(177 days)
The Kneehab XP, Type 412/421, Indications for use are as follows:
In NMES mode (Programs 1-6) the Kneehab XP is intended to:
- Maintain or increase the range of motion.
- Prevention or retardation of disuse atrophy
- Re-educate muscles
- Early post-surgical quadriceps strengthening and improved post surgical knee stability secondary to quadriceps strengthening
- Relax muscle spasms
- Increase blood circulation
In TENS Mode (Programs 7 - 9) the Kneehab XP is intended to:
- Provide symptomatic relief and management of chronic, intractable pain
- Provide an adjunctive treatment in the management of acute, post-surgical or post-traumatic pain
- Provide symptomatic relief and management of intractable pain and relief of pain associated with arthritis
- Provide an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee
The Kneehab XP, Type 412/421 is a portable, battery operated, combination device which can provide both neuromuscular electronic stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). The device incorporates multipath®, a patented technology developed by neurotech® which enables the Kneehab XP Conductive Garment to deliver highly focused and accurate NMES muscle contractions. This device also provides a method of pain management and relief through the use of TENS technology.
The Kneehab XP pack consists of a rechargeable control unit, a left or right universally sized garment, a pack of custom adhesive electrodes, a battery charger and instructions for use. The garment is fastened around the thigh and above the kneecap and contains a connector socket into which the control unit is plugged. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. A battery charger is included with the device and the device cannot be used while being charged. The adhesive electrodes have an estimated usage capability of 20 sessions when used under the recommended conditions of use.
All internal connections of the unit are over molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path. There are nine treatment programs in total (six NMES and three TENS) with a duration of 20 minutes each. Program details are included in the instructions for use. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.
The provided document is a 510(k) Summary for the Kneehab XP, Type 412/421. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing clinical study data to meet specific performance acceptance criteria. Therefore, the document does not describe a study that proves the device meets specific acceptance criteria.
Instead, it focuses on comparing the technological characteristics and intended uses of the Kneehab XP to existing predicate devices to argue for substantial equivalence. The document primarily highlights technical and functional comparisons rather than performance metrics from a clinical trial.
Based on the provided document, I cannot fulfill all sections of your request as it does not contain the information regarding an acceptance criteria study.
However, I can extract the following relevant information regarding the device and its intended use, which would typically form the basis for performance evaluation in a clinical study:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance from a study. It only provides electrical output specifications.
Device Electrical Output Parameters (Technical Characteristics, not performance data):
| Parameter | Kneehab XP (Proposed Device) |
|---|---|
| Frequency/Phase Duration of program with highest output power (Program 7) | 99Hz / 300 µS |
| Baseline to Peak Current | 80mA @ 500Ω, 28mA @ 2kΩ, 3.9mA @ 10kΩ |
| Baseline to Peak Output Voltage | 40.0V @ 500Ω, 55.6V @ 2kΩ, 39.3V @ 10kΩ |
| Maximum RMS Output Voltage (+/-10%) Vrms | 9.3 V @ 500 Ω, 17.1V @ 2kΩ, 14.1V @ 10kΩ |
| Maximum RMS Output Current (+/-10%) Irms | 18.6 mA@ 500 Ω, 8.6 mA@ 2kΩ, 1420 µA@ 10kΩ |
| Pulse Width | 640 µs sum of both phases (300µs + 40µs interphase interval) |
| Net Charge (µC per pulse) | 0µC @ 500Ω |
| Maximum Phase Charge @500 (+/-20%) | 24 µC @ 500Ω |
| Maximum Current Density @500 Ω | 0.22 mA/cm² (using smallest electrode conductive surface area, 83 cm²) |
| Maximum Power Density @500 Ω (Program 7) | 2.1mW/cm² @ 500Ω |
Intended Use and Indications:
NMES Mode (Programs 1-6):
- Maintain or increase the range of motion.
- Prevention or retardation of disuse atrophy.
- Re-educate muscles.
- Early post-surgical quadriceps strengthening and improved post-surgical knee stability secondary to quadriceps strengthening.
- Relax muscle spasms.
- Increase blood circulation.
TENS Mode (Programs 7-9): - Provide symptomatic relief and management of chronic, intractable pain.
