(88 days)
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.
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.
The provided text describes a 510(k) premarket notification for a "Biological Feedback and Stimulation System." It lists the device's indications for use, its comparison to a predicate device, and performance data to support substantial equivalence. However, it does not specify acceptance criteria, nor does it conduct any clinical studies with human participants for determining the device's performance against such criteria. The "Performance Data" section focuses entirely on non-clinical testing and compliance with recognized standards.
Therefore, many of the requested details cannot be extracted from the given document as they pertain to clinical performance studies, which are not detailed here.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for a study involving the device's efficacy or diagnostic capability. The "performance data" mentioned is entirely non-clinical and refers to compliance with safety, electromagnetic compatibility, and specific medical electrical equipment standards.
| Acceptance Criteria (Clinical) | Reported Device Performance (Clinical) |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance
No test set involving human subjects or patient data is described. The "performance data" refers to engineering and laboratory tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no test set requiring expert ground truth is described.
4. Adjudication method for the test set
Not applicable, as no test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a "Biological Feedback and Stimulation System," a powered muscle stimulator, biofeedback device, and non-implanted electrical continence device. It does not appear to be an AI-assisted diagnostic tool that would involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical device, not an algorithm, and the performance data described is non-clinical verification of its design specifications and compliance with standards.
7. The type of ground truth used
Not applicable, as no clinical performance study requiring ground truth is described. The "performance data" listed relates to engineering specifications and compliance with voluntary standards.
8. The sample size for the training set
Not applicable, as no machine learning/AI model requiring a training set is described. The device includes "Software verification and validation test," but this refers to the software embedded within the medical device, not a training set for an AI algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI algorithm mentioned.
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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
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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
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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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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 stimulatorNon-implantable electrical continence deviceBiofeedback device |
| Regulatory Class | Class II |
| Regulation number | 21 CFR 890.585021 CFR 876.532021 CFR 882.5050 |
| Product code: | IPF, KPI, HCC |
| Review panel | Physical MedicineGastroenterology/UrologyNeurology |
| Submission type | Traditional 510(K) |
3. Subject Device Information
Predicate Device 4.
Shenzhen Konmed Technology Co., Ltd., Biofeedback Nerve and Muscle Stimulator under
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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: BiologicalFeedback and Stimulation System(K222201) | Predicate Device: BiofeedbackNerve and Muscle Stimulator(K202648) | Comparison |
|---|---|---|---|
| ProductCode | IPF, KPI, HCC | IPF, KPI, HCC | Same |
| RegulationNumber | 21 CFR 890.585021 CFR 876.532021 CFR 882.5050 | 21 CFR 890.585021 CFR 876.532021 CFR 882.5050 | Same |
Comparison to the Predicate Device 7.
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| Classification | Class II | Class II | Same |
|---|---|---|---|
| Type of use | Prescription | Prescription | Same |
| Indications forUse | As a powered muscle stimulator theBiological Feedback andStimulation System is indicated forthe following conditions: | As a powered muscle stimulator theBiofeedback Nerve and MuscleStimulator is indicated for thefollowing conditions: | Same |
| • Relaxation of muscle spasm | • Relaxation of muscle spasm | ||
