(185 days)
The Love Liquid® 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 and Polyisoprene condoms. It is not compatible with polyurethane condoms.
The Love Liquid® Personal Lubricant is a non-sterile; water based personal lubricant, an over-the-counter personal lubricant, formulated to be a clear, non-irritating, non-greasy, liquid and odorless, aqueousbased. The proposed device contains a blend of 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 a latex condom during intimate sexual activity as evidenced by condom compatibility testing. The device formula is neither a contraceptive nor a spermicide.
The provided text describes the 510(k) summary for the "Love Liquid® Personal Lubricant," and includes information about its performance testing. However, it does not contain specific "acceptance criteria" as clear numerical thresholds that the device must meet for approval. Instead, it presents the results of various tests and concludes that the device is safe and substantially equivalent to predicate devices.
Therefore, the response below will present the reported device performance and infer the implied "acceptance criteria" from the successful outcome of those tests.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Implied Acceptance Criteria (Based on successful results) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity (Direct Contact) | Non-toxic | Product is Non-toxic |
| ISO GUINEA PIG MAXIMIZATION SENSITIZATION TEST (Method for Liquid Test Articles) | Does not elicit a sensitization response | Product does not elicit a sensitization response |
| Vaginal Mucosa Irritation with Histopathology | 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 | ||
| Natural Rubber Latex Condoms (ASTM D7661-10) | Compatible | Product is compatible with natural rubber latex condoms |
| Polyisoprene Condoms (ASTM D7661-10) | Compatible | Product is compatible with Polyisoprene condoms |
| Polyurethane Condoms (ASTM D7661-10) | Not compatible (stated as a known limitation) | Product is not compatible with polyurethane condoms |
| Microbiology | ||
| Antimicrobial Effectiveness (USP <51>) | Passed tests | Passed the tests for Antimicrobial Effectiveness |
| Total Microbial Count (USP <61>) | Passed tests | Passed the tests for Total Microbial Count |
| Total Yeast and Mold Count (USP <61>) | Passed tests | Passed the tests for Total Yeast and Mold Count |
| Absence of Pathogenic organism (USP <62>) | Passed tests | Passed the tests for Absence of Pathogenic organism |
| Shelf-life | ||
| Maintained appearance, color, odor, pH, osmolality, viscosity, and microbiology for 9 months | Maintained specifications for the tested duration | Maintained its appearance, color, odor, pH, osmolality, viscosity and microbiology specifications over a period of nine (9) months (On-going testing for 3 years) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the individual biocompatibility tests (e.g., number of animals for sensitization, irritation, or toxicity tests), nor for the microbiology tests or shelf-life samples.
For Condom Compatibility, the testing was performed on "three marketed brands of Natural Rubber Latex condoms, one brand of Polyisoprene condoms, and one brand of Polyurethane condoms." The number of individual condoms tested per brand is not specified.
The data provenance (e.g., country of origin, retrospective/prospective) is not explicitly stated in the provided text, but these types of tests are typically conducted in a laboratory setting per specific standards.
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 provided in the document. The tests described are laboratory-based assays (biocompatibility, microbiology, physical performance) that rely on standardized protocols and measurements, rather than subjective expert interpretation for "ground truth" in the way a medical image analysis might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the tests described are primarily objective laboratory measurements following standardized protocols, not subjective assessments requiring expert adjudication like in certain clinical trials or image interpretation studies.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists reading medical images with AI assistance), which is not the nature of this personal lubricant product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a personal lubricant, not an algorithm or AI system. Its performance is assessed directly through laboratory tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed is established by the results of standardized laboratory assays and protocols. For example:
- Biocompatibility: Based on established biological endpoints (e.g., cell viability for cytotoxicity, lack of specific tissue changes for irritation, absence of systemic effects for toxicity, absence of immune response for sensitization).
- Condom Compatibility: Based on physical integrity measurements (Air Burst and Tensile) according to ASTM D7661-10.
