(123 days)
The indications for use of the proposed device are the same as those for the predicate devices.
Ultrasound therapy:
- Relief of pain, muscle spasms and joint contractures
- Relief of pain, muscle spasms and joint contractures that may be associated with:
- Adhesive capsulitis
- Bursitis with slight calcification
- Myositis
- Soft tissue injuries
- Shortened tendons due to past injuries and scar tissues
- Relief of pain, muscle spasms and joint contractures resulting from:
- Capsular tightness
- Capsular scarring
Electrotherapy:
- Relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
- Symptomatic relief or management of chronic, intractable pain
- Post-traumatic acute pain
- Post-surgical acute pain
The Soleoline has a clear contemporary color screen showing all parameters necessary for therapy as well as modem touch control. Individual program start configuration and clear, simple menu navigation make operation of the device easy and comfortable for users. 120 storage bins for individual program settings makes working with the Soleoline a lot easier. The compact design saves room in the practice and is highly suited for use in home visits. The combination of electrotherapy and ultrasound therapy in a single system enables the use of the established combination therapy. It is a prescription device administered to patients by a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics.
Soleoline is a device family consisting of Soleo Stim and Soleo SonoStim, Soleo Sono includes an ultrasound module, Soleo Stim includes a stimulation current therapy module and Soleo SonoStim includes a combination of a stimulation current module and an ultrasound module.
The stimulation current module is used for stimulation current therapy according to the standard medical practices. It offers multiple waveforms; Monophasic, High Voltage, Micro Current, Asymmetrical Biphasic, Interferential, Medium Frequency, Premodulated currents for nerve stimulation and muscle therapy for mono channel and dual channel operation. The regulated output of the current stimulation module may be chosen from Constant Current (CC) or Constant Voltage (CV).
The dual frequency ultrasound module (800kHz and 2.4MHz) offers two different size ultrasound heads, 1cm² and 5cm² and pulsed and continuous duty cycles.
At combination therapy (simultaneous procedure) the features for ultrasound can be used together with the different stimulation waveforms. All functions of the 0.8MHz and 2.4MHz ultrasound can be combined with the following waveforms:
Monophasic, High Voltage, Micro Current, Symmetrical Biphasic, Medium Frequency, Premodulated
The therapy menu helps the clinicians to assign the indications of each body region to the appropriate therapy program.
The provided document is a 510(k) Summary for the Zimmer MedizinSysteme Soleoline device family. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy from scratch through entirely novel clinical studies. Therefore, the information provided focuses on comparisons to existing devices and compliance with standards, rather than new studies with acceptance criteria and detailed performance metrics as one might find for a novel AI device.
Based on the provided text, here is an attempt to address the points, acknowledging the nature of a 510(k) summary:
1. A table of acceptance criteria and the reported device performance
The document doesn't present "acceptance criteria" in the typical sense of a novel device study (e.g., target sensitivity/specificity). Instead, substantial equivalence is demonstrated by showing that the new device (Soleoline) has the same intended use and similar technological characteristics as the predicate devices, and that any differences do not raise new questions of safety or effectiveness. The "reported device performance" is essentially a comparison of technical specifications against the predicate devices.
Here's a table summarizing key comparisons from the document, which implicitly serve as demonstration of equivalent performance to the established predicate devices:
| Feature/Parameter | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (Zimmer Soleoline) |
|---|---|---|
| General | ||
| Intended Use | Same as Predicate Devices (Ultrasonic diathermy, Powered muscle stimulator, etc.) | Same as Predicate Devices (Ultrasonic diathermy, Powered muscle stimulator, Ultrasound and muscle stimulator) |
| Indications (Electrotherapy) | Matched to Predicate Devices (Relaxation of muscle spasm, pain relief, etc.) | Matched to Predicate Devices (Relaxation of muscle spasm, pain relief, etc.) |
| Indications (Ultrasound) | Matched to Predicate Devices (Pain relief, muscle spasms, joint contractures, etc.) | Matched to Predicate Devices (Pain relief, muscle spasms, joint contractures, etc.) |
| Prescriptive Use | Yes | Yes |
| Maximum adjustable therapy time | 60 min (for electrotherapy), 30 min (for ultrasound) | 60 min (electrotherapy, general), 30 min (ultrasound) |
| Patient Leakage Current (Normal) | < 1mA | < 1mA |
| Patient Leakage Current (Single Fault) | < 0.5mA | < 0.5mA |
| Compliance with Voluntary Standards | IEC/EN 60601-1, -1-2, -2-5, -2-10; 21 CFR 898 | Yes, IEC/EN 60601-1, -1-2, -2-5, -2-10; 21 CFR 898 (for relevant modules) |
| Electrotherapy Specifics (Examples) | ||
| Number of Output Modes | Varied across predicates (e.g., 10 for Vectra Genisys, 5 for Galva 5M) | 8 (Interferential, Premodulated, Monophasic, Medium Frequency, Asymmetrical Biphasic, Symmetrical Biphasic, High Volt, Microcurrent) |
| Regulated Current/Voltage | Both CC and CV | Both CC and CV |
| Monophasic Rectangular (Max Output Voltage) | 25V@500Ω, 100V@2kΩ, 200V@10kΩ (Galva 5M) | 24.7V@500Ω, 99.9V@2kΩ, 180V@10kΩ |
| Microcurrent (Max Output Current) | 1mA@500Ω, 1mA@2KΩ, 1mA@10kΩ (Vectra Genisys) | 0.98mA@500Ω, 0.99mA@2kΩ, 1.02mA@10kΩ |
| Symmetric Biphasic Rectangular (Pulse Width) | 20μs-1000μs (Vectra Genisys), 100μs-1500μs (Galva 5M) | 100μs-1000μs |
| High Voltage (Max Output Current) | 250mA@500Ω, 100mA@2kΩ, 20mA@10kΩ (Galva 5M) | 250mA@500Ω, 75mA@2kΩ, 15mA@10kΩ |
| Ultrasound Specifics | ||
| Frequencies | 1 and 3.3MHz (Vectra Genisys), 0.8 and 3 MHz (Sono 5) | 0.8 and 2.4 MHz |
| Intensity | 0-3.0 W/cm² | 0-3.0 W/cm² |
| Duty Cycle | Examples: 1:1, 1:2, 1:5 (Vectra Genisys); 1:2, 1:5 (Sono 5) | 1:1, 1:2, 1:3, 1:5, 1:10 |
| BNR | 5.0:1 or less (Vectra Genisys), 6.0:1 or less (Sono 5) | 4.3:1 or less |
| ERA | Varied across predicates and applicator sizes | Examples: 5cm²: 2.30 cm² (0.8MHz), 2.38 cm² (2.4MHz); 1cm²: 1.08 cm² (0.8MHz), 0.54 cm² (2.4MHz) (all values ±20%) |
Note: The "acceptance criteria" here are implied by the specifications of the predicate devices. The study demonstrating compliance is the "Non-clinical Tests Performed" which verified the device's technical characteristics against these standards.
