(88 days)
No
The description focuses on standard biofeedback and electrical stimulation techniques, with no mention of AI or ML algorithms for data analysis, pattern recognition, or adaptive stimulation. The "EMG Game" and "ETS" features are based on pre-set thresholds and user-controlled muscle contractions, not learned patterns.
Yes
The device is described as a "Biofeedback Nerve and Muscle Stimulator," intended for various medical conditions such as muscle spasm relaxation, prevention of disuse atrophy, increasing blood circulation, muscle re-education, and treatment of urinary incontinence. These indications point to its use in therapy and treatment.
Yes
The device explicitly states in its "Intended Use" that it is indicated for "Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles," and in the "Device Description," it mentions "dual-channel EMG signals acquisition," which are indicative of diagnostic capabilities.
No
The device description explicitly mentions hardware components such as a battery-powered main unit, display screen, vaginally inserted probe, anal probe (optional), biofeedback reference lead wire, skin electrodes, and cables. It also details hardware functionalities like EMG signal acquisition and electrical stimulation output. While software is mentioned for verification and validation, the device is clearly a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Biofeedback Nerve and Muscle Stimulator works by applying electrical stimulation to muscles and nerves and acquiring myoelectric signals (EMG) from the body. It does not analyze samples taken from the body.
- Intended Use: The intended uses listed are all related to direct interaction with the body for therapeutic and assessment purposes (muscle stimulation, biofeedback, incontinence treatment).
- Device Description: The description details the device's components and how it interacts with the user's body via probes and electrodes.
- Performance Studies: The performance studies mentioned are related to electrical safety, electromagnetic compatibility, biological evaluation of materials, and software validation, which are typical for medical devices that interact directly with the body, not IVDs.
Therefore, the Biofeedback Nerve and Muscle Stimulator is a therapeutic and assessment medical device that operates in vivo (within the living body), not in vitro (in glass or outside the living body).
N/A
Intended Use / Indications for Use
As a powered muscle stimulator the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
· Relaxation of muscle spasm
· Prevention or retardation of disuse atrophy
·Increasing local blood circulation
· Muscle re-education
·Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
· Maintaining or increasing range of motion
As a biofeedback device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
· Biofeedback, relaxation and muscle re-education purposes
As a nonimplanted electrical continence device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
· Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles.
·Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles.
Product codes (comma separated list FDA assigned to the subject device)
IPF, KPI, HCC
Device Description
This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
There are two models of Biofeedback Nerve and Muscle Stimulator which are KM530 and KM531. Their intended use, working principle, product structure and major parameters are all same, apart from the difference of product appearance, and KM531 has several more programs than KM530.
The device is battery-powered with a display screen and offers the user a choice of EMG Test (Only for EMG acquisition, not for electrical stimulation), EMG Game (6 biofeedback responsebased vivid games, active training for the user to contract the muscles of the treatment area, no electrical stimulation is generated), ETS (electromyography triggered stimulation; Only when the EMG value reaches the set threshold, the electrical stimulation is triggered; This module is a combination of active and passive treatment module, which exercise the self-contracting ability of the user), and STIM (Neuromuscular stimulation with fixed programs and customized programs of which parameters can be adjusted under the directions of physicians or professionals).
The device is supplied with vaginally inserted probe used with the device to stimulate the muscle of the pelvic floor (the probe is identical to that used in the model KM518 with 510(k) number K163288). Anal probe is optional, user can choose to purchase qualified probe. The device is supplied with biofeedback reference lead wire with skin electrodes. The device main unit connects directly to the vaginal electrode and reference wire by cable and plug. The device provides independent dual-channel EMG signals acquisition and dual-channel electrical stimulation output which is convenient for the treatment of different sites.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pelvic floor, calf muscles, and other muscles as indicated for treatment.
Indicated Patient Age Range
Adult
Intended User / Care Setting
Prescription Use
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 testings have been conducted to verify that the Biofeedback Nerve and Muscle Stimulator meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the targeted device complies with the following standards:
- A ANSI AAMI ES 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- A IEC 60601-1-11, 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. Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- A IEC 60601-2-40, Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
The body-contacting components of this device are electrode patches and vaginal probe. For these components, FDA 510(k) clearance and test reports have been provided. So we have reason to believe that the electrode patches and vaginal probe are safe for the users. They comply with the following standards.
