(30 days)
The HandiNor HandiVipp is a manually operated device with wheels that is intended for medical purposes to provide mobility to physically challenged persons. The Handivipp is intended for indoor and outdoor use on firm surfaces free of climbing obstacles.
The HandiNor HandiVipp is indicated for individuals with postural challenges e.g. Individuals with Scoliosis, Kyphosis, Cerebral Palsy, Muscular Dystrophy, Multiple Sclerosis, CVA, Spinal Chord injury, Spina Bifida, ALS and similar Neuromuscular and Musculoskeletal pathologies.
The HandiVipp comfort wheelchair, "HandiVipp", is a manually operated, self propelled or attendant propelled mechanical wheelchair. The HandiVipp 's intended use is to provide mobility to persons who may require specialized postural support and tilting features to assist in feeding and pressure relief. It is designed to meet the mobility and positioning needs of individuals with postural challenges e.g. Individuals with Scoliosis, Kyphosis. Cerebral Palsy. Muscular Dystrophy, Multiple Sclerosis and the like.
The HandiVipp frame is constructed from both 22 mm and 18 mm outside diameter (OD) round, mechanical, steel tubing. The side frames are of welded construction and are secured to the remaining frame members using screws and bolts. This device is a rigid wheelchair that incorporates a solid seating surface. The back frame can be folded by releasing a bolt. The seating plate (plain seat) has different hooks and different height levels on the hooks (short (standard), long and plain). This type of seat makes the chair easily adaptable to the various types of wheelchair cushions and seating systems.
Here's the analysis of the provided 510(k) summary for the HandiNor HandiVipp manual wheelchair, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary for a mechanical wheelchair. Medical devices like wheelchairs are typically cleared based on demonstrating substantial equivalence to a predicate device, often through engineering performance testing against recognized standards, rather than clinical trials or AI-specific performance metrics (like sensitivity, specificity, or reader studies). Therefore, many of the requested AI-centric points (like multi-reader multi-case studies, ground truth establishment for training data, etc.) are not applicable to this type of device and submission.
Acceptance Criteria and Device Performance for HandiNor HandiVipp Wheelchair
The HandiNor HandiVipp wheelchair demonstrated compliance with recognized international standards for wheelchairs.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 7176, part 1 | Passed |
| ISO 7176, part 3 | Passed |
| ISO 7176, part 5 | Passed |
| ISO 7176, part 7 | Passed |
| ISO 7176, part 8 | Passed |
| Overall Goal: | Substantially Equivalent to Sunrise Medical Quickie TSR (K952641) |
Notes on the Standards:
- ISO 7176-1: "Wheelchairs – Part 1: Determination of static stability" – Assesses the wheelchair's stability against tipping.
- ISO 7176-3: "Wheelchairs – Part 3: Determination of effectiveness of brakes" – Evaluates the braking system's ability to hold the wheelchair.
- ISO 7176-5: "Wheelchairs – Part 5: Determination of dimensions, mass and manoeuvring space" – Specifies methods for measuring various dimensions, mass, and the space required for maneuvering.
- ISO 7176-7: "Wheelchairs – Part 7: Measurement of seating and wheel dimensions" – Focuses on measuring specific dimensions related to seating and wheels.
- ISO 7176-8: "Wheelchairs – Part 8: Requirements and test methods for static, impact and fatigue strengths" – Assesses the structural integrity, durability, and resistance to impact and fatigue.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "test set" in the context of clinical data. For mechanical device testing against ISO standards, usually, a defined number of production units or prototypes are subjected to the tests. The document doesn't specify this number.
- Data Provenance: The testing was conducted to prove compliance with international ISO standards. The country of origin for the testing itself is not stated, but the submitter (HandiNor as) is from Norway. This is engineering performance data, not patient data, so "retrospective or prospective" is not applicable in the clinical sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable: For this mechanical device, "ground truth" in the clinical AI sense (e.g., expert consensus on medical images) is not relevant. The "ground truth" or standard for comparison is the performance specified by the ISO standards and the predicate device. Compliance with these standards is typically assessed by engineers or testing agencies.
4. Adjudication Method for the Test Set
- Not Applicable: As there are no human-interpreted "test cases" requiring adjudication in the AI sense, this is not relevant. Device performance is determined by passing objective engineering tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: This is a mechanical wheelchair, not an AI or imaging device. Therefore, no MRMC study was performed or is relevant.
6. Standalone (Algorithm Only) Performance Study
- No: This is a mechanical wheelchair. "Algorithm only" performance is not applicable. The device's performance is its physical function and durability in accordance with the specified standards.
7. Type of Ground Truth Used
- Engineering Standards and Predicate Device Performance: The "ground truth" or benchmark for this submission is established by the requirements outlined in the ISO 7176 series of standards (parts 1, 3, 5, 7, and 8) and the performance characteristics of the predicate device (Sunrise Medical Quickie TSR, K952641). The device is deemed safe and effective if it meets these established engineering and safety benchmarks, and is substantially equivalent to the predicate.
8. Sample Size for the Training Set
- Not Applicable: This is a mechanical device, not a machine learning model. There is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set, this question is not relevant.
§ 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).