(83 days)
EMS: The Compex Sport Elite is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the Compex is not suitable for rehable for rehabilitation or physiotherapy.
TENS: The Compex Sport Elite TENS is intended for:
· Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
· They symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The Compex® Sport Elite is an Over-The-Counter device to be used by adults only.
The Compex® Sport Elite is an electrical stimulation device, which stimulates healthy muscles by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex® Sport Elite stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex® Sport Elite may therefore be considered a technique of muscle training.
TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training; warming up or recovering.
The Compex® Sport Elite system consists of these components:
- 1x Stimulator
- 1x Lead Wire Set
- 2x Small Performance Snap Electrode package ●
- 2x Large Performance Snap Electrode package
- 1x Battery Charger ●
These components are packaged together in a carrying case along with the user guide and a battery charger.
The stimulator is a microprocessor controlled 4 channels electro-stimulator. The stimulator drives each output channel independently based upon the parameters pre-defined for a program selected by the user. The user operates the device through a User Interface (UI) consisting of a graphic LCD, keypad controls and supporting software. The User Interface is made up of different menus that allow the following functions: set up the device (Options Menu), select a desired category (Category Menu), select a preset program (Treatments' Menu), tune a selected program (Stimulation Menu), and adjust the stimulation intensities (Level Menu).
The provided document is a 510(k) premarket notification for the Compex® Sport Elite, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to predicate devices (Compex Sport Plus and Strive) rather than providing extensive clinical study data for acceptance criteria.
Therefore, the information requested regarding a study proving acceptance criteria for device performance is largely not available in this document. The document primarily describes the technical characteristics of the new device and compares them to predicate devices, along with adherence to electrical safety, electromagnetic compatibility, software verification, and usability standards.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for a study in numerical terms like sensitivity, specificity, or improvement effect size. Instead, it demonstrates compliance with recognized medical device standards and provides detailed comparisons of technical specifications to predicate devices. The "performance" is therefore reported in terms of these technical characteristics.
| Acceptance Criteria (Inferred/Stated) | Reported Device Performance (Compex Sport Elite) |
|---|---|
| Electrical Safety & Essential Performance (as per IEC 60601-1) | Complies with IEC 60601-1 |
| Electromagnetic Compatibility (as per IEC 60601-1-2) | Complies with IEC 60601-1-2 |
| Use in Home Healthcare Environment (as per IEC 60601-1-11) | Complies with IEC 60601-1-11 |
| Performance of Nerve and Muscle Stimulators (as per IEC 60601-2-10) | Complies with IEC 60601-2-10 |
| Software Verification (meets design requirements) | Software verified in accordance with FDA guidance "General Principles of Software Validation, January 11, 2002." Demonstrated to meet design requirements. Cybersecurity vulnerability and management approach established. |
| Usability/Human Factors (meets requirements, appropriate for users/environment, mitigates use-related risks) | Usability/Human Factors testing performed. Demonstrated that established requirements for usability were met, and the design is appropriate for intended users and use environment. The study substantiates acceptability of use-related risks. |
| Conformity with other standards (e.g., Risk Management, Software Life Cycle) | Complies with ISO 14971 (Risk Management) and AAMI/ANSI /IEC 62304 (Software Life Cycle Processes). |
| Technical Specifications (e.g., Waveform, Max Output Voltage/Current, Pulse Width, Frequency, Net Charge, Max Phase Charge, Max Current Density, Max Power Density) | Detailed specifications are provided in the comparison tables for the new device (Compex Sport Elite) and predicate devices. For most parameters (waveform, shape, voltages, currents, pulse widths, frequencies for NMES programs), the Compex Sport Elite matches or is similar to the Compex Sport Plus. For TENS specific parameters, it aligns with or is similar to the Strive. Differences are noted but deemed not to raise safety and effectiveness questions (e.g., Compex Sport Elite has two output modes (NMES/TENS) vs. Compex Sport Plus (NMES) and Strive (TENS)). Specific values are extensive in the source document and are essentially the "reported performance" for these technical aspects. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The performance testing described (electrical safety, EMC, software, usability) are typically internal validation tests and not clinical studies involving patient data.
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)
This information is not provided. The "ground truth" in this context would likely be compliance with engineering standards, software requirements, and usability principles, assessed by engineers and human factors specialists rather than medical experts for clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Standard engineering and software verification often involve peer reviews and structured testing, but specific adjudication methods like those used in clinical trials (e.g., 2+1 consensus) are not applicable or mentioned here.