- Provide an adjunctive treatment in the management of acute, post-surgical or post-traumatic pain.
- Provide symptomatic relief and management of intractable pain and relief of pain associated with arthritis.
- Provide an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no performance study data is presented in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no performance study data is presented in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no performance study data is presented in this 510(k) summary.
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. This is a medical device application for a physical device (electrical stimulator), not an AI/imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device application for a physical device (electrical stimulator), not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no performance study data is presented in this 510(k) summary.
8. The sample size for the training set
Not applicable, as no performance study data is presented in this 510(k) summary.
9. How the ground truth for the training set was established
Not applicable, as no performance study data is presented in this 510(k) summary.
Summary of Device and 510(k) Submission:
The Kneehab XP is a portable, battery-operated combination device that provides both Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS). Its primary purpose within this 510(k) submission is to demonstrate substantial equivalence to previously cleared predicate devices (Kneehab XP Conductive Garment, MediStim XP, MediTens XP, Staodyn Max Preset, 300 PV Complete Electrotherapy System, Bioncicare® Stimulator System). The submission details the technological characteristics, intended use, and indications for use of the Kneehab XP and compares them to these predicate devices, ensuring that there are "no new technological characteristics that could affect safety or effectiveness." The focus is on meeting international safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) and demonstrating similarity in electrical parameters and functionality to the predicate devices.
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Image /page/0/Picture/1 description: The image shows the logo for "bio-medical research ltd.". The logo consists of the letters "bmr" in a stylized font, with the words "bio-medical research ltd." written in a smaller font below the letters. The letters "bmr" are connected to each other.
Bio-Medical Research Ltd.
AUG - 3 2011 Parkmore Business Park West, Galway, Ireland Tel: +353 (0)91 774300 - Fax: +353 (0)91 774301
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Contact Details
| Name: | Anne-Marie Keenan |
|---|---|
| Title: | Quality/Regulatory Engineer |
| Address: | Bio-Medical Research Ltd.,Parkmore Business Park, WestGalway, Ireland |
| Telephone: | +353 91 774300 |
| Fax: | +353 91 774302 |
| E-Mail: | akeenan@bmr.ie |
| Prepared: | July 25, 2011. |
2. Device Name
| Trade Name of Device: | Kneehab XP, Type 412/421 |
|---|---|
| Common Name: | Transcutaneous Electrical Nerve StimulatorPowered Muscle Stimulator |
| Regulation Number: | 21 CFR 882.589021 CFR 890.5850 |
| Regulation Description: | Transcutaneous electrical nerve stimulator for pain reliefPowered muscle stimulator |
| Product Code: | IPF, GZJ, NYN |
| Device Class: | 2 |
3. Identification of Equivalent Legally Marketed Device
| 510(k) Number: | K083105 |
|---|---|
| Manufacturer: | Bio-Medical Research Ltd. |
| Trade Name: | Kneehab XP Conductive Garment, Type 411 |
Directors: T. Kirwan (Chairman), Dr. P.A. Smith (Managing), Dr. B. McDonnell, C. Minogue, P. McGrath
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Image /page/1/Picture/0 description: The image shows a blurry, high contrast image of what appears to be a collection of small, dark spots against a white background. The spots are irregularly shaped and scattered across the image. Due to the blurriness, it is difficult to determine the exact nature or origin of the spots.
| 510(k) Number: | K082011 |
|---|---|
| Manufacturer: | Bio-Medical Research Ltd. |
| Trade Name: | MediStim XP, Type 281 |
| 510(k) Number: | K082011 |
| Manufacturer: | Bio-Medical Research Ltd. |
| Trade Name: | MediTens XP, Type 458 |
| 510(k) Number: | K061516 |
| Manufacturer: | Compex Technologies, Inc |
| Trade Name: | Staodyn Max Preset |
| 510(k) Number: | K021100 |
| Manufacturer: | Empi |
| Trade Name: | 300 PV Complete Electrotherapy System |
| 510(k) Number: | K971437 |
| Manufacturer: | BioniCare Medical Technologies |
| Trade Name: | Bionicare® Stimulator System |
4. Description of Device
The Kneehab XP, Type 412/421 is a portable, battery operated, combination device which can provide both neuromuscular electronic stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). The device incorporates multipath®, a patented technology developed by neurotech® which enables the Kneehab XP Conductive Garment to deliver highly focused and accurate NMES muscle contractions. This device also provides a method of pain management and relief through the use of TENS technology.