| • Prevention or retardation ofdisuse atrophy | • Prevention or retardation ofdisuse atrophy | ||
| • Increasing local bloodcirculation | • Increasing local bloodcirculation | ||
| • Muscle re-education | • Muscle re-education | ||
| • Immediate post- surgicalstimulation of calf muscles toprevent venous thrombosis | • Immediate post- surgicalstimulation of calf muscles toprevent venous thrombosis | ||
| • Maintaining or increasingrange of motion | • Maintaining or increasing rangeof motion | ||
| As a biofeedback device theBiological Feedback andStimulation System is indicated forthe following conditions: | As a biofeedback device theBiofeedback Nerve and MuscleStimulator is indicated for thefollowing conditions: | ||
| • Biofeedback, relaxation andmuscle re-education purposes | • Biofeedback, relaxation andmuscle re-education purposes | ||
| As a nonimplanted electricalcontinence device the BiologicalFeedback and Stimulation System isindicated for the followingconditions: | As a nonimplanted electricalcontinence device the BiofeedbackNerve and Muscle Stimulator isindicated for the followingconditions: | ||
| • Acute and ongoing treatmentof stress, urge or mixedurinary incontinence andwhere the following resultsmay improve urinary control:Inhibition of the detrusormuscles through reflexivemechanisms andstrengthening of pelvic floormuscles. | • Acute and ongoing treatment ofstress, urge or mixed urinaryincontinence and where thefollowing results may improveurinary control: Inhibition of thedetrusor muscles throughreflexive mechanisms andstrengthening of pelvic floormuscles. | ||
| • Incontinence treatment forassessing EMG activity of thepelvic floor and accessory | • Incontinence treatment forassessing EMG activity of thepelvic floor and accessorymuscles such as the abdominal | ||
| muscles such as the | and the gluteus muscles. | ||
| abdominal and the gluteus | |||
| muscles. | |||
| Patientpopulation | Adult | Adult | Same |
| Basic unit specification | |||
| Power supply | 14.8VDC, 5Ahrechargeable lithium battery | 7.4V DC/1200mAhrechargeable lithium battery | Different |
| Method of LineCurrentIsolation | N/A | N/A | Same |
| Leakage current– Normalcondition- Single faultcondition | N/A (Battery) | N/A (Battery) | Same |
| Number ofoutput modes | 4 | 2 | Different |
| Number ofoutput channel | 4 | 2 | Different |
| Software/Firmware/Microprocessorcontrol | Yes | Yes | Same |
| AutomaticOverload trip | Yes | Yes | Same |
| Automatic no-load trip | Yes | Yes | Same |
| Patient overridecontrol method | Yes | Yes | Same |
| Indicatordisplay-On/Off status-Low battery-Output mode-Time to cutoff-Voltage/currentlevel | Yes | Yes | Same |
| Automatic ShutOff | Yes | Yes | Same |
| Timer range | 1min~60min, adjustable | 1-99min, adjustable | Different |
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| Dimensions | 280mm × 280mm × 110mm | KM530:140.5×25.5×69mmKM531:146.5×29×74mm | Different |
|---|---|---|---|
| Weight | 2Kg | KM530: 192 gKM531: 230g | Different |
| Housingmaterial andconstruction | Plastic | Plastic | Same |
| Compliancewith voluntarystandards | 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 |
| Compliancewith 21CFR898 | Yes | Yes | Same |
| Output specifications | |||
| Waveform | Pulsed biphasic, The positivewave is rectangular and thenegative wave is spike | Pulsed symmetric, asymmetric,biphasic square wave | Different |
| Maximumoutputvoltage | $50V@500Ω$ , error: ±20%;$145V@2ΚΩ$ , error: ±20%;$226V@10ΚΩ$ , error: ±20% | $47.2V @ 500 Ω$$108V @ 2k Ω$$150V@ 10kΩ$ | Similar |
| Maximumoutputcurrent | $100mA@500Ω$ , 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 |
| MaximumPhaseCharge(500 Ω ) | ≤11.5 μ C @500Ω | 51.4 µ C @ 500 Ω | Similar |
| Maximumcurrentdensity(500 Ω ) | ≤17.5 mA/cm²@500Ω | 6.01mA/cm²@ 500 Ω | Similar |
| Maximumpowerdensity(500 Ω ) | ≤0.01W/cm²@500Ω | 0.012W(12mW) / cm2@ 500 Ω | Similar |
| Pulsefrequency | 0.5Hz-1000Hz | 2-100Hz | Similar |
| Pulseduration | 10 μ s~1000 μ s | 50-450 μ s | Similar |
| Biofeedback performance | |||
| Number ofEMGchannel | 2 | 2 | Same |
| EMGdetection(bipolar/monopolar) | Bipolar | Bipolar | Same |
| EMG range( μ V) | 1-3000 μ V | 0.2-2000 μ V | Similar |
| EMGbandwidth | 20Hz-550Hz | 20Hz-500Hz | Similar |
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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
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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.
§ 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).