(248 days)
Not Found
Unknown
The description mentions "specific algorithms" are used to process EMG signals for control, but it does not explicitly state whether these algorithms utilize AI or ML. The lack of information on training/test sets and performance metrics commonly associated with AI/ML further contributes to the uncertainty.
No
The Dexus Prosthetic System is designed to compensate or make up for lost functions of an amputated upper limb, acting as a functional replacement rather than providing therapy to cure or treat a disease or condition.
No
The Dexus Prosthetic System is described as a prosthetic device for external limb fittings, designed to compensate for lost function in upper limb amputees. Its primary function is to enable control of the prosthetic hand through surface electromyography (sEMG) signals, which are then processed to facilitate movement. The device's description, intended use, and functional details all point to it being a therapeutic and assistive device, not one used for diagnosing medical conditions or diseases.
No
The device description explicitly lists multiple hardware components including an electric prosthetic hand, electrodes, cords, battery, adapter plate, and other physical parts. While it utilizes software for signal processing and control, it is not solely software.
Based on the provided text, the Dexus Prosthetic System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Dexus Prosthetic System Function: The Dexus Prosthetic System is an external prosthetic device designed to replace or compensate for the function of a missing upper limb. It uses surface electromyography (sEMG) signals from the user's muscles to control the prosthetic hand.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the body. It interacts with the body externally to interpret muscle signals for control.
Therefore, the Dexus Prosthetic System falls under the category of a prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dexus Prosthetics System is to be used exclusively for external prosthetic fittings of the upper limbs.
Product codes (comma separated list FDA assigned to the subject device)
GXY, IQZ
Device Description
The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs. This Dexus Prosthetic System is suitable for upper limb disabled groups (wrist disarticulated, forearm amputated, congenital missing hand, etc.), for upper limb amputees to compensate or make up for some of the functions of the amputated limb. It applies the surface electromyography (sEMG) signal to realize the control of the upper limb prosthetic device. The collected EMG signals are processed through specific algorithms to achieve the delicate control of the prosthetic hand. The Dexus Prosthetic System is developed to facilitate daily life and must not be used for unusual activities (e.g. sports that may damage the mechanical wrist, like pushups) and should not be used for the operation of motor vehicles, heavy equipment, industrial machines, or motor-driven equipment.
The Dexus Prosthetic System is not suitable for patients with severe disorders of blood clotting mechanism, patients with mental diseases, patients with unhealed wound on the stump, and other patients who are considered medically unable to fit a prosthetic hand.
The Dexus Prosthetic System is intended exclusively for use on one patient. The Dexus Prosthetics System needs to be installed by trained prosthetists to meet the needs of the end-users.
The Dexus Prosthetic system consists of an electric prosthetic hand and a socket (customized according to the stump of the user and does not come with the subject device), two electrodes, electrode patch cord and electrode screw, charging cord, battery cable and adapter plate, heat-shrinkable sleeve, Power switch assembly, some screws and glove.
The Dexus Prosthetic System has a total of 6 degrees of freedom (DOF), the distribution is as follows:
- Thumb (1st finger) DOF: 2 degrees of freedom, which are flexion/extension, ● adduction/abduction, respectively, a combination of them can make the thumb move freely, and the state can be identified;
- Index finger (2nd finger) DOF: 1 degree of freedom, flexion/extension movement;
- Middle finger (3rd finger) DOF: 1 degree of freedom, flexion/extension movement;
- Ring finger (the 4th finger) DOF: 1 degree of freedom, flexion/extension movement;
- Little finger (5th finger) DOF: 1 degree of freedom, flexion/extension movement.
In addition, its gesture functions include Prehensile Grasp, Tipping, Tripod Pinch, Index pointing, Lateral Pinch, and Hook. The functions can be switched through the buttons on the back of the hand.
