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K Number
K042563
Device Name
DUREX PLAY WARMER LUBRICANT
Manufacturer
SSL AMERICAS, INC.
Date Cleared
2005-02-23

(155 days)

Product Code
KMJ
Regulation Number
880.6375
Type
Traditional
Panel
HO
Reference & Predicate Devices
K955648,K935299
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Durex Play™ Warmer™ is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.

Device Description

Durex Play Warmer™ is a clear colorless personal lubricant composed of Purified Water, Hydroxyethyl Cellulose (Natrosol 250), Propylene Glycol, Benzoic Acid, Sodium Hydroxide, Sodium Saccharin, Glycerol.

AI/ML Overview

This 510(k) summary for Durex Play Warmer™ personal lubricant does not contain information about acceptance criteria or a study proving the device meets those criteria, as such studies are typically not required for Class II devices seeking substantial equivalence via the 510(k) pathway.

The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or meeting specific performance criteria through a standalone study.

Therefore, I cannot provide the requested information. The document focuses on:

  • Device Description: Composition and general characteristics.
  • Intended Use: What the lubricant is designed for.
  • Substantial Equivalence: Comparison to existing predicate devices (K-Y Jelly and AstroGlide) based on intended use, composition, and marketing.

There is no mention of:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes, data provenance, or ground truth establishment.
  • Expert involvement or adjudication methods.
  • MRMC comparative effectiveness studies.
  • Standalone algorithmic performance.
  • Ground truth types or training set details.

§ 880.6375 Patient lubricant.

(a)
Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.(b)
Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.