(364 days)
The STIWELL med4 is a neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator the STIWELL med4 is indicated for the following conditions:
- Relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
As a transcutaneous electrical nerve stimulator for pain relief the STIWELL med4 is indicated for the following conditions:
- Symptomatic relief and management of chronic (long-term), intractable pain
- Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain
As a biofeedback device the STIWELL med4 is indicated for the following conditions:
- Biofeedback, relaxation and muscle re-education purposes
As an external functional neuromuscular stimulator the STIWELL med4 is indicated for the following conditions:
- Helps to relearn voluntary motor functions of the extremities
As a nonimplanted electrical continence device the STIWELL med4 is indicated for the following conditions:
- Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles
- Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles
The STIWELL med4 is powered by rechargeable batteries. It has four stimulation channels and two EMG measurement channels.
The STIWELL med4 is intended for stationary use in a hospital as well as home use by the patient. The physician/therapist has the flexibility to adjust the programs and monitors the progress of the therapy. Statistics regarding the completed treatments can be retrieved from the STIWELL med4 and from the PC.
The provided document is a 510(k) premarket notification for the STIWELL med4, a neuromuscular electronic stimulator. It focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding clinical study design, performance metrics, and expert adjudication is not present in this type of submission.
Here's an analysis based on the available information:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to legally marketed predicate devices, meaning the new device has the same intended use and the same technological characteristics as the predicate device, or has different technological characteristics but does not raise different questions of safety and effectiveness and is as safe and effective as a legally marketed device.
The document provides extensive tables comparing the STIWELL med4's technical characteristics across various stimulation programs (Functional Electrical Stimulation, Incontinence, TENS, Biofeedback) with its predicate devices. The "performance" in this context is the successful demonstration that these characteristics are similar enough to existing devices to not introduce new safety or effectiveness concerns.
Summary Table of Equivalence (Acceptance Criteria are inferred from predicate device characteristics):
| Characteristic/Program Type | Acceptance Criteria (inferred by predicate) | STIWELL med4 Performance (Reported) | Notes |
|---|---|---|---|
| General Unit Characteristics | |||
| Power Source | Battery Pack (NiMH or Alkaline) | Battery Pack Li-Ion 11,1V | Different battery chemistry, but the submission implicitly argues it does not raise new safety/effectiveness concerns. |
| Method of Line Current Isolation | Medical Class II Power Adapter/N/A | Medical Class II Power Adapter | Consistent. |
| Patient Leakage Current | N/A (Battery) | N/A (Battery) | Consistent. |
| Number of Output Modes | 1 | 1 | Consistent. |
| Number of Output Channels | 2 or 4 | 4 | Consistent with some predicates, exceeds others (e.g., Elpha II3000 has 2). |
| Number of EMG (input) Channels | 1 or 2 (or N/A) | 2 | Consistent with predicates that have EMG (e.g., Myotrac Infinity, Mentamove). |
| EMG Sensitivity | <0.1μV or 1μV | 1μV | Within range of predicate devices. |
| EMG Sampling Rate | 2.048kHz or Unknown | 3kHz | Higher than Myotrac Infinity (2.048kHz), but within acceptable range for biofeedback functionality. |
| EMG detection | Bipolar | Bipolar | Consistent. |
| EMG Range | 0-2000μV or 2-2000μV | 1-2000μV | Within range of predicate devices. |
| EMG Bandwidth | 10Hz-1kHz or Unknown | 70-480Hz | Falls within the broader range of predicate devices. |
| EMG Signal Processing | RMS or Unknown | AVR (Average Rectified Value) | Different method from Myotrac Infinity (RMS), but implicitly argued to not raise new safety/effectiveness concerns. The submission suggests this is equivalent in function. |
| Software/Firmware/Microprocessor Contr | Yes | Yes | Consistent. |
| Automatic Overload Trip? | Yes | Yes | Consistent. |
| Automatic No-Load Trip? | Yes | Yes | Consistent. |
| Automatic Shut Off? | Yes (e.g., 10min) | Yes (10min) | Consistent. |
| Patient Override Control? | Yes (Stop Button) | Yes (Stop Button) | Consistent. |
| Display Indicators | Yes (On/Off, Low Batt, V/C Level) | Yes (On/Off, Low Batt, V/C Level) | Consistent. |
| Compliance with Voluntary Standards | IEC 60601-1, -1-2, -2-10 (etc.) | IEC 60601-1, -1-2, -2-10 (etc.) | The device passed the equivalent standards as the predicate devices and additional environmental/electrical tests. |
| Output Specifications (Stimulation) | |||
| Waveform | Biphasic symmetrical/asymmetrical | Biphasic symmetrical | Consistent with some predicates (e.g., Mentamove, Compex 2). Elpha models have asymmetrical. The selection of symmetrical is a technological characteristic; the submission implies it does not raise new safety or effectiveness concerns compared to asymmetrical. |
| Shape | Rectangular (with/without discharge) | Rectangular | Consistent. |
| Max Output Voltage (500Ω/2kΩ) | Similar to predicates | 50V/115V | Within ranges or similar to predicate devices. |
| Max Output Current (500Ω/2kΩ) | Similar to predicates | 100mA/58mA | Within ranges or similar to predicate devices. |
| Pulse Width | 50μs-400μs, etc. | 50-400μs (FES), 500μs/300μs/350-500μs (Inc.) | Within or overlapping ranges of predicate devices. Slight differences in incontinence programs are noted but are implicitly presented as equivalent. |
| Frequency | 1-140Hz, 1-10Hz, etc. | Ranges vary by program | Similar to, within, or overlapping ranges of predicate devices across different program types. |
| Net Charge (μC per pulse) | 0μC | 0μC | Consistent across all stimulation types, achieved by "some positive and negative impulse" or "output capacitor." |
| Max Phase Charge (μC) | Similar to predicates | Varies by program | Within or similar to predicate device values. For incontinence, New Device has 50μC and predicate has 40μC (program U1), and New Device has 30μC while predicate has 40μC (program U2). These differences are implicitly argued to be acceptable for substantial equivalence. |
| Max Current Density (mA/cm²) | Similar to predicates | Varies by program | Values are provided for the new device and compared to predicates. In some incontinence programs, the new device's current density (4.7mA/cm²) is lower than the predicate (Vaginal: 20.4mA/cm², Anal: 33.3mA/cm²), which could be considered within acceptable safety margins. |
| Max Power Density (mW/W/cm²) | Similar to predicates | Varies by program | Values are provided for the new device and compared to predicates. Similar to current density, in some incontinence programs, the new device's power density is significantly lower than the predicate (e.g., 23.5 μW/cm² vs. Vaginal: 2.3mW/cm², Anal: 3.8mW/cm²), indicating a potentially safer profile for these differences. |
| ON/OFF Times | Ranges similar to predicates | Ranges vary by program | Similar to or overlapping various predicate device ranges. |
Detailed Study Information from the Provided Text:
This submission is a 510(k) Premarket Notification, which primarily relies on demonstrating substantial equivalence to predicate devices already on the market. It typically does not involve prospective clinical trials to prove efficacy or performance against specific, pre-defined quantitative acceptance criteria in the same way a PMA (Premarket Approval) application would.
Therefore, many of the specific details requested below regarding clinical studies (sample size, data provenance, expert adjudication, MRMC studies, standalone performance, training sets) are generally not part of a 510(k) submission unless there are significant technological differences requiring new clinical data to establish safety and effectiveness. The document itself states, "Tests have been carried out according to the following standards," referring to various IEC and ISO standards for electrical safety, EMC, and environmental testing, confirming that the primary testing was focused on meeting recognized standards and comparing technical specifications.
-
A table of acceptance criteria and the reported device performance:
- See the table above for inferred acceptance criteria (based on predicate device characteristics) and the STIWELL med4's reported performance against those. The "acceptance criteria" here are implicitly defined by the technical specifications and safety features of the predicate devices.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable (N/A) for clinical data. This document outlines a 510(k) submission based on substantial equivalence and engineering/safety testing, not new clinical trials.
- The "test set" primarily refers to the device itself being tested in a lab setting against various electrical and environmental standards. The document mentions tests according to IEC standards for general safety, EMC, nerve/muscle stimulators, environmental conditions (transport, cold, dry heat, damp heat, vibration), and 21 CFR 898 for electrode lead wires and patient cables.
- Data Provenance: The standards listed implicitly suggest the testing was done by the manufacturer (Otto Bock Healthcare Product GmbH, Austria) or a contracted lab to meet international and US regulatory requirements for device safety and performance according to engineering specifications.
-
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):
- N/A. The "ground truth" in this context is defined by the technical specifications of the predicate devices and the requirements of the international safety and performance standards listed (e.g., IEC 60601 series). Compliance is assessed through engineering tests, not expert clinical evaluation.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods like 2+1 or 3+1 are used in clinical trials to establish ground truth or resolve discrepancies in expert interpretation of clinical data. This type of study was not performed as part of this 510(k) submission.
-
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:
- N/A. The STIWELL med4 is an electrical stimulator and biofeedback device, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies comparing human readers with and without AI assistance are irrelevant and were not performed.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This device is hardware for neuromuscular electrical stimulation and biofeedback. It does not have a "standalone algorithm" in the sense of a software-only diagnostic or therapeutic AI. Its performance is defined by its electrical output characteristics and biomechanical sensing capabilities as verified by engineering and safety testing.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Specifications and Regulatory Standards. The "ground truth" for this 510(k) submission is that the device's technical specifications and safety features meet or are equivalent to those of legally marketed predicate devices, and that it complies with relevant electrical and medical device safety standards (e.g., IEC 60601 series, 21 CFR 898).
-
The sample size for the training set:
- N/A. There is no "training set" in the context of a machine learning model. The STIWELL med4 is a physical medical device whose design and manufacturing processes are validated, not "trained" on data.
-
How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.
{0}------------------------------------------------
Otto Bock®
APR - 2 2009
QUALITY FOR L
Summary of Safety and Effectiveness STIWELL med4
Manufacturer: A
Otto Bock Healthcare Product GmbH Kaiserstrasse 39 1070 Vienna Austria
Telephone: +43 1 523 37 86 692 Fax Number: +43 1 523 22 64 Juergen Weiss Contact: Regulatory Affairs Manager
B Contact:
Otto Bock Healthcare Product GmbH Kaiserstrasse 39 1070 Vienna Austria
+43 1 523 37 86 692 Telephone: Fax Number: +43 1 523 22 64 Contact: Juergen Weiss Regulatory Affairs Manager
C Product Name/ Classification Name:
Common or Usual Name: Proprietary or Trade Name: Model Number:
Powered Muscle Stimulator STIWELL med4 900101S
| Class | Regulation No. | Device Classification Name | Product Code | Speciality |
|---|---|---|---|---|
| II | 890.5850 | Stimulator, Muscle, Powered | IPF | Physical Medicine |
| II | 882.5890 | Stimulator, Nerve,Transcutaneous, For Pain Relief | GZJ | Neurology |
| II | 882.5050 | Device, Biofeedback | HCC | Neurology |
| II | 882.5810 | Stimulator, Neuromuscular,External Functional | GZI | Neurology |
| II | 876.5320 | Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | Gastroenterology/Urology |
Otto Bock Healthcare Products GmbH
Koiserstraße 39 - 1070 Wien - Austria Telefox (+43-1) 523 22 64 - e-moil: vertreb.austria@ottobock.com · www.ottobock.at Kundenservice: Telefon (+43-1) 526 95 48 · Teletax (+43-1) 526 79 85 HG WIEN FN 242378p · UID Nr.: ATU 57528204 · ARA-Nr.; 8864 · ERA-Nr.: 50411
Bonk Austria Creditanstalt Aktiergesellschaft, Filiale Westbahnstraße Switt Code: BKAUATWW BLZ 12 000, Konto-Nr. 09743146400 Erste Bonk, Kommerzcenter Wien West 2 Swift Code: GIBAATWW BLZ 20 111, Konto-Nr. 30001045517
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for Otto Bock. The logo is in a cursive font and is black. There is a registered trademark symbol to the right of the word Bock.
D Predicate Devices:
| 510(k)No. | Predicate Device | Manufacturer | RegulationNumber | ProductCode(s) | ClearanceDate |
|---|---|---|---|---|---|
| K032954 | Elpha Models II500, II 1000, II2000, II 3000 A | Danmeter A/S | 890.5850 | IPF, GZJ | 08/09/2004 |
| K053434 | Myotrac InfinityElectrical Stimulator | ThoughtTechnology Ltd. | 876.5320 | KPI,HCC, IPF | 03/15/2006 |
| K040849 | Mentamove | Cole &Associates | 890.5850 | IPF, HCC | 10/01/2004 |
| K940301 | Compex 2 | Biodex MedicalSystems, Inc. | 890.5850 | IPF, GZJ | 12/28/1994 |
| K032988 | Elpha 4 Conti | Danmeter A/S | 876.5320 | KPI | 12/03/2003 |
| K031900 | Handmaster | Ness-NeuromuscularElectricalStimulationSystems | 882.5810 | GZI | 08/08/2003 |
E Description:
The STIWELL med4 is powered by rechargeable batteries. It has four stimulation channels and two EMG measurement channels.
The STIWELL med4 is intended for stationary use in a hospital as well as home use by the patient. The physician/therapist has the flexibility to adjust the programs and monitors the progress of the therapy. Statistics regarding the completed treatments can be retrieved from the STIWELL med4 and from the PC.
In order to gain a proper understanding of STIWELL med4, it is important to read the manual before beginning to use the STIWELL med4.
Otto Bock Healthcare Products GmbH Kaisarstraße 38 - 1070 Wien • Austria • Telefox (+43 1) 523 22 64 • e-mail: vertrieb.costria@ottobock.com • www.attobock.cl Kundenservice: Telefon (+43-1) 526 95 48 · Telefax (+43-1) 526 79 85 HG WIEN FN 242378p - UID-Nr.: ATU 57529204 · ARA-Nr.: 8864 · ERA-Nr.: 50411 Bank Austria Creditonstalt Aktiongesellschatt, Filicle Westbanstraße Swift Code: BKAUATWW BLZ 12 000, Konto-Nr. 09743146400 Erste Bonk, Kommerzcenter Wien West 2 Switt Code: GIBAATWW BLZ 20 111, Konto-Nr. 30001045517
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for Otto Bock. The logo is in a cursive font and is black. There is a registered trademark symbol to the right of the word "Bock".
