(89 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a personal lubricant, with no mention of AI or ML technology.
No
The device is a personal lubricant intended to enhance comfort during sexual activity, not to treat or cure a medical condition, which is the defining characteristic of a therapeutic device.
No
The device is a personal lubricant intended to moisturize and lubricate for sexual activity, not to diagnose any condition.
No
The device description clearly states it is a "non-sterile, water-based personal lubricant" with a specific chemical formulation and packaging, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for personal lubrication during sexual activity, applied to the penile and/or vaginal areas. This is a topical application for physical comfort and enhancement, not for diagnosing a condition or analyzing a sample from the body.
- Device Description: The description details a personal lubricant with specific ingredients and packaging. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting specific analytes (e.g., glucose, antibodies, DNA).
- Providing diagnostic information about a disease or condition.
- Using reagents or test strips.
The performance studies mentioned (biocompatibility, condom compatibility, shelf life) are relevant to the safety and functionality of a personal lubricant, not an IVD.
N/A
Intended Use / Indications for Use
Coconu Water Based 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. This product is not compatible with polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Coconu Water Based Personal Lubricant is a non-sterile, water-based personal lubricant that is intended for penile and vaginal application 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. This product is not compatible with polyurethane condoms.
Its formulation consists of water, Cocos Nucifera (Coconut) fruit juice, Microcare SB (water, sodium benzoate, potassium sorbate), Keltrol CG (xanthan gum), Purac FCC 50 (water, lactic acid), Geogard 111S (sodium dehydroacetate), CMC 7H3SF PHARM (sodium carboxymethylcellulose).
Coconu Water Based Personal Lubricant is packaged in a MDPE (medium density polyethylene) 3 oz tube, packaged in an outer box. Coconu Water Based Personal Lubricant is a personal lubricant for over-the-counter (OTC) use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility:
Coconu Water Based Personal Lubricant has undergone biocompatibility testing in accordance with the 2020 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." Testing included:
- Cytotoxicity Direct Contact Method, ISO 10993-5:2009/(R)2014
- Dermal Sensitization - Guinea Pig Maximization Sensitization, ISO 10993-10:2010/(R)2014
- Vaginal Irritation - Vaginal Mucosa Irritation Test, ISO 10993-10:2010/(R)2014
- Acute Systemic Toxicity - ISO 10993-11:2017
The results of testing demonstrated the subject device is non-sensitizing, non-irritating, and nonsystemically toxic.
Condom Compatibility:
Coconu Water Based Personal Lubricant was tested in accordance with ASTM D7661-10 Standard for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Results showed that Coconu Water Based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Shelf Life Testing:
Coconu Water Based Personal Lubricant has a shelf-life of 8.5 months, according to the results of an accelerated aging study per ASTM F1980-16. All device specifications listed in Section V. Device Description of this summary were evaluated in the shelf-life study. The subject device specifications at all time points.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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 14, 2021
COCONU, LLC. % Louie Goryoka Sr. QA/RA Consultant Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301
Re: K210814
Trade/Device Name: Coconu Water Based Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 11, 2021 Received: March 17, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current
good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia -S
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210814
Device Name Coconu Water Based Personal Lubricant
Indications for Use (Describe)
Coconu Water Based 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. This product is not compatible with 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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3
510(k) Summary K210814 Coconu Water Based Personal Lubricant
Submitter Information l.
Applicant: | COCONU, LLC. |
---|---|
Company Address: | 1968 E. ASHLEY MESA LANE |
SANDY, UT 84092 USA | |
Company Phone: | (801) 550-8611 |
Company Contact: | Taylor Warnick |
Contact Person: | Louie Goryoka |
Sr. Regulatory and Quality Consultant | |
Med-Device Consulting, Inc. | |
Email: mdci@m-dci.us | |
(818) 585-7488 |
- ll. Date Prepared June 11, 2021
lll. Device Information
Trade Name: | Coconu Water Based Personal Lubricant |
---|---|
Common Name: | Personal Lubricant |
Regulation Number: | 21 CFR 884.5300 |
Regulation Name: | Condom |
Regulatory Class: | Class II |
Product Code: | NUC (lubricant, personal) |
- IV. Predicate Device
Trade Name: | Coconut Infused Hybrid Personal Lubricant |
---|---|
510(k) Number: | K180712 |
Manufacturer: | United Consortium |
Common Name: | Personal Lubricant |
Device Class: | Class II |
Product Code: | NUC (lubricant, personal) |
The predicate device has not been subject to a design-related recall.
V. Device Description
Coconu Water Based Personal Lubricant is a non-sterile, water-based personal lubricant that is intended for penile and vaginal application 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. This product is not compatible with polyurethane condoms.
Its formulation consists of water, Coconut) fruit juice, Microcare SB (water, sodium benzoate, potassium sorbate), Keltrol CG (xanthan gum), Purac FCC 50 (water, lactic acid), Geogard 111S (sodium dehydroacetate), CMC 7H3SF PHARM (sodium carboxymethylcellulose).
