MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS by LS RUBBER SDN BHD

The intended use of these latex coloured condoms with flavour lubricant is for contraception and prophylactics purposes (preventing transmission of venereal diseases.)

Device Description

Natural and Colored Lubricated Latex Condoms with Flavors (Maxima, Trustex, Ria, Premium and EL LES)

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for several brands of colored latex condoms with flavored lubricant. As such, it does not contain the kind of detailed information about acceptance criteria and a study proving a device meets them that one would find for a more complex medical device, especially software or AI-driven diagnostic tools.

This letter is primarily concerned with establishing "substantial equivalence" to a predicate device already on the market. The key "test" mentioned is compliance with existing regulations for latex condoms, particularly regarding labeling and expiration dating.

Therefore, many of your requested points cannot be answered from the provided text.

Here's an attempt to answer based on the information available, and highlighting what is not present:

Description of Acceptance Criteria and the Study:

The primary "acceptance criteria" discussed are regulatory compliance and substantial equivalence to legally marketed predicate devices. The "study" referenced implicitly is the manufacturer's internal testing to support shelf-life claims for expiration dating, which is not detailed in this document but is required to be maintained by the manufacturer for FDA inspection.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from document)	Reported Device Performance (from document)
Substantial Equivalence to legally marketed predicate devices	The FDA has "determined the device is substantially equivalent... to legally marketed predicate devices."
Compliance with 21 CFR 884.5300 (Latex Condoms) and 884.5310 (Spermicidal Condoms)	Implied as met for clearance.
Compliance with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435	The letter states that "labeling for latex condoms... must comply" with this regulation, and an "expiration date, supported by test data developed under the conditions specified in 801.435(d), must be displayed prominently and legibly." The manufacturer must "maintain this data and that it be available for inspection by FDA." The FDA assumes compliance with Current Good Manufacturing Practice requirements (21 CFR Part 820). The letter does not explicitly state that the company provided this data in the 510(k) submission, only that it must maintain it.
Compliance with Current Good Manufacturing Practice (GMP) requirements (21 CFR Part 820)	"A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements... and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions."
Indications for Use as stated	Stated as: "The intended use of these latex coloured condoms with flavour lubricant is for contraception and prophylactics purposes (preventing transmission of venereal diseases.)" The FDA's clearance refers to these stated indications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided in the document. The document refers to "test data developed under the conditions specified in 801.435(d)" for expiration dating, but no specifics on sample size, data provenance, or study design are given. This data is to be maintained by the manufacturer, not necessarily submitted with the 510(k). The device manufacturer is LS Rubber SDN.BHD., located in Malaysia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. This type of information would be relevant for devices involving expert assessment or diagnostic accuracy, which is not the primary focus of this condom clearance letter.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document is for a physical medical device (condoms), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" implicitly referred to would be established through laboratory testing to confirm properties like burst pressure, tensile strength, freedom from holes, and shelf-life stability, as required by standards for condoms (e.g., ISO, ASTM, and FDA regulations like 21 CFR 801.435). This involves objective measurements rather than expert consensus on diagnostic images or pathology.

8. The sample size for the training set

Not applicable/Not provided. This document does not describe a machine learning algorithm or a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 1999

Mr. Mohamad Firdaos Mohamed Quality Assurance Manager LS Rubber SDN.BHD. PLO 22, Senai Industrial Estate Phase 1, 81400 Senai Johor, MALAYSIA

Re: K980964

Colored Latex Condom with Flavored Lubricant (Maxima, Trustex, Ria, Premium and, EL LES Condoms) Dated: December 10, 1998 Received: January 19, 1999 Regulatory Class: II 21 CFR 884.5300/Procode: 85HIS

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 QS 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 shelf life 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(i) 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 vours,

for

Daniel G. Schulttz, M.D.
CAPT

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): K980964

Natural and Colored Lubricated Latex Condoms with Flavors Device Name: (Maxima, Trustex, Ria, Premium and EL LES)

Indications For Use:

The intended use of these latex coloured condoms with flavour 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)

Over-The-Counter Use $\checkmark$

(Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Dev 510(k) Number.

Regulation Number and Section

§ 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.