(540 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description of the control unit and software suggests standard prosthetic control based on EMG signals.
No
The device is a prosthetic system for replacing lost upper limbs, which is a reconstructive and assistive function, not a therapeutic treatment for a disease or condition.
No
The device is described as an exoprosthetic system for fitting upper limbs, which is a therapeutic or assistive device, not one used for diagnosis.
No
The device description explicitly lists multiple hardware components (Michelangelo Hand, AxonFlexion Adapter, AxonRotation Adapter, AxonArm, AxonEnergy Integral, AxonCharge, AxonMaster, Electrode, AxonSkin) in addition to the software (AxonSoft).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "exoprosthetic fittings of the upper limbs." This describes a device used externally on the body to replace a missing limb, not a device used to examine specimens taken from the body.
- Device Description: The description details a prosthetic system with components like a hand, adapters, elbow joint, battery, control unit, electrodes, software, and a prosthetic glove. These are all components of an external prosthetic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro testing, or providing diagnostic information based on such analysis.
The device is clearly an external prosthetic system for replacing a missing upper limb.
N/A
Intended Use / Indications for Use
The Axon-Bus Prosthetic System is to be used exclusively for exoprosthetic fittings of the upper limbs.
Product codes
GXY, IQZ
Device Description
The Axon-Bus Prosthetic System is to be used exclusively for upper limb exoprosthetic fitting. The Axon-Bus Prosthetic System is suitable for unilateral amputations starting with the transradial/transhumeral amputation level or, in case of dysmelia, for forearm or upper arm fittings.
The Axon-Bus prosthetic system was developed for everyday use and must not be used for unusual activities. These unusual activities include, for example, sports with excessive strain and/or shocks to the wrist unit (pushups, downhill, mountain biking) or extreme sports (free climbing, paragliding, etc.). Furthermore, the Axon-Bus prosthethic system should not be used for the operation of motor vehicles, heavy equipment (e.g. construction machines), industrial machines or motor-driven equipment. The prosthesis is intended exclusively for use on one patient. Use of the product by another person is not approved by the manufacturer. Fitting a patient with the Axon-Bus prosthetic system may only be carried out by a prosthetist who has been authorized by Ottobock after completion of a corresponding training course.
System Components:
- Michelangelo Hand (terminal device)
- AxonFlexion Adapter (passive flexion)
- AxonRotation Adapter (passive rotation)
- AxonArm (passive elbow joint with mechanical and/or electrical lock)
- AxonEnergy Integral (battery)
- AxonCharge (charger)
- AxonMaster (control unit)
- Electrode (detecting EMG Input signals)
- AxonSoft (adjustment software)
- AxonSkin (prosthetic glove)
The components of the Axon-Bus Prosthetic System are assembled by a prosthetist according to the individual needs of the amputee. Adjustments to the prosthesis components can be performed through Bluetooth data transfer using the AxonSoft software. The Bluetooth module is integrated into the control unit. The program is selected for the respective user situation from among four control option. The adjustment software running on a personal computer allows the prosthetist to adjust the settings of the system by selecting the right program from among four control option.
The hand component contains two drives. The main drive of the hand component is responsible for the gripping movements and gripping force. Actively driven elements are the thumb, index finger and middle finger while the ring finger and little finger passively follow the other fingers. The thumb drive permits electronic positioning. Rotating the thumb outward creates a wide open palm, so that additional movement options are possible.
Flexion and extension (bending and stretching) are based on the relaxed wrist (flexible mode). Pronation and supination (inward and outward rotation) can be passively performed by the user.
The elbow component allows passive flexion and extension. Locking and unlocking is carried out mechanically (e.g., by means of body harnesses) or electrically (e.g., by means of electrode).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper limbs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prosthetist authorized by Ottobock after completion of a corresponding training course.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Extensive testing was performed (e.g. software testing and electrical safety tests including EMC). Also biocompatibility testing according to ISO 10993-1 was performed on all patient contacting materials. No clinical studies were performed. Since all samples tested met the acceptance criteria, substantial equivalence has been demonstrated through these tests.
Internal testing regarding performance characteristics of the hand, wrist and elbow has been conducted on the Axon-Bus Prosthetic System to ensure that the device meets design specifications, operates as it is intended, and ensures that safety functions and features operate as they are intended.
