic application for addressing foot drop, not a diagnostic test performed on a sample.
- Device Description: The description details a wearable device with electrodes that deliver electrical pulses, not a device for analyzing biological samples.
Therefore, the Nerve and Muscle Stimulator (Model: XFT-2001EA) falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Nerve and Muscle Stimulator (Model: XFT-2001EA) 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 Nerve and Muscle Stimulator (Model: XFT-2001EA) 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 reeducation, 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 (Model: XFT-2001EA) is a wearable and DC 3.7V rechargeable lithium battery powered multifunction device, and integrated metal (stainless-steel) electrodes, offering Functional Electrical Stimulation (FES) in device. It can be attached to the leg just below the knee, near the head of the fibula. During a gait cycle, the Nerve and Muscle Stimulates the common peroneal nerve via metal electrode, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle.
The Nerve and Muscle Stimulator is a microprocessor-controlled device, and uses a smart phone operating application (APP) to store device, user and configuration information via Bluetooth. it can be operated by both smart phone application and the control panel of the device.
Nerve and Muscle Stimulator has 3 working mode, Walk Mode, Training Mode and Evaluation Mode. The walk mode and training mode which can give certain electrical pulses through metal electrode to the proposed area of the leg where the Nerve and Muscle Stimulator are placed. There is no electrical stimulation in the evaluation mode, it is intended to collect the tilt angle data generated by the Stimulator during the patient's walking, and can calculate the recommend parameters based on the collected data.
The control panel of the device has the operating elements of ON/OFF touch button, OLED display, mode selection touch button, intensity touch button and USB port for battery charging. The OLED display can show battery power, selected mode, current intensity and indication of a pause.
The stimulator will connect the APP via Bluetooth, user can set the parameters, mode selection, and intensity adjustment of the stimulation by APP. Logout of the APP or disconnect the Bluetooth, the stimulator can continue to work.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Limb
Indicated Patient Age Range
Adult
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)
Non-Clinical Test Summary
The proposed device Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) has passed safety testing in according to following standards.
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for 2) basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-2-10:2012+AM1:2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- ANSI/IEEE C63.27:2017 American National Standard for Evaluation of Wireless Coexistence
- FCC Rules and Regulations, Part 15, Subpart C and Subpart B
The rechargeable lithium battery has passed the IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
The power adapter has passed the ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-11:2005, MOD).
Biocompatibility Test
The proposed device Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) has passed biocompatibility tests in according to following standards:
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
Performance Testing-Bench
The proposed device Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) has conducted and passed performance testing in according to FDA guidance-Guidance for Industry, FDA Reviewer/Staff and Compliance-Guidance Document for Powered Muscle Stimulator 510(k)s, document issued on June 9, 1999.
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.
Not Found
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
§ 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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
September 23, 2020
Shenzhen XFT Medical Limited % Yovo Chen Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town Shenzhen, 518100 Cn
Re: K193276
Trade/Device Name: Nerve and Muscle Stimulator Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI Dated: September 3, 2020 Received: September 9, 2020
Dear Yoyo Chen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Nerve and Muscle Stimulator
Indications for Use (Describe)
Nerve and Muscle Stimulator (Model: XFT-2001EA) 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 Nerve and Muscle Stimulator (Model: XFT-2001EA) 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 reeducation, 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
This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.
1. Administrative Information
| Submission Date | September 3 ,2020 |
|---|---|
| Manufacturer | |
| information | Submitter's Name: Shenzhen XFT Medical Limited |
| Address: Room 203, Building 1, Biomedicine Innovations | |
| Industrial Park #14 Jinhui Road, Pingshan New District | |
| Shenzhen Guangdong, CHINA 518118 | |
| Contact person: Ms. Julia Ye | |
| TEL:+86(0755) 29888818 | |
| FAX: +86(0755) 28312625 | |
| E-Mail: xftrs2@xft.cn; xfthr1@xft.cn; | |
| Submission | |
| Correspondent | Shenzhen Joyantech Consulting Co., Ltd. |
| 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian | |
| Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong | |
| Province, China. | |
| Contact person: Ms. Yoyo Chen, Mr. Field Fu | |
| E-Mail: yoyo@cefda.com; field@cefda.com | |
| Image: [logo] | |
| Establishment | |
| registration number | 3004438577 |
2. Device Information
| Type of 510(k) Submission: | Traditional |
|---|---|
| Common name of the device: | Nerve and Muscle Stimulator |
| Trade name of the device: | Foot Drop System |
| Type/Model of the device: | XFT-2001E and XFT-2001EA |
| Classification name: | Stimulator, Neuromuscular, External Functional; |
| Review Panel: | Neurology |
| Device Class | II |
| Regulation Number | 21 CFR 882.5810 |
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3. Predicate Device
| Manufacturer | Shenzhen XFT Medical Limited |
|---|---|
| Trade name | Foot Drop System |
| Model | XFT-2001D |
| 510(K) Number: | K162718 |
| Product Code | GZI |
4. Device Description
Nerve and Muscle Stimulator (Model: XFT-2001EA) is a wearable and DC 3.7V rechargeable lithium battery powered multifunction device, and integrated metal (stainless-steel) electrodes, offering Functional Electrical Stimulation (FES) in device. It can be attached to the leg just below the knee, near the head of the fibula. During a gait cycle, the Nerve and Muscle Stimulates the common peroneal nerve via metal electrode, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle.
The Nerve and Muscle Stimulator is a microprocessor-controlled device, and uses a smart phone operating application (APP) to store device, user and configuration information via Bluetooth. it can be operated by both smart phone application and the control panel of the device.
Nerve and Muscle Stimulator has 3 working mode, Walk Mode, Training Mode and Evaluation Mode. The walk mode and training mode which can give certain electrical pulses through metal electrode to the proposed area of the leg where the Nerve and Muscle Stimulator are placed. There is no electrical stimulation in the evaluation mode, it is intended to collect the tilt angle data generated by the Stimulator during the patient's walking, and can calculate the recommend parameters based on the collected data.
The control panel of the device has the operating elements of ON/OFF touch button, OLED display, mode selection touch button, intensity touch button and USB port for battery charging. The OLED display can show battery power, selected mode, current intensity and indication of a pause.
The stimulator will connect the APP via Bluetooth, user can set the parameters, mode selection, and intensity adjustment of the stimulation by APP. Logout of the APP or disconnect the Bluetooth, the stimulator can continue to work.
5. Intended Use/Indication for Use
Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) 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 Nerve and Muscle
5
Stimulator (Model: XFT-2001E, XFT-2001EA) 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 reeducation, and maintained or increased joint range of motion.
6
6. Comparison with predicate device
The Nerve and Muscle Stimulator (Model, XFT-2001EA) is substantially equivalent to the predicate device (K162718). This conclusion is based upon comparison on intended use, technological characteristics, output mode and standards. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.
| Items | New Device
(K193726)
XFT-2001E and XFT-2001EA | Predicate Device
(K162718)
XFT-2001D | Comparison |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Product code | GZI | GZI | Same |
| Regulation number | 21 CFR 882.5810 | 21 CFR 882.5810 | Same |
| Device class | 2 | 2 | Same |
| Manufacturer | Shenzhen XFT Medical Limited | Shenzhen XFT Medical Limited | Same |
| Intended use | Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) 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 Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) 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 reeducation, | 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 reeducation, and maintained or increased joint range of motion. | Same |
| Items | New Device
(K193726)
XFT-2001E and XFT-2001EA
and maintained or increased joint range of
motion. | Predicate Device
(K162718)
XFT-2001D | Comparison |
| Patient Population | Adult | Adult | Same |
| Power source | DC 3.7V, 450mAh, rechargeable lithium battery | DC 3.7V, 400mAh, rechargeable lithium battery | Different
(Note1) |
| -Method of Line Current Isolation | Type BF | Type BF | Same |
| -Patient Leakage Current (mA):
-Normal condition | Normal condition: 0.5mA | Normal condition: 0.5mA | Same |
| - Single fault condition | Single fault condition: 2mA | Single fault condition: 2mA | |
| Number of Output Modes | 3 modes:
Walk Mode, Training Mode and Evaluation Mode:
• There are 2 modes under walk mode- Smart mode and Normal mode;
• There are 10 modes under training mode- 9 preset modes and 1 customize mode. | 2 modes:
Gait Mode and Training Mode:
• There are 3 modes under gait mode-Smart mode, Normal mode and Gait Analysis;
• There are 10 modes under training mode- 9 preset modes and 1 customized mode. | Different
(Note2) |
| Number of Output Channels | 1 | 1 | Same |
| Waveform | Asymmetrical Biphasic | Asymmetrical Biphasic | Same |
| Shape | Rectangular | Rectangular | Same |
| Maximum Output Voltage (volts) (+/-
10%) | 45V@500 Ω
90V@1KΩ
156V@2K Ω
158V@10K Ω | 45V@500 Ω
90V@1KΩ
156V@2K Ω
158V@10K Ω | Same |
| Items | New Device
(K193726)
XFT-2001E and XFT-2001EA | Predicate Device
(K162718)
XFT-2001D | Comparison |
| Maximum Output Current (mA) (+/-
10%) | 15.58mA rms @500 Ω
13.51mA rms @ 2 kΩ
2.73mA rms @ 10 kΩ | 14mA rms @500 Ω
11mA rms @ 2 kΩ
2.2mA rms @ 10 kΩ | Different
(Note3) |
| Duration of primary (depolarizing)
phase (µ sec) | Unknown | Unknown | Same |
| Pulse Duration (µ sec) (+/- 10%) | 100300 µ sec300 µ sec
Pulse width adjustable in following discrete
steps:100/150/200/250/300 µ sec | 100
Pulse width adjustable in following discrete
steps:100/150/200/250/300 µ sec | Same |
| Frequency (Hz) (+/- 10%) | 1650 Hz33Hz
Frequency adjustable in following discrete steps:
16/ 20/ 25/ 33/ 40 / 50Hz | 16
Frequency adjustable in following discrete steps:
16/ 20/ 25/ 33Hz | Different
(Note3) |
| For interferential modes only:
-Beat Frequency (Hz) | Unknown | Unknown | Same |
| For multiphasic waveforms only:
-Symmetrical phases?
