(46 days)
To provide mobility to disabled or elderly persons limited to a seated position.
The Zip'r3 and Zip'r3 Xtra scooter are the indoor/outdoor electrical scooter. The design of the scooters is basically similar to other electrical scooters that are already on the market. By providing the electrical scooter that breaks down into three manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
The Zip'r3 and Zip'r3 Xtra scooters are with a 113 kg (250 lbs) weight capacity. They are basic conventional rear wheel drive, rigid frame vehicle that are battery powered. They consist primarily of a welded steel frame, lighting system, a sealed transaxle motor (155W, DC24V) drive system, electromagnetic braking system, electric motor controller (PG S-Drive 45A) and two batteries with an off-board battery charger (2A). They are powered by two 12 volt lead-acid DC batteries with 16 km (10 miles) with 12 AH which maximum speed upto 6.8 km/hr (4.25 mph).
The provided document describes the 510(k) summary for the "Zip'r3 / Zip'r3 Xtra scooter" by Global FabTech Wheelchair (Shanghai) Co., Ltd. This is a medical device submission, and the focus is on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials for novel devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC/Vol.1 section 1-1998 / ISO7176-1-1999 | Complied with requirements |
| ANSI/RESNA WC/Vol.1 section 6-1998 / ISO7176-6-2001 | Complied with requirements |
| ANSI/RESNA WC/Vol.2 section 21-1998 / ISO7176-21-2003 | Complied with requirements |
| IEC 61000-4-2-2001 (Electromagnetic Compatibility - ESD) | Complied with requirements |
| IEC 61000-4-3-2008 (Electromagnetic Compatibility - RF Immunity) | Complied with requirements |
| CISPR 11: 2004+A2: 2006 (Industrial, Scientific and Medical RF) | Complied with requirements |
| California Bureau of Home Furnishings 117 Flammability Standards | Complied with requirements |
| Functional Equivalence to Predicate Device (Ruike 3331 K062676) | Substantially equivalent; minor performance differences do not alter intended function/cause new safety/effectiveness questions |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state a sample size for a test set in the way a clinical study would. Instead, it refers to compliance with a series of non-clinical testing standards. These standards typically involve a defined number of units or components subjected to specific tests, but the exact number isn't specified in this summary.
- Data Provenance: The testing was conducted by Global FabTech Wheelchair (Shanghai) Co., Ltd., implying it occurred in China. It is retrospective in the sense that the results are reported after the tests were completed to demonstrate compliance for a premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable (N/A) for this type of submission. The "ground truth" here is compliance with established international and national technical standards (e.g., ISO, ANSI/RESNA, IEC, CISPR, Flammability Standards). These standards themselves define the criteria for success or failure, and the testing is performed by accredited labs or internal quality control departments, not typically "experts" establishing a clinical ground truth in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
- This is not applicable (N/A). The "adjudication" in this context refers to whether the device passed or failed the specified tests within the standards. This is generally a clear pass/fail outcome determined by measurement against the standard, not an expert panel consensus or dispute resolution.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No, an MRMC study was not done. This document pertains to a physical medical device (an electrical scooter) and its compliance with engineering and safety standards, not a diagnostic or AI-driven system that would involve human readers interpreting data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not done. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is compliance with established international and national performance, safety, and electromagnetic compatibility (EMC) standards. These standards (e.g., ISO 7176 series, IEC 61000 series, CISPR 11, California Flammability Standards) define the objective criteria and test methods that the device must meet to be considered safe and effective for its stated intended use.
8. The Sample Size for the Training Set
- This is not applicable (N/A). There is no concept of a "training set" in the context of a 510(k) submission for a physical device demonstrating substantial equivalence through standard compliance. The device itself is the product being tested.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable (N/A) for the same reasons as point 8.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).