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

Device Description

This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. It is either lubricated with silicone or non-lubricated; with cornstarch as a dressing material, and Benzocaine (an over-the-counter drug generally recognized as safe and effective by the USFDA) placed inside the condom for desensitizing the male genitals. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.

AI/ML Overview

The provided text describes a 510(k) submission for a male latex condom. It mostly focuses on the regulatory process, the device's description, and its intended use, rather than a detailed study proving the device meets specific acceptance criteria in the way a medical imaging AI device study would.

Therefore, for many of the requested points, the information is not available in the provided document. I will fill in what can be inferred and state when information is not present.

Acceptance Criteria and Device Performance

The core of the acceptance criteria for this device (a male latex condom) is compliance with established national and international voluntary standards. The document specifically mentions ASTM D3492 and ISO 4074. While it doesn't provide a table of performance against specific measurable criteria within these standards, the statement "The design is in conformance with ASTM Latex Condom Standard D3492 and the condom is made of natural rubber latex" implies that the device meets the criteria outlined in these standards.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Conformance to ASTM Latex Condom Standard D3492	The design is in conformance with ASTM D3492.
Conformance to ISO 4074 (International Voluntary Standard)	The design is in conformance with ISO 4074 (stated as a general goal).
Nominal length 180-mm	Nominal length 180-mm
Nominal width 52-mm	Nominal width 52-mm
Nominal thickness 0.06mm	Nominal thickness 0.06mm
Use of Benzocaine as a male genital desensitizer	Benzocaine is placed inside the condom.
Lubrication with silicone or non-lubricated with cornstarch	Lubricated with silicone or non-lubricated with cornstarch.

Note: The document states the device "is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074." It then explicitly states "The design is in conformance with ASTM Latex Condom Standard D3492." The actual performance data (e.g., burst pressure, leakage, tensile strength tests specified by these standards) is not included in this summary but would have been part of the full 510(k) submission.

Study Details

Sample size used for the test set and the data provenance: Not explicitly stated in the provided text. The evaluation is focused on adherence to standards rather than a clinical trial with a "test set" in the context of an AI device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a condom, "ground truth" is typically defined by adherence to manufacturing specifications and performance standards, not expert interpretation of diagnostic images.
Adjudication method for the test set: Not applicable.
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 is not an AI device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device (male latex condom), the "ground truth" would be the device meeting the physical and material specifications outlined in the applicable standards (ASTM D3492, ISO 4074). This would involve laboratory testing for properties like burst strength, freedom from holes, dimensions, etc.
The sample size for the training set: Not applicable. This is not an AI device.
How the ground truth for the training set was established: Not applicable. This is not an AI device.

Summary

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DEC 2 3 2003

K033541

Abbreviated 510 (k) Notification for a Male Latex Condom

II. 510(k) SUMMARY

Submitted By:	UNIDUS CorporationSeokyung Bldg., 51 Bang-1 DongSongpa-KuSeoul, Republic of Korea
Contact Persons:	Eli J. CarterConsultant to UNIDUS Corporation1219 Little Creek RoadDurham, NC 27713	B.S. LeeManaging DirectorUNIDUS CorporationSeokyung Building 51,Bangi-dong, Songpa-KuSeoul, Korea
Date Prepared:	November 5, 2003
Proprietary Name:	"Long Love" Condom
Common Name:	Male Latex Condom
Classification Name:	Male Latex Condom
Predicate Device:	Lifestyle Male Latex Condom w/ Genital Desensitizer -- K030176
Description of Device:	This condom is made of a natural latex sheath, which completelycovers the erect penis with a closely fitted membrane. This condom isstraight-walled with a reservoir tip; nominal length 180-mm, nominalwidth 52-mm, and nominal thickness 0.06mm. It is either lubricatedwith silicone or non-lubricated; with cornstarch as a dressing material,and Benzocaine (an over-the-counter drug generally recognized as safeand effective by the USFDA) placed inside the condom fordesensitizing the male genitals. This condom is designed to conform toestablished national and international voluntary standards includingASTM D3492 and ISO 4074.
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 tohelp prevent pregnancy and the transmission of sexually transmitteddiseases, including HIV. The male genital desensitizer in the condomhelps to temporarily prolong the time until ejaculation. If used

il helps to temporarily prolong the time until ejaculation. 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, 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 contraceptive methods.

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Technological Characteristics:

This condom has the same technological characteristics as the predicate i condom identified above. The design is in conformance with ASTM Latex Condom Standard D3492 and the condom is made of natural rubber latex. Accordingly, when compared to the predicate device, the UNIDUS condom intended to be introduced does not incorporate any significant changes in the intended use, method of operation, materials, or design that could affect safety and effectiveness.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an emblem of an eagle-like bird with three stylized lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2003

UNIDUS Corporation % Mr. Eli J. Carter Consultant 1219 Little Creek Rd. DURHAM NC 27713

Re: K033541

Trade Name/Device: Male Rubber Latex Condom with Genital Desensitizer Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: 85 HIS Dated: November 5, 2003 Received: November 10, 2003

Dear Mr. Carter:

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 probibitions 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.

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

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Page 2 - Mr. Carter

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(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, 8801.435(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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR §807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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.

David A. Hegmann

Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K033541 Device Name: Male Rubber Latex Condom with Genital Desensitizer Indications for Use: The UNIDUS Condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use
X
(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Lypson

(Division Sign-Off)

Division of Reproductive, Abdominal. and Radiological Devi 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.