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
No MRMC comparative effectiveness study was done or reported. This device is a muscle stimulator, not an AI diagnostic tool, so this type of study is not relevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical muscle stimulator and does not involve AI algorithms in the way described for "standalone performance" in AI/CADe devices. Its "standalone performance" is essentially its ability to meet the technical specifications and safety standards independently. This was assessed through the electrical safety, EMC, software verification, and usability testing, as detailed above.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is compliance with:
- Recognized consensus standards (IEC 60601-1, -1-2, -1-11, -2-10, IEC 62366, ISO 14971, AAMI/ANSI/IEC 62304).
- Design requirements for software functionality.
- Usability requirements for safe and effective user interaction.
There is no mention of clinical expert consensus, pathology, or outcomes data being used as ground truth for this 510(k) submission, as the submission explicitly states: "This submission does not contain clinical data."
8. The sample size for the training set
This information is not applicable/not provided for this type of device and submission. The device is not an AI/machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided as there is no "training set" for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2017
DJO, LLC Neeta Sharma Sr. Director, Regulatory Affairs 1430 Decision Street Vista. California 92081
Re: K170918
Trade/Device Name: Compex Sport Elite Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH, NYN Dated: March 28, 2017 Received: March 29, 2017
Dear Neeta Sharma:
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, 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 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-
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Hoffmann -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170918
Device Name Compex Sport Elite
Indications for Use (Describe)
EMS: The Compex Sport Elite is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the Compex is not suitable for rehable for rehabilitation or physiotherapy.
TENS: The Compex Sport Elite TENS is intended for:
· Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
· They symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The Compex® Sport Elite is an Over-The-Counter device to be used by adults only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is K170918.
| Submitted by: | DJO, LLC1430 Decision StreetVista, CA 92081FDA Establishment Registration: 2020737 |
|---|---|
| Contact Person: | Neeta SharmaSr. Director, Regulatory Affairs760-734-3551 |
| Date Summary Prepared: | June 19, 2017 |
| Trade Name: | Compex® Sport Elite |
| Classification Name: | Stimulator, muscle, powered (21 CFR 890.5850)Stimulator, Nerve, Transcutaneous (21 CFR 882. 5890) |
| Product Code: | Powered Muscle Stimulator, For Muscle Conditioning – 21 CFR890.5850; Product Code NGX; Review Panel: Physical Medicine(primary product code) |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter- 21 CFR 882.5890;Product Code NUH; Review Panel: Neurology | |
| Stimulator, Electrical, Transcutaneous, For Arthritis 21 CFR 890.5850;Product Code NYN (subsequent code); Review Panel: Neurology | |
| Regulatory Class: | Class II |
| Predicate Device: | Compex Sport Plus (K083140) - Class II(primary predicate device)Strive (K153704) - Class II |
Device Description:
The Compex® Sport Elite is an electrical stimulation device, which stimulates healthy muscles by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex® Sport Elite stimulate motor nerves to stimulate a muscular response. Depending on the
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parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex® Sport Elite may therefore be considered a technique of muscle training.
TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training; warming up or recovering.
The Compex® Sport Elite system consists of these components:
- 1x Stimulator
- 1x Lead Wire Set
- 2x Small Performance Snap Electrode package ●
- 2x Large Performance Snap Electrode package
- 1x Battery Charger ●
These components are packaged together in a carrying case along with the user guide and a battery charger.
The stimulator is a microprocessor controlled 4 channels electro-stimulator. The stimulator drives each output channel independently based upon the parameters pre-defined for a program selected by the user. The user operates the device through a User Interface (UI) consisting of a graphic LCD, keypad controls and supporting software. The User Interface is made up of different menus that allow the following functions: set up the device (Options Menu), select a desired category (Category Menu), select a preset program (Treatments' Menu), tune a selected program (Stimulation Menu), and adjust the stimulation intensities (Level Menu).
Indications for Use:
The Compex Sport Elite EMS is used for:
The Compex Sport Elite is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The work imposed on the muscles by the Compex Sport Elite programs is definitely not suitable for rehabilitation and physiotherapy.
The Compex Sport Elite TENS is intended for:
- Temporary relief of pain associated with sore and aching muscles due to strain from exercise or ● normal household and work activities
- The symptomatic relief and management of chronic, intractable pain and relief of pain ● associated with arthritis.
The Compex Sport Elite is an Over-the-Counter device to be used by adults only.
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Comparison to the Predicate Device:
The indications for use for the Compex® Sport Elite are similar to those of the predicate devices, Compex Sport Plus (K083140) and Strive (K153704).
