ONE® SILICONE Personal 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

ONE® SILICONE Personal Lubricant is a non-sterile, personal lubricant for use with or without a condom. It is specifically formulated to be a clear, non-irritating, non-greasy and odorless. liquid. This device is not a contraceptive nor does it contain any spermicidal component. Two forms of packaging are intended. The first primary packaging (having direct contact with product) consists of a plastic packaging. The second primary packaging is foil wrappers.

AI/ML Overview

This 510(k) notification describes ONE® SILICONE Personal Lubricant, a medical device. This product is a personal lubricant for penile and/or vaginal use to enhance comfort during sexual activity and supplement natural lubrication. It is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Test Performed	Reported Device Performance (Results)
Biocompatibility:
Cytotoxicity	Product is Non-toxic
ISO Guinea Pig Maximization Sensitization Test	Product does not elicit a sensitization response
Acute Systemic Toxicity	There is no evidence of systemic toxicity
Vaginal Irritation and Systemic Toxicity Study Following Repeated Exposure in Rabbits	Product produced no macroscopic or microscopic evidence of systemic toxicity and is considered a nonirritant.
Condom Compatibility:
ASTM D7661-10: Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms (tested with NRL, Polyisoprene, and Polyurethane condoms)	Compatible with commercially available male condoms made from natural rubber latex, polyurethane, and polyisoprene materials.
Shelf-Life:
Accelerated Aging Study (evaluating both versions of packaging)	Product met specifications for a one-year shelf life.
Real-time aging study	Being conducted to confirm results.

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

Biocompatibility Studies: The specific sample sizes for each biological test (Cytotoxicity, Sensitization, Acute Systemic Toxicity, Vaginal Irritation, and Systemic Toxicity in Rabbits) are not explicitly stated in the provided document. However, these are standard laboratory tests where sample sizes are dictated by the ISO 10993-1 standard and specific test methodologies.
- Data Provenance: The document does not specify the country of origin. These are laboratory studies. The document implicitly states these were prospective studies conducted for this device.
Condom Compatibility Study: The document mentions testing was performed on "three marketed brands of Natural Rubber Latex condoms, one brand of Polyisoprene condoms, and one brand of Polyurethane condoms." The specific number of individual condoms tested for each brand or material is not provided.
- Data Provenance: Not specified, but likely laboratory testing. These were prospective studies.
Shelf-Life Study (Accelerated Aging): The document states that the study "evaluated both versions of packaging." The specific number of samples or batches tested is not provided.
- Data Provenance: Not specified, but likely laboratory testing. These were prospective studies.

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

This information is not applicable to the studies described. The tests performed are laboratory-based, objective assessments of material properties and biological responses, or compatibility with other materials. The "ground truth" is established by the standardized methods themselves (e.g., ISO 10993-1, ASTM D7661-10) and the interpretation of results by trained laboratory personnel, rather than expert consensus on subjective findings.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation of data, such as imaging studies where a consensus among experts is needed for a diagnosis. The studies for this device are laboratory-based, following predefined protocols where results are generally objective and interpreted against established criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically used to evaluate the diagnostic accuracy of imaging or other interpretive medical devices with and without AI assistance, involving multiple human readers and a dataset of medical cases. The ONE® SILICONE Personal Lubricant is a consumer product (personal lubricant) and its evaluation involves chemical, physical, and biological compatibility testing, not diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a personal lubricant, not an algorithm or an AI-powered system. Therefore, the concept of "standalone performance" for an algorithm does not apply.

7. The Type of Ground Truth Used:

The "ground truth" for the studies performed is based on:
- Standardized Test Methods and Criteria: For biocompatibility, the ground truth is defined by the established pass/fail criteria of ISO 10993-1 tests (e.g., absence of cytotoxicity, no sensitization response, no systemic toxicity, non-irritant).
- Material Compatibility Standards: For condom compatibility, the ground truth is defined by the requirements and outcomes of the ASTM D7661-10 standard.
- Product Specifications and Stability Data: For shelf-life, the ground truth is established by the product's defined specifications (e.g., chemical stability, physical properties) and the results of accelerated aging interpreted against these specifications.

