LogoFDA 510(k) Search
K Number
K992438
Device Name
INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
Manufacturer
INDUS MEDICARE LTD.
Date Cleared
1999-08-02

(11 days)

Product Code
LTZ
Regulation Number
884.5310
Type
Abbreviated
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Invigra Plus condom is used for contraception and for prophytic purposes. Invigra Plus Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphliss. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.

Device Description

Invigra Plus (With Spermicidal Lubricant) - Male Natural Rubber Latex Condom

AI/ML Overview

The provided document does not contain any information about acceptance criteria, device performance studies, or clinical trial data.

The document is a US FDA 510(k) clearance letter for a medical device (Invigra Plus Brand Male Latex Condom with Spermicidal Lubricant). This letter indicates that the FDA has found the device to be "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.

While 510(k) submissions typically include data to demonstrate substantial equivalence, this specific letter from the FDA does not report those data. It focuses on the regulatory decision and relevant general controls and labeling requirements.

Therefore, I cannot fulfill your request for:

  1. Table of acceptance criteria and reported device performance: This information is not in the document.
  2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and ground truth establishment for a study: All of this information pertains to device performance studies, which are not detailed in this FDA clearance letter.

The document only provides:

  • Device Name: Invigra Plus (With Spermicidal Lubricant) - Male Natural Rubber Latex Condom
  • Indications for Use: Used for contraception and for prophylactic purposes, highly effective against pregnancy, and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. Also states, "No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used."

To get the information you are looking for, you would need to access the original 510(k) submission (K992438) filed by INDUS Medicare LTD, where they would have presented the data demonstrating equivalence to predicate devices and adherence to relevant standards. That submission would contain the details of the testing performed.

§ 884.5310 Condom with spermicidal lubricant.

(a)
Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).(b)
Classification. Class II (performance standards).