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 510(k) summary. For a 510(k) submission, the primary "test set" is often the comparison of technical specifications against predicate devices and adherence to recognized standards. It's likely that internal engineering and performance testing was conducted, but details on sample size, data provenance, and study design are not typically required or included in this summary document beyond stating that "Validation documentation, product testing and a comparison of the technical characteristics and features according to relevant standards were provided."
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 is not applicable/not provided. The document describes a medical device, not an AI or diagnostic tool that requires expert-established ground truth for its performance evaluation in the clinical sense. The ground truth for this type of device is its adherence to technical specifications and safety standards as verified by engineering tests and comparison to predicate devices, and its intended effect being recognized within standard medical practices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable/not provided. Adjudication methods are typically associated with resolving discrepancies in expert interpretations during the establishment of ground truth for diagnostic studies, which is not the nature of this 510(k) submission.
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
This is not applicable/not provided. MRMC studies are used for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not relevant to a powered muscle stimulator/ultrasound diathermy device. The study described is a technical comparison for substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable/not provided. This device is not an algorithm, but a physical medical device. Its "standalone" performance is its technical operation according to specifications, which was implicitly demonstrated through the non-clinical tests and comparison to predicates.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is the technical specifications and safety performance demonstrated by the predicate devices and the relevant voluntary standards (e.g., IEC/EN 60601 series, 21 CFR 898). The new device is considered substantially equivalent if it meets or has comparable technical characteristics within the established safety and effectiveness profile of these predicate devices and standards.
8. The sample size for the training set
This is not applicable/not provided. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This is not applicable / not provided for the same reason as point 8.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo for "zimmer MedizinSysteme". The word "zimmer" is in a bold, sans-serif font, with the "i" having a square dot. Below "zimmer" is the word "MedizinSysteme" in a smaller, sans-serif font. The logo appears to be a scan or photocopy, as the text has a slightly rough or pixelated appearance.
(12/059 AGE | OF ID
Zimmer Medizinsysteme GmbH Junkersstraße 9 D-89231 Neu-Uim
Tel. 073179761-0
info@zimmer.de Fax 0731 / 9761-118
AUG
5. 510(k) Summary
The following information is provided as required in 21CFR807.87 and the Guidance Document "Guidance Document for Powered Muscle Stimulators 510(k)s"
a.) General
| 510(k) Submitter: | Zimmer MedizinSysteme GmbHJunkersstrasse 9D-89231 Neu-UlmGermany |
|---|---|
| Contact person: | Mr. Armin PétraschkaProject ManagerPhone: +49-731-9761-140Fax: +49-731-9761-4475E-mail: a.petraschka@zimmer.de |
| Establishment Registration: | 8010720 |
| Submission Date: | January 13th, 2012 |
| Device Names: | |
| Device family name: | Soleoline |
| Trade Names: | Soleo StimSoleo SonoSoleo SonoStim |
| Common Names: | Ultrasound and muscle stimulatorPowered muscle stimulatorTranscutaneous electrical nerve stimulator for pain reliefUltrasonic diathermy |
| Regulation Numbers and Classification Names: | 21 CFR 890.5850 - Stimulator, Muscle, Powered21 CFR 890.5300 - Ultrasonic diathermy21 CFR 890.5860 - Ultrasound and muscle stimulator21 CFR 882.5890 - Transcutaneous electrical nerve stimulator for pain relief |
| Classification: | Class II |
| Product Codes: | IPF, IMI, IMG, GZJ |
| Panel: | 89 - Physical Medicine84 - Neurology |
{1}------------------------------------------------
K121059 PAGE 2 OF IO
b.) Predicate Devices
| 1-Device:Manufacturer:510(k) number: | Vectra GenisysCHATTANOOGA GROUP (Encore Medical)4717 adams rd. P.O. Box 489Hixson, Tennessee 37343-0489K031077 |
|---|---|
| 2.Device:Manufacturer: | Galva 5 MZimmer MedizinSysteme GmbH (former Zimmer Elektromedizin GmbH) |
| Junkersstrasse 989231 Neu-UlmGermany | |
| 510(k) number: | K954411 |
| 3. | |
| Device: | Sono 5 |
| Manufacturer: | Zimmer MedizinSysteme GmbH |
| Junkersstrasse 9 | |
| 89231 Neu-Ulm | |
| 510(k) number: | GermanyK952536 |
c.) Device Description
The Soleoline has a clear contemporary color screen showing all parameters necessary for therapy as well as modem touch control. Individual program start configuration and clear, simple menu navigation make operation of the device easy and comfortable for users. 120 storage bins for individual program settings makes working with the Soleoline a lot easier. The compact design saves room in the practice and is highly suited for use in home visits. The combination of electrotherapy and ultrasound therapy in a single system enables the use of the established combination therapy. It is a prescription device administered to patients by a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics.
