(70 days)
Not Found
No
The device is a personal lubricant and the description focuses on its physical properties, intended use, and compatibility with condoms. There is no mention of any computational or analytical functions that would involve AI/ML.
Yes.
The device is a personal lubricant intended to enhance comfort in intimate sexual activity and supplement natural lubrication, which are considered therapeutic functions.
No
This device is a personal lubricant intended to lubricate and moisturize for enhanced sexual activity. It does not perform any diagnostic function.
No
The device is a personal lubricant, which is a physical substance, not software. The description details its composition, packaging, and physical properties.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "personal lubricants 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 describes a device used on the body for physical lubrication, not a device used in vitro (outside the body) to diagnose a condition.
- Device Description: The description details the physical form, packaging, and composition of the lubricants. It does not mention any components or functions related to testing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, shelf-life, and condom compatibility. These are relevant to a personal lubricant, but not to an IVD. IVD performance studies would typically involve evaluating accuracy, precision, sensitivity, and specificity in detecting or measuring specific analytes in biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic results.
In summary, the device's intended use, description, and performance studies all point to it being a personal lubricant, which is a medical device but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are personal lubricants 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. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are clear, semi-viscous personal lubricants that are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.
H2O Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL, 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
H2O Anal Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz/60 mL and 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
JO 2 To Tango for Me is sold as an over the counter (OTC) product in 2 fl. oz/60 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
JO 2 To Tango Couples Pleasure Kit is sold as an over the counter (OTC) product in 2 fl. oz/60 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
#LubeLife Sensations Cooling is sold as an over the counter (OTC) product in 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 4 fl. oz./120 mL size bottles are capped with natural disc tops. The individual bottles are hermetically sealed during the production process.
#LubeLife Sensations Pleasure Kit for Two is sold as an over the counter (OTC) product in 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 4 fl. oz./120 mL size bottles are capped with natural disc tops. The individual bottles are hermetically sealed during the production process.
These devices are composed of Water (Aqua), Glycerin, Polysorbate 20, Propylene Glycol, Hydroxyethylcellulose, Chlorphenesin, Mentha Piperita (Peppermint) Leaf Extract and Sodium Hydroxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, anal and/or vaginal application
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 studies, including cytotoxicity, sensitization, vaginal irritation, and acute systemic toxicity testing were performed 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" and ISO 10993-1:2019 as follows:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017)
The results of this testing demonstrated that the subject lubricants are biocompatible.
Shelf-Life: The subject devices are non-sterile personal lubricants with a three-year shelf-life in accordance with the results of a real time aging study. All the devices 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 with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 (Reapproved 2017) Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicated that H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 10, 2021
CC Wellness LLC Marlent Perez Quality/Regulatory Affair Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355
Re: K210986
Trade/Device Name: H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 30, 2021 Received: April 1, 2021
Dear Marlent Perez:
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.
1
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 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 (OS) 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 medical devices and radiation-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, 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210986
| Device Name |
|---|
| H2O Cooling Personal Lubricant |
| H2O Anal Cooling Personal Lubricant |
| JO 2 To Tango for Me |
JO 2 To Tango Couples Pleasure Kit #LubeLife Sensations Cooling #LubeLife Sensations Pleasure Kit for Two
Indications for Use (Describe)
H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are personal lubricants 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. These products are compatible with natural rubber latex and polyisoprene condoms. These products are 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Image /page/3/Picture/0 description: The image shows a logo for a wellness company. The logo features two stylized, cursive letters that appear to be "CC". To the right of the letters, the word "WELLNESS" is written in a simple, sans-serif font. The overall design is minimalist and elegant.
