(63 days)
Not Found
No
The description focuses on sensor-based control and standard performance testing, with no mention of AI or ML algorithms.
No
The device is an auxiliary power module providing augmented power for manual wheelchair users, not for treating a disease or condition.
No
The device is described as an "auxiliary power module to provide augmented power to manual wheelchair users," reducing the effort required for propulsion. Its intended use is to assist with mobility, not to diagnose a medical condition or ailment.
No
The device description clearly outlines hardware components such as an electric drive wheel, sensors (inclinometer, accelerometer), a battery pack, and an actuator. The performance studies also include tests related to hardware performance (e.g., static, impact, and fatigue testing).
Based on the provided information, the Empulse R90 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide power assistance to manual wheelchair users, reducing the effort required for propulsion. This is a physical assistance function, not a diagnostic test performed on biological samples.
- Device Description: The description details a mechanical and electrical system for augmenting wheelchair propulsion. It involves a drive wheel, sensors, battery, and actuator. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The Empulse R90 is clearly a medical device designed to assist with mobility, falling under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Empulse R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The Empulse R90 is an auxiliary power module to provide augmented power to manual wheelchair users. The device utilizes a single electric drive wheel to provide the augmented power. The device mounts to a camber tube (rigid wheelchair) or a compressible axle (folding wheelchair) to provide the assisted power. On-board sensors, including an inclinometer, accelerometer and motor current sensing to determine when the user wishes to move forward and if the system is on an incline or decline. The removable Lithium lon battery pack is easily switched out to an alternate battery pack if additional range is required. The battery can also be removed if the user wishes to reduce the overall weight. The actuator is used to automatically engage and disengage the locking latch as well as compress the pre-load traction spring when the user wishes to disconnect the EMPULSE R90 from the wheelchair. In the extended position, the actuator allows the pre-load spring to provide sufficient pre-load to the drive wheel to ensure sufficient traction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Indoors and outdoors; care facilities and private residences.
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)
The following tests were performed to demonstrate substantial equivalence based on current industry and FDA recognized standards:
- Energy consumption (per ISO 7176-4)
- Maximum speed, acceleration, and deceleration (per ISO 7176-6)
- . Static, impact, and fatigue (per ISO 7176-8)
- Climatic test (per ISO 7176-9)
- Obstacle climbing (per ISO 7176-10)
- Power and control systems for power wheelchairs (per ISO 7176-14)
- Documentation and labeling (per ISO 7176-15)
- EMC testing (per ISO 7176-21)
- . Vocabulary (per ISO 7176-26)
- Alkaline or other non-acid electrolyte batteries safety testing (IEC 62133-2)
- Evaluation and testing within a risk management process (per ISO 10993-1)
- Software life cycle process (per IEC 62304)
Key results: Based on the testing performed, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Empulse R90 Power Assist Device is assessed to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 30, 2022
Sunrise Medical (US) LLC Devin Mcelroy Senior Director Quality Assurance and Regulatory Affairs 2842 N Business Park Ave. Fresno, California 93727
Re: K220213
Trade/Device Name: Empulse R90 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: January 21, 2022 Received: January 26, 2022
Dear Devin Mcelroy:
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.
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
1
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 (OS) 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 mediation-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,
for Heather Dean, PhD 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
2
Indications for Use
510(k) Number (if known) K220213
Device Name Empulse R90
Indications for Use (Describe)
The Empulse R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
DATE PREPARED
January 10, 2021
MANUFACTURER AND 510(K) OWNER
Sunrise Medical (US) LLC 2842 N Business Park Ave., Fresno, CA 93727 USA Telephone: 1-559-294-2374 Official Contact: Mr. Devin I. McElroy, Senior Director Quality Assurance and Regulatory Affairs
REPRESENTATIVE / CONTACT
Devin I. McElroy, Senior Director Quality Assurance and Regulatory Affairs Sunrise Medical (US) LLC 2842 N Business Park Ave., Fresno, CA 93727 USA Telephone: 1-559-294-2374 Email: devin.mcelroy@sunmed.com Website: www.sunmed.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Empulse R90 |
|---|---|
| Common Name: | Power Assist Device |
| Regulation Number: | 21 CFR 890.3860 |
| Class: | II |
| Product Code: | ITI: Powered Wheelchair |
| Premarket Review: | Neurological and Physical Medicine Devices (OHT5) |
| Neuromodulation and Physical Medicine Devices (DHT5B) | |
| Review Panel: | Physical Medicine |
PREDICATE DEVICE IDENTIFICATION
The Empulse R90 is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K151199 | Smart Drive MX2 / Max Mobility (Permobil) | $\checkmark$ |
| K140204 | JWX-2 (Navione) / Yamaha |
DEVICE DESCRIPTION
The Empulse R90 is an auxiliary power module to provide augmented power to manual wheelchair users. The device utilizes a single electric drive wheel to provide the augmented power. The device mounts to a camber tube (rigid wheelchair) or a compressible axle (folding wheelchair) to provide the assisted power. On-board sensors, including an inclinometer, accelerometer and motor current sensing to determine when the user wishes to move forward and if the system is on an incline or decline.