F Substantial Equivalence:
Powered Muscle Stimulator:
| Characteristics/ Specific,Basic Unit Characteristics | New Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device | Characteristics/SpecificationsBasic UnitChrocteristics | New Device | PredicateDevice | New Device | PredicateDevice | New Device | PredicateDevice | New Device | PredicateDevice |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 510(k) Number | K080950 | K032954 | K053434 | K040849 | K940301 | Program | FES 1Grasp/Release | Exercise Open | FES 2Grasp/Release(EMG) | Exercise Open | FES 3Open/Close | Exercise | FES 4Open/Close(EMG) | Palmar Grasp |
| Manufacturer | Otto Bock | Dannmeler A/S | Thought Technology Ltd. | Mentamove North America, LCC | Comper SA | 510(k) Number | K080950 | K031900 | K080950 | K031900 | K080050 | K031900 | K080950 | K031900 |
| Device Name, Model | STIWELL mad4 | Elpha 113000 | Myotrac Infinity | Mentamove | Compex 2 | Manufacturer | Otto Bock | Ness | Otto Bock | Ness | Otto Bock | Ness | Otto Bock | Ness |
| Power Source(s) | Battery Pack Li-Ion 11,1V | Battery NMH or Alkaline 9V | Battery Pack NiMH rechargeable | Battery Pack NiMH rechargeable | Battery Pack NiMH 7,2 V | Device Name | STIWELL med4 | Handmaster | STIWELL med4 | Handmaster | STIWELL med4 | Handmaster | STIWELL med4 | Handmaster |
| Method of Line CurrentIsolation | Medical Class II PowerAdapter - Mascot(12,6VDC-15,1W) | N/A | Medical Class II PowerAdapter (6VDC-15W) | Battery Charger (6VDC-2,1W) | Battery Charger (11VDC-7,2W) | Power Source(s) | Battery Pack Li-Ion 11,1V | Battery Pack NiCd 9,6V | Battery Pack Li-Ion 11,1V | Battery Pack NiCd 9,6V | Battery Pack Li-Ion 11,1V | Battery Pack NiCd 9,6V | Battery Pack Li-Ion 11,1V | Battery Pack NiCd 9,6V |
| Patient Leakage Current(normal condition) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | Method of LineCurrent Isolation | Medical Class IIPower Adapter | N/A | Medical Class IIPower Adapter | N/A | Medical Class IIPower Adapter | N/A | Medical Class IIPower Adapter | N/A |
| Patient Leakage Current(single fault condition) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | Leakage Current(normal condition) | N/A (Battery) | N/A | N/A (Battery) | N/A | N/A (Battery) | N/A | N/A (Battery) | N/A |
| Number of Output Modes | 1 | 1 | 1 | 1 | 1 | Leakage Current(single fault cond.) | N/A (Battery) | N/A | N/A (Battery) | N/A | N/A (Battery) | N/A | N/A (Battery) | N/A |
| Number of Output Channels | 4 | 2 | 2 | 2 | 4 | No. Output Mod. | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Number of EMG (input)Channels | 2 | N/A | 2 | 1 | N/A | No. Output Chan | 3 | 2 | 3 | 2 | 3 | 2 | 5 | 5 |
| EMG sensitivity | N/A | N/A | <0.1μV | 1μV | N/A | Stimulated Muscl. | Wrist extensorsFinger flexorsThumb flexor | Finger extensorsThumb extensor | Wrist extensorsFinger flexorsThumb flexor | Finger extensorsThumb extensor | Finger/thumbextensorsFinger flexorsThumb flexor | Finger extensorsThumb extensorFinger flexorsThumb flexorThenar muscle | Finger/thumbextensorsFinger flexorsThumb flexor | Finger extensorsThumb extensorFinger flexorsThumb flexorThenar muscle |
| EMG Sampling Rate | 3kHz | N/A | 2.048kHz | Unknown | N/A | No. of EMG Chan. | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 |
| EMG detection (bipolar/monopolar) | Bipolar | N/A | Bipolar | Bipolar | N/A | EMG sensitivity | N/A | N/A | 1μV | N/A | N/A | N/A | 1μV | 1μV |
| EMG range (μV) | 1-2000μV | N/A | 0-2000μV | 2-2000μV | N/A | EMG Sampl. Rate | N/A | N/A | 3kHz | N/A | N/A | N/A | 3kHz | 3kHz |
| EMG bandwidth | 70-480Hz | N/A | 10Hz-1kHz | Unknown | N/A | EMG detection | N/A | N/A | Bipolar | N/A | N/A | N/A | Bipolar | Bipolar |
| EMG signal processing (eg.RMS) | AVR(Average Rectified Value) | N/A | RMS(Root Mean Square) | Unknown | N/A | EMG range (μV) | N/A | N/A | 1-2000μV | N/A | N/A | N/A | 1-2000μV | 1-2000μV |
| Synchronous or Alternating? | Alternating | Unknown | Alternating | N/A | Synchronous | EMG bandwidth | N/A | N/A | 70-480Hz | N/A | N/A | N/A | 70-480Hz | 70-480Hz |
| Method of Channel Isolation | Transformer, Inductivecouplers | Unknown | Unknown | Unknown | Transformer | EMG signal proc.Synchr. or Altern.? | N/AAlternating | N/AAlternating | AVRAlternating | N/AAlternating | N/AAlternating | N/AAlternating | AVRAlternating | AVRAlternating |
| Regulated Current orRegulated Voltage? | Regulated Current | Regulated Current | Regulated Current | Regulated Current | Regulated Current | Meth. Chan. Isol. | Transformer,Inductive couplers | Transformer, Optisolator | Transformer,Inductive couplers | Transformer, Optisolator | Transformer,Inductive couplers | Transformer, Optisolator | Transformer,Inductive couplers | Transformer, Optisolator |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Yes | Yes | RC or RV? | Regulated Current | Regulated Voltage | Regulated Current | Regulated Voltage | Regulated Current | Regulated Voltage | Regulated Current | Regulated Voltage |
| PC Software? | Yes | No | Yes | No | No | Firmware/?PC Software? | YesNo | YesNo | YesNo | YesNo | YesNo | YesNo | YesNo | YesNo |
| Automatic Overload Trip? | Yes | Yes | Yes | Yes | Yes | Aut. Overload Trip | Yes | Unknown | Yes | Unknown | Yes | Unknown | Yes | Unknown |
| Automatic No-Load Trip? | Yes | Yes | Yes | Yes | Yes | Aut. No-Load Trip | Yes | Unknown | Yes | Unknown | Yes | Unknown | Yes | Unknown |
| Automatic Shut Off? | Yes (10min) | Unknown | Unknown | Unknown | Unknown | Aut. Shut Off | Yes (10min) | No | Yes (10min) | No | Yes (10min) | No | Yes (10min) | No |
| Patient Override Control? | Yes (Stop Button) | Yes | Yes | Yes | Yes | Override Control?Display: On/Off? | Yes (Stop Button) | Yes | Yes (Stop Button) | Yes | Yes (Stop Button) | Yes | Yes (Stop Button) | Yes |
| Indicator Display: On/OffStatus? | Yes | Yes | Yes | Yes | Yes | Display: Low Batt? | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Indicator Display: Low Batt.? | Yes | Yes | Yes | Yes | Yes | Display: V/C Level | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Indicator Display:Voltage/Current Level? | Yes | Yes | Yes | Yes | Yes | Timer Range | 15-60min | Max. 90min | 15-60min | Max. 90min | 15-60min | Max. 90min | 15-60min | Max. 45min |