Soleoline is a device family consisting of Soleo Stim and Soleo SonoStim, Soleo Sono includes an ultrasound module, Soleo Stim includes a stimulation current therapy module and Soleo SonoStim includes a combination of a stimulation current module and an ultrasound module.
The stimulation current module is used for stimulation current therapy according to the standard medical practices. It offers multiple waveforms; Monophasic, High Voltage, Micro Current, Asymmetrical Biphasic, Interferential, Medium Frequency, Premodulated currents for nerve stimulation and muscle therapy for mono channel and dual channel operation. The regulated output of the current stimulation module may be chosen from Constant Current (CC) or Constant Voltage (CV).
The dual frequency ultrasound module (800kHz and 2.4MHz) offers two different size ultrasound heads, 1cm² and 5cm² and pulsed and continuous duty cycles.
At combination therapy (simultaneous procedure) the features for ultrasound can be used together with the different stimulation waveforms. All functions of the 0.8MHz and 2.4MHz ultrasound can be combined with the following waveforms:
Monophasic, High Voltage, Micro Current, Symmetrical Biphasic, Medium Frequency, Premodulated
The therapy menu helps the clinicians to assign the indications of each body region to the appropriate therapy program.
{2}------------------------------------------------
K121059
PAGE 3 OF 10
d.) Statement of indications for use
The indications for use of the proposed device are the same as those for the predicate devices Ultrasound therapy:
- Relief of pain, muscle spasms and joint contractures 1.
- Relief of pain, muscle spasms and joint contractures that may be associated with: "
- · Adhesive capsulitis
- Bursitis with slight calcification o
- · Myositis
- Soft tissue injuries o
- Shortened tendons due to past injuries and scar tissues o
- Relief of pain, muscle spasms and joint contractures that may be associated with: "
-
- Relief of pain, muscle spasms and joint contractures resulting from:
- · Capsular tightness
- · Capsular scarring
Electrotherapy:
-
- Relaxation of muscle spasm
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- Muscle re-education
-
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- ର. Maintaining or increasing range of motion
-
- Symptomatic relief or management of chronic, intractable pain
-
- Post-traumatic acute pain
- ு. Post-surgical acute pain
e.) Comparison of Technological Characteristics
General:
| Feature | Zimmer Soleoline(Soleo Sono,Soleo Stim,Soleo SonoStim) | Chattanooga VectraGenisys w/o EMG | Zimmer Galva 5 | Zimmer Sono 5 |
|---|---|---|---|---|
| Number of channels | 2 | 2/4 | 2 | - |
| Number of connections | 2 | 2 | 1 | - |
| Touch screen interface | + | - | - | - |
| Color LCD screen | + | + | - | - |
| Intended use | Ultrasound diathermy,Powered musclestimulator,Ultrasound andmuscle stimulator | Ultrasound and musclestimulator | Powered musclestimulator, | Ultrasound diathermy |
| Indicationselectrotherapy | Relaxation ofmuscle spasmPrevention orretardation ofdisuse atrophyIncreasing localblood circulationMuscle re-educationImmediate post-surgicalstimulation of calf | Relaxation ofmuscle spasmPrevention orretardation ofdisuse atrophyIncreasing localblood circulationMuscle re-educationImmediate post-surgicalstimulation of calf | Relaxation of musclespasmPrevention orretardation of disuseatrophyIncreasing localblood circulationMuscle re-educationImmediate post-surgical stimulationof calf muscles toprevent thrombosis | - |
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K121059
PASE 4 OF D
| muscles to | muscles to | Maintaining or | |||||||
|---|---|---|---|---|---|---|---|---|---|
| prevent | prevent | increasing range of | |||||||
| thrombosis | thrombosis | motion | |||||||
| Maintaining or | Maintaining or | ||||||||
| increasing range | increasing range | ||||||||
| of motion | of motion | ||||||||
| Symptomatic | Symptomatic | ||||||||
| relief or | relief or | ||||||||
| management of | management of | ||||||||
| chronic, | chronic, | ||||||||
| intractable pain | intractable pain | ||||||||
| Post-traumatic | Post-traumatic | ||||||||
| acute pain | acute pain | ||||||||
| Post-surgical | Post-surgical | ||||||||
| acute pain | acute pain | ||||||||
| Indications ultrasound | Relief of pain, | Relief of pain, | Relief of pain | ||||||
| therapy | muscle spasms | muscle spasms | Muscle spasm | ||||||
| and joint | and joint | Joint contractures | |||||||
| contractures | contractures | ||||||||
| Relief of pain, | Relief of pain, | ||||||||
| muscle spasms | muscle spasms | ||||||||
| and joint | and joint | ||||||||
| contractures that | contractures that | ||||||||
| may be | may be | ||||||||
| associated with: | associated with: | ||||||||
| • Adhesive | • Adhesive | ||||||||
| capsulitis | capsulitis | ||||||||
| • Bursitis with | • Bursitis with | ||||||||
| slight | slight | ||||||||
| calcification | calcification | ||||||||
| • Myositis | • Myositis | ||||||||
| • Soft tissue | • Soft tissue | ||||||||
| injuries | injuries | ||||||||
| • Shortened | • Shortened | ||||||||
| tendons due to | tendons due to | ||||||||
| past injuries | past injuries | ||||||||
| and scar | and scar | ||||||||
| tissues | tissues | ||||||||
| Relief of pain, | Relief of pain, | ||||||||
| muscle spasms | muscle spasms | ||||||||
| and joint | and joint • | ||||||||
| contractures | contractures | ||||||||
| resulting from: | resulting from: | ||||||||
| • Capsular | • Capsular | ||||||||
| tightness | tightness | ||||||||
| • Capsular | • Capsular | ||||||||
| scarring | scarring | ||||||||
| Prescriptive use | + | + | + | + | |||||
| Maximum adjustable therapy | Maximum adjustable therapy time [min] | 60 | 60 | 60 | 60 | 60 | 60 | 30 | 30 |
| Modifiable Waveform Parameters | + | + | + | - | |||||
| Power source(s) | Universal power supply:100 - 240VAC, 50/60Hz | Onboard switchable power supply:120/240VAC, 50/60Hz | 120 VAC, 60Hz | 120 VAC, 60Hz | |||||
| Method of Line Current Isolation | Fuse - Two 2,0A Time Lag | Fuse - Two 5.6A Time Lag | Decoupling by mains transformer, Fuses, Electrical overcurrent limiter | N/A | |||||
| Patient Leakage Current:Normal condition | < 1mA | 69μΑ | < 1mA | < 1mA | |||||
| Patient Leakage Current:Single fault condition | < 0.5mA | 31μΑ | < 0.5mA | < 0.5mA |
Author: A. Petraschka
510 (k) Premarket Notification Soleoline
.
