(284 days)
The intended use of these latex coloured condoms with spermicidal lubricant is for contraception and prophylactics purposes (preventing transmission of venereal diseases.)
Colored Latex Condom with Spermicidal Lubricant (Maxima, Trustex, Ria, Premium and, EL LES Condoms)
The provided text is a 510(k) clearance letter from the FDA for a medical device: "Colored Latex Condom with Spermicidal Lubricant (Maxima, Trustex, Ria, Premium and, EL LES Condoms)".
This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance studies.
The letter explicitly states:
- "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
- It also mentions requirements for "Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435," and the need for "test data developed under the conditions specified in 801.435(d)" to support expiration dates. However, it clarifies that "Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA."
Therefore, based solely on the provided text, I cannot extract the requested information:
- A table of acceptance criteria and the reported device performance: Not present. The letter does not describe specific performance metrics for the condom, only that it is substantially equivalent to predicates.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable, as no test set data is provided.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not present or applicable to this type of device clearance document.
- Standalone performance study: The letter refers to "test data developed under the conditions specified in 801.435(d)" for expiration dating, but the details of this study (if it can be considered a standalone performance study in the context of device function beyond shelf-life) are not included.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable (this is not an AI/ML device).
- How the ground truth for the training set was established: Not applicable (this is not an AI/ML device).
The letter merely grants clearance based on substantial equivalence to predicate devices and outlines ongoing regulatory compliance requirements for labeling and manufacturing. It does not disclose the technical performance data that would typically be used to demonstrate meeting acceptance criteria for a novel device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 1999
Mr. Mohamad Firdaos Mohamed Quality Assurance Manager LS Rubber SDN.BHD. PLO 22, Senai Industrial Estate Phase 1, 81400 Senai Johor, MALAYSIA
Re: K981955
Colored Latex Condom with Spermicidal Lubricant (Maxima, Trustex, Ria, Premium and, EL LES Condoms) Dated: December 10, 1998 Received: December 28, 1998 Regulatory Class: II 21 CFR 884.5310/Procode: 85 LTZ
Dear Mr. Mohamed:
We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Mohamad Firdaos Mohamed
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR 884.5300 and 884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in 801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the of the condom and labeled with the earlier of the two expiration dates. Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, 801.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in 801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597,or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Simist le. Nymm
$\pi$
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1 . ________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K981955
Device Name: Colored and Spermicidal Lubricated Latex Condoms (Maxima, Trustex, Ria, and Premium El Les
Indications For Use:
The intended use of these latex coloured condoms with spermicidal lubricant is for contraception and prophylactics purposes (preventing transmission of venereal diseases.)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
David h. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Dev 510(k) Number
§ 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).