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
Professional healthcare facility and home use
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)
Summary of Non-Clinical Tests:
Dexus Prosthetics System has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1 and IEC 60601-1-11 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- Safety test of lithium battery according to IEC 62133-2 standard
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- A Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
Summary of Clinical Performance Test:
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Max. Gripping force: 70N (opposition mode); 60N (lateral mode); 15N (neutral mode)
Max. Grip Speed: 150mm/s
Max. Opening Width: 106mm
Frequency bandwidth: 80 - 500 Hz
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/2 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
September 9, 2022
Zhejiang Qiangnao Technology Co.,Ltd % Cassie Lee Official Correspondent Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 510000 China
Re: K220002
Trade/Device Name: Dexus Prosthetics System (Model: MSL1, MSR1) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY, IQZ Dated: June 8, 2022 Received: June 13, 2022
Dear Cassie Lee:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220002
Device Name
Dexus Prosthetics System (Model: MSL1, MSR1)
Indications for Use (Describe)
The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary for K220002
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 801.92.
1. Submitter's Information
510(k) Owner's Name: Zhejiang Qiangnao Technology Co.,Ltd Establishment Registration Number: Applying Address: Room 201-5, Building 1, No.1818-2, Wenyi West Road, Yuhang Street, Yuhang District, Hangzhou, Zhejiang, China Tel: +(86)15814407855 Contact Person: Boyuan Meng E-mail: boyuan.meng@brainco.cn
Application Correspondent:
Contact Person: Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 E-mail: regulatory@share-info.com
Date of the summary prepared: 8/19/2022
2. Subject Device Information
Type of 510(k): Traditional Common Name: Powered, External Upper Limb Prosthetic System Classification Name: Cutaneous electrode Trade Name: Dexus Prosthetics System Model Name: MSL1, MSR1 Review Panel: Neurology Product Code: GXY, IQZ Regulation Number: 21 CFR 882.1320 Regulatory Class: II
3. Predicate Device Information
Sponsor: Otto Bock Healthcare Products GmbH Trade Name: Axon-Bus Prosthetic System Common Name: Powered, External Upper Limb Prosthetic System
4
Classification Name: Cutaneous Electrode 510(K) Number: K123795 Review Panel: Neurology Product Code: GXY, IQZ Regulation Number: 21 CFR 882.1320 Regulation Class: II
4. Device Description
The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs. This Dexus Prosthetic System is suitable for upper limb disabled groups (wrist disarticulated, forearm amputated, congenital missing hand, etc.), for upper limb amputees to compensate or make up for some of the functions of the amputated limb. It applies the surface electromyography (sEMG) signal to realize the control of the upper limb prosthetic device. The collected EMG signals are processed through specific algorithms to achieve the delicate control of the prosthetic hand. The Dexus Prosthetic System is developed to facilitate daily life and must not be used for unusual activities (e.g. sports that may damage the mechanical wrist, like pushups) and should not be used for the operation of motor vehicles, heavy equipment, industrial machines, or motor-driven equipment.
The Dexus Prosthetic System is not suitable for patients with severe disorders of blood clotting mechanism, patients with mental diseases, patients with unhealed wound on the stump, and other patients who are considered medically unable to fit a prosthetic hand.
The Dexus Prosthetic System is intended exclusively for use on one patient. The Dexus Prosthetics System needs to be installed by trained prosthetists to meet the needs of the end-users.
The Dexus Prosthetic system consists of an electric prosthetic hand and a socket (customized according to the stump of the user and does not come with the subject device), two electrodes, electrode patch cord and electrode screw, charging cord, battery cable and adapter plate, heat-shrinkable sleeve, Power switch assembly, some screws and glove.
The Dexus Prosthetic System has a total of 6 degrees of freedom (DOF), the distribution is as follows:
- Thumb (1st finger) DOF: 2 degrees of freedom, which are flexion/extension, ● adduction/abduction, respectively, a combination of them can make the thumb move freely, and the state can be identified;
- Index finger (2nd finger) DOF: 1 degree of freedom, flexion/extension movement;
- Middle finger (3rd finger) DOF: 1 degree of freedom, flexion/extension movement;
- Ring finger (the 4th finger) DOF: 1 degree of freedom, flexion/extension movement;
- Little finger (5th finger) DOF: 1 degree of freedom, flexion/extension movement.
In addition, its gesture functions include Prehensile Grasp, Tipping, Tripod Pinch, Index pointing, Lateral Pinch, and Hook. The functions can be switched through the buttons on the back of the
5
hand.
5. Intended Use / Indications for Use
The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs.
