ID® Millennium® 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.

ID® Moments® Silicone 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

ID® Millennium® is non-sterile, an over-the-counter silicone based personal lubricant, formulated to be clear, non-irritating, non-greasy natural and odorless. This device is silicone soluble liquid for use as a personal lubricant. ID® Millennium® Personal Lubricant contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device. ID® Millennium® Personal Lubricant is neither a contraceptive nor a spermicide.

The device is available in the following variant personal lubricant formulas: ID® Millennium® and ID Moments® Silicone.

ID® Millennium® Personal Lubricant is provided in plastic/PET bottles with screw-on cap, flip top closure, pump dispensers, and foils.

AI/ML Overview

This document is a 510(k) Premarket Notification for a personal lubricant, ID® Millennium® and ID® Moments® Silicone, classified as a Class II device under Condoms (21 CFR 884.5300). The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, Wet Platinum Premium Lubricant® (K130012).

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes several tests performed to demonstrate the safety and effectiveness of the ID® Millennium® and ID® Moments® Silicone lubricants. The acceptance criteria are implicitly or explicitly stated as the desired outcome of these tests (e.g., "not cytotoxic," "non-sensitizing," "not an irritant and not systemically toxic," compatible with condoms).

Acceptance Criteria Category	Specific Test / Standard Reference #	Acceptance Criteria (Implicit/Explicit)	Reported Device Performance
Biocompatibility	Cytotoxicity (Agar Overlay)ISO 10993-5:2009	The device is not cytotoxic.	The device is not cytotoxic.
	ISO Guinea Pig Maximization SensitizationISO 10993-10:2010	The device is non-sensitizing.	The device is non-sensitizing.
	Vaginal Irritation and Systemic Toxicity Study (Rabbits)ISO 10993-10:2010, ISO 10993-11:2006	The device is not an irritant and not systemically toxic.	The device is not an irritant and not systemically toxic.
Product Specifications	Viscosity, Specific Gravity, Appearance, Color, Odor	Meet predefined specifications (not detailed in document).	(Implied to meet specifications for the product line)
	Absence of Pathogenic Organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans)USP <62>	Absence of specified pathogenic organisms.	(Implied to meet specifications for the product line)
	Total Aerobic Microbial CountUSP <61>	Meet predefined limits.	(Implied to meet specifications for the product line)
	Total Yeast and Mold CountUSP <61>, <1111>	Meet predefined limits.	(Implied to meet specifications for the product line)
	Water Activity TestUSP <1112>	Meet predefined limits.	(Implied to meet specifications for the product line)
Condom Compatibility	ASTM 7661-10 on major brand name latex, polyurethane, and polyisoprene condoms	The lubricant is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.	The condom compatibility testing demonstrate that ID® Millennium® lubricants are compatible with commercially available male condoms made from natural rubber latex, polyurethane, and polyisoprene materials.
Shelf Life	Retained samples tested per Westridge Laboratories, Inc. specifications	Three-year shelf-life is maintained.	ID® Millennium Personal Lubricant has three year shelf-life. Retains were obtained and tested per Westridge Laboratories, Inc. specifications.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the specific numerical sample sizes for each test (e.g., how many rabbits for irritation, how many condoms for compatibility testing, how many batches for specifications). It mentions "retains" for shelf-life testing and "major brand name" condoms, which implies a representative selection.
Data Provenance: The studies appear to be conducted by or for Westridge Laboratories, Inc. The standards referenced (ISO, USP, ASTM) are international and national standards, but the physical location where the tests were performed is not specified. The studies are prospective in nature, as they involve testing the actual device to generate performance data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of product does not involve "ground truth" established by human experts in the way an AI diagnostic device would. Instead, the "ground truth" or acceptance criteria are derived from:

Standardized Test Methods: ISO, USP, and ASTM standards provide predefined methodologies and acceptable limits for chemical, biological, and physical properties.
Scientific Principles: Biocompatibility, sterility, and material compatibility are judged against established scientific and regulatory principles for medical devices.

Therefore, the concept of "number of experts" and their "qualifications" for establishing a diagnostic ground truth is not applicable here. The expertise lies in the certified labs and personnel who conduct these tests according to the specified standards.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI performance evaluations where subjective expert interpretations are involved. For the objective laboratory tests described for this lubricant, such adjudication is not applicable. The results are based on objective measurements and observations according to the test protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. MRMC studies are specific to evaluating human reader performance, often in diagnostic imaging, and comparing it with or without AI assistance. This device is a personal lubricant, not a diagnostic or imaging device, so MRMC studies are not relevant.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. This device is a physical product (a personal lubricant), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The performance studies evaluate the physical and chemical properties of the lubricant itself.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the defined acceptable biological, chemical, and physical properties as determined by:

International Standards: ISO 10993 for biocompatibility.
National Pharmacopeia: USP <61>, <62>, <1111>, <1112> for microbiological and certain physical properties.
Industry Standards: ASTM 7661-10 for condom compatibility.
Manufacturer's Internal Specifications: For viscosity, specific gravity, appearance, color, and odor, as well as for defining the shelf-life testing parameters.