- A ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests for InVitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
We have also conducted:
- Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- The waveform test report has also been conducted to verify the output specifications of the A device according to Guidance Document for Powered Muscle Stimulator 510(k)s
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.
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
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(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.
December 8, 2020
Shenzhen Konmed Technology Co., Ltd. % Tracy Che Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K202648
Trade/Device Name: Biofeedback Nerve and Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, KPI, HCC Dated: September 7, 2020 Received: September 11, 2020
Dear Tracy Che:
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,
for Heather Dean, PhD Assistant Director DHT5B: Division of Physical Medicine- Acute Injury 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) K202648
Device Name
Biofeedback Nerve and Muscle Stimulator (Model: KM530, KM531)
Indications for Use (Describe)
As a powered muscle stimulator the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
· Relaxation of muscle spasm
· Prevention or retardation of disuse atrophy
·Increasing local blood circulation
· Muscle re-education
·Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
· Maintaining or increasing range of motion
As a biofeedback device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions: · Biofeedback, relaxation and muscle re-education purposes
As a nonimplanted electrical continence device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
· Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles.
·Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles.
| 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
K202648
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information:
| 510(k) owner's name: | Shenzhen Konmed Technology Co., Ltd. |
|---|---|
| Address: | 601, Building B4, Shenchengtou Creative Factory Life Science Park |
| Julongshan A Road, Xiuxin Block, Kengzi Street, Pingshan District, | |
| Shenzhen, Guangdong, CHINA, 518118 | |
| Contact person: | Shuishan Yin |
| Title | General manager |
| Phone number: | +86 755 8670 4556 |
| Fax number: | +86 755 8670 4556 |
| Email: | 2519021651@qq.com |
| Date of summary prepared: | December 3, 2020 |
(2) Reason for the submission
New device, there were no prior submissions for the device.
(3) Proprietary name of the device
| Trade name/model: | Biofeedback Nerve and Muscle Stimulator/ KM530, KM531 | |
|---|---|---|
| Common name: | Powered muscle stimulator | |
| Non-implantable electrical continence device | ||
| Biofeedback device | ||
| Regulation number: | 21 CFR 890.5850 | |
| 21 CFR 876.5320 | ||
| 21 CFR 882.5050 | ||
| Product code: | IPF, KPI, HCC | |
| Review panel: | Physical Medicine | |
| Gastroenterology/Urology | ||
| Neurology | ||
| Regulation class: | Class II |
(4) Predicate and reference device
> Predicate device
| Sponsor | Otto Bock Healthcare Product GmbH |
|---|---|
| --------- | ----------------------------------- |
4
| Device Name and Model | STIWELL med4/ Model: 900101S |
|---|---|
| 510(k) Number | K080950 |
| Product Code | IPF, GZI, KPI, GZJ, HCC |
| Regulation Number | 21 CFR 890.5850 |
| 21 CFR 876.5320 | |
| 21 CFR 882.5050 | |
| 21 CFR 882.5890 | |
| 21 CFR 882.5810 | |
| Regulation Class | II |
- V Reference device
| Sponsor | Thought Technology Ltd | Mantra International (HK) Ltd |
|---|---|---|
| Device Name and Model | MyoTrac Infiniti System | Kegel8 |
| 510(k) Number | K053434 | K081480 |
| Product Code | IPF, KPI, HCC | KPI |
| Regulation Number | 21 CFR 890.5850 | |
| 21 CFR 882.5050 | ||
| 21 CFR 876.5320 | 21CFR876.5320 | |
| Regulation Class | II | II |
(5) Description/ Design of device:
This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
There are two models of Biofeedback Nerve and Muscle Stimulator which are KM530 and KM531. Their intended use, working principle, product structure and major parameters are all same, apart from the difference of product appearance, and KM531 has several more programs than KM530.
The device is battery-powered with a display screen and offers the user a choice of EMG Test (Only for EMG acquisition, not for electrical stimulation), EMG Game (6 biofeedback responsebased vivid games, active training for the user to contract the muscles of the treatment area, no electrical stimulation is generated), ETS (electromyography triggered stimulation; Only when the EMG value reaches the set threshold, the electrical stimulation is triggered; This module is a combination of active and passive treatment module, which exercise the self-contracting ability of the user), and STIM (Neuromuscular stimulation with fixed programs and customized programs of which parameters can be adjusted under the directions of physicians or professionals).
