(54 days)
This wheelchair provides mobility to non-ambulatory persons. The device is used primarily for transferring individuals into a swimming pool via a ramp.
The MAC-Mobile Aquatic Chair features a rigid frame design and is suitable to provide mobility both indoors and in wet conditions. Primarily designed to assist non-ambulatory users to gain entry to a swimming pool via a ramp, the Aquatic Wheelchair features anti-tip wheels that are built into the design. The MAC-Mobile Aquatic Chair is fabricated from stainless steel that is coated with a tough powder coated finish. The wheels and casters are made from a water friendly plastic material. The rigid plastic seat is specifically designed for use in an aquatic environment. The entire product can be submersed into pool water with no harmful effects. The User's Manual provides information on warnings, maintenance, and operating instructions.
The provided text describes a 510(k) premarket notification for a mechanical wheelchair, the "MAC-Mobile Aquatic Chair," and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the way typically expected for performance-based medical devices (e.g., AI algorithms, diagnostic tools).
Instead, this document focuses on establishing substantial equivalence for a Class I mechanical wheelchair, which is a different type of regulatory pathway. For such devices, acceptance criteria often relate to design specifications, material properties, and functional safety, rather than performance metrics like sensitivity or specificity.
Based on the provided text, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Intended Use: Provides mobility to non-ambulatory persons; primarily for transferring into a swimming pool via a ramp. | The MAC-Mobile Aquatic Chair is primarily designed to assist non-ambulatory users to gain entry to a swimming pool via a ramp. |
| Technological Characteristics: | The device features a rigid frame design, anti-tip wheels, fabricated from stainless steel with a powder-coated finish, water-friendly plastic wheels and casters, and a rigid plastic seat designed for aquatic use. It can be fully submersed in pool water with no harmful effects. |
| Material Compatibility: Stainless steel construction, powder-coated finish, water-friendly plastic for wheels/casters, rigid plastic seat suitable for aquatic environment. | All described materials are consistent with the aquatic intended use and predicate device. |
| Safety Features: Anti-tip wheels. | Anti-tip wheels are built into the design. |
| No harmful effects upon submersion. | The entire product can be submersed into pool water with no harmful effects. |
| User Manual: Provides warnings, maintenance, and operating instructions. | A User's Manual provides this information. |
Important Note: The document asserts substantial equivalence to the predicate device (Stainless Steel Aquatic Wheelchair, K031910). This means the device is considered to meet the same safety and effectiveness standards as the predicate, rather than presenting novel performance data against specific, quantitative acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable in this context. The 510(k) summary does not describe a clinical performance study with a test set of patients or data. The "test" for this type of device is typically a comparison to a legally marketed predicate device, focusing on design, materials, and intended use, rather than a statistical evaluation of patient outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. There is no "test set" in the sense of patient data requiring expert ground truth establishment.
4. Adjudication Method:
Not applicable. There is no adjudication method described as no expert review of patient data is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This type of study is not relevant for a mechanical wheelchair.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No. This concept is not applicable to a mechanical wheelchair.
7. Type of Ground Truth Used:
Not applicable. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate device (K031910), against which the new device demonstrates substantial equivalence based on design and intended use.
8. Sample Size for the Training Set:
Not applicable. This device does not involve a "training set" as it's a mechanical device, not an AI or diagnostic algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
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JUN 2 3 2010
RehaMed International, LLC 522 West Mowry Drive Homestead, FL 33030
305-586-7779
510(k) Summary Prepared 4/28/10
| Submitted By | RehaMed International. LLC522 West Mowry DriveHomestead, FL 33030Phone: 305-586-7779 |
|---|---|
| Contact Person | John CadenPresident144 Severino DriveIslamorada, FL 33036Phone: 305-586-7779eMail: johnjcaden@gmail.com |
| Trade Name of Device | MAC-Mobile Aquatic Chair |
| Common Name of Device | Wheelchair, Mechanical |
| Proposed Classification ofNew Device | Class 121 CFR section 890.3850Wheelchair, Mechanical |
| Panel | Physical MedicineProsthetic DevicesSubpart D 890 |
| Product Code | IOR |
| Existing Classification ofPredicate Device | Class 121 CFR section 890.3850Wheelchair, Mechanical |
| Legally Marketed PredicateDevice for ClaimedEquivalence | Stainless Steel Aquatic WheelchairMarketed by D.B. Perks & AssociatesUnder 510(k) K031910Granted July 25, 2003 |
| Intended Use of the Device | This wheelchair provides mobility to non-ambulatory persons. The device is usedprimarily for transferring into a swimming poolvia a ramp |
| Target Populations | Any non-ambulatory person who wishes togain access to a swimming pool via a ramp. |
| Device Comparison | The device is substantially equivalent to thepredicate device listed above. Both productshave the same technological characteristicsand indications for use. Both products aredesigned to be used in a swimming poolenvironment. |
| Appendix 1 contains product information of thepredicate device. | |
| Device Description | The MAC-Mobile Aquatic Chair features a rigidframe design and is suitable to provide mobilityboth indoors and in wet conditions. Primarilydesigned to assist non-ambulatory users togain entry to a swimming pool via a ramp, theAquatic Wheelchair features anti-tip wheelsthat are built into the design. |
| The MAC-Mobile Aquatic Chair is fabricatedfrom stainless steel that is coated with a toughpowder coated finish. The wheels and castersare made from a water friendly plastic material.The rigid plastic seat is specifically designedfor use in an aquatic environment. The entireproduct can be submersed into pool water withno harmful effects. | |
| The User's Manual provides information onwarnings, maintenance, and operatinginstructions. | |
| Photographs of the product are contained inAppendix 2 |
Image /page/0/Picture/6 description: The image shows a logo with the letters 'RMT' in bold, black font. The letters are stacked vertically, with 'R' on top, 'M' in the middle, and 'T' at the bottom. A thick, black line is drawn above the letters. Behind the letters is a faded image of a globe, with lines encircling it, suggesting a global or international context. The overall design appears to represent a company or organization with a global reach, possibly in the fields of research, management, or technology.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract image of an eagle with outstretched wings, symbolizing freedom and the pursuit of health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
RehaMed International, LLS % Mr. John Caden President 522 West Mowry Drive Homestead, Florida 33030
JUN 2 3 2010
Re: K101217
Trade/Device Name: MAC-Mobile Aquatic Chair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: 1 Product Code: IOR Dated: April 28, 2010 Received: April 30, 2010
Dear Mr. Caden:
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 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
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Page 2 - Mr. John Caden
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.
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/ucm115809.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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark A. Mikkelsen
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): K101217 Device Name: MAC-Mobile Aquatic Chair Indications For Use:
This wheelchair provides mobility to non-ambulatory persons. The device is used primarily for transthe the only pronues moonly to hon-ambulatory persons. This device is used primarily for trans.
fering individuals into a swimming pool via a ramp. This device is designed to wheel chair for this into a swimming pool via a ra
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use_ X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
concurrence of cdRH, office of device evaluation (ode)
(Division Sign-C Diff Division of Surgical, Ormopedic, and Restorative Devices
510(k) Number K101217
PAGE 1 OF 1
§ 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).