Component: Hand
Performance Attribute: Weight of the prosthesis, Compatibility of components, Activating and deactivating the system, Performing different types of grips, Gripping different sizes of objects, max. opening distance, Grip force (strength, increase and decrease, maintaining grip force when engine not running), Positioning speed, Emergency opening, Mechanical strength (static and dynamic testing)
Test Result: Passed
Component: Wrist
Performance Attribute: Positions of flexion and rotation unit, Mechanical strength (static and dynamic testing, support a specific weight), Connecting/ disconnecting of flexion adapter to/from rotation adapter
Test Result: Passed
Component: Elbow
Performance Attribute: Mechanical strength (static and dynamic testing), Maintaining position (Maximum holding force): Overload Protection
Test Result: Passed
Component: Tube Valve
Performance Attribute: Function of Tube Valve for Suction Socket
Test Result: Passed
All tests that has been conducted on the Axon-Bus Prosthetic System to ensure that the device meets design specifications, operates as it is intended, and ensures that safety functions and features operate as they are intended were passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
ottobock.
510(k) Summary Axon-Bus Prosthetic System
Project document Nr. PB-PP00120100A-641
Page 1 of 13
K123795
510(k) Summary
1 Submitter Information
Manufacturer: Otto Bock Healthcare Product GmbH Establishment Registration: 9615892 Kaiserstrasse 39 Adress: 1070 Vienna Austria Contact Person: Reinhard Wolkerstorfer Regulatory Affairs Manager reinhard.wolkerstorfer@ottobock.com Telephone: +43 1 523 37 86 676 Fax Number: +43 1 523 22 64 Date Prepared: October 8, 2012 Date Revised: May 30, 2014
2 Device Information
| . Trade Name: | Axon-Bus Prosthetic System |
|---|---|
| Common or Usual Name: | Powered, External Upper Limb Prosthetic System |
| Classification Name: | Cutaneous Electrode (21 CFR 882.1320) |
| Classification Product Code: | GXY (Electrode, Cutaneous) |
| Subsequent Product Code: | IQZ (Hand, External Limb Component, Powered) |
3 Identification of Legally Marketed Predicate Devices
| Name: | MyoSystem with Customizing |
|---|---|
| Manufacturer: | Otto Bock HealthCare Products GmbH |
| 510k Number: | K032833 |
| Date Cleared: | June 3rd, 2010 |
| Name: | i-limb System |
|---|---|
| Manufacturer: | Touch Bionics, Inc. |
| 510k Number: | - |
| Date Cleared: | - |
JUN 0 3 2014
1
| Name: | Pro Hand System |
|---|---|
| Manufacturer: | Motion Control, Inc |
| 510k Number: | - |
| Date Cleared: | - |
| Name: | Bebionic System |
| Manufacturer: | RSL Steeper |
| 510k Number: | - |
| Date Cleared: | - |
4 Description of the Device
4.1 General Description
The Axon-Bus Prosthetic System is to be used exclusively for upper limb exoprosthetic fitting. The Axon-Bus Prosthetic System is suitable for unilateral amputations starting with the transradial/transhumeral amputation level or, in case of dysmelia, for forearm or upper arm fittings.
The Axon-Bus prosthetic system was developed for everyday use and must not be used for unusual activities. These unusual activities include, for example, sports with excessive strain and/or shocks to the wrist unit (pushups, downhill, mountain biking) or extreme sports (free climbing, paragliding, etc.). Furthermore, the Axon-Bus prosthethic system should not be used for the operation of motor vehicles, heavy equipment (e.g. construction machines), industrial machines or motor-driven equipment. The prosthesis is intended exclusively for use on one patient. Use of the product by another person is not approved by the manufacturer. Fitting a patient with the Axon-Bus prosthetic system may only be carried out by a prosthetist who has been authorized by Ottobock after completion of a corresponding training course.
System Components:
- Michelangelo Hand (terminal device) .
- AxonFlexion Adapter (passive flexion) .
- . AxonRotation Adapter (passive rotation)
- AxonArm (passive elbow joint with mechanical and/or electrical lock) .
- AxonEnergy Integral (battery) .
- AxonCharge (charger) �
- AxonMaster (control unit) .
- Electrode (detecting EMG Input signals) .
- AxonSoft (adjustment software) .