| Timer Range [minutes] | 2 - 120min | 5 - 95min and cont. | 1 - 120min | Unknown | 3 - 84min | Compliance withVoluntaryStandards? | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | Unknown | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | Unknown | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | Unknown | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | Unknown |
| Compliance with VoluntaryStandards? (if yes, specify) | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | Unknown | Unknown | Unknown | Compliance with21 CFR 898? | Yes | Unknown | Yes | Unknown | Yes | Unknown | Yes | Unknown |
| Compliance with 21 CFR 898? | Yes | Unknown | Unknown | Unknown | Unknown | Weight | 440g | 685g | 440g | 685g | 440g | 685g | 440g | 685g |
| Weight | 440g | 158g | 330g | Unknown | 420g | Dimensions(WxHxD) in (mm) | 175x95x30 | 172x91x40(Control unit) | 175x95x30 | 172x91x40(Control unit) | 175x95x30 | 172x91x40(Control unit) | 175x95x30 | 172x91x40(Control unit) |
| Dimensions (WxHxD) in [mm] | 175x95x30 | 114x60x31 | 102x152x51 | Unknown | 148x80x30 | Housing Materialand Construction | Plastics | Plastics | Plastics | Plastics | Plastics | Plastics | Plastics | Plastics |
| Housing Material and Constr. | Plastics | Plastics | Plastics | Plastics | Aluminium | OutputSpecifications | ||||||||
| Output Specifications | Waveform | Biphasicsymmetrical | Biphasicsymmetrical | Biphasicsymmetrical | Biphasicsymmetrical | Biphasicsymmetrical | Biphasicsymmetrical | Biphasicsymmetrical | Biphasicsymmetrical | |||||
| Waveform | Biphasic symmetrical | Biphasic asymmetrical | Biphasic asymmetrical | Biphasic symmetrical | Biphasic symmetrical, Triangular | Shape | Rectangular | Sinusoidal | Rectangular | Sinusoidal | Rectangular | Sinusoidal | Rectangular | Sinusoidal |
| Shape | Rectangular | Rectangular with discharge | Rectangular with discharge | Rectangular | Rectangular | Maximum OutputVoltage (500Ω) | 50V | 106V | 50V | 106V | 50V | 106V | 50V | 106V |
| Maximum Output Voltage(500Ω) | 50V | 50V | 50V | Unknown | 50V | Maximum OutputVoltage (2kΩ) | 115V | 163V | 115V | 163V | 115V | 163V | 115V | 163V |
| Maximum Output Voltage(2kΩ) | 115V | 164V | Unknown | Unknown | 200V | Maximum OutputVoltage (10kΩ) | N/A | Unknown | N/A | Unknown | N/A | Unknown | N/A | Unknown |
| Maximum Output Voltage(10Ω) | N/A | Unknown | Unknown | Unknown | N/A | Maximum OutputCurrent (500Ω) | 100mA | 212mA | 100mA | 212mA | 100mA | 212mA | 100mA | 212mA |
| Maximum Output Current(500Ω) | 100mA | 100mA | 100mA | Unknown | 100mA | Maximum OutputCurrent (2kΩ) | 58mA | 92mA | 58mA | 92mA | 58mA | 92mA | 58mA | 92mA |
| Maximum Output Current(2kΩ) | 58mA | 82mA | Unknown | Unknown | 100mA | Maximum OutputCurrent (10kΩ) | N/A | Unknown | N/A | Unknown | N/A | Unknown | N/A | Unknown |
| Maximum Output Current(10Ω) | N/A | Unknown | Unknown | Unknown | N/A | Pulse Width | 50-400μs | 100-350μs | 50-400μs | 100-350μs | 50-400μs | 100-350μs | 50-400μs | 100-500μs |
| Pulse Width (specify units) | 50μs - 400μs | 100μs - 400μs | 50μs - 400μs | 320μs | 15μs – 999μs | Frequency [Hz] | 1-140HzDefault: 35Hz | 38Hz | 1-140HzDefault: 35Hz | 38Hz | 1-140HzDefault: 35Hz | 38Hz | 1-140HzDefault: 35Hz | 18Hz |
| Frequency (Hz) | 1-140Hz | 2-100Hz | 2-100Hz | 3,1kHz GF, 33Hz AMF | 1-200Hz | Net Charge [μCper pulse]; (500Ω) | 0μC | 0μC | 0μC | 0μC | 0μC | 0μC | 0μC | 0μC |
| For interferential modes only:Beat Frequency (Hz) | N/A | N/A | N/A | N/A | N/A | Maximum PhaseCharge [μC](500Ω) | 40μC | 75μC | 40μC | 75μC | 40μC | 75μC | 40μC | 106μC |
| For multiphasic waveformsonly: Symmetrical phases? | N/A | N/A | N/A | N/A | N/A | Maximum CurrentDensity (mA/cm²)(500Ω) | 12,5mA/cm² | 15,9mA/cm² | 12,5mA/cm² | 15,9mA/cm² | 12,5mA/cm² | 15,9mA/cm² | 12,5mA/cm² | 15,9mA/cm² |
| For multiphasic waveformsonly: Phase Duration (includingunits); | N/A | N/A | N/A | N/A | N/A | Maximum PowerDensity [W/cm²](500Ω) | 7,9mW/cm² | 0,39 mW/cm² | 7,9mW/cm² | 0,39 mW/cm² | 7,9mW/cm² | 0,39 mW/cm² | 7,9mW/cm² | 0,39 mW/cm² |
| Net Charge [μC per pulse];(500Ω) | 0μCSome positive and negativeimpulse | 0μCOutput capacitor | 0μCOutput capacitor | 0μCSome positive and negativeimpulse | 0μCSome positive and negativeimpulse | Burst Mode:Pulses per burst | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Maximum Phase Charge [μC](500Ω) | 40μC | 40μC | 60μC | Unknown | 80μC | Burst Mode:Bursts per second | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Maximum Current Density[mA/cm²] (500Ω) | 12.5mA/cm² | 5.3mA/cm² | 20.4mA/cm² | Unknown | 5.0mA/cm² | Burst Mode: Burstduration (seconds) | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Maximum Power Density[W/cm²] (500Ω) | 7.9mW/cm² | 1.7mW/cm² | 6.5mW/cm² | Unknown | 39.9mW/cm² | Burst Mode: DutyCycle | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Burst Mode (i.e., pulse trains):Pulses per burst | N/A | N/A | N/A | N/A | N/A | ON Time (sec.) | 1 - 20s | Unknown | 1 - 20s | Unknown | 1 - 20s | Unknown | 1 - 20s | Trigger controlled |
| Burst Mode (i.e., pulse trains):Bursts per second | N/A | N/A | N/A | N/A | N/A | OFF Time (sec.) | 1 - 30s | Unknown | Trigger controlled(min. 1 - 30s) | Unknown | 1 - 30s | Unknown | Trigger controlled(min. 1 - 30s) | Trigger controlled |
| Burst Mode (i.e., pulse trains):Burst duration (seconds) | N/A | N/A | N/A | N/A | N/A | |||||||||
| Burst Mode (i.e., pulse trains):Duty Cycle [Line (b) ÷ Line (c)] | N/A | N/A | N/A | N/A | N/A | |||||||||
| ON Time [seconds] | 1 - 20s | 2 - 20s | 2 - 20s | Default 6s | Unknown | |||||||||
| OFF Time [seconds] | 1 - 50s | 2 - 20s | 2 - 50s | Default 12s | Unknown |
Otto Bock Hoolthcore Products
HG WIEN FN 242378p UID-Nr.: ATU 57529204 ARA-Nr.: 8864 ERA-Nr.: 5041
Bonk Austria Creditorstalt Aktiengesellschett, Filiale Westball Crown BLZ 12 000, Konto. Nr. 08743146400
{3}------------------------------------------------
Otto Bock®
QUALITY FOR LIFE
Functional Electrical Stimulation Programs:
Otto Bock Healthcare Products GmbH
Kaiserstraße 39 · 1070 Wien · Austrio · Telefox (+43-1) 523 22 64 · e-mail: vertrieb.austria@atria@othobock.com · www.ottobock.ct Kundenservice: Telefon (+43-1) 526 95 48 · Telefox (+43-1) 526 79 85
