(90 days)
Not Found
No
The device description mentions "motion sensor based algorithm" and "dynamic gait tracking algorithm" for detecting heel events and synchronizing stimulation. While these are algorithms, the description does not indicate that they are based on artificial intelligence or machine learning. The summary also explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to assist knee flexion or extension, facilitate muscle re-education, prevent disuse atrophy, maintain/increase joint range of motion, increase local blood flow, provide post-surgical strengthening, improve post-surgical knee stability, and relax muscle spasms, all of which are therapeutic indications.
No
The device is described as assisting knee flexion or extension, facilitating muscle re-education, and improving gait through electrical stimulation, all of which are therapeutic rather than diagnostic functions.
No
The device description clearly lists multiple hardware components including Thigh Functional Stimulation Cuffs, a Central External Pulse Generator, an optional Control Unit, an optional Gait Sensor, and a power supply. While it includes software components (Clinician's Programming System and Mobile Application), it is not solely software.
Based on the provided information, the L360 Thigh System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- L360 Thigh System Function: The L360 Thigh System is a therapeutic device that uses electrical stimulation applied externally to the skin to assist muscle function and improve gait. It does not analyze any biological samples from the patient.
- Intended Use: The intended use clearly describes a therapeutic application for muscle weakness and gait improvement, not diagnostic testing.
- Device Description: The components described are all related to external electrical stimulation and control, not sample collection or analysis.
Therefore, the L360 Thigh System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The L360 Thigh System is intended to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual's gait.
The L360 Thigh System may also:
- Facilitate muscle re-education
- Prevent/retard disuse atrophy
- Maintain or increase joint range of motion
- Increase local blood flow
- Provide early post-surgical quadricep and hamstring strengthening
- Improve post-surgical knee stability secondary to quadricep and hamstring strengthening
- Relax muscle spasms
Product codes
GZI, IPF
Device Description
The L360 Thigh System is intended to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damaqe to pathways to the spinal cord). The L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual's gait.
The L360 Thigh System consists of:
-
- One or two Thigh Functional Stimulation Cuffs (Thigh Cuff) that include surface electrodes.
-
- Central External Pulse Generator (EPG). The EPG delivers stimulation to their respective cuffs, and have user interface, including visual, audio, and tactile feedback. The EPG can use motion sensor based algorithm to detect heel events.
-
- An optional Control Unit that allows simple wireless remote control of the EPG's while displaying real-time information regarding the system's status.
-
- An optional Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
-
- A Clinician's Programming System with software, which is used for system programming by a trained clinician during configuration of the system for optimal fitting to the patient.
-
- An optional Mobile Application (MAPP) enabling the patients to wirelessly control the EPG(s) and retrieve and monitor their daily activity.
-
- A power supply with two USB outputs and a proprietary cable to charge the EPG(s).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Affected leg (Thigh for knee flexion or extension)
Indicated Patient Age Range
Adult individuals
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 L360 Thigh System is a subset and consists of the same components as the Thigh Standalone configuration of the predicate L300 Go System. Therefore, the performance tests conducted on L300 Go System can also be applied to the L360 Thigh System.
The predicate L300 Go System was qualified through the following electrical, mechanical, and functional testing:
- Lifetime test
- Reliability, mechanical durability
- Environmental conditions testing
- Functional Verification and Validation Tests
- Software Verification and Validation Tests
- Electrical Safety and Electromagnetic Compatibility (EMC)
The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is substantially equivalent to the predicate devices.
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 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). 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.
September 12, 2019
Bioness Inc. Shanna Hu Sr. Regulatory Affairs Specialist 25103 Rye Canyon Loop Valencia, California 91355
Re: K191587
Trade/Device Name: L360 Thigh System Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: June 11, 2019 Received: June 14, 2019
Dear Shanna Hu:
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.
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
1
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 (OS) 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,
Vivek Pinto. PhD Director (Acting) 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
2
Indications for Use
510(k) Number (if known) K191587
Device Name L360 Thigh System
Indications for Use (Describe)
The L360 Thigh System is intended to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual's gait.
