(463 days)
Not Found
No
The summary describes functional electrical stimulation triggered by gait phase detection, which is a rule-based system, not AI/ML. There is no mention of AI, ML, or related concepts like training/test sets.
Yes
The device is intended to provide ankle dorsiflexion, prevent/retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow, all of which are therapeutic effects.
No
Explanation: The MStim Drop LGT-233 is described as a therapeutic device that uses functional electrical stimulation (FES) to address foot drop and improve gait, prevent muscle atrophy, maintain range of motion, and increase blood flow. Its function is to treat, not to diagnose.
No
The device description explicitly states it consists of a "stimulator main unit, electrode lead wire, electrodes pad, leg bandage and battery charger," which are all hardware components. While it uses an APP for control, it is not solely software.
Based on the provided information, the MStim Drop LGT-233 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to provide ankle dorsiflexion and improve gait in individuals with dropped foot. This is a therapeutic and functional purpose, not a diagnostic one.
- Device Description: The description details a wearable device that uses electrical stimulation to treat a physical condition. It does not involve analyzing biological samples (like blood, urine, or tissue) to diagnose a disease or condition.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases.
The device is a therapeutic medical device that uses functional electrical stimulation (FES) to improve motor function.
N/A
Intended Use / Indications for Use
The MStim Drop LGT-233 is intended to provide ankle dorsiflexion in individuals who have a dropped foot as a consequence of upper motor neuron injury. The device electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait. The MStim Drop LGT-233 may also: ·Prevent/retard disuse atrophy · Maintain or increase joint range of motion •Increase local blood flow
Product codes
GZI, IPF
Device Description
The MStim Drop LGT 233 is a wearable foot drop device, which is mainly consist s of stimulator main unit, electrode lead wire, electrodes pad, leg bandage and battery charger. The stimulator main unit can be charge by the battery charger. The device can control the out stimulation and treatment time setting by APP application provided by the manufacturer, and it can trigger and control the pulse stimulation on and off by detecting the swing phase of gait during walking. The device was design to use FES (Functional Electrical Stimulation) to treat and improve the patient s foot drop and help to improve walking ability. It has two modes: Training mode, Walk mode. Training mode is suitable for muscle training when the patient is seated or lying down (patient lacking active training), which can promote muscle recover, prevent muscle atrophy, improve joint range of motion, and increase local blood flow. Walk mode is walking with the electrical stimulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Leg
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Device has been evaluated the safety and performance by lab bench testing according to the following standards:
- IEC 60601-1-2: 2014: Medical Electrical Equipment -Part 1-2: General requirements for basic salety 1. and essential performance. Collateral Standard: Electromagnetic Compatibility
- IEC 60601-1:2005: Medical Electrical Equipment Part 1: General requirements for basic safety 2. and essential performance
-
- 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: A1 2016 Medical Electrical Equipment - Part 2: 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
-
- IEC 62133-2: 2017: Secondary cells and batteries containing alkaline or other non-acid electrolytes-Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications- Part 2: Lithium systems
-
- Biological evaluation ofmedical device Part 10: Tests for irritation and skin sensitization(ISO 10993-10:2010)
-
- Biological evaluation of medical device Part 5: Cytotoxicity test- In vitro method (ISO 10993-5:2009)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 5, 2021
Guangzhou Longest Science & Technology CO., Ltd. % Jet Li Regulation Manager Guangzhou Keda Biological Tech Co., Ltd. 6F, No. I TianTai road, Science City, LuoGang District Guangzhou, Guangdong 510060 China
Re: K202110
Trade/Device Name: MStim Drop Model: LGT-233 Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: October 5, 2021 Received: October 6, 2021
Dear Jet Li:
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 mediation-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.
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202110
Device Name MStim Drop Model: LGT-233
Indications for Use (Describe)
The MStim Drop LGT-233 is intended to provide ankle dorsiflexion in individuals who have a dropped foot as a consequence of upper motor neuron injury. The device electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait. The MStim Drop LGT-233 may also:
·Prevent/retard disuse atrophy
· Maintain or increase joint range of motion
•Increase local blood flow
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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 510K number: K202110
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Date of the summary prepared: November 04, 2021 1.
Submitter'sInformation 2.