4
The removable Lithium lon battery pack is easily switched out to an alternate battery pack if additional range is required. The battery can also be removed if the user wishes to reduce the overall weight.
The actuator is used to automatically engage and disengage the locking latch as well as compress the pre-load traction spring when the user wishes to disconnect the EMPULSE R90 from the wheelchair. In the extended position, the actuator allows the pre-load spring to provide sufficient pre-load to the drive wheel to ensure sufficient traction.
INTENDED USE
The EMPULSE R90 is designed to be used on both indoor and outdoor environments, smooth flat surfaces, inclined surfaces up to 6 degrees and lightly rough surfaces such as asphalt. It is not designed to be used on highly rough surfaces such as grass or loose soil.
INDICATIONS FOR USE
The Empulse R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Sunrise Medical (US) LLC believes that the Empulse R90 Power Assist Device is substantially equivalent to the predicate devices based on the information summarized here and in Table 5.1:
The subject device has a similar design and dimensions to the device cleared in K151199 and uses similar or identical materials as the devices cleared in K140204. The subject device has the same intended use and similar technological characteristics to the devices cleared in K151199 and K140204. The subject device has the same intended use environment as the devices cleared in K151199 and K140204. The subject device uses similar software to the devices cleared in K151199 and K140204. The Empulse R90 Power Assist Device has undergone testing to ensure that any differences in technological characteristics (e.g., battery, controls, and power assistance) do not negatively affect safety and effectiveness when compared to the predicate devices.
5
| Table 5.1: Table of Technological Comparison | ||||
|---|---|---|---|---|
| Primary Predicate | ||||
| Permobil (Max Mobility) | ||||
| Smart Drive MX2 | Secondary Predicate | |||
| Yamaha JWX-2 (Navione) | Subject Device | |||
| Empulse R90 | Statement of Equivalence | |||
| 1 | ||||
| Intended Use | K151199 | |||
| ITI 890.3860 | ||||
| 30-Jul-15 | K140204 | |||
| ITI 890.3860 | ||||
| 28-Aug-14 | K220213 | |||
| ITI 890.3860 | ||||
| 1.1 Intended Use | Not provided. | The device JWX-2 (Navione) is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force. | The Empulse R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair. | Substantially equivalent to Secondary Predicate. No new issues of safety or effectiveness. |
| 1.2 Indications for Use | The SmartDrive MX2 Wheelchair Power Assist is intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users, including pediatrics. It is intended to be used by users capable of operating and maneuvering a powered and manual wheelchair | The Yamaha JWX-2 is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force. | The Empulse R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair. | Substantially Equivalent to Predicates. No new issues of safety or effectiveness. |
| Primary Predicate | ||||
| Permobil (Max Mobility) | ||||
| Smart Drive MX2 | Secondary Predicate | |||
| Yamaha JWX-2 (Navione) | Subject Device | |||
| Empulse R90 | Statement of Equivalence | |||
| 1.3 Where Used | Indoors and outdoors; | |||
| care facilities and private | ||||
| residences. | Indoors and outdoors; | |||
| care facilities and private | ||||
| residences. | Indoors and outdoors; | |||
| care facilities and private | ||||
| residences. | Identical to Predicates. No | |||
| new issues of safety or | ||||
| effectiveness | ||||
| 2 Safety | ||||
| 2.1 Mechanical Safety | Subject to ANSI/RESNA or | |||
| ISO 7176 Requirements | ||||
| for Power Wheelchairs, | ||||
| where applicable. | Subject to ANSI/RESNA or | |||
| ISO 7176 Requirements | ||||
| for Power Wheelchairs, | ||||