The L360 Thigh System may also:
- · Facilitate muscle re-education
- · Prevent/retard disuse atrophy
- · Maintain or increase joint range of motion
- · Increase local blood flow
- · Provide early post-surgical quadricep and hamstring strengthening
- · Improve post-surgical knee stability secondary to quadricep and hamstring strengthening
- Relax muscle spasms
| 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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Image /page/3/Picture/0 description: The image contains the logo for "Bioness LiveOn". The logo consists of an abstract sun-like symbol on the left, with the word "Bioness" in a bold, sans-serif font to the right of it. Below "Bioness" is the word "LiveOn" in a smaller, lighter font. The sun-like symbol is orange, while the text is gray.
510(k) Summary
| 510(k) Summary: | L360 Thigh System |
|---|---|
| Applicant Name: | Bioness Inc. |
| Contact person (s): | Shanna Hu |
| Sr. Regulatory Affairs Specialist | |
| Bioness Inc. | |
| 25103 Rye Canyon Loop | |
| Valencia, CA 91355, U.S.A | |
| Office Number: (661) 362-6694 | |
| Email: shanna.hu@bioness.com | |
| Mercedes Bayani | |
| Global Director, Clinical & Regulatory Affairs | |
| Bioness Inc. | |
| Office Number: (661) 902-5324 | |
| Fax Number: (661) 362-4851 | |
| Email: mercedes.bayani@bioness.com | |
| Date prepared: | September 12, 2019 |
| Device Trade Name: | L360 Thigh System |
| Classification: | Name: External functional neuromuscular stimulator |
| Product Code: GZI and IPF | |
| Regulation No: 21 CFR § 882.5810, § 890.5850 | |
| Class: II | |
| Classification Panel: Neurology |
Establishment Registration No.: 3004553866
Reason for Submission: Expansion of the Indication for Use
Type of Submission: Traditional 510(k)
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Image /page/4/Picture/0 description: The image contains the logo for "Bioness LiveOn". The logo consists of an orange sun-like symbol with several rays emanating from a central point. To the right of the symbol is the word "Bioness" in a bold, gray sans-serif font. Below "Bioness" is the word "LiveOn" in a smaller, lighter font, also in gray. A registered trademark symbol is present to the right of the word "Bioness".
Predicate devices:
-
- Company: Bioness Inc. Device: L300 Go System (K190285)
-
- Company: Bio-Medical Research, Ltd. Device: Kneehab XP, Type 412/421 (K110350)
Purpose of the traditional 510(k) notice:
The L360 Thigh System is the Thigh Standalone configuration of its predicate device, the L300 Go System, with expanded indication for use. The L360 Thigh System is substantially equivalent to its own superset device, the L300 Go System, and the Bio-Medical Research Ltd. Kneehab XP, Type 412/421(hereinafter referred to as Kneehab XP).
Device description:
The L360 Thigh System is intended to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damaqe to pathways to the spinal cord). The L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual's gait.
The L360 Thigh System consists of:
-
- One or two Thigh Functional Stimulation Cuffs (Thigh Cuff) that include surface electrodes.
-
- Central External Pulse Generator (EPG). The EPG delivers stimulation to their respective cuffs, and have user interface, including visual, audio, and tactile feedback. The EPG can use motion sensor based algorithm to detect heel events.
-
- An optional Control Unit that allows simple wireless remote control of the EPG's while displaying real-time information regarding the system's status.
5
Image /page/5/Picture/0 description: The image contains the logo for "Bioness LiveOn". The logo features an abstract sun-like symbol on the left, composed of interconnected orange lines. To the right of the symbol is the word "Bioness" in a bold, gray sans-serif font. Below "Bioness" is the word "LiveOn" in a smaller, lighter gray font, with a trademark symbol next to it.
-
- An optional Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation.
-
- A Clinician's Programming System with software, which is used for system programming by a trained clinician during configuration of the system for optimal fitting to the patient.
-
- An optional Mobile Application (MAPP) enabling the patients to wirelessly control the EPG(s) and retrieve and monitor their daily activity.
-
- A power supply with two USB outputs and a proprietary cable to charge the EPG(s).