The Kneehab XP pack consists of a rechargeable control unit, a left or right universally sized garment, a pack of custom adhesive electrodes, a battery charger and instructions for use. The garment is fastened around the thigh and above the kneecap and contains a connector socket into which the control unit is plugged. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. A battery charger is included with
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the device and the device cannot be used while being charged. The adhesive electrodes have an estimated usage capability of 20 sessions when used under the recommended conditions of use.
All internal connections of the unit are over molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path. There are nine treatment programs in total (six NMES and three TENS) with a duration of 20 minutes each. Program details are included in the instructions for use. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.
5. Statement of Intended Use and Indications for Use
Kneehab XP, Type 412/421 delivers stimulation based on the principles of NMES and TENS. NMES may be defined as the application of electrical stimulation of the peripheral nervous system to contract a muscle, either through the direct activation of the motor neurons in the mixed peripheral nerve, or indirectly through reflex recruitment. TENS can be defined as a pain therapy based on the application of electrical stimuli to the skin via stimulation of the nerve fibers.
In NMES mode (Programs 1-6), the Kneehab XP, Types 412/421. is indicated for use as follows:
- Maintain or increase the range of motion. 1.
- Prevention or retardation of disuse atrophy 2.
- Re-educate muscles 3.
-
- Early post-surgical quadriceps strengthening and improved post surgical knee stability secondary to quadriceps strengthening
- Relax muscle spasms 5.
- Increase blood circulation 6.
Programs 1-6 use multipath technology.
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| ProgramNumber | Duration(Minutes) | Frequency/Rate (Hz) | PulseWidth(µsec) | RampUpTime(seconds) | ContractionTime(seconds) | RampDownTime(seconds) | RelaxationTime(seconds) | AdditionalFunction | IndicationNo. |
|---|---|---|---|---|---|---|---|---|---|
| P1 | 20 | 50 | 300-400 | 1 | 5 | 0.5 | 10 | Trigger | 4 |
| P2 | 20 | 50 | 300-400 | 1 | 10 | 0.5 | 10 | Trigger | 1, 2, 3, 5, 6 |
| P3 | 20 | 50 | 300-400 | 1 | 10 | 0.5 | 20 | Trigger | 1, 2, 3, 5, 6 |
| P4 | 20 | 50 | 300-400 | 1 | 10 | 0.5 | 30 | Trigger | 1, 2, 3, 5, 6 |
| P5 | 20 | 35 | 300-400 | 1 | 5 | 0.5 | 5 | Trigger | 1, 2, 3, 5, 6 |
| P6 | 20 | 70 | 300-400 | 1 | 10 | 0.5 | 50 | Trigger | 1, 2, 3, 5, 6 |
Neuromuscular Electrical Stimulation (NMES) Programs on Kneehab XP:
In TENS Mode (Programs 7 - 10), the Kneehab XP, Type 412/421 is indicated for use as follows:
- Provide symptomatic relief and management of chronic, intractable pain 7.
