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K Number
K041186
Device Name
CADDY
Manufacturer
AFIKIM ELECTRIC VEHICLES
Date Cleared
2004-09-09

(126 days)

Product Code
ITI
Regulation Number
890.3860
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Caddy is a transportable / foldable electric scooter. The Caddy Scooter has been developed especially for those people with Mobility problems are generally problems with walking or with the stamina. wanting or was as a suite for the use of elderly persons and physically disabled persons. The Caddy scooter was developed especially for use in and around the house and to be taken along for trips. For this purpose the scooter can be folded and disassembled easily and the separate parts can be handled with ease.

Device Description

The Caddy is a transportable / foldable electric scooter.

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a powered wheelchair named "CADDY." This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter explicitly states: "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..."

Substantial equivalence (SE) is a regulatory pathway that allows a new device to be marketed if it is as safe and effective as a legally marketed predicate device. It does not typically require the submission of clinical trials with specific acceptance criteria and detailed study results as would be the case for a premarket approval (PMA) application or certain novel devices.

Therefore, I cannot provide the requested information based on the given text. The text does not describe:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for any test set.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication method.
  5. MRMC comparative effectiveness study or its effect size.
  6. Standalone (algorithm-only) performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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).