(156 days)
NMES Relaxation of muscle spasms 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
EMG Triggered Stimulation (ETS) (nonimplanted electrical continence device only) 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 of pelvic floor muscles Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles (abdominal or gluteal)
TENS Symptomatic relief and management of chronic (long-term), intractable pain Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain
EMG Biofeedback, relaxation muscle training and muscle re-education
Levator Elite(Model LE9011) is a single channel, hand-held, non-sterile, battery-powered, multi-patient device intended to be used by adult patients under the supervision of a trained clinical healthcare provider. The device contains EMG biofeedback, TENS (Transcutaneous Electrical Nerve Stimulation), ETS (EMG triggered stimulation) and NMES (Neuromuscular Electrical Stimulator). Each of them has pre-set and custom programs. The parameters of the device are controlled by the buttons, the levels of intensity are adjustable to the needs of the patient and treatments prescribed by their healthcare providers.
The device is designed to provide safe and effective electrical stimulation by sending small electrical currents to underlying nerves and muscle groups via electrode pads applied on the skin or through a vaginal probe/rectal probe (for incontinence treatment protocols only). It can be used with or without linkage to a PC. Connecting the device with the PC via USB cable, the data can be transmitted between PC and device (It needs purchase the PC software Nu-Tek System and USB connection cable).
For EMG biofeedback, EMG is for detecting the signal of muscle, which display muscle strength via EMG biofeedback bar graph or waveform format viewed on the LCD screen of the unit. Surface EMG is used for recording from superficial muscles in clinical or kinesiological protocols, where intramuscular electrodes are used for investigating deep muscles or localized muscle activity.
For NMES is the elicitation of muscle contraction using electric impulses. The impulses are generated by a device and delivered through the electrodes in direct proximity to the muscles to be stimulated or via the probe. The impulses mimic the action potential coming from the central nervous system, causing the muscles to contract. NMES is both a form of electrotherapy and of muscle training. Neuromuscular Stimulation has been used to stimulate muscle and nerve fibers for muscle strengthening, maintenance of muscle mass and strength during prolonged periods of immobilization, selective muscle retraining.
For ETS (i.e. EMG triggered stimulation), ETS involves initiating a voluntary contraction for a specific movement until the muscle activity reaches a threshold level. As soon as the EMG activity reaches a target threshold then an assisting electrical stimulus begins which helps to support the contracted muscle. A microprocessor connected to the surface electrodes, vaginal probe or rectal probe monitors the EMG activity levels as well as administers the neuromuscular stimulation. The target threshold could be set to automated regime, when it goes up and down depending on the running muscle performance.
For TENS, the device provides a non-invasive, low-risk nerve stimulation in order to reduce pain (both acute and chronic). In TENS, mild electrical impulses are transmitted through the skin via surface electrodes to relieve muscle pain by modifying the body's pain perception. TENS does not cure problematic physiological conditions: it only helps to control the pain perception.
LE9011 consists of the following elements:
- Main device
- Pedestal
- Lead wire
- Electrode pad
- Vaginal probe
- Rectal probe (optional)
- PC Software(optional)
- USB Cable(optional)
The provided text does not contain acceptance criteria or a study that proves the device meets acceptance criteria in the way typically expected for a medical device's clinical performance.
Instead, this document is a 510(k) Summary for a medical device (Levator Elite Model LE9011), which aims to demonstrate substantial equivalence to previously cleared predicate devices. The focus is on comparing the proposed device's technical characteristics, indications for use, and performance data (primarily non-clinical) to those of the predicate devices.
Here's a breakdown of what is and isn't present, based on your request:
What's missing that you asked for:
- Acceptance Criteria for clinical performance: The document does not specify quantitative clinical acceptance criteria (e.g., minimum sensitivity, specificity, accuracy, or specific thresholds for clinical improvement).
- Study Proving Device Meets Acceptance Criteria: There is no clinical study described that directly evaluates the device's performance against predefined clinical acceptance criteria.
- Reported Device Performance (against clinical criteria): Because there are no clinical acceptance criteria or clinical studies described, there's no reported device performance in those terms.
- Sample size for test set: No test set of patients/cases is described for clinical evaluation.
- Data provenance (country, retrospective/prospective): Not applicable as no clinical study is presented.
- Number of experts for ground truth & qualifications: Not applicable.
