(424 days)
The FR-W04 (Luggie Chair) provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.
The FR-W04 (Luggie Chair) is a battery-powered, four-wheeled electric wheelchair intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. The FR-W04 (Luggie Chair) is meant to be used by a single rider weighing up to 360 pounds. The wheelchair is rear-wheel drive and has electric, regenerative electromechanical brakes. The steering and user controls are provided on the armrest for ease of use by the rider. Steering is controlled simply by turning the top controller in the desired direction. There is one lever, and speed knobs on the top controller to control movement speed of the wheel chair. The specification of control method is the same as the predicate device, Freerider FR168-W Power Chair (K033370). The FR-W04 (Luggie Chair) has a controller and one lithium battery. There is also an off-board battery charger, which has also been previously cleared. It has an adjustable seat that has several height adjustments. The specification of battery charger and adjustable seat is the same as the predicate device, Freerider Luggie Super FR-L05 (K151944).
This document is a 510(k) premarket notification for a powered wheelchair, the Luggie Chair (model FR-W04). It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving performance against acceptance criteria for a novel AI or diagnostic device.
Therefore, much of the requested information regarding acceptance criteria, specific study design (MRMC, standalone), expert involvement, and ground truth establishment is not applicable or cannot be extracted from this document, as it pertains to a different type of medical device submission.
However, I can extract the information related to non-clinical testing which serves a similar purpose of demonstrating safety and performance against established standards.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of acceptance criteria in the sense of specific performance metrics (e.g., sensitivity, specificity for a diagnostic device). Instead, it lists various national and international standards against which the device was tested and found to comply. Compliance with these standards is the acceptance criterion for this type of device submission.
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| IEC 6100-4-2 | Passed |
| IEC 6100-4-3 | Passed |
| IEC 6100-4-8 | Passed |
| EN 12184:2009 | Passed |
| EN 55011:2010 | Passed |
| EN55022 | Passed |
| ISO 7176 (multiple sections) | Passed |
| ISO 10993-1 | Passed |
| ISO 10993-5 | Passed |
| ISO 10993-10 | Passed |
| IEC60601-1 | Passed |
| Ground current leakage bench testing | Passed |
| Summary matrix testing | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of "samples" in the way a diagnostic device would have patient cases. The testing was performed on the FR-W04 (Luggie Chair) device itself. It's implied that one or a few units were tested to demonstrate compliance.
- Data Provenance: The testing was "non-clinical testing" conducted for regulatory submission. The document doesn't specify the country of origin of the testing data beyond the manufacturer being in Taiwan. It's retrospective in the sense that the testing was completed prior to submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable: For this type of device (a powered wheelchair), "ground truth" is not established by human experts in the way it is for diagnostic imaging or AI devices. Compliance with engineering and safety standards is determined through objective measurement and testing by qualified test laboratories/personnel.
4. Adjudication Method for the Test Set:
- Not Applicable: As "ground truth" is not established by expert review, there is no adjudication method involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- Not Applicable: This is a physical medical device (powered wheelchair), not an AI or diagnostic application that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is a physical medical device and does not involve an algorithm working in a standalone capacity without a human user.
7. The Type of Ground Truth Used:
- Technical Specifications and Compliance with Standards: The "ground truth" for this device is its adherence to established engineering, safety, and performance standards (e.g., ISO, IEC, EN standards for powered wheelchairs and electrical safety). Performance metrics like maximum speed, braking distance, weight capacity, and incline ability are objectively measured during testing.
8. The Sample Size for the Training Set:
- Not Applicable: This device does not use an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable: As there is no AI algorithm or training set, this information is not relevant.
In summary: The provided document is a 510(k) for a physical medical device (a powered wheelchair). Its acceptance criteria are defined by compliance with a comprehensive set of national and international engineering and safety standards, as demonstrated through non-clinical bench testing. The concepts of "AI models," "human readers," "ground truth experts," and "training/test sets" as outlined in your prompt are not applicable to this type of device submission.
