LogoFDA 510(k) Search
K Number
K971271
Device Name
BESECURE EXTERNAL URINARY COLLECTION SYSTEM
Manufacturer
UROLOGY RESEARCH INTL., INC.
Date Cleared
1997-08-18

(136 days)

Product Code
KNX
Regulation Number
876.5250
Type
Traditional
Panel
GU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The BeSECURE External Urinary Collection System is an external urine collection system for the incontinent patient.

Device Description

Not Found

AI/ML Overview

The provided text is a letter from the FDA regarding a 510(k) submission for the "BeSECURE External Urinary Collection System," and an "Indications for Use" statement.

Unfortunately, this document does not provide any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The letter is a regulatory approval document stating that the device is substantially equivalent to legally marketed devices, implying that it has met certain regulatory requirements, but it does not detail the technical performance studies and their results.

Therefore, I cannot fulfill your request for the specific information about:

  1. A table of acceptance criteria and the reported device performance
  2. Sample sized used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and their qualifications
  4. Adjudication method
  5. Whether a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
  6. Whether a standalone performance study was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

§ 876.5250 Urine collector and accessories.

(a)
Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and
(2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
(b)
Classification —(1)Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2)
Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.