(79 days)
Coconut Infused Hybrid Personal Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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. This product is not compatible with polyurethane condoms.
Coconut Infused Hybrid Personal Lubricant is a translucent cream, white to off-white in color, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This device is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural disc top dispenser caps and the 4 oz. size bottles are capped with silver disc top dispenser caps. The individual bottles are hermetically sealed during the production process. This product is also available in polyester-faced laminated pouches.
The provided text is a 510(k) summary for a medical device (Coconut Infused Hybrid Personal Lubricant). It describes the device, its indications for use, comparison to a predicate device, and a summary of performance data.
However, the questions you've asked are typically related to the performance evaluation of a diagnostic or AI-powered medical device, which would involve metrics like accuracy, sensitivity, specificity, and studies with human readers or standalone algorithm performance.
The provided document describes a personal lubricant, which is a Class II medical device, and the "performance data" presented focuses on biocompatibility, shelf-life, and condom compatibility. These are very different types of evaluations than what your questions imply.
Therefore, I cannot extract the information you've requested regarding acceptance criteria and study details as they pertain to diagnostic performance, MRMC studies, or ground truth establishment in the context of an AI/diagnostic device.
Here's why I cannot answer your questions with the provided text:
- No Diagnostic Acceptance Criteria: The document does not define acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it focuses on physical and chemical specifications, biocompatibility, and compatibility with other products (condoms).
- No Device Performance Metrics: There are no reported device performance metrics like sensitivity, specificity, or accuracy that would be relevant to diagnosing a condition or aiding in image interpretation.
- No Test Set/Ground Truth: The concept of a "test set" with "ground truth" established by experts is not applicable to a personal lubricant. The "ground truth" here is determined by chemical and biological testing results against established standards.
- No Experts/Adjudication Method: The studies described (biocompatibility, shelf-life, condom compatibility) do not involve human experts establishing ground truth or adjudication methods.
- No MRMC or Standalone Studies: These types of studies are for evaluating diagnostic accuracy or reader improvement with AI assistance, which is irrelevant for a personal lubricant.
- No Training Set: The processes involved in developing a personal lubricant do not include "training sets" in the machine learning sense.
Instead, the document details the following performance and acceptance criteria relevant to a personal lubricant:
1. Table of Acceptance Criteria and Reported Device Performance (as per the document):
| Property | Acceptance Criteria (Specification) | Reported Device Performance (as met) |
|---|---|---|
| Appearance | Translucent, semi-viscous cream | Translucent, semi-viscous cream |
| Color | White to off-white | White to off-white |
| Odor | Odorless | Odorless |
| Viscosity (cps) | 20,000 cps to 31,000 cps | Within range (implied, as device 'met specifications at all time points' for shelf-life study) |
| pH | 5.7 to 6.30 | Within range (implied, as device 'met specifications at all time points' for shelf-life study) |
| Specific Gravity | 0.930 to 1.010 | Within range (implied, as device 'met specifications at all time points' for shelf-life study) |
| Osmolality | 450 to 900 mOsm/kg | Within range (implied, as device 'met specifications at all time points' for shelf-life study) |
| Antimicrobial effectiveness per USP <51> | Meets US <51> acceptance criteria for Category 2 products | Met USP <51> acceptance criteria for Category 2 products |
| Total aerobic microbial count (TAMC) per USP <61> & <1111> | Less than 10 cfu/g | Less than 10 cfu/g |
| Total yeast and mold count (TYMC) per USP <61> & <1111> | Less than 10 cfu/g | Less than 10 cfu/g |
| Presence of Pathogens per USP <62> | Specification (Absent) | Reported Performance (Absent) |
| Pseudomonas aeruginosa | Absent | Absent |
| Staphylococcus aureus | Absent | Absent |
| Salmonella/Shigella | Absent | Absent |
| Escherichia coli | Absent | Absent |
| Candida Albicans | Absent | Absent |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic (ISO 10993-5:2009) | Non-cytotoxic |
| Biocompatibility (Sensitization) | Non-sensitizing (ISO 10993-10:2010) | Non-sensitizing |
| Biocompatibility (Vaginal Irritation) | Non-irritating (ISO 10993-10:2010) | Non-irritating |
| Biocompatibility (Penile Irritation) | Non-irritating (ISO 10993-10:2010) | Non-irritating |
| Biocompatibility (Acute Systemic Toxicity) | Non-systemically toxic (ISO 10993-11:2006) | Non-systemically toxic |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms (ASTM D7661-10) | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms |
| Shelf-Life | 3 years (maintaining all device specifications) | Met device specifications at 0, 1, 2, and 3 years in a real-time aging study, demonstrating a 3-year shelf-life. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable in the diagnostic sense. The "test sets" here refer to samples of the lubricant product used in laboratory testing for physical properties, microbiological counts, biocompatibility (animal or in-vitro models), and condom compatibility.
