(90 days)
Not Found
No
The device description and intended use are for a standard condom, and there is no mention of AI, ML, or any related technologies in the provided text.
No.
Explanation: The device is intended for contraception and prophylactic purposes (preventing pregnancy and STDs), not for treating a disease or disorder.
No
Explanation: The device, a condom, is described as being used for contraceptive and prophylactic (disease prevention) purposes. There is no mention of it being used to diagnose any disease or 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 about a person's health. This information is used for diagnosis, monitoring, or screening.
- UNIDUS Condom Function: The UNIDUS condom is a physical barrier device used for contraception and preventing the transmission of STDs. It does not involve the examination of bodily specimens to provide diagnostic information.
The description clearly states its intended use is for contraceptive and prophylactic purposes, and its mechanism is a physical sheath covering the penis. This falls under the category of a medical device, but not an In Vitro Diagnostic.
N/A
Intended Use / 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)
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 lubricated with silicone 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penis
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
KO23059
Abbreviated 510 (k) Notification for a Male Latex Condom______________________________________________________________________________________________________________________
Page 5 of 13
510(k) SUMMARY II.
| 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
H.S. Lee
Managing Director
UNIDUS Corporation
Seokyung Building 51,
Bangi-Dong, Songpa-Ku
Seoul, Korea |
| Date Prepared: | September 5, 2002 |
| Proprietary Name: | N/A |
| Common Name: | Male Latex Condom |
| Classification Name: | Male Latex Condom |
| Predicate Device: | Thai Nippon Condom; K982380 |
| 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 lubricated with
silicone 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. |
| 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. |
| 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 that the condom is made of natural
rubber latex. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right and is enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Unidus Cororation % Mr. Eli J. Carter Consultant 1219 Little Creek Road DURHAM NC 27713
Re: K023059
Trade Name/Device: Male Natural Rubber Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: September 5. 2002 Received: September 13, 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 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.
2
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 8884.5300 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, 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Information for a Male Latex Condom 510(k) Submission
Page 11 of 13
INDICATIONS FOR USE STATEMENT VII.
| 510(k) Number | Not Known | |
|---|---|---|
| -- | --------------- | ----------- |
Male Natural Rubber Latex Condom 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)
Over-the-Counter Use Prescription Use OR (Per 21 CFR 801.109) (Division Sign-Off) Division of Reproductive. Abdoming and Radiological Devices 510(k) Number __