The technological characteristics of the predicate devices are very similar, but there are a few minor differences.
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| Basic Unit Characteristics - Comparison with Predicate Device | |||||
|---|---|---|---|---|---|
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different | |
| 1 | 510(k) Number | Pending | K083140 | K153704 | |
| 2 | Device Name, Model | Compex Sport Elite | Compex Sport Plus | Strive | |
| 3 | Manufacturer | DJO, LLC | DJO, LLC510(k) sponsor:ChattanoogaGroup | DJO, LLC | Similar |
| 4 | Prescription/OTC | OTC | OTC | OTC | Similar |
| 5 | Type of device | A non-implantable,battery powered, handheld, electricalstimulator, used formedical purposesthrough applying anelectrical current toelectrodes on apatient's skin | A non-implantable,battery powered, handheld, electricalstimulator, used formedical purposesthrough applying anelectrical current toelectrodes on a patient'sskin | A non-implantable,battery powered, handheld, electricalstimulator, used formedical purposesthrough applying anelectrical current toelectrodes on apatient's skin | Similar |
| 6 | Indications for Use | The Compex SportElite EMS is used for:The Compex SportElite is intended tostimulate healthymuscles in order toimprove or facilitatemuscle performance.The work imposed onthe muscles by theCompex Sport Eliteprograms is definitely | The Compex SportElite is intended tostimulate healthymuscles in order toimprove or facilitatemuscle performance.The Compex Sport Eliteis not intended foradjunctive therapy inthe treatment of medicaldiseases and conditionsof any kind. None ofthe Compex Sport Elite | Over the CounterUse: The Strive™TENS device isused for: -temporary relief ofpain associated withsore and achingmuscles due tostrain from exerciseor normalhousehold and workactivities. -thesymptomatic relief | NMES -Indicationfor use are the sameas Compex SportPlus deviceandTENS-Indication for useare the same asStrive |
| not suitable forrehabilitation andphysiotherapy. | stimulation programs aredesigned for injured ordisease afflictedmuscles. Its use on suchmuscles iscontraindicated. Thework imposed on themuscles by the CompexSport Elite programs isdefinitely not suitablefor rehabilitation andphysiotherapy.The Compex SportElite electricalimpulses allow thetriggering of actionpotentials onmotoneurones ofmotor nerves(excitations).These excitations ofmotoneurones aretransmitted to themuscle fibers via themotor endplate wherethey generatemechanical musclefiber responses thatcorrespond to musclework.Depending on theparameters of theelectrical impulses(pulse frequency | and management ofchronic, intractablepain and relief ofpain associated witharthritis. | |||
| The Compex SportElite TENS is intendedfor:• Temporary relief ofpain associated withsore and achingmuscles due tostrain from exerciseor normalhousehold and workactivities• The symptomaticrelief andmanagement ofchronic, intractablepain and relief ofpain associated witharthritis.The Compex SportElite is an Over-the-Counter device to beused by adults only. | |||||
| duration ofcontraction, durationof rest, total sessionduration), differenttypes of muscle workcan be imposed on thestimulated muscles.The Compex Sport Elitemay therefore beconsidered a techniqueof muscle training. | |||||
| 7 | Connection of device toelectrodes | Lead wiresWith 6-pole cablesincluding femalecustom SNAPplugged on thecustom Compexfemale SNAPassembled in theelectrode. Entireelectronic circuit forfour (4) StimulationChannels and UserInterface is combinedinto same casing,connected to theelectrodes with 6-pole cables. | Lead wiresWith 6-pole cablesincluding female customSNAP plugged on thecustom Compex femaleSNAP assembled in theelectrode. Entireelectronic circuit forfour (4) StimulationChannels and UserInterface is combinedinto same casing,connected to theelectrodes with 6-polecables. | Lead wires | Similar |