The device is supplied with vaginally inserted probe used with the device to stimulate the muscle of the pelvic floor (the probe is identical to that used in the model KM518 with 510(k) number
5
K163288). Anal probe is optional, user can choose to purchase qualified probe. The device is supplied with biofeedback reference lead wire with skin electrodes. The device main unit connects directly to the vaginal electrode and reference wire by cable and plug. The device provides independent dual-channel EMG signals acquisition and dual-channel electrical stimulation output which is convenient for the treatment of different sites.
(6) Indications for use:
As a powered muscle stimulator the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
- Relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post- surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
As a biofeedback device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
- Biofeedback, relaxation and muscle re-education purposes
As a nonimplanted electrical continence device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
● Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles.
● Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles.
| Component
| name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| Electrode | |||
| patches | Three layers: |
- Insulation backing
material:
Fabric/Foam/Tan fabric - Conductive film:
Carbon film/Carbon film
coated with silver/Aluminum
foil film | Surface-contacting
device: Intact skin | Less than 24 hours |
(7) Materials
6
| 3. Conductive hydrogel
| (A, T or U gel) | |||
|---|---|---|---|
| Vaginal probe | ABS plastic, stainless steel | Surface-contacting device: Mucosal membrane | Less than 24 hours |
We have selected 510(k) cleared electrode patches to be used with our device, its 510(k) number is K160138 (model: OCWN2505), and its biocompatibility complies with ISO 10993. The vaginal probe is the same probe with that used in another model KM518 manufactured by our company, which has already obtained 510(k) number K163288 on 01/18/2018, biocompatibility test reports were submitted during that application. For details, please refer to "Biocompatibility Discussion".
(8) Technological characteristics and substantial equivalence:
| Item | Targeted device | Predicate device 1 | Reference device 1 | Reference device
2 | Remark |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Trade name | Biofeedback Nerve
and
Muscle
Stimulator | STIWELL med4/
Model: 900101S | MyoTrac
Infiniti
System | Kegel8 | / |
| 510 (k)
number | K202648 | K080950 | K053434 | K081480 | / |
| Manufacturer | Shenzhen Konmed
Technology Co.,
Ltd | Otto Bock
Healthcare Product
GmbH | Thought Technology
Ltd | Mantra
International (HK)
Ltd | / |
| Regulation
number | 21 CFR 890.5850
21 CFR 876.5320
21 CFR 882.5050 | 21 CFR 890.5850
21CFR876.5320
21CFR882.5050
21CFR882.5890
21CFR882.5810 | 21 CFR 890.5850
21 CFR 882.5050
21CFR876.5320 | 21CFR876.5320 | Same |
| Regulation
description | Powered muscle
stimulator;
Nonimplanted
electrical continence
device;Biofeedback
device | Powered muscle
stimulator;
Nonimplanted
electrical continence
device;Biofeedbackd
evice;
Transcutaneouselectr
icalnervestimulatorfo
rpainrelief;Externalfu
nctionalneuromuscul
arstimulator | Powered muscle
stimulator;Biofeedb
ackdevice;
Nonimplanted
electrical continence
device | Non-implanted
electrical
continence device | Same |
| Product code | IPF, KPI, HCC | IPF, KPI, HCC,
GZJ,GZI | IPF, HCC, KPI | KPI | Same |
| Class | II | II | II | II | Same |
| Indications
for use/
Intended use | | | | | |
| | As a powered
muscle stimulator
the Biofeedback
Nerve and Muscle
Stimulator is
indicated for the
following
conditions:
· Relaxation of
muscle spasm
· Prevention or
retardation of disuse
atrophy
· Increasing local
blood circulation
· Muscle re-
education
· Immediate post-
surgical stimulation
of calf muscles to
prevent venous
thrombosis
· Maintaining or
increasing range of
motion
As a biofeedback
device the
Biofeedback Nerve
and Muscle
Stimulator is
indicated for the
following
conditions:
· Biofeedback,
relaxation and
muscle re-education
purposes
As a nonimplanted
electrical continence
device the
Biofeedback Nerve
and Muscle | The STIWELL med4
is a neuromuscular
electronic stimulator
indicated for use
under medical
supervision for
adjunctive therapy in
the treatment of
medical diseases and
conditions.