| where applicable. | Subject to ANSI/RESNA or | |||
| ISO 7176 Requirements | ||||
| for Power Wheelchairs, | ||||
| where applicable. | Identical to Predicates. No | |||
| new issues of safety or | ||||
| effectiveness. | ||||
| 2.2 Electrical Safety | Subject to ANSI/RESNA or | |||
| ISO 7176 Requirements | ||||
| for Power Wheelchairs, | ||||
| where applicable. | Subject to ANSI/RESNA or | |||
| ISO 7176 Requirements | ||||
| for Power Wheelchairs, | ||||
| where applicable. | Subject to ANSI/RESNA or | |||
| ISO 7176 Requirements | ||||
| for Power Wheelchairs, | ||||
| where applicable. | Identical to Predicates. No | |||
| new issues of safety or | ||||
| effectiveness. | ||||
| 2.3 Biocompatibility | No indications of | |||
| compliance | Compliant to ISO 10993-1, | |||
| -5 | Compliant to ISO 10993-1, | |||
| -5 (See Section 15 of this | ||||
| submission for details). | Identical to Secondary | |||
| Predicate. No new issues | ||||
| of safety or effectiveness. | ||||
| 3 Overall System | ||||
| 3.1 Weight Capacity | 14 kg to 150 kg | 130 kg | 136 kg | Substantially equivalent to |
| Primary Predicate. No new | ||||
| issues of safety or | ||||
| effectiveness. | ||||
| 3.2 Expected Product Life | 5 years | Not provided | 5 years | Identical to Primary |
| Predicate. No new issues | ||||
| of safety or effectiveness. | ||||
| 4 Mechanical Enclosure and Mounting | ||||
| 4.1 Structural Materials | Aluminum and Steel | Aluminum and steel | Aluminum and steel | Identical to Predicates. No |
| new issues of safety or | ||||
| effectiveness. | ||||
| 4.2 Width | 141 mm | 91mm (both left and right | ||
| wheels) | 150mm | Substantially equivalent to | ||
| Primary Predicate. No new | ||||
| issues of safety or | ||||
| effectiveness. Slightly | ||||
| Primary Predicate | ||||
| Permobil (Max Mobility) | ||||
| Smart Drive MX2 | Secondary Predicate | |||
| Yamaha JWX-2 (Navione) | Subject Device | |||
| Empulse R90 | Statement of Equivalence | |||
| 4.3 Depth | 389mm | Same as height | 310mm | wider width does not |
| interfere with safe | ||||
| operation of manual | ||||
| wheelchairs. | ||||
| 4.4 Height | 242mm | 609 mm (24") | ||
| 559 mm (22") | 377mm – 428mm | Substantially equivalent to | ||
| Primary Predicate. No new | ||||
| issues of safety or | ||||
| effectiveness. | ||||
| 4.5 Overall Mass | 5.7 kg | 17 kg (Ni-MH) | ||
| 17.7 kg (Li-Ion) | 5.5 kg + 1.1 kg (battery) | Substantially equivalent to | ||
| Primary Predicate. No new | ||||
| issues of safety or | ||||
| effectiveness. | ||||
| 4.6 Manual Wheelchair | ||||
| Mount | Rigid: Clamp mount to | |||
| the camber tube. Drive | ||||
| assembly pivotally mount | ||||
| onto clamp. | ||||
| Folding: Same as rigid but | ||||
| with the addition of a | ||||
| cross member that | ||||
| extends horizontally | ||||
| between the two axle | ||||
| plates, thus simulating a | ||||
| camber tube. | Quick Release axle mount. | |||
| One wheel per side. | Rigid: Receiver fixed | |||
| mounted to the camber | ||||
| tube. Drive assembly free | ||||
| to move vertically relative | ||||
| to mount. | ||||
| Folding: Same as rigid but | ||||
| with the addition of a | ||||
| cross member that | ||||
| extends horizontally | ||||
| between the two axle | ||||
| plates, thus simulating a | ||||
| camber tube. | Substantially equivalent to | |||
| Primary Predicate. No new | ||||
| issues of safety or | ||||
| effectiveness. | ||||
| 4.7 Housing Material | Plastic | Aluminum | Plastic | Identical to Primary |
| Predicate. No new issues | ||||
| of safety or effectiveness. | ||||
| 5 Performance | ||||
| Primary Predicate | ||||
| Permobil (Max Mobility) | ||||
| Smart Drive MX2 | Secondary Predicate | |||
| Yamaha JWX-2 (Navione) | Subject Device | |||
| Empulse R90 | Statement of Equivalence | |||
| 5.1 Max Speed (fwd) | 5.5 mph | Not Specified | 5.5 mph | Identical to Primary |