- Adjudication method for test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned or conducted.
- Effect size of human readers with/without AI assistance: Not applicable as it's not an AI-assisted diagnostic device and no MRMC study was done.
- Standalone (algorithm-only) performance: Not applicable as it's a physical electrical stimulator, not an algorithm-based diagnostic tool.
- Type of ground truth used: Not applicable as no clinical study is presented.
- Sample size for training set: Not applicable as it's not an AI/ML device that requires a training set in that context.
- How ground truth for training set was established: Not applicable.
What is provided regarding "Performance Data" in the 510(k) Summary (Section 6):
The "Performance Data" section focuses on non-clinical testing to ensure the device is safe and performs as intended, and that any technological differences from predicates do not raise new questions of safety or effectiveness.
-
Biocompatibility testing:
- Acceptance Criteria (implicit): Compliance with ISO 10993-1.
- Reported Performance: "The biocompatibility evaluation for the accessories (Electrode pad, Vaginal probe and Rectal probe) was conducted in accordance with the International Standard ISO 10993-1..."
- Tests Conducted: Cytotoxicity, Sensitization, Irritation.
- This is not a "study that proves" clinical effectiveness, but rather a demonstration of material safety.
-
Electrical safety and electromagnetic compatibility (EMC):
- Acceptance Criteria (implicit): Compliance with relevant IEC standards.
- Reported Performance: "The system complies with the IEC 60601-1, IEC60601-1-11 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC."
- This is technical performance testing, not clinical.
-
Software Verification and Validation Testing:
- Acceptance Criteria (implicit): Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Reported Performance: "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance..." "The software for this device was considered as a 'Moderate' level of concern."
- This ensures the software functions correctly and safely, not clinical effectiveness.
-
Output waveform Testing:
- Acceptance Criteria (implicit): Verification of output specifications according to IEC 60601-2-10.
- Reported Performance: "oscilloscope tracing diagrams describing the electrical output waveform was provided to verify the output specifications of the device according to IEC 60601-2-10."
- This confirms the device delivers the specified electrical output, which is a technical performance aspect.
Conclusion from the document:
The document concludes that the device is substantially equivalent to the predicate devices and that any technological differences do not raise new questions regarding safety and effectiveness. This is the premise of a 510(k) submission – to demonstrate equivalence to an already cleared device, often without new clinical studies if non-clinical data suffice.
In summary, based only on the provided text, a comprehensive response to your structured request for acceptance criteria and clinical study details is not possible because the document focuses on non-clinical performance and substantial equivalence rather than a clinical trial demonstrating performance against specific clinical acceptance criteria.
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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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 25, 2022
Shenzhen Dongdixin Technology Co., Ltd. Siping Yuan R.A. Specialist Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang Nanshan District Shenzhen, Guangdong 518108 China
Re: K213043
Trade/Device Name: Levator Elite (Model LE9011) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF, KPI, HCC, GZJ Dated: January 20, 2022 Received: January 27, 2022
Dear Siping Yuan:
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
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213043
Device Name Levator Elite (Model LE9011)
Indications for Use (Describe) NMES Relaxation of muscle spasms 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
EMG Triggered Stimulation (ETS) (nonimplanted electrical continence device only) 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 of pelvic floor muscles Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles (abdominal or gluteal)
TENS
Symptomatic relief and management of chronic (long-term), intractable pain Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain
EMG
Biofeedback, relaxation muscle training and muscle re-education
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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Image /page/3/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, except for the X in DONGDIXIN, which is in yellow. There are also three Chinese characters to the right of the English text.
510(k) SUMMARY
as required by section 21 CFR 807.92
Levator Elite (Model LE9011)
| Date of Submission: | 02/25/2022 |
|---|---|
| Submitter's Name: | Shenzhen Dongdixin Technology Co., Ltd. |
| Address: | Floor 1-2, No.3 Building, Fanshen Xusheng IndustrialEstate Xilixiaobaimang 518108 Nanshan District,Shenzhen P. R. China |
| E-mail: | yuansp@dundex.com |
| Tel: | +86(755) 27652471 |
| FAX: | +86(755) 27652674 |
| Contact: | Siping Yuan |
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Image /page/4/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, except for a diagonal line through the "X" in "DIXIN", which is in orange. To the right of the English text is the company name in Chinese characters.
Proposed Device: 1.