- Provide an adjunctive treatment in the management of acute, post-surgical or post-8. traumatic pain
- Provide symptomatic relief and management of intractable pain and relief of pain 9. associated with arthritis
- Provide an adjunctive therapy in reducing the level of pain and symptoms 10. associated with osteoarthritis of the knee
-
Transcutaneous Electrical Nerve Stimulation (TENS) Programs on Kneehab XP:
| ProgramNumber | Duration(Minutes) | Frequency/Rate (Hz) | PulseWidth(µsec) | RampUpTime(seconds) | ContractionTime(seconds) | RampDownTime(seconds) | RelaxationTime(seconds) | AdditionalFunction | IndicationNo. |
|---|---|---|---|---|---|---|---|---|---|
| P7 | 30 | 99 | 300 | N/A | Continuous | N/A | N/A | No Trigger | 7-10 |
| P8 | 30 | 4 | 300 | N/A | Continuous | N/A | N/A | No Trigger | 7, 8, 9 |
| P9 | 30 | 125 | 175 | N/A | Continuous | N/A | N/A | No Trigger | 7, 8, 9 |
6. Summary of Technological Characteristics
There are no new technological characteristics that could affect safety or effectiveness of the Kneehab XP, Type 412/421 device. A summary of the technological characteristics of the new device in comparison to the predicate device has been included below:
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| General ComparisonName of Device: | Proposed DeviceKnechab XP | Predicate DeviceKnechab XPConductive Garment | Predicate DeviceMediTens XP | Predicate DeviceMediStim XP | Predicate DeviceStaodyn Max | Predicate Device300 PV CompleteElectrotherapy System | Predicate DeviceBlonicare® StimulatorSystem |
|---|---|---|---|---|---|---|---|
| 510k Number: | K110350 | K083105 | K082011 | K082011 | K061516 | K021100 | K971437 |
| Intended Use | The Kneehab XP isintended to providetranscutaneousNeuromuscular ElectricalStimulation (NMES) andTranscutaneousElectrical NerveStimulation (TENS). | The Knechab XP isintended to providetranscutaneousNeuromuscular ElectricalStimulation (NMES) andTranscutaneousElectrical NerveStimulation (TENS) | The MediTens XP isintended to provideTranscutaneousElectrical NerveStimulation (TENS). | The Knechab XP isintended to providetranscutaneousNeuromuscular ElectricalStimulation (NMES) andTranscutaneousElectrical NerveStimulation (TENS) | The Knechah XP isintended to providetranscutaneousNeuromuscular ElectricalStimulation (NMES) andTranscutaneousElectrical NerveStimulation (TENS) | The 300 PV is amultifunctionelectrotherapy deviceintended to provideNeuromuscular ElectricalStimulation (NMES),TranscutaneousElectrical NerveStimulation (TENS).Interferential CurrentStimulation (IFS) andFunctional ElectricalStimulation (FES). | The Bionicare isbattery operated TENSstimulator producingpulses at 100 HzElectrodes are applied tothe knee and thigh. |
| Prescriptive Use | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Indications for Use | In NMES mode(Programs 1-6) theKnechab XP is intendedto:Maintain or increaserange of motion,Prevention or retardationof disuse atrophy,Re-educate muscles,Early post-surgicalquadriceps strengtheningand improved postsurgical knee stabilitysecondary to quadricepsstrengthening. Relaxmuscle spasms &Increase local bloodcirculationIn TENS Mode(Programs 7 - 9) theKnechab XP is intendedto:Provide symptomaticrelief and management ofchronic, intractable pain,Provide an adjunctivetreatment in themanagement of acute,post-surgical or post-traumatic pain, Provide | Muscle re-education ofthe quadriceps.Maintaining or increaserange of motion of theknee joint. Prevention orretardation of disuseatrophy in thequadriceps, Early post-surgical quadricepsstrengthening andimproved post-surgicalknee stability secondaryto quadricepsstrengthening &Increasing local bloodcirculation. | The symptomatic reliefand management ofchronic intractable pain.It is also an adjunctivetreatment in themanagement of post-surgical and post-traumatic pain. Thedevice has no curativevalue and should only beused in conjunction withmedical supervision. | Neuromuscular ElectricalStimulation (NMES) forrelaxation