As a powered muscle
stimulator the
STIWELL med4 is
indicated for the
following conditions:
· Relaxation of
muscle spasm
· Prevention or
retardation of disuse
atrophy
· Increasing local
blood circulation
· Muscle re-
education
· Immediate post-
surgical stimulation
of calf muscles to
prevent venous
thrombosis
· Maintaining or
increasing range of
motion
As a transcutaneous
electrical nerve
stimulator for pain
relief the STIWELL
med4 is indicated for
the
followingconditions:
· Symptomatic relief
and management of
chronic (long-term),
intractable pain
· Adiunctive | The MyoTrac
Infiniti system is
indicated for acute
and ongoing
treatment ofstress,
urge or mixed
urinary incontinence
and where the
following results
mayimprove urinary
control: Inhibition of
the detruser muscle
through reflexive
mechanisms,
strengthening of
pelvic floor muscle.
It is also indicated
duringincontinence
treatment for
assessing EMG
activity of the pelvic
floor and accessory
muscles such as the
abdominal or gluteal
muscles.
The MyoTrac
Infiniti system is
also indicated for the
ongoing treatment of
thefollowing
conditions:
Relaxation ofMuscle
Spasms, Prevention
or retardation of
disuse atrophy,
increasing local
blood circulation,
immediate post-
surgical
stimulation of calf
muscles to prevent
venous thrombosis,
Maintaining or
increasingrange of | The 'Kegel8' Pelvic
Muscle Trainer is
intended to provide
electrical
stimulation and
neuromuscular re-
education for
the purpose of
rehabilitation of
weak pelvic floor
muscles for the
treatment of stress
urge and mixed
urinary
incontinence in
Women. | Similar,
the
indications for
use of
the
targeted
device is
within
that of
the
predicate
device |
7
8
| Stimulator is
indicated for the
followingconditions
: | treatment in the
management of post-
surgical pain and
post traumatic acute
pain. | motion and Stroke
Rehab by Muscle re-
education. It is also
used for
Biofeedback,
Relaxation &
MuscleRe-
Education purposes. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| • Acute and ongoing
treatment of stress,
urge or mixed
urinary incontinence
and where the
following results
may improve
urinary control:
Inhibition of the
detruser muscles
through reflexive
mechanisms and
strengthening of
pelvic floor muscles
• Incontinence
treatment for
assessing EMG
activity of the pelvic
floor and
accessorymuscles
such as the
abdominal and the
gluteus muscles | As a biofeedback
device the STIWELL
med4 is indicated for
the following
conditions:
• Biofeedback,
relaxation and
muscle re-education
purposes
As an external
functional
neuromuscular
stimulator the
STIWELL med4 is
indicated for the
following conditions:
• Helps to relearn
voluntary motor
functions of the
extremities
As a nonimplanted
electrical continence
device the STIWELL
mad4 is indicated for
the following
conditions:
• Acute and ongoing
treatment of stress,
urge or mixed
urinary incontinence
and where the
following results
may improve urinary
control: Inhibition of
the detruser muscles
through reflexive
mechanisms and
strengthening of
pelvic floor muscles | |
9
| | | | · Incontinence
treatment for
assessing EMG
activity of the pelvic
floor and accessory
muscles such as the
abdominal and the
gluteus muscles | | | |
|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------|---------------------|
| Patient
population | Adult | Adult | Adult | Adult | Prescription | Same |
| Location for
use | Prescription | Prescription | Prescription | Prescription | Prescription | Same |
| Basic unit specification | | | | | | |
| Power
supply | 7.4V DC/1200mAh
rechargeable lithium
battery | Battery Pack Li-lon
11.1V | 4X AAA 1.5
Alkaline or
rechargeable NiMH
Battery pack
6VDC-15W Medical
Class II power
adapter | 9V PP3 | | Different
Note 1 |