Company Name: Guangzhou Longest Science & Technology CO., Ltd. Address: 5&6F, Building B4, No.11, Kaiyuan Avenue, Science City, Guangzhou Hi-tech Industrial Development Zone, 510530 Guangzhou, Guangdong Province, P.R. China Phone: +86 020 6635 3999 Fax:+86 020 6635 3920 URL: www.longest.cn
E-mail: qzlongest@126.com
Contact Person: Xiaobing Luo (Deputy general manager) E-mail: service@longest.cn
Application Correspondent:
Company: Guangzhou KEDA Biological Tech Co., Ltd. Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhouCity, China
Contact Person: Mr. Jet Li
Tile: Regulation Manager
Tel: +86-18588874857
Email: med-jl@foxmail.com
3. Subject Device Information
Type of 510(k) submission: Traditional Common Name: External functional neuromuscular stimulator Trade Name: MStim Drop Model: LGT-233 Classification Name: Stimulator, neuromuscular, external functional; Stimulator, muscle, powered Review Panel: Neurology, Physical Medicine Product Code: GZI, IPF
Requlation Number: 882.5810, 890.5850
4
Regulation Class: 2
| Sponsor | Bioness Inc | Otto Bock Healthcare
Products GmbH |
|----------------------|--------------------------------------|----------------------------------------|
| Device Name | L300 Go System | Otto Bock Healthcare
Products GmbH |
| 510(k) Number | K162407 | K141812 |
| Product
Code | GZI, IPF | GZI; GZI |
| Regulation
Number | 21 CFR §882.5810
21 CFR §890.5850 | 21 CFR 882.5850 and
21 CFR 882.5810 |
| Regulation
Class | 2 | 2 |
Predicate Device Information 4.
5. Device Description
The MStim Drop LGT 233 is a wearable foot drop device, which is mainly consist s of stimulator main unit, electrode lead wire, electrodes pad, leg bandage and battery charger. The stimulator main unit can be charge by the battery charger.
The device can control the out stimulation and treatment time setting by APP application provided by the manufacturer, and it can trigger and control the pulse stimulation on and off by detecting the swing phase of gait during walking. The device was design to use FES (Functional Electrical Stimulation) to treat and improve the patient s foot drop and help to improve walking ability. It has two modes: Training mode, Walk mode. Training mode is suitable for muscle training when the patient is seated or lying down (patient lacking active training), which can promote muscle recover, prevent muscle atrophy, improve joint range of motion, and increase local blood flow. Walk mode is walking with the electrical stimulation.
6. Intended Use / Indicationsfor Use
The MStim Drop LGT-233 is intended to provide ankle dorsiflexion in individuals who have a dropped foot as a consequence of upper motor neuron injury. The device electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the flexion or extension; thus, it also may improve the individual's gait.
- The MStim Drop LGT-233 may also:
- Prevent/retard disuse atrophy
- Maintain or increase joint range of motion
5
· Increase local bloodflow
7. Test Summary
The Device has been evaluated the safety and performance by lab bench testing according to the following standards:
- IEC 60601-1-2: 2014: Medical Electrical Equipment -Part 1-2: General requirements for basic salety 1. and essential performance. Collateral Standard: Electromagnetic Compatibility
- IEC 60601-1:2005: Medical Electrical Equipment Part 1: General requirements for basic safety 2. and essential performance
-
- 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: A1 2016 Medical Electrical Equipment - Part 2: 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
-
- IEC 62133-2: 2017: Secondary cells and batteries containing alkaline or other non-acid electrolytes-Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications- Part 2: Lithium systems
-
- Biological evaluation ofmedical device Part 10: Tests for irritation and skin sensitization(ISO 10993-10:2010)
-
- Biological evaluation of medical device Part 5: Cytotoxicity test- In vitro method (ISO 10993-5:2009)
8. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, mode of operation, and intended use of the MStim Drop Model: LGT-233 is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate device do not raise new issues of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
|---|---|---|---|---|---|
| Device Name | |||||
| and Model | MStim Drop Model: LGT- | ||||
| 233 | L300 Go System | MyGait Stimulation | |||
| System | -- | ||||
| Elements of | |||||
| Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| 510 (K) | |||||
| Number | Applying | K162407 | K141812 | -- | |
| Product Code | GZI, IPF | GZI, IPF | GZI, IPF | -- | |
| Regulation | |||||
| Number | 882.5810, 890.5850 | 21 CFR § 882.5810 |
21 CFR § 890.5850 | 21 CFR 882.5810, 21 CFR § 890.5850 | -- | |
| Indication for
use | The MStim Drop LGT-233 is
intended to provide ankle
dorsiflexion in individuals who
have a dropped foot as a
consequence of upper motor
neuron injury. The device
electrically stimulates muscles
in the affected leg to provide
ankle dorsiflexion of the foot
and/or knee flexion or
extension; thus, it also may
improve the individual's gait.