HG WIEN FN 242378p · UID-Nr.: ATU 57529204 · ARA-Nr.: 8864 · ERA-Nr.: 5041
HO WEN FN 242376 - SUDN: : ATU 5752920 - ARA-N: : 884 - ERA-N: 5041
Bonk Austria Creditors (Alicel Vestbohstrode Swit Code: BKAUATWW BLZ 12 000, Konto-Nr. 08743146400
{4}------------------------------------------------
Otto Bock®
Incontinence Programs:
| Characteristics/Specifications | New Device | PredicateDevice | New Device | PredicateDevice | New Device | PredicateDevice | New Device | PredicateDevice | |
|---|---|---|---|---|---|---|---|---|---|
| Basic UnitCharacteristics | |||||||||
| Program | U1 | P2, P3 | U2 | P1 | U3 | P4 | U4 | EMG Script | |
| 510(k) Number | K080950 | K032988 | K080950 | K032988 | K080950 | K032988 | K080950 | K053434 | |
| Manufacturer | Otto Bock | Donnermeter A/S | Otto Bock | Donnermeter A/S | Otto Bock | Donnermeter A/S | Otto Bock | ThoughtTechnology Ltd. | |
| Device Name | STIWELL med4 | Elpha 4 Conti | STIWELL med4 | Elpha 4 Conti | STIWELL med4 | Elpha 4 Conti | STIWELL med4 | Myotroc Infinity | |
| Power Source(s) | Battery Pack Li-Ion 11,1V | Battery NMH orAlkaline 9V | Battery Pack Li-Ion 11,1V | Battery NMH orAlkaline 9V | Battery Pack Li-Ion 11,1V | Battery NMH orAlkaline 9V | Battery Pack Li-Ion 11.1V | Battery PackNIMH | |
| Method of LineCurrent Isolation | Medical Class IIPower Adapter | N/A | Medical Class IIPower Adapter | N/A | Medical Class IIPower Adapter | N/A | Medical Class IIPower Adapter | Medical Class IIPower Adapter | |
| Leakage Current(normal condition) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | |
| Leakage Current(single fault cond.) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | |
| No. Output Mod. | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | |
| No. Output Chan | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| No. of EMG Chan.EMG sensitivity | N/A | N/A | N/A | N/A | N/A | N/A | 1μV | <0,1μV | |
| EMG Sampl. Rate | N/A | N/A | N/A | N/A | N/A | N/A | 3kHz | 2,048kHz | |
| EMG detection | N/A | N/A | N/A | N/A | N/A | N/A | Bipolar | Bipolar | |
| EMG range (μV) | N/A | N/A | N/A | N/A | N/A | N/A | 1-2000μV | 0-2000μV | |
| EMG bandwidth | N/A | N/A | N/A | N/A | N/A | N/A | 70-480Hz | 10Hz-1kHz | |
| EMG signal proc. | N/A | N/A | N/A | N/A | N/A | N/A | AVR | RMS | |
| Synchr. or Altern.? | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| Math. Chan. Isol.RC or RV7 | Regulated Current | Regulated Current | Regulated Current | Regulated Current | Regulated Current | Regulated Current | N/A | N/A | |
| Firmware/? | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Aut. Overload Trip | Yes | Yes | Yes | Yes | Yes | Yes | N/A | N/A | |
| Aut. No-Load Trip | Yes | Yes | Yes | Yes | Yes | Yes | N/A | N/A | |
| Aut. Shut Off | Yes (10min) | Yes | Yes (10min) | Yes | Yes (10min) | Yes | Yes (10min) | Unknown | |
| Override Control? | Yes (Stop Button) | Yes | Yes (Stop Button) | Yes | Yes (Stop Button) | Yes | Yes (Stop Button) | Yes | |
| Display: On/Off? | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Display: Low Batt? | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Timer Range | 5 - 25min | 5 - 95min | 5 - 25min | 5 - 95min | 5 - 25min | 5 - 95min | 2-4min | 1-120min | |
| Compliance withVoluntaryStandards? | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | IEC 60601-1IEC 60601-1-2 | Unknown | |
| Compliance with21 CFR 898? | Yes | Unknown | Yes | Unknown | Yes | Unknown | Yes | Unknown | |
| Weight | 440g | 158g | 440g | 158g | 440g | 158g | 440g | 330g | |
| Dimensions(WxHxD) in (mm) | 175x95x30 | 114x60x31 | 175x95x30 | 114x60x31 | 175x95x30 | 114x60x31 | 175x95x30 | 102x152x51 | |
| Housing Materialand Construction | Plastics | Plastics | Plastics | Plastics | Plastics | Plastics | Plastics | Plastics | |
| OutputSpecifications | |||||||||
| Waveform | Biphasicsymmetrical | Pulsed biphasicasymmetrical | Biphasicsymmetrical | Pulsed biphasicasymmetrical | Biphasicsymmetrical | Pulsed biphasicasymmetrical | N/A | N/A | |
| Shape | Rectangular | Rectangular withdischarge | Rectangular | Rectangular withdischarge | Rectangular | Rectangular withdischarge | N/A | N/A | |
| Maximum OutputVoltage (500Ω) | 50V | 50V | 50V | 50V | 50V | 50V | N/A | N/A | |
| Maximum OutputVoltage (2kΩ) | 115V | 150V | 115V | 150V | 115V | 150V | N/A | N/A | |
| Maximum OutputVoltage (10kΩ) | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| Maximum OutputCurrent (500Ω) | 100mA | 100mA | 100mA | 100mA | 100mA | 100mA | N/A | N/A | |
| Maximum OutputCurrent (2kΩ) | 58mA | 80mA | 58mA | 80mA | 58mA | 80mA | N/A | N/A | |
| Maximum OutputCurrent (10kΩ) | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| Pulse Width | 500μs | 50-400μs | 300μs | 50-400μs | 350-500μs | 50-400μs | N/A | N/A | |
| Frequency (Hz)Net Charge (μCper pulse); (500Ω) | 10Hz0μC | 1-10Hz0μC | 35Hz0μC | 20-80Hz0μC | 5-60Hz0μC | 1-80Hz0μC | N/A | N/A | |
| Maximum PhaseCharge (μC)(500Ω) | 50μC | 40μC | 30μC | 40μC | 50μC | 40μC | N/A | N/A | |
| Surface area ofthe electrodes[cm²] | Axel Gaard(Surface) PR10021,2cm² | Vaginal: 4,9cm²Anal: 3 cm² | Axel Gaard(Surface) PR10021,2cm² | Vaginal: 4,9cm²Anal: 3 cm² | Axel Gaard(Surface) PR10021,2cm² | Vaginal: 4,9cm²Anal: 3 cm² | N/A | N/A | |
| Maximum CurrentDensity [mA/cm²](500Ω) | 4,7 mA/cm² | Vaginal:20,4mA/cm²Anal: 33,3mA/cm² | 4,7 mA/cm² | Vaginal:20,4mA/cm²Anal: 33,3mA/cm² | 4,7 mA/cm² | Vaginal:20,4mA/cm²Anal: 33,3mA/cm² | N/A | N/A | |
| Maximum PowerDensity [μW/cm²](500Ω) | 23,5 μW/cm² | Vaginal:2,3mW/cm²Anal: 3.8mW/cm² | 105 μW/cm² | Vaginal:2,3mW/cm²Anal: 3.8mW/cm² | 0,42 mW/cm² | Vaginal:2,3mW/cm²Anal: 3,8mW/cm² | N/A | N/A | |
| Burst Mode:Pulses per burst | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| Burst Mode:Bursts per second | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| Burst Mode: Burstduration (seconds) | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| Burst Mode: DutyCycle | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| ON Time (sec.) | 9-12s | 2-20s | 9-11s | 2-20s | N/A | N/A | |||
| OFF Time (sec.) | 1-5s | 7-9s | 2-20s | 3-6s | 2-20s | N/A | N/A | ||
| Characteristics/ Specifications | New Device | Predicate Device | Predicate Device | Predicate Device | |||||