Indications for use:
The L360 Thigh System is intended to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual's gait.
The L360 Thigh System may also:
- Facilitate muscle re-education
- Prevent/retard disuse atrophy
- · Maintain or increase joint range of motion
- Increase local blood flow
- · Provide early post-surgical quadricep and hamstring strengthening
- · Improve post-surgical knee stability secondary to quadricep and hamstring strengthening
- Relax muscle spasms
Substantial Equivalence:
The table on next page summarize the indication for use and technological characteristics of the new device in comparison to those of the predicate devices.
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Image /page/6/Picture/0 description: The image contains the logo for "Bioness LiveOn". The logo consists of an orange sun-like symbol on the left, followed by the word "Bioness" in gray, and the words "LiveOn" in a smaller font below "Bioness". The sun-like symbol is made up of several orange lines that converge at the center.
| | L360 Thigh System
(This submission) | L300 Go System
(K190285) | Kneehab XP
(K110350) |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Bioness Inc. | Bioness Inc. | Bio-Medical Research Ltd. |
| 510(k) number | To be assigned | K190285 | K110350 |
| Product Code | GZI & IPF | GZI & IPF | IPF, GZJ, NYN |
| Prescription
Use | Yes | Yes | Yes |
| Indication
for Use
Statement | The L360 Thigh System
is intended to assist knee
flexion or extension in
adult individuals with
muscle weakness related
to upper motor neuron
disease/injury (e.g.,
stroke, damage to
pathways to the spinal
cord). The L360 Thigh
System electrically
stimulates muscles in the
affected leg to provide
knee flexion or extension;
thus, it also may improve
the individual's gait.
The L360 Thigh System
may also:
Facilitate muscle re-education Prevent/retard disuse atrophy Maintain or increase joint range of motion Increase local blood flow Provide early post-surgical quadriceps and
hamstring strengthening Improve post-surgical knee stability secondary
to quadriceps and hamstring strengthening Relax muscle spasms | The L300 Go System is
intended to provide
ankle dorsiflexion in
adult and pediatric
individuals with foot drop
and/or to assist knee
flexion or extension in
adult individuals with
muscle weakness
related to upper motor
neuron disease/injury
(e.g. stroke, damage to
pathways to the spinal
cord). The L300 Go
System 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 L300 Go System
may also:
Facilitate muscle re-education Prevent/retard disuse atrophy Maintain or increase joint range of motion Increase local blood flow | In NMES mode (Programs
1-6) the Kneehab XP is
intended to:
Maintain or increase the range of motion Prevention or retardation of disuse atrophy Re-educate muscles Early post-surgical quadriceps strengthening
and improved post surgical knee stability
secondary to quadriceps strengthening Relax muscle spasms Increase blood circulation
In TENS Mode (Programs
7-9) the Kneehab XP is
intended to:
Provide symptomatic relief and management of
chronic, intractable pain Provide an adjunctive treatment in the
management of acute, post-surgical or post-
traumatic pain Provide symptomatic relief and management of
intractable pain and relief of pain associated with
arthritis Provide an adjunctive therapy in reducing the level
of pain and symptoms associated with
osteoarthritis of the knee |
| Energy
source | 3.7V, 1000mAh Lithium
ion rechargeable
prismatic battery | 3.7V, 1000mAh Lithium
ion rechargeable
prismatic battery | 3.6V NiMH rechargeable
battery pack |
| | L360 Thigh System
(This submission) | L300 Go System
(K190285) | Kneehab XP
(K110350) |
| Housing
Material
and
Construction | Control Unit: Bay State
Polymer PA-2000RX | Control Unit: Bay State
Polymer PA-2000RX | Control Unit: ABS-PA-757) |
| | EPG: Bay State Polymer
PA-2000RX | EPG: Bay State Polymer
PA-2000RX | Garment: Contains
EEPROM
(A |
| | Thigh FSC: TPU | Thigh FSC: TPU | Outer fabric: 100% Nylon
Inner fabric: 70% |
| | Foot Sensor: ABS
(Sensor housing),