6. Test Summary
6.1 Summary of Non-Clinical Tests
Dexus Prosthetics System has been evaluated the safety and performance by lab bench testing as following:
- ≫ Electrical safety test according to IEC 60601-1 and IEC 60601-1-11 standards
-
Electromagnetic compatibility test according to IEC 60601-1-2 standard
-
Safety test of lithium battery according to IEC 62133-2 standard
-
Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- A Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
6.2 Summary of Clinical Performance Test
No clinical study is included in this submission.
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Dexus Prosthetics System is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Manufacturer | Zhejiang Qiangnao | ||
| Technology Co.,Ltd | Otto Bock Healthcare | ||
| Products GmbH | -- | ||
| Trade Name | Dexus Prosthetic System | Axon-Bus Prosthetic | |
| System | -- | ||
| Models | MSL1, MSR1 | -- | -- |
| 510(k) Number | K220002 | K123795 | -- |
| Classification Name | Cutaneous electrode | Cutaneous electrode | Same |
| Classification Product | |||
| Code | GXY | GXY | Same |
| Subsequent Product | |||
| Code | IQZ | IQZ | Same |
| Intended Use / Indications | |||
| for Use | The Dexus Prosthetic | ||
| System is to be used | The Axon-Bus Prosthetic | ||
| System is to be used | Same | ||
| Elements of Comparison | Subject Device | Predicate Device | Verdict |
| exclusively for external | |||
| prosthetic fittings of the upper | |||
| limbs. | exclusively for | ||
| exoprosthetic | |||
| fittings of the upper limbs. | |||
| Principle of operation | Detect, process, and transmit | ||
| physiological signals for use | |||
| with a prosthesis and controls | |||
| the terminal device. | Detect, process, and | ||
| transmit physiological | |||
| signals for use with a | |||
| prosthesis and controls the | |||
| terminal device. | Same | ||
| System Components | Dexus Hand (terminal | ||
| device) | |||
| Dexus Wrist (passive | |||
| rotation) | |||
| Dexus Power (battery) | |||
| Dexus Charge (charger) | |||
| Dexus Center (control unit) | |||
| Dexus Electrode (detect | |||
| EMG signals) | |||
| Dexus Skin (prosthetic glove) | 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) | Similar | ||
| Note 1 | |||
| Environment of Use | Professional healthcare | ||
| facility and home use | Professional healthcare | ||
| facility and home use | Same | ||
| Assembling procedure | Components are assembled | ||
| by a prosthetist | Components are | ||
| assembled by a prosthetist | Same | ||
| Technological Characteristics - System | |||
| Signal acquisition | EMG electrode | EMG electrode | Same |
| Power Source | Rechargeable battery | Rechargeable battery | Same |
| Adjustment software | No | Yes | |
| AxonSoft | Different | ||
| Note 2 | |||
| Software/Firmware/Micropr | Yes | Yes | Same |
| Elements of Comparison | Subject Device | Predicate Device | Verdict |
| ocessor Control? | |||
| Terminal device (e.g., Hand, wrist or elbow) included? | Yes | Yes | Same |
| Wireless Communication | No | Yes | |
| Bluetooth | Different | ||
| Note 2 | |||
| Technological Characteristics - Hand | |||
| Operating temperature | +5°C to +40°C | -10°C to +60°C | Different |
| Note 3 | |||
| Weight | 530g | 600g (incl. Passive flexion and rotation) | Different |
| Note 3 | |||
| Max. Gripping force | 70N (opposition mode) | ||
| 60N (lateral mode) | |||
| 15N (neutral mode) | 70N (opposition mode) | ||
| 60N (lateral mode) | |||
| 15N (neutral mode) | Same | ||
| Max. Grip Speed | 150mm/s | 325mm/s | Different |
| Note 4 | |||
| Max. Opening Width | 106mm | 120mm | Different |
| Note 3 | |||
| Technological Characteristics - Electrode | |||
| Dimensions | 34.5mm x 16mm x 11.5mm | 27mm x 18mm x 9.5mm | Different |
| Note 3 | |||
| Operating temperature | 0°C - 40°C | -15°C to +60°C | Similar |
| Note 3 | |||
| Material | Polycarbonate: PC2858, | ||
| Thermoplastic Elastomer: | |||
| TM5ADT and Metal Pieces | |||
| (Copper gold plated): | |||
| C1SQIN | Piastics (ASA) | ||
| Silicone | |||
| Cyanacrylate | Different | ||
| Note 5 | |||
| Contact area | Copper gold plated | Titanium (grade 1) | Different |
| Note 5 | |||
| Frequency bandwidth | 80 - 500 Hz | 90 - 450 Hz | Similar |
| Note 4 | |||