510(k) Summary – K210986
H2O Cooling Personal Lubricant/ H2O Anal Cooling Personal Lubricant/ JO 2 To Tango for Me/ JO 2 To Tango Couples Pleasure Kit/ #LubeLife Sensations Cooling/ #LubeLife Sensations Pleasure Kit for Two
K210986 Page 1 of 5
| 510(k) Owner: | CC Wellness LLC |
|---|---|
| Street Address: | 29000 N. Hancock Parkway |
| Valencia, CA 91355 | |
| Contact Person: | Marlent Perez |
| Quality/Regulatory Affairs Specialist |
Bruce Albert
Chief Scientific Officer |
| Contact Numbers: | Phone: (661) 295-1700, ext. 1007
Phone: (661) 295-1700, ext. 231 |
| Summary Preparation Date: | May 25, 2021 |
| Trade Name: | H2O Cooling Personal Lubricant
H2O Anal Cooling Personal Lubricant
JO 2 To Tango for Me
JO 2 To Tango Couples Pleasure Kit
#LubeLife Sensations Cooling
#LubeLife Sensations Pleasure Kit for Two |
| Common Name: | Personal Lubricant |
| Device Classification: | Regulation Name: Condom
Regulation Number: 21 CFR § 884.5300
Product Code: NUC (lubricant, personal)
Device Class: Class II |
| Predicate Device: | Product Name: Agape Cooling Personal Lubricant
510(k) Number: K200894
Manufacturer: CC Wellness LLC
Product Code: NUC (lubricant, personal)
Device Class: Class II |
The predicate device has not been subject to a design-related recall.
4
510(k) Summary - K210986
Image /page/4/Picture/1 description: The image shows a logo with the letters "CC" in a stylized, cursive font. Below the letters, the word "WELLNESS" is written in smaller, sans-serif letters. The overall design is simple and elegant, suggesting a focus on health and well-being. The logo is in black and white.
K210986 Page 2 of 5
H2O Cooling Personal Lubricant/ H2O Anal Cooling Personal Lubricant/ JO 2 To Tango for Me/ JO 2 To Tango Couples Pleasure Kit/ #LubeLife Sensations Cooling/ #LubeLife Sensations Pleasure Kit for Two
Device Description:
H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are clear, semi-viscous personal lubricants that are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.
H2O Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL, 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
H2O Anal Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz/60 mL and 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
JO 2 To Tango for Me is sold as an over the counter (OTC) product in 2 fl. oz/60 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
JO 2 To Tango Couples Pleasure Kit is sold as an over the counter (OTC) product in 2 fl. oz/60 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
#LubeLife Sensations Cooling is sold as an over the counter (OTC) product in 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 4 fl. oz./120 mL size bottles are capped with natural disc tops. The individual bottles are hermetically sealed during the production process.
#LubeLife Sensations Pleasure Kit for Two is sold as an over the counter (OTC) product in 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 4 fl. oz./120 mL size bottles are capped with natural disc tops.
5
510(k) Summary - K210986
Image /page/5/Picture/1 description: The image shows a logo for "CC Wellness". The logo features two stylized, cursive letters "C" connected by a flowing line. The word "WELLNESS" is written in small, sans-serif letters below the two "C"s.
K210986 Page 3 of 5
H2O Cooling Personal Lubricant/ H2O Anal Cooling Personal Lubricant/ JO 2 To Tango for Me/ JO 2 To Tango Couples Pleasure Kit/ #LubeLife Sensations Cooling/ #LubeLife Sensations Pleasure Kit for Two
The individual bottles are hermetically sealed during the production process.
These devices are composed of Water (Aqua), Glycerin, Polysorbate 20, Propylene Glycol, Hydroxyethylcellulose, Chlorphenesin, Mentha Piperita (Peppermint) Leaf Extract and Sodium Hydroxide.
The devices specifications are listed in the table below:
| Table 1: Device Specifications for H2O Cooling Personal Lubricant, H2O Anal Cooling |
|---|
| Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife |
| Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two |
| Property | Specification |
|---|---|
| Appearance | Semi-viscous liquid |
| Color | Colorless |
| Odor | Peppermint |
| Viscosity (cps) per USP | 2150 - 4000 |
| pH per USP | 3.50 - 4.50 |
| Specific Gravity per USP | 1.010 - 1.030 |
| Osmolality per USP | 1000 – 1100 (1:1 dilution with purified water) |
| Antimicrobial effectiveness per USP | Meets USP acceptance criteria for Category 2 products. |
| Total aerobic microbial count (TAMC) per USP and | Less than 100 cfu/g |
| Total yeast and mold count (TYMC) per USP and | Less than 10 cfu/g |
| Presence of Pathogens per USP | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella/Shigella | Absent |
| Escherichia coli | Absent |
| Candida albicans | Absent |
Indications for Use:
H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are personal lubricants 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. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.