- ♥ AxonSkin (prosthetic glove)
4.2 Device Functions
The components of the Axon-Bus Prosthetic System are assembled by a prosthetist according to the individual needs of the amputee.
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Adjustments to the prosthesis components can be performed through Bluetooth® data transfer using the AxonSoft software. The Bluetooth module is integrated into the control unit. The program is selected for the respective user situation from among four control option.
The adjustment software running on a personal computer allows the prosthetist to adjust the settings of the system by selecting the right program from among four control option.
The hand component contains two drives. The main drive of the hand component is responsible for the gripping movements and gripping force. Actively driven elements are the thumb, index finger and middle finger while the ring finger and little finger passively follow the other fingers. The thumb drive permits electronic positioning. Rotating the thumb outward creates a wide open palm, so that additional movement options are possible.
Flexion and extension (bending and stretching) are based on the relaxed wrist (flexible mode). Pronation and supination (inward and outward rotation) can be passively performed by the user.
The elbow component allows passive flexion and extension. Locking and unlocking is carried out mechanically (e.g., by means of body harnesses) or electrically (e.g., by means of electrode).
| Feature | OPEN | CLOSE | Indication |
|---|---|---|---|
| Channel | Input signal no. 2 | Input signal no. 1 | For patients with 2 |
| (strong) electrode | |||
| signals | |||
| Needed signals | Sustained electrode | ||
| signal | Sustained electrode | ||
| signal. | |||
| Application of gripping | |||
| force | N.A. (no gripping force | ||
| applied during opening | |||
| of the hand) | Proportional, according | ||
| to strength of the | |||
| electrode signal | |||
| (resulting from the | |||
| muscle contraction). | The neutral position of | ||
| the Michelangelo Hand | |||
| is the initial position for | |||
| Opposition Mode and | |||
| Lateral | |||
| Mode. | |||
| Application of gripping | |||
| speed | Proportional, according to strength of the electrode | ||
| signal (resulting from the muscle contraction). | |||
| Stopping | No electrode signal |
4.3 Description and Comparison of the Control Options
Comparison of this control option with the predicate devices:
No differences (all predicate devices and the Axon-Bus Prosthetic System (2-Multi) are controlled proportional (gripping force and gripping speed) with 2 electrodes.
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Page 4 of 13
| Control Option 2 - "2-ELE" | |||
|---|---|---|---|
| Feature | OPEN | CLOSE | Indication |
| Channel | Input 2 | Input 1 | For patients with 2 |
| (weak) electrode | |||
| signals. | |||
| Needed signals | Sustained electrode | ||
| signal | Sustained electrode | ||
| signal. | |||
| Application of gripping | |||
| force | N.A. (no gripping force | ||
| applied during opening | |||
| of the hand) | Proportional, according | ||
| to strength of the | |||
| electrode signal | |||
| (resulting from the | |||
| muscle contraction). | The open position of the | ||
| Michelangelo Hand is | |||
| the initial position for | |||
| Lateral Mode, | |||
| Opposition | |||
| Mode and Neutral | |||
| Mode. | |||
| Application of gripping | |||
| speed | Proportional, according to strength of the electrode | ||
| signal (resulting from the muscle contraction). | |||
| Stopping | No electrode signal |
Comparison of this control option with the predicate devices:
Both, Pro Hand System and the Axon-Bus Prosthetic System (2-ELE) can be controlled with reduced proportionality (gripping force and gripping speed) with 2 electrodes. The MyoSystem with Customizing offers reduced proportionality for only 1 electrode. No detailed information about other predicate devices.
