(140 days)
No
The 510(k) summary describes a personal lubricant and does not mention any AI or ML technology.
No.
The device is a lubricant intended to facilitate the entry of other devices or enhance sexual experience, not to treat a medical condition itself.
No
The device is a lubricant intended to facilitate the entry of other devices or enhance the sexual experience, not to diagnose a medical condition.
No
The device is a gel lubricant, which is a physical substance and not software. The description clearly indicates it is a "clear, high viscosity gel" packaged in a tube.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is described as a "patient lubricant" to "lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device" and "principally designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse." This describes a device used on the body for lubrication and sexual enhancement, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description details a gel lubricant, which aligns with its intended use as a topical or internal lubricant, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The information clearly indicates this is a personal lubricant, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The TROJAN® PASSION BERRY™ Gel patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. The TROJAN® PASSION BERRY™ Gel is principally designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. The TROJAN® PASSION BERRY™ Gel may be used with condoms.
Product codes
NUC
Device Description
The TROJAN® PASSION BERRYTM Gel personal lubricant is formulated as a clear, high viscosity gel with a pink color and lubricant is lonnalise as agrance and packaged in a clear plastic 2.5 oz. tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body orifice, vaginal
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)
H•R® Lubricating Jelly, TROJAN® FOR WOMEN Personal Lubricant [#K890863]
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 TROJAN® PASSION BERRYTM Gel Personal Lubricant
5 2002 MAR
October 15,
510(k) Summary
| Submitted by: | ArmKel LLC
469 North Harrison Street
Princeton, NJ 08543 |
|----------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen C. Kolakowsky
Director, Regulatory Affairs
Church & Dwight Co., Inc.
(609) 655-6308 |
| Date Prepared: | October 15, 2001 |
| Proprietary Name: | TROJAN® PASSION BERRY™ Gel |
| Common Name: | Personal Lubricant |
| Classification Name: | Patient Lubricant [21 CFR §880.6375] |
| Predicate Device: | H•R® Lubricating Jelly
[Pre-1976 Amendments Device]
TROJAN® FOR WOMEN Personal Lubricant
[#K890863] |
Description of Device: The TROJAN® PASSION BERRYTM Gel personal lubricant is formulated as a clear, high viscosity gel with a pink color and lubricant is lonnalise as agrance and packaged in a clear plastic 2.5 oz. tube.
Intended Use of the Device: A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. The TROJAN® PASSION BERRY™ Gel personal lubricant is principally intended to provide supplemental vaginal lubrication during sexual intercourse, and it may be used with condoms.
There are no exceptional technological Technological Characteristics: characteristics associated with TROJAN® PASSION BERRYTN Gel. Although a proprietary formulation, the basic formulation of TROJAN® PASSION BERRYTM Gel follows that of conventional water-soluble I Aborent bases. [e.g., Remington's Pharmaceutical Sciences, ed. XIV, 1970, Mack Publishing Co., Easton, PA., Chp 85.] Both the TROJAN® PASSION BERRYTM Gel and the predicate lubricant devices follow conventional formulation concepts.
Image /page/0/Picture/11 description: The image shows the text "ARMKL, LLC" in a bold, sans-serif font. The text is black and appears to be printed on a white background. A thick black line is located underneath the text.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
FEB 2 4 2014
ARMKEL, LLC % Mr. Stephen C. Kolakowsky Director, Regulatory Affairs Church & Dwight Co., Inc. P.O. Box 1001 Half Acre Road CRANBERRY NJ 08512
Re: K013433 Trade/Device Name: TROJAN® PASSION BERRYTM Gel, Personal Vaginal Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): January 30, 2002 Received (Date on orig SE Itr): January 31, 2002
Dear Mr. Kolakowsky:
This letter corrects our substantially equivalent letter of March 5, 2002.
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
2
Page 2 -
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); 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 contact 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. 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.
Benjamin R. Fisher -S
Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
| 510(k) Number: | KO13433 |
|---|---|
| Device Name: | TROJAN® PASSION BERRY™ Gel |
| Personal Lubricant | |
| Indications for Use: | The TROJAN® PASSION BERRY™ Gel patient |
| lubricant is a device intended for medical | |
| purposes that is used to lubricate a body | |
| orifice to facilitate entry of a diagnostic or | |
| therapeutic device. The TROJAN® PASSION | |
| BERRY™ Gel is principally designed to help | |
| enhance the sexual experience by providing | |
| supplemental vaginal lubrication during | |
| sexual intercourse. The TROJAN® PASSION | |
| BERRY™ Gel may be used with condoms. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR §8001.109) OR
Over-the-Counter Use X
David G. Severson
Division
Division for inductive, A terminal,
and R. Devices
510(K) Number K013433
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church & dwight co., inc.
Image /page/3/Picture/13 description: The image shows the text "ARMKEL, LLC" in a bold, sans-serif font. The text is black and appears to be slightly pixelated. There is a horizontal line underneath the text, which may be part of a logo or design element.