| Basic Unit Characteristics | |||||||||
| 510(k) Number | K080950 | K032954 | K032954 | K940301 | |||||
| Manufacturer | Otto Bock | Danmeter A/S | Danmeter A/S | Compez SA | |||||
| Device Name, Model | STIWELL med4 | Elpho II1000 | Elpho 113000 | STIWELL med4 | |||||
| Power Source(s) | Battery Pack L-Ion 11,1V | Battery NiMH or Alkoline 9V | Battery Pack NMH or Alkaline 9V | Battery Pack Li-Ion 11,1V | |||||
| Medical Class II Power Adapter - | Medical Class II Power Adapter - | ||||||||
| Method of Line Current Isolation | Mascot(12,6VDC-15,1W) | N/A | N/A | Mascot(12.6VDC-15,1W) | |||||
| Patient Leakage Current (normalcondition) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | |||||
| Patient Leakage Current (single faultcondition) | N/A (Battery) | N/A (Battery) | N/A (Battery) | N/A (Battery) | |||||
| Number of Output Modes | 1 | 1 | 1 | 1 | |||||
| Number of Output Channels | 4 | 2 | 2 | 4 | |||||
| Number of EMG (input) Channels | N/A | N/A | N/A | N/A | |||||
| EMG sensibvity | N/A | N/A | N/A | N/A | |||||
| EMG Sompling Rata | N/A | N/A | N/A | N/A | |||||
| EMG delection (bipolar/ manopolar) | N/A | N/A | N/A | N/A | |||||
| EMG range ( $\mu V$ ) | N/A | N/A | N/A | N/A | |||||
| EMG bandwidth | N/A | N/A | N/A | N/A | |||||
| EMG signal processing (eg. RMS) | N/A | N/A | N/A | N/A | |||||
| Synchronous or Alternating? | Alternating | Unknown | Unknown | Synchronous | |||||
| Method of Channel Isolation | Transformer, Inductive couplers | Unknown | Unknown | Transformer | |||||
| Regulated Current or RegulatedVoltage? | Regulated Current | Regulated Current | Regulated Current | Regulated Current | |||||
| Software/Firmware/ MicroprocessorControl? | Yes | Yes | Yes | Yes | |||||
| Automatic Overload Trip? | Yes | Yes | Yes | Yes | |||||
| Automatic No-Lood Tnp? | Yes | Yes | Yes | Yes | |||||
| Automatic Shut Off? | Yes (10min) | Yes | Yes | Unknown | |||||
| Patient Overnde Control? | Yes (Stop Button) | Yes | Yes | Yes | |||||
| Indicator Display: On/Off Status? | Yes | Yes | Yes | Yes | |||||
| Indicator Display: Low Battery? | Yes | Yes | Yes | Yes | |||||
| Indicator Display: Votage/CurrentLevel? | Yes | Yes | Yes | Yes | |||||
| Timer Range (minutes) | 10 - 120min | -45min and cont. | 5 - 95min and cont. | 3 - 54min | |||||
| Compliance with VoluntoryStandards? (if yes, speaty) | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | Unknown | |||||
| Compliance with 21 CFR 808? | Yes | Unknown | Unknown | Unknown | |||||
| Weight | 440g | 168g | 158g | 420g | |||||
| Dimensions (WxHxD) in [mm] | 175x95x30 | 117x60x31 | 114x60x31 | 148x80x30 | |||||
| Housing Material and Construction | Plastics | Plastics | Plastics | Aluminium | |||||
| Output Specifications | |||||||||
| Waveform (e.g., pulsed monophasic,biphasic) | Biphasic symmetrical | Biphasic asymmetrical | Biphasic asymmetrical | Biphasic symmetrical | |||||
| Shape (e.g., rectangular, spike,rectified sinusoidal) | Rectangular | Rectangular with discharge | Rectangular with discharge | Rectangular | |||||
| Maximum Output Voltage (500Ω) | 50V | 20V | 50V | 50V | |||||
| Maximum Output Voltage (2kΩ) | 115V | 76V | 164V | 200V | |||||
| Maximum Output Voltage (10kΩ) | N/A | Unknown | Unknown | N/A | |||||
| Maximum Output Current (500Ω) | 100mA | 40mA | 80mA | 100mA | |||||
| Maximum Output Current (2kΩ) | 58mA | 38mA | 82mA | 100mA | |||||
| Maximum Output Current (10kΩ) | N/A | Unknown | Unknown | N/A | |||||
| Pulse Width (specify units) | 150μs, 200μs | 150μs, 160μs, 200μs | 50 - 400μs | Unknown | |||||
| Frequency (Hz) | 2 - 100Hz | 2 - 120Hz | 0,5 - 150Hz | Unknown | |||||
| For interferential modes only: BeatFrequency (Hz) | Shape (e.g., rectangular, spike, rectified sinusoidan) | N/A | Rectangular | N/A | Rectangular with discharge | N/A | Rectangular with discharge | N/A | Rectangular |
| Maximum Output Voltage (500Ω) | 50V | 20V | 50V | 50V | |||||
| Maximum Output Voltage (2kΩ) | 115V | 76V | 164V | 200V | |||||
| Maximum Output Voltage (10kΩ) | N/A | Unknown | Unknown | N/A | |||||
| Maximum Output Current (500Ω) | 100mA | 40mA | 60mA | 100mA | |||||
| Maximum Output Current (2kΩ) | 58mA | 38mA | 62mA | 100mA | |||||
| Maximum Output Current (10kΩ) | N/A | Unknown | Unknown | N/A | |||||
| Pulse Width (specify units) | 150μs, 200μs | 150μs, 160μs, 200μs | 50 - 400μs | Unknown | |||||
| Frequency (Hz) | 2 - 100Hz | 2 - 120Hz | 0,5 - 150Hz | Unknown | |||||
| For interferential modes only: Beat Frequency (Hz) | N/A | N/A | N/A | N/A | |||||
| For multiphasic waveforms only: Symmetrical phases? | N/A | N/A | N/A | N/A | |||||
| For multiphasic waveforms only: Phase Duration (including units); state range, if applicable; both phases, if asymmetrical | N/A | N/A | N/A | N/A | |||||
| Net Charge [μC per pulse]; (500Ω) if zero, state method of achieving zero net charge. | 0μCSome positive and negative impulse | 0μCOutput capacitor | 0μCOutput capacitor | 0μCSome positive and negative impulse | |||||
| Maximum Phase Charge (μC) (500Ω) | 20μC | 8μC | 24μC | Unknown | |||||
| Maximum Current Density [mA/cm²] (500Ω) | 12,5mA/cm² | 2,1mA/cm² | 3,2mA/cm² | 5,0mA/cm² | |||||
| Maximum Power Density [W/cm²] (500Ω) using smallest electrode conductive surface area | 1,0mW/cm² | 0,09mW/cm² | 1,4mW/cm² | Unknown | |||||
| Burst Mode (i.e., pulse trains): Pulses per burst | 8 | 7 | 7 | Unknown | |||||
| Burst Mode (i.e., pulse trains): Bursts per second | 2 | 2 | 0,5 - 5 | Unknown | |||||
| Burst Mode (i.e., pulse trains): Burst duration (seconds) | 100ms | 87,5ms | 87,5ms | Unknown | |||||
| Burst Mode (i.e., pulse trains): Duty Cycle [Line (b) x Line (c)] | 20% | 17,5% | 4,4% - 44% | Unknown | |||||
| ON Time [seconds] | Continuous or Burst | Continuous or Burst | Continuous or Burst | Continuous | |||||
| OFF Time [seconds] | N/A | N/A | N/A | N/A | |||||
| Additional features (if applicable) | N/A | N/A | N/A | N/A |
HG WIEN FN 242378p UID-Nr.: ATU 57529204 ARA-Nr.: 8864 ERA-Nr.: 5041
Bonk Austria Creditonstoh Aktiengesellschoft, Flicole Westboller BKAUATVW BLZ 12 000, Konto-Nr. 09743146400
{5}------------------------------------------------
Otto Bock®
TENS:
.