8. Sample Size for the Training Set

This product is not an AI/ML device, so there is no "training set" in the computational sense. The product development would involve formulations, pilot batches, and iterative testing, but not a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an algorithm, this question is not applicable. The formulation and development of the lubricant would be based on chemical engineering principles, material science, and regulatory requirements, rather than a data-driven "ground truth" for machine learning.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, stacked one behind the other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 9, 2015

Westridge Laboratories, Inc. Albert Rego, Ph.D. Regulatory Consultant 27001 La Paz Road, Suite 312 Mission Vieio. CA 92691

Re: K141767

Trade/Device Name: ID® Millennium®, ID® Moments® Silicone Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: February 21, 2015 Received: February 23, 2015

Dear Albert Rego,

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Albert Rego, Ph.D.

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 Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education 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

510(k) Number (if known) K141767

Device Name ID® Millennium® . ID® Moments® Silicone

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

Submitted by:	Westridge Laboratories, Inc.1671 E. Saint Andrew PlaceSanta Ana, CA 92705-4932
Contact Person:	Robert GrantQuality & Regulatory Affairs ManagerTel: (714) 259-9400 Ext. 230Fax: (714) 259-9550Email: bGrant@westridgelabs.com
Date Prepared:
Propriety Name:	ID® Millennium Personal Lubricant
Proposed Trade Name:	ID® Millennium Personal Lubricant
Common Name:	Personal Lubricant
Classification Name:	Condoms21 CFR 884.5300 Class IINUC
Predicate Device:	Wet Platinum Premium Lubricant®510(K) No. (K130012)
Device Description:	ID® Millennium® is non-sterile, an over-the-counter silicone basedpersonal lubricant, formulated to be clear, non-irritating, non-greasynatural and odorless. This device is silicone soluble liquid for use as apersonal lubricant. ID® Millennium® Personal Lubricant contains ablend of silicone fluid ingredients similar to ingredients found in the predicate device. ID® Millennium® Personal Lubricant is neither a contraceptive nor a spermicide.The device is available in the following variant personal lubricant formulas:ID® Millennium® and ID Moments® Silicone.ID® Millennium® Personal Lubricant is provided in plastic/PET bottles with screw-on cap, flip top closure, pump dispensers, and foils.
Intended Use:	ID® Millennium® Personal Lubricant is non-sterile, over-the-counterpersonal lubricant. This device is compatible with natural rubber latex,polyisoprene, and polyurethane condoms.

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510(K) Summary

Indications for Use:	ID® Millennium®:ID® Millennium® is a personal lubricant, for penile and /or vaginalapplication, intended to moisturize and lubricate, to enhance the easeand comfort of intimate sexual activity and supplement the body'snatural lubrication. This product is compatible with natural rubberlatex, polyisoprene, and polyurethane condoms.
	ID® Moments® Silicone:ID® Moments® Silicone is a personal lubricant, for penile and /or vaginalapplication, intended to moisturize and lubricate, to enhance the easeand comfort of intimate sexual activity and supplement the body'snatural lubrication. This product is compatible with natural rubberlatex, polyisoprene, and polyurethane condoms.
	ID® Millennium® Personal Lubricant and predicate device have the sameIndications for Use Statement.
TechnologicalCharacteristics:	There are no differences in the fundamental technologicalcharacteristics of ID® Millennium ® Personal Lubricant and predicateWet Platinum Premium Lubricant®. ID® Millennium® PersonalLubricant consists mainly of silicone; it contains a blend of silicone fluidingredients similar to other lubricants currently on the U.S. markets andis substantially equivalent to the predicate device. ID® Millennium®Personal Lubricant formula is neither a contraceptive nor a spermicide.

BIOCOMPATIBILITY:

As with the predicate, testing for cytotoxicity, vaginal irritation, sensitization, and systemic toxicity demonstrate that the device is biocompatible.

Testing Performed	Standard Reference #	Results
Cytotoxicity (Agar Overlay)	ISO 10993-5:2009	The device is not cytotoxic
ISO Guinea Pig Maximization Sensitization	ISO 10993-10:2010	The device is non-sensitizing
Vaginal Irritation and Systemic ToxicityStudy Following Repeated Exposure inRabbits (The study utilizes FDArecommended hybrid ISO Irritation / AcuteSystemic Toxicity test)	ISO 10993-10:2010ISO 10993-11:2006	The device is not an irritant and notsystemically toxic.

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510(K) Summary

Specifications:	ID® Millennium line of products has the following specifications:viscosity, specific gravity, appearance, color and odor, absence ofpathogenic organisms (Pseudomonas aeruginosa, Staphylococcusaureus, and Candida albicans) per USP <62>, total aerobic microbialcount, and total yeast and mold count per USP <61> and <1111>, andwater activity test per USP <1112>.
CondomCompatibility:	Condom Compatibility Testing was performed in accordance withASTM 7661-10 on major brand name latex, polyurethane, andpolyisoprene condoms.The condom compatibility testing demonstrate that ID® Millennium®lubricants are compatible with commercially available male condomsmade from natural rubber latex, polyurethane, and polyisoprenematerials.
Shelf Life Testing:	ID® Millennium Personal Lubricant has three year shelf-life. Retainswere obtained and tested per Westridge Laboratories, Inc.specifications.
Conclusion:	ID® Millennium® Personal Lubricant has the same intended use andbasic technological characteristics as the predicate device and is as safeand effective as its predicate device. Therefore, ID® MillenniumPersonal Lubricant is substantially equivalent to the predicate device.

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.