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Page 5 of 13
| Establishing digital control option (using and adjustment of "2-ELE") | |||
|---|---|---|---|
| Feature | OPEN | CLOSE | Indication |
| Channel | Input 2 | Input 1 | For patients with 2 very |
| weak electrode signals. | |||
| Needed signals | Sustained electrode | ||
| signal | Sustained electrode | ||
| signal. | |||
| Application of gripping | |||
| force | N.A. (no gripping force | ||
| applied during opening | |||
| of the hand) | Time proportional: The | ||
| level of the gripping | |||
| force is determined by | |||
| the duration of the | |||
| electrode signal | Adjust working range | ||
| according to the weak | |||
| electrode signals -> if | |||
| selected threshold is | |||
| reached, constant | |||
| gripping force and | |||
| constant gripping speed | |||
| are applied (digital | |||
| behavior). | |||
| Application of gripping | |||
| speed | constant speed by | ||
| means of a muscle | |||
| signal at any level | |||
| exceeding the adjusted | |||
| threshold | constant speed by | ||
| means of a muscle | |||
| signal at any level | |||
| exceeding the adjusted | |||
| threshold | |||
| Stopping | No electrode signal | The open position of the | |
| Michelangelo Hand is | |||
| the initial position for | |||
| Lateral Mode, | |||
| Opposition | |||
| Mode and Neutral | |||
| Mode. |
Comparison of this control option with the predicate devices:
Both, MyoSystem with Customizing and the Axon-Bus Prosthetic System (using and adjustment of control option "2-ELE") are controlled with constant speed and time proportional gripping force with 2 electrodes. No detailed information about other predicate devices.
| Control Option 3 - "1-Vario" | |||
|---|---|---|---|
| Feature | OPEN | CLOSE | Indication |
| Channel | Input 1 | For patients with 1 | |
| Needed signals | Increasing signal | ||
| through muscle | |||
| contraction | Declining signal through | ||
| muscle relaxation | (strong) electrode signal | ||
| The open position of the | |||
| Michelangelo Hand is | |||
| Application of gripping | |||
| force | N.A. (no gripping force | ||
| applied during opening | |||
| of the hand) | Proportional to the | ||
| decline of the electrode | |||
| signal | the initial position for | ||
| Lateral Mode, | |||
| Opposition | |||
| Application of gripping | |||
| speed | Proportional: | ||
| The speed is determined by the speed and strength | |||
| of the muscle contraction/relaxation. | Mode and Neutral | ||
| Mode. | |||
| Stopping | Through very slow muscle relaxation via the | ||
| electrode. |
Comparison of this control option with the predicate devices:
Pro Hand System, MyoSystem with Customizing and the Axon-Bus Prosthetic System (1-Vario) are controlled with increasing/declining signals with 1 electrode. No detailed information about other predicate devices.
5
| Control Option 4 - "1-Double" | |||
|---|---|---|---|
| Feature | OPEN | CLOSE | Indication |
| Channel | Input 1 | For patients with 1 strong electrode signal | |
| Needed signals | with a fast and strong signal | with a slow, gentle signal | The open position of the Michelangelo Hand is the initial position for Lateral Mode, |
| Opposition Mode and Neutral Mode. | |||
| Application of gripping force | N.A. (no gripping force applied during opening of the hand) | determined by the duration of the electrode signal | |
| Application of gripping speed | Constant | ||
| Stopping | No electrode signal |
Comparison of this control option with the predicate devices:
Pro Hand System, MyoSystem with Customizing and the Axon-Bus Prosthetic System (1-Double) are controlled with time proportional gripping force and constant gripping speed with 1 electrode. A high or strong muscle signal opens the hand, and a low signal closes the hand. No detailed information about other predicate devices.
4.4 Description and Comparison of Switching Methodes
The AxonMaster offers five switching methodes. The prosthetist selects the switching methodes according to the user needs. The switching events are triggered by muscle signals of the user. As a result of a triggered switching event the user can switch between different joints and gripping patterns.
| Method | Co-
Contraction | Four-Channel
Control | Pulse | Long Open | Automatic
Switching after
Neutral Position is
Reached |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Description | | | | | |
| Required
signals | 2 | 2 | 1 | 1 | 0 (no signal
required, switching
after neutral position
is reached) |
| Indication | For patients
with co-
contraction
ability | For patients with 2
fast HI signals | For
patients
with one
HI signal | For patients who
can maintain the
open hand
position with a
high signal. | For patients who
have a preferred
type of grip |
| Execution | Both
electrode
signals
must
exceed the
co-
contraction
thresholds
within a
certain time,
and then
decline. | Quick and strong
signals from either
electrode controls
one joint or gripping
pattern. Slow and
weak signals from
either electrode
controls another
joint. | The
electrode
signal
must
exceed
the pulse
threshold
and then
decline. | The electrode
signal for
opening must be
held at the value
for the maximum
speed for a
certain period of
time when the
hand is already
fully open. | Switching is
triggered after the
neutral position has
been reached and a
certain delay time
has passed. |
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Comparison of the switching methods with the predicate devices:
Co-Contraction:
No differences, all predicate devices and the Axon-Bus Prosthetic System offer Co-Contraction switching mode
Four-Channel Control:
The MyoSystem with Customizing and the Axon-Bus Prosthetic System offer Four-Channel Control for switching between the joints.
