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K Number
K053007
Device Name
SKYLARK URO PROBE
Manufacturer
SKYLARK DEVICE & SYSTEMS CO., LTD
Date Cleared
2005-12-05

(40 days)

Product Code
KPI
Regulation Number
876.5320
Type
Traditional
Panel
GU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Skylark Uro Probe is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and allows assessment of EMG activity of the pelvic floor muscles.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device called "Skylark Uro Probe." This document primarily focuses on regulatory approval and does not contain information about specific acceptance criteria for device performance, the results of a study proving those criteria were met, or details regarding the methodologies of such a study (sample sizes, ground truth establishment, expert qualifications, etc.).

The letter confirms:

  • Trade/Device Name: Skylark Uro Probe
  • Regulation Number: 21 CFR §876.5320
  • Regulation Name: Nonimplanted electrical continence device
  • Regulatory Class: II
  • Product Code: KPI
  • Indications for Use: The Skylark Uro Probe is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and allows assessment of EMG activity of the pelvic floor muscles.

Therefore, I cannot provide the requested information from the given document as it does not contain the details about acceptance criteria or a study proving device performance.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report that explicitly details the device's performance testing and the criteria it needed to meet.

§ 876.5320 Nonimplanted electrical continence device.

(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).