(81 days)
Not Found
No
The device description and intended use are for a standard latex condom, with no mention of AI or ML technology.
No
Explanation: The device is a condom, used for contraception and prevention of STDs, not for treating any medical condition or disease.
No
Explanation: The device is a condom, used for contraception and disease prevention, not for diagnosing conditions.
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:
- Intended Use: The intended use of the UNIDUS condom is for contraception and prophylaxis (preventing pregnancy and STDs). This is a physical barrier method used in vivo (on the body), not a test performed in vitro (outside the body) on biological samples to diagnose or detect conditions.
- Device Description: The description details a physical device designed to cover the penis. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information about a disease or condition
Based on the provided information, the UNIDUS condom is a medical device, but it falls under a different regulatory category than IVDs.
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
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, nominal thickness 0.06mm and is colored. It is lubricated with silicone containing flavoring, 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
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)
LS Rubber Latex Condom; K020633
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 1 3 2002
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 | H.S. Lee
Managing Director
UNIDUS Corporation
Seokyung Building 51,
Bangi-Dong, Songpa-Ku
Seoul, Korea |
| Date Prepared: | September 18, 2002 | |
| Proprietary Name: | UNIDUS, (and other private labels) | |
| Common Name: | Male Latex Condom | |
| Classification Name: | Male Latex Condom | |
| Predicate Device: | LS Rubber Latex Condom; K020633 | |
| 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, nominal thickness 0.06mm and is colored. It is
lubricated with silicone containing flavoring, 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, possibly representing people.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 13 2002
Unidus Cororation % Mr. Eli J. Carter Consultant 1219 Little Creek Road DURHAM NC 27713
Re: K023175
Trade Name/Device: Male Natural Rubber Latex Condom (colored and flavored) Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: September 18, 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 (QS) 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.
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 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(i) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, $801.435(c) 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,
Yurind le. de germon
4-24
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health cc: HFZ-401
3
Information for a Male Latex Condom 510(k) Submission
:
. . . . . .
INDICATIONS FOR USE STATEMENT VII.
.
・
| 510(k) Number | Not Known |
|---|---|
| Device Name | Male Natural Rubber Latex Condom (colored and flavored) |
| Indications for Use: | The UNIDUS condom is used for contraceptive and for prophylactic |
| purposes (to help prevent pregnancy and the transmission of sexually |
100 - 100
:
transmitted diseases) 1. September 19.
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(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 (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _