Biological Feedback and Stimulation System

{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) | | |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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,<br>MLD M4D, MLD M4E, MLD M4Plus | | Common Name | Powered muscle stimulator<br>Non-implantable electrical continence device<br>Biofeedback device | | Regulatory Class | Class II | | Regulation number | 21 CFR 890.5850<br>21 CFR 876.5320<br>21 CFR 882.5050 | | Product code: | IPF, KPI, HCC | | Review panel | Physical Medicine<br>Gastroenterology/Urology<br>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<br>Feedback and Stimulation System<br>(K222201) | Predicate Device: Biofeedback<br>Nerve and Muscle Stimulator<br>(K202648) | Comparison | |----------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------|------------| | Product<br>Code | IPF, KPI, HCC | IPF, KPI, HCC | Same | | Regulation<br>Number | 21 CFR 890.5850<br>21 CFR 876.5320<br>21 CFR 882.5050 | 21 CFR 890.5850<br>21 CFR 876.5320<br>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<br>Use | As a powered muscle stimulator the<br>Biological Feedback and<br>Stimulation System is indicated for<br>the following conditions: | As a powered muscle stimulator the<br>Biofeedback Nerve and Muscle<br>Stimulator is indicated for the<br>following conditions: | Same | | | • Relaxation of muscle spasm | • Relaxation of muscle spasm | | | | • Prevention or retardation of<br>disuse atrophy | • Prevention or retardation of<br>disuse atrophy | | | | • Increasing local blood<br>circulation | • Increasing local blood<br>circulation | | | | • Muscle re-education | • Muscle re-education | | | | • Immediate post- surgical<br>stimulation of calf muscles to<br>prevent venous thrombosis | • Immediate post- surgical<br>stimulation of calf muscles to<br>prevent venous thrombosis | | | | • Maintaining or increasing<br>range of motion | • Maintaining or increasing range<br>of motion | | | | As a biofeedback device the<br>Biological Feedback and<br>Stimulation System is indicated for<br>the following conditions: | As a biofeedback device the<br>Biofeedback Nerve and Muscle<br>Stimulator is indicated for the<br>following conditions: | | | | • Biofeedback, relaxation and<br>muscle re-education purposes | • Biofeedback, relaxation and<br>muscle re-education purposes | | | | As a nonimplanted electrical<br>continence device the Biological<br>Feedback and Stimulation System is<br>indicated for the following<br>conditions: | As a nonimplanted electrical<br>continence device the Biofeedback<br>Nerve and Muscle Stimulator is<br>indicated for the following<br>conditions: | | | | • Acute and ongoing treatment<br>of stress, urge or mixed<br>urinary incontinence and<br>where the following results<br>may improve urinary control:<br>Inhibition of the detrusor<br>muscles through reflexive<br>mechanisms and<br>strengthening of pelvic floor<br>muscles. | • Acute and ongoing treatment of<br>stress, urge or mixed urinary<br>incontinence and where the<br>following results may improve<br>urinary control: Inhibition of the<br>detrusor muscles through<br>reflexive mechanisms and<br>strengthening of pelvic floor<br>muscles. | | | | • Incontinence treatment for<br>assessing EMG activity of the<br>pelvic floor and accessory | • Incontinence treatment for<br>assessing EMG activity of the<br>pelvic floor and accessory<br>muscles such as the abdominal | | | | muscles such as the | and the gluteus muscles. | | | | abdominal and the gluteus | | | | | muscles. | | | | Patient<br>population | Adult | Adult | Same | | Basic unit specification | | | | | Power supply | 14.8VDC, 5Ah<br>rechargeable lithium battery | 7.4V DC/1200mAh<br>rechargeable lithium battery | Different | | Method of Line<br>Current<br>Isolation | N/A | N/A | Same | | Leakage current<br>– Normal<br>condition<br>- Single fault<br>condition | N/A (Battery) | N/A (Battery) | Same | | Number of<br>output modes | 4 | 2 | Different | | Number of<br>output channel | 4 | 2 | Different | | Software/<br>Firmware/<br>Microprocessor<br>control | Yes | Yes | Same | | Automatic<br>Overload trip | Yes | Yes | Same | | Automatic no-<br>load trip | Yes | Yes | Same | | Patient override<br>control method | Yes | Yes | Same | | Indicator<br>display<br>-On/Off status<br>-Low battery<br>-Output mode<br>-Time to cutoff<br>-Voltage/current<br>level | Yes | Yes | Same | | Automatic Shut<br>Off | Yes | Yes | Same | | Timer range | 1min~60min, adjustable | 1-99min, adjustable | Different | {6}------------------------------------------------ {7}------------------------------------------------ | Dimensions | 280mm × 280mm × 110mm | KM530:<br>140.5×25.5×69mm<br>KM531:<br>146.5×29×74mm | Different | |---------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-----------| | Weight | 2Kg | KM530: 192 g<br>KM531: 230g | Different | | Housing<br>material and<br>construction | Plastic | Plastic | Same | | Compliance<br>with voluntary<br>standards | IEC 60601-1;<br>IEC 60601-1-2;<br>IEC 60601-2-10;<br>IEC 60601-2-40 | IEC 60601-1;<br>IEC 60601-1-2;<br>IEC 60601-2-10;<br>IEC 60601-1-11;<br>IEC 60601-2-40 | Similar | | Compliance<br>with 21CFR<br>898 | Yes | Yes | Same | | Output specifications | | | | | Waveform | Pulsed biphasic, The positive<br>wave is rectangular and the<br>negative wave is spike | Pulsed symmetric, asymmetric,<br>biphasic square wave | Different | | Maximum<br>output<br>voltage | $50V@500Ω$ , error: ±20%;<br>$145V@2ΚΩ$ , error: ±20%;<br>$226V@10ΚΩ$ , error: ±20% | $47.2V @ 500 Ω$<br>$108V @ 2k Ω$<br>$150V@ 10kΩ$ | Similar | | Maximum<br>output<br>current | $100mA@500Ω$ , error: ±20%;<br>$72.5mA@2ΚΩ$ , error: ±20%;<br>$22.6mA@10ΚΩ$ , error: ±20% | $94.4mA @ 500 Ω$<br>$54mA @ 2k Ω$<br>$15mA@ 10k Ω$ | Similar | | Net Charge<br>(per pulse) | ≤3.5 μ C @500Ω | For pulsed symmetric, biphasic:<br>0 μ C @500 Ω ;<br>For pulsed asymmetric, biphasic:<br>15.68 μ C @ 500 Ω | Similar | | Maximum<br>Phase<br>Charge<br>(500 Ω ) | ≤11.5 μ C @500Ω | 51.4 µ C @ 500 Ω | Similar | | Maximum<br>current<br>density<br>(500 Ω ) | ≤17.5 mA/cm²@500Ω | 6.01mA/cm²@ 500 Ω | Similar | | Maximum<br>power<br>density<br>(500 Ω ) | ≤0.01W/cm²@500Ω | 0.012W(12mW) / cm2@ 500 Ω | Similar | | Pulse<br>frequency | 0.5Hz-1000Hz | 2-100Hz | Similar | | Pulse<br>duration | 10 μ s~1000 μ s | 50-450 μ s | Similar | | Biofeedback performance | | | | | Number of<br>EMG<br>channel | 2 | 2 | Same | | EMG<br>detection<br>(bipolar/<br>monopolar) | Bipolar | Bipolar | Same | | EMG range<br>( μ V) | 1-3000 μ V | 0.2-2000 μ V | Similar | | EMG<br>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.