(113 days)
No
The summary describes a physical condom and lubricant, with no mention of AI or ML technology.
No
The device is described as being used for contraception and prophylaxis against sexually transmitted diseases, not for treating a disease or condition.
No
The device description indicates its purpose is for contraception and prophylactic purposes, not for diagnosing any medical condition.
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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Durex latex condom described is a physical barrier device used for contraception and disease prevention. It does not involve testing samples from the body to diagnose or monitor a condition.
- Intended Use: The intended use clearly states "for contraception and for prophylactic purposes," which aligns with a barrier method, not an in vitro test.
Therefore, based on the provided information, the Durex latex condom is not an IVD.
N/A
Intended Use / Indications for Use
This latex condom has the same intended use as the predicate condoms. This lates condom nas the camo mon and for prophylactic purposes (to help The condom is aoou for contrassmission of sexually transmitted diseases). prevent pregnancy and the transmit the same intended use as the predicate rne warming condowhen used as an accessory to a condom. It relieves portonial labrisant and comfort of intimate sexual activity.
Durex latex condom used for contraception and for manoutic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Product codes
85 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 shaped, teat ended, lubricated condom which is lubricated with a water based warming lubricant.
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
Premarket Notification [510(k)] application
K 0512957
FEB 1 7 2005
Section II Summary
Submitter Information A. _
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
October 8, 2004
D. Proprietary Name
Durex Male Latex Condom with warming lubricant. Trade name: Durex Warming Pleasure.
E. Common Name
Male Latex Condom
F. Classification Name
મારિ
G. Predicate Device
Durex Latex Rubber Condom - 510(k) Number K980319 Trojan Shared Pleasure condom - 510(K) Number unknown. KY Warming liquid personal lubricant - 510(k) Number K021492
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 shaped, teat ended, lubricated condom which is lubricated with a water based warming lubricant.
The device is designed to conform to national and international voluntary standards, including ISO 4074 and ASTM D3492, except where noted.
1
I. Intended Use of the Device
This latex condom has the same intended use as the predicate condoms. This lates condom nas the camo mon and for prophylactic purposes (to help The condom is aoou for contrassmission of sexually transmitted diseases). prevent pregnancy and the transmit the same intended use as the predicate rne warming condowhen used as an accessory to a condom. It relieves portonial labrisant and comfort of intimate sexual activity.
J. Technological Characteristics
This condom has the same technological characteristics as the predicate rmle Sondom nus the condoms described in K980319 are manufactured of ootuothe latex with the same shape as the condoms in this application. The competitor Trojan Shared Pleasure condoms are Natural Rubber Latex male condoms with 'Warm Sensations' lubricant to help enhance sexual pleasure.
The K-Y Warming liquid (K021492) is a water based, condom compatible personal lubricant which provides a warming sensation. It is of similar composition as the warming lubricant on the Durex condom in this submission.
The condom design conforms to domestic and international regulations: ASTM D3942 and ISO 4074. 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 the logo for the Department of Health & Human Services (HHS). The logo features a stylized bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
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: K042957
FEB 1 7 2005
Trade/Device Name: Durex Male Latex Condom with Warming Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: January 31, 2005 Received: February 9, 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 FI)A 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 clectronic 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) This letter will and my was finding of substantial equivalence of your device to a legally prematicated notified by one of 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 11 you don't 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/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
Enclosure
4
Durex Male Latex Condom with Warming Lubricant
Premarket Notification [510(k)] application
Indications for Use K042957 510(k) Number (if known):
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use: Durex latex condom used for contraception and for manoutic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Subpart C)
AND/OR
Over-The-Counter Use
01 Subpart D)
(21 CFR 807
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ernst M. Seyrum
Division Sion-Off Division of Reproductive, Abdomina and Radiological Device 510(k) Number
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