(283 days)
The Elevation Manual Wheelchair is intended to provide mobility to persons limited to a seated position.
The PDG Product Design Group, Inc. Elevation Manual Wheelchair (Elevation) is a manually operated, user propelled, manual, mechanical wheelchair. Its intended function and use is to provide mobility to persons ages 12 and up (adolescents and adults) limited to a seated position. It is an ultra-light, rigid (non-folding frame) type wheelchair.
The device consists primarily of a lower frame assembly, a seat sling, a back rest and back upholstery, large rear wheels with hand rims for self-propelling the chair and front swivel type pivoting casters for turning.
The Elevation also has seat height and back rest recline angle adjustment capability that allow the user to self-adjust either the seat to floor height or the back rest recline angle while seated in the wheelchair. The Elevation is capable of up to 5 inches of rear to front seat height difference.
This document describes the premarket notification for the Elevation Manual Wheelchair (K140023). Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices, particularly those in Class I, the "acceptance criteria" often refer to meeting established safety standards (like ISO standards) and demonstrating substantial equivalence to a predicate device. The "reported device performance" indicates how the new device fulfills these standards and compares to the predicate.
| Item/Specification | Acceptance Criteria (Predicate: ICON Adult Manual Wheelchair K110985) | Reported Device Performance (PDG Product Design Group Elevation) | Discussion (Meeting Criteria) |
|---|---|---|---|
| Indications for Use | Provide mobility to persons limited to a seated position | Same | No difference. Device meets the same intended use. |
| Front Seat to Floor Height | 12"-21" | 19 1/2"-20 1/2" | The Elevation's range is narrower but falls within the predicate's range, indicating acceptable adjustability for its target user population. |
| Caster Size | 3"-6" | 4"x1", 4"x 1.5" or 5"x 1.5" | The Elevation's caster sizes are within the range of the predicate, despite not offering the 3" or 6" options. This is considered acceptable. |
| Rear Wheel Diameters | 24"-25" | 24", 25" and 26" | The Elevation offers a 26" wheel, which the predicate does not. However, the existing common sizes (24", 25") are shared. The 26" wheel is noted as making the chair slightly easier to self-propel, which is considered a non-significant difference in terms of safety or effectiveness, thus meeting acceptance functionally. |
| Seat Width | 12"-19" | 14"-18" | The Elevation's seat widths are within the predicate's range. |
| Seat Depth | 12"-20" | 14"-18" | The Elevation's seat depths are within the predicate's range. |
| User Weight Limit | 250 lbs. | Same | No difference. The device meets the same weight capacity. |
| Chair Weight | 23 lbs. | 25 lbs. (including wheels) | The Elevation is slightly heavier, attributed to gas springs. This 2-pound difference is considered "not significant and has no effect on safety or effectiveness," thus meeting acceptance for practical use. |
| Frame Material | Aluminum, Titanium and Composite | Aluminum | Both use aluminum, which is acceptable. The Elevation uses aluminum entirely while the predicate also offers Titanium and Composite; however, using aluminum is deemed equivalent given its presence in the predicate and its established safety. |
| Upholstery | Polyurethane Foam with Nylon Cover | Same | No difference. Device uses the same upholstery materials. |
| Hand Rims | Aluminum Tubing | Same | No difference. Device uses the same hand rim material. |
| Ultra-Light Frame | Yes | Yes | No difference. Both are ultra-light frames. |
| Back Angle Adjustment | Yes but must be done without user seated in the wheelchair | Yes but can be adjusted with the user in the wheelchair. | While the method differs, both have back angle adjustment. The ability to adjust with the user seated is a new feature. The discussion explicitly states this has "no effect on safety" due to slow gas spring movement and the non-compromise of safety even in case of failure. This demonstrates the new feature meets safety acceptance criteria. |
| Elevating Seat | No | Yes. Seat may be raised and lowered while the user is seated in the wheelchair. | This is a new feature not present in the predicate. Acceptance is based on passing the ISO 7176-1 Static Stability test with the seat in its highest position and the slow, safe operation of gas springs minimizing safety risk in case of failure. |
| Full Frame Design | Yes | No. Frame is in two pieces mounted with gas springs. | The two-piece frame is a design difference from the predicate's full frame. Acceptance is based on the statement that it "has no effect on device safety" and "frame strength is not compromised," implying it met structural integrity standards despite the design change. |
| Non-clinical Standards Testing | Adherence to ISO 7176-1, -3, -5, -7, -8, -13, -15, -16, -22 | Conforms to all listed ISO standards. | Device successfully passed all required non-clinical tests based on recognized international standards for wheelchairs, demonstrating its mechanical safety and performance characteristics meet established criteria. Materials conform to ISO 7176-16. |
The study that proves the device meets the acceptance criteria is a series of non-clinical tests conducted according to international ISO standards. The document explicitly states: "The Elevation Manual Wheelchair has been tested to the following standards."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated as a numerical sample size of devices, but rather indicated by testing "The Elevation Manual Wheelchair" against the listed ISO standards. This implies at least one device was tested to each standard, which is typical for mechanical device performance and safety testing.
- Data Provenance: The testing was non-clinical. The standards are international (ISO), making the origin of the testing methodology international. The manufacturer (PDG Product Design Group, Inc.) is based in Vancouver, British Columbia, Canada, suggesting the device and possibly the testing might have originated there, or at a contracted testing facility. The data is prospective in the sense that the testing was performed on this specific device to demonstrate its compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device. The "ground truth" for a mechanical wheelchair's performance and safety is established by its adherence to internationally recognized engineering and safety standards (ISO standards), rather than expert medical consensus or interpretation of images. The tests themselves are objective measurements against specified criteria within the ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical data or image interpretation where there's subjectivity. For objective mechanical testing against ISO standards, the results are derived directly from the test procedures.
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
Not applicable. An MRMC study is relevant for diagnostic imaging AI devices, not for a manual mechanical wheelchair.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical wheelchair, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance and safety is its conformance to established international safety and performance standards (ISO standards). These standards define the acceptable mechanical properties, stability, braking effectiveness, dimensions, material ignition resistance, etc. The results of non-clinical tests against these standards serve as the objective evidence of "ground truth."
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI or algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As noted above, there is no "training set" for this type of device.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).