(49 days)
The Hippocampe Wheelchair is a versatile, mechanical wheelchair intended for use on various terrains including sand, grass, gravel, snow, foot/hiking paths, and in water.
The Hippocampe Wheelchair is an all terrain wheelchair suitable for use on various terrains and in water. It can be used on surfaces such as the beach, seaside, snow, mountain pathways, forest, hiking paths, gardens and grass. The Hippocampe Wheelchair is a versatile durable wheelchair that is comprised of the following components.
- Wheel chair t
- Pushbar .
- Trunk harness (optional) .
- Armrest (optional) .
- Headrest (optional) .
- . Skiing kit (optional)
- . Traction kit
- Transport bag (optional) .
The Hippocampe is available in small, medium, large and extra large configurations which all vary in length but have the same seat wydth, total width and seat height dimensions. Two versions of the Hippocampe, standard and pool, are available. The standard Hippocampe is intended for use in natural water (beaches, ponds, lakes). The pool Hippocampe is only intended for pool use by children and thin adults and is only available in a small size.
The provided text is a 510(k) summary for the Vipamat Technologie Hippocampe Wheelchair. It describes the device, its intended use, technological characteristics, and performance testing. However, it does not contain detailed information about specific acceptance criteria or a comprehensive study that proves the device meets those criteria in the way a medical AI/ML device submission would.
Instead, the document states: "Testing has been performed to evaluate the overall stability, dimensions and mechanics of the Hippocampe Wheelchair. The testing showed that the Hippocampe is safe and effective for its intended use."
This indicates that general safety and effectiveness testing was conducted, but specific metrics, thresholds, or detailed study designs are not provided. The information typically requested for AI/ML device performance studies (like sample sizes for test/training sets, expert adjudication methods, MRMC studies, etc.) is not applicable to this type of mechanical device submission from 2005.
Therefore, I cannot fulfill the request with the provided information in the format requested for an AI/ML device.
However, I can extract the general "performance testing" information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Overall stability | Testing showed the Hippocampe is safe and effective for its intended use. |
| Dimensions | Testing showed the Hippocampe is safe and effective for its intended use. |
| Mechanics | Testing showed the Hippocampe is safe and effective for its intended use. |
2. Sample size used for the test set and the data provenance: Not specified. The document only mentions "testing has been performed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a mechanical device, not one requiring expert human interpretation for "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a mechanical device would be compliance with engineering standards and functional specifications through direct measurement and observation.
8. The sample size for the training set: Not applicable. This is a mechanical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable.
Summary based on the provided text:
The Vipamat Technologie Hippocampe Wheelchair underwent "performance testing" to evaluate its overall stability, dimensions, and mechanics. The outcome of this testing was a determination that the device is "safe and effective for its intended use." The 510(k) summary does not elaborate on the specific acceptance criteria, testing methodologies, sample sizes, or detailed results of these tests, which is typical for mechanical device submissions around 2005. It focuses on demonstrating substantial equivalence to predicate devices based on design and intended use, supported by general safety and effectiveness testing.
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AUG 1 5 2005 510(k) Summary
for
Vipamat Technologie Hippocampe Wheelchair
1. SPONSOR
Vipamat Technologie ZA La Vraie Croix 56270 Ploeumer France
Contact Person: Franck Coeudo 33 2 97 86 24 87 Telephone:
Date Prepared: June 23, 2005
2. DEVICE NAME
| Proprietary Name: | Hippocampe Wheelchair |
|---|---|
| Common/Usual Name: | Mechanical Wheelchair |
| Classification Name: | Mechanical Wheelchair |
3. PREDICATE DEVICES
| DB Perks and Associates Stainless Steel Aquatic Chair | K031910 |
|---|---|
| Landeez All-Terrain Sport Chair | K031342 |
4. DEVICE DESCRIPTION
The Hippocampe Wheelchair is an all terrain wheelchair suitable for use on various terrains and in water. It can be used on surfaces such as the beach, seaside, snow, mountain pathways, forest, hiking paths, gardens and grass. The Hippocampe Wheelchair is a versatile durable wheelchair that is comprised of the following components.
- Wheel chair t
- Pushbar .
- Trunk harness (optional) .
- Armrest (optional) .
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- Headrest (optional) .
- . Skiing kit (optional)
- . Traction kit
- Transport bag (optional) .
The Hippocampe is available in small, medium, large and extra large configurations which all vary in length but have the same seat wydth, total width and seat height dimensions. Two versions of the Hippocampe, standard and pool, are available. The standard Hippocampe is intended for use in natural water (beaches, ponds, lakes). The pool Hippocampe is only intended for pool use by children and thin adults and is only available in a small size.
INTENDED USE ട.
The Hippocampe Wheelchair is a versatile, mechanical, wheelchair intended for use on various terrains including sand, grass, gravel, snow, foot/hiking paths, and in water.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The overall design of the Hippocampe and the predicate wheelchairs are similar in that they are all low to the ground wheelchairs made of rugged metals and flame retardant materials. They are all compatible with various types of water (pool, occans, lakes etc). All of these devices consist of 3 or 4 wheels with a chassis and pushbar. One minor difference is that the Hippocampe Wheelchair is comprised of three wheels whereas the predicate devices have a four wheel configuration. This difference does not affect safety or effectiveness since safety testing (stability testing) has been completed successfully using the Hippocampe. The technological characteristics are similar in that both the proposed and predicate devices are compatible with various terrains and water. Like the small-pool Hippocampe Wheelchair, the DB Perks Chair is intended only for pool water whereas the standard Hippocampe and Landeez Chairs are intended for either pool water or natural water (ocean, lakes, and ponds) and various terrains.
7. PERFORMANCE TESTING
Testing has been performed to evaluate the overall stability, dimensions and mechanics of the Hippocampe Wheelchair. The testing showed that the Hippocampe is safe and effective for its intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Public Health Service
AUG 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vipamat Technologie c/o Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K051709
Trade/Device Name: Hippocampe Wheelchair Regulation Number: 21 CFR 890.3880 Regulation Name: Special grade wheelchair Regulatory Class: II Product Code: IQC Dated: June 23, 2005 Received: June 28, 2005
Dear Ms. McNamara-Cullinane:
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 (QS) 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. Mary McNamara-Cullinane, RAC
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 (240) 276-0115. 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,
Muh A. Millers
Mark N. Melkerson Acting 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: Hippocampe Wheelchair
Indications For Use:
The Hippocampe Wheelchair is a versatile, mechanical wheelchair intended for use on various terrains including sand, grass, gravel, snow, foot/hiking paths, and in water.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milkus
. 13131 Sign-Off) 7:30% Sign-Oral, Restorative
Wision of General, Restorative 71310n of Sical Devices
§ 890.3880 Special grade wheelchair.
(a)
Identification. A special grade wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is intended to be used in all environments for long-term use, e.g., for paraplegics, quadraplegics, and amputees.(b)
Classification. Class II (performance standards).