| 8 | Power Sources | Rechargeable Ni-MhBattery 4.8V (4 cellsAA=R6) | Rechargeable Ni-MhBattery 4.8V (4 cellsAA=R6) | LiPo 250 [mAh](3.7[V]), not removable | Same as CompexSport PlusDifferent fromStrive |
| Method of line currentisolation | N/A (battery operateddevice) | N/A (batteryoperated device) | N/A (battery operateddevice) | Similar | |
| Patient Leakage Current | N/A (battery operated device) | N/A (battery operated device) | N/A (battery operated device) | Similar | |
| • Normal condition | N/A (battery operated device) | N/A (battery operated device) | N/A (battery operated device) | Similar | |
| • Single fault condition | N/A (battery operated device) | N/A (battery operated device) | N/A (battery operated device) | Similar | |
| 9 | Number of Output Modes | Two (NMES/TENS) | One (NMES) | Two (2 x TENS) | Different |
| 10 | Number of Output Channels | Four | Four | 1, split | Same as CompexSport PlusDifferent fromStrive |
| Synchronous or Alternating? | Synchronous, but never 2 channels activated at the same time | Synchronous, but never 2 channels activated at the same time | N/A | Same as CompexSport PlusDifferent fromStrive | |
| Method of Channel Isolation | Each channel is the middle of a H-Bridge. Except when it is activated, each channel is always in high impedance state. | Each channel is the middle of a H- Bridge. Except when it is activated, each channel is always in high impedance state. | N/A | Same as CompexSport PlusDifferent fromStrive | |
| 11 | Regulated Current or Regulated Voltage? | Regulated current (all channels) | Regulated current (all channels) | Regulated Current | Similar |
| 12 | Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Similar |
| 13 | Automatic Overload Trip? | Yes | Yes | No | Same as CompexSport PlusDifferent fromStrive |
| 14 | Automatic No-Load Trip? | Yes | Yes | Yes | Similar |
| 15 | Automatic Shut Off? | "On/Off" switch | "On/Off" switch | "On/Off" switch | Similar |
| ા ર17 | Patient Override Control?Indicator Display | Yes | Yes | No | Same as CompexSport PlusDifferent fromStriveSimilar |
| On/Off Status?। | Yes | Yes | Yes | ||
| Low Battery?- | Yes | Yes | No | Same as CompexSport PlusDifferent fromStrive | |
| Voltage/Current Level? | Yes, unit =[Energy] | Yes, unit =[Energy] | Active/inactive output | Same as CompexSport PlusDifferent fromStrive | |
| 18 | Timer Range (minutes) | Yes, unit=[seconds], max = 55[minutes] | Yes, unit= [seconds],max = 55 [minutes] | Unlimited | Same as CompexSport PlusDifferent fromStrive |
| 19 | Compliance withVoluntaryStandards? | Yes-IEC 60601-1-IEC 60601-1-2-IEC 60601-1-6-IEC 60601-2-10-IEC60601-1-11-IEC 62366-IEC 62304 | Yes-IEC 60601-1-IEC 60601-1-2-IEC 60601-1-4-IEC 60601-2-10 | Yes-IEC 60601-1-IEC 60601-1-2-IEC 60601-1-11-IEC 60601-2-10-IEC 60601-1-6 | Different |
| 20 | Compliance with 21CFR 898? | Yes | Yes | Yes | Similar |
| 21 | Weight | 300 [g] | 300 [g] | 0.99 oz | Same as CompexSport PlusDifferent fromStrive |
| 22 | Dimensions [W x H x D] | 99 x 142 x 36 [mm]3.9 x 5.6 x 1.4 [in] | 99 x 142 x 36 [mm]3.9 x 5.6 x 1.4 [in] | 49 mm x 64mm x 14mm | Same as CompexSport Plus |
| Different fromStrive | |||||
| 23 | Housing Materials andConstruction | Casing:Plastic (ABS,with PMMAon thewindows)Buttons:SiliconrubberBattery Pack: RigidABS housingaround the batterycellsBattery contacts: SK5steel | Casing: Plastic(ABS, withPMMA on thewindows)Buttons:Silicon rubberBattery Pack: RigidABS housing aroundthe battery cellsBattery contacts:SK5 steel | Casing: Plastic(ABS+PC)Buttons: silicons rubber | Similar |
| 24 | Programs | - Endurance- Resistance- Strength- Explosive Strength- Potentiation- Training Recovery(same as ActiveRecovery)- CompetitionRecovery (same asRecovery Plus)- Pre-WarmupProgram- Muscle Relaxation(same as Massage)-Pain relief TENS(same as FM) | - Endurance- Resistance- Strength- Explosive Strength- Potentiation- Active Recovery- Recovery Plus- Pre-Warmup- Massage | Frequency Modulation(FM) and SMP | Different |
| 25 | Electrodes | Article number :11-911911-9120 | Article number :11-911911-9120 | Article number:6250900 | Same as Sport PlusDifferent fromStrive |