Pulse:
The i-limb System uses double and triple impulse for switching. The Axon-Bus Prosthetic System uses single impulse for switching.
Long Open:
The Bebionic System and the Axon-Bus Prosthetic System offer the long opening method for switching between the grip patterns.
Switching when Neutral Position is reached:
No predicate device uses this switching method.
4.5 Technological and Performance Characteristics
| System | ||
|---|---|---|
| Power Source | rechargeable battery | |
| PC Software for adjustment | Yes | |
| Software/Firmware/ Microprocessor Control? | Yes | |
| Hand | ||
| Operating temperature [°C] | -10 to +60 | |
| Weight [g] | 600 (incl. Passive flexion and rotation) | |
| max. Gripping force (opposition mode) [N] | 70 | |
| max. Gripping force (lateral mode) [N] | 60 | |
| max. Gripping force (neutral mode) [N] | 15 | |
| max. Grip Speed [mm/s] | 325 | |
| max. Opening Width [mm] | 120 | |
| Battery | ||
| Chemistry | Li Ion | |
| Number of cells | 3 | |
| Battery capacity [mAh] | various (1150 / 1500) | |
| Nominal voltage [V] | 11,1 | |
| Charging time [hrs] | max. 3,5 | |
| Battery weight [g] | 142 | |
| Battery dimensions (LxWxH) [mm] | various (75x60x21 / 55x35x23) | |
| Installation | integrated | |
| Electrode | ||
| Electrode Temp. Range | -15°C to 60°C | |
| Material | ||
| of Main | Housing | Plastics (ASA) |
| Contact Area | Titanium (Grade 1) | |
| Pad | Silicone | |
| Bonding Agent | Cyanacrylate | |
| Frequency Bandwidth [Hz] | 90 - 450 | |
| Adjustment | Potentiometer 1-7 | |
| Installation | suspension arms / suction socket | |
| Dimensions [mm] | 27 x 18 x 9,5 | |
| Elbow | ||
| Elbow Temp. Range [°C] | 0 to 60 | |
| Automatic Forearm Balance | Yes | |
| Lock | Mechanical electric |
7
| Maximum vertical load with locked elbow joint and
| a forearm length of 305 mm / 12 inch [kg] | 23 |
|---|---|
| Weight [g] (without hand, wrist and battery) | 750 |
| Max. forearm length [mm] | 305 |
| Flexion angle [°] | 15 - 145 |
The Axon-Bus Prosthetic System offers the following functions:
- Multiple control strategies .
- O Different Control Options available for individual patient needs
- Different grip patterns .
- Power grip o
- Three-Point grip O
- Two-Point grip 0
- Rest position 0
- o Two Thumb positions
- Passive wrist functions .
- Mechanical and electrical elbow lock .
4.6 Comparison to Predicate Devices
The Axon-Bus Prosthetic System has similar intended use and technical features compared to the predicate devices listed above.
4.6.1 Similarities
The subject device shows the following similarities in functional performance:
Available control options:
| Similarity: | Various control options available for individual patient needs |
|---|---|
| Description: | All devices allow the selection of various control strategies. Regarding application of |
| gripping force and gripping speed all devices allow the selection of proportional control | |
| methods. The Axon-Bus Prosthetic System and the MyoSystem with Customizing also allow | |
| the selection of digital control methods (time proportional application of gripping force and | |
| constant gripping speed). | |
| Regarding number of input channels all devices allow the control via 2 individual electrode | |
| signals. Pro Hand System, MyoSystem with Customizing and the Axon-Bus Prosthetic | |
| System allow also the control via 1 electrode signal. |
Available switching methodes:
Various switching methodes available for individual patient needs Similarity:
All devices allow the patient to switch between various joints and gripping patterns. All Description: devices offer the Co-Contraction switching method. The MyoSystem with Customizing and the Axon-Bus Prosthetic System offer Four-Channel Control for switching between the joints. The Bebionic System and the Axon-Bus Prosthetic System offer the long opening method for switching between the grip patterns.