Bay state Polymer PA-
2000RX (Electronics
housing) | Foot Sensor: ABS
(Sensor housing),
Bay state Polymer PA-
2000RX (Electronics
housing) | Polychloroprene & 30%
Polyurethane
Binding: 82% Nylon & 18%
Elastane
Fastening: 100 Nylon |
| Electrode | Two non-woven cloth | Two non-woven cloth | Four gel pad electrodes |
| | electrodes, oval
(Proximal 130x75mm,
91.1 $cm^2$ and Distal
120x63mm, 72 $cm^2$ ) | electrodes, oval
(Proximal 130x75mm,
91.1 $cm^2$ and Distal
120x63mm, 72 $cm^2$ ) | Electrode A: 194 $cm^2$
Electrode B: 74 $cm^2$
Electrode C: 83 $cm^2$
Electrode D: 66 $cm^2$ |
| | Constructed from non-
conductive plastic back,
stainless steel mesh, and
cloth facing towards the
leg. | Constructed from non-
conductive plastic back,
stainless steel mesh,
and cloth facing towards
the leg. | |
| Lead wires | Wires embedded in the
cuff | Wires embedded in the
cuff | Over-molded SATA
connector splitting to 5
leads / studs embedded in
the garment |
| Stimulation
Site | Quadriceps or
Hamstring | Quadriceps or
Hamstring | Quadriceps |
| Standards Met | IEC 60601-1
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-1-11
IEC 60601-1-2
IEC 60601-2-10
IEC 62304
ISO 14971
ISO 10993-1
ISO 10993-5
ISO 10993-10
21 CFR 801
21 CFR 898 | IEC 60601-1
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-1-11
IEC 60601-1-2
IEC 60601-2-10
IEC 62304
ISO 14971
ISO 10993-1
ISO 10993-5
ISO 10993-10
21 CFR 801
21 CFR 898 | IEC 60601-1
IEC 60601-2-10
IEC 60601-1-2
ISO 14971
ISO 10993-1
ISO 10993-5
ISO 10993-10
21 CFR 898
21 CFR 801 |
| Method of line
isolation | N/A (battery operated) | N/A (battery operated) | No line connection (battery
operated) |
| Patient
Leakage
current | Normal condition:
Less than 1.0µA (as
required by IEC 60601- 1)
Single fault | Normal condition:
Less than 1.0µA (as
required by IEC 60601-
-
| Information is not available |
| | condition:
3.0µA (as required
by IEC 60601-1) | Single fault condition:
3.0µA (as required by
IEC 60601-1) | |
| | L360 Thigh System
(This submission) | L300 Go System
(K190285) | Kneehab XP
(K110350) |
| Stimulation
Modes | - Gait
- Training
- Cycle Training
- Clinician | - Gait
- Training
- Cycle Training
- Clinician | NMES (Programs 1-6)
TENS (Programs 7-10) |
| Waveform/
shape | Pulsed, Biphasic,
Rectangular with
interphase interval | Pulsed, Biphasic,
Rectangular with
interphase interval | Pulsed, Biphasic,
Rectangular with interphase
interval |
| Number of
output
channels | 1 channel
(EPG has 2
channels, but only 1
channel is
connected to the
thigh cuff electrodes) | Thigh cuff:
1 channel
(EPG has 2 channels,
but only 1 channel is
connected to the thigh
cuff electrodes) | 2 |
| Synchronous
or
Alternating? | N/A, only one output
channel | N/A, only one output
channel for thigh cuff | Synchronous (multiplexed) |
| Method of
Channel
Isolation | N/A, only one output
channel | N/A, only one output
channel for thigh cuff | Transistor |
| Regulated
current or
voltage | Current | Current | Current |
| Software /
Firmware /
Microprocess
or Control? | Yes | Yes | Yes |
| Automatic
overload trip? | Yes | Yes | Yes, current limited,
indefinite short circuit
allowed |
| Automatic No-
load trip? | Yes | Yes | Yes |
| Automatic
shut off? | Yes | Yes | Yes |
| Patient
override
control? | Yes | Yes | Yes, pause button |
| Indicator Display: | | | |
| On/Off
Status? | Yes | Yes | Yes |
| Lower
Battery? | Yes | Yes | Yes |
| Voltage/
Current
Level? | Yes | Yes | Yes |
| | L360 Thigh System
(This submission) | L300 Go System
(K190285) | Kneehab XP
(K110350) |
| Timer range | Gait mode: N/A,
stimulation timing is
determined by heel on /
heel off events
Cycle Training Mode:
N/A, stimulation timing
is determined by
position of the pedals
Training mode: 5-60
minutes | Gait mode: N/A,
stimulation timing is
determined by heel on /
heel off events
Cycle Training Mode:
N/A, stimulation timing is
determined by position
of the pedals
Training mode: 5-60
minutes | 20 min > - open |
| Compliance
with 21 CFR
898? | Yes | Yes | Yes |
| Weight | EPG: 60g
Thigh cuff: 300g | EPG: 60g
Thigh cuff: 300g | Control Unit: 116g (inc.