·
·
{4}------------------------------------------------
K121059
PAGE 5 OF ID
| Number of Output Modes | 8: Interferential,Premodulated,Monophasic, MediumFrequency,AsymmetricalBiphasic, SymmetricalBiphasic, High Volt,Microcurrent | 10: Interferential,Premodulated, VMS,VMS Burst, Russian,AsymmetricalBiphasic, SymmetricalBiphasic, High Volt,Microcurrent, DirectCurrent | 5: Diadynamic current,Medium Frequency,Monophasic, Biphasicsymmetric, High voltage | |
|---|---|---|---|---|
| Number of Output Channels | 2 | 2 & 4 channel units | 1 | - |
| Synchronous or Alternating | Both | Both | Synchronous | - |
| Method of Channel Isolation | LAN spacingscompliant with IEC60601-1 isolationrequirements | LAN spacingscompliant with IEC60601-1 isolationrequirements, andprotective softwareisolation | - | - |
| Regulated Current orRegulated Voltage? | Yes, both CC and CV | Yes, both CC and CV | Yes, both CC and CV | - |
| Software/Firmware/Microprocessor Control? | + | + | + | + |
| Automatic Overload Trip? | + | + | + | + |
| Automatic No-load Trip? | - | - | - | - |
| Automatic Shut-Off? | + | + | + | + |
| Patient Override Control? | + | + | + | N/A |
| Indicator Display:On/Off Status | + | + | + | + |
| Low BatteryVoltage/Current Level | N/A | N/A | N/A | N/A |
| Compliance with VoluntaryStandards? | Yes, IEC/EN 60601-1,IEC/EN60601-1-2,IEC/EN 60601-2-5,IEC/EN 60601-2-10, | Yes, IEC/EN 60601-1,IEC/EN60601-1-2,IEC/EN 60601-2-5,IEC/EN 60601-2-10, | Yes, IEC/EN 60601-1,IEC/EN60601-1-2,IEC/EN 60601-2-10, | Yes, IEC/EN 60601-1,IEC/EN60601-1-2,IEC/EN 60601-2-5 |
| Compliance with 21 CFR898 | + | + | + | + |
| Dimensions (w x d x h)[cm] | 32.2 x 23.4 x 13 | 28.9 x 32.4 x 22.2 | 45 x 32.5 x 14 | 3.25 x 4.5 x 1.4 |
| Weight[kg] | 2.1 | 3.2 | 5.7 | 6.8 |
| Housing Materials andConstruction | Molded PC-ABSplastic material withscrew assemblyconstruction | ABS/PC injection-molded top andbottom shells,Thermo-PlasticElastomer (TPE)partial overmolding ontop, Acryl lens, Topand bottom aresecured together withmachine screws. | Bottom and front:Polystyrene;Cover: steel sheet;Front panel: glass | Bottom and front:Polystyrene;Cover: steel sheet;Front panel: glass |
| Surge Mode | Ramp up:0.5 - 60sOn Time:0 - 60sRamp down:0.2 - 5s | N/A | Ramp up:0.5 - 60sOn Time:0 - 60sRamp down:0.5s | - |
| Specifications | New Device | Vectra Genisys | Galva 5M | |
| Waveform | Monophasic | - | Biphasic symmetric | |
| Shape | Rectangular | - | Rectangular | |
| Maximum Output Voltage(+/- 20 %) | 24.7V@500Ω99.9V@2kΩ180V@10kΩ | - | 25V@500Ω100V@2kΩ200V@10kΩ | |
| Maximum Output Current(+/- 20 %) | 50mA@500Ω50mA@2kΩ12mA@10kΩ | - | 50mA@500Ω50mA@2kΩ20mA@10kΩ | |
| Pulse Width | 200μs – 1500μs | - | 200μs – 1500μs | |
| Frequency [Hz] | 0-1667 | - | 0-1667 | |
| Beat Frequency [Hz] | N/A | - | N/A | |
| Symmetrical Phases | No | - | No | |
| Phase Duration | 200μs – 1500μs | - | 200μs – 1500μs | |
| Net Charge | 75μC | - | 75μC | |
| Maximum Phase Charge | 75μC | - | 75μC | |
| Maximum Current Density [mA/cm²] | 3.9@500Ω | - | 3.9@500Ω | |
| Maximum Power Density [W/cm²] | 0.097@500Ω | - | 0.097@500Ω | |
| Burst Mode | N/A | - | N/A | |
| a. Pulses per burst [PPB] | N/A | - | N/A | |
| b. Bursts per second [BPS] | N/A | - | N/A | |
| c. Burst duration [BD] | N/A | - | N/A | |
| d. Duty Cycle | N/A | - | N/A | |
| ON Time | See surge mode point 28. | - | See surge mode point 28. | |
| OFF Time | See surge mode point 28. | - | See surge mode point 28. | |
| Additional Features | Polarity reversal: Selectable. positive, negative or alternating; switches after each minute | - | Polarity reversal: Selectable. positive, negative or alternating; switches after each minute |
.