Proprietary Name: Levator Elite(Model LE9011) Classification Name: Stimulator, Muscle, Powered Regulation #: 21 CFR 890.5850 Panel: Physical Medicine Regulatory Class: Class II Product Code: IPF, KPI, GZJ, HCC
2. Predicate Device:
| Predicate Device | 510(k) | Trade Name | Manufacturer |
|---|---|---|---|
| Predicate Device1 | K201290 | Medline DeNovo 4ProElectrical Stimulation Device | Medline Industries Inc |
| Predicate Device2 | K201014 | MyOnyx System | Thought Technology Ltd. |
3. Device Description:
Levator Elite(Model LE9011) is a single channel, hand-held, non-sterile, battery-powered, multi-patient device intended to be used by adult patients under the supervision of a trained clinical healthcare provider. The device contains EMG biofeedback, TENS (Transcutaneous Electrical Nerve Stimulation), ETS (EMG triggered stimulation) and NMES (Neuromuscular Electrical Stimulator). Each of them has pre-set and custom programs. The parameters of the device are controlled by the buttons, the levels of intensity are adjustable to the needs of the patient and treatments prescribed by their healthcare providers.
The device is designed to provide safe and effective electrical stimulation by sending small electrical currents to underlying nerves and muscle groups via electrode pads applied on the skin or through a vaginal probe/rectal probe (for incontinence treatment protocols only). It can be used with or without linkage to a PC. Connecting the device with the PC via USB cable, the data can be transmitted between PC and device (It needs purchase the PC software Nu-Tek System and USB connection cable).
For EMG biofeedback, EMG is for detecting the signal of muscle, which display muscle strength via EMG biofeedback bar graph or waveform format viewed on the LCD screen of the unit. Surface EMG is used for recording from superficial muscles in clinical or kinesiological protocols, where intramuscular electrodes are used for investigating deep muscles or localized muscle activity.
For NMES is the elicitation of muscle contraction using electric impulses. The impulses are generated by a device and delivered through the electrodes in direct proximity to the muscles to be stimulated or via the probe. The impulses mimic the action potential coming from the central nervous system, causing the muscles to contract. NMES is both a form of electrotherapy and of muscle training. Neuromuscular Stimulation has been used to stimulate muscle and nerve fibers for muscle strengthening, maintenance of
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Image /page/5/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, except for a diagonal line through the "X" in "DIXIN", which is in yellow. To the right of the English text is the company name in Chinese characters.
muscle mass and strength during prolonged periods of immobilization, selective muscle retraining.
For ETS (i.e. EMG triggered stimulation), ETS involves initiating a voluntary contraction for a specific movement until the muscle activity reaches a threshold level. As soon as the EMG activity reaches a target threshold then an assisting electrical stimulus begins which helps to support the contracted muscle. A microprocessor connected to the surface electrodes, vaginal probe or rectal probe monitors the EMG activity levels as well as administers the neuromuscular stimulation. The target threshold could be set to automated regime, when it goes up and down depending on the running muscle performance.
For TENS, the device provides a non-invasive, low-risk nerve stimulation in order to reduce pain (both acute and chronic). In TENS, mild electrical impulses are transmitted through the skin via surface electrodes to relieve muscle pain by modifying the body's pain perception. TENS does not cure problematic physiological conditions: it only helps to control the pain perception.
LE9011 consists of the following elements:
- Main device
- Pedestal
- Lead wire
- Electrode pad
- Vaginal probe
- Rectal probe (optional)
- · PC Software(optional)
- · USB Cable(optional)
4. Indications for Use:
NMES
- Relaxation of muscle spasms
- 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
EMG Triggered Stimulation (ETS) mode (nonimplanted electrical continence device only):
- 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 (abdominal or gluteal)
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Image /page/6/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The logo is in blue and yellow. The text "DONGDIXIN" is in large, bold, blue letters, with a yellow line crossing through the "X". Below that, the text "TECHNOLOGY CO., LTD." is in smaller, blue letters. To the right of the main text, there are three Chinese characters in blue.
TENS
- Symptomatic relief and management of chronic (long-term), intractable pain
- Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain
EMG
- Biofeedback, relaxation muscle training and muscle re-education
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Image /page/7/Picture/0 description: The image contains a company logo. The logo consists of the text "DONGDIXIN" in a bold, dark blue font, with an orange line crossing through the "X". Below the company name, the text "TECHNOLOGY CO., LTD." is written in a smaller, dark blue font. To the right of the company name, there are three Chinese characters stacked vertically, also in dark blue.