Available grip patterns:
Similarity: Various grip patterns available for individual patient needs
All devices allow the patient to use various grip patterns. All devices allow power grip which Description: allows holding objects with large diameters. In addition all devices allow a two-point grip, whereby objects can be fixated between two fingers. The Axon-Bus prosthetic System also allows a three point grip (also supported by i-limb System and Bebionic System), which allows the user to fixate small objects. The Axon-Bus Prosthetic System, the i-limb System and the Bebionic System allow the user to switch between 2 individual thumb positions, whereby the users can switch between opposition and lateral grip. The Axon-Bus Prosthetic
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System, the i-limb System and the Bebionic System allow the user to use a rest position, which gives the hand a natural and physiological appearance.
Passive wrist functions
Similarity: Passive rotation and flexion of the wrist available
All devices allow the patient to rotate the wrist joint passive. The Pro Hand System and the Description: Axon-Bus Prosthetic System also allow passive flexion of the wrist joint. Due to wrist rotation pro- and supination of the hand is possible.
Mechanical and electrical elbow lock
Similarity: Mechanical and electrical locking mechanism available for the elbow joint Description: The MyoSystem with Customizing and the Axon-Bus Prosthetic System allow mechanical and electrical lock of the elbow joint. The Bebionic System allows electrical lock of the elbow joint.
4.6.2 Differences and Comparison
The subject device shows the following differences:
| Weight of Hand: | Description
& Comparison: | The Axon-Bus Prosthetic System's hand is a little bit heavier in weight compared to the
predicate devices. |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Discussion: | This is because the Axon-Bus Prosthetic System supports also passive flexion for the wrist.. |
| Grip Forces: | Description
& Comparison: | Grip forces vary for the different devices. |
| | Discussion: | The Axon-Bus Prosthetic System's grip forces for the different types of grips are at least
higher than compared to one or more predicate devices. The deviations in grip force do not
result in any risk for the user. |
| Speed: | Description
& Comparison: | Grip Speed varies for the different devices. |
| | Discussion: | The Axon-Bus Prosthetic System's grip speed is higher than compared to all predicate
devices and therefore it does not result in any risk for the user. |
| Battery Characteristics: | Description
& Comparison: | The Axon-Bus Prosthetic System has a rechargeable Li-Ion Battery Pack with 11,1 V. Most
of the predicated devices use rechargeable 7V Li-Ion Battery Packs. |
| | Discussion: | The higher capacity and nominal voltage is needed to provide the performance related to
grip force and grip speed. This also leads to varieties in charging time, weight and
dimensions. None of these deviations do result in any risk for the user. |
| | Material of Electrode Contact Area: | |
| Description
& Comparison: | The contact area of the Axon-Bus Prosthetic System electrode is made up of titanium (grade
1). The electrode of the predicate device (MyoSystem with Customizing) uses stainless steel | |
| Discussion: | Titan is known as a material with good biocompatibility properties, and is therefore very
common e.g. for use in implants. Nevertheless, the used material (titanium grade 1) is tested
according to biocompatibility requirements of ISO 10993. | |
| | Material of other Parts Contacting Patient Skin (Electrode Housing, Silicone Pad): | |
| Description
& Comparison: | The Housing of the Axon-Bus Prosthetic System Electrode is made up of ASA, whereas the
Housing of the predicate device (MyoSystem with Customizing) uses ABS. The Axon-Bus
Prosthetic System Electrode uses also a Silicone Pad. | |
| Discussion: | The used Silicone Pad is certified according to USP Class VI. In addition, all used materials
(ASA, Silicone Pad and Bonding Agent) are tested according to biocompatibility
requirements of ISO 10993. | |
| Index-Point Grip: | | |
| Difference: | The Axon-Bus Prosthetic System does not support an index-point grip. | |
| Description
& Comparison: | The I-limb System offers an Index-Point Grip: thumb, little, ring and middle fingers close and
switch off. Only the index finger will move. This option is particularly useful when operating a
computer keyboard, cell phone or elevator button.
The Bebionic System also offers an index-point grip, where middle, ring and small fingers
close against the palm and the thumb is driven against the middle finger. Once this position
is selected, typing on a keyboard or input pad, pressing a bell or a button can be achieved.