| Method
Line Current
Isolation | N/A | Medical Class II
Power Adapter | N/A | N/A-
powered | Battery | Same |
| Leakage
current
- Normal
condition - Single fault
condition | N/A (Battery) | N/A (Battery) | N/A | N/A-
powered | Battery | Same |
| Number of
output modes | 2 | 1 | / | 1 | | Different
Note 2 |
| Number of
output
channel | 2 | 4 | / | 2 | | Same |
| Synchronous
or
Alternating? | Synchronous | Alternating | | Synchronous/
Alternating | | Similar |
| Method of
channel
isolation | Transformer | Transformer,
inductive couplers | / | Individually
isolated circuits | | Same |
| Software/
Firmware/ | Yes | Yes | Yes | Yes | | Same |
| Microprocess
or Control? | | | | | | |
| Automatic
Overload
trip | Yes | Yes | / | Not
publicly
available | Same | |
| Automatic
no-load trip | Yes | Yes | / | Not
publicly
available | Same | |
| Patient
override
control
method | Yes | Yes (Stop Button) | / | Not
publicly
available | Similar | |
| Indicator
display
-On/Off
status
-Low battery
-Output
mode
-Time to cut-
off
-Voltage/
current level | Yes | Yes | / | Yes | Same | |
| Automatic
Shut Off | Yes | Yes | / | Yes | Same | |
| Timer range | 1-99min, adjustable | 2-120min | / | Up to 90 | Similar | |
| Dimensions | KM530:
140.5×25.5×69mm
KM531:
146.5×29×74mm | 175×95×30mm | / | 6.2cm W x 2.3cm
D x 10.8cm H
[2.4" W x 0.9" D x
4.25" H] | Different
Note 3 | |
| Weight | KM530: 192 g
KM531: 230g | 440g | / | 0.07
Kg without
battery, 0.1KG
with battery | Different
Note 3 | |
| Housing
material and
construction | Plastic | Plastics | / | / | Same | |
| Compliance
with
voluntary
standards | IEC 60601-1;
IEC 60601-1-2;
IEC 60601-2-10;
IEC 60601-1-11;
IEC 60601-2-40 | IEC 60601-1;
IEC 60601-1-2;
IEC 60601-2-10 | / | IEC 60601-1;
IEC 60601-1-2;
IEC 60601-2-10 | Same | |
| Compliance
with 21CFR
898 | Yes | Yes | Yes | Yes | Same | |
10
11
| Output specifications | |||||
|---|---|---|---|---|---|
| Waveform | Pulsed symmetric, | ||||
| asymmetric, | |||||
| biphasic square | |||||
| wave | Pulsed symmetrical, | ||||
| rectangular wave | Asymmetrical | ||||
| Balanced Pulsed | |||||
| Current | Biphasic, | ||||
| Rectangular | Similar | ||||
| Maximum | |||||
| output | |||||
| voltage | 47.2V @ 500Ω | ||||
| 108V @ 2kΩ | |||||
| 150V@ 10kΩ | 50V @500Ω | ||||
| 115V@2kΩ | |||||
| N/A | / | 45V @ 500Ω | |||
| 100V @ 2kΩ | |||||
| 190V @ 10kΩ | Similar | ||||
| Within | |||||
| the range | |||||
| of | |||||
| predicate | |||||
| device | |||||
| Maximum | |||||
| output | |||||
| current | 94.4mA @ 500Ω | ||||
| 54mA @ 2kΩ | |||||
| 15mA@ 10kΩ | 100mA@500Ω | ||||
| 58mA@2kΩ | |||||
| N/A | 100mA | 90mA @ 500Ω | |||
| 50mA @ 2kΩ | |||||
| 19mA @ 10kΩ | Similar | ||||
| Within | |||||
| the range | |||||
| of | |||||
| predicate | |||||
| device | |||||
| Net Charge | |||||
| (per pulse) | For pulsed | ||||
| symmetric, | |||||
| biphasic: 0µC @ | |||||
| 500Ω; | |||||
| For pulsed | |||||
| asymmetric, | |||||
| biphasic: | |||||
| 15.68μC @ 500Ω | 0µC @ 500Ω | / | 0 [μC] @ 500Ω | Similar | |
| Note 4 | |||||
| Maximum | |||||
| Phase | |||||
| Charge | |||||
| (500Ω) | 51.4µC @ 500Ω | EMS: 40µC @500Ω | |||
| Incontinence: 50µC | |||||
| @ 500Ω | 60μC | 40.5µC @ 500Ω | Similar | ||
| Maximum | |||||
| current | |||||
| density | |||||
| (500Ω) | 6.01mA/ cm²@ | ||||
| 500Ω | EMS: 12.5mA/cm²@ | ||||
| 500Ω | |||||
| Incontinence: | |||||
| 4.7mA/cm²@ 500Ω | St-Cloud Vaginal | ||||
| 6.76mA/cm² | |||||
| Femelex Vaginal | |||||
| 4.76mA/cm² | |||||
| St-Cloud Rectal | |||||
| 19.72mA/cm² | 14.1 [mA/cm²] | Similar | |||
| Maximum | |||||
| power | |||||
| density | |||||
| (500Ω) | 0.012W(12mW) | ||||
| cm2@ 500Ω | / | ||||
| EMS: 7.9mW/cm²@ | |||||
| 500Ω | |||||
| (0.0079W/cm²@ | |||||
| 500Ω) | |||||
