(88 days)
Not Found
No
The 510(k) summary describes a personal lubricant and does not mention any AI or ML components or functionalities.
Yes
The "Intended Use / Indications for Use" section states that the device "is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device." This indicates it is used in conjunction with therapeutic devices, thereby making it a therapeutic device itself.
No
This device is a personal lubricant used to facilitate sexual intercourse or the entry of other devices (diagnostic or therapeutic), but it does not perform any diagnostic function itself.
No
The device description clearly states it is a liquid lubricant packaged in a bottle, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is for supplemental vaginal lubrication during sexual intercourse and to facilitate entry of diagnostic or therapeutic devices into a body orifice. This is a direct application to the body for lubrication purposes, not for testing samples of bodily fluids or tissues in vitro (outside the body).
- Device Description: The description details a liquid lubricant, not a test kit, reagent, or instrument used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any aspects related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Diagnosing diseases or conditions based on sample analysis
- Reagents, calibrators, or controls typically associated with IVDs
The second part of the intended use, "facilitate entry of a diagnostic or therapeutic device," describes the lubricant's function in aiding the use of other devices, not as a diagnostic device itself.
Therefore, the TROJAN® CRYSTAL CLEAR Liquid is a medical device (specifically a lubricant), but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TROJAN® CRYSTAL CLEAR Liquid is principally designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. The TROJAN® CRYSTAL CLEAR Liquid may be used with condoms. The TROJAN CRYSTAL CLEAR Liquid 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.
Product codes
NUC
Device Description
The TROJAN® CRYSTAL CLEAR Liquid personal lubricant is a water-soluble, greaseless, unscented, clear, colorless liquid, 2.1 oz of which is packaged in a clear plastic bottle.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
H·R® Lubricating Jelly, 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
FEB 0 1 2002
November 1, 2001
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: | November 1, 2001 |
| Proprietary Name: | TROJAN® CRYSTAL CLEAR Liquid |
| 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® CRYSTAL CLEAR Liquid personal lubricant is a water-soluble, greaseless, unscented, clear, colorless liquid, 2.1 oz of which is packaged in a clear plastic bottle.
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® CRYSTAL CLEAR Liquid personal lubricant is principally intended to provide supplemental vaginal lubrication during sexual intercourse, and it may be used with condoms.
Technological Characteristics: There are no exceptional technological characteristics associated with TROJAN® CRYSTAL CLEAR Liquid. Although a proprietary formulation, the basic formulation of TROJAN® CRYSTAL CLEAR Liquid follows that of conventional water-soluble lubricant bases. [e.g., Remington's Pharmaceutical Sciences, ed. XIV. 1970, Mack Publishing Co., Easton, PA., Chp 85.] Both the TROJAN® CRYSTAL CLEAR Liquid 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 underlined with a thick black line. The letters are closely spaced, and the comma between "ARMKL" and "LLC" is clearly visible.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
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. 469 North Harrison Street PRINCETON NJ 08543
Re: K013614
Trade/Device Name: TROJAN® Crystal Clear Liquid Personal Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): November 1, 2001 Received (Date on orig SE ltr): November 5, 2001
Dear Mr. Kolakowsky:
This letter corrects our substantially equivalent letter of February 1, 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, listing 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 (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.
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
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
3
November 1, 2001
Indications for Use Statement
510(k) Number: K013614
Device Name: TROJAN® CRYSTAL CLEAR Liquid
Personal Lubricant
Indications for Use: The TROJAN® CRYSTAL CLEAR Liquid is
principally designed to help enhance the
sexual experience by providing
supplemental vaginal lubrication during
sexual intercourse. The TROJAN®
CRYSTAL CLEAR Liquid may be used with
condoms. The TROJAN CRYSTAL CLEAR
Liquid 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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR §801.109)
× Over-the-Counter Use
David A. Spencer
Image /page/3/Picture/10 description: The image shows a black and white emblem. The emblem is circular and contains a stylized figure in the center. The figure appears to be a person in a dynamic pose, possibly dancing or moving energetically. The figure is surrounded by text that follows the curve of the circle, although the specific words are not clear due to the image quality.
Image /page/3/Picture/13 description: The image shows the text "ARMKL, LLC" in a bold, sans-serif font. The text is black and appears to be a logo or heading. A thick black line is present underneath the text, emphasizing the name. The overall impression is clean and professional.