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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Wet Platinum Premium Lubricant®, however, it's crucial to note that this 510(k) summary is for a personal lubricant, not a medical device involving AI or complex performance metrics typically found in device studies. Therefore, many of the requested points related to AI, medical imaging, human experts, and specific statistical analyses (like MRMC) are not applicable to this document.

I will fill in the relevant information and explicitly state when a requested point is not applicable or cannot be determined from the provided text.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility:
Non-toxic (Cytotoxicity - MEM Elution Test)	Product is Non-toxic
Does not elicit a sensitization response (ISO Guinea	Product does not elicit a sensitization response
Pig Maximization Sensitization Test)
Non-irritant & no acute systemic toxicity (Vaginal	Product produced no macroscopic or microscopic evidence of acute systemic toxicity and it is considered a non-irritant.
Irritation and Systemic Toxicity Following Once Daily
Application for Ten Consecutive Days)
Condom Compatibility (ASTM D7661-10):
Compatible with Natural Rubber Latex 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.
Compatible with Polyisoprene condoms	The results demonstrated that the condom compatibility testing of the silicone lubricant is compatible with commercially available male condoms made from... Polyisoprene materials.
Compatible with Polyurethane condoms	The results demonstrated that the condom compatibility testing of the silicone lubricant is compatible with commercially available male condoms made from... polyurethane materials.
Shelf Life:
1-year shelf life (accelerated aging study)	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, but 1 year is the initial proven shelf life based on the accelerated study).
Product Specifications:	Not explicitly stated as acceptance criteria, but listed as specifications: 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 as it is anhydrous.
Intended Use:	The device meets its intended use as 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, and is compatible with specified condoms. (Substantially equivalent to predicate devices).

Study Details

Sample size used for the test set and the data provenance:
- Biocompatibility Tests: The document does not specify the exact sample sizes (number of lubricant samples or animals used) for the cytotoxicity, sensitization, and vaginal irritation tests. The provenance is implied to be laboratory testing conducted to ISO 10993-1 and other standards. It is a prospective laboratory study.
- Condom Compatibility Tests: The tests were performed on "three marketed brands of Natural Rubber Latex condoms, two brands of Polyisoprene condoms, and one brand of Polyurethane condoms." The specific number of condoms tested per brand is not provided. The provenance is laboratory testing in accordance with ASTM Condom D7661-10. This is a prospective laboratory study.
- Shelf Life Testing: The sample size for the accelerated aging study is not specified. This is a prospective laboratory study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a personal lubricant, not an diagnostic or imaging device requiring expert interpretation for "ground truth." The "ground truth" for this product is established through standardized laboratory testing protocols (e.g., ISO, ASTM standards) and direct measurement of physical and biological properties.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As per the previous point, there are no human interpretations or judgments in the "test set" that would require adjudication in the way medical imaging or AI performance studies do. The results are objective measurements from laboratory tests.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI-assisted device. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance of this personal lubricant is established through objective measurements and observations from standardized laboratory tests (e.g., cytotoxicity assays, sensitization responses in animal models, visual and microscopic examination for irritation, mechanical properties of condoms after lubricant exposure, and stability readings from aging studies). It's essentially the direct experimental outcome based on established scientific protocols.
The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a "training set."
How the ground truth for the training set was established:
- Not Applicable. No training set was used.

Summary

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510(k) Summary K130012

TRIGG LABORATORIES,INC.28650 Braxton Ave.Valencia, CA. 91355-4163USA:(800) 248-4811FAX:(661) 775-3131	Submitted by:	Trigg Laboratories Inc.28650 Braxton AvenueValencia CA 91355
	Contact Person:	Ernie JohnsonVice President, OperationsTel.: 1(800) 248-4811Fax: 1(661) 775-3143Email: 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:	Condom21 CFR §884.5300 Class IINUC
	Predicate Devices:	One Silicone Personal LubricantONE510(k) No.: K110690
		and
		K-Y® Brand IntriguePersonal Products Co.510(k) No.: K062796.
	Device Description:	The Wet Platinum Premium Lubricant® is a non-sterile, siliconebased personal lubricant, an over-the-counter personal lubricant,formulated to be clear, non-irritating, non-greasy natural andodorless. It is a Silicone soluble, gel-like liquid for use as a personalubricant. The Wet Platinum Premium Lubricant® contains a blendof silicone fluid ingredients similar to ingredients found in thepredicate device.
		The specifications for Wet Platinum include appearance, odor,viscosity, specific gravity, total aerobic microbial count, total yeastand mold count, absence of pathogenic organisms (Pseudomonasaeruginosa, Staphylococcus aureus, Candida albicans, Escherichiacoli, Salmonella, and Clostrida), and antimicrobial effectiveness.Osmolality and pH are not applicable specifications because thesubject lubricant is anhydrous.
	Intended Use:	Wet Platinum Premium Lubricant Personal Lubricant is non-sterile, an over-the-counter personal lubricant.

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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 MAXIMIZATIONSENSITIZATION TEST- (Method forLiquid Test Articles)	Product does not elicit a sensitization response
Vaginal Irritation and SystemicToxicity Following Once DailyApplication for Ten ConsecutiveDays	Product produced no macroscopic ormicroscopic evidence of acute systemic toxicityand 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.

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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

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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

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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

Regulation Number and Section

§ 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.