of musclespasms. prevention orretardation of disuseatrophy, increasing localblood circulation, musclere-education, immediatepost-surgical stimulationof calf muscles toprevent venousthrombosis andmaintaining or increasingrange of motion.TranscutaneousElectrical NerveStimulation (TENS) foran adjunctive treatmentin the management ofpost-surgical and post-traumatic acute painproblems. | The Staodyn® MaxPreset TranscutaneousElectrical NerveStimulator Device is usedfor the symptomaticrelief and management ofchronic intractable painand relief of painassociated with arthritis.It is also used as anadjunctive treatment inthe management of post-surgical and post-traumatic pain | (TENS/NMESIndications for use)As a NMES device, the300 PV is indicated forthe following conditions:Re-educating muscles,Relaxation of musclespasm. Increasing localblood circulation,Retarding or preventingdisuse atrophy.Maintaining orincreasing range ofmotion & Prevention ofvenous thrombosis of thecalf muscles immediatelyafter surgeryAs a TENS device, the300 PV is indicated forthe following conditions:Symptomatic relief andmanagement of chronic,intractable pain andAdjunctive treatment forpost-surgical and post-trauma acute pain | Provide an adjunctivetherapy in reducing thelevel of pain andsymptoms associatedwith osteoarthritis of theknee and for overallimprovement of the knee |
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| General ComparisonName of Device: | Proposed DeviceKneehab XP | Predicate DeviceKneehab XPConductive Garment | Predicate DeviceMediTens XP | Predicate DeviceMediStim XP | Predicate DeviceStaodyn Max | Predicate Device300 PV CompleteElectrotherapy System | Predicate DeviceBionicare® StimulatorSystem | |
|---|---|---|---|---|---|---|---|---|
| 510k Number: | K110350 | K083105 | K082011 | K082011 | K061516 | K021100 | K971437 | |
| symptomatic relief andmanagement ofintractable pain. Relief ofpain associated witharthritis.Program 7 provides anadjunctive therapy inreducing the level of painand symptoms associated | ||||||||
| with osteoarthritis of theknee. | ||||||||
| Energy Used orDelivered: | 3.6VRechargeablePack | NiMHBattery | Same as proposed device | 9V Battery (type 6LR61) | 9V Battery (type 6LR61) | 3 x AAA Batteries | 2 x AA | 9V Battery (type 6LR61) |
| Unit: | Constructed frominjection mouldedthermosetting plastic(ABS-PA-757) | Same as proposed device | Same as proposed device | Same as proposed device | Not available | Not available | 9V Battery (type 6LR61) | |
| Garment: | Contains an EEPROM.Outer Fabric: 100%Nylon, Inner Fabric: 70%Polychloroprene & 30%Polyurethane,Binding: 82% Nylon &18% Elastane.Fastenings: 100% Nylon | Same as proposed device | Not Applicable (N/A) | N/A | N/A | N/A | Garment wraps aroundknee and thigh, containsconductive surfaces ontowhich conductive gel isapplied. | |
| Electrode | Electrode A: 194 cm2,Electrode B: 74 cm2,Electrode C: 83 cm2 andElectrode D: 66 cm2 | Same as proposed device | Industry standardelectrodes5 x 5cm &7 cm round5 cm x 9cm etc. | Industry standardelectrodes5 x 5cm &7 cm round5 cm x 9 cm etc. | Industry standardelectrodes5 x 5cm &7 cm round5 cm x 9 cm etc. | Industry standardelectrodes5 x 5cm &7 cm round5 cm x 9 cm etc. | 2 of 12 x 9 cm approx | |
| Lead Wires: | Over-moulded SATAconnector, splitting to 5leads / studs. | Same as proposed device | Set of two (dark blue andlight blue), each leadwire has 2 wires andterminates with a 2mmmoulded pin forconnection to electrodes.Constructed of PVCinsulated, containing 7-strand tinsel copper withinterwoven Kevlarreinforcing fibers. | Set of two (dark blue andlight blue), each leadwire has 2 wires andterminates with a 2mmmoulded pin forconnection to electrodes.Constructed of PVCinsulated, containing 7-strand tinsel copper withinterwoven Kevlarreinforcing fibers. | Set of two, each leadwire has 2 wires andterminates with a 2mmmoulded pin forconnection to electrodes. | Set of two, each leadwire has 2 wires andterminates with a 2mmmoulded pin forconnection to electrodes. | Set of two, each leadwire has 2 wires andterminates with a 2mmmoulded pin forconnection to electrodes. | |
| Charger: | PC/ABS, complies withIEC 60950 and UI, 1950 | Same as proposed device | N/A | N/A | N/A | YES, charges batteriesexternal to unit | N/A | |
| Standards Met | IEC 60601-1 (1998) & | Same as proposed device | Same as proposed device | Same as proposed device | Not available | Not Available | Not Available |
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| General ComparisonName of Device: | Proposed DeviceKneehab XP | Predicate DeviceKneehab XPConductive Garment | Predicate DeviceMediTens XP | Predicate DeviceMediStim XP | Predicate DeviceStaodyn Max | Predicate Device300 PV CompleteElectrotherapy System | Predicate DeviceBionicare® StimulatorSystem |
|---|---|---|---|---|---|---|---|
| 510k Number: | K1103501991, A2: 1995.IEC 60601-2-10 (1987)&A1: 2001.IEC 60601-1-2 (2001),ISO 14971:2007,ISO 10993-1:2009ISO 10993-5:2009ISO 10993-10:2002 &A1:200621 CFR 89821 CFR 801 | K083105 | K082011 | K082011 | K061516 | K021100 | K971437 |
| Biocompatibility | Electrodes - K000947 | Same as proposed device | Electrodes - K970426,K874469 & K965194 | Electrodes - K970426,K874469 & K965194 | Not available | Not available | Not Available |
| Compatibility with theenvironment & otherdevices | Complies to IEC 60601-1-2 Medical electricalequipment - Part 1-2:General requirements forsafety - Collateralstandard:ElectromagneticcompatibilityRequirements and tests | Same as proposed device | Same as proposed device | Same as proposed device | Not available | Not Available | Not Available |
| Sterility | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Electrical &Mechanical Safety | Complies to IEC 60601-1Medical electricalequipment - Part 1:General requirements forsafety & IEC 60601-2-10Medical electricalequipment - Part 2-10:Particular requirementsfor the safety of nerveand muscle stimulators | Same as proposed device | Same as proposed device | Same as proposed device | Not available | Not available | Not available |
| Chemical Safety | MSDS Sheet (ElectrodeGel) | Same as proposed device | Same as proposed device | Same as proposed device | Not available | Not available | Not available |
| Thermal Safety | Complies to IEC 60601-1& IEC 60601-2-10 | Same as proposed device | Same as proposed device | Same as proposed device | Not available | Not available | Not available |
| Radiation Safety | N/A | N/A | N/A | N/A | Not available | Not available | Not available |
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| UNIT Comparison | Proposed Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device |
|---|---|---|---|---|---|---|---|
| Name of Device: | Kneehab XP | Kneehab XPConductive Garment | MediTens XP | MediStim XP | Staodyn Max | 300 PV CompleteElectrotherapy System | |
| 510k Number: | K110350 | K083105 | K082011 | K082011 | K061516 | K021100 | |
| Manufacturer | China Turnkey SolutionsLogistics(Shenzhen)Co., Futian Free TradeZone. CHINA 518038 | Same as proposed device | Same as proposed device | Same as proposed device | Compex Technologies | Empi599 Cardigan RoadSt. Paul,Minnesota 55126-4099 | BioniCare MedicalTechnologies, Inc.,47 R Loveton CircleSparks, MD 21152 |
| -Method oflineIsolation | No line connection | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | No line connection |
| Patient LeakageCurrent | N/A | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | |
| No. of Output Modes | 1 | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | Several. eg Hi Volt, FES. | |
| Waveform/Shape | Pulsed, Symmetrical,Biphasic. Rectangularwith interphase interval | Same as proposed device | Same as proposed device | Same as proposed device | Symmetrical BiphasicSquare | Asymmetric andSymmetric square waveoptions, Hi Volt pulseoption: exponentialspikes. | Monophasic spikeshaped pulse |
| No. of Output Channels | 2 | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | 2 |