| Predicate. No new issues | ||||
| of safety or effectiveness. | ||||
| 5.2 Max Speed (rev) | N/A | Not Specified | N/A | Identical to Predicates. No |
| new issues of safety or | ||||
| effectiveness. | ||||
| 5.3 Max Safe Slope | As specified by manual | |||
| wheelchair manufacturer | 6° | 6° | Identical to Secondary | |
| Predicate. No new issues | ||||
| of safety or effectiveness. | ||||
| 5.4 Maximum Range on | ||||
| Full Charge | 19.8 km | 20 km (NiMH) | ||
| 40 km (Li-ion) | 19 ± 1.5 km | Substantially equivalent to | ||
| Primary Predicate. No new | ||||
| issues of safety or | ||||
| effectiveness. | ||||
| 5.5 Bluetooth | Bluetooth LE | Not Available | Bluetooth LE 5.2 | Identical to Primary |
| Predicate. No new issues | ||||
| of safety or effectiveness. | ||||
| 6 Power System | ||||
| 6.1 Motor Power | 250 W | 2x 110 W | 250 W | Identical to Primary |
| Predicate. No new issues | ||||
| of safety or effectiveness. | ||||
| 6.2 Battery Type | Li-lon | Ni-MH or Li-Ion | Li-Ion | Identical to Primary |
| Predicate. No new issues | ||||
| of safety or effectiveness. | ||||
| 6.3 Battery Capacity | 122 Whr | 160 Whr (Ni-MH) | ||
| 283 Whr (Li-ion) | 100 Whr – 160 Whr | Substantially equivalent to | ||
| Predicates. No new issues | ||||
| of safety or effectiveness. | ||||
| 6.4 Battery Charger Input | 100-240 Vac, 50/60Hz | 100-240 Vac, 50/60Hz | 100-240 Vac, 50/60Hz | Identical to Predicates. No |
| new issues of safety or | ||||
| effectiveness. | ||||
| 6.5 Battery Charger Output | 2.0 A | 2.6 A | 2.0 A | Identical to Primary |
| Predicate. No new issues | ||||
| Primary Predicate | ||||
| Permobil (Max Mobility) | ||||
| Smart Drive MX2 | Secondary Predicate | |||
| Yamaha JWX-2 (Navione) | Subject Device | |||
| Empulse R90 | Statement of Equivalence | |||
| 6.6 Operating Voltage | 36 Vdc | 24 Vdc | 36 Vdc | of safety or effectiveness. |
| Identical to Primary | ||||
| Predicate. No new issues | ||||
| of safety or effectiveness. | ||||
| 7 Control System | ||||
| 7.1 Control Type | Constant power on. Stop | |||
| and start of power assist | ||||
| is controlled by wrist | ||||
| strap sensor with | ||||
| Bluetooth communication | ||||
| to the drive unit. | Torque sensing handrim | |||
| applies proportional | ||||
| power based on torque | ||||
| applied to the handrim. | ||||
| Power is pulsed on for | ||||
| specified duration. Gain of | ||||
| applied power is | ||||
| adjustable. | The device will sense | |||
| acceleration (torque) and | ||||
| apply a power pulse to the | ||||
| drive motor for a specified | ||||
| duration. Gain of applied | ||||
| power is adjustable. | Substantially equivalent to | |||
| Predicates. No new issues | ||||
| of safety or effectiveness. | ||||
| 7.2 Operating Voltage | 36 Vdc | 24 Vdc | 36 Vdc | Identical to Primary |
| Predicate. No new issues | ||||
| of safety or effectiveness. | ||||
| 7.3 Moisture Resistance | ISO 7176-9 | ISO 7176-9 | ISO 7176-9 | Identical to Predicates. No |
| new issues of safety or | ||||
| effectiveness | ||||
| 7.4 Operating | ||||
| Temperature | -25°C to +50°C | -25°C to +50°C | -25°C to +50°C | Identical to Predicates. No |
| new issues of safety or | ||||
| effectiveness | ||||
| 7.5 Storage Temperature | -40°C to +65°C | -40°C to +65°C | -40°C to +65°C | Identical to Predicates. No |
| new issues of safety or | ||||
| effectiveness | ||||
| 8 EMC | ||||
| 8.1 EMC - Immunity | Compliant to ANSI/RESNA | |||
| WC2-21 or ISO 7176-21 | Compliant to ANSI/RESNA | |||
| WC2-21 or ISO 7176-21 | Compliant to ANSI/RESNA | |||
| WC2-21 or ISO 7176-21 | Identical to Predicates. No | |||
| new issues of safety or | ||||
| effectiveness. | ||||
| 8.2 EMC - Radiated | ||||
| Emissions | Compliant to ANSI/RESNA | |||
| WC2-21 or ISO 7176-21 | Compliant to ANSI/RESNA | |||
| WC2-21 or ISO 7176-21 | Compliant to ANSI/RESNA | |||
