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The Convaid Trekker models are manual wheelchairs; Their intended use is to provide mobility to persons with disabilities who are partially or permanently non-ambulatory and limited to a sitting position.

In addition the Trekker models TR12T and TR14T comply with the requirements of RESNA WC4:2012-section 19 Wheelchairs used as seats in motor vehicles.

The Trekker TR12, TR12T and TR14, TR14T are attendant propelled manual wheelchairs. They are lightweight compact folding wheelchairs with tubular 6061 aluminum frames with removable seating modules for easy transport and stowage. The seating module is also reversible to allow the caregiver the option to observe the user during use.

Front small casters for steering and maneuverability and larger wheels in the rear. A tilt function for pressure relief and the recline function provide adjustability for the lower extremities.

Foot operated wheel locks provide easy operation.

Positioning options include H-harness, two point seat belt, three point seat belt with crotch pad additional non-positioning accessories include under seat storage basket, adjustable I.V. Pole.

Trekker transit option TR12T and TR14T transit models are identical to the TR12 and TR14 except for the factory installation of four (4) tie-down anchors and required labeling. They meet the requirements for use as seating in motor vehicles when used in conjunction with the vehicle supplied four (4) wheelchair tie-down system that attaches to the four (4) transport anchors on the wheelchair and a three (3) point occupant restraint system in accordance with SAE J2249 or WC4:2012 section 18 that creates the shoulder and lap belt combination that attaches to the wheelchair or to the floor of the vehicle.

This document describes the Convaid Trekker manual wheelchairs (TR12, TR14, TR12T, TR14T) and their substantial equivalence to the predicate device, the Convaid Champ (CH10, CH10T). Since this is a 510(k) premarket notification for a Class I device, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving efficacy through clinical studies for a novel device. Therefore, the information provided below will reflect this specific regulatory context.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Convaid Trekker wheelchairs are defined by their compliance with various industry standards, primarily from ANSI-RESNA and ISO. The "reported device performance" is essentially the statement of compliance to these standards and the determination of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a "sample size" in terms of number of manufactured units tested. Instead, it states that Convaid's Trekker manual wheelchairs "meet the applicable performance requirements as specified below," referring to the list of ANSI-RESNA and ISO standards. This implies that testing was conducted on representative units of the Trekker models to demonstrate compliance with these engineering and safety standards. The specific number of units tested per standard is not detailed in this summary.
• Data Provenance: The data provenance is from non-clinical testing conducted by the manufacturer, Convaid Products Inc., to demonstrate compliance with recognized industry standards. The country of origin of the data is implicitly the United States (where Convaid is based and where the FDA evaluates the submission). The testing is prospective in the sense that it was performed specifically for this 510(k) submission to demonstrate compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable to a 510(k) submission for a Class I mechanical device like a wheelchair. "Ground truth" in this context refers to compliance with established engineering and safety standards, which is typically validated through objective laboratory testing and measurements. Expert consensus or clinical adjudication is not typically used to establish ground truth for adherence to these types of performance standards. The "experts" involved would be qualified test engineers and technicians performing the standard-defined tests.

4. Adjudication Method for the Test Set

Not applicable in the context of demonstrating compliance with engineering and safety standards. The "adjudication" is essentially the testing laboratory reporting whether the device passed or failed each specific requirement of the cited standards.

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. This is not an AI-powered diagnostic or assistive device. It is a mechanical wheelchair.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical wheelchair, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this device's acceptance is adherence to the technical, safety, and performance requirements specified in the following industry standards:

• ANSI-RESNA WC 1:2009 series (Sections 1, 5, 7, 8, 11, 13, 15, 16, 22, 26) - These are likely standards related to general wheelchair performance, stability, durability, strength, and other mechanical aspects.
• ANSI-RESNA WC 2:2009-3 (likely for pediatric or specific user group wheelchairs)
• RESNA WC4:2012 section 19 - Specifically for wheelchairs used as seats in motor vehicles (for the Trekker Transit models).
• WCVol.1 section 19:2000 - The equivalent standard for the predicate Champ Transit models.
• ISO 10993-5 (Biocompatibility) - Specifically for in vitro cytotoxicity testing of patient-contacting materials.

The "ground truth" is verified by objective measurements and tests according to the methodology outlined in these standards.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and there is no "training set" in the machine learning sense. The design and manufacturing processes are refined through engineering development and testing, not algorithmic training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set." The design and validation of the device are based on engineering principles and compliance with established standards, which serve as the "ground truth" for its safety and performance.

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Convaid's Champ model CH10 is a lightweight non-ridge high strength aluminum and steel manual wheelchair with a tilt and recline mobility system for everyday indoor and outdoor use on flat firm terrain. The Convaid Champ is a self or attendant propelled device, its' intended function and use is to provide mobility to children with physical disabilities who are frequently or permanently nonambulatory and limited to a sitting position.

In addition the Champ CH10T transit model has been tested and approved for use as seating in a motor vehicle when used in conjunction with an approved fourpoint, strap-type tiedown system per ANSI-RESNA WC-19:2000.

The Champ CH10 and CH10T are lightweight folding aluminum and steel framed wheelchairs with a seating module that can be used with an optional activity base. It contains the same typical components found on most manual wheelchairs. Champ CH10T transit model is the CH10 model with the addition of transport anchors. The CH10T model has been crash tested to WC- Vol 1 section 19:2000 and approved for use as seating in a motor vehicle.

The Convaid Champ Manual Wheelchair (model CH10 and CH10T) is a lightweight folding aluminum and steel framed wheelchair designed to provide mobility for children with physical disabilities. The CH10T transit model includes transport anchors and has been crash-tested for use as seating in a motor vehicle.

