(43 days)
Not Found
No
The device description is for a standard condom with a desensitizing agent, and there is no mention of AI or ML in the provided text.
No.
The primary stated uses are contraception and disease prevention, not treating a medical condition. While it contains Benzocaine for desensitizing, this is a drug component for an effect, but the device itself is not a therapeutic device.
No
The text explicitly states the intended use is for contraceptive and prophylactic purposes, not for diagnosing a condition.
No
The device description clearly states it is a physical condom made of natural latex, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- UNIDUS Condom Function: The UNIDUS Condom is a physical barrier device used externally on the male genitals for contraception and disease prevention. It does not involve the analysis of any bodily specimens.
The description clearly outlines its function as a physical barrier and its intended use for preventing pregnancy and STDs, which are not activities associated with in vitro diagnostics.
N/A
Intended Use / Indications for Use
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, including HIV. The male genital desensitizer in the condom 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.
The UNIDUS Condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
Product codes (comma separated list FDA assigned to the subject device)
85 HIS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
DEC 2 3 2003
Abbreviated 510 (k) Notification for a Male Latex Condom
II. 510(k) SUMMARY
| Submitted By: | UNIDUS Corporation
Seokyung Bldg., 51 Bang-1 Dong
Songpa-Ku
Seoul, Republic of Korea | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Persons: | Eli J. Carter
Consultant to UNIDUS Corporation
1219 Little Creek Road
Durham, NC 27713 | B.S. Lee
Managing Director
UNIDUS Corporation
Seokyung Building 51,
Bangi-dong, Songpa-Ku
Seoul, 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 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. | |
| 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, including HIV. The male genital desensitizer in the condom
helps 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.
Page 5 of 14
1
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.
2
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
3
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
4
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.