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March 20, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Freerider Corporation Michael Chen R&D Department and Assistant Vice President No. 22 Bengong 5th Road Kang-Shan District, TW
Re: K160139
Trade/Device Name: Luggie Chair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: March 7, 2017 Received: March 17, 2017
Dear Mr. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -S
Carlos L. Peña. PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160139
Device Name Luggie Chair
Indications for Use (Describe)
The FR-W04 (Luggie Chair) provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.
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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510(k) Summary K160139
1. Contact Details
Applicant Name: Freerider Corporation
No. 22, Bengong 5th Road Kang-Shan Dist, Kaohsiung 820, Taiwan
| Contact Name: | Michael Chen |
|---|---|
| Freerider Corporation | |
| No. 22, Bengong 5th Road | |
| Kang-Shan Dist, Kaohsiung 820, Taiwan | |
| Phone: 886-7-6223093 | |
| Fax: 886-7-6230373 |
Date Prepared: Nov 03, 2015
2. Device Name
Trade Name: Luggie Chair Common Name: Powered Wheelchair Classification Code: ITI Regulation Number: 21 CFR 890.3860
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K033370 | ITI | Freerider FR 168-WPower chair | Freerider Corp. |
| K151944 | INI | Freerider FR-L05Luggie Super | Freerider Corp. |
3. Legally Marketed Predicate Device(s)
4. Device Description
The FR-W04 (Luggie Chair) is a battery-powered, four-wheeled electric wheelchair intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. The FR-W04 (Luggie Chair) is meant to be used by a single rider weighing up to 360 pounds. The wheelchair is rear-wheel drive and has electric, regenerative electromechanical brakes. The steering and user controls are provided on the armrest for ease of use by the rider. Steering is
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controlled simply by turning the top controller in the desired direction. There is one lever, and speed knobs on the top controller to control movement speed of the wheel chair. The specification of control method is the same as the predicate device, Freerider FR168-W Power Chair (K033370).
The FR-W04 (Luggie Chair) has a controller and one lithium battery. There is also an off-board battery charger, which has also been previously cleared. It has an adjustable seat that has several height adjustments. The specification of battery charger and adjustable seat is the same as the predicate device, Freerider Luggie Super FR-L05 (K151944).
5. Intended Use/Indications for use
The FR-W04 (Luggie Chair) provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.
| K160139 (subject device) | K033370 (predicate) | K151944 (predicate) | |
|---|---|---|---|
| General DeviceCharacteristics | |||
| Manufacturer | Freerider | Freerider | Freerider |
| Model | FR-W04 (LuggieChair) | FR168W | Luggie Super |
| Indications for Use | The FR-W04(Luggie Chair)providestransportation for anelderly or disabledperson. It can beused in a variety ofindoor and outdoorsettings. | The fr168wpoweredwheelchairprovidestransportationfor an elderlyor disabledperson. It canbe used in avariety ofindoor andoutdoorsettings. | The FR-L05(Luggie Super)providestransportationfor an elderly ordisabled person.It can be used ina variety ofindoor andoutdoor settings. |
| Framework | Folding seat and | Folds for | |
| footrest | transport | ||
| Adjustable height | |||
| Overall Dimensions | |||
| Length (in) | 37.44 | 32 | 39 |
| Width (in) | 23.86 | 22 | 20.7 |
| Height (in) | 30.11-33.11 | 40 (46 withheadrest) | 35.7 |
| Seat Dimensions | |||
| Width (in) | 17 | 16.9 | |
| Depth (in) | 15.43 | 13.2 | |
| Height (in) | 8.98 | 17.3 | |
| Folded Dimensions (ifapplicable) | |||
| Length (in) | 31.73 | 27.76 | |
| Width (in) | 23.86 | ||
| Height (in) | 17 (w/o armrest) | ||
| Wheelchair Weight | |||
| With batteries | 76.56 lbs. | 84.5 lbs. | 67.1 lbs. |