| Output Specifications – Comparison with Predicate Device | |||||
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different | |
| 1 | 510(k) Number | Pending | K083140 | K153704 | |
| 2 | Device Name, Model | Compex Sport Elite | Compex Sport Plus | Strive | |
| 3 | Manufacturer | DJO, LLC | DJO, LLC510(k) sponsor:Chattanooga Group | DJO, LLC | Similar |
| 4 | Waveform (program perprogram) | -Endurance:Symmetrical Biphasic-Resistance:Symmetrical Biphasic-Strength :Symmetrical Biphasic-Explosive Strength:Symmetrical Biphasic-Potentiation:Symmetrical Biphasic-Training Recovery(same as ActiveRecovery):Symmetrical Biphasic-CompetitionRecovery (same asRecovery Plus):SymmetricalBiphasic-Pre-WarmupProgram: Symmetrical | -Endurance:Symmetrical Biphasic-Resistance:Symmetrical Biphasic-Strength : SymmetricalBiphasic-Explosive Strength:Symmetrical Biphasic-Potentiation:Symmetrical Biphasic-Active Recovery:Symmetrical Biphasic-Recovery Plus:SymmetricalBiphasic-Pre-Warmup Program:Symmetrical Biphasic-Massage: SymmetricalBiphasic | Same asCompex SportPlusDifferent fromStrive | |
| Biphasic-Muscle Relaxation(same as Massage):Symmetrical Biphasic-Pain relief TENS(same as FM):Balanced, asymetricalBiphasic | Balanced, AsymmetricalBiphasic | Same as StriveDifferent fromCompex SportPlus | |||
| 5Shape (program per program) | -Endurance:Rectangular-Resistance:Rectangular-Strength :Rectangular-Explosive Strength:Rectangular-Potentiation:Rectangular-Training Recovery(same as ActiveRecovery):Rectangular-CompetitionRecovery (same asRecovery Plus):Rectangular-Pre-WarmupProgram: Rectangular-Muscle Relaxation(same as Massage):Rectangular | -Endurance: Rectangular-Resistance: Rectangular-Strength : Rectangular-Explosive Strength:Rectangular-Potentiation:Rectangular-Active Recovery:Rectangular-Recovery Plus:Rectangular-Pre-Warmup Program:Rectangular- Massage: Rectangular | Square positive pulse,current controlledLogarithmic negative | Same asCompex SportPlusDifferent fromStrive | |
| Different from | |||||
| -Pain relief TENS(same as FM): | Compex SportPlus | ||||
| 6 | Maximum Output Voltage (± 10%) | Endurance:60 V @ 500 Ω165 V @ 2 ΚΩ165 V @ 10 ΚΩ | Endurance:60 V @ 500 Ω165 V @ 2 ΚΩ165 V @ 10 ΚΩ | Same asCompex SportPlusDifferent fromStrive | |
| Resistance:60 V @ 500 Ω165 V @ 2 ΚΩ165 V @ 10 ΚΩ | Resistance:60 V @ 500 Ω165 V @ 2 ΚΩ165 V @ 10 ΚΩ | Same asCompex SportPlusDifferent fromStrive | |||
| Strength:60 V @ 500 Ω165 V @ 2 ΚΩ165 V @ 10 ΚΩ | Strength:60 V @ 500 Ω165 V @ 2 ΚΩ165 V @ 10 ΚΩ | Same asCompex SportPlusDifferent fromStrive | |||
| Explosive Strength:60 V @ 500 Ω165 V @ 2 ΚΩ165 V @ 10 ΚΩ | Explosive Strength:60 V @ 500 Ω165 V @ 2 ΚΩ165 V @ 10 ΚΩ | Same asCompex SportPlusDifferent fromStrive | |||
| Potentiation:60 V @ 500 Ω165 V @ 2 ΚΩ165 V @ 10 ΚΩ | Potentiation:60 V @ 500 Ω165 V @ 2 ΚΩ165 V @ 10 ΚΩ | Same asCompex SportPlusDifferent fromStrive | |||
| Training Recovery:60 V @ 500 Ω165 V @ 2 ΚΩ165 V @ 10 ΚΩ | Training Recovery:60 V @ 500 Ω165 V @ 2 ΚΩ165 V @ 10 ΚΩ | Same asCompex SportPlusDifferent fromStrive |
Device Comparison Tables
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| CompetitionRecovery:60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩPre Warmup60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩMuscle Relaxation:60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩPain Relief TENS:165[V] peak on10[kΩ]152[V] peak on 2[kΩ]60[V] peak on 500[Ω] | Competition Recovery:60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩPre Warmup60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩMuscle Relaxation:60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | 110[V] peak on 10[kΩ]110[V] peak on 2[kΩ]30[V] peak on 500[Ω] | Same asCompex SportPlusDifferent fromStriveSame asCompex SportPlusDifferent fromStriveSame asCompex SportPlusDifferent fromStriveSame asCompex SportPlusDifferent fromStriveDifferent fromStrive and fromCompex SportPlus |
|---|
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| 7 | Maximum Output Current (± 10%) | Endurance: | Endurance: | Same as | |
|---|---|---|---|---|---|
| 120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ | 120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ | Compex SportPlusDifferent fromStrive | |||
| Resistance: | Resistance: | ||||
| 120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ | 120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ | Same asCompex SportPlusDifferent fromStrive | |||
| Strength: | Strength: | ||||
| 120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ | 120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ | Same asCompex SportPlusDifferent fromStrive | |||
| Explosive Strength: | Explosive Strength: | ||||
| 120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ | 120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ | Same asCompex SportPlusDifferent fromStrive | |||
| Potentiation: | Potentiation: | ||||
| 120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ | 120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ | Same asCompex SportPlusDifferent fromStrive | |||
| Training Recovery: | Training Recovery: | ||||
| 120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ | 120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ | Same asCompex SportPlusDifferent fromStrive | |||
| CompetitionRecovery: | Competition Recovery: | Same as | |||
| 120 mA @ 500 Ω82 mA @ 2 kΩ | 120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ | Compex SportPlus | |||
| 8 | Pulse Width | 16 mA @ 10 kΩPre Warmup120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩMuscle Relaxation:120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩPain Relief TENS:12[mA] peak@10[kΩ]76[mA] peak@2[kΩ]119[mA]peak@500[Ω] | Pre Warmup120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩMuscle Relaxation:120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ | 12[mA] peak @10[kΩ]55[mA] peak@2[kΩ]60[mA] peak@500[Ω] | Different fromStriveSame asCompex SportPlusDifferent fromStriveSame asCompex SportPlusDifferent fromStriveSame asCompex SportPlusDifferent fromStrive |
| Different fromStrive and fromCompex SportPlus | |||||
| Endurance:200 to 400 [μs] | Endurance:200 to 400 [μs] | Same asCompex SportPlus | |||
| Resistance:200 to 400 [μs] | Resistance:200 to 400 [μs] | Different fromStriveSame asCompex SportPlus | |||
| Strength: | Strength: | ||||
| 200 to 400 [μs] | 200 to 400 [μs] | Different fromStriveSame asCompex SportPlus | |||
| Explosive Strength: | Explosive Strength: | ||||
| 200 to 400 [μs] | 200 to 400 [μs] | Different fromStriveSame asCompex SportPlus | |||
| Potentiation: | Potentiation: | ||||
| 200 to 400 [μs] | 200 to 400 [μs] | Different fromStriveSame asCompex SportPlus | |||
| Training Recovery: | Training Recovery: | ||||
| 200 to 400 [μs] | 200 to 400 [μs] | Different fromStriveSame asCompex SportPlus | |||
| CompetitionRecovery: | Competition Recovery: | ||||
| 200 to 400 [μs] | 200 to 400 [μs] | Different fromStriveSame asCompex SportPlus | |||
| Pre Warmup | Pre Warmup | ||||
| 200 to 400 [μs] | 200 to 400 [μs] | Different fromStriveSame asCompex SportPlus | |||
| Muscle Relaxation: | Muscle Relaxation: | ||||
| 200 to 400 [μs] | 200 to 400 [μs] | Different fromStriveSame asCompex SportPlus | |||
| Pain Relief TENS:70 to 300[μs](measured at 50% ofpositive pulse) | 70 to 300[μs] (measured at50% of positive pulse) | Different fromStrive | |||
| Same asCompex SportPlusDifferent fromStrive | |||||
| Same as Strive,different fromCompex SportPlus | |||||
| 9 | Frequency | Endurance:10 [Hz] | Endurance:10 [Hz] | Same asCompex SportPlusDifferent fromStrive | |
| Resistance:50 [Hz] | Resistance:50 [Hz] | ||||
| Strength:75 [Hz] | Strength:75 [Hz] | ||||
| Explosive Strength:100 [Hz]Potentiation:From 1 to 75 [Hz] | Explosive Strength:100 [Hz]Potentiation:From 1 to 75 [Hz] | ||||
| Training Recovery:10 [Hz] | Training Recovery:10 [Hz] | ||||
| CompetitionRecovery:0.5 [Hz] | Competition Recovery:0.5 [Hz] | ||||
| Pre Warmup | Pre Warmup4 [Hz] | ||||