The other predicate devices do not offer this type of grip. | |
| Discussion: | This additional available option of the predicate devices is considered only for special
activities of daily living (e.g. typing on a computer keyboard, etc.). Therefore the difference in
the available grip options does not raise any questions with respect to safety and
effectiveness in comparison to the predicate device. | |
| Switching Method - "Pulse": | | |
| Difference: | The Axon-Bus Prosthetic System offers uses single impulse for switching, whereas the i-limb
System uses double and triple impulse for switching. | |
| Description
& Comparison: | A single impulse (single muscle signal generated by the user) can be selected as switching
method for the Axon-Bus Prosthetic System, and as a result the user can switch between
different joints and gripping patterns. The i-limb System also allows the selection of a
switching method triggered via impulses, but to trigger such a switching the user has to
generate double impulses (two uninterrupted muscle signals) or triple impulses (three
uninterrupted muscle signals).
The other predicate devices do not offer this type of switching method. | |
| Discussion: | This switching method needs only 1 impulse instead of 2 or 3 impulses of the muscle signal.
For the user these switching methods differ only in the number of impulses which must be | |
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510(k) Summary Axon-Bus Prosthetic System
generated. Therefore this difference in the available switching method does not raise any questions with respect to safety and effectiveness in comparison to the predicate device.
| Switching Method - "Automatic Switching after Neutral Position is Reached": | |||||
|---|---|---|---|---|---|
| Difference: | No predicate device uses this switching method. | ||||
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Description
& Comparison: This switching method does not require a muscle signal for triggering Switching is triagered after the neutral position of the hand has been reached, and a certain delay time has passed.
This switching method is for patients who have a preferred type of grip. So it such a Discussion: preferred grip type and this switching method are selected, this helps the user to start the next movement always with the preferred type of grip. Therefore this allows the user to control the prosthetic device more efficiently, but it does not raise any questions with respect to safety and effectiveness in comparison to the predicate device.
Positioning of thumb:
Difference: Electrical rotation of the thumb instead of passive rotation
Description
& Comparison: The Axon-Bus Prosthetic System allows the patient to move the thumb lateral to the index fingers so that the user can grip items from the side. This is established electronically, whereas the i-limb System and the Bebionic System allow this lateral movement of the thumb only in a mechanically way.
The MyoSystem with Customizing and the Pro Hand System do not offer this lateral movement of the thumb (neither electronically nor mechanically).
Discussion: The electrical positioning of the thumb does not require the other hand of the patient for moving the thumb. Therefore this feature helps the patient to control the prosthetic device more efficiently, but it does not raise any questions with respect to safety and effectiveness in comparison to the predicate device.
4.6.3 Conclusion of Comparison to Predicate Devices:
All patient contacting materials of the Axon-Bus Prosthetic System are equivalent to those of the predicates and are in compliance with ISO 10993-1. The subject device is also substantially equivalent to its predicates based on comparison of functional and performance characteristics. The differences of the subject device don't raise any questions with respect to safety and effectiveness of the device.
5 Indications for Use
The Axon-Bus Prosthetic System is to be used exclusively for exoprosthetic fittings of the upper limbs.