5. Comparison of Technological Characteristic
Comparison of proposed device and predicate device
| No. | Item | Proposed device | Primary Predicate device | Secondary Predicatedevice | S.E. Discussion |
|---|---|---|---|---|---|
| 1 | 510K# | K213043 | K201290 | K201014 | N/A |
| 2 | Device Nameand Model | Levator Elite(Model LE9011) | Medline DeNovo 4ProElectrical Stimulation Device | MyOnyx System | N/A |
| 3 | Manufacturer | Shenzhen Dongdixin TechnologyCo., Ltd. | Medline (Sponsor)Verity (Manufacturer) | Thought TechnologyLtd. | N/A |
| 4 | Product Code | IPFKPIHCCGZJ | IPFKPIHCCGZJGZI | KPIHCC | Similar, the proposeddevice does not have FESfunction. |
| 5 | ClassificationCode | Class II | Class II | Class II | Same |
| 6 | RegulationNumber | 21 CFR 890.585021 CFR 876.532021 CFR 882.505021 CFR 882.5890 | 21 CFR 890.585021 CFR 876.532021 CFR 882.505021 CFR 882.589021 CFR 882.5810 | 21 CFR 876.532021 CFR 882.5050 | Similar, the proposeddevice does not have FESfunction. |
| 7 | Indicationsfor use | NMES● Relaxation of muscle spasms● Prevention or retardation ofdisuse atrophy● Increasing local bloodcirculation● Muscle Re-education● Immediate post-surgicalstimulation of calf muscles toprevent venous thrombosis | For EMG mode:- Relaxation muscle training andmuscle re-educationFor NMES (also known as STIM)mode:- Relaxation of muscle spasms- Prevention or retardation ofdisuse atrophy- Increasing local blood | The MyOnyx System isindicated for acuteand ongoingtreatment of stress,urge, or mixed urinaryincontinence, whereurinary control may beimproved throughelectrical stimulationthat strengthens the | Similar, the proposeddevice does not have FESfunction. |
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Image /page/8/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The logo is in blue, with the exception of a yellow line that crosses through the "X" in DONGDIXIN. To the right of the company name are three Chinese characters in blue.
| ● Maintaining or increasingrangeof motionEMG Triggered Stimulation (ETS)(nonimplanted electricalcontinence device only):● Acute and ongoing treatmentof stress, urge or mixed urinaryincontinence and where thefollowing results may improveurinary control: Inhibition ofthe detruser muscles throughreflexive mechanisms andstrengthening of pelvic floormuscles● Incontinence treatment forassessing EMG activity of thepelvic floor and accessorymuscles (abdominal or gluteal)TENS● Symptomatic relief andmanagement of chronic(long-term),intractable pain● Adjunctive treatment in themanagement of post-surgicalpain and post traumatic acutepainEMG● Biofeedback, relaxation muscle | circulation- Immediate post-surgicalstimulation of calf muscles toprevent venous thrombosis- Maintaining or increasingrange of motion- Muscle Re-EducationFor TENS mode:- Symptomatic relief andmanagement of chronic(long-term), intractable pain- Adjunctive treatment in themanagement of post-surgicalpain and post traumatic acutepainFor EMG Triggered Stimulation(ETS) mode (nonimplantedelectrical continence deviceonly):-Acute and ongoing treatmentof stress, urge or mixed urinaryincontinence and where thefollowing results may improveurinary control: Inhibition of thedetruser muscles throughreflexive mechanisms andstrengthening of pelvic floormuscles-Incontinence treatment forassessing EMG activity of the | pelvic floor muscles orinhibits the detrusormuscle throughreflexive mechanisms.The system also usesEMG-based orpressure-basedbiofeedback to helpcontrol andstrengthen the pelvicfloor muscles in thetreatment of urinaryincontinence. |
|---|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Image /page/9/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The logo is in blue, with the letters "DONGDIXIN" in a large, bold font. There is an orange line going through the "X" in DONGDIXIN. Below the company name is the text "TECHNOLOGY CO., LTD." in a smaller font. To the right of the company name are three Chinese characters.