·
·
Kaiserstrule 39 · 1070 Vien · Austrial · 44 ·
Bank Austria Creditanstalt Aktiengesellschaft, Filiale Westbohnstraße Swift Code: BKAUATWW BLZ 12 000, Konto-Nr. 09743146400 Erste Bank, Kommerzcenter Wien West 2 Switt Code: GIBAATWW BLZ 20 111, Konto-Nr. 30001045517
{6}------------------------------------------------
Otto Bock®
Biofeedback:
| Characteristics/ Specifications | New Device | Predicate Device | Predicate Device | ||||
|---|---|---|---|---|---|---|---|
| Basic Unit Chracteristics | |||||||
| 510(k) Number | K080950 | K053434 | K040849 | ||||
| Manufacturer | Otto Bock | Thought Technology Ltd. | Mentamove North America, LCC | ||||
| Device Name, Model | STIWELL med4 | Myotroc Infinity | Mentamove | ||||
| Power Source(s) | Battery Pack Li-Ion 11.1V | Battery Pack NiMH rechargeable | Battery Pack NiMH rechargeable | ||||
| Method of Line Current Isolation | Medical Class II Power Adapter -Mascol(12,6VDC-15, 1W) | Medical Class II Power Adapter (6VDC-15W) | Battery Charger (6VDC-2,1W) | ||||
| Patient Leakage Current (normalcondition) | N/A (Battery) | N/A (Battery) | N/A (Battery) | ||||
| Patient Leakage Current (single faultcondition) | N/A (Battery) | N/A (Battery) | N/A (Battery) | ||||
| Number of Output Modes | 1 | 0 | 0 | ||||
| Number of Output Channels | 1 | 0 | 0 | ||||
| Number of EMG (input) Channels | 2 | 2 | 1 | ||||
| EMG sensitivity | $1\mu V$ | $<0,1\mu V$ | $1\mu V$ | ||||
| EMG Sampling Rate | 3kHz | 2,048kHz | Unknown | ||||
| EMG detection (bipolar/ monopolar) | Bipolar | Bipolar | Bipolar | ||||
| EMG range ( $\mu$ V) | $1-2000\mu V$ | $0-2000\mu V$ | $2-2000\mu V$ | ||||
| EMG bandwidth | 70-480Hz | 10Hz-1kHz | Unknown | ||||
| EMG signal processing (eg. RMS) | AVR(Average Rectified Value) | RMS(Root Mean Square) | Unknown | ||||
| Synchronous or Alternating? | N/A | N/A | N/A | ||||
| Method of Channel Isolation | N/A | N/A | N/A | ||||
| Regulated Current or RegulatedVoltage? | N/A | N/A | N/A | ||||
| Software/Firmware/ MicroprocessorControl ? | Yes | Yes | Yes | ||||
| Automatic Overload Trip? | N/A | N/A | N/A | ||||
| Automatic No-Load Trip? | N/A | N/A | N/A | ||||
| Automatic Shut Off? | Yes (10min) | Unknown | Unknown | ||||
| Patient Override Control? | Yes (Stop Button) | Yes | Yes | ||||
| Indicator Display: On/Off Status? | Yes | Yes | Yes | ||||
| Indicator Display: Low Battery ? | Yes | Yes | Yes | ||||
| Indicator Display: Voltage/CurrentLevel? | N/A | N/A | N/A | ||||
| Timer Range [minutes] | 5-30min | 1-120min | Unknown | ||||
| Compliance with Voluntary Standards?(if yes, specify) | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | Unknown | Unknown | ||||
| Compliance with 21 CFR 898? | Yes | Unknown | Unknown | ||||
| Weight | 440g | 330g | Unknown | ||||
| Dimensions (WxHxD) in [mm] | 175x95x30 | 102×152×51 | Unknown | ||||
| Housing Material and Construction | Plastics | Plastics | Plastics | ||||
| Output Specifications | |||||||
| Waveform (e.g., pulsed monophasic,biphasic) | N/A | N/A | N/A | ||||
| Shape (e.g., rectangular, spike, rectifiedsinusoidal) | N/A | N/A | N/A | ||||
| Maximum Output Voltage (500Ω) | N/A | N/A | N/A | ||||
| Maximum Output Voltage (2kΩ) | N/A | N/A | N/A | ||||
| Maximum Output Voltage (10kΩ) | N/A | N/A | N/A | ||||
| Maximum Output Current (500Ω) | N/A | N/A | N/A | ||||
| Maximum Output Current (2kΩ) | N/A | N/A | N/A | ||||
| Maximum Output Current (10kΩ) | N/A | N/A | N/A | ||||
| Pulse Width (specify units) | N/A | N/A | N/A | ||||
| Frequency (Hz) | N/A | N/A | N/A | ||||
| For interferential modes only: BeatFrequency (Hz) | N/A | N/A | N/A | ||||
| For multiphasic waveforms only:Symmetrical phases? | N/A | N/A | N/A | ||||
| For multiphasic waveforms only: PhaseDuration (including units); | N/A | N/A | N/A | ||||
| Net Charge ( $\mu$ C per pulse); (500Ω) | N/A | N/A | N/A | ||||
| Maximum Phase Charge ( $\mu$ C) (500Ω) | N/A | N/A | N/A | ||||
| Maximum Current Density [mA/cm²](500Ω) | N/A | N/A | N/A | ||||
| Maximum Power Density [W/cm²](500Ω) | N/A | N/A | N/A | ||||
| Burst Mode (i.e., pulse trains): Pulsesper burst | N/A | N/A | N/A | ||||
| Burst Mode (i.e., pulse trains): Burstsper second | N/A | N/A | N/A | ||||
| Burst Mode (i.e., pulse trains): Burstduration (seconds) | N/A | N/A | N/A | ||||
| Burst Mode (i.e., pulse trains): DutyCycle [Line (b) x Line (c)] | N/A | N/A | N/A | ||||
| ON Time (seconds) | OFF Time [seconds] | N/A | N/A | N/A | N/A | N/A | N/A |
| Additional features (if applicable) | N/A | N/A | N/A |
Otto Bock Healthcare Products GmbH
Kisersroße 30 · 1070 Wer · Austin (44 · 1 · 200 B0cer · 143 · 143 · 1404 · · erieb suingothobotiogottoock.com · · www.dtbck.com · · ww.stabbk.com · · ww.catobk.c
HG WIEN FN 242378p UID-Nr.: ATU 57529204, ARA-Nr.: 8864 ERA-Nr.: 50411
Erste Bonk, Kommerzcenter Wien West 2 Switt Code: GIBAATWW BLZ 20 11 1, Konto-Nr. 30001045517
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows the logo for Otto Bock. The logo is written in a cursive font. The registered trademark symbol is located to the right of the word "Bock".
