(88 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on standard biofeedback and electrical stimulation techniques.
Yes
The device description explicitly states it is a "new type of biofeedback and neuromuscular electrical stimulation therapy device." Additionally, the "Intended Use / Indications for Use" section lists several therapeutic conditions it aims to address, such as relaxation of muscle spasm, prevention of disuse atrophy, and treatment of urinary incontinence.
Yes
The device description indicates that it performs "evaluation of myoelectric signal acquisition" which is a diagnostic function. Additionally, one of the indications for use as a nonimplanted electrical continence device is "Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles," explicitly stating an assessment (diagnostic) purpose.
No
The device description explicitly states it is a "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." This indicates the device includes hardware components for signal acquisition and electrical stimulation, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description and intended use of this device clearly indicate it is a powered muscle stimulator and biofeedback device used for therapeutic purposes (muscle relaxation, re-education, pain relief, incontinence treatment, etc.) by applying electrical stimulation and monitoring muscle activity. It does not involve the analysis of specimens taken from the body.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
As a powered muscle stimulator the Biological Feedback and Stimulation System 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 Biological Feedback and Stimulation System is indicated for the following conditions:
- Biofeedback, relaxation and muscle re-education purposes
As a nonimplanted electrical continence device the Biological Feedback and Stimulation System 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 detrusor 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 Biological Feedback and Stimulation System 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
- Biocompatibility testing: The biocompatibility evaluation for the proposed device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests: Cytotoxicity, Skin Sensitization, Vaginal and rectal irritation.
- Non-clinical data: Non-clinical testing has been conducted to verify that the Biological Feedback and Stimulation System 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: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-2-40.
- 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 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.
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
§ 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 contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
October 21, 2022
Medlander Medical Technology Inc. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China
Re: K222201
Trade/Device Name: Biological Feedback and Stimulation System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, KPI, HCC Dated: July 7, 2022 Received: July 25, 2022
Dear Kevin Wang:
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
1
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,
Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team 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
2
Indications for Use
510(k) Number (if known) K222201
Device Name
Biological Feedback and Stimulation System
Indications for Use (Describe)
As a powered muscle stimulator the Biological Feedback and Stimulation System is indicated for thefollowing 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 Biological Feedback and Stimulation Systemis indicated for thefollowing conditions:
- Biofeedback, relaxationand muscle re-education purposes
As a nonimplanted electrical continence device the Biological Feedback and Stimulation Systemisindicated 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 detrusor 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
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2022/7/18
1. Submission sponsor
Name: Medlander Medical Technology Inc. Address: Building 5, Acceleration Zone, Nanjing Life Science and Technology, Innovation Park, No. 2 Qiande Road, Jiangning District, 211100 Nanjing, Jiangsu, PEOPLE'S REPUBLIC OF CHINA. Contact person: Wang Wang Title: Management Representative E-mail: wangwang@medlander.com
2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd. Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067 Contact person: Kevin Wang E-mail: kevin(@chonconn.com Tel: +86-755 33941160
| Trade/Device Name | Biological Feedback and Stimulation System |
|---|---|
| Model | MLD M2R, MLD M2A, MLD M2B, MLD M2D, MLD M4R, |
| MLD M4D, MLD M4E, MLD M4Plus | |
| Common Name | Powered muscle stimulator |
| Non-implantable electrical continence device | |
| Biofeedback device | |
| Regulatory Class | Class II |
| 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 | |
| Submission type | Traditional 510(K) |
3. Subject Device Information
Predicate Device 4.
Shenzhen Konmed Technology Co., Ltd., Biofeedback Nerve and Muscle Stimulator under
4
K202648.
5. Device Description
This Biological Feedback and Stimulation System 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.
Intended use & Indication for use 6.
As a powered muscle stimulator the Biological Feedback and Stimulation System 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 Biological Feedback and Stimulation System is indicated for the following conditions:
-
Biofeedback, relaxation and muscle re-education purposes
As a nonimplanted electrical continence device the Biological Feedback and Stimulation System 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 detrusor 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.
| Features | Subject Device: Biological
Feedback and Stimulation System
(K222201) | Predicate Device: Biofeedback
Nerve and Muscle Stimulator
(K202648) | Comparison |
|----------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------|------------|
| Product
Code | IPF, KPI, HCC | IPF, KPI, HCC | Same |
| Regulation
Number | 21 CFR 890.5850
21 CFR 876.5320
21 CFR 882.5050 | 21 CFR 890.5850
21 CFR 876.5320
21 CFR 882.5050 | Same |
Comparison to the Predicate Device 7.