| Incontinence: | |||||
| 23.5μW/cm²@ 500Ω | St-Cloud Vaginal | ||||
| 22.84mW/cm² | |||||
| Femelex Vaginal | |||||
| 11.32mW/cm² | |||||
| St-Cloud Rectal | |||||
| 194mW/cm² | 57 [mW/cm²] | ||||
| At maximum | |||||
| frequency of | |||||
| 100Hz, pulse width | |||||
| 450µS and current | |||||
| of 90mA | |||||
| PC Electrode area: | |||||
| 6.4 cm2 | Similar |
12
| Pulse frequency | 2-100Hz | 1-140Hz | 12.5,50,100,200Hz | 2 to 100Hz | Similar |
|---|---|---|---|---|---|
| Pulse duration | 50-450μs | 50-400μs | 0.2ms | 50 to 450 [μsec] | |
| Program dependent | Similar | ||||
| Biofeedback performance | |||||
| Number of EMG channel | 2 | 2 | 2 | / | Same |
| EMG sampling rate | 3kHZ | 3kHz | / | / | Same |
| EMG detection (bipolar/ monopolar) | Bipolar | Bipolar | Bipolar | / | Same |
| EMG range (μV) | 0.2-2000μV | 1-2000μV | 0-5, 0-10, 5-10, 0- | ||
| 20, 5-20, 10-20, 0- | |||||
| 50, 10-50, 0-100, | |||||
| 50-100,0-200, 50- | |||||
| 200, 100-200, 0- | |||||
| 500,100-500, 0- | |||||
| 1000, 0-2000 | / | Similar | |||
| EMG bandwidth | 20Hz-500Hz | 70-480Hz | 20Hz-500Hz | / | Same |
| EMG signal processing | Root mean square (RMS) | AVR (Average Rectified Value) | Root mean square (RMS) | / | Same |
Comparison in details:
Note 1: The targeted device uses lithium battery for power supply which is the same as the predicate device, although the voltage of the two batteries are different, the lithium battery used in the targeted device has been tested according to IEC 62133, so this difference should not raise any problems.
Note 2: The number of output modes are defined by the manufacturer, although it's different from that of the predicate device, the output parameters are similar to that of the predicate device, so this difference should not raise safety and effectiveness problem.
Note 3: Although the appearance, weight and dimensions are different between the targeted and predicate device, these differences are insignificant and do not raise any problems.
Note 4: Although the parameter is different from that of the predicate device, the targeted device has passed IEC 60601-1 and IEC 60601-2-10, so this difference should not affect safety and effectiveness.
Conclusion:
Biofeedback Nerve and Muscle Stimulator is substantially equivalent to the predicate devices.
13
(9) Non-clinical studies and tests performed:
Non-clinical testings have been conducted to verify that the Biofeedback Nerve and Muscle Stimulator meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the targeted device complies with the following standards:
- A ANSI AAMI ES 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- A IEC 60601-1-11, 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. Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- A IEC 60601-2-40, Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
The body-contacting components of this device are electrode patches and vaginal probe. For these components, FDA 510(k) clearance and test reports have been provided. So we have reason to believe that the electrode patches and vaginal probe are safe for the users. They comply with the following standards.
- A ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests for InVitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
We have also conducted:
-
Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- The waveform test report has also been conducted to verify the output specifications of the A device according to Guidance Document for Powered Muscle Stimulator 510(k)s
(10) Conclusion
Based on the above analysis and tests performed, it can be concluded that the performance and function of Biofeedback Nerve and Muscle Stimulator are normal, it is Substantially Equivalent (SE) to the predicate device.