The MStim Drop LGT-233
may also:
Prevent/retard disuse
atrophy
Maintain or increase joint
range of motion
Increase local blood flow | The L300 Go System is
intended to provide ankle
dorsiflexion in adult and
pediatric individuals with
foot drop and/or assist
knee flexion or extension
in adult individuals with
muscle w eakness related
to upper motor neuron
disease/injury (e.g.,
stroke, damage to
pathways to the spinal
cord). The L300 Go
Systemelectrically
stimulates muscles in the
affected leg to provide
ankle dorsiflexion of the
foot and/or knee flexion or
extension; thus, it also
may improve the
individual's gait. | The stimulation system is
intended to provide ankle
dorsiflexion and knee flexion
or extension in individuals with
foot drop and thigh muscle
weakness following an upper
motor neuron injury or
disease.
During gait, the stimulation
system sends electric stimuli
to muscles in the affected leg,
initiating dorsiflexion of the foot
and knee extension or flexion
and may thus improve the
individual's gait. The
stimulation system may also
prevent or retard atrophy
caused by inactivity, facilitate
muscle reeducation, maintain
or improve the range of motion
in the joints and promote local
blood circulation. | SE | |
| Apply parts | Leg | Leg and foot | Leg and foot | SE | |
| Power Sources | Adapter model: HYI11-005
(USA) and HYI11-005
(Europe)
Adapter supply voltage: AC
100~240V, 50/60Hz
Adapter output: DC 5V, 2A
Battery: 3.7V, 1200mAh,
lithium battery. | Battery operated | Battery operated | Minor
difference
Note 1 | |
| Indicator
display | LED and APP | -- | -- | Minor
difference
Note 1 | |
| Elements of
Compariso
n | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Method of Line
Current
Isolation | Battery operated | -- | Medical Class II Power
Adapter | SE | |
| Number of
Modes for
Micro current
stimulation | 2
(For Evaluation mode: no
micro current stimulation) | Two modes: Biphasic
Symmetric and Biphasic
Asymmetric.
Applicable to both lower
leg and thigh position of
the device. | 2 | SE | |
| Number of
Channels for
Micro current
stimulation | 1 | Lower leg small cuff
- 1 channel;
Lower leg regular
cuff - 1 or 2 channels (in 2
channel configuration,
both
channels function as a
single channel with
separately adjustable
medial / lateral stimulation
intensity);
Thigh cuff - 1 channel | 2 | SE | |
| Synchronous
or Alternating | Not applicable – single
channel device | Alternating (at one time
only one channel is
activated) | Synchronous or alternating | SE | |
| Regulated
Current or
Regulated
Voltage | Regulated Voltage | Current | Regulated Current | SE
Note 2 | |
| Elements of
Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Software/Firmware/
Microprocessor
control | Yes | Yes | Yes | SE | |
| Automatic Overload
Trip | Yes | Yes | Yes | SE | |
| Automatic No-load
Trip | Yes. | Yes | Yes | SE | |
| Automatic Shut Off | Yes. | Yes | No | SE | |
| Patient Override
Control | Yes | Yes | Yes
ON/OFF Button | SE | |
| Indic
ator
Displ
ay | On/Off
Status | Yes | Yes | Yes | SE |
| | Low
Battery | Yes | Yes | Yes | SE |
| | Voltag
e/Curr ent
Level | Yes | Yes | No | SE |
| Timer Range | | Treatment time: 1min-
60min, stepping 1min;
Timer tolerance: ±2%;
When finish, the device
can stop output and
prompt | Max
stimulation
duration (clinician
selectable)
Training mode: 5-60
minutes | 5 to 120min in steps of
5 min | Minor difference
Note 2 |
| Elements of
Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Console weight | 60g (only main unit) | Control Unit: 60g, EPG:
60g, Lower leg FSC:150g,
Thigh cuff: 300g, Foot
Sensor: 25g | 78g | SE | |
| Housing
Materials and
Construction | ABS | Remote Control:
Bay State Polymer
PA-2000RX
EPG: Bay State Polymer
PA-2000RX
(Polycarbonate + ABS)
Lower Leg FSC:
Biocompatible fabric over
plastic (POM Hi) skeleton
Thigh FSC: TPU Foot
Sensor: ABS (Sensor
housing), Bay state
Polymer
PA-2000RX (Electronics
housing) | ABS | SE | |
| Waveform | Biphasic square | Biphasic Symmetrical | Biphasic | SE | |
| Shape | Rectangular | Rectangular | Rectangular | SE | |
| Maximum