4
Coconu Water Based Personal Lubricant is packaged in a MDPE (medium density polyethylene) 3 oz tube, packaged in an outer box. Coconu Water Based Personal Lubricant is a personal lubricant for over-the-counter (OTC) use.
Property | Specification |
---|---|
Appearance | Opaque Flowable Gel |
Color | Off-White - Light Yellow |
Odor | None |
Viscosity@25°C | 2,800 cps - 4,500 cps |
Spindle #RVS@20rpm (cps) | |
Specific Gravity@25°C | 0.90-1.11 |
pH @ 25° | 4.0 to 5.0 |
Osmolality (mOSm/kg) (1:10 dilution) per | |
USP | 42.0 mOsm/kg - 46.0 mOsm/kg |
Total aerobic microbial count (TAMC) per | |
USP and | and |
Category 2 products. Category 2, bacteria | |
should show not less than 2.0 log reduction | |
at 14 days and no increase from 14-day | |
count at the 28-day count. Yeast and molds | |
should show no increase from the initial | |
calculated count at 14 and 28 days | |
Presence of Pathogens per USP | |
(Pseudomonas aeruginosa, Staphylococcus | |
aureus, Salmonella/Shigella, Escherichia | |
coli and Candida albicans per USP ) | Absent |
Device specifications are listed in the Table below:
VI. Indications for Use
Coconu Water Based 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. This product is not compatible with polyurethane condoms.
VII. Predicate Device Comparison
A comparison of the intended use and technological characteristics of the subject and predicate device is summarized in the table below:
| Characteristic/Feature | Coconu Water Based Personal
Lubricant – Subject Device | Coconut
Personal Lubricant
(Predicate Device) | Infused
Hybrid
K180712 | Comparison |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------|
| Indications for Use | Coconu Water Based 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 | 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 | Similar | |
| | compatible with natural rubber
latex and polyisoprene
condoms. This product is not
compatible with polyurethane
condoms. | product is compatible with
natural rubber latex and
polyisoprene condoms. This
product is not compatible with
polyurethane condoms. | | |
| Water-Based Lubricant | Yes | Yes | Same | |
| Over the Counter | Yes | Yes | Same | |
| Non-sterile | Yes | Yes | Same | |
| Odorless | Yes | Yes | Same | |
| Viscosity (cps) | 2,800 - 4,500 | 20,000 - 31,000 | Different | |
| pH | 4.0 - 5.0 | 5.7 - 6.3 | Different | |
| Osmolality (mOsm/kg) | 42.0 - 46.0 (1:10 dilution) | 450 – 900 | Different | |
| Condom Compatibility | Natural rubber latex and
polyisoprene condoms only. | Natural rubber latex and
polyisoprene condoms only. | Same | |
| Primary Ingredients | Water (Aqua), Cocos Nucifera
(Coconut) Fruit Juice, Microcare
SB (Water, Sodium Benzoate,
Potassium Sorbate), Keltrol CG
(Xanthan Gum), Purac FCC 50
(Water, Lactic Acid), Geogard
111S (Sodium Dehydroacetate),
CMC 7H3SF PHARM (Sodium
Carboxymethylcellulose) | Water (Aqua), Propylene Glycol,
Caprylic/Capric Triglyceride,
Cocos Nucifera (Coconut) Oil,
Flavor (Aroma),
Phenoxyethanol, Polyacrylate
13, Cellulose Gum (Sodium
Carboxymethylcellulose),
Raphanus Sativus (Radish) Seed
Extract, Polyisobutene,
Polysorbate 20, PEG-45M | Different | |
| Shelf life | 8.5 months | 3 years | Different | |
5
The subject and predicate device have similar indications for use and have the same intended use, i.e., provides lubrication during intimate sexual activity. The subject and predicate device have different technological characteristics, including different formulations, viscosity, pH, osmolality, and shelf life. The different technological characteristics of the subject device do not raise different questions of safety and effectiveness as compared to the predicate device.
VIII. Summary of Non-Clinical Performance Testing
Biocompatibility
Coconu Water Based Personal Lubricant has undergone biocompatibility testing in accordance with the 2020 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." Testing included:
- Cytotoxicity Direct Contact Method, ISO 10993-5:2009/(R)2014 ●
6
- Dermal Sensitization Guinea Pig Maximization Sensitization, ISO 10993-10:2010/(R)2014 ●
- Vaginal Irritation - Vaginal Mucosa Irritation Test, ISO 10993-10:2010/(R)2014
- . Acute Systemic Toxicity - ISO 10993-11:2017
The results of testing demonstrated the subject device is non-sensitizing, non-irritating, and nonsystemically toxic.
Condom Compatibility
Coconu Water Based Personal Lubricant was tested in accordance with ASTM D7661-10 Standard for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Results showed that Coconu Water Based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Shelf Life Testing
Coconu Water Based Personal Lubricant has a shelf-life of 8.5 months, according to the results of an accelerated aging study per ASTM F1980-16. All device specifications listed in Section V. Device Description of this summary were evaluated in the shelf-life study. The subject device specifications at all time points.
IX. Conclusion
The results of performance testing described above demonstrate that Coconu Water Based Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.