- Microbiology: Based on quantitative microbial counts and detection of specific microorganisms according to USP <51>, <61>, and <62> standards.
- Shelf-life: Based on maintaining pre-defined chemical and physical specifications (appearance, color, odor, pH, osmolality, viscosity) over time.
8. The sample size for the training set
Not Applicable. This product is a physical medical device (personal lubricant), not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. As stated above, this device does not involve a training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2016
The Kama Sutra Company Louie Goryoka Regulatory Consultant 5804 Rainbow Hill Rd. Agoura Hills, CA 91301
Re: K152168 Trade/Device Name: Love Liquid Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: January 6, 2016 Received: January 8, 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. 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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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,
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) K152168
Device Name Love Liquid® Personal Lubricant
Indications for Use (Describe)
The Love Liquid® 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 and Polyisoprene condoms. It is not compatable with polyurethane condoms.
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) |
_ | 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 K152168 Love Liquid® Personal Lubricant
| Company Name: | The Kama Sutra Company |
|---|---|
| Company Address: | 2151 Anchor CourtThousand Oaks, California 91320 |
| Contact Person: | Med-Device Consulting Inc.Louie Goryoka – Regulatory Consultant |
| Contact Numbers: | Phone 1 (818) 735-0488mdci@m-dci.us |
| Summary Preparation Date: | February 3, 2016 |
| Trade Name: | Love Liquid® Personal Lubricant |
| Common Name: | Personal Lubricant |
| Classification Name(s): | Condom |
| Product Code: | NUC (lubricant, Personal)21 CFR § 884.5300Class II |
| Predicate Devices | ONE Personal Lubricant |
| 510 (k) Number: | K110691 |
| Manufacturer: | ONE Personal Lubricant |
Device Description
The Love Liquid® Personal Lubricant is a non-sterile; water based personal lubricant, an over-the-counter personal lubricant, formulated to be a clear, non-irritating, non-greasy, liquid and odorless, aqueousbased.
The proposed device contains a blend of 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 a latex condom during intimate sexual activity as evidenced by condom compatibility testing. The device formula is neither a contraceptive nor a spermicide.
Indication for Use Statement
The Love Liquid® 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 and Polyisoprene condoms. It is not compatible with polyurethane condoms.
Technological Characteristics
The technology involved in this product, Love Liquid® Personal Lubricant, has no exceptional technological characteristics.
The Love Liquid® Personal Lubricant contains mainly of ingredients that are substantially similar to other lubricants currently on the U.S. markets and substantially equivalent to the predicate device. All ingredients are either NF, USP, or are considered "generally recognized as safe for their intended use."
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510(K) SUMMARY K152168 Love Liquid® Personal Lubricant
Performance Data
Biocompatibility: The Love Liquid® Personal Lubricant is a mucosal membrane contacting device with limited contact duration (<24 hours) in accordance with ISO 10993-1:2009. Biocompatibility testing was performed in accordance with ISO 10993 standards. The results provided scientific evidence that this product 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: The testing was performed in accordance with ASTM D7661-10 (Air Burst and Tensile); "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 result showed that the product is compatible with natural rubber latex and Polyisoprene condoms and is not compatible with polyurethane condoms.
Microbiology: The Love Liquid® Personal Lubricant has passed the tests for Antimicrobial Effectiveness based on USP <51>, Total Microbial Count and Total Yeast and Mold Count based on USP <61>, and Absence of Pathogenic organism based on USP <62>.
Shelf-life: The real-time and accelerated shelf-life testing have been conducted on Love Liquid® Personal Lubricant. The results showed that the product maintained its appearance, color, odor, pH, osmolality, viscosity and microbiology specifications over a period of nine (9) months. Ongoing shelf-life testing will support extension of shelf-life to three years.
Conclusion
Laboratory and safety testing conducted on the provided scientific evidence that this product is safe for its intended use, and that it 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.