.
. .
{5}------------------------------------------------
Output specifications:
.
Monophasic rectangular:
Microcurrent:
| Specifications | New Device | Vectra Genisys | Galva 5M |
|---|---|---|---|
| Waveform | Microcurrent, monophasic | Microcurrent, monophasic | - |
| Shape | Rectangular | Rectangular | - |
| Maximum Output Voltage(+/- 20 %) | 0.49V@500Ω1.98V@2kΩ10.20V@10kΩ | 0.51V@500Ω2V@2KΩ10V@10kΩ | - |
| Maximum Output Current(+/- 20%) | 0.98mA@500Ω0.99mA@2kΩ1.02mA@10kΩ | 1mA@500Ω1mA@2KΩ1mA@10kΩ | - |
| Pulse Width | 1ms-10000ms | 1ms-10000ms | - |
| Frequency [Hz] | 0.1-1000 | 0.1-1000 | - |
| Beat Frequency [Hz] | N/A | N/A | - |
| Symmetrical Phases | No | No | - |
| Phase Duration | 0.5ms-5000ms. | 0.5ms-5000ms | - |
| Net Charge | N/A (monophasic) | N/A (monophasic) | - |
| Maximum Phase Charge | 5000μC | 5000μC | - |
| Maximum Current Density[mA/cm²] | 0.078@500Ω | 0.026@500Ω | - |
| Maximum Power Density[W/cm²] | 0.4*10-4@500Ω | 0.1*10-4@500Ω | - |
| Burst Mode | N/A | N/A | - |
| a. Pulses per burst [PPB] | N/A | N/A | - |
| b. Bursts per second [BPS] | N/A | N/A | - |
| c. Burst duration [BD] | N/A | N/A | - |
| d. Duty Cycle | N/A | N/A | - |
| ON Time | See surge mode point 28. | N/A | - |
{6}------------------------------------------------
| The first of the count of the count of the count of the county of the county ofOFF TimeStatus of the American of Children of Children | A Status of Children Comments of Children Comments of ChildrenonSee surge modepoint 28.100 - 400 - 400 - 400 - 400 - 400 - 400 - 4000 - 4000 - 4000 - 4000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - | And American Company of Comments of | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|---|---|---|---|---|
| Additional FeaturesAcres of Acres of Acres of Acres | N/A | A . Annual of all and and on AlleActive And CharlesNIA | And Annon Charles Children Children | A 400-600-August |
·
.
| Symmetric biphasic rectanqular; | ||
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Specifications | New Device | Vectra Genisys | Galva 5M |
|---|---|---|---|
| Waveform | Biphasic symmetric | Biphasic symmetric | Biphasic symmetric |
| Shape | Rectangular | Rectangular | Rectangular |
| Maximum Output Voltage | 40V@500Ω | 40V@500Ω | 25V@500Ω |
| (+/-20 %) | 146V@2kΩ | 158V@2kΩ | 100V@2kΩ |
| 150V@10kΩ | 200V@10kΩ | 200V@10kΩ | |
| Maximum Output Current | 80mA@500Ω | 80mA@500Ω | 50mA@500Ω |
| (+/-20 %) | 73mA@2kΩ | 79mA@2kΩ | 50mA@2kΩ |
| 15mA@10kΩ | 20mA@10kΩ | 20mA@10kΩ | |
| Pulse Width | 100μs -1000μs | 20μs-1000μs | 100μs-1500μs |
| Frequency [Hz] | 0-1667 | 1-250 | 0-1667 |
| Beat Frequency [Hz] | N/A | N/A | N/A |
| Symmetrical Phases | Yes | Yes | Yes |
| Phase Duration | 50μs-500μs | 10μs-500μs | 50μs-750μs |
| Net Charge | 0 (symmetric) | 0 (symmetric) | 0 (symmetric) |
| Maximum Phase Charge | 80μC | 80μC | 75μC |
| Maximum Current Density | 6.25@500Ω | 2.08@500Ω | 3.9@500Ω |
| [mA/cm²] | |||
| Maximum Power Density | 0.25@500Ω | 0.083@500Ω | 0.097@500Ω |
| [W/cm²] | |||
| Burst Mode | N/A | ||
| a. Pulses per burst (PPB) | 5-100 | 7 | N/A |
| b. Bursts per second (BPS) | 1-200 | 1 - 10 | N/A |
| c. Burst duration (BD) | 0.7-0.028s | 0.7 - 0.028s | N/A |
| d. Duty Cycle | 1 - 0.0042 | 0.7 - 0.28 | N/A |
| ON Time | See surge mode point 28. | See additional features | See surge mode point 28. |
| OFF Time | See surge mode point 28. | See additional features | See surge mode point 28. |
| Additional Features | See definition surge mode | Cycle times of 4/4, 4/8, 7/7, 5/5,4/12, 10/10, 10/20, 10/30, 10/50,continuous (On/Off) | See definition surge mode |
Asymmetric biphasic rectanqular:
・ー
| Specifications | New Device | Vectra Genisys | Galva 5M |
|---|---|---|---|
| Waveform | Biphasic symmetric | Biphasic symmetric | - |
| Shape | Rectangular | Rectangular | - |
| Maximum Output Voltage(+/- 20 %) | 48V@500Ω104V@2kΩ153V@10kΩ | 55V@500Ω197V@2kΩ200V@10kΩ | - |
| Maximum Output Current(+/- 20 %) | 100mA@500Ω52mA@2kΩ15mA@10kΩ | 110mA@500Ω99mA@2kΩ20mA@10kΩ | - |
| Pulse Width | 20µs-1000µs | 20µs-1000µs | - |
| Frequency [Hz] | 1-331 | 1-250 | - |
| Beat Frequency [Hz] | N/A | N/A | - |
| Symmetrical Phases | No | No | - |
| Phase Duration | 20µs-1000µs positive2000µs negative | 20µs-1000µs positive80µs-4000µs negative | - |
| Net Charge | 0 (symmetric) | 0 (symmetric) | - |
| Maximum Phase Charge | 100µC | 110µC | - |
| Maximum Current Density[mA/cm²] | 6.25@500Ω | 2.86@500Ω | - |
| Maximum Power Density[W/cm²] | 0.25@500Ω | 0.157@500Ω | - |
| Burst Mode | |||
| a. Pulses per burst [PPB] | 7 | 7 | - |
| b. Bursts per second [BPS] | 1 - 10 | 1 - 10 | - |
| c. Burst duration [BD] | 0.7 - 0.028s | 0.7 - 0.028s | - |
| d. Duty Cycle | 0.7 - 0.0028 | 0.7 - 0.28 | - |
| ON Time | See surge mode point 28 | See additional features | - |
.
