(134 days)
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Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on providing mobility.
No
The device, ELEXUS(PC-1450), is described as providing mobility to persons in a seated position. It is a powered wheelchair, which is a mobility aid, not a device used for treating a medical condition or disease.
No
Explanation: The device, ELEXUS(PC-1450), is described as providing mobility to persons limited to a seated position, indicating it is a powered wheelchair. There is no mention of it being used for diagnosis, disease detection, or monitoring physiological parameters.
No
The intended use describes a powered wheelchair, which is a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, the ELEXUS (PC-1450) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to persons limited to a seated position. This is a physical function, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention anything related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting diseases, conditions, or states of health
- Providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
The device is a powered wheelchair, which is a medical device but falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The intended use of the ELEXUS(PC-1450) is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Product codes
ITI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a bird with human profiles incorporated into its design. The bird is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
NOV - 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
Mr. Will Ridgway Sales Manager Dalton Medical Corporation 1103 Venture Ct. Carrollton, Texas 75006
Re: K052534
Trade/Device name: Tacahe Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: January 11, 2006 Received: January 12, 2006
Dear Mr. Ridgway:
This letter corrects our substantially equivalent letter of January 27, 2006.
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 (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 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.
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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.
This letter will allow you to continue 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milliron
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Image /page/1/Picture/6 description: The image is a black and white circular logo or seal. The central element is the acronym 'FDA' in a bold, stylized font, with the word 'Centennial' written below it in a smaller font. Above the 'FDA' acronym, the years '1906 - 2006' are displayed, indicating a centennial celebration. The outer ring of the circle contains text, but it is difficult to read due to the image quality. There are also three stars below the word 'Centennial'.
Protecting and Promoting Public Health
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Indications for Use
The Children of the
K052534 510(k) Number (if known):
Device Name: ELEXUS(PC-1450)
Indications For Use:
The intended use of the ELEXUS(PC-1450) is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use xx (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NE-1 DF-1)
Concurrence of CDRH, Off ce of Device Evaluation (ODE)
2
(Division Sign-Off) (Division Sign-Ord) Restorative, and Neurological Londes
510(k) Number K052534
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