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical product (personal lubricant), not an AI algorithm that requires a training set. The studies described are experimental validations of the product's properties.

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

This is not applicable, as there is no training set for this type of medical device.

Summary

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Abbreviated 510(k) Notification for ONE® Personal Lubricant (Silicone)

II. 510(k) Summary

K110690

MAR 2 8 2012

	510(k) SUMMARY
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ONE® 12 Channel Street Boston, MA 02210

Contact Persons:

Submitted by:

Sharon Pietila Regulatory Affairs / Quality Assurance Manager Tel .: 617-946-2800 ext. 15 Fax: 617-946-3246 Email: sharon@globalprotection.com

Davin Wedel President Tel .: 617-946-2800 ext. 14 Fax: 617-946-3246 Email: davin@globalprotection.com

ONE® SILICONE Personal Lubricant

Date Prepared:

March 19, 2012

Personal Lubricant

Propriety Name:

Proposed Trade Name:

Common Name:

Classification Name:

Predicate Device:

Device Description:

Condom Class II (21 CFR §884.5300) NUC

ONE® Personal Lubricant

K-Y Brand Intrigue Personal Products Co. 510(k) No. K062796

Image /page/0/Picture/20 description: The image shows the word "ONE" in bold, white letters against a black rectangular background with rounded corners. The letters are large and fill most of the rectangle. The letter "E" is slightly stylized, with the horizontal bar in the middle being shorter than the top and bottom bars.

12 Channel Street Boston, MA 02210

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Abbreviated 510(k) Notification for ONE® Personal Lubricant (Silicone) .

Intended Use:

Indications For Use:

ONE® SILICONE Personal Lubricant is an over-the-counter personal lubricant.

Technological Characteristics:

ONE® SILICONE Personal Lubricant contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device.

Biocompatibility:

Biocompatibility testing was performed in accordance with ISO 10993-1.

Testing Performed	Results
Cytotoxicity	Product is Non-toxic
ISO Guinea Pig Maximization SensitizationTest	Product does not elicit asensitization response
Acute Systemic Toxicity	There is no evidence of systemtoxicity
Vaginal Irritation and Systemic Toxicity StudyFollowing Repeated Exposure in Rabbits(The study utilizes FDA recommended alternatedesign that is a hybrid between ISO VaginalIrritation test and ISO Acute Systemic Toxicity)	Product produced no macroscopic ormicroscopic evidence of systemictoxicity and is considered anonirritant.

Condom Compatibility:

Compatibility Testing was performed in accordance with ASTM D7661-10, 'Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms' on three marketed brands of Natural Rubber Latex condoms, one brand 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.

Image /page/1/Picture/13 description: The image shows the word "ONE" in bold, white letters against a black, rounded rectangle. The letters are large and fill most of the rectangle's space. The overall design is simple and modern, with a focus on readability and contrast.

12 Channel Street Boston, MA 02210

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Abbreviated 510(k) Notification for ONE® Personal Lubricant (Silicone)

Shelf-Life:

ONE® SILICONE Personal Lubricant has a one-year shelf life based on the results of an accelerated aging study. The accelerated aging study evaluated both versions of packaging. The product met specifications.

A real-time aging study is being conducted to confirm results of the accelerated aging study.

Image /page/2/Picture/4 description: The image shows the word "ONE" in white letters against a black background. The letters are bold and sans-serif. The black background is a rounded rectangle, and there is a small black dot in the lower right corner of the image.

12 Channel Street Boston, MA 02210

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

MAR 2 8 2012

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

Ms. Sharon Pietila Regulatory Affairs / Quality Assurance Manager ONE 12 Channel Street BOSTON MA 02210

Re: K110690

Trade/Device Name: ONE® SILICONE Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 19, 2012 Received: March 20, 2012

Dear Ms. Pietila:

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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Eicher

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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VII. Indications for Use Statement

Indications for Use

510(k) Number:
----------------	--

K110690

Device Name:

ONE® SILICONE Personal Lubricant

Indications For Use:

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(Part 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)

2 Channel Street oston, MA 02210

Page 18 of 215

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.