-Phase Duration (include units)
(state range, if applicable)
(both phases, if asymmetrical) | No symmetrical phase | No symmetrical phase | Same |
| Net Charge (microcoulombs (µC) per
pulse) | 0µC@500 Ω | 0µC@500 Ω | Same |
| Maximum Phase Charge, (µC) ±10% | 27µC @500Ω
23.4µC @2kΩ
4.74μC @10kΩ | 27µC @500Ω
23.4µC @2kΩ
4.74μC @10kΩ | Same |
7
8
9
| Items | New Device
(K193726)
XFT-2001E and XFT-2001EA | Predicate Device
(K162718)
XFT-2001D | Comparison | | |
|----------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------|--------------------------|
| Maximum Current Density (mA/cm², r.m.s.) ±10% | 0.53mA/cm² @500Ω
0.46mA/cm² @2kΩ
0.09mA/cm² @10kΩ | 0.7mA/cm² @500Ω
0.58mA/cm² @2kΩ
0.11mA/cm² @10kΩ | Different
(Note3) | | |
| Maximum Average Current (average absolute value), mA±10% | 15.58mA @500Ω
13.51mA @2kΩ
2.73mA @10kΩ | 12.66mA @500Ω
10.97mA @2kΩ
2.22mA @10kΩ | Different
(Note3) | | |
| Maximum Average Power Density, (W/cm²) | 0.008W/cm² @500Ω
0.025 W/cm² @2KΩ
0.005 W/cm² @10KΩ | 0.005W/cm²@500 Ω
0.014W/cm²@2KΩ
0.003W/cm²@2KΩ | Different
(Note3) | | |
| Burst
Mode | (a) Pulses per burst | Burst length and PPS dependent | Burst length and PPS dependent | Same | |
| | (b) Bursts per second | Depends on duration times and interval times | Depends on duration times and interval times | Same | |
| | (c) Burst duration (seconds) | 1 to 5 sec in 0.1 sec steps Depends on duration times and interval times | 1 to 5 sec in 0.1 sec steps Depends on duration times and interval times | | |
| | (d) Duty Cycle: Line (b) x Line (c) | unknow | unknow | | |
| Indicator
Display | | On/Off Status?
Low Battery?
