(67 days)
No
The 510(k) summary describes a standard latex condom and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is clearly indicated for contraception and prophylactic purposes (reducing risk of pregnancy and STDs), not for treating a disease or condition.
No
Explanation: The device description states its use for contraception and prophylactic purposes (reducing risk of pregnancy and STDs), not for diagnosing any condition.
No
The device description clearly states it is a physical product made of natural rubber latex, a colored pigment, and a flavored water-based lubricant. It is a tangible condom, not software.
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, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly states that the TROJAN® MINT TINGLE™ Latex Condom is a physical barrier device used for contraception and reducing the risk of STD transmission. It does not involve testing samples from the body.
The description focuses on the physical characteristics of the condom and its function as a barrier, not on any diagnostic testing.
N/A
Intended Use / Indications for Use
The TROJAN® MINT TINGLE™ Latex Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).
Product codes
85 HIS
Device Description
The TROJAN® MINT TINGLE™ Brand Latex Condom is a male condom consisting of a sheath of natural rubber latex with a colored pigment and a flavored water-based lubricant. The condom is a straight-walled, nipple-end condom with a nominal length of 180 mm and an approximate width of 52 mm. [Refer to ASTM D-3492-97 Specification for Rubber Contraceptives (Male Condoms).]
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
TROJAN-ENZ® Lubricated Condom, K013433
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
1023405
510(k) Summary
| Submitted by: | Church & Dwight Co., Inc./ArmKel, LLC
469 North Harrison Street
Princeton, NJ 08543 | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Stephen C. Kolakowsky
Director, Regulatory Affairs
(609) 279-7748 | DEC 16 2002 |
| Date Prepared: | October 1, 2002 | |
| Proprietary Name: | TROJAN® MINT TINGLETM Brand Latex Condom | |
| Common Name: | Latex Condom | |
| Classification Name: | Condom [21 CFR §884.5300] | |
| Predicate Device: | TROJAN-ENZ® Lubricated Condom
(Pre-1976 Amendments Device)
and
TROJANTM PASSION BERRYTM Personal Lubricant
(K013433) | |
Description of Device: The TROJAN® MINT TINGLE™ Brand Latex Condom is a male condom consisting of a sheath of natural rubber latex with a colored pigment and a flavored water-based lubricant. The condom is a straight-walled, nipple-end condom with a nominal length of 180 mm and an approximate width of 52 mm. [Refer to ASTM D-3492-97 Specification for Rubber Contraceptives (Male Condoms).]
Intended Use of the Device: The 510(k)-subject condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).
Technological Characteristics: Both the 510(k)-subject condom and the predicate condom are of the same basic design meeting ASTM Standard Specification for Rubber Contraceptives (Male Condoms) D3492 - both are straight-walled, nipple-ended. lubricated condoms and made using the same basic formulations of compounded natural rubber latex. The 510(k)-subject condom most notably differs from the predicate condom in that a pigment is added to the latex formulation to vield a colored condom and that the lubricant utilized with the 510(k)-subject condom is similar to the predicate flavored personal lubricant.
Image /page/0/Picture/8 description: The image is a black and white logo for Arm & Hammer. The logo is circular and contains an arm holding a hammer. The text "ARM & HAMMER" is written around the top of the circle, and the text "of purity since 1846" is written around the bottom of the circle.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an eagle or bird with stylized wings and tail feathers.
HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 2002
ArmKel, LLC % Mr. Stephen C. Kolakowsky Director, Regulatory Affairs Church & Dwight Co., Inc. 469 North Harrison Street PRINCETON NJ 08543-5297
Re: K023405
Trade Name/Device: TROJAN® MINT TINGLE™ Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: October 3, 2002 Received: October 10, 2002
Dear Mr. Kolakowsky:
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.
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
2
Page 2 - Mr. Kolakowsky.
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 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(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. 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,
Eaird A. Lyon
pin Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use Statement
510(k) Number:
Device Name:
Indications for Use:
The TROJAN® MINT TINGLE™ Latex Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).
TROJAN® MINT TINGLE™ Male Latex Condom
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR §8001.109)
× Over-the-Counter Use OR
Frint C. Simmon
(Division Sign 74) Division of Reproductive, Abdominal, and Radiological Devices 102340 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Image /page/3/Picture/14 description: The image shows a logo for Arm & Hammer. The logo is circular and contains the words "ARM & HAMMER" in a circular fashion around the top half of the circle. In the center of the circle is an arm holding a hammer. The words "THE STANDARD OF PURITY" are written along the bottom half of the circle.