(90 days)
Just like 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 latex, polyisoprene, and polyurethane condoms.
The Just Like Me Personal Lubricant is a non-sterile, water based, over-the- counter personal lubricant formulated to be a clear, non-irritating, non-greasy, odorless liquid.
The proposed device contains a blend of ingredients similar to ingredients found in the predicate device.
The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with or without natural rubber latex, polyisoprene, and polyurethane condoms during intimate sexual activity as evidenced by condom compatibility testing.
The provided document is a 510(k) summary for a personal lubricant, "Just Like Me Personal Lubricant." It details the device's characteristics and performance testing to establish substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on your request:
1. A table of acceptance criteria and the reported device performance
The document provides the results of various performance tests, with a focus on safety and compatibility. The "acceptance criteria" are implied by the "Results" column, indicating that the product passed or met specific safety standards.
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cytotoxicity (Direct Contact) | Product should be non-toxic | Product is Non-toxic |
| ISO GUINEA PIG MAXIMIZATION SENSITIZATION TEST | Product should not elicit a sensitization response | Product does not elicit a sensitization response |
| Vaginal Mucosa Irritation with Histopathology | Product should be considered a non-irritant to vaginal tissue | Product is considered a non-irritant to vaginal tissue |
| Acute Systemic Toxicity | No evidence of systemic toxicity | There is no evidence of system toxicity |
| Condom Compatibility (ASTM D7661-10 with Natural Rubber Latex, Polyisoprene, and Polyurethane condoms) | Compatible with natural rubber latex, polyisoprene, and polyurethane condoms | Compatible with natural rubber latex, polyisoprene, and polyurethane condoms |
| Shelf Life Testing (Accelerated aging study) | Met specifications for viscosity, specific gravity, appearance, color, odor, Preservative Effectiveness, Antimicrobial Effectiveness, TAMC, TYMC, Absence of Pathogenic organism for 2 years | Achieved a 2-year shelf life, meeting all specified parameters after aging |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not explicitly state the sample sizes for the individual biocompatibility tests or the condom compatibility testing (e.g., number of animals for in-vivo tests, number of condoms tested). It mentions testing "three marketed brands of Natural Rubber Latex condoms, one brand of Polyisoprene condoms, and one brand of Polyurethane condoms," but not the number of individual condoms per brand.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It is implied that the testing was performed to support a US FDA submission, but the location of the labs is not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this document. The studies described are laboratory-based performance tests (biocompatibility, shelf life, condom compatibility), not clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests is established by objective measurements and standardized protocols, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically relevant for clinical studies where multiple experts evaluate ambiguous cases. For the laboratory tests detailed, the results are determined by analytical methods and direct measurement, not by interpretive adjudication.
5. 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
This information is not applicable. This document describes performance testing for a personal lubricant, not an AI-powered diagnostic device or a device involving human readers. Therefore, an MRMC study and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. As previously stated, this document does not concern an AI algorithm or software. It pertains to a physical medical device (personal lubricant) where performance is measured through laboratory testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed is based on:
- Standardized Laboratory Assays: For biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity), the ground truth is established by the specific endpoints and criteria defined in ISO 10993 standards. These involve biological responses measured in cells or animals.
- Physical Property Measurements: For condom compatibility, the ground truth is determined by meeting the criteria outlined in ASTM D7661-10, which assesses physical integrity after lubricant exposure.
- Chemical and Microbiological Specifications: For shelf-life testing, the ground truth is the product's ability to maintain its specified viscosity, specific gravity, appearance, color, odor, preservative effectiveness, antimicrobial effectiveness, and freedom from pathogens (TAMC, TYMC, Absence of Pathogenic organism) over time.
These are all objective, measurable parameters defined by recognized standards and specifications, rather than expert interpretation of complex clinical data.
8. The sample size for the training set
This information is not applicable. This submission is for a physical medical device (a lubricant) and not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set for an AI/ML algorithm, the method for establishing its ground truth is irrelevant to this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2016
WTFN - dba Classic Erotica/Holiday Products % Louie Goryoka Regulatory Consultant Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301
Re: K161385
Trade/Device Name: Just Like Me Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 12, 2016 Received: May 19, 2016
Dear Louie Goryoka,
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.
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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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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
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Indications for Use
510(k) Number (if known) K161385
Device Name Just Like Me Personal Lubricant
Indications for Use (Describe)
Just like 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 latex, polyisoprene, and polyurethane condoms.
Type of Use (Select one or both, as applicable)| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY Just Like Me Personal Lubricant
| Company Name:Company Address: | WTFN - dba Classic Erotica20950 Lassen StreetChatsworth, California 91311 |
|---|---|
| Contact Person: | Med-Device Consulting Inc.Louie Goryoka - Regulatory ConsultantPhone 1 (818) 735-0488mdci@m-dci.us |
| Summary Preparation Date: | August 16, 2016 |
| Device Trade Name:Common Name:Classification Name(s):Classification Regulation:Device Code:Advisory Panel:Predicate Devices | Just Like Me Personal LubricantPersonal LubricantCondom21 CFR §884.5300, Class IINUCObstetrics and GynecologyLove Liquid® Personal Lubricant510(k) number K152168 |
Device Description
The Just Like Me Personal Lubricant is a non-sterile, water based, over-the- counter personal lubricant formulated to be a clear, non-irritating, non-greasy, odorless liquid.
The proposed device contains a blend of ingredients similar to ingredients found in the predicate device.
The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with or without natural rubber latex, polyisoprene, and polyurethane condoms during intimate sexual activity as evidenced by condom compatibility testing.
Indication for Use Statement
The Just Like Me 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 latex, polyisoprene, and polyurethane condoms.
Technological Characteristics
The Just Like Me Personal Lubricant has the same intended use as the predicate device.
The Just Like Me Personal Lubricant has similar technological characteristics to the predicate device. It contains ingredients that are similar to those found in the predicate device.
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Performance Data
Biocompatibility
The device contact duration with the user is A-limited <24 hours, in accordance with ISO 10993.
Biocompatibility testing was performed in accordance with ISO 10993. The results demonstrate that the device is safe for its intended use.
| Test Performed | Results |
|---|---|
| Cytotoxicity (Direct Contact) | Product is Non-toxic |
| ISO GUINEA PIG MAXIMIZATIONSENSITIZATION TEST- (Method for LiquidTest Articles) | Product does not elicit a sensitizationresponse |
| Vaginal Mucosa Irritation withHistopathology | Product is considered a non-irritant tovaginal tissue |
| Acute Systemic Toxicity | There is no evidence of system toxicity |
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.
This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms as demonstrated by the condom compatibility testing.
Shelf Life Testing
The Just Like Me Personal Lubricant has a 2-years shelf life based on the results of an accelerated aging study. The accelerated aging study evaluated the single version of packaging (3.8 oz.) 4 oz. packaging. Following aging, the product met its specifications for viscosity, specific gravity, appearance, color, odor passed the testing, Preservative Effectiveness and Antimicrobial Effectiveness Testing based on USP <51>, Total Microbial Aerobic Count (TAMC) and Total Yeast and Mold Count (TYMC) based on USP <61>, and Absence of Pathogenic organism based on USP <62>.
Conclusion
The results of performance testing demonstrate that the Me Personal Lubricant is substantially equivalent to predicate devices.
§ 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.