(156 days)
Not Found
No
The description focuses on the mechanical and material properties of a manual wheelchair and explicitly states it is attendant-operated. There is no mention of AI, ML, or any automated or intelligent features.
No.
The device is a wheelchair designed to provide mobility for people with reduced-mobility problems, which is a supportive device, not a therapeutic one that treats or cures a medical condition.
No
Explanation: The provided text describes the Oceanic as a manual attendant-operated wheelchair intended for mobility, not for diagnosing medical conditions. Its components and functions are related to providing physical support and transport, not medical diagnosis.
No
The device description clearly outlines a physical wheelchair with various hardware components (wheelchair frame, armrests, footrest, starring/traction bar) made of aluminum and other materials. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to people with reduced-mobility problems. This is a physical function, not a diagnostic one.
- Device Description: The description details a wheelchair designed for mobility on various terrains and in water. It does not mention any components or functions related to testing biological samples or diagnosing conditions.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
- Predicate Devices: The predicate devices listed are also wheelchairs, further supporting the classification as a mobility aid, not a diagnostic device.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or screening of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
This wheelchair is a manual attendant-operated wheelchair intended to provide mobility to people with reduced-mobility problems.
The Oceanic is a manual attendant-operated wheelchair intended to provide mobility to people with reduced-mobility problems.
Product codes
IQC
Device Description
The Oceanic Wheelchair is a wheelchair suitable for use on different terrains and also in water. It can be used on surfaces like sand, snow, gravel, grass and in water. The user must be accompanied at all times, since it can not be driven by the person sat on it. This is a very long life product with the following components: Wheelchair, Foldable armrests, Foldable footrest, Starring/traction bar. The Oceanic is available in large (Oceanic) and small (Oceanic Baby) configurations which vary in length and also in the width and height of the Seat. The Oceanic Baby and Oceanic intended use is the same, but the Oceanic Baby has a maximum weight load of 50kg while the maximum weight load for the Oceanic is 100kg. All parts on our wheelchair are fabricated from aluminium and selected materials suitable for use in an aquatic environment. The chair can be submersed in water without any harmful effects. Users manual provides information on warnings, cautions, maintenance and operation instructions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
manual attendant-operated wheelchair
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing has been performed to evaluate the overall stability, dimensions and mechanics of the Oceanic. The testing showed that the Oceanic is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
PAGE 1 OF 2 K120302
510K Summary
FOR
Novaf Oceanic Wheelchair
JUL 6 2012
SPONSOR:
Novaf Andalucia 2007, S.L. Camino de Santa Teresa , Nave 1 11520 Rota (Cádiz) Spain
Phone: 00 34 956 843 675 / 00 34 658 141 454 Email: fernando@novaf.es
DATE PREPARED: July 2nd, 2012
DEVICE NAME:
Proprietary Name: | The Oceanic |
---|---|
Generic Name: | Manual Wheelchair |
Device Name: | Mechanical Chair |
Models: | Oceanic/Oceanic Baby |
PREDICATE DEVICES:
DB Perks and Associates Steel Aquatic Chair | K031910 |
---|---|
Landeez All-Terrain Sport Chair | K954261 |
Vipamat Technologie Hippocampe Wheelchair | K051709 |
FDA Product Code: | IQC |
---|---|
FDA CLASSIFICATION: | Class II |
Panel Code: | Physical Medicine |
Regulation Number: | 890.3880 |
Device Prescription:
The Oceanic Wheelchair is a wheelchair suitable for use on different terrains and also in water. It can be used on surfaces like sand, snow, gravel, grass and in water. The user must be accompanied at all times, since it can not be driven by the person sat on it.
1
This is a very long life product with the following components:
- · Wheelchair
- Foldable armrests
- · Foldable footrest
- · Starring/traction bar
The Oceanic is available in large (Oceanic) and small (Oceanic Baby) configurations which vary in length and also in the width and height of the Seat. The Oceanic Baby and Oceanic intended use is the same, but the Oceanic Baby has a maximum weight load of 50kg while the maximum weight load for the Oceanic is 100kg.
All parts on our wheelchair are fabricated from aluminium and selected materials suitable for use in an aquatic environment. The chair can be submersed in water without any harmful effects.
Users manual provides information on warnings, cautions, maintenance and operation instructions.
INTENDED USE
This wheelchair is a manual attendant-operated wheelchair intended to provide mobility to people with reduced-mobility problems.
SUBSTANTIAL EQUIVALENCE
The Oceanic is substantially equivalent to the predicate devices listed above. The all have similar technological characteristics and indications of use. The overall design of the Oceanic and the predicate wheelchairs are similar too. All of them are suitable to be used in various kind of water (pools, oceans, lakes and ponds). All these devices consist of 3 or 4 wheels with a chassis and a push bar. The Hippocampe has three wheels like the while the other two have four. This difference does not affect the safety or Oceanic effectiveness of the Oceanic as safety tests (stability tests) has been carried out successfully using the Oceanic.
A minor difference between the Oceanic and the Hippocampe and BD Perks is that the Oceanic does not have a pushbar, but just because it compromises a steering/traction bar to be propelled. The Landeez is also intentded to be used with the help of an attendant.
PERFORMACE TESTING
Testing has been performed to evaluate the overall stability, dimensions and mechanics of the Oceanic. The testing showed that the Oceanic is safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a single snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Novaf Andalucia 2007, SL % Mr. Fernando Saenz De Santamaria Camino Se Santa Teresa Nave I Rota, Spain PC 11520
Re: K120302
Trade/Device Name: Oceanic Regulation Number: 21 CFR 890.3880 Regulation Name: Special grade wheelchair Regulatory Class: II Product Code: IQC Dated: June 28, 2012 Received: June 28, 2012
Dear Mr. Saenz De Santamaria:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
6 2012 JUL
3
Page 2 - Mr. Fernando Saenz De Santamaria
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K120302
Device Name: Oceanic
Indications For Use: The Oceanic is a manual attendant-operated wheelchair intended to provide mobility to people with reduced-mobility problems.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
× Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K120302