- Provenance: Not specified in terms of country of origin. The studies are performed "in accordance with" international and FDA guidance documents (e.g., ISO, USP, ASTM).
- Nature: These are likely prospective laboratory tests performed on samples of the manufactured device.
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)
- Not applicable. The ground truth for this device is established by standardized laboratory tests and their results, not expert consensus in a clinical diagnostic sense. The expertise lies in the laboratory technicians and scientists performing and interpreting these standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used to reconcile disagreements among human readers/experts, which is not part of this type of device testing.
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, this is a personal lubricant, not an AI-powered diagnostic device. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on standardized laboratory test results and adherence to established international and national standards (e.g., ISO 10993 for biocompatibility, USP <51>, <61>, <62>, <1111> for microbiological quality, ASTM D7661-10 for condom compatibility).
8. The sample size for the training set
- Not applicable. There is no training set in the context of machine learning for this device.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 6, 2018
United Consortium Stephanie Morris Regulatory Specialist 29000 North Hancock Parkway Valencia, CA 91355
Re: K180712
Trade/Device Name: Coconut Infused Hybrid Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 16, 2018 Received: March 19, 2018
Dear Stephanie Morris:
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 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Charles Viviano -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the overall impression is clean and professional.
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) K180712
Device Name
Coconut Infused Hybrid Personal Lubricant
Indications for Use (Describe)
Coconut Infused Hybrid Personal Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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. This product is not compatible with polyurethane condoms.
Type of Use (Select one or both, as applicable)
| Residential (Part 24 CFR 982 Subpart D) | Homeownership (Part 24 CFR 982 Subpart O) |
|---|---|
| ------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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K180712 - Coconut Infused Hybrid Personal Lubricant
K180712 - 510(k) Summary
| 510(k) Owner: | United Consortium | |
|---|---|---|
| Street Address: | 29000 N. Hancock ParkwayValencia, CA 91355 | |
| Contact Person: | Stephanie MorrisRegulatory Specialist | |
| Bruce AlbertHead of Technical Services | ||
| Contact Numbers: | Phone: (661) 295-1700, ext. 232Phone: (661) 295-1700, ext. 231FAX: (661) 295-1800 | |
| Summary Preparation Date: | June 5, 2018 | |
| Trade Name: | Coconut Infused Hybrid Personal Lubricant | |
| Common Name: | Personal Lubricant | |
| Device Classification: | RegulationName:RegulationNumber:Product Code:Device Class: | Condom21 CFR § 884.5300 (Condom)NUC (lubricant, personal)Class II |
| Predicate Device: | Product Name:510(k) Number:Manufacturer:Product Code:Device Class: | Gun Oil H2O water-based lubricantK152918Empowered Products, Inc.NUCClass II |
The predicate device has not been subject to a design-related recall.
Device Description:
Coconut Infused Hybrid Personal Lubricant is a translucent cream, white to off-white in color, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This device is not compatible with polyurethane condoms.
This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1
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K180712 - Coconut Infused Hybrid Personal Lubricant
oz. size bottles are capped with natural disc top dispenser caps and the 4 oz. size bottles are capped with silver disc top dispenser caps. The individual bottles are hermetically sealed during the production process. This product is also available in polyester-faced laminated pouches.
The device specifications are listed in the table below:
| Property | Specification |
|---|---|
| Appearance | Translucent, semi-viscous cream |
| Color | White to off-white |
| Odor | Odorless |
| Viscosity (cps) | 20,000 cps to 31,000 cps |
| pH | 5.7 to 6.30 |
| Specific Gravity | 0.930 to 1.010 |
| Osmolality | 450 to 900 mOsm/kg |
| Antimicrobial effectiveness per USP <51> | Meets US <51> acceptance criteria for Category 2 products |
| Total aerobic microbial count (TAMC) per USP <61>and <1111> | Less than 10 cfu/g |
| Total yeast and mold count (TYMC) per USP <61>and <1111> | Less than 10 cfu/g |
| Presence of Pathogens per USP <62> | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella/Shigella | Absent |
| Escherichia coli | Absent |
| Candida Albicans | Absent |
Table 1: Device Specifications for Coconut Infused Hybrid Personal Lubricant
Indications for Use:
Coconut Infused Hybrid Personal Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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. This product is not compatible with polyurethane condoms.
Predicate Device Comparison:
The table below lists the comparative indication for use and technological characteristics of the subject and predicate devices.
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| Feature | Coconut Infused Hybrid PersonalLubricant | Gun Oil H2O water-based lubricant(K152918) |
|---|---|---|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indication for Use | Coconut Infused Hybrid PersonalLubricant is a water-based personallubricant for penile, anal and/orvaginal application, intended tolubricate and moisturize, to enhancethe ease and comfort of intimatesexual activity and supplement thebody's natural lubrication. Thisproduct is compatible with naturalrubber latex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms. | Gun Oil H2O water-based is apersonal lubricant intended tomoisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity. Thisproduct is compatible withpolyisoprene condoms. This productis not compatible with polyurethaneor natural rubber latex condoms. |
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Water (Aqua), Propylene Glycol,Caprylic/Capric Triglyceride, CocosNucifera (Coconut) Oil, Flavor(Aroma), Phenoxyethanol,Polyacrylate 13, Cellulose Gum(sodium carboxymethylcellulose),Raphanus Sativus (Radish) SeedExtract, Polyisobutene, Polysorbate20, PEG-45M | Purified Water, Propylene Glycol,Hydroxyethlcellulose, AloeBarbadensis Leaf, PotassiumSorbat), Tetrasodium EDTA, PanaxGinseng Root, Paulina Cupana,Avena Sativa, Polysorbate 20, PEG-45, Polyquarternium-5, Citric Acid |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Latex, Polyisoprene | Polyisoprene |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 3 years | 3 years |
Table 2: Comparator Table for Subject Device – Coconut Infused Hybrid Personal Lubricant and Predicate Device Gun Oil H2O water-based lubricant
The subject and predicate device have similar indications for use. The indication for the subject device has been expanded to also include anal use. This change does not represent a new intended use as the intended use of this device is the same as the predicate device, i.e., lubrication of an orifice during intimate sexual activity. The subject and predicate device have different technological characteristics, including different formulations and condom compatibility. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.
Summary of Performance Data:
Biocompatibility
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing, were performed in
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K180712 - Coconut Infused Hybrid Personal Lubricant
accordance with the 2016 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:
- Cytotoxicity (ISO 10993-5:2009) ●
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Penile Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2006)
The results of this testing demonstrated that the subject lubricant is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.
Shelf-Life:
The subject device device, Coconut Infused Hybrid Personal Lubricant, is a non-sterile personal lubricant with a three-year shelf-life in accordance with the results of a real time aging study. All device specifications listed in Table 1 were tested at 0, 1, 2 and 3 years. The subject device met the device specifications at all time points.
Condom Compatibility:
The compatibility of the subject device, Coconut Infused Hybrid Personal Lubricant, with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicate that that the Coconut Infused Hybrid Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms.
Conclusion:
The results of the performance testing described above demonstrate that the Coconut Infused Hybrid Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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.