| Adjustment | None | Potentiometer 1-7 | Different |
| Note 3 | |||
| Installation | Suction socket | Suspension arms/suction socket | Same |
| Technological Characteristics - Battery | |||
| Chemistry | Li Ion | Li Ion | Same |
| Elements of Comparison | Subject Device | Predicate Device | Verdict |
| Number of cells | 2 | 3 | Different |
| Note 6 | |||
| Nominal voltage | 7.4V | 11.1V | Different |
| Note 6 | |||
| Battery capacity | 2200mAh | Various | |
| (1150mAh/1500mAh) | Different | ||
| Note 6 | |||
| Charging time | Max.3.0h | Max.3.5h | Different |
| Note 6 | |||
| Battery weight | 110g | 140g | Different |
| Note 3 | |||
| Battery dimensions (LWH) (mm) | 68x38x20 | various (75x60x21 / 55x35x23) | Different |
| Note 3 | |||
| Installation | Integrated | Integrated | Same |
| Safety and Performance Testing | |||
| Electrical Safety | IEC 60601-1:2005/A1:2012 | ||
| IEC 60601-1-11:2015 | IEC 60601-1:2005 | Similar | |
| Note 7 | |||
| Electromagnetic Compatibility | IEC 60601-1-2:2014 | IEC 60601-1-2:2007 | Similar |
| Note 7 | |||
| Biocompatibility | ISO 10993-1:2018 | ||
| ISO 10993-5:2009 | |||
| ISO 10993-10:2010 | ISO 10993-1:2009 | ||
| ISO 10993-5:2009 | |||
| ISO 10993:2009 | Same |
6
7
8
Comparison in Detail(s):
Note 1:
Although the "System Components" of the subject device is different from the predicate device, the difference is that the subject device does not have related components and adjustment software for the elbow joint part. Because the subject device is only suitable for users with residual limbs of the elbow and forearm, not for users with deformed elbow joints, so the subject device is no related components for the elbow joint part. And the adjustment software is for the subsequent adjustment of the assembly posture, but the theme device will adjust the preset posture for the user before assembly. So, the difference will not affect the safety and effectiveness of the subject device.
Note 2:
The "Adjustment software" and "Wireless Communication" of the subject device are different from the predicate device, although there is no adjustment software, wireless function or control method, it is already adjusted in the product when the subject device preset, which will not affect any daily
9
usage. So, the slight difference will not affect the safety and effectiveness of the subject device.
Note 3:
Although the "Operating temperature", "Dimensions", "Max. Opening Width", and "Adjustment" of the subject device are different from the predicate device, all of them meet the requirements of safety and performance standards IEC 60601-1. So, the differences between the predicate device and the subject device will not affect the safety and effectiveness of the subject device.
Note 4:
Although the "Max. Grip Speed" and "Frequency bandwidth" of the subject device are different from the predicate device, all of them meet the requirements of performance requirements. The differences between the predicate device and the subject device will not affect the safety and effectiveness of the subject device.
Note 5:
Although the "Material" and "Contact area" of the subject device are different from the predicate device, all the materials intended to be contacted by the patients of them meet the requirements of ISO 10993 series standards. So, the differences between the predicate device and the subject device will not affect the safety and effectiveness of the subject device.
Note 6:
Although the "Operating temperature", "Dimensions", "Max. Opening Width", and "Adjustment" of the subject device are different from the predicate device, all of them meet the requirements of safety and performance standards IEC 60601-1. So, the differences between the predicate device and the subject device will not affect the safety and effectiveness of the subject device.
Note 7:
Although the subject device and the predicate device use slightly different versions of the test standards, the subject device is in compliance with the currently valid standards. So, the differences between the predicate device and the subject device will not affect the safety and effectiveness of the subject device.
8. Final Conclusion:
The subject device Dexus Prosthetics System has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device K123795.