| WC2-21 or ISO 7176-21 | Identical to Predicates. No | |||
| new issues of safety or | ||||
| effectiveness | ||||
| Primary Predicate | ||||
| Permobil (Max Mobility) | ||||
| Smart Drive MX2 | Secondary Predicate | |||
| Yamaha JWX-2 (Navione) | Subject Device | |||
| Empulse R90 | Statement of Equivalence | |||
| 8.3 EMC - ESD | Compliant to ANSI/RESNA | |||
| WC2-21 or ISO 7176-21 | Compliant to ANSI/RESNA | |||
| WC2-21 or ISO 7176-21 | Compliant to ANSI/RESNA | |||
| WC2-21 or ISO 7176-21 | Identical to Predicates. No | |||
| new issues of safety or | ||||
| effectiveness. | ||||
| 8.4 Power Frequency | ||||
| Magnetic Field Immunity | Compliant to ANSI/RESNA | |||
| WC2-21 or ISO 7176-21 | Compliant to ANSI/RESNA | |||
| WC2-21 or ISO 7176-21 | Compliant to ANSI/RESNA | |||
| WC2-21 or ISO 7176-21 | Identical to Predicates. No | |||
| new issues of safety or | ||||
| effectiveness. | ||||
| 9 User Input Controls | ||||
| 9.1 On/Off Button | Located on the drive unit | Located on the drive unit | Located on the drive unit | Identical to Predicates. No |
| new issues of safety or | ||||
| effectiveness. | ||||
| 9.3 Speed Up/Speed Down | Available by tapping on | |||
| the wrist control. | ||||
| Maximum speed | ||||
| adjustable through App. | Maximum speed | |||
| adjustable on the drive | ||||
| unit. | Speed adjustable by | |||
| applying an | ||||
| acceleration/retardation | ||||
| torque to the manual | ||||
| wheelchair handrims. | Substantially equivalent to | |||
| Predicates. No new issues | ||||
| of safety or effectiveness. | ||||
| 9.4 Battery state of charge | ||||
| indication | LED Indicator | LED Indicator | LED Indicator | Identical to Predicates. No |
| new issues of safety or | ||||
| effectiveness. | ||||
| 9.5 Programming Tool | Smart phone app | Not programmable | Smart phone app | Identical to Primary |
| Predicate. No new issues | ||||
| of safety or effectiveness. | ||||
| 9.6 Bluetooth functionality | Parameter setting | |||
| Over the air firmware | ||||
| updates | ||||
| Distance, pushes and time | ||||
| tracker | ||||
| Route Tracking | Not available | The Control Box connects | ||
| with the primary drive | ||||
| unit through a wireless | ||||
| Bluetooth connection. The | ||||
| Control Box provides | ||||
| secondary speed increase, | ||||
| speed decrease and motor | ||||
| de-energization through | ||||
| the control box. The | Substantially equivalent | |||
| to the Primary | ||||
| Predicate. No new | ||||
| issues of safety or | ||||
| effectiveness. | ||||
| Primary Predicate | Secondary Predicate | Subject Device | Statement of Equivalence | |
| Permobil (Max Mobility) | ||||
| Smart Drive MX2 | Yamaha JWX-2 (Navione) | Empulse R90 | Control Box also provides | |
| a means to toggle | ||||
| between lifting and | ||||
| deploying the drive wheel | ||||
| actuator. |
Table 5.1: Table of Technological Comparison
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SUMMARY OF NON-CLINICAL TESTING
The following tests were performed to demonstrate substantial equivalence based on current industry and FDA recognized standards.
- Energy consumption (per ISO 7176-4)
- Maximum speed, acceleration, and deceleration (per ISO 7176-6)
- . Static, impact, and fatigue (per ISO 7176-8)
- Climatic test (per ISO 7176-9)
- Obstacle climbing (per ISO 7176-10)
- Power and control systems for power wheelchairs (per ISO 7176-14)
- Documentation and labeling (per ISO 7176-15)
- EMC testing (per ISO 7176-21)
- . Vocabulary (per ISO 7176-26)
- Alkaline or other non-acid electrolyte batteries safety testing (IEC 62133-2)
- Evaluation and testing within a risk management process (per ISO 10993-1)
- Software life cycle process (per IEC 62304) ●
CONCLUSION
Based on the testing performed, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Empulse R90 Power Assist Device is assessed to be substantially equivalent to the predicate devices.