5
| Classification | Class II | Class II | Same |
|---|---|---|---|
| Type of use | Prescription | Prescription | Same |
| Indications for | |||
| Use | As a powered muscle stimulator the | ||
| Biological Feedback and | |||
| Stimulation System is indicated for | |||
| the following conditions: | As a powered muscle stimulator the | ||
| Biofeedback Nerve and Muscle | |||
| Stimulator is indicated for the | |||
| following conditions: | Same | ||
| • Relaxation of muscle spasm | • Relaxation of muscle spasm | ||
| • Prevention or retardation of | |||
| disuse atrophy | • Prevention or retardation of | ||
| disuse atrophy | |||
| • Increasing local blood | |||
| circulation | • Increasing local blood | ||
| circulation | |||
| • Muscle re-education | • Muscle re-education | ||
| • Immediate post- surgical | |||
| stimulation of calf muscles to | |||
| prevent venous thrombosis | • Immediate post- surgical | ||
| stimulation of calf muscles to | |||
| prevent venous thrombosis | |||
| • Maintaining or increasing | |||
| range of motion | • Maintaining or increasing range | ||
| of motion | |||
| As a biofeedback device the | |||
| Biological Feedback and | |||
| Stimulation System is indicated for | |||
| the following conditions: | As a biofeedback device the | ||
| Biofeedback Nerve and Muscle | |||
| Stimulator is indicated for the | |||
| following conditions: | |||
| • Biofeedback, relaxation and | |||
| muscle re-education purposes | • Biofeedback, relaxation and | ||
| muscle re-education purposes | |||
| As a nonimplanted electrical | |||
| continence device the Biological | |||
| Feedback and Stimulation System is | |||
| indicated for the following | |||
| conditions: | 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 detrusor | |||
| muscles through reflexive | |||
| mechanisms and | |||
| strengthening of pelvic floor | |||
| muscles. | • Acute and ongoing treatment of | ||
| stress, urge or mixed urinary | |||
| incontinence and where the | |||
| following results may improve | |||
| urinary control: Inhibition of the | |||
| detrusor muscles through | |||
| reflexive mechanisms and | |||
| strengthening of pelvic floor | |||
| muscles. | |||
| • Incontinence treatment for | |||
| assessing EMG activity of the | |||
| pelvic floor and accessory | • Incontinence treatment for | ||
| assessing EMG activity of the | |||
| pelvic floor and accessory | |||
| muscles such as the abdominal | |||
| muscles such as the | and the gluteus muscles. | ||
| abdominal and the gluteus | |||
| muscles. | |||
| Patient | |||
| population | Adult | Adult | Same |
| Basic unit specification | |||
| Power supply | 14.8VDC, 5Ah | ||
| rechargeable lithium battery | 7.4V DC/1200mAh | ||
| rechargeable lithium battery | Different | ||
| Method of Line | |||
| Current | |||
| Isolation | N/A | N/A | Same |
| Leakage current | |||
| – Normal | |||
| condition |
- Single fault
condition | N/A (Battery) | N/A (Battery) | Same |
| Number of
output modes | 4 | 2 | Different |
| Number of
output channel | 4 | 2 | Different |
| Software/
Firmware/
Microprocessor
control | Yes | Yes | Same |
| Automatic
Overload trip | Yes | Yes | Same |
| Automatic no-
load trip | Yes | Yes | Same |
| Patient override
control method | Yes | Yes | Same |
| Indicator
display
-On/Off status
-Low battery
-Output mode
-Time to cutoff
-Voltage/current
level | Yes | Yes | Same |
| Automatic Shut
Off | Yes | Yes | Same |
| Timer range | 1min~60min, adjustable | 1-99min, adjustable | Different |
6
7
| Dimensions | 280mm × 280mm × 110mm | KM530:
140.5×25.5×69mm
KM531:
146.5×29×74mm | Different |
|---------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-----------|
| Weight | 2Kg | KM530: 192 g
KM531: 230g | Different |
| Housing
material and
construction | Plastic | Plastic | Same |
| Compliance
with voluntary
standards | IEC 60601-1;
IEC 60601-1-2;
IEC 60601-2-10;
IEC 60601-2-40 | IEC 60601-1;
IEC 60601-1-2;
IEC 60601-2-10;
IEC 60601-1-11;
IEC 60601-2-40 | Similar |
| Compliance
with 21CFR
898 | Yes | Yes | Same |
| Output specifications | | | |
| Waveform | Pulsed biphasic, The positive
wave is rectangular and the
negative wave is spike | Pulsed symmetric, asymmetric,
biphasic square wave | Different |
| Maximum
output
voltage | $50V@500Ω$ , error: ±20%;
$145V@2ΚΩ$ , error: ±20%;
$226V@10ΚΩ$ , error: ±20% | $47.2V @ 500 Ω$
$108V @ 2k Ω$
$150V@ 10kΩ$ | Similar |
| Maximum
output
current | $100mA@500Ω$ , error: ±20%;
$72.5mA@2ΚΩ$ , error: ±20%;
$22.6mA@10ΚΩ$ , error: ±20% | $94.4mA @ 500 Ω$
$54mA @ 2k Ω$
$15mA@ 10k Ω$ | Similar |
| Net Charge
(per pulse) | ≤3.5 μ C @500Ω | For pulsed symmetric, biphasic:
0 μ C @500 Ω ;
For pulsed asymmetric, biphasic:
15.68 μ C @ 500 Ω | Similar |
| Maximum
Phase
Charge
(500 Ω ) | ≤11.5 μ C @500Ω | 51.4 µ C @ 500 Ω | Similar |
| Maximum
current
density
(500 Ω ) | ≤17.5 mA/cm²@500Ω | 6.01mA/cm²@ 500 Ω | Similar |
| Maximum
power
density
(500 Ω ) | ≤0.01W/cm²@500Ω | 0.012W(12mW) / cm2@ 500 Ω | Similar |
| Pulse
frequency | 0.5Hz-1000Hz | 2-100Hz | Similar |
| Pulse
duration | 10 μ s~1000 μ s | 50-450 μ s | Similar |
| Biofeedback performance | | | |
| Number of
EMG
channel | 2 | 2 | Same |
| EMG
detection
(bipolar/
monopolar) | Bipolar | Bipolar | Same |
| EMG range
( μ V) | 1-3000 μ V | 0.2-2000 μ V | Similar |
| EMG
bandwidth | 20Hz-550Hz | 20Hz-500Hz | Similar |
8
Performance Data 8.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the proposed device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- Cytotoxicity
- Skin Sensitization ●
- Vaginal and rectal irritation
Non-clinical data
Non-clinical testing has been conducted to verify that the Biological Feedback and Stimulation System 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:
- IEC 60601-1, Medical electrical equipment -- Part 1: General
9
requirements for basic safety and essential performance
- . 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
- IEC 60601-2-10, Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- 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
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 device according to Guidance Document for Powered Muscle Stimulator 510(k)s
9. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.