{7}------------------------------------------------
K121059 PAGE 8 OF ID
| OFF Time | See surge mode point 28. | See additional features | - |
|---|---|---|---|
| Additional Features | See definition surge mode | Cycle times of 4/4, 4/8, 7/7, 5/5, 4/12, 10/10, 10/20, 10/30, 10/50, continuous (On/Off); | - |
| High Voltage: | |||
|---|---|---|---|
| Specifications | New Device | Vectra Genisys | Galva 5M |
| Waveform | High Voltage, monophasic symmetric | - | High Voltage, monophasic symmetric |
| Shape | Rectangular | - | Rectangular |
| Maximum Output Voltage (+/- 20 %) | 122V@500Ω180V@2kΩ180V@10kΩ | - | 125V@500Ω200V@2kΩ200V@10kΩ |
| Maximum Output Current (+/- 20 %) | 250mA@500Ω75mA@2kΩ15mA@10kΩ | - | 250mA@500Ω100mA@2kΩ20mA@10kΩ |
| Pulse Width | 10μs-100μs | - | 10μs-100μs |
| Frequency [Hz] | 0-1961 | - | 0-1961 |
| Beat Frequency [Hz] | N/A | - | N/A |
| Symmetrical Phases | No | - | No |
| Phase Duration | 10μs-100μs | - | 10μs-100μs |
| Net Charge | 25μC | - | 25μC |
| Maximum Phase Charge | 25μC | - | 25μC. |
| Maximum Current Density [mA/cm²] | 19.5@500Ω | - | 19.5@500Ω |
| Maximum Power Density [W/cm²] | 2.44@500Ω | - | 2.44@500Ω |
| Burst Mode | N/A | - | N/A |
| a. Pulses per burst [PPB] | N/A | - | N/A |
| b. Bursts per second [BPS] | N/A | - | N/A |
| c. Burst duration [BD] | N/A | - | N/A |
| d. Duty Cycle | N/A | - | N/A |
| ON Time | See surge mode point 28. | - | See surge mode point 28. |
| OFF Time | See surge mode point 28. | - | See surge mode point 28. |
| Additional Features | Polarity reversal: Selectable. positive, negative or alternating | - | Polarity reversal: Selectable. positive, negative or alternating |
| Specifications | New Device | Vectra Genisys | Galva 5M |
|---|---|---|---|
| Waveform | Medium Frequency | Medium Frequency | Medium Frequency |
| Shape | Sinusoidal, unmodulated | Sinusoidal, unmodulated | Sinusoidal, unmodulated |
| Maximum Output Voltage(+/- 20 %) | 50V@500Ω157V@2kΩ153V@10kΩ | 52V@500Ω188V@2kΩ200V@10kΩ | 60V@500Ω206V@2kΩ200V@10kΩ |
| Maximum Output Current(+/- 20 %) | 99mA@500Ω77mA@2kΩ15 mA@10kΩ | 104mA@500Ω94mA@2kΩ20mA@10kΩ | 120mA@500Ω100mA@2kΩ20mA@10kΩ |
| Pulse Width | N/A | N/A | N/A |
| Frequency [Hz] | 2000-8000 | 2000-10000 | 5000 |
| Beat Frequency [Hz] | N/A | N/A | N/A |
| Symmetrical Phases | Yes | Yes | Yes |
| Phase Duration | N/A | N/A | N/A |
| Net Charge | 0 (symmetric) | 0 (symmetric) | 0 (symmetric) |
| Maximum Phase Charge | 15.9μC | 16.6μC | 7.64μC |
| Maximum Current Density[mA/cm²] | 4.38@500Ω | 2.6@500Ω | 9.4@500Ω |
| Maximum Power Density[W/cm²] | 0.123@500Ω | 0.129@500Ω | 0.562@500Ω |
| Burst Mode | N/A | N/A | N/A |
| a. Pulses per burst [PPB] | N/A | N/A | 17.5-835 |
| b. Bursts per second [BPS] | N/A | N/A | 0.1-250Hz |
| c. Burst duration [BD] | N/A | N/A | 3.5ms-167ms |
| d. Duty Cycle | N/A | N/A | N/A |
{8}------------------------------------------------
Off E9OF10
| ON Time | See surge mode point 28. | See additional features | See surge mode point 28. |
|---|---|---|---|
| OFF Time | See surge mode point 28. | See additional features | See surge mode point 28. |
| Additional Features | See definition surge mode | Cycle Times of 5/5, 4/12, 10/10,10/20, 10/30, 10/50, Continuous(On/Off) | See definition surge mode |
| Premodulated: | |||
|---|---|---|---|
| Specifications | New Device | Vectra Genisys | Galva 5M |
| Waveform | Medium Frequency | Medium Frequency | - |
| Shape | Sinusoidal, modulated | Sinusoidal, modulated | - |
| Maximum Output Voltage(+/- 20 %) | 50V@500Ω162V@2kΩ166V@10kΩ | 52V@500Ω188V@2kΩ200V@10kΩ | - |
| Maximum Output Current(+/- 20 %) | 100mA@500Ω81mA@2kΩ17mA@10kΩ | 104mA@500Ω94mA@2kΩ20mA@10kΩ | - |
| Pulse Width | 12.5μs-500μs | 10μs-500μs | - |
| Frequency [Hz] | 2000-8000 | 2000-10000 | - |
| Beat Frequency [Hz] | 1-200 | 1-200 | - |
| Symmetrical Phases | Yes | Yes | - |
| Phase Duration | 6.25μs-250μs | 5μs-250μs | - |
| Net Charge | 0 (symmetric) | 0 (symmetric) | - |
| Maximum Phase Charge | 15.9μC | 16.6μC | - |
| Maximum Current Density [mA/cm²] | 6.25@500Ω | 2.6@500Ω | - |
| Maximum Power Density [W/cm²] | 0.25@500Ω | 0.129@500Ω | - |