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6 Summary of Performance Testing
The following Performance Standards were used for performance testing of the Axon-Bus Prosthetic System:
| No. | Title | Version | Comments |
|---|---|---|---|
| ISO 22523 | External limb prostheses and external orthoses |
- Requirements and test methods | 2006-
10-01 | |
| IEC 60601-1 | Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance | 2005 | Protection against electrical
hazards from ME equipment:
Classification according to
chapter 6, testing according
to chapter 8. |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2:
General requirements for basic safety and
essential performance - Collateral standard:
Electromagnetic compatibility - Requirements
and tests | 2007 | Electromagnetic
Compatibility |
| ISO 10993-1 | Biological evaluation of medical devices
Part 1: Evaluation and testing within a risk
management process | 2009 | Biocompatibility |
| ISO 10993-5 | Biological evaluation of medical devices Part
5: Tests for in vitro cytotoxicity | 2009 | |
| ISO 10993-10 | Biological evaluation of medical devices
Part 10: Tests for irritation and skin
sensitization | 2009 | |
| EN 980 | Symbols for use in the labeling of medical
devices | 2008 | Labeling Symbols |
| IEC 60721-3-2 | Classification of environmental conditions Part
3: Classification of groups of environmental
parameters and their severities - Section 2:
Transport | 1997 | |
| IEC 60068-2-1 | Environmental testing Part 2-1: Tests - Test A:
Cold | 2007 | |
| IEC 60068-2-2 | Environmental testing Part 2-2: Tests - Test B:
Dry heat | 2007 | |
| IEC 60068-2-30 | Environmental testing Part 2-30: Tests - Test
Db: Damp heat, cyclic (12 + 12-hour cycle) | 2005 | |
| IEC 60068-2-78 | Environmental testing Part 2-78: Tests - Test
Cab: Damp heat, steady state | 2001 | Shipping test |
| IEC 60068-2-14 | Environmental testing Part 2: Tests - Test N:
Change of temperature | 1986 | |
| IEC 68-2-64
(EN 60068-2-64) | Environmental testing Part 2-64: Test methods - Test Fh: Vibration, broad-band random
(digital control) and guidance | 1993 | |
| IEC 68-2-27
(EN 60068-2-27) | Environmental testing Part 2-27: Tests - Test
Ea and guidance: Shock | 1987 | |
| IEC 68-2-32
(EN 60068-2-32) | Basic environmental testing procedures Part 2:
Tests - Test Ed: Free fall | 1990 | |
Table 1: Standards used for performance testing
Extensive testing was performed (e.g. software testing and electrical safety tests including EMC). Also biocompatibility testing according to ISO 10993-1 was performed on all patient contacting materials. No clinical studies were performed. Since all samples tested met the acceptance criteria, substantial equivalence has been demonstrated through these tests.
12
ottobock.
In Addition, internal testing regarding performance characteristics of the hand, wrist and elbow has been conducted on the Axon-Bus Prosthetic System to ensure that the device meets design specifications, operates as it is intended, and ensures that safety functions and features operate as they are intended.
| Component | Performance Attribute | Test Result |
|---|---|---|
| Hand | Weight of the prosthesis | Passed |
| Compatibility of components | Passed | |
| Activating and deactivating the system | Passed | |
| Performing different types of grips | Passed | |
| Gripping different sizes of objects, max. opening distance | Passed | |
| Grip force (strength, increase and decrease, maintaining grip force when | ||
| engine not running) | Passed | |
| Positioning speed | Passed | |
| Emergency opening | Passed | |
| Mechanical strength (static and dynamic testing) | Passed | |
| Wrist | Positions of flexion and rotation unit | Passed |
| Mechanical strength (static and dynamic testing, support a specific | ||
| weight) | Passed | |
| Connecting/ disconnecting of flexion adapter to/from rotation adapter | Passed | |
| Elbow | Mechanical strength (static and dynamic testing) | Passed |
| Maintaining position (Maximum holding force): Overload Protection | Passed | |
| Tube Valve | Function of Tube Valve for Suction Socket | Passed |
Table 2: Overview of internal testing regarding performance characteristics
All tests that has been conducted on the Axon-Bus Prosthetic System to ensure that the device meets design specifications, operates as it is intended, and ensures that safety functions and features operate as they are intended were passed.
7 Conclusion
The Axon-Bus Prosthetic System is safe and effective for its intended use. The Axon-Bus Prosthetic System is substantially equivalent to the predicate devices.
13
Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms, possibly representing care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2014
Otto Bock Health Care Products Reinhard Wolkerstorfer Regulatory Affairs Manager Kaiserstrasse 39 1070 Vienna AUSTRIA
Re: K123795
Trade Name: Axon-Bus Prosthetic System Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY, IQZ Dated: May 20, 2014 Received: May 23, 2014
Dear Mr. Wolkerstorfer:
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 I he general condons proving practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3 1558anted or or device complies with other requirements of the Act that I DA has inade a decommiations administered by other Federal agencies. You must
14
Page 2 - Mr. Reinhard Wolkerstorfer
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,
Felipe Aquel -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
15
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K123795
Device Name Axon-Bus Prosthetic System
Indications for Use (Describe)
The Axon-Bus Prosthetic System is to be used exclusively for exoprosthetic fittings of the upper limbs.
Type of Use (Select one or both, as applicable)
[ Prescription Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
ല --- Date: 2014.06.03
21:19:23 -04'00'
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
16
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