| 4 [Hz]Muscle Relaxation:1 [Hz]Pain Relief TENS:5 to 122[Hz] | Muscle Relaxation:1 [Hz] | 5 to 122[Hz] | Same as Strive,different fromCompex SportPlus | ||
| 10 | For interferential modes only:- Beat Frequency [Hz] | N/A | N/A | N/A | Similar |
| 11 | For multiphasic waveformsonly:- Symmetrical phases?- Phase Duration (include units)(state range, if applicable)(both phases, if asymmetrical) | Endurance:Symmetrical, 280 -400 μsResistance:Symmetrical, 280 -400 μsStrength:Symmetrical, 280 -400 μsExplosive Strength:Symmetrical, 280 -400 μs | Endurance:Symmetrical, 280 - 400μsResistance:Symmetrical, 280 - 400μsStrength:Symmetrical, 280 - 400μsExplosive Strength:Symmetrical, 280 - 400μs | Same asCompex SportPlusDifferent fromStriveSame asCompex SportPlusDifferent fromStriveSame asCompex SportPlusDifferent fromStriveSame asCompex SportPlusDifferent fromStrive | |
| Potentiation: | Potentiation: | ||||
| Symmetrical, 280 -400 µs | Symmetrical, 280 - 400µs | Same asCompex SportPlusDifferent fromStrive | |||
| Training Recovery: | Training Recovery: | Same asCompex SportPlusDifferent fromStrive | |||
| Symmetrical, 280 -400 µs | Symmetrical, 280 - 400 µs | ||||
| CompetitionRecovery: | Competition Recovery: | Same asCompex SportPlusDifferent fromStrive | |||
| Symmetrical, 280 -400 µs | Symmetrical, 280 - 400 µs | ||||
| Pre Warmup | Pre Warmup | Same asCompex SportPlusDifferent fromStrive | |||
| Symmetrical, 280 -400 µs | Symmetrical, 280 - 400 µs | ||||
| Muscle Relaxation: | Muscle Relaxation: | Same asCompex SportPlusDifferent fromStrive | |||
| Symmetrical, 280 -400 µs | Symmetrical, 280 - 400 µs | ||||
| Pain Relief TENS: | Biphasic:- Asymmetrical- 70 to 300[µs] for positivepulse, logarithmic negativepulse, decrease current. | ||||
| Symmetrical, 70 -300 µs | |||||
| 12 | Net Charge [µC/pulse] | ||||
| Endurance:0 [µC] @ 500ΩExcitation pulse fullycompensated | Endurance:0 [µC] @ 500ΩExcitation pulse fullycompensated | Different fromCompex SportPlus and Strive | |||
| Resistance:0 [µC] @ 500ΩExcitation pulse fullycompensated | Resistance:0 [µC] @ 500ΩExcitation pulse fullycompensated | Same asCompex SportPlusDifferent fromStrive | |||
| Strength:0 [µC] @ 500ΩExcitation pulse fullycompensated | Strength:0 [µC] @ 500ΩExcitation pulse fullycompensated | Same asCompex SportPlusDifferent fromStrive | |||
| Explosive Strength:0 [µC] @ 500ΩExcitation pulse fullycompensated | Explosive Strength:0 [µC] @ 500ΩExcitation pulse fullycompensated | Same asCompex SportPlusDifferent fromStrive | |||
| Potentiation:0 [µC] @ 500ΩExcitation pulse fullycompensated | Potentiation:0 [µC] @ 500ΩExcitation pulse fullycompensated | Same asCompex SportPlusDifferent fromStrive |
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| Training Recovery:0 [μC] @ 500ΩExcitation pulse fullycompensated | Training Recovery:0 [μC] @ 500ΩExcitation pulse fullycompensated | Same asCompex SportPlusDifferent fromStrive | |
|---|---|---|---|
| CompetitionRecovery:0 [μC] @ 500ΩExcitation pulse fullycompensated | Competition Recovery:0 [μC] @ 500ΩExcitation pulse fullycompensated | Same asCompex SportPlusDifferent fromStrive | |
| Pre Warmup0 [μC] @ 500ΩExcitation pulse fullycompensated | Pre Warmup0 [μC] @ 500ΩExcitation pulse fullycompensated | Same asCompex SportPlusDifferent fromStrive | |
| Muscle Relaxation:0 [μC] @ 500ΩExcitation pulse fullycompensated | Muscle Relaxation:0 [μC] @ 500ΩExcitation pulse fullycompensated | Same asCompex SportPlusDifferent fromStrive | |
| Pain Relief TENS:0 [μC] @ 500ΩExcitation pulse fullycompensated | 18[uC] on 1[kΩ] |
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| Different fromCompex SportPlus and Strive | |||||
|---|---|---|---|---|---|
| 13 | Maximum Phase Charge [µC] | 48 [µC] @ 500Ω | 48 [µC] @ 500Ω | 0[uC] on 1[kΩ] | Same asCompex SportPlusDifferent fromStrive |
| 14 | Maximum Current Density[mA/cm²] | 4.8 [mA/cm²] @500Ω | 4.8 [mA/cm²] @ 500Ω | 0.31[mA/cm2] (over 1[s]period) | Same asCompex SportPlusDifferent fromStrive |