| training and muscle re-education | pelvic floor and accessorymuscles (abdominal or gluteal) | |||||
|---|---|---|---|---|---|---|
| For FES- Helps to relearn voluntarymotor functions of theextremities | ||||||
| 8 | Prescription vs.OTC | Prescription Use | Prescription Use | Prescription Use | Same | |
| 9 | Sterilevs.Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same | |
| 10 | Waveforms | Symmetrical Biphasic | ● Symmetrical Biphasic DCzero[TENS and HAN (TENS)]● Symmetrical Biphasic [NMES] | Symmetrical,rectangular, bipolar,biphasic | Same | |
| 11 | TargetPopulation | Adult | Adult | Adult | Same | |
| 12 | Power Source | DC 6V, 4*AA batteries | 4x AA NiMh 4.8V RechargeableBattery pack | Internal Battery (notuser replaceable):Rechargeable(3200mAh) Li-ionPolymer batterycertified to IEC 62133- up to 8 hours ofautonomous deviceoperation; External15W, 5V MedicalGrade(Class II DoubleInsulated) PowerSupply /BatteryCharger | Different, but the proposeddevice has passed thetesting according to therequirement of IEC60601-1.The difference does notraise any safety issue. | |
| 13 | Electrical Type | Type BF | Type BF | Type BF | Same | |
| 14 | Patient LeakageCurrent (μΑ)-Normalcondition | 1uA | N/ABattery Operated Device (<100µA patient leakage) | / | Different, but the proposeddevice has passed thetesting according to therequirement of IEC60601-1.The difference does notraise any safety issue. | |
| 15 | Patient LeakageCurrent (μΑ)-Single faultcondition | N/A | N/ABattery Operated Device (<100µA patient leakage) | / | Same | |
| 16 | Number ofOutput Modes | Two● Muscle stimulator: Electrodes● TENS (Transcutaneous electricalnerve stimulator): Electrodes | Two● Muscle stimulator: Electrodes● TENS (Transcutaneouselectrical nerve stimulator):Electrodes | One● Muscle stimulator:Electrodes | Same with primarypredicate device. | |
| 17 | Number ofOutputChannels | 1 | 4 | 4 | Different, the number ofoutput channels is thefeature of device, doesn'taffect the safety andeffectiveness. | |
| 18 | Synchronous orAlternating? | N/A, one channel | Synchronous and Alternating | / | Different, the proposeddevice has one channel. | |
| 19 | Method ofChannelIsolation | N/A, one channel | Each channel is the middle of anH bridge.Each channel is in a highimpedance stateexcept when it is activated for aspecificoutput pulse | / | ||
| 20 | Regulated | Constant current | Constant current on all four | Constant current | Same | |
| Current orRegulatedVoltage? | channels | |||||
| 21 | Software/Firmw are/Micro processorControl? | Yes | Yes | Yes | Same | |
| 22 | AutomaticOverload Trip | Yes | No Device can withstand indefinite short circuit | Yes | Different, but the proposed device has passed the testing according to the requirement of IEC60601-1. The difference does not raise any safety issue. | |
| 23 | Automatic NoLoad contactTrip | Yes | Yes | Yes | Same | |
| 24 | Automatic Shutoff | Yes | Yes | Yes | Same | |
| 25 | User OverrideControl? | Yes | Yes | Yes | Same | |
| 26 | IndicatorDisplay:- On/Off- Low Battery?- Voltage/Current Level? | Yes | Yes | Yes | Same | |
| 27 | Compliancewith VoluntaryStandards? | YesIEC 60601-1:2005+A1:2012IEC60601-1-2IEC 60601-1-6IEC 60601-2-10 | YesIEC 60601-1:2005+A1:2012IEC60601-1-2IEC 60601-1-6IEC 60601-2-10 | YesIEC/ES 60601-1 (Ed.3.1)IEC 60601-1-6IEC 60601-2-10 | Similar | |
| FCC PART 15 Subpart B:2008Class BFCC CFR Title 47 Part 15 Subpart C | IEC 60601-2-40IEC 60601-1-2 (4th Ed.) | |||||
| 28 | Compliancewith 21 CFR898? | Yes. leads with conductiveconnection to apatient are constructed such thatnoconductive connection remotefrom thepatient can contact earth orhazardousvoltages | Yes. leads with conductiveconnection to apatient are constructed such thatnoconductive connection remotefrom thepatient can contact earth orhazardousvoltages | Yes. | Same | |
