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K Number
K113056
Device Name
ORANGE COLORED CONDOMS ORANGE SCENT
Manufacturer
KAREX INDUSTRIES SDN BHD
Date Cleared
2012-07-03

(263 days)

Product Code
HIS
Regulation Number
884.5300
Type
Special
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Karex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Description

Orange colored condoms with orange scents

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding a condom, specifically "Orange colored condoms with orange scents." This document does not contain information about a medical device that utilizes AI, machine learning, or complex imaging. Therefore, it does not include the details typically found in an acceptance criteria and study report for such devices.

The request asks for specific information related to the performance evaluation of a device, including:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size and data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC study details and effect size.
  6. Standalone performance.
  7. Type of ground truth.
  8. Training set sample size.
  9. Ground truth establishment for training set.

None of this information is available in the provided FDA 510(k) clearance letter for the condom.

To fulfill the request, one would need a performance study report for an AI/ML medical device, which is not what has been provided.

§ 884.5300 Condom.

(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.