(22 days)
Therapeutic effect:
- Provision of out-of-bed seating for disabled persons.
- Transportation of disabled persons from one location to another in a room or in a building or outdoors.
- Transportation of disabled persons in the device in motor vehicles.
Medical conditions for which the device is indicated:
- Post-operative weakness or debility.
- Age-related weakness or debility.
- Paralysis due to stroke, tumour, etc.
- Impairment of function due to MS, ALS, Polio.
- Impairment from physical trauma.
- Impairment from accidents at birth.
Designed to remedy perceived shortfalls in the design of standard wheelchairs, particularly in the category of user safety, the GOVAN+ device's distinctive appearance confirms that it is not meant to be a duplicate of the predicate device.
The provided text describes the GOVAN+ wheelchair and its substantial equivalence to a predicate device, focusing on safety improvements, particularly for transportation in vehicles.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (GOVAN+) |
|---|---|
| Lower center of gravity to prevent tip-over | Tipping doesn't begin until 22° left or right, 27° posterior, 20° anterior; with occupant aboard. |
| Crash-tested to ANSI/RESNA WC VOL.1 Section 19 | Meets or exceeds dynamic test requirements of Section 19 ANSI/RESNA WC VOL.1. |
| Docking system tested to SAE J2249 | Meets or exceeds the requirements of SAE J2249 (when used with the GOVAN+ docking plate accessory). |
| General safety and effectiveness compared to predicate device | Provides an added measure of safety and effectiveness, matches or exceeds the predicate device. |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of a number of wheelchairs or human subjects. The testing is described qualitatively (e.g., "crash-tested repeatedly") and by citing compliance with standards, rather than a specific number of units tested.
- Data Provenance:
- Country of Origin: Not explicitly stated for all tests. Compliance with ANSI/RESNA and SAE standards are mentioned, which are US-based organizations, suggesting testing might have occurred in the US or Canada (company is based in Winnipeg, Manitoba, Canada).
- Retrospective or Prospective: Not specified. Standard compliance testing is typically prospective, involving new products and controlled tests.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable or not specified. This document does not describe a study involving expert review for establishing ground truth as it would for, for instance, image analysis or diagnostic devices. The acceptance criteria are based on engineering and safety standards (ANSI/RESNA, SAE), which are objective and quantifiable, not subject to expert consensus in the same way clinical ground truth is.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Since the 'ground truth' is defined by compliance with established engineering and safety standards, there's no need for an adjudication method involving multiple human readers. The results are based on objective measurements and calculations during standardized tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human interpretation is involved, and the AI's effect on human performance is being evaluated. The GOVAN+ is a physical medical device (wheelchair) and its performance is evaluated against engineering standards.
- Effect Size: Not applicable.
6. Standalone Performance Study (Algorithm Only)
- Standalone Study: Yes, in a sense. The "standalone" performance is assessed by direct compliance with the ANSI/RESNA and SAE standards. The device itself (the GOVAN+ wheelchair) is the "algorithm" in this context, and its physical properties and crashworthiness are tested independently of a human operator, beyond the presence of an occupant for realistic testing conditions. The testing of the device and its docking accessory against these standards represents an evaluation of its intrinsic performance.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the GOVAN+ wheelchair's performance is established by engineering and safety standards. Specifically:
- ANSI/RESNA WC VOL.1 Section 19 for dynamic crash testing of wheelchairs.
- SAE J2249 for wheelchair docking/tie-down systems.
- Observed physical characteristics (e.g., tipping angles).
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not a machine learning or AI device that requires a training set of data. The "training" for the GOVAN+ device comes from its design and engineering principles rather than data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As there's no training set in the AI/ML sense, there's no ground truth established for it. The design and development of the GOVAN+ would have been guided by existing engineering principles, safety regulations, and potentially feedback from users or designers, but this is distinct from establishing a "ground truth" for a data-driven model.
{0}------------------------------------------------
DESCRIPTION OF THE GOVAN+ WHEELCHAIR
Designed to remedy perceived shortfalls in the design of standard wheelchairs, particularly in the category of user safety, the GOVAN+ device's distinctive appearance confirms that it is not meant to be a duplicate of the predicate device.
SUBSTANTIAL EQUIVALENCE IMPERATIVE
It has nonetheless been a constant imperative in the design of the GOVAN+ wheelchair to replicate the features of a standard wheelchair such as the predicate device. In comparison of the GOVAN+ device in its raised seating mode to the specifications of the Tracer EX confirms that this has been achieved. See comparison table on page 169.
: INTENDED USE
Intended use of the GOVAN+ device (see Indications for Use on page 170) parallels usage of the predicate device. More on this in a moment, regarding use in vehicles.
NEW TECHNOLOGY
As might be expected with a new design, the GOVAN+ device incorporates technological characteristics that improve on those of the predicate device and result in a capacity to do the same things even better:
- Lower centre of gravity makes the GOVAN+ device much less prone to 0 tip over - a real safety advantage. Tipping doesn't begin until 22° left or right; 27° posterior, 200 anterior; with occupant aboard.
- o. An ergonomically contoured, deeply padded automotive type seat provides more comfort for the user, especially one who has to sit in the wheelchair for long periods.
- Extensive postural adjustments are convenient to make when change of ರ position is desired.
- The "normal" and handsome appearance of the device makes wheelchair 0 users feel good about themselves, helps reduce the stigma of disability.
These technological features actually reinforce substantial equivalence, providing added safety and effectiveness to the equation, while retaining the original values of the predicate device.
MOBILITY DEVICES IN VEHICLES .
In the real world, there is a massive safety issue in the use of the predicate device and other standard wheelchairs like it to transport disabled people in motor vehicles. Despite disclaimers in owner's manuals saying these devices are not to be used to carry persons in vehicles, it is common practice, and it is dangerous. Crash tests of such devices show what can happen, and it is not pleasant.
{1}------------------------------------------------
The GOVAN+ device, explicitly designed to resolve this problem, has The GOVAN+ device, expiritity and meets or exceeds the dynamic test require= been crash-tested repeatedly and weets of cleared of Color a digest of conments of Section 19 ANST/RESNA WC VOL.1. "Bec page of the May ----------------------------------------------------------------------------------------------------------------
So any vehicle with a compliant 4-point strap tie-down setup - and a lot So any vehicle with a compilance with the occupant aboard and be
of them have it - can carry the GOVAN+ device anchor points integral. of them have it - can carry the Goven, devices « strap anchor points integral.
The GOVAN+ docking plate accessory provides users of the GOVAN+ wheelchair with a much more convenient alternative to the 4-point strap system chair with a much more convenience with the GOVAN wheelchair this Docking if desired. Tested in comination #rent of SAE J2249, the applicable docking/
System meets or exceeds the requirements of SAE J2249, the from the System meets of exceeds the requirem a digest of confirming data from the Cle-down Scandation of University of Michigan, Ann Arbor.
The combination of the GOVAN+ wheelchair and its docking accessory plate, because of its low profile in transit mode, enables company in a ly plate, because of ICS for profile in orailed person in a wheelchair and be fully compliant.
SUBSTANTIALLY EQUIVALENT? INDEED IT IS. AND MUCH MORE.
In use outside a vehicle, with the seat raised, the GOVAN+ device in comparison with the predicate device is remarkably similar in standard Spec-Comparison with the fitting for Use, yet provides an added measure of safety and effectiveness.
The commonplace use of the predicate device in vehicles is positively dangerous, whereas the GOVAN+ device is eminently safe and effective there, having met or exceeded the ANSI/RESNA STANDARD.
So across the whole spectrum, GOVAN+ matches or exceeds the predicate device at its own game, especially in the key characteristics of safety and effectiveness, to achieve substantial equivalence plus.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 8 2001
Mr. Don Logan President Accufast, Inc. 251 Cree Crescent Winnepeg, Manitoba, Canada R3J 3X4
Re: K011752 Trade Name: Regulation Number: 890.3850 Regulatory Class: I Product Code: IOR Dated: June 4, 2001 Received: June 6, 2001
Dear Mr. Logan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
{3}------------------------------------------------
Page 2 - Mr. Don Logan
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mihhailovs
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
2
Enclosure
{4}------------------------------------------------
Attachment I b
Page 5 of 72
నేన
K011752 510(k) Number (if known):
GOVAN+ Wheelchair and docking accessory Device Name:_
Indications For Use:
Therapeutic effect:
- Provision of out-of-bed seating for disabled persons. 1)
- disabled persons from one location to another Transportation of 2) building or outdoors. in a room or in a
- Transportation of disabled persons in the device in motor vehicles. 3)
Medical conditions for which the device is indicated:
- Post-operative weakness or debility. 1)
- Age-related weakness or debility. 2)
- Paralysis due to stroke, tumour, etc. 3)
- Impairment of function due to MS, ALS, Polio. 4)
- Impairment from physical trauma. રે)
Impairment from accidents at birth. ર) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
/s Mahn Mellk
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number. K011752
escription Use __
(Per 21 CFR 801.109)
OR Over-The-Counter Use ✓
(Optional Format 1-2-96)
§ 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).