batteries) |
| Dimensions
(W x H x D) | EPG: 82x47x15mm
Thigh cuff:
- Length: 200mm
- Circumference (min)
- Proximal panel:
270mm - Distal panel: 310mm | EPG: 82x47x15mm
Thigh cuff: - Length: 200mm
- Circumference (min)
- Proximal panel:
270mm - Distal panel: 310mm | Control Unit: 60x32x115mm |
| Frequency /
Phase
duration | Frequency: 10, 15,
20, 25, 30, 35, 40, 45 Hz
Symmetric and
Asymmetric positive:
100, 150, 200, 250,
300 $μ$ s
Asymmetric Negative:
300, 450, 600, 750,
900 $μ$ s | Frequency: 10, 15, 20,
25, 30, 35, 40, 45 Hz
Symmetric and
Asymmetric positive:
100, 150, 200, 250,
300 $μ$ s
Asymmetric Negative:
300, 450, 600, 750, 900
$μ$ s | 300 $μ$ sNMES Programs:
P1: 50 Hz, 300 - 400 $μ$ s
P2: 50 Hz, 300 - 400 $μ$ s
P3: 50 Hz, 300 - 400 $μ$ s
P4: 50 Hz, 300 - 400 $μ$ s
P5: 35 Hz, 300 - 400 $μ$ s
P6: 70 Hz, 300 - 400 $μ$ s |
| Baseline to
peak current
(+/-10%) | 100mA @ 500 Ohm
65mA @ 2k Ohm
13mA @ 10k Ohm | 100mA @ 500 Ohm
65mA @ 2k Ohm
13mA @ 10k Ohm | 80mA @ 500 Ohm
28mA @ 2k Ohm
3.9mA @ 10k Ohm |
| Baseline to
peak output
voltage (+/-
10%) | 50V @ 500 Ohm
130V @ 2k Ohm
130V @ 10k Ohm | 50V @ 500 Ohm
130V @ 2k Ohm
130V @ 10k Ohm | 40.0V @ 500 Ohm
55.6V @ 2k Ohm
39.3V @ 10k Ohm |
| Maximum
RMS output
voltage (+/-
10%) Vrms | 8.2V @ 500 Ohm
21.3V @ 2 kOhm
21.3 @ 10 kOhm | 8.2V @ 500 Ohm
21.3V @ 2 kOhm
21.3 @ 10 kOhm | 9.3V @ 500 Ohm
17.1V @ 2kOhm
14.1V @ 10kOhm |
| Maximum
RMS output
current (+/-
10%) Irms | Symmetric:
16.4mA @ 500 Ohm
10.7mA @ 2 kOhm
2.1mA @ 10 kOhm | Symmetric:
16.4mA @ 500 Ohm
10.7mA @ 2 kOhm
2.1mA @ 10 kOhm | 18.6 mA @ 500 Ohm
8.6mA @ 2k Ohm
1.42mA @ 10k Ohm |
| | L360 Thigh System
(This submission) | L300 Go System
(K190285) | Kneehab XP
(K110350) |
| Pulse width | Positive phase: 100,
150, 200, 250,300µs
(positive phase) | Positive phase: 100,
150, 200, 250,300µs
(positive phase) | 640 µs - sum of both
phases 300 µs + 40 µs
interphase interval |
| | Interphase interval:
20, 50, 200 µs | Interphase interval:
20, 50, 200 µs | (There is a discrepancy
between the 510K summary
of the device and the |
| | Total pulse duration
for symmetric
waveform (for 50 µs
interphase
interval): 250, 350,
450, 550, 650 µs | Total pulse duration
for symmetric
waveform (for 50 µs
interphase
interval): 250, 350,
450, 550, 650 µs | device's IFU). |
| | Total pulse duration
for asymmetric
waveform
(for 50 µs interphase
interval): 450, 650,
850, 1050, 1250 µs | Total pulse duration
for asymmetric
waveform
(for 50 µs interphase
interval): 450, 650,
850, 1050, 1250 µs | |
| Net charge
(µC per pulse) | 0 µC @ 500 Ohm | 0 µC @ 500 Ohm | 0 µC @ 500 Ohm |
| Maximum
phase charge
@ 500 Ohm
(+/-20%) | 30 µC @ 500 Ohm
(300 µs * 100mA) | 30 µC @ 500 Ohm
(300 µs * 100mA) | 24 µC @ 500 Ohm |
| Maximum
current
density @ 500
Ohm (mA/cm²) | 0.228 mA/cm²
(calculated as 16.4
mA/72cm²) | Thigh:
0.228 mA/cm²
(calculated as 16.4
mA/72cm²) | 0.224 mA/cm²
(calculated as 18.6
mA/83cm²) |
| Maximum
power density
@ 500 Ohm
using smallest
electrode | 1.87 mW/cm² (500
Ohm, electrode area
of 74cm²) | 1.87 mW/cm² (500
Ohm, electrode area