| Without batteries | 71.72 lbs. | 84.5 lbs. | 62.26 lbs. |
| Controller | Dynamic 40A | P&G VSIController | Rhino R-series50 |
| Motor (include output) | 2 | 2 | 1 |
| 24V | 0.339hp | ||
| Batteries | |||
| Quantity | 1 | 2 | 1 |
| Type | Lithium24V, 10.5Ah | 12V, U-1sealed | Lithium24V 10.5 Ah |
| Range per Charge | 8.19 mi (198 lbs.)6.31 miles (360 lbs.) | 25 mi | 10.5 mi (198 lbs)7.25 miles (360 lbs) |
| Charger | Off boardSwitching Mode AC-DC100V~240V 50/60HzOutput :5A | Onboard standard, off board optional4A110V | Off boardSwitching Mode AC-DC100V~240V 50/60HzOutput :5A |
| Actuator | Dynamic LiNX 40A module | ||
| Brake | Electronic regenerative, electromechanical | Electronic regenerative | Electronic regenerative, electromechanic al |
| Minimum braking distance | |||
| Forward (in) | 73.14 | 44.8 | 75.9 |
| Reverse (in) | 30.87 | 47.2 | |
| Max speed | |||
| Forward | 4 mph | 4 mph | 4 mph |
| Reverse | 2.4 mph | 3.8 mph | 2.4 mph |
| Rear Wheels (in) | 2 x 8 | 10 | 2 x 7 |
| Castors (in) | 2 x 7 | 8 | 2 x 6 |
| Anti-tip wheels | 2.55 in | 6 in | Yes |
| Max Weight Capacity | 360 lbs. | 300 lbs. | 360 lbs. |
| Curb Climbing ability | 0.98 in | ||
| Ground clearance | 1.22 in | 2.13 in | |
| Minimum Turning Radius | 30.7 in | 26 in | 41.3 in |
| Maximum Incline (°) | 6 | 5 | 6 |
| Footplates | Foldable | ||
| Armrest Type | Fold up | ||
| Warranty | Provided |
6. Substantial Equivalence Comparison
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The control method of the FR-W04 (Luggie chair) is substantially equivalent to Freerider FR168-W (K033370).
The device features of the FR-W04 (Luggie Chair) and the FR168-W (K033370) are similar. Both are electric wheelchairs that are battery operated and have automatic breaking systems. Operating mode and interface are very similar, the control lever is mounted on an armrest, and directional control is the same as FR168-W (K033370). The differences are as follows: The FR-W04 has an adjustable seat that has several height adjustments. The front and rear wheels are 7" and 8" respectively, smaller than that of the FR168-W (K033370).
The battery with charger and adjustable seat features on the FR-W04 (Luggie Chair) is substantially equivalent to that of the FR-L05 Luggie Super (K151944). The device features of the FR-W04 (Luggie Chair) and the FR-L05 Luggie Super (K151944) are similar. Both are battery operated and have automatic breaking systems. The charger and adjustable seat is the same between the two devices. The differences are as follows: The control lever of the FR-W04 is mounted on the armrest. The FR-W04 does not have a front handle bar and front chassis.
7. Non-clinical Testing
Electromagnetic interference testing was conducted to IEC 6100-4-2, IEC 6100-4-3, IEC 6100-4-8, EN 12184:2009, EN 55011:2010, and EN55022. ISO 7176 testing to multiple sections; Section 1, Section 2, Section 4, Section 5, Section 6, Section 6, Section 7, Section 8, Section 9, Section 10, Section 11, Section 14, Section 14, Section 15, Section 16, and Section 21 was conducted, as well as ISO 10993-1, ISO 10993-5, ISO 10993-10 and IEC60601-1. Additional bench testing related to ground current leakage and summary matrix testing was also conducted. The FR-W04 (Luggie Chair) passed all testing.
8. Clinical Testing
No clinical testing is included in this submission.
9. Conclusion
The safety and effectiveness of the FR-W04 (Luggie Chair) was demonstrated by the
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testing in compliance with national and international standards. The intended use, basic technology, and many features of the FR-W04 (Luggie Chair) are similar to the predicate device. No new issues of safety and effectiveness are raised by the differences between the FR-W04 (subject device), FR168-W (K033370), and FR-L05 Luggie Super (K151944). Therefore, the subject device is substantially equivalent to the predicate devices.
§ 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).