| Synch/Alternating? | Synchronous(Multiplexed) | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | Synchronous andalternating | Synchronous |
| -Method of channelisolation | Transistor | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | Transformer | unknown |
| Regulated Current orRegulated Voltage | Regulated Current | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | Claimed to be regulatedvoltage |
| Software/Firmware/MicroprocessorControl? | Yes | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device |
| Automatic OverloadTrip? | Yes, current limited,indefinite short circuitallowed | Same as proposed device | Same as proposed device | Same as proposed device | Unknown | Unknown | unknown |
| Automatic No-LoadTrip? | Yes | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | unknown |
| Automatic Shut Off? | Yes | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | Same as proposed device | Unknown |
| PatientControl? | Override Yes, pause button | Same as proposed device | Same as proposed device | Same as proposed device | Not available | Yes, Pause, FES modes | Yes stop button endstreatment |
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| UNIT Comparison | Proposed Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device |
|---|---|---|---|---|---|---|---|
| Name of Device: | Kneehab XP | Kneehab XPConductive Garment | MediTens XP | MediStim XP | Staodyn Max | 300 PV CompleteElectrotherapy System | |
| 510k Number: | K110350 | K083105 | K082011 | K082011 | K061516 | K021100 | |
| Timer range (mins) | 20 mins - open | Same as proposed device | Open | 30 minutes - open | 120 mins | 5 mins to open | Open |
| Weight (unit) | 116g (inc. batteries) | Same as proposed device | 142g (inc. batteries) | 142g (inc. batteries) | 145g | 226g | 136g |
| Dimensions(W x H x D) | 60x23x115mm | Same as proposed device | 105x68x28mm | 105x68x28mm | 2.5" x 5.25" x 1.0" | 1.26" x 3.3" x 4.5" | 95x64x30mm |
| Frequency/Phase Duration ofprogram with highestoutput power. | Program 799Hz$300\mu S$ | Program 150Hz$400 \mu S$ | Program 399 Hz$150\mu S$ | Program 350Hz$400 \mu S$ | Program A100HZ$350\mu S$ | Custom User 2150Hz$400\mu S$ | 100Hz$640\mu S$ |
| Baseline to PeakCurrent | $80mA @ 500\Omega$$28mA @ 2k\Omega$$3.9mA @ 10k\Omega$ | $80mA @ 500\Omega$$28mA @ 2k\Omega$$3.9mA @ 10k\Omega$ | $75mA @ 500\Omega +/- 10%$$35mA @ 2k\Omega$$7mA @ 10k\Omega$ | $75mA @ 500\Omega +/- 10%$$35mA @ 2k\Omega$$7mA @ 10k\Omega$ | $60mA @ 500\Omega$ | $100mA @ 500\Omega$ | $24mA @ 500\Omega$ |
| Baseline to PeakOutput Voltage | $40.0V @ 500\Omega$$55.6V @ 2k\Omega$$39.3V @ 10k\Omega$ | $40.0V at 500 \Omega$$55.6V @ 2k \Omega$$39.3V at 10k \Omega$ | $37V @ 500\Omega$$70V @ 2k\Omega$$70V @ 10k\Omega$ | $37V @ 500\Omega$$70V @ 2k\Omega$$70V @ 10k\Omega$ | $30V @ 500\Omega$ | $50V @ 500\Omega$ | $12V 500\Omega$ |
| Maximum RMS OutputVoltage(+/-10%) Vrms | $9.3 V @ 500 \Omega$$17.1V @ 2k\Omega$$14.1V @ 10k\Omega$ | $9.15V@ 500\Omega$$10.74V @ 2k\Omega$$5.65V @ 10k \Omega$ | $6.4 V @ 500\Omega$$12.1V @ 2k\Omega$$7 V @ 10k\Omega$ | $7.5V @ 500\Omega$$14 @ 2k\Omega$$7 V @ 10k\Omega$ | $8.85V @ 500\Omega$ | $10.5V @ 500\Omega$ | 4.3VEstimated assuming asquare pulse shape0.64ms |
| Maximum RMS OutputCurrent(+/-10%) Irms | $18.6 mA@ 500 \Omega$$8.6 mA@ 2k\Omega$$1420 \mu A@ 10k\Omega$ | $18.3mA@ 500\Omega$$5.37mA @ 2k\Omega$$565\mu A @ 10k\Omega$ | $12.8mA @ 500\Omega$$6.1mA @ 2k\Omega$$700\mu A @ 10k\Omega$ | $15mA @ 500\Omega$$7 mA @ 2k\Omega$$490\mu A@ 10k\Omega$ | $15.9mA @ 500\Omega$ | $21mA @ 500\Omega$(Asstated in device IFU,however is inconsistentwith other statedparameters) | 8.6mA |
| Pulse Width | $640 \mu s$ sum of bothphases $300\mu s$ +40 $\mu s$interphase interval | $840\mu s$ (both phases max$400\mu s$ with interphaseinterval of $40\mu S$ ) | $300\mu S$ ( sum of bothphases; $150\mu S$ ) (Prog 1) | $800\mu S$ sum of bothphases; $400\mu S$ ) (Prog | $700\mu S$ - sum of bothphases; $350\mu S$(Prog A) | $1200\mu S$ . sum of bothphases andinterphase interval | $640 \mu S$ |