G Functional and Safety Testing:
Tests have been carried out according to the following standards:
| No. | Title | Version | Comments |
|---|---|---|---|
| IEC 60601-1 | Medical electrical equipmentPart 1: General requirements for safety | 1996-03 | Medical electricaldevices(Testing) |
| IEC 60601-1-1 | Medical electrical equipmentPart 1-1: General requirements forsafety - Safety requirements for medicalelectrical systems | 2002-09-01 | Medical electricaldevices(Testing) |
| IEC 60601-1-2 | Medical electrical equipmentPart 1-2: General requirements forsafety -Electromagnetic compatibility -requirements and tests | 2001 | EMC(Testing) |
| IEC 60601-1-4 | Medical electrical equipmentPart 1-4: General requirements forsafety - Programmable electricalmedical systems | 2001-06-01 | ProgrammableSystems |
| IEC 60601-2-10 | Medical electrical equipmentPart 2-10: Particular requirements forthe safety of nerve and musclestimulators | 2003-04 | Medical electricaldevices; EMC(Testing) |
| IEC 721-3-2 | Classification of EnvironmentalConditions Part 3-2: Classes ofInfluencing Factors - Transport | 1981 | Transport(Testing) |
| ISO 2248 | Packaging - Complete, filled transportpackages - Vertical impact test bydropping | 1985 | Transport(Testing) |
| ISO 2876 | Packaging - Complete, filled transportpackages - Rolling test | 1985 | Transport(Testing) |
| IEC 60512-8 | Electromechanical components forelectronic equipment; basic testingprocedures and measuring methodsPart 8: Connector test (mechanical)and mechanical test on contacts andterminations | 3.0/1994-05 | Specific sectionswere used forverification testing |
| IEC 60512-9 | Electromechanical components forelectronic equipment; basic testingprocedures and measuring methodsPart 9: Miscellaneous tests | 2.0/1992-05 | Specific sectionswere used forverification testing |
| IEC 68-1+Corr.+A1 | Environmental testingPart 1: General and Guidance | 1998 | Specific sectionswere used forverification testing |
| IEC 68-2-1+A1+A2 | Environmental testingPart 2-1: Tests, Tests A: Cold | 1994 | Specific sectionswere used forverification testing |
| No. | Title | Version | Comments |
| IEC 68-2-2+IEC68-2-2A+A2 | Environmental testingPart 2-2: Tests, Tests B: Dry heat | 1994 | Specific sectionswere used forverification testing |
| IEC 68-2-30 | Environmental testing - Part 2-30: Tests- Test Db: Damp heat, cyclic (12 h + 12 h cycle) | 2000 | Specific sectionswere used forverification testing |
| IEC 68-2-33 | Environmental testing - Part 2-33: Tests.Guidance on change of temperaturetests | 2000 | Specific sectionswere used forverification testing |
| IEC 68-2-36 | Environmental testingPart 2-36, Tests Fdb: Vibrations, noise(broadband), repeatability: medium | 1973 | Specific sectionswere used forverification testing |
| IEC 68-2-78 | Environmental testingPart 2-78: Tests, Test Cb: Damp heat,steady state, primarily intended fordevices | 2001 | Specific sectionswere used forverification testing |
| 21 CFR 898 | Performance Standard for electrodelead wires and patient cables | 1997 | Electrical safety(Testing) |
Otto Bock Healthcare Products GmbH
HG WIEN FN 242378p · UID-Nr.: ATU 57529204 · ARA-Nr.: 8864 · ERA-Nr.: 50411
Bank Austria Creditanstatt Aktiengesellschaft, Filiale Westbahnstraße Swift Code: BKAUATWW BLZ 12 000, Korno-Nr. 09743146400 Erste Bonk, Kommerzcenter Wien West 2 Switt Code: GIBAATWW BLZ 20 111, Konto-Nr. 30001045517
{8}------------------------------------------------
Otto Bock®
In addition to tests according to the above mentioned standards several functional and safety tests defined by the manufacturer have been conducted.
Otto Bock Healthcare Products GmbH
Kassrado 39 - 1070 Wien - Austrio (+43-1) 523 37 86 - Telefa (+43-1) 523 22 64 - e-moil: vertreb.oustrio@otobock.com - www.ottobock.com - Kundenservice: Telefon (+43-1) 526 95 48 · Telefax (+43-1) 526 79 85 HG WIEN FN 242378p · UID-Nr.: ATU 57529204 · ARA-Nr.: 8864 · ERA-Nr.: 50411 Bonk Austria Creditanstalt Aktiengesellschaft, Filiale Westbohnstraße Swift Code: BKAUATWW BLZ 12 000, Konto-Nr. 09743146400 Erste Bank, Kommerzcenter Wien West 2 Swift Code: GIBAATWW BLZ 20 111, Konto-Nr. 30001045517
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the logo for Otto Bock. The logo is written in a cursive font. A registered trademark symbol is present to the right of the word Bock.
H Indications for use:
The STIWELL med4 is a neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator the STIWELL med4 is indicated for the following conditions:
- Relaxation of muscle spasm .
- . Prevention or retardation of disuse atrophy
- . Increasing local blood circulation
- . Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis .
- . Maintaining or increasing range of motion
As a transcutaneous electrical nerve stimulator for pain relief the STIWELL med4 is indicated for the following conditions:
- Symptomatic relief and management of chronic (long-term), intractable pain .
- . Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain
As a biofeedback device the STIWELL med4 is indicated for the following conditions:
-
Biofeedback, relaxation and muscle re-education purposes .
As an external functional neuromuscular stimulator the STIWELL med4 is indicated for the following conditions: -
Helps to relearn voluntary motor functions of the extremities
As a nonimplanted electrical continence device the STIWELL med4 is indicated for the following conditions: -
Acute and ongoing treatment of stress, urge or mixed uringry incontinence and where the . following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles
-
Incontinence treatment for assessing EMG activity of the pelvic floor and accessory . muscles such as the abdominal and the gluteus muscles
I Conclusion:
The STIWELL med4 stimulation device is safe and effective for its intended use. The STIWELL med4 is substantially equivalent to the predicate devices.
J Date summary submitted:
21st January 2008
Otto Bock Healthcare Products GmbH
Koiserstraße 39 · 1070 Wien · Austrio · Telefox (+43-1) 523 22 64 · e-mail: vertrieb austria@ottobock.com · www.ottobock.ot Kundenservice: Telefon (+43-1) 526 95 48 · Telefax (+43-1) 526 79 85 HG WIEN FN 242378p · UID-Nr : ATU 57529204 · ARA-Nr .: 8864 · ERA-Nr.: 50411
Bank Austria Creditanstalt Aktiencesellschaft, Fliiole Westbahnstraße Switt Code: BKAUATWW BLZ 12 000 Konto-Nr. 08743146400 Erste Bank, Kommerzcenter Wien West 2 Swift Code: GIBAATWW BLZ 20 111, Konto-Nr. 30001045517
{10}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/10/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is oriented to the upper right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Otto Bock, Austria GmbH % W.F. Jackson Associates, Ltd Mr. William Jackson 2247 Jennifer Lane North St. Paul, Minnesota 55109-2851
Re: K080950
Trade/Device Name: STIWELL med4 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF, GZI, KPI, GZJ, HCC Dated: March 2, 2009 Received: March 25, 2009
APR - 2 2009
Dear Mr. Jackson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
{11}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sincerely yours,
Mark H. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{12}------------------------------------------------
Indications for Use
510(k) Number (if known): K080950
Device Name: STIWELL med4
Indications for Use:
The STIWELL med4 is a neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator the STIWELL med4 is indicated for the following conditions:
- · Relaxation of muscle spasm
- · Prevention or retardation of disuse atrophy
- Increasing local blood circulation .
- . Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis .
- t Maintaining or increasing range of motion
As a transcutaneous electrical nerve stimulator for pain relief the STIWELL med4 is indicated for the following conditions:
- · Symptomatic relief and management of chronic (long-term), intractable pain
- Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain
As a biofeedback device the STIWELL med4 is indicated for the following conditions:
-
· Biofeedback, relaxation and muscle re-education purposes
As an external functional neuromuscular stimulator the STIWELL med4 is indicated for the following conditions: -
· Helps to relearn voluntary motor functions of the extremities
As a nonimplanted electrical continence device the STIWELL med4 is indicated for the following conditions: -
Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the . following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles
-
· Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
Mark A. Milkerm
Division Sign-Of Division of General, Restorative, and Neurological Devices
· Page 1 of 1
510(k) Number K08093
§ 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).