(232 days)
Not Found
No
The 510(k) summary describes a personal lubricant and its physical and chemical properties, biocompatibility, and condom compatibility. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is a personal lubricant intended to enhance the ease and comfort of intimate sexual activity, which is not considered a therapeutic function.
No
Explanation: The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to diagnose any condition.
No
The device description clearly states it is a "non-sterile, silicone based personal lubricant," which 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 intended use is clearly stated as a personal lubricant for penile and/or vaginal application to enhance sexual activity and supplement natural lubrication. This is a topical application for physical comfort and function, not for diagnosing a condition or examining specimens from the body.
- Device Description: The description focuses on the physical properties and composition of the lubricant itself, not on its use in a diagnostic test.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a person's health status or disease.
- Performance Studies: The performance studies focus on biocompatibility, irritation, and condom compatibility, which are relevant for a personal lubricant, not for a diagnostic device.
IVD devices are specifically designed to perform tests on specimens taken from the human body 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 Trigg Laboratories Wet Platinum Premium Lubricant® is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polvisoprene, and polyurethane condoms."
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
The Wet Platinum Premium Lubricant® is a non-sterile, silicone based personal lubricant, an over-the-counter personal lubricant, formulated to be clear, non-irritating, non-greasy natural and odorless. It is a Silicone soluble, gel-like liquid for use as a personal lubricant. The Wet Platinum Premium Lubricant® contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device. The specifications for Wet Platinum include appearance, odor, viscosity, specific gravity, total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia coli, Salmonella, and Clostrida), and antimicrobial effectiveness. Osmolality and pH are not applicable specifications because the subject lubricant is anhydrous.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or 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)
BIOCOMPATIBILITY: Biocompatibility testing was performed in accordance with ISO 10993-1 and other standards.
Test Performed: Cytotoxicity (MEM Elution Test)
Results: Product is Non-toxic
Test Performed: ISO GUINEA PIG MAXIMIZATION SENSITIZATION TEST- (Method for Liquid Test Articles)
Results: Product does not elicit a sensitization response
Test Performed: Vaginal Irritation and Systemic Toxicity Following Once Daily Application for Ten Consecutive Days
Results: Product produced no macroscopic or microscopic evidence of acute systemic toxicity and it is considered a non-irritant.
Compatibility Testing: Compatibility Testing was performed in accordance with ASTM Condom D7661-10 {Air Burst and Tensile); 'Standard Test Method for Compatibility: Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms' on three marketed brands of Natural Rubber Latex condoms, two brands of Polyisoprene condoms, and one brand of Polyurethane condoms.
Results: The results demonstrated that the condom compatibility testing of the silicone lubricant is compatible with commercially available male condoms made from natural rubber latex, polyurethane, and Polyisoprene materials.
Shelf Life Testing: The Wet Platinum Premium Lubricant® has a one-year shelf life based on the results of an accelerated aging study. Real-time aging studies continue to extend period to 3 years.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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) Summary K130012
|
TRIGG LABORATORIES,
INC.
28650 Braxton Ave.
Valencia, CA. 91355-4163
USA:(800) 248-4811
FAX:(661) 775-3131 | Submitted by: | Trigg Laboratories Inc.
28650 Braxton Avenue
Valencia CA 91355 |
|-------------------------------------------------------------------------------------------------------------------------------|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Ernie Johnson
Vice President, Operations
Tel.: 1(800) 248-4811
Fax: 1(661) 775-3143
Email: erniej@trigglabs.com |
| | Date Prepared: | August 19, 2013 |
| | Propriety Name: | Wet Platinum Premium Lubricant® |
| | Proposed Trade Name: | Wet Platinum Premium Lubricant® |
| | Common Name: | Personal Lubricant |
| | Classification Name: | Condom
21 CFR §884.5300 Class II
NUC |
| | Predicate Devices: | One Silicone Personal Lubricant
ONE
510(k) No.: K110690 |
| | | and |
| | | K-Y® Brand Intrigue
Personal Products Co.
