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 205mm, nominal flat width 57mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dression material. This condom is designed to conform to established. national and international voluntary standards including ASTM D3492 and ISO 4074.

AI/ML Overview

This document is a 510(k) summary for a male latex condom, focusing on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the context of an AI/ML device.

Therefore, many of the requested elements (1-9) which are relevant to studies proving a device's performance against specific acceptance criteria (especially for AI/ML or diagnostic devices) are not directly applicable or available in this submission for a medical device like a condom.

However, I can extract the information that is present concerning the device's conformance to standards, which serves as its "acceptance criteria" and "proof of meeting these criteria" in this specific context.

Here's the breakdown based on the provided text, with explanations for why certain fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Conformance)	Reported Device Performance
Conformance to ASTM D3492 (Latex Condom Standard)	The condom is designed to conform to established national and international voluntary standards including ASTM D3492.
Conformance to ISO 4074 (Natural latex rubber condoms — Requirements and test methods)	The condom is designed to conform to established national and international voluntary standards including ISO 4074.
Same natural rubber latex compound as UNIDUS 510(k) K023059	Uses the same natural rubber latex compound as listed in UNIDUS 510(k) number K023059.
Same production equipment as UNIDUS 510(k) K023059	Uses the same production equipment as listed in UNIDUS 510(k) number K023059.
Comparable dimensions (longer length, wider flat width for "Magnum" size)	Nominal length 205mm, nominal flat width 57mm, nominal thickness 0.06mm (These are explicitly stated dimensions for the Magnum condom, differentiating it from "regular" sizes).
Lubricated with silicone	Lubricated with silicone (explicitly stated).
Cornstarch used as dressing material	Cornstarch is used as a dressing material (explicitly stated).

2. Sample size used for the test set and the data provenance

Not Applicable. This submission focuses on conformance to existing standards and demonstrating substantial equivalence to a predicate device based on material, design, and manufacturing process similarities, rather than a clinical trial or performance study with a "test set" in the sense of AI/ML or diagnostic device evaluation. Condom performance is typically evaluated through standardized physical tests (e.g., burst strength, leakage, dimensions) which are inherent to the ASTM and ISO standards it claims conformance with, but specific sample sizes for these tests are not provided in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. See explanation for point 2. No "ground truth" in the clinical or diagnostic sense is established by experts here. Conformance to standards is the primary "verification."

4. Adjudication method for the test set

Not Applicable. See explanation for point 2.

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 a medical device (condom), not an AI/ML diagnostic or assistive technology.

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

Not Applicable. This is a medical device (condom), not an AI/ML algorithm.

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

Conformance to established national and international voluntary standards (ASTM D3492 and ISO 4074). The "ground truth" here is adherence to engineering and material specifications defined by these standards, along with documented material and manufacturing similarities to a previously cleared device.

8. The sample size for the training set

Not Applicable. See explanation for point 2. This device doesn't involve a "training set" in the context of AI/ML.

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

Not Applicable. See explanation for point 2.

Summary

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K072747

Abbreviated 510(k) Notification for Magnum Male Latex Condom

Page 5 of 13

II. 510(k) SUMMARY

Submitted by:	UNIDUS CorporationSeokyung Building 51, Bangi-DongSongpa-KuSeoul, Republic of Korea	NOV 15 2007
Contact Persons:	Claude L. WrightConsultant to UNIDUS Corp.507 Shallow Creek RoadTuscaloosa, Alabama 35406Telephone: 205-752-3774Email: clwright44@comcast.net	Sung Hoon KimPresidentUNIDUS CorporationSeokyung Building 51,Bangi-DongSongpa-Ku, Seoul, KoreaTelephone: 02 2203 3830Fax: 02 420 8779Email: unidus@unidusok.com
Date Prepared:	September 27, 2007
Proprietary Name:	UNIDUS or Private Label
Common Name:	Male Latex Condom
Classification Name:	Male Latex Condom
Predicate Device:	Carter-Wallace Version One Trojan Extra Large Latex Condom

With silicone lubricant 510(k) number K001212

Description of Device:

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

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prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV.

Technological Characteristics:

This condom has the same technological characteristics as the predicate condom identified above. The design is in conformance with ASTM Latex Condom Standard D3492 and the condom is made from the same natural rubber latex compound as listed in UNIDUS 510(k) number K023059 along with using the same production equipment. The Magnum Latex Condom is designed with a longer length of 205mm and wider flat width of 57mm for the man who needs a larger size condom.

The UNIDUS Magnum Latex Condom is intended for men who feel that current regular size condoms are too small.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract human figures, possibly representing a family or community, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1-5 2007

Mr. Claude L. Wright Consultant to UNIDUS Corporation 507 Shallow Creek Road TUSCAL00SA ALABAMA_35406

Re: K072747

Trade Name: UNIDUS or Private Label Regulation Number: 21 CFR §884.5300 Regulation Name: condom Regulatory Class: II Product Code: HIS Dated: September 27, 2007 Received: September 27, 2007

Dear Mr. Wright:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours.

Nancy C Brogdon

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

Enclosure

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INDICATIONS FOR USE STATEMENT VII.

510(k) Number	Not Known K072747
Device Name	Male Natural Rubber Latex Condom
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).

(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_

Julius Remer

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_ |< 0 7 2-7 L

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.