(121 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a latex condom and its lubricant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is primarily used for contraception and the prevention of sexually transmitted infections, which are prophylactic and contraceptive purposes, not therapeutic.
No
Explanation: The device, a condom, is described for contraception and prophylactic purposes, not for diagnosing any medical condition.
No
The device description clearly indicates it is a physical condom made of natural rubber latex with applied lubricant, not a software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and prevention of sexually transmitted infections. 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 a condition.
- Device Description: The description details a physical condom made of latex with lubricant. It does not describe any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on biocompatibility, physical properties (meeting ASTM standards), and stability of the condom itself, not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Product codes
HIS
Device Description
The TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane and has a glycol-based lubricant containing low levels of sensory ingredients applied directly to the condom to create a perception of warming and tingling. The condom is a bulbous shaped condom consistent with ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male condom) with a reservoir end. The TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) is designed with ribs on its shank and on its bulb. The condom has a nominal length of 185 mm and a maximum nominal flat-width of 54 mm, measured 30 mm from the open end. The bulbous portion at the closed end of the condom has a flat-width of 65 mm.
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
Biocompatibility Studies: Biocompatibility studies applicable to the TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) were performed on the final 510(k)subject device. These studies in vitro cytotoxicity study using the ISO Elution method; cytotoxicity study using the end-point titration method; rabbit vaginal irritation study; rabbit penile irritation study; acute systemic toxicity study; guinea pig maximization sensitization study; primary rabbit skin irritation study. Based on the results of these studies, TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) is considered safe for consumer use under normal and reasonably foreseeable misuse conditions.
Physical testing data: Three (3) lots of TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingline Lubricant (TM-TBD) were tested and met specifications of ASTM D 3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms).
Shelf-life: Stability of the TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) was established from results of physical testing data using a protocol that followed 21 CFR §801.435 as a guide. Based on the evaluation of the results of the physical testing data, the expiration date has been initially set at 36 months and will be then verified through real-time stability through five (5) years in compliance with FDA expiration labeling requirements in 21 CFR §801.435.
Key Metrics
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
510(k) Notification Church & Dwight Co., Inc. Confidential Page 2 of 684
II. 510(k) SUMMARY
| Submitted by: | Church & Dwight Co., Inc.
500 Charles Ewing Blvd
Ewing, NJ 08628 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Emily Perez
Sr. Regulatory Affairs Specialist
Phone: (609) 806-1430
Fax: (609) 403-7415
email: EMILY.PEREZ@CHURCHDWIGHT.COM |
| Date Prepared: | June 24, 2013 |
| Proprietary
Name: | TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and
Tingling Lubricant (TM-TBD) |
| Common
Name: | Natural Rubber Latex Condom with Lubricant |
| Classification
Name: | Condom (21 CFR §884.5300) HIS |
| Predicate
Device: | TROJAN™ (TM-TBD) Latex Condom with Lubricant (K912901)
[Secondary Brand Name HER PLEASURE™ added when introduced to
market] |
OCT 2 4 2013Description of the Device: The TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane and has a glycol-based lubricant containing low levels of sensory ingredients applied directly to the condom to create a perception of warming and tingling. The condom is a bulbous shaped condom consistent with ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male condom) with a reservoir end. The TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) is designed with ribs on its shank and on its bulb. The condom has a nominal length of 185 mm and a maximum nominal flat-width of 54 mm, measured 30 mm from the open end. The bulbous portion at the closed end of the condom has a flat-width of 65 mm.
Intended Use of the Device; The 510(k)-subject device, TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD), has the same intended use as the predicate TROJANTM.HER PLEASURE™ Latex Condom with Lubricant (K912901). The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections.)
1
510(k) Notification Church & Dwight Co., Inc. Confidential Page 3 of 684
Technological Characteristics: The TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) has the same bulbous-shaped condom design and material (natural rubber latex) as the predicate TROJAN™ HER PLEASURE™ Latex Condom with Lubricant (K912901). The predicate was designed with smooth wall and silicone lubricant, the 510(k)-subject device is designed with ribs on the shank and on the bulb of the condom and contains a tingling and warming lubricant. The nominal width remains 54 mm, measured at 30 mm from the open-end of the condom as specified by ASTM D3492-08. Labeling for the 510(k)-subject device is consistent with the Special Controls provisions of 21 CFR §884.5300 and that of the predicate device. The primary purpose of the added ribbing and the warming and tingling lubricant is based on preferred aesthetics by the consumer.
Summary of Studies
Biocompatibility Studies:
Biocompatibility studies applicable to the TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) were performed on the final 510(k)subject device. These studies in vitro cytotoxicity study using the ISO Elution method; cytotoxicity study using the end-point titration method; rabbit vaginal irritation study; rabbit penile irritation study; acute systemic toxicity study; guinea pig maximization sensitization study; primary rabbit skin irritation study. Based on the results of these studies, TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) is considered safe for consumer use under normal and reasonably foreseeable misuse conditions.
Physical testing data
Three (3) lots of TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingline Lubricant (TM-TBD) were tested and met specifications of ASTM D 3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms).
Shelf-life
Stability of the TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) was established from results of physical testing data using a protocol that followed 21 CFR §801.435 as a guide. Based on the evaluation of the results of the physical testing data, the expiration date has been initially set at 36 months and will be then verified through real-time stability through five (5) years in compliance with FDA expiration labeling requirements in 21 CFR §801.435.
Accordingly, when compared to the predicate HER PLEASURE™ male latex condom, the data from the performance and biocompatibility studies demonstrate that the TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) is substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 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 wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2013
Church & Dwight Co., Inc. % Emily Perez Senior Regulatory Affairs Specialist 500 Charles Ewing Boulevard Ewing, NJ 08628
Re: K131887
Trade/Device Name: TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: August 6, 2013 Received: August 7, 2013
Dear Emily Percz,
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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.
3
Page 2 - Emily Perez
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Notification Church & Dwight Co., Inc. Confidential Page 1 of 684
I. INDICATIONS FOR USE STATEMENT
510(k)
Number: K131887
TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Device Name: Tingling Lubricant (TM-TBD)
Indications For The TROJAN™ Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant (TM-TBD) is used for contraception and for Use: prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR §801.109)
OR
.
× Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________