| 15 | Maximum Power Density[mW/cm²] | 27.6 [mW/cm²] @500Ω | 27.6 [mW/cm²] @500Ω | 4.92[mW/cm2](split on 2x1[ΚΩ] in //) | Same asCompex SportPlusDifferent fromStrive |
| 16 | Burst Mode (i.e. pulse trains)a) Pulses per burstb) Bursts per secondc) Burst duration (seconds)Duty Cycle [Line (b) x Line(c)] | N/A, no burst mode | N/A, no burst mode | N/A, no burst mode | Similar |
| 17 | ON Time (seconds) | Depends on theselected program | Depends on theselected program | Once started, the output isactive until user manuallystops the unit | Same asCompex SportPlusDifferent fromStrive |
| 18 | OFF Time (seconds) | Depends on theselected program | Depends on theselected program | N/A, no OFF time | Same asCompex SportPlusDifferent fromStrive |
| 19 | Additional Features (ifapplicable) | N/A | N/A | N/A | Similar |
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Although there are minor differences observed between the subject devices, those differences do not raise any question in regards to safety and effectiveness.
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Performance Testing:
Electrical Safety and Electromagnetic Compatibility: The Compex Sport Plus was tested and found to comply with the following standards for electrical safety and electromagnetic compatibility.
- IEC 60601-1 for basic safety and essential performance ●
- IEC 60601-1-2 for electromagnetic compatibility
- IEC 60601-1-11 for use in a home healthcare environment ●
- IEC 60601-2-10 for performance of nerve and muscle stimulators ●
Software Verification: The device's software was verified in accordance with the requirements of FDA's guidance document: General Principles of Software Validation, January 11, 2002. The software testing demonstrated that the software meets its design requirements. DJO,LLC establish design inputs for the devices related to cybersecurity, and establish a cybersecurity vulnerability and management approach as part of the software validation and risk analysis that is required by 21 CFR 820.30(g).
Usability/Human Factors Testing: Usability/Human Factors testing was performed, which demonstrated that the established requirements for usability were met, and the device's design is appropriate for the intended users and use environment. The result of this study substantiates the acceptability of the use-related risks identified during the risk assessment activities.
Standards:
The Compex Sport Plus conforms to the following standards:
- . AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1, Mod.). FDA Recognition No. 19-4.
- . IEC 60601-1-2 Edition 3:2007-03, Medical Electrical Equipment - Part 1 -2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests. FDA Recognition No. 19-1.
- . IEC 60601-1-6 Edition 3.1 2013-10. Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability. FDA Recognition No. 5-89.
- . IEC 60601-1-11 Edition 2.0 2015-01. Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment . (General II (ES/EMC)). FDA Recognition No. 19-14.
- . IEC 60601-2-10 Edition 2.0 2012-06. Medical Electrical Equipment - Part 2-10: Particular Requirements for the Basic Safety and Essential Performance of Nerve and Muscle Stimulators. FDA Recognition No. 17-11.
- . IEC 62366 Edition 1.1 2014-01 , Consolidated Version Medical Devices - Application Of Usability Engineering To Medical Devices. (General I (OS/RM)). FDA Recognition No. 5-87
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- ISO 14971 Second Edition 2007-03-01. Medical Devices Applications of Risk Management to Medical . Devices. FDA Recognition No. 5-40.
- AAMI /ANSI /IEC 62304:2006, Medical Device Software - Software Life Cycle Processes. FDA Recognition No. 13-32.
This submission does not contain clinical data.
Conclusion:
Based on the performance testing and the technological characteristics, it can be concluded that the Compex Sport Elite is as safe and effective as, and substantially equivalent to, the predicate devices.
§ 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).