| 29 | Weight (grams.) | 158g without batteries | 160 grams (0.35 lbs) withoutbatteries andother accessories | 272g | Different, the differentweight and dimensiondoesn't affect the safetyand effectiveness. | |
| 30 | Dimensions(mm.) | 139×68×32mm | 96×160×36mm | 155×83×20.95mm | and effectiveness. | |
| 31 | HousingMaterials &Construction | Plastic(Injection Molded ABS) | Plastic(Injection Molded ABS) | Polycarbonate andABS blend;Plexiglass tinted frontpanel, aluminum ringfor structural support | Same with primarypredicate device. | |
| NMES Waveform | ||||||
| 1 | Shape | Symmetrical Biphasic | • Symmetrical rectangularBiphasic [TENS and HAN(TENS)]• Symmetrical rectangularBiphasic [NMES] | -- | Similar | |
| 2 | Max OutputVoltage (V) | 45V @500Ω70V @2kΩ | 45V @500Ω70V @2kΩ | -- | Same | |
| ±10% | 70V @10kΩ | 70V @10kΩ(open lead detected above 0.5 [mA]) | ||||
| 3 | Max Output Current (mA) ±10% | 90mA @500Ω35mA @2kΩ7mA @10kΩ | 90mA @500Ω35 mA @2kΩ7 mA @10kΩ(open lead detected above 0.5 [mA]) | -- | ||
| 4 | Pulse Width | 50-450μs | 50-450μs in 10μs step to 100μsand thereafter 25μs up to 450μs | -- | Same | |
| 5 | Frequency (Hz) | 2-100Hz | 2-100Hz in 1Hz steps from 2 to20Hzthereafter in steps of 5Hz up to100Hz | -- | Same | |
| 6 | Net Charge (μC/pulse) | 0 μC | 0 μC | -- | Same | |
| 7 | Maximum Phase Charge (μC) 500Ω | 40.5μC [90mA for 450μs] | 40.5(μC) [90mA for 450μs] | -- | Same | |
| 8 | Average Current(IRMS, 500Ω) | 27mA | Not publicly available | -- | Same | |
| 9 | Maximum Average Current Density 500Ω | Electrode pad: 1.42 mA/cm² | 1.42mA /sq cm for electrode of19sq cm | -- | Same | |
| 10 | Maximum Average Power Density | Electrode pad: 19 mW/cm² | 19[mW/cm²] @ 500Ω forElectrode of 19sq cm | -- | Same | |
| 11 | On Time (sec) | 2-99 secs | 2-99 secs | -- | Same | |
| 12 | Off Time (sec) | 2-99 secs | 2-99 secs | -- | Same | |
| 13 | Treatment | 1-99 minutes | 2-99 minutes | -- | Similar | |
| Time(min) | ||||||
| TENS Waveforms | ||||||
| 1 | Shape | Symmetrical Biphasic | Symmetricalrectangular | -- | Same | |
| Biphasic | ||||||
| [TENS and HAN (TENS)] | ||||||
| 2 | Max Output | 40V @500Ω | 40V @500Ω | Same | ||
| Voltage (V) | 70V @2kΩ | 70V @2kΩ | ||||
| ±10% | 70V @10kΩ | 70V @10kΩ | ||||
| (open lead detected above 0.5 | ||||||
| [mA]) | ||||||
| 3 | Max Output | 80mA @500Ω | 80mA @500Ω | -- | ||
| Current (mA) | 35 mA @2kΩ | 35 mA @2kΩ | ||||
| ±10% | 7 mA @10kΩ | 7 mA @10kΩ | ||||
| (open lead detected above 0.5 | ||||||
| [mA]) | ||||||
| 4 | Pulse Width | 50-450µs | 50-450µs in 5µs steps | -- | Same | |
| 5 | Frequency (Hz) | 2-120Hz | 2-120Hz in 1Hz steps from 2 to | -- | Same | |
| 20Hz | ||||||
| thereafter in steps of 5Hz up to | ||||||
| 100Hz | ||||||
| 6 | Net Charge | 0 µC | 0 µC | -- | Same | |
| (µC/pulse) | ||||||
| 7 | Maximum | 36µC [80mA for 450µs] | not publicly available | -- | Same | |
| Phase Charge | ||||||
| (μC) 500Ω | ||||||
| 8 | Average | 26.3mA | not publicly available | -- | Same | |
| Current(Irms, | ||||||
| 500Ω) | ||||||
| 9 | Maximum | Electrode pad: 1.38 mA/cm² | not publicly available | -- | Same | |
| Average | ||||||
| Current Density500Ω | ||||||
| 10 | MaximumAverage PowerDensity | Electrode pad:18 mW/cm² | not publicly available | -- | Same | |
| 11 | On Time (sec) | N/A | N/A | -- | Same | |
| 12 | Off Time (sec) | N/A | N/A | -- | Same | |
| 13 | TreatmentTime(min) | 1-99 minutes | 0-99 minutes | -- | Similar | |
| Incontinence Programs (For vaginal probe only) | ||||||
| 1 | Shape | Symmetrical Biphasic | Symmetrical RectangularBiphasic | -- | Same | |
| 2 | Max OutputVoltage (V)±10% | 45V @500Ω70V @2kΩ70V @10kΩ | 40V @500Ω70V @2kΩ70V @10kΩ(open lead detected above 0.5[mA]) | -- | Same | |
| 3 | Max OutputCurrent (mA)±10% | 90mA @500Ω35 mA @2kΩ7mA @10kΩ | 90mA @500Ω35 mA @2kΩ7 mA @10kΩ(open lead detected above 0.5[mA]) | -- | Same | |
