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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Novaf Oceanic Wheelchair. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting extensive clinical studies to prove effectiveness with specific acceptance criteria in the same way a new drug or high-risk medical device might. The "performance testing" mentioned is primarily for safety and mechanical aspects to support this substantial equivalence.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria (like sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance with metrics like sensitivity/specificity, and training set details) are not applicable to this type of regulatory submission and are not present in the provided document.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document states "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." However, it does not provide a detailed table of specific acceptance criteria (e.g., maximum deflection under load, specific stability angles, etc.) or quantitative results against those criteria. It only offers a high-level statement of successful testing.

Acceptance Criteria (Implied)	Reported Device Performance
Overall stability requirements	Successful (Tested as "safety tests (stability tests) has been carried out successfully")
Dimensional requirements	Successful (Tested as "dimensions")
Mechanical requirements	Successful (Tested as "mechanics")
Safety for intended use	Demonstrated
Effectiveness for intended use	Demonstrated

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document only mentions "Testing has been performed" without detailing the number of wheelchairs or components tested.
Data Provenance: Not specified, but implied to be from internal testing conducted by the manufacturer, Novaf Andalucia 2007, S.L., likely in Spain (country of origin for the sponsor). The testing is retrospective in the context of the 510(k) submission, meaning it was performed before filing the notification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This type of device (manual wheelchair) does not typically involve expert review for "ground truth" establishment in the sense of diagnostic accuracy or interpretation. The performance testing would be against engineering standards and specifications.

4. Adjudication method for the test set

Not Applicable. As there's no expert interpretation or "ground truth" adjudication in the diagnostic sense, no adjudication method would be used. The testing would involve objective measurements and comparisons to predetermined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This device is a manual wheelchair, and its safety and effectiveness are determined by mechanical and functional performance, not diagnostic interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a mechanical device, not an algorithm or AI system. Therefore, standalone performance in this context is irrelevant. The "standalone" performance refers to the device itself (the wheelchair) performing its function as intended.

7. The type of ground truth used

The "ground truth" for this device would be established by engineering specifications, regulatory standards (e.g., ISO standards for wheelchairs if referenced, though not explicitly stated here), and internal design requirements. For example, the "ground truth" for stability would be a specific angle or load threshold it must withstand. For weight capacity, it would be a specific weight it must support without failure. The document implies these standards were met, but doesn't list the exact standards or specifications.

8. The sample size for the training set

Not Applicable. This is a mechanical device, not an AI/ML algorithm. There is no concept of a "training set" for this product.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set.

Summary

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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:

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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.

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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

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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

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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

Regulation Number and Section

§ 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).