Comparison of Intended Use and Technological Characteristics to the Predicate Device:
The table below lists a comparison of the intended use and technological characteristics of the subject and predicate devices.
6
Image /page/6/Picture/0 description: The image shows a logo with the letters "CC" in a stylized, cursive font. To the right of the letters, the word "WELLNESS" is written in a smaller, sans-serif font. The overall design is simple and elegant, with a focus on the flowing lines of the cursive letters.
510(k) Summary – K210986
H2O Cooling Personal Lubricant/ H2O Anal Cooling Personal Lubricant/
JO 2 To Tango for Me/ JO 2 To Tango Couples Pleasure Kit/ #LubeLife Sensations Cooling/ #LubeLife Sensations Pleasure Kit for Two
| Feature | H2O Cooling Personal Lubricant
H2O Anal Cooling Personal Lubricant
JO 2 To Tango for Me
JO 2 To Tango Couples Pleasure Kit
#LubeLife Sensations Cooling
#LubeLife Sensations Pleasure Kit for
Two | Agape Cooling Personal
Lubricant
(K200894) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | H2O Cooling Personal Lubricant, H2O
Anal Cooling Personal Lubricant, JO 2 To
Tango for Me, JO 2 To Tango Couples
Pleasure Kit, #LubeLife Sensations
Cooling and #LubeLife Sensations
Pleasure Kit for Two are personal
lubricants 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. These products are
compatible with natural rubber latex and
polyisoprene condoms. These products
are not compatible with polyurethane
condoms. | Agape Cooling Personal
Lubricant is a 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. |
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Aqua, Glycerin, Polysorbate 20, Propylene
Glycol, Hydroxyethylcellulose,
Chlorphenesin, Mentha Piperita
(Peppermint) Leaf Extract and Sodium
Hydroxide | Aqua, Propanediol,
Gluconolactone,
Hydroxyethylcellulose,
Sodium Benzoate,
Polysorbate 20, Citric
Acid and Mentha
Piperita (Peppermint)
Leaf Extract |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Latex and Polyisoprene | Latex and Polyisoprene |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Shelf life | 3 years | 3 years |
Table 2: Comparator Table for Subject and Predicate Device
The subject and predicate devices have similar indications for use statements and have the same intended use – to provide lubrication during intimate sexual activity. The subject and predicate devices have different technological characteristics; for example, different formulations. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.
Summary of Performance Data:
Biocompatibility
7
510(k) Summary - K210986
Image /page/7/Picture/1 description: The image shows a logo for a wellness company. The logo features a stylized, cursive font. The word "WELLNESS" is written in smaller, block letters below the cursive letters.
K210986 Page 5 of 5
H2O Cooling Personal Lubricant/ H2O Anal Cooling Personal Lubricant/ JO 2 To Tango for Me/ JO 2 To Tango Couples Pleasure Kit/ #LubeLife Sensations Cooling/ #LubeLife Sensations Pleasure Kit for Two
Biocompatibility studies, including cytotoxicity, sensitization, vaginal irritation, and acute systemic toxicity testing were performed 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" and ISO 10993-1:2019 as follows:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017)
The results of this testing demonstrated that the subject lubricants are biocompatible.
Shelf-Life:
The subject devices are non-sterile personal lubricants with a three-year shelf-life in accordance with the results of a real time aging study. All the devices 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 with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 (Reapproved 2017) Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicated that H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.
Conclusion:
The results of the performance testing described above demonstrate that H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are safe and effective as the predicate device and supports a determination of substantial equivalence.