| Burst Mode | N/A | N/A | - |
| a. Pulses per burst [PPB] | N/A | N/A | - |
| b. Bursts per second [BPS] | N/A | N/A | - |
| c. Burst duration [BD] | N/A | N/A | - |
| d. Duty Cycle | N/A | N/A | - |
| ON Time | See surge mode point 28. | See additional features. | - |
| OFF Time | See surge mode point 28. | See additional features | - |
| Additional Features | See surge mode point 28. | Cycle Times of 5/5, 4/12, 10/10,10/20, 10/30, 10/50, Continuous(On/Off) | - |
Interferential:
| Specifications | New Device | Vectra Genisys | Galva 5M |
|---|---|---|---|
| Waveform | Interferential | Interferential | - |
| Shape | Sinusoidal, channel modulation | Sinusoidal, channel modulation | - |
| Maximum Output Voltage(+/- 20 %) | 52V@500Ω164V@2kΩ103V@10kΩ | 52V@500Ω172V@2kΩ200V@10kΩ | - |
| Maximum Output Current(+/- 20 %) | 103mA@500Ω82mA@2kΩ10mA@10kΩ | 100mA@500Ω86mA@2kΩ19mA@10kΩ | - |
| Pulse Width | N/A | N/A | - |
| Frequency [Hz] | 2000-8000 | 2000-10000 | - |
| Beat Frequency [Hz] | 1-200 | 1-200 | - |
| Symmetrical Phases | Yes | Yes | - |
| Phase Duration | N/A | N/A | - |
| Net Charge | 0 (symmetric) | 0 (symmetric) | - |
| Maximum Phase Charge | 16.4μC | 15.9μC | - |
| Maximum Current Density [mA/cm²] | 6.25@500Ω | 2.6@500Ω | - |
| Maximum Power Density [W/cm²] | 0.25@500Ω | 0.129@500Ω | - |
| Burst Mode | N/A | N/A | - |
| a. Pulses per burst [PPB] | N/A | N/A | - |
| b. Bursts per second [BPS] | N/A | N/A | - |
| c. Burst duration (BD) | N/A | N/A | - |
・
{9}------------------------------------------------
K121059
PAGE 10 OF 10
| A1737ﺎ ﻓﺎ ﻛﺴﺎﺭ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺑﻘﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤwww.rademall.com/should/ship/divide/space | .AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAACompany of Children Company of Children Company ofN/P------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Company of Children------------------------------------------------------------------------------------------------------------------------------------------------------------------------------I-N/r. | ---------- |
|---|---|---|---|
| i imeAAAAAA---------- | NA------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Authorized which theBucker Book Book BBARRANGE | WF | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| AFF Tthe-------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------N/F | |
| 1000 21 | 11 | N/A | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------LANDA |
Ultrasound Specification
| Parameter | New Device | Vectra Genisys | Sono 5 |
|---|---|---|---|
| Frequencies | 0.8 and 2.4 MHz | 1 and 3.3MHz | 0.8 and 3 MHz |
| Intensity | 0-3.0 W/cm² | 0-3.0W/cm² | 0-3.0W/cm² |
| Wave form | Pulsed, continuous | Pulsed, continuous | Pulsed, continuous |
| Pulse Rate | 20Hz, 50Hz, 100Hz | 100Hz | 20Hz, 50Hz |
| Duty Cycle | 1:1, 1:2, 1:3, 1:5, 1:10 | 1:1, 1:2, 1:5 | 1:2, 1:5 |
| Treatment Time | 0-30 Minutes | 0-30 Minutes | 0-30 Minutes |
| Applicator Sizes | 1cm², 5cm² | 1cm², 2cm², 5cm², 10cm² | 1.5 cm², 5 cm² |
| Maximum output | 5 cm²: 0-6.9W (800kHz),0-7.1W (2.4MHz)1 cm²: 0-1W (800kHz),0-0.6W (2.4MHz) | 10 cm²: 0-20 W (1MHz),0-10 W (3.3 MHz)5 cm²: 0-10 W,(1 and 3.3 MHz)2 cm²: 0-4 W,(1 and 3.3 MHz)1 cm²: 0-2 W(3.3 MHz only) | 5 cm²: 0-10W (800kHz),1.5 cm²: 0-1W (2.4MHz) |
| BNR | 4.3:1 or less | 5.0:1 or less | 6.0:1 or less |
| ERA. | 5 cm²: 2,30 cm² (0,8MHz)2,38 cm² (2,4MHz)1 cm²: 1,08 cm² (0,8MHz)0,54 cm² (2,4MHz)all values ±20% | 10 cm²: 8.5 cm², ±1.55 cm²: 4.0 cm², ±1.02 cm²: 1.8 cm², +0.2/-0.41 cm²: 0.8 cm², +0.2/-0.4 | 5 cm²: 3.3 cm²,1.5 cm²: 1.0 cm²,all values ±20% |
| Applicator Temporal Peak/ Average Ratio | 1:1, 2:1, 3:1, 5:1, 10:1 | 2:1, 5:1, 9:1 | 2:1, 5:1 |
f.) Summary Comparison with predicate devices
The Soleo Sono, Soleo Stim and Soleo SonoStim share intended use and the same or similar basic characteristics and features as the predicate devices. In addition, any differences in their technological characteristics are explained to demonstrate in this submission that these differences do not raise any new questions of safety and effectiveness.