Voltage/Current Level? | Yes
Yes
Yes | | Yes
Yes
Yes |
| | | Duration Time /ON time (Seconds) | 1-5 sec in 0.1 sec steps | | 1-5 sec in 0.1 sec steps |
| | | Interval Time /OFF time (Seconds) | 1-10 sec in 0.1 sec steps | 1-10 sec in 0.1 sec steps | Same |
| Timer Range (Minutes) | | 20 minutes | | 20 minutes | Same |
| Stimulation Trigger Source | | Tilt sensor | | Tilt sensor | Same |
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| Items | New Device
(K193726)
XFT-2001E and XFT-2001EA | Predicate Device
(K162718)
XFT-2001D | Comparison |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-----------------------|
| Anatomical Sites | Limb | Limb | Same |
| Shipping and Storage | Temp:-20°C to 55°C
Relative Humidity ≤93%
Atmos: 70-106KPa | Temp:-20°C to 55°C
Relative Humidity ≤93%
Atmos: 70-106KPa | Same |
| Operating Conditions | Temp:5°C to 40°C
Relative Humidity ≤80%
Atmos: 86-106KPa | Temp:5°C to 40°C
Relative Humidity ≤80%
Atmos: 86-106KPa | Same |
| Electrode Size and Shape | Rectangular 1(29.3218.04mm),
Rectangular 2(28.2618.38mm),
Rectangular 3(29.0117.89mm),
Rectangular 4(89.0032.80mm) | 5 cm diameter Round | Different
(Note4) |
| Electrode materials | Stainless steel SUS 316L | Hydrogel/conductive fabrics | Different
(Note4) |
| Materials-Cuff | TPE (Thermoplastic Elastomer) | Fabric | Different
(Note5) |
| Maximum Stimulation Period | 5 seconds | 5 seconds | Same |
| Wireless Communication | Blue tooth 4.0 | Blue tooth 4.0 | Same |
| Wireless Control | Smart phone application | Remote control | Different
(Note 6) |
| Weight | XFT-2001E:155g;
XFT-2001EA: 140g | 43g | Different
(Note7) |
| Dimensions (mm) [W x H x D] | XFT-2001E: 126.8 x102.4 x15.5mm;
XFT-2001EA: 122.8 x104.8 x15.9mm | 737010mm | Different
(Note7) |
| Items | New Device
(K193726)
XFT-2001E and XFT-2001EA | Predicate Device
(K162718)
XFT-2001D | Comparison |
| Housing Materials and Construction | ABS | ABS | Same |
| Expected Service Life | 5 years | 5 years | Same |
| Compliance with 21 CFR 898? | Yes | Yes | Same |
| Compliance with Voluntary Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10 | Same |
11
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Note1: Power source
The difference between the subject device and predicate device for power source is the capacity of rechargeable lithium battery. However, the battery is complied with IEC 62133-2:2017 standard requirements, and the subject devices have passed the IEC 60601-1 test standard. Therefore, the difference between the subject and predicate devices do not impact safety and effectiveness.
Note 2: Number of Output Modes
Based on the performance testing in comparison with the predicate device under different loads, it is concluded that the difference does not raise any safety or effectiveness issues.
Note 3: Maximum Output Current, Frequency, Maximum Current Density, Maximum Average Current, Maximum Average Power Density
Although the above parameters of subject device are different with the predicate device, but these parameters are within the acceptable range by comparison with the device which previously cleared. Therefore, the difference between the subject and predicate devices do not impact safety and effectiveness.
Note 4: Electrode Size, Shape and Electrode materials
Although the electrode is different with predicate device, however, the tests for biocompatibility, durability and electrical safety test are all carried out to ensure the device could be safe and effective during normal use. Therefore, it is considered that the difference between the subject and predicate devices does not impact safety and effectiveness.
Note 5: Materials-Cuff
Even though the electrode and cuff material of subject devices are is different with Predicate Device, but they all passes biocompatibility test in according to ISO 10993-5 and ISO 10993-10 standards. Therefore, these differences do not impact safety and effectiveness.
Note 6: Wireless Control
Although the wireless control of subject device is different with predicate device, but they all meet the requirements of wireless coexistence. Based on the performance test result of wireless coexistence, the quality of wireless could be assured during normal use. Therefore, the difference does not raise any safety or effectiveness issues.
Note 7: Weight and Dimensions
After comparison with the previously declared device, we believe that the weight of subject device could be safe and effective during normal use for this type of device. Regarding the dimension of subject device, it could be adjusted during normal use to accommodate the leg circumferences of intended population, and ensure the device could be fit during normal use. Therefore, the difference does not raise any safety or effectiveness issues.
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Non-Clinical Test Summary 7.
7.1. Electromagnetic Compatibility and Electrical Safety Test
The proposed device Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) has passed safety testing in according to following standards.
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- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for 2) basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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- IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
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- IEC 60601-2-10:2012+AM1:2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
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- ANSI/IEEE C63.27:2017 American National Standard for Evaluation of Wireless Coexistence
- FCC Rules and Regulations, Part 15, Subpart C and Subpart B 6)
The rechargeable lithium battery has passed the IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
The power adapter has passed the ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-11:2005, MOD).
7.2. Biocompatibility Test
The proposed device Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) has passed biocompatibility tests in according to following standards:
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- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation 2) and skin sensitization
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7.3. Performance Testing-Bench
The proposed device Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) has conducted and passed performance testing in according to FDA guidance-Guidance for Industry, FDA Reviewer/Staff and Compliance-Guidance Document for Powered Muscle Stimulator 510(k)s, document issued on June 9, 1999.
8. Clinical Test Data
Substantial equivalence does not depend on the clinical test data.
9. Conclusion
The Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) is substantially equivalent to the predicate device (K162718). This conclusion is based upon comparison on intended use, technological characteristics, output mode and applicable safety standards. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.