(98 days)
Not Found
No
The device description and performance studies focus on physical properties and standard testing, with no mention of AI/ML.
No.
The device description clearly states its intended uses are for "contraception" and for "prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease)," which are preventative rather than therapeutic.
No
Explanation: The device is a condom, used for contraception and preventing STDs, not for diagnosing medical conditions.
No
The device description clearly states it is a physical condom made of natural rubber 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Durex latex condom described is a physical barrier device used for contraception and disease prevention. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states contraception and prophylactic purposes, not diagnostic testing.
Therefore, based on the provided information, the Durex latex condom is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Product codes
HIS
Device Description
The condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The device is a straight walled, teat ended, coloured condom containing either red, yellow, orange or green pigment. The condoms are lubricated with a water based flavoured lubricant containing either lychee, guava, pineapple, mango or kiwi scent.
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)
Physical testing and release testing of the finished product revealed results in conformance with required specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Durex Male Latex Colored Condom with Scented Lubricants Premarket Notification [510(k)] application
Section II: Summary
A. Submitter Information
SSL Americas 3585 Engineering Dr. Suite 200 Norcross, GA 30092-9214 Phone: 770 - 582 - 2222 Fax: 770 - 582 - 2233
B. Contact Person
Chris Robinson, Controller Head of Global Regulatory Affairs, SSL Americas
C. Date Prepared
September 2005
D. Proprietary Name
Durex male latex colored shaped condoms with scented lubricants Trade name: Durex Tropical
E. Common Name
Male latex condom
ட் Classification Name માર્ડ
G. Predicate Devices
Durex Colors and Scents - 510(k) Number K980174 Durex Mint Scented Condom - 510(k) Number K900679 (plus 'note to file' line extension dated 30.09.2003)
H. Description of the Device
The condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The device is a straight walled , teat ended, coloured condom containing either red, yellow, orange or green pigment. The condoms are lubricated with a water based flavoured lubricant containing either lychee, guava, pineapple, mango or kiwi scent.
The device is designed to conform to national and international voluntary standards, including ISO 4074:2002 and ASTM D3492-03.
1
Durex Male Latex Colored Condom with Scented Lubricants
Premarket Notification [510(k)] application
Intended Use of the Device -
This latex condom has the same intended use as the predicate condoms. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
J. Technological Characteristics
This condom has the same technological characteristics as the predicate condoms identified.
The condoms described in K980174 are natural rubber latex, straight walled, teat ended condoms containing pigments (red, yellow, orange) lubricated with scented lubricants (strawberry, banana, tangerine). This application is also concerned with straight walled, teat ended, colored natural rubber latex condoms of the same basic formulation containing the same pigments as used in the predicate devices, but with aqueous based lubricants with the alternative scents of lychee, guava, pineapple, mango.
The condoms described in K900679 are straight walled, teat ended, natural rubber latex condoms lubricated with a spearmint flavor. An 'Add to File' was prepared in September 2003 to cover a natural rubber latex condom containing green pigment and lubricated with spearmint flavour sourced from a new supplier. This application is also concerned with the same green pigmented natural rubber latex condom with an alternative scented (kiwi) lubricant.
The condom design conforms to domestic and international regulations: ASTM D3942-03 and ISO 4074:2002. Physical testing and release testing of the finished product revealed results in conformance with required specifications.
2
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the left.
Public Health Service
JAN 2 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chris Robinson Controller Head of Global Regulatory Affairs SSL Americas, Inc. Office of Regulatory Affairs 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-9214
Re: K052959
Trade/Device Name: Durex Male Latex Colored Condom with Scented Lubricants Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: October 10, 2005 Received: November 7, 2005
Dear Mr. Robinson:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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.
3
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 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" (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/industry/support/index.html.
Sincerely yours,
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Durex Male Latex Colored Condom with Scented Lubricants
Premarket Notification [510(k)] application
Indications for Use
510(k) Number (if known):
Device Name:
Durex Tropical (male latex colored condom with scented lubricants)
Indications For Use: Durex latex condom used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Nancy C. Brodon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052959