of 74cm²) | 2.1mW/cm² @ 500 Ohm |
| conductive
surface area | | | |
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| | L360 Thigh System
(This submission) | L300 Go System
(K190285) | Kneehab XP
(K110350) |
|----------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Burst mode | Yes
Bursts can be
triggered by three
different sources: | Yes
Bursts can be
triggered by three
different sources: | Yes
Bursts are triggered by
on/off settings of the timer,
per selected NMES
program. |
| | Gait mode:
Bursts triggered
either by 'heel off' or
'heel contact' events
(or both). | Gait mode:
Bursts triggered
either by 'heel off' or
'heel contact' events
(or both). | |
| | Cycle Training
Mode:
Bursts triggered by
position of the pedals
during pedaling cycle. | Cycle Training
Mode:
Bursts triggered by
position of the pedals
during pedaling cycle. | |
| | Training mode:
Bursts triggered by
on/off settings of the
timer. | Training mode:
Bursts triggered by
on/off settings of the
timer. | |
| Pulse per
burst | Pulses per burst =
Burst
$durationFrequency$ | Pulses per burst =
Burst
$durationFrequency$ | Pulses per burst = Burst
$durationFrequency$ |
| Bursts per
second | Gait mode:
Bursts per second =
$2Strides per second$ | Gait mode:
Bursts per second =
$2*Strides per second$ | Average number of bursts
per second = $1 / (time on + time off)$ |
| | Cycle Training mode:
Burst per second =
revolutions per second | Cycle Training mode:
Burst per second =
revolutions per second | |
| | Training mode:
Average number of
bursts per second =
$1 / (time on + time off)$ | Training mode:
Average number of
bursts per second =
$1 / (time on + time off)$ | |
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| | L360 Thigh System
(This submission) | L300 Go System
(K190285) | Kneehab XP
(K110350) |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Duty Cycle
(Bursts per
second * burst
duration) | Gait mode:
For example, for
pace of one stride
per second, Duty Cycle =
0.48 sec * 1 (stride/sec) *
100% = 48%
Cycle Training
mode:
For example, for one
revolution per second,
Duty cycle = 0.3 sec
- 1rps * 100% = 30%
Training mode:
On time: 4 – 20 sec
Off time: 4 – 20 sec
Min Duty Cycle = 4
sec * (1/40)(1/sec) *
100% = 10%
Max Duty Cycle = 20
sec * (1/24)(1/sec) *
100% = 83% | Gait mode:
For example, for
pace of one stride
per second, Duty Cycle=
0.48 sec * 1 (stride/sec)*
100% = 48%
Cycle Training
mode:
For example, for one
revolution per second,
Duty cycle = 0.3 sec - 1rps * 100% = 30%
Training mode:
On time: 4 – 20 sec
Off time: 4 – 20 sec
Min Duty Cycle = 4
sec * (1/40)(1/sec) *
100% = 10%
Max Duty Cycle = 20
sec * (1/24)(1/sec) *
100% = 83% | NMES mode:
P1 Duty Cycle = 5 sec *
(1/15)(1/sec) * 100% =
33%
P2 Duty Cycle = 10 sec *
(1/20)(1/sec) * 100% =
50%
P3 Duty Cycle = 10 sec *
(1/30)(1/sec) * 100% =
33%
P4 Duty Cycle = 10 sec *
(1/40)(1/sec) * 100% =
25%
P5 Duty Cycle = 5 sec *
(1/10)(1/sec) * 100% =
33%
P6 Duty Cycle = 10 sec *
(1/60)(1/sec) * 100% = 17% |
| Pulse
frequency | 10, 15, 20, 25, 30,
35, 40, 45 Hz | 10, 15, 20, 25, 30,
35, 40, 45 Hz | NMES mode:
35, 50, 70Hz |
| Ramp up time | 0-2 sec (0.5 sec
step) | 0-2 sec (0.5 sec
step) | NMES mode: 0.5 sec |
| Ramp down
time | 0-2 sec (0.5 sec
step) | 0-2 sec (0.5 sec
step) | NMES mode: 0.5 sec |
| On time
(contraction
time) | 4 – 20 sec (1 sec
step) | 4 – 20 sec (1 sec
step) | NMES mode:
5 sec or 10 sec |
| Off time
(relaxation
time) | 4 – 20 sec (1 sec
step) | 4 – 20 sec (1 sec
step) | NMES mode:
5, 10, 20, 30, or 50 sec |
End of table
The L360 Thigh System, subject of this submission is exactly the same device in all aspect to the Thigh Standalone configuration of its predicate device, the L300 Go System, cleared for marketing under K190285. The only difference between the devices is the expansion of the indication to provide relaxation of muscle spasms and post-surgical muscle strengthening and knee stability. The proposed indication for use is supported by its substantial equivalence to that of the Predicate Device #1, the L300 Go System (K190285) and Predicate Device #2, the Kneehab XP (K110350) with regards to its use as a neuromuscular electronic stimulator (NMES),
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and additionally supported by scientific literature, the principle of the NMES, and the standard indication for use for Powered Muscle Stimulators classified under 21 CFR 890.5850 (product code: IPF) per FDA Guidance Document for Powered Muscle Stimulator 510(k)s issued on June 9, 1999.
Performance Tests:
Since the L360 Thigh System is a subset and consists of the same components as the Thigh Standalone configuration of the predicate L300 Go System, there are no differences in the technological characteristics between the two devices. Therefore, the performance tests conducted on L300 Go System can also be applied to the L360 Thigh System.
The predicate L300 Go System was qualified through the following electrical, mechanical, and functional testing:
- . Lifetime test
- Reliability, mechanical durability ●
- Environmental conditions testing
- Functional Verification and Validation Tests .
- Software Verification and Validation Tests
- . Electrical Safety and Electromagnetic Compatibility (EMC)
The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is substantially equivalent to the predicate devices.
Biocompatibility:
The L360 Thigh System uses the exact same material and has the same type of skin contact as its predicate device, the L300 Go System, so new biocompatibility testing was not run. The predicate device underwent the following biocompatibility test evaluation in accordance with the FDA Good Laboratory Practice and requirements specified under ISO 10993.
- . Cytotoxicity
- Sensitization .
- . Irritation
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Conclusion:
Bioness concludes that the L360 Thigh System is substantially equivalent to the company's own L300 Go System (K190285) and the Bio-Medical Research, Ltd.'s, Kneehab XP (K110350) predicate devices, and does not raise any new issues or concerns of safety or effectiveness.