(540 days)
The Axon-Bus Prosthetic System is to be used exclusively for exoprosthetic fittings of the upper limbs.
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. The prosthesis is intended exclusively for use on one patient. 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 provided text describes the Axon-Bus Prosthetic System and its performance testing, but it does not include a study proving that the device meets specific acceptance criteria in the format requested. The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to various performance standards.
Here's an attempt to extract and interpret the information based on the provided text, acknowledging where specific details for the requested format are missing:
The document states, "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." and "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."
This indicates that internal performance testing against design specifications served as the "study" to prove acceptance criteria. However, the specific quantitative acceptance criteria for each "Performance Attribute" are not explicitly listed, only "Passed" as the test result.
1. A table of acceptance criteria and the reported device performance
| Performance Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Weight of the prosthesis | Meets design specifications (not explicitly stated) | Passed |
| Compatibility of components | Meets design specifications (not explicitly stated) | Passed |
| Activating and deactivating the system | Meets design specifications (not explicitly stated) | Passed |
| Performing different types of grips | Meets design specifications (not explicitly stated) | Passed |
| Gripping different sizes of objects, max. opening distance | Meets design specifications (not explicitly stated) | Passed |
| Grip force (strength, increase and decrease, maintaining grip force when engine not running) | Meets design specifications (not explicitly stated) | Passed |
| Positioning speed | Meets design specifications (not explicitly stated) | Passed |
| Emergency opening | Meets design specifications (not explicitly stated) | Passed |
| Mechanical strength (static and dynamic testing) (Hand) | Meets design specifications (not explicitly stated) | Passed |
| Positions of flexion and rotation unit (Wrist) | Meets design specifications (not explicitly stated) | Passed |
| Mechanical strength (static and dynamic testing, support a specific weight) (Wrist) | Meets design specifications (not explicitly stated) | Passed |
| Connecting/disconnecting of flexion adapter to/from rotation adapter (Wrist) | Meets design specifications (not explicitly stated) | Passed |
| Mechanical strength (static and dynamic testing) (Elbow) | Meets design specifications (not explicitly stated) | Passed |
| Maintaining position (Maximum holding force): Overload Protection (Elbow) | Meets design specifications (not explicitly stated) | Passed |
| Function of Tube Valve for Suction Socket | Meets design specifications (not explicitly stated) | Passed |
The document also lists various standards adhered to (e.g., ISO 22523, IEC 60601-1, ISO 10993-1, etc.). The acceptance criteria for these would be compliance with the requirements of each standard. For example, for biocompatibility:
- Biocompatibility (patient contacting materials): Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10.
- Reported Device Performance for Biocompatibility: All patient contacting materials tested according to biocompatibility requirements of ISO 10993 and stated that "Titan (grade 1) is tested according to biocompatibility requirements of ISO 10993", "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." (implicitly "Passed")
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document mentions "all samples tested met the acceptance criteria," but does not specify the number of units or components tested.
- Data Provenance: The testing was "internal testing regarding performance characteristics," implying it was conducted by the manufacturer, Otto Bock HealthCare Products GmbH in Austria. The nature of this testing (retrospective/prospective) and specific country of origin for any "data" beyond internal testing are not detailed. "No clinical studies were performed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as the testing described is primarily engineering/performance-based, not involving "ground truth" derived from expert interpretation in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable/provided for the type of engineering performance testing conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical studies were performed." The device is a prosthetic system, not an AI-assisted diagnostic tool typically evaluated with MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not directly applicable as the device is a physical prosthetic system with embedded software, not a standalone algorithm. The "AxonSoft" (adjustment software) and "AxonMaster" (control unit) are integral parts of the system with human-in-the-loop interaction by the user and prosthetist. Internal testing ensured the device "operates as it is intended, and ensures that safety functions and features operate as they are intended," which implies standalone function within its control scheme.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the internal performance testing was based on engineering design specifications and compliance with recognized international standards (e.g., ISO, IEC). It was not clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
- This information is not applicable/provided as the device is not described as utilizing machine learning or AI that requires a "training set" in the conventional sense. The "AxonSoft" is adjustment software, not explicitly an AI model trained on data.
9. How the ground truth for the training set was established
- This information is not applicable/provided for the reasons stated in point 8.
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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
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| 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) electrodesignals |
| Needed signals | Sustained electrodesignal | Sustained electrodesignal. | |
| Application of grippingforce | N.A. (no gripping forceapplied during openingof the hand) | Proportional, accordingto strength of theelectrode signal(resulting from themuscle contraction). | The neutral position ofthe Michelangelo Handis the initial position forOpposition Mode andLateralMode. |
| Application of grippingspeed | Proportional, according to strength of the electrodesignal (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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| Control Option 2 - "2-ELE" | |||
|---|---|---|---|
| Feature | OPEN | CLOSE | Indication |
| Channel | Input 2 | Input 1 | For patients with 2(weak) electrodesignals. |
| Needed signals | Sustained electrodesignal | Sustained electrodesignal. | |
| Application of grippingforce | N.A. (no gripping forceapplied during openingof the hand) | Proportional, accordingto strength of theelectrode signal(resulting from themuscle contraction). | The open position of theMichelangelo Hand isthe initial position forLateral Mode,OppositionMode and NeutralMode. |
| Application of grippingspeed | Proportional, according to strength of the electrodesignal (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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| Establishing digital control option (using and adjustment of "2-ELE") | |||
|---|---|---|---|
| Feature | OPEN | CLOSE | Indication |
| Channel | Input 2 | Input 1 | For patients with 2 veryweak electrode signals. |
| Needed signals | Sustained electrodesignal | Sustained electrodesignal. | |
| Application of grippingforce | N.A. (no gripping forceapplied during openingof the hand) | Time proportional: Thelevel of the grippingforce is determined bythe duration of theelectrode signal | Adjust working rangeaccording to the weakelectrode signals -> ifselected threshold isreached, constantgripping force andconstant gripping speedare applied (digitalbehavior). |
| Application of grippingspeed | constant speed bymeans of a musclesignal at any levelexceeding the adjustedthreshold | constant speed bymeans of a musclesignal at any levelexceeding the adjustedthreshold | |
| Stopping | No electrode signal | The open position of theMichelangelo Hand isthe initial position forLateral Mode,OppositionMode and NeutralMode. |
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 signalthrough musclecontraction | Declining signal throughmuscle relaxation | (strong) electrode signalThe open position of theMichelangelo Hand is |
| Application of grippingforce | N.A. (no gripping forceapplied during openingof the hand) | Proportional to thedecline of the electrodesignal | the initial position forLateral Mode,Opposition |
| Application of grippingspeed | Proportional:The speed is determined by the speed and strengthof the muscle contraction/relaxation. | Mode and NeutralMode. | |
| Stopping | Through very slow muscle relaxation via theelectrode. |
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.
