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.

Device Description

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.

AI/ML Overview

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.

Summary

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HandiNor

510(k) Premarket Notification

K033125

HandiVipp

OCT 3 0 2003

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: September 29, 2003 510(k) Number __

Submitter's Name, Address and Contact Person

HandiNor as Heiasvingen 65 N-1900 Fetsund Norway

Contact Person: B. Chiponis President, Lake Shore Consulting, LLC

Trade Name: HandiVipp

Common Name: Manual Wheelchair

Classification Name: Wheelchair, mechanical

Predicate Devices

The HandiNor HandiVipp wheelchair is substantially equivalent to the Sunrise Medical Quickie TSR (K952641).

Intended Use

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Technological Characteristics and Substantial Equivalence

Device Description

Substantial Equivalence Comparison

The HandiNor HandiVipp wheelchair is substantially equivalent to the Sunrise Medical Quickie TSR (K952641).

Performance Data

The HandiNor HandiVipp wheelchair passed all technical requirements identified in ISO 7176: parts 1, 3, 5, 7, and 8.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three abstract shapes that resemble a bird.

Public Health Service

OCT 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

HandiNor USA, Inc. C/o Ms. Barbara Chiponis Lake Shore Consulting, LCC 17610 26th Avenue North Plymouth, Minnesota 55447

Re: K033125

Trade/Device Name: HandiNor HandiVipp Mechanical Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: September 29, 2003 Received: September 30, 2003

Dear Ms. Chiponis:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Page 2 - Ms. Barbara Chiponis

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Millikan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_

Device Name:

Indications for Use:

b Mark N. Milken.

(Division Sign-Off) Division of General, Restorative and Neurological Devi. 510(k) Number_

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 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).