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 lubricated with silicone containing one of five flavors (strawberry, mint, vanilla, banana, or chocolate) and cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, which generally does not include detailed study reports or acceptance criteria tables in the same way a scientific publication or a PMA would. The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove safety and effectiveness through extensive new clinical trials.

Based on the provided text, here's what can be extracted and inferred regarding acceptance criteria and supporting information:

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

The document states that the condom is designed to conform to established national and international voluntary standards, specifically ASTM D3492 and ISO 4074. While the document doesn't provide a direct table of acceptance criteria from these standards or the specific reported device performance values against each criterion, it asserts conformance.

For a latex condom, key performance criteria typically covered by these standards include:

Physical Integrity (Burst Pressure and Volume): To ensure the condom does not break under intended use.
Dimensions (Length, Width, Thickness): To ensure proper fit.
Freedom from Holes: To prevent leakage.
Tensile Properties (Elongation at Break, Tensile Strength): To confirm material strength and elasticity.
Shelf Life/Stability: To ensure performance over time (though 510(k) typically defers to a separate labeling requirement for expiration dating, as noted in the FDA letter).

Since the submission is an Abbreviated 510(k), it relies on the consensus standards. The "reported device performance" is implicitly stated as "conforming" to these standards.

*Acceptance Criteria (from ASTM D3492 / ISO 4074 - Inferred, not explicitly stated in document)*	Reported Device Performance
Various physical and mechanical properties (e.g., burst pressure, freedom from holes, dimensions, tensile strength, elongation at break) as specified in ASTM D3492 and ISO 4074.	"This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074."

                                                                                            | "The design is in conformance with ASTM Latex Condom Standard D3492."

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

The document does not specify the sample size for any testing, the country of origin of the data, or whether the testing was retrospective or prospective. Such details are typically found in the full test reports referenced by the 510(k), but not included in this summary.

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 question is not applicable to this device submission. This device is a male latex condom, not an AI or diagnostic imaging device that involves expert interpretation or ground truth establishment in that context. The "ground truth" for a condom is its physical performance meeting specified engineering standards.

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

Not applicable, as this is not a study involving human readers or interpretation requiring adjudication.

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 is not an AI or diagnostic device that would involve MRMC studies.

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

Not applicable. This is not an algorithm-based device. "Standalone performance" for a condom refers to its physical characteristics and integrity, which are tested against the consensus standards.

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

The "ground truth" for this device pertains to its physical and functional properties. These are established through performance testing against recognized national and international consensus standards (ASTM D3492 and ISO 4074). These standards define the acceptable performance parameters (e.g., minimum burst pressure, maximum number of holes allowed per batch).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

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

Not applicable. This is not a machine learning or AI device.

Summary

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K023176

Abbreviated 510 (k) Notification for a Male Latex Condom

510(k) SUMMARY
Submitted By:	UNIDUS CorporationSeokyung Bldg., 51 Bang-1 DongSongpa-KuSeoul, Republic of Korea	DEC 13 2002
Contact Persons:	Eli J. CarterConsultant to UNIDUS Corporation1219 Little Creek RoadDurham, NC 27713	H.S. LeeManaging DirectorUNIDUS CorporationSeokyung Building 51,Bangi-Dong, Songpa-KuSeoul, Korea
Date Prepared:	September 12 , 2002
Proprietary Name:	UNIDUS; (and other private label brands)
Common Name:	Male Latex Condom (w/Flavored Lubricant)
Classification Name:	Male Latex Condom
Predicate Device:	Remed Pharma Flavored Latex Condom - 510(k) 993403
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 lubricated withsilicone containing one of five flavors (strawberry, mint, vanilla,banana, or chocolate) and cornstarch is used as a dressing material.This condom is designed to conform to established national andinternational voluntary standards including ASTM D3492 and ISO4074.
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.
Technological Characteristics:	This condom has the same technological characteristics as the predicatecondom identified above. The design is in conformance with ASTMLatex Condom Standard D3492 and that the condom is made of naturalrubber latex.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FC. 1 3 2002

Unidus Cororation % Mr. Eli J. Carter Consultant 1219 Little Creek Road DURHAM NC 27713

Re: K023176

Trade Name/Device: Male Natural Rubber Latex Condom with flavored lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: September 12, 2002 Received: September 23, 2002

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 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 (OS) 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.

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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 8884.5310) 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, $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, 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/cdrlv/dsma/dsmamain.html".

Sincerely yours,

Ernst A. Lygum

for

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health cc: HFZ-401

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K02-3176

Information for a Male Latex Condom 510(k) Submission

Page 11 of 13

VII. INDICATIONS FOR USE STATEMENT

510(k) Number Not Known Male Natural Rubber Latex Condom (with flavored lubricant) Device Name The UNIDUS condom is used for contraceptive and for prophylactic Indications for Use: purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-the-Counter Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K023176

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.