| 4 | Pulse Width | 50-450µs | 50-450µs in 5µs steps | -- | Same | |
| 5 | Frequency (Hz) | 2-120Hz | 2-120Hz in 1Hz steps from 2 to20Hz thereafter in steps of 5Hzup to 100Hz | -- | Same | |
| 6 | Net Charge(µC/pulse ) | 0 µC | 0 µC | -- | Same | |
| 7 | MaximumPhase Charge | 40.5µC [90mA for 450µs] | 40.5(µC) [90mA for 450µs] | -- | Same | |
| ( $\mu$ C) 500 $\Omega$ | ||||||
| 8 | AverageCurrent( $I_{RMS}$ ,500 $\Omega$ ) | 29.5mA | not publicly available | -- | Similar. The difference isbecause that our vaginalprobe has a differentsurface area, which leadsto slightly different maxcurrent/power density | |
| 9 | MaximumAverageCurrent Density500 $\Omega$ | Vaginal probe NT1041:3.9mA/cm² | Everyway IncontinenceStimulation Electrode:4.2mA/cm² | -- | ||
| 10 | MaximumAverage PowerDensity | Vaginal probe NT1041:57mW/cm² | Everyway IncontinenceStimulation Electrode:56mW/cm² | -- | ||
| 11 | On Time (sec) | 2-99 s | 2-99 secs | -- | Same | |
| 12 | Off Time (sec) | 2-99 s | 2-99 secs | -- | Same | |
| Incontinence Programs (For rectal probe only) | ||||||
| 1 | StimulatorOutput | 0-100mA | -- | 0-100mA | Same | |
| 2 | Waveforms | Symmetrical Biphasic | -- | Symmetrical,rectangular, bipolar,biphasic | ||
| 3 | Charge/Pulse at500ohms | 80 $\mu$ C (100mA for 400 $\mu$ s) | -- | 80 $\mu$ C (100mA for400 $\mu$ s) | ||
| 4 | Frequency | 5-80Hz | -- | 5-80Hz | ||
| 5 | Pulse Width | 150-400 $\mu$ s | -- | 150-400 $\mu$ s | ||
| 6 | Ramps | 0.1-9.9 seconds | -- | 0.1 – 9.9 seconds (0.1sincrease) | Same | |
| 7 | Duty Cycle | On (sec): 2-20Off (sec): 2 -50 | -- | On (sec): 2-20Off (sec): 2 -50 | Same | |
| 8 | AverageCurrent( $I_{RMS}$ , | 25.3mA | -- | not publicly available | Same | |
| 500Ω) | ||||||
| 9 | MaximumAverageCurrent Density500Ω(Rectalprobe) | 6.76 mA/ cm² | not publicly available | Same | ||
| 10 | MaximumAverage PowerDensity(Rectal probe) | 86mW/cm² | not publicly available | Same | ||
| Biofeedback(EMG) | ||||||
| 1 | EMG Range inμV | 0-2000μV | 0- 2000 in steps of 0.1μV to20μVand thereafter steps of1μV up to 2000μV | 0-4420 μV | Same with primarypredicate device. | |
| 2 | EMG Bandwidth | 20-500 Hz | 10- 370Hz | 20-500 Hz | Similar with primarypredicate device, and theproposed device isequivalent with secondarypredicate device. | |
| 3 | EMGSignalProcession | Root Mean Square (RMS) | Root Mean Square (RMS) | Root Mean Square(RMS) | Same | |
| 4 | EMG Detection | Bipolar | Bipolar | Bipolar | Same | |
| 5 | WorkPeriod(sec) | 2-99 s | 2-99 s | 2 - 20 seconds | Same with primarypredicate device. | |
| 6 | Rest Period(sec) | 2-99 s | 2-99 s | 2 - 50 seconds | Same with primarypredicate device. | |
| 7 | SessionDuration(min) | 1-99 minutes | 1-99 minutes | 1-120 minutes | Same with primarypredicate device. | |
| 8 | FeedbackModes | Line graph,Bar graph, | Line graph,Bar graph, | Line graph,Bar graph, | Similar |
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Image /page/10/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is composed of the company name in a bold, sans-serif font, with the "X" in "DIXIN" stylized as two intersecting orange lines. To the right of the English name is the company name in Chinese characters.
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Image /page/11/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is composed of the company name in a bold, sans-serif font, with the "X" in "DIXIN" stylized as two intersecting orange lines. To the right of the English name is the company name in Chinese characters.
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Image /page/12/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The logo is in blue and orange. The text "DONGDIXIN" is in large, bold, blue letters, with an orange line crossing through the "X". Below that, the text "TECHNOLOGY CO., LTD." is in smaller, blue letters. To the right of the main text are three Chinese characters in blue.