Here’s a breakdown of the acceptance criteria and the study proving the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a "test set" in the context of human studies or data. The testing described is primarily non-clinical, evaluating the physical device against established performance standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This section is not applicable as the study involves physical testing against established ISO and RESNA standards, not expert-adjudicated ground truth for a test set of data. The "ground truth" or acceptance criteria are defined by the performance requirements outlined in the standards themselves.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical performance testing against established standards. The determination of whether the device "met applicable requirements" would be made by the testing facility based on objective measurements and compliance with the specified parameters of each standard.

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

This is not applicable. The device is a manual wheelchair, and the described studies are non-clinical performance tests against engineering and safety standards, not an AI-powered diagnostic tool requiring MRMC studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable for a manual wheelchair. The performance tests are performed on the physical device itself.

7. The Type of Ground Truth Used

The ground truth used in this context is the performance thresholds and specifications defined by internationally recognized standards for wheelchairs and medical devices. These include:

• RESNA WC standards (e.g., WC 1:2009-1, 1:2009-3, etc.) for various aspects of wheelchair performance, durability, and safety.
• ANSI-RESNA WC Vol 1 section 19:2000 for crash testing and occupant safety in motor vehicles.
• ISO 10993-5 and ISO 10993-10 for biocompatibility of materials.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no training set for an AI algorithm. The performance evaluation relies on the device's ability to meet the predefined criteria of the mentioned industry standards.

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The Rodeo manual wheelchairs are a tilt in space mobile positioning system for everyday use on flat terrain. They are available in a range of sizes to accommodate a particular fit to the user. It is an attendant propelled device, its' intended function and use is to proved mobility to persons that are limited to a sitting position.
Convaid's Rodeo manual wheelchairs and Sunrise Medical Zippie TS are a tilt in space mobile positioning system for everyday indoor and outdoor use on flat firm terrain. They are available in a range of sizes to accommodate a particular fit to the user. The Convaid Rodeo is a attendant propelled device, its' intended function and use is to proved mobility to persons that are limited to a sitting position. It has a variety of options to control or support the users specific needs.
This device is indicated for individuals with the specific medical conditions Listed, but the indications are not necessarily limited to such conditions: Amputee; Arthritis: Arthrogriposis; Cerebral Palsy; Geriatric conditions; Head injury or trauma; Hemiplegics; Multiple Scierosis; Muscular Dystrophy; Paraplegic; Polio; Quadriplegic; Spina Bifida; StokeJCVA; Tetraplegic; and Other immobilizing or debilitating conditions, including spinal cord injuries and Other lower and upper extremity paralysis

The Rodeo model is constructed of the same materials and contains the same typical components found on most manual wheelchairs. The frame consists primarily of powder coated round tubular steel from 5/8" to 1" diameter, that is welded, bolted and riveted. With 6" front wheels attached to pivoting casters for steering and turning, and 8" wheels in the rear. The product is a lightweight folding or non-rigid type wheelchair, which is designed for everyday indoor or outdoor use on firm terrain. Also available with a transit option for use in approved transport vehicles. The Rodeo offers its users a 10°-45° of adjustable tilt and 90°-105° of seat to back angle adjustment and comes with a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy. Adjustable seat depth, footplate and height of push handle.

The Convaid Rodeo Manual Wheelchair is a Class 1 device that was cleared via the 510(k) pathway (K032402) on September 24, 2003. This submission focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study with performance metrics in the traditional sense of AI/diagnostic devices. Therefore, some of the requested information regarding AI study design is not applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. The "test set" here refers to the physical wheelchairs undergoing non-clinical performance and safety testing, not a dataset of patient data. The quantity of wheelchairs tested is not specified, but it would typically involve representative samples.
• Data Provenance: Not applicable in the context of patient data. The testing refers to engineering and mechanical assessments of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable. The "ground truth" for mechanical performance is established through adherence to standardized testing protocols and measurements, not expert consensus on diagnostic images or patient outcomes.
• Qualifications of Experts: Not applicable. The personnel conducting the tests would be qualified engineers or technicians with expertise in wheelchair testing protocols, but they are not "experts establishing ground truth" in a medical diagnostic sense.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on medical data. For non-clinical device testing, results are typically determined by direct measurement against established objective criteria in the standards.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant to AI/diagnostic imaging devices.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Standalone Study: No, a standalone study (in the context of an algorithm) was not done. This device is a manual wheelchair, not an AI algorithm.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" for this device's performance is objective compliance with established engineering and safety standards (ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards, and California Technical Bulletin CAL 117 for flammability).

8. The sample size for the training set

• Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

• Ground Truth Establishment: Not applicable. There is no training set for this type of device.

Summary of the Study:

The provided information describes a substantial equivalence submission for a manual wheelchair. The core of the "study" demonstrating that the device meets acceptance criteria is non-clinical testing against relevant industry standards. Convaid Products Inc. states that their Rodeo manual wheelchairs meet the applicable performance requirements of ANSI/RESNA WC vol. 1 or ISO 7176 Wheelchair Standards for various aspects like dimensions, fatigue strength, documentation, labeling, and use as seating in motor vehicles (ANSI/RESNA W/C 19). Additionally, the upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy.

The FDA's clearance (K032402) confirms that Convaid demonstrated substantial equivalence to predicate devices (Sunrise Medical's Quickie Model "Zippie TS Folding Model" and Quickie/Zippie Series) based on these non-clinical tests and a comparison of technological characteristics. The equivalence is based on shared performance features, technology, construction, and the absence of new safety and effectiveness issues.

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