(171 days)
Not Found
No
The device description and performance studies focus on the chemical composition, biocompatibility, and condom compatibility of a personal lubricant, with no mention of AI or ML technologies.
No.
The document states its intended use is to "moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication," which describes a personal care product rather than a medical therapy.
No
Explanation: The device is a personal lubricant intended to moisturize and lubricate for enhancing comfort during intimate sexual activity. Its purpose is not to diagnose any condition or disease.
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 clearly stated as a personal lubricant for penile and/or vaginal application to enhance sexual activity and supplement natural lubrication. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical properties and ingredients of a lubricant. There is no mention of any components or mechanisms designed to detect or measure substances in biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, DNA, chemicals, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a personal lubricant, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Passion Natural 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 compatible with polyisoprene condoms. This product is not compatible with natural rubber latex and polyurethane condoms.
Product codes
NUC
Device Description
The Passion Natural Water Based 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 polyisoprene condoms, and is not compatible with natural rubber latex and polyurethane condoms. Its formulation consists of purified water, propanediol, xanthan gum, methocel, sodium benzoate, potassium sorbate, citric acid, and hydroxyethylcellulose. Passion Natural Water Based Lubricant is packaged in 4 oz polyethylene terephthalate bottles with a cap. Passion Natural Water Based 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
Passion Natural Water Based 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 (ISO Direct Contact Method, ISO 10993-5:2009)
- Sensitization (ISO Guinea Pig Maximization Sensitization, ISO 10993-10:2010)
- Vaginal Irritation (ISO Vaginal Irritation Study in Rabbits, ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO Tests for Systemic Toxicity, ISO 10993-11:2017)
The results of testing demonstrated the subject device is non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic.
Condom Compatibility
Passion Natural Water Based Lubricant was tested in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Results showed that Passion Natural Water Based Lubricant is compatible with polyisoprene condoms. This product is not compatible with natural rubber latex and polyurethane condoms.
Shelf Life Testing
Passion Natural Water Based 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 met the device specificaitons at all time points.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 8, 2021
XR, LLC % Louie Goryoka Sr. QA/RA Consultant Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301
Re: K202017
Trade/Device Name: Passion Natural Water Based Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 25, 2020 Received: December 1, 2020
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,
For 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) K202017
Device Name Passion Natural Water Based Lubricant
Indications for Use (Describe)
Passion Natural 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 compatible with polyisoprene condoms. This product is not compatible with natural rubber latex 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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3
| Applicant: | XR LLC. |
|---|---|
| Company Address: | 5251 PIPELINE LANE |
| HUNTINGTON BEACH, CA 92649 | |
| Company Phone: | (714) 907-1034 |
| Company Contact: | Gerardo Ramos |
| Contact Person: | Louie Goryoka |
| Sr. Regulatory and Quality Consultant | |
| Med-Device Consulting, Inc. | |
| Email: mdci@m-dci.us | |
| (818) 585-7488 | |
| Date Prepared: | January 7, 2021 |
| Device Information | |
| Trade name: | Passion Natural Water Based Lubricant |
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Regulatory Class: | Class II |
| Product Code: | NUC (lubricant, personal) |
| Predicate Device: | Pulse H20h! |
510(k) number: K152628
The predicate device has not been subject to a design-related recall.
V. Device Description
ll.
III.
IV.
The Passion Natural Water Based 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 polyisoprene condoms, and is not compatible with natural rubber latex and polyurethane condoms. Its formulation consists of purified water, propanediol, xanthan gum, methocel, sodium benzoate, potassium sorbate, citric acid, and hydroxyethylcellulose. Passion Natural Water Based Lubricant is packaged in 4 oz polyethylene terephthalate bottles with a cap. Passion Natural Water Based Lubricant is a personal lubricant for over-the-counter (OTC) use.
| Property | Specification |
|---|---|
| Appearance | Clear, viscous liquid |
| Color | Colorless |
| Odor | Odorless |
| Viscosity@25°C | 700 cps – 900 cps |
| Spindle LV#3hu@60rpm (cps) | |
| Specific Gravity@25°C | 1.00 – 1.20 |
| pH | 4.0 – 5.0 |
Device specifications are listed in the Table below
4
| Osmolality | 92.5 - 192.5 mOsm/kg (1:10 dilution) |
|---|---|
| Total aerobic microbial count (TAMC) per USP and | and |
| Presence of Pathogenic organisms ( Staphylococcus aureus , Pseudomonas aeruginosa , and Candida albicans per USP ) | Absent |
VI. Indications for Use
Passion Natural 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 compatible with polyisoprene condoms. This product is not compatible with natural rubber latex and polyurethane condoms.
VII. Predicate Device Comparison
A comparison of the indications for use an technological characteristics of the subject and predicate device is summarized in the table below:
| Characteristic/Feature | Passion Natural Water Based
Lubricant (K202017) | Pulse H20h! (K152628) |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Indications for Use | Passion Natural 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
compatible with polyisoprene
condoms. This product is not
compatible with natural rubber
latex and polyurethane condoms. | The Pulse H2Oh!
Personal lubricant is
intended for vaginal
and/or penile
application to moisturize
and lubricate, enhance
the ease and comfort of
intimate sexual activity,
and supplement the
body's natural
lubrication. This
personal lubricant 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 | Purified Water, Propanediol,
Xanthan Gum, Methocel, Sodium
Benzoate, Potassium Sorbate,
Citric Acid, Hydroxyethylcellulose
(HEC). | Purified water,
Propanediol/Zemea
Propanediol,
Hydroxyethylcellulose/N
atrosol 250H Pharm,
Potassium Sorbate, Chia
Seed Extract, Citric Acid. |
| Over-the-Counter Use | Yes | Yes |
| Labeled condom compatible | Yes | Yes |
| Condom Compatibility | Polyisoprene | Natural Rubber Latex,
Polyisoprene |
| Biocompatibility Tested | Yes | Yes |
| pH | 4.0 - 5.0 | 4.8 - 5.2 |
| Osmolality | 92.5 mOsm - 192.5 mOsm (1:10
dilution) | Tested - specification
not stated in predicate
summary |
| Microbial Limits | Total mold/yeast count Candida albicans ,
Pseudomonas aeruginosa ,
Staphylococcus aureus ) | Parameters Tested –
specifications not stated
in predicate summary |
| Antimicrobial Effectiveness
Tested (USP Category 2
Product) | Yes | Yes |
| Viscosity | 700 cps - 900 cps | Tested - specification
not stated in predicate
summary |
| The product is not a
contraceptive and does not
contain spermicide | Yes | Yes |
| Non-Sterile | Yes | Yes |
| Shelf life | 8.5 months | 2 years |
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, specifications (e.g., pH, etc.), 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
Passion Natural Water Based 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:
6
- Cytotoxicity (ISO Direct Contact Method, ISO 10993-5:2009) ●
- Sensitization (ISO Guinea Pig Maximization Sensitization, ISO 10993-10:2010)
- Vaginal Irritation (ISO Vaginal Irritation Study in Rabbits, ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO Tests for Systemic Toxicity, ISO 10993-11:2017)
The results of testing demonstrated the subject device is non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic.
Condom Compatibility
Passion Natural Water Based Lubricant was tested in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Results showed that Passion Natural Water Based Lubricant is compatible with polyisoprene condoms. This product is not compatible with natural rubber latex and polyurethane condoms.
Shelf Life Testing
Passion Natural Water Based 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 met the device specificaitons at all time points.
IX. Conclusion
The results of performance testing described above demonstrate that the Passion Natural Water Based Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.