Output Voltage
(+/- 10%) | 50V ±10% @ 500Ω
90V ±10% @ 1KΩ
120V ±10% @ 2KΩ
130V ±10% @ 10KΩ | Lower leg: 50V@500Ω
Thigh: 50V@500Ω
Lower leg: 130V@2K Ω
Thigh: 130V@2K Ω
lower leg: 130V@10K Ω
Thigh: 130V@10K Ω | 45V +-10% @ 500Ω
90V +-10% @ 1KΩ
120V +-10%@2K Ω
n/a @10K Ω
(no stimulation possible at
10kΩ) | Minor difference
Note 3 | |
| Elements of
Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Maximum
output Current | 100mA ±10% @ 500Ω
90mA ±10% @ 1KΩ
60mA ±10% @ 2KΩ
13mA ±10% @ 10KΩ | Lower leg: 100mA@500Ω
Thigh: 100mA@500Ω
Lower leg: 65mA@2KΩ
Thigh: 65mA@2KΩ
Lower leg: 13mA@10KΩ
Thigh: 13mA@10KΩ | 90mA (+/- 10%) @ 500Ω
90mA (+/- 10%) @ 1KΩ
60mA (+/- 10%)@ 2K Ω
n/a @10K Ω
(no stimulation possible at
10KΩ) | Minor difference
Note 3 | |
| Frequency
range | 1080Hz | 10, 15, 20, 25, 30, 35, 40,500µs; | 100, 150, 200, 250, 300µs
45 Hz | 10 to 80Hz in 1Hz steps | Minor difference
Note 4 | |
| Pulse width
range | 50
(each: positive and phase) | Symmetrical:
50 400µs in steps of1600µs in
50µs
Asymmetrical:
pos.: 50 ~ 400µs in steps
of 50µs
Neg.: 200
steps of 100µs | Minor difference
Note 4 | |
| Pulse duration | 50500µs; | Positive phase:40s
100, 150, 200, 250,
300 µs
Negative phase:
100, 150, 200, 250,
300 µs | Symmetrical:
50 400µs in steps of1600µs in
50µs
Asymmetrical:
pos.: 50 ~ 400µs in steps
of 50µs
Neg.: 200
steps of 100µs | Minor difference
Note 4 | |
| Elements of
Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Net Charge | 0uC @ 500Ω | 0µC using inverted
balanced phases | 0µC @ 500Ω
Balanced pulses | SE | |
| Maximum
Current
Density | Train mode: 0.532mA/cm2
@500Ω,
Walk mode: 0.53mA/cm2
@500Ω | Maximum current levels
are:
Lower leg: 16.43 mA (rms)
Thigh: 16.43 mA (rms)
Maximum current density
is:
Lower leg (small cuff):
1.63 mA/cm2 (rms), for
smallest electrodes area
of 10.1 cm2
Lower leg (regular cuff):
1.04 mA/cm2 (rms), for
smallest electrodes area
of 15.8 cm2
Thigh: 0.23 mA/cm2 (rms),
for smallest electrodes
area
of 72 cm2 | 1.51 mA/cm2 @500Ω, | Minor difference
Note 5 | |
| Maximum
Power Density | Train mode: 5.66 mW/cm2
@500Ω,
Walk mode: 5.62 mW/cm2
@500Ω | Lower leg (small cuff):
13.4 mW/cm2, for smallest
Electrodes area of 10.1 cm2
Lower leg (regular cuff):
8.5 mW/cm2, for smallest
electrodes area of 15.8 cm2
Thigh: 1.9 mW/cm2,
For smallest electrodes
area of 72 cm2 | 0.024 W/cm2 | Minor difference
Note 5 | |
| ON time | For Train mode:
2
For Walk mode:
N/A | Training mode: 4-20 sec
Gait mode: 1-10 sec (the
max stimulation duration
after triggering event is
detected) | 1 to 4 sec in 0.1sec steps | Minor difference
Note 6 | |
| OFF time | For Train mode: 2.0~60.0s
For Walk mode: N/A(As
swing phase detecting) | Training mode: 4-20 sec
Gait mode: not limited (As
swing phase detecting) | 1 to 30 sec in 1sec steps | Minor difference
Note 6 | |
| Elements of
Comparison | Subject Device | Predicate Device I | Predicate Device II | Remark | |
| Contraction and
Relaxation time | Adjustable, due to
different modes. | -- | Adjustable, due to different SE
modes. | | |
| Environment for
operating | Temperature: 5 to 40°C;
Rel. humidity: ≤80%; | -- | | SE | |
| Environment
for storage and
transport | Temperature: -20 to 55°C;
Rel. humidity: ≤93%; | -- | | SE | |
| Biocompatibility | Electrode pad and Belt:
Compliant with
requirements of
ISO10993-5,
ISO10993-10,
ISO10993-12,
standards | -- | | SE | |
| Electrical Safety,
EMC | Compliant with
requirements of
IEC 60601-1, IEC60601-
2- 10 , IEC 60601-1-2,
IEC 60601-1-11, IEC
62133-2 safety standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10,
FCC part 15 subpart C
and B1 | IEC 60601-1:2005
+A1:2012;
IEC 60601-1-11:2010;
IEC 60601-2-10:2012;
IEC 60601-1-2:2007 | SE | |
6
7
8
9
10
11
12
Comparison in Detail(s):
Note 1 (Power Source(s) and Method of Line Current Isolation):
The power source is only energy source for the operation of the device, it do not affect the output of the micro current. And the device complies with IEC 60601-1 requirements for evaluation of safety. So such minor difference do not raise safety and effectiveness issue.