| Net Charge( $\mu C$ per pulse) | $0\mu C @ 500\Omega$ | $0\mu C @ 500\Omega$ | $0\mu C @ 500\Omega$ | $0\mu C @ 500\Omega$ | $0\mu C @ 500\Omega$ | $<20\mu A$ | Not available |
| Maximum PhaseCharge @500(+/-20%) | $24 \mu C @ 500\Omega$ | $32.8\mu C$ | $10.5\mu C @ 500\Omega$ | $30 \mu C$ | $21 \mu C @ 500\Omega$ | $40 \mu C$ | $21 \mu C @ 500\Omega$ |
| Maximum CurrentDensity @500 $\Omega$ | $=18.6 mA/83 cm^2$$=0.22 mA/cm^2$ | $0.22 mA/cm2$ | Using 2" squareelectrode$= 12.8 mA/25 cm^2$$= 0.5 mA/ cm^2$ | Using 2" squareelectrode$= 15 mA/25 cm^2$$= 0.6 mA/ cm^2$ | Using 2" squareelectrode$=15.9 mA/25 cm^2$$= 0.64mA/ cm^2$ | Using 2" squareelectrode$=21 mA/25 cm^2$$= 0.84mA/ cm^2$ | Using 12 x 9 squareelectrodes$=8.6 mA/108 cm^2$$=0.08 mA/cm^2$ |
| Maximum PowerDensity @500 $\Omega$(using smallestelectrode conductivesurface area) | Program 7$2.1mW/cm^2 @ 500\Omega$ | $2.55 mW/cm2$ | $3.3 mW/cm^2$ | $4.5 mW/cm^2$ | $2.9 mW/cm^2$ | $8.8 mW/cm^2$ | $0.34 mW/cm^2$ |
| Burst Mode(ie pulse trains) | YES, NMES on off cycle | Yes, NMES on off cycle | Yes, burst mode TENS | Yes, NMES on off cycle | Yes, burst mode TENS | Yes. NMES and TENSmodes | Yes |
Page 9 of 10
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7. Substantial Equivalence
Bio-Medical Research Ltd (BMR) has over 30 years experience in the research, design, manufacture and marketing of medical grade products for both muscle strengthening and pain relief. Bio-Medical Research Ltd. complies with 21 CFR 820 and is registered to I.S. EN ISO 13485:2003, Medical Device Quality Management System for the design. manufacture and distribution of electro-medical devices.
Kneehab XP, Type 412/421 device complies with the following international safety standards:
- ロ IEC 60601-1 (1998) + A1: 1991, A2: 1995, Medical Electrical Equipment Part 1: General Requirements for Safety
- D IEC 60601-1-2 (2001). Medical Electrical Equipment Part 1-2: General Requirements for Safety; Electromagnetic Compatibility Requirements & Tests.
- ロ IEC 60601-2-10 (1987) + Al: 2001 Medical electrical equipment Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
A risk management plan has been carried out to I.S. EN ISO 14971 2007.
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Image /page/10/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bio-Medical Research LTD. c/o Anne Marie Keenan Quality/Regulatory Engineer Parkmore Business Park, West Galway Ireland EI
Re: K110350
AUG - 3 2011
Trade/Device Name: Kneehab XP, Type 412/421 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Codes: GZJ, IPF, NYN Dated: June 24, 2011 Received: June 30, 2011
Dear Ms. Keenan:
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Anne Marie Keenan
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KI 10350 510(k) Number (if known):
Device Name:
Kneehab XP, Type 412/421
Indications for Use:
The Kneehab XP, Type 412/421, Indications for use are as follows:
In NMES mode (Programs 1-6) the Kneehab XP is intended to:
- Maintain or increase the range of motion. ◆
- . Prevention or retardation of disuse atrophy
- . Re-educate muscles
- Early post-surgical quadriceps strengthening and improved post surgical knee . stability secondary to quadriceps strengthening
- . Relax muscle spasms
- . Increase blood circulation
In TENS Mode (Programs 7 - 9) the Kneehab XP is intended to:
- Provide symptomatic relief and management of chronic, intractable pain .
- . Provide an adjunctive treatment in the management of acute, post-surgical or post-traumatic pain
- . Provide symptomatic relief and management of intractable pain and relief of pain associated with arthritis
- . Provide an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee
Prescription Use ﺟ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use . (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stan Olchov
(Division Sien-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110350
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).