g.) Non-clinical Tests Performed
Validation documentation, product testing and a comparison of the technical characteristics and features according to relevant standards were provided to demonstrate that Soleo Stim and Soleo SonoStim are safe and effective in its intended use.
h.) Conclusion Substantial Equivalence
Drawn from the comparison between the predicate devices it demonstrates that the Soleoline devices are as safe and effective as the predicate devices and therefore are substantially equivalent to the compared devices on the basis of similarities in operating principles, intended use and functional performance.
{10}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/10/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer MedizinSysteme GmbH % TÜV SÜD America, Incorporated Mr. Alexander Schapovalov 1775 Old Highway 8 New Brighton, Minnesota 55112-1891
AUG 7 2012
Re: K121059
Trade/Device Name: Soleo Sono, Soleo Stim, and Soleo SonoStim Regulation Number: 21 CFR 890.5860 Regulation Name: Ultrasound and muscle stimulator Regulatory Class: II Product Code: IMG, IPF, IMI, GZJ, LIH Dated: July 18, 2012 Received: July 23, 2012
Dear Mr. Schapovalov:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have as nowed your would the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass barrain to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to 114) 2011-12-11 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 I ou may, therefore, mains of the Act include requirements for annual registration, listing of general controls proficturing 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 If your device is blassified (ooo arols. Existing major regulations affecting your device can be may or salled 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 that I Dri has made a averalations administered by other Federal agencies. You must of any I odetar statures and states and one of limited to: registration and listing (21 Comply with an the Pict of CFR Part 801); medical device reporting (reporting of medical CI IT rat 007), hooimly (21 CFR 803); good manufacturing practice requirements as set
{11}------------------------------------------------
Page 2 - Mr. Alexander Schapovalov
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.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 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,
Mark N. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo is in black and white and features the word "zimmer" in a stylized font. Below the word "zimmer" is the phrase "MedizinSysteme" in a smaller, sans-serif font.
K121059
PAGE 1 OF 2
- MedizinSystem.
Zimmer Medizinsysteme GmbH Junkersstraße 9 D-89231 Neu-Ulm
Tel. 0731 / 9761-0
Fax 073179761-118
4. Indications for Use Statement
Indications for Use Soleo Sono:
Ultrasound therapy:
| Relief of pain, muscle spasms and joint contractures |
|---|
| Relief of pain, muscle spasms and joint contractures that may be associated with: |
| • Adhesive capsulitis |
| • Bursitis with slight calcification |
| • Myositis |
| • Soft tissue injuries |
| • Shortened tendons due to past injuries and scar tissues |
| Relief of pain, muscle spasms and joint contractures resulting from: |
| • Capsular tightness. |
| • Capsular scarring |
Indications for Use Soleo Stim:
Electrotherapy:
For Medium Frequency, Monophasic Currents, Biphasic Symmetric Currents and High Voltage
Relaxation of muscle spasm
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion
For IFC, Premodulated, Microcurrent, Asymmetric Biphasic Currents and Symmetric Biphasic Currents
Symptomatic relief or management of chronic, intractable pain Post-traumatic acute pain Post-surgical acute pain
Vanderly C. Clay
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121059
{13}------------------------------------------------
K121059
PAGE 2 OF 2
Indications for Use Soleo SonoStim:
Ultrasound therapy:
| Relief of pain, muscle spasms and joint contractures | |
|---|---|
| Relief of pain, muscle spasms and joint contractures that may be associated with: | |
| Adhesive capsulitis | |
| Bursitis with slight calcification | |
| Myositis | |
| � | Soft tissue injuries |
| Shortened tendons due to past injuries and scar fissues | |
| Relief of pain, muscle spasms and joint contractures resulting from: | |
| Capsular tightness | |
| Capsular scarring |
Electrotherapy:
For Medium Frequency, Monophasic Currents, Biphasic Symmetric Currents and High Voltage
(
Relaxation of muscle spasm
Prevention or retardation of disuse atrophy Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion
For IFC, Premodulated, Microcurrent, Asymmetric Biphasic Currents and Symmetric Biphasic Currents
Symptomatic relief or management of chronic, intractable pain
Post-traumatic acute pain
Post-surgical acute pain
Prescription Use _ x (21 CFR 801 Subpart D)
AND/OR Over-the-counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number: K121059
§ 890.5860 Ultrasound and muscle stimulator.
(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.