For display method, even there is minor difference on display design. However it is only for status and setting interface display, and the display APP function and interface had been evaluated in software
13
validation; So such minor difference do not raise safety and effectiveness issue.
Note 2 (Timer Range ):
The design of the timer range is based on the intended use. For MStim Drop Model: LGT-233, the operating time is adjustable by operator according to physician direction. So the timer setting range difference would not impact its safety and effectiveness, comparing predicate devices.
Note 3 (Maximum Output Voltage and Maximum Output Current):
The effect of micro current stimulation is determined by micro-current output waleform and output current. There is only little difference between the output voltage and current of the subject device from the predicated devices, it can still obtain the same effect because our output voltage and output current are in the range which is similar to the value of K162407 and predicate device K 141812. Even the predicate device II have no stimulation at 10K ohm, but its output voltage at 500, 1K and 2 KOhm is similarto subject device; and the predicate device I have similar output voltage as proposed subject device,
Also, the subject device comply with IEC 60601-1, and IEC60601-2-10 for its safety verification, comparing with the predicate devices. Therefore, the minor difference would not affect safety and effectiveness of the subject.
Note 4 (Frequency and Pulse-width):
For Frequency: There is minor difference on frequency of output waveform pulse between subject device and predicate device I, but the frequency means that pulse number in a completed cycle of waveform, the frequency difference means that the pulse numbers difference which deliver to patient body per second. And the frequency of subject device is same to the one of predicate device II (K141812), so its minor difference would not impact the safety and effectiveness of subject device.
For Pulse width: The stimulation time of micro current stimulation is determined by pulse width of micro-current output waveform. Frequency and pulse is the time parameter of the waveform. There is only little difference between the pulse width of the subject device from the predicated device I, it can still obtain the same effect because output current and pulse width is similar to the value of Predicate device II (K141812). Also, the subject device complies with IEC 60601-1, and IEC60601-2- for safety evaluation. Therefore, the minor difference on pulse width would not affect its safety and effectiveness of subject device.
Note 5 (Maximum current density and Maximum power density):
The effect of micro current stimulation is determined by micro-current output pulse width and output current. Even there is only little difference between the value of current density and maximum power density of the subject device and the predicated device due to electrode pad size, but the value of current density and maximum power density of subject device are in the range which is similar to the value K162407. Even the maximum current density and the maximum power density of subject
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device is less than predicate device II (K141812), but its value was covered in predicate device l(K162407).
And the maximum power density meet with the maximum allowed value 0.25 (W/cm²) required in FDA guidance. Therefore, the subject device and predicate device are substantially equivalence on these parameters.
Note 6 (On time and OFF time):
On time and OFF time are designed according to the circuit design of the device for max stimulation time. Even there is minor difference for on time and Off time between subject device and predicate device. But for MStim Drop Model: LGT-233, the operating time is adjustable so that the operator can made applicable stimulation time to apply on patient body by adjusting operation time based on physician direction. So the minor difference for On time and Off time between subject device and predicate device would not affect safety and effectiveness of subject device.
Finial Conclusion:
The subject device MStim Drop Model: LGT-233 is Substantial Equivalence to the predicate devices.