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Image /page/13/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The company name is written in blue, with an orange line crossing through the "X" in the name. To the right of the company name are three Chinese characters written vertically.
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Image /page/14/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The logo is in blue, with the exception of a yellow line that crosses through the "X" in DONGDIXIN. To the right of the English text is the company name in Chinese characters.
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Image /page/15/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The logo is in blue, with the exception of an orange line that goes through the "X" in DONGDIXIN. To the right of the English text is the company name in Chinese characters.
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Image /page/16/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The text "DONGDIXIN" is in large, bold, blue font, with the "X" in "DIXIN" being orange. Below this, the text "TECHNOLOGY CO., LTD." is in a smaller, blue font. To the right of "DONGDIXIN" are three Chinese characters in blue.
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Image /page/17/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The logo is in blue and yellow, with the company name in large letters. The word "DONGDIXIN" is written in English, with the "X" in "DIXIN" being yellow. Below the company name, the words "TECHNOLOGY CO., LTD." are written in smaller letters.
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| Digital display,Signal linked animationsVoice | Digital display,Signal linked animations | Digital display,Signal linked animationsVoice | ||
|---|---|---|---|---|
| -- | ------------------------------------------------------- | ---------------------------------------------- | ------------------------------------------------------- | -- |
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Image /page/19/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, with the "X" in "DIXIN" being orange. To the right of the English text is the company name in Chinese.
6. Performance Data:
The following performance data are provided in support of the substantial equivalence determination:
6.1 Biocompatibility testing
The Levator Elite (Model LE9011) itself has no direct contact with the patient. The accessories (Electrode pad, Vaginal probe and Rectal probe) would be the primary patient-contacting components, as they have direct contact with the patient at the treatment site. The biocompatibility evaluation for the accessories (Electrode pad, Vaginal probe and Rectal probe) was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process". The testing included the following tests:
- · Cytotoxicity
- Sensitization
- Irritation
6.2 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject device. The system complies with the IEC 60601-1, IEC60601-1-11 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.
6.3 Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.
6.4 Output waveform Testing
For each program, oscilloscope tracing diagrams describing the electrical output waveform was provided to verify the output specifications of the device according to IEC 60601-2-10.
7. Conclusions
The intended use and basic technological characteristics of the Levator Elite (Model LE9011) is substantially equivalent with those of the Predicate device K201290 and K201014. Any technological differences do not raise new questions regarding safety and effectiveness.
§ 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).