510(k) No.: K062796. |
| | Device Description: | The Wet Platinum Premium Lubricant® is a non-sterile, silicone
based personal lubricant, an over-the-counter personal lubricant,
formulated to be clear, non-irritating, non-greasy natural and
odorless. It is a Silicone soluble, gel-like liquid for use as a persona
lubricant. The Wet Platinum Premium Lubricant® contains a blend
of silicone fluid ingredients similar to ingredients found in the
predicate device. |
| | | The specifications for Wet Platinum include appearance, odor,
viscosity, specific gravity, total aerobic microbial count, total yeast
and mold count, absence of pathogenic organisms (Pseudomonas
aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia
coli, Salmonella, and Clostrida), and antimicrobial effectiveness.
Osmolality and pH are not applicable specifications because the
subject lubricant is anhydrous. |
| | Intended Use: | Wet Platinum Premium Lubricant Personal Lubricant is non-
sterile, an over-the-counter personal lubricant. |
1
510(k) Summary K130012
Image /page/1/Picture/1 description: The image is a black and white logo. The logo is a black circle with a white shape in the center. The white shape is an irregular shape with a rounded bottom. The letters TM are in the bottom right corner of the logo.
TRIGG LABORATORIES, INC. 28650 Braxton Ave. Valencia, CA. 91355-4163
Technological
USA:(800) 248•4811 FAX:(661) 775.3131
The Trigg Laboratories Wet Platinum Premium Lubricant® is a Indications For Use: personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polvisoprene, and polyurethane condoms.
The Wet Platinum Premium Lubricant® and the predicate devices have the same Indications for Use Statement.
The Wet Platinum Premium Lubricant® consists mainly of silicone based personal lubricants, contains a blend of silicone fluid Characteristics: ingredients similar to other lubricants currently on the U.S. markets and substantially equivalent to the predicate devices.
Wet Platinum Premium Lubricant® formula is neither a contraceptive nor a spermicide.
BIOCOMPATIBILITY: Biocompatibility testing was performed in accordance with ISO 10993-1 and other standards.
| Test Performed | Results |
|---|---|
| Cytotoxicity (MEM Elution Test) | Product is Non-toxic |
| ISO GUINEA PIG MAXIMIZATION | |
| SENSITIZATION TEST- (Method for | |
| Liquid Test Articles) | Product does not elicit a sensitization response |
| Vaginal Irritation and Systemic | |
| Toxicity Following Once Daily | |
| Application for Ten Consecutive | |
| Days | Product produced no macroscopic or |
| microscopic evidence of acute systemic toxicity | |
| and it is considered a non-irritant. |
Compatibility Testing was performed in accordance with ASTM Condom D7661-10 {Air Burst and Tensile); 'Standard Test Method for Compatibility: Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms' on three marketed brands of Natural Rubber Latex condoms, two brands of Polyisoprene condoms, and one brand of Polyurethane condoms.
The results demonstrated that the condom compatibility testing of the silicone lubricant is compatible with commercially available male condoms made from natural rubber latex, polyurethane, and Polyisoprene materials.
- Shelf Life Testing: The Wet Platinum Premium Lubricant® has a one-year shelf life based on the results of an accelerated aging study.
- Real-time aging studies continue to extend period to 3 years.
- Conclusion: The performance data demonstrate that the Wet Platinum Premium Lubricant® is substantially equivalent to its proposed predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2013
Trigg Laboratories, Inc. % Ernie Johnson Vice President, Operations 28650 Braxton Avenue Valencia, CA 91355
Re: K130012
Trade/Device Name: Wet Platinum Premium Lubricant® Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: July 12, 2013 Received: July 23, 2013
Dear Ernie Johnson:
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 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 of medical
3
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/Resourcesfor You/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,
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
INDICATIONS FOR USE
K130012 510(k) Number:
Device Name: Wet Platinum Premium Lubricant®
Indications for Use:
"The Trigg Laboratories Wet Platinum Premium Lubricant® is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms."
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) Division of Reproductive. Gastro-Renal, and Urological Devices 510(k) Number KI30012