SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED by P.T. VONIX LATEXINDO CONDOM (RUBBER) MFG.

The Simplex brand condom is a male contraceptive device, fabricated of natural latex. which is designed to completely cover the penis during sexual intercourse. This condom is intended to be used for contraception and for prophylactics purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100 % effectiveness. Failure to use as directed, may further result in loss of protection. Furthermore. sexually transmitted diseases can be transmitted through lesions and various body fluids, during intimate contact. Therefore, the condom should be applied before any such contact.

Device Description

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is made of first grade latex material, teatended, single wall and contoured. Its dimensions are: length 170mm minimum, width: 51mm, thickness: 0.04-0.06 mm (single wall), weight: 1.0-1.3 gm/piece.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, specifically Simplex Condoms. It is not a study about an AI/ML device, therefore, the requested information about acceptance criteria and device performance in the context of AI/ML is not applicable.

The document describes the device, its intended use, and technological characteristics, and then states that it is substantially equivalent to a predicate device (Trustex aromatic, 510(K) # K991892). The FDA concurred with this assessment in their letter.

The submission focuses on meeting regulatory requirements for substantial equivalence to a legally marketed predicate device, rather than providing a study comparing the performance of the Simplex condom against specific, quantifiable acceptance criteria through controlled testing, as would be expected for an AI/ML device.

However, based on the provided text, I can infer some "acceptance criteria" through the lens of regulatory compliance, even though they are not explicitly presented as a table or study results in the traditional sense for AI/ML.

Here's an analysis based on the provided text, addressing the points where information is available or inferable, and explicitly stating where information is not applicable or available given the nature of the document:

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

Since this is a submission for a physical medical device (condoms) and not an AI/ML device, the concept of "acceptance criteria" and "reported device performance" is framed in terms of substantial equivalence to a predicate device and compliance with established standards, rather than performance metrics of an algorithm.

Acceptance Criteria (Inferred from regulatory compliance)	Reported Device Performance (Inferred from substantial equivalence)
Technological Characteristics: Match predicate device (e.g., material, design)	Simplex Condoms have the "same technological characteristics as the predicate condoms". Design conforms to WHO, ISO, EN 600, DIN, and ASTM D3492-96.
Intended Use: Match predicate device (contraception, STD prevention)	Simplex Condoms have the "same intended use as the predicate condom".
Material: Natural rubber latex sheath	Made of "first grade latex material".
Dimensions: Meet specified ranges (length, width, thickness, weight)	Length: 170mm minimum; Width: 51mm; Thickness: 0.04-0.06 mm (single wall); Weight: 1.0-1.3 gm/piece. (These are part of the description, implying they meet expected standards).
Manufacturing Process: Conform to quality standards	Made using a "German-made automatic dipping line".
Labeling/Shelf Life: Comply with 21 CFR 801.435 for expiration dating.	Shelf life data must be developed and maintained as per 21 CFR 801.435(d). Product must be relabeled if real-time data doesn't confirm shelf life. Max shelf life 5 years. (This is a requirement for post-market, not a reported performance metric within the 510(k) itself).

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

This information is not applicable as this is a 510(k) for a physical medical device, not an AI/ML study. There is no "test set" in the context of an algorithm's performance. The documentation instead relies on demonstrating conformity to standards and substantial equivalence to a predicate device.

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)

This information is not applicable. "Ground truth" in the context of expert consensus for AI/ML is not relevant here. The "truth" in this submission relies on established standards for condom manufacturing and performance, as well as the design and material comparison to a predicate device.

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

This information is not applicable. There is no "test set" or adjudication method relevant to an algorithm's performance being described.

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

This information is not applicable. This is not an AI/ML device.

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

This information is not applicable. This is not an AI/ML device.

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

For this device, the "ground truth" for regulatory approval is based on:

Compliance with recognized standards: WHO, ISO, EN 600, DIN, and ASTM D3492-96. These standards specify physical properties, test methods, and performance criteria for condoms.
Established performance of the predicate device: The Simplex Condoms are stated to have "the same intended use" and "same technological characteristics" as the predicate device (Trustex aromatic, K991892), which is already legally marketed.
Physical and material specifications: The stated dimensions, material (natural rubber latex), and manufacturing process (German-made automatic dipping line) are expected to meet the requirements for safe and effective condoms.

8. The sample size for the training set

This information is not applicable. There is no "training set" for an AI/ML algorithm.

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

This information is not applicable. There is no "training set" for an AI/ML algorithm.

Summary

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K99 3779. 6

II 510(K) SUMMARY

Submitted by:	PT Vonix LatexindoJI. Balikpapan 21 E JakartaPusat 10160, IndonesiaPhone: 62-21-385 0222/385 0202
Contact Person:	Vijay Mahal (Applicant)Vineel EnterprisesPhone:617-973-7157
Date Prepared:	November 4th, 1999
Proprietary Name:	Simplex Condoms
Common Name:	Latex Condom
Classification Name:	Condom (21 CFR 884.5300)
Predicate Device:	Trustex aromatic, 510(K) # K991892

Description of Device: This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is made of first grade latex material, teatended, single wall and contoured. Its dimensions are: length 170mm minimum, width: 51mm, thickness: 0.04-0.06 mm (single wall), weight: 1.0-1.3 gm/piece.
Intended Use of the Device: This latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Technological Characteristics: This condom has the same technological characteristics as the predicate condoms identified above. This condom is made of first grade natural rubber latex material using a German- made automatic dipping line. The design of this condom is in conformance with WHO, ISO, EN 600, DIN and ASTM D3492-96.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three horizontal lines representing the snakes and a central form representing the staff. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 2000 FEB

P.T. Vonix Latexindo c/o Vijay Mahal, Ph.D. Vineel Enterprises 7 Riverview Road Framingham, MA 01701

Re: K993779

Simplex Brand Male Latex Condoms (Aromatic and Lubricated) Dated: November 4, 1999 Received: November 8, 1999 Regulatory Class: II 21CFR §884.5300/Procode: 85 HIS

Dear Dr. Mahal:

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 Act. 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.

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

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Page 2 - Vijay Mahal, Ph.D.

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 yours,

Daniel li Szyon
CAPT Daniel C. Szyhon, MD

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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VII. INDICATIONS FOR USE STATEMENT

510(k) Number:

Not available yet K993779

Device Name:

Indications For Use:

Simplex brand Male Rubber Latex Condom
(Avomatic and Lubricated

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	OR Over-The-Counter Use ✓
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(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,

and Radiological Devices

510(k) Number	K993779
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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.