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| 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-ChannelControl | Pulse | Long Open | AutomaticSwitching afterNeutral Position isReached |
|---|---|---|---|---|---|
| Description | |||||
| Requiredsignals | 2 | 2 | 1 | 1 | 0 (no signalrequired, switchingafter neutral positionis reached) |
| Indication | For patientswith co-contractionability | For patients with 2fast HI signals | Forpatientswith oneHI signal | For patients whocan maintain theopen handposition with ahigh signal. | For patients whohave a preferredtype of grip |
| Execution | Bothelectrodesignalsmustexceed theco-contractionthresholdswithin acertain time,and thendecline. | Quick and strongsignals from eitherelectrode controlsone joint or grippingpattern. Slow andweak signals fromeither electrodecontrols anotherjoint. | Theelectrodesignalmustexceedthe pulsethresholdand thendecline. | The electrodesignal foropening must beheld at the valuefor the maximumspeed for acertain period oftime when thehand is alreadyfully open. | Switching istriggered after theneutral position hasbeen reached and acertain delay timehas 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 | |
| Materialof 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 |
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| Maximum vertical load with locked elbow joint anda 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 ofgripping force and gripping speed all devices allow the selection of proportional controlmethods. The Axon-Bus Prosthetic System and the MyoSystem with Customizing also allowthe selection of digital control methods (time proportional application of gripping force andconstant gripping speed).Regarding number of input channels all devices allow the control via 2 individual electrodesignals. Pro Hand System, MyoSystem with Customizing and the Axon-Bus ProstheticSystem 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 thepredicate 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 leasthigher than compared to one or more predicate devices. The deviations in grip force do notresult 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 predicatedevices 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. Mostof the predicated devices use rechargeable 7V Li-Ion Battery Packs. |
| Discussion: | The higher capacity and nominal voltage is needed to provide the performance related togrip force and grip speed. This also leads to varieties in charging time, weight anddimensions. 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 (grade1). 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 verycommon e.g. for use in implants. Nevertheless, the used material (titanium grade 1) is testedaccording 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 theHousing of the predicate device (MyoSystem with Customizing) uses ABS. The Axon-BusProsthetic 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 biocompatibilityrequirements 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 andswitch off. Only the index finger will move. This option is particularly useful when operating acomputer keyboard, cell phone or elevator button.The Bebionic System also offers an index-point grip, where middle, ring and small fingersclose against the palm and the thumb is driven against the middle finger. Once this positionis 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 specialactivities of daily living (e.g. typing on a computer keyboard, etc.). Therefore the difference inthe available grip options does not raise any questions with respect to safety andeffectiveness in comparison to the predicate device. | |
| Switching Method - "Pulse": | ||
| Difference: | The Axon-Bus Prosthetic System offers uses single impulse for switching, whereas the i-limbSystem uses double and triple impulse for switching. | |
| Description& Comparison: | A single impulse (single muscle signal generated by the user) can be selected as switchingmethod for the Axon-Bus Prosthetic System, and as a result the user can switch betweendifferent joints and gripping patterns. The i-limb System also allows the selection of aswitching method triggered via impulses, but to trigger such a switching the user has togenerate double impulses (two uninterrupted muscle signals) or triple impulses (threeuninterrupted 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: Generalrequirements for basic safety and essentialperformance | 2005 | Protection against electricalhazards from ME equipment:Classification according tochapter 6, testing accordingto chapter 8. |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - Collateral standard:Electromagnetic compatibility - Requirementsand tests | 2007 | ElectromagneticCompatibility |
| ISO 10993-1 | Biological evaluation of medical devicesPart 1: Evaluation and testing within a riskmanagement process | 2009 | Biocompatibility |
| ISO 10993-5 | Biological evaluation of medical devices Part5: Tests for in vitro cytotoxicity | 2009 | |
| ISO 10993-10 | Biological evaluation of medical devicesPart 10: Tests for irritation and skinsensitization | 2009 | |
| EN 980 | Symbols for use in the labeling of medicaldevices | 2008 | Labeling Symbols |
| IEC 60721-3-2 | Classification of environmental conditions Part3: Classification of groups of environmentalparameters 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 - TestDb: Damp heat, cyclic (12 + 12-hour cycle) | 2005 | |
| IEC 60068-2-78 | Environmental testing Part 2-78: Tests - TestCab: 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 - TestEa 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.
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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 whenengine 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 specificweight) | 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.
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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
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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
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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.
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§ 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).