(167 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a personal lubricant, with no mention of AI or ML technology.
No.
The product is a personal lubricant/moisturizer intended to enhance comfort during sexual activity, which is not considered a therapeutic function.
No
The device is a personal lubricant and moisturizer, intended to enhance comfort during sexual activity, not to diagnose any condition.
No
The device description clearly states it is a "non-sterile, water-soluble personal lubricant" and is supplied in a "tube" with an "applicator," indicating it is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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 describes a topical application for physical comfort and function, not a test performed on a sample taken from the body to diagnose a condition or provide information about a physiological state.
- Device Description: The description is of a personal lubricant and applicator, which aligns with the intended use of a topical product.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing diagnostic information
- Using reagents or test strips
The information provided clearly indicates that this is a personal lubricant, which is a medical device but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Sage 2-in-1 Personal Lubricant and Moisturizer is 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 condoms. This product is not compatible with polyisoprene or polyurethane condoms
Product codes
NUC
Device Description
Sage 2-in-1 Personal Lubricant and Moisturizer™ is a non-sterile, water-soluble personal lubricant for over-the-counter (OTC) use. The lubricant will be provided in a 1.6 oz tube and will also be supplied with a low-density polyethylene applicator.
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
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
Biocompatibility studies of the lubricant and applicator were performed in 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)
- Acute Systemic Toxicity (ISO 10993-11:2006) this test only conducted on the personal lubricant component
Condom compatibility testing was performed in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results of testing demonstrated that the subject device is compatible with natural rubber latex condoms and is not compatible with polyisoprene and polyurethane condoms.
The shelf-life of the device is 16 months in accordance with the results of an accelerated aging study. All device specifications (see table on page 2 of this summary) were met at all timepoints assessed (equivalent to 0-16 months of real-time aging).
Key Metrics
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.
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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.
July 16, 2019
Fairhaven Health, LLC Suzanne Munson VP of Product Development/Compliance 1410 11th St Bellingham, WA 98225
Re: K190150
Trade/Device Name: Sage 2-in-1 Personal Lubricant and Moisturizer™ Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 6, 2019 Received: June 17, 2019
Dear Suzanne Munson:
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. You must comply with all the Act's
1
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-regulatory-information/postmarketing-safety-reportingcombination-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,
For Sharon Andrews Assistant Division 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) K190150
Device Name
Sage 2-in-1 Personal Lubricant and Moisturizer™
Indications for Use (Describe)
Sage 2-in-1 Personal Lubricant and Moisturizer is 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 condoms. This product is not compatible with polyisoprene or 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 - K190150 Sage 2-in-1 Personal Lubricant and Moisturizer™
Submitter:
| Applicant: | Fairhaven Health, LLC
1410 11th Street
Bellingham, WA 98225 |
|-----------------------------------------|-------------------------------------------------------------------|
| Telephone:
Email:
Contact Person: | 360-543-7888
suzanne@fairhavenhealth.com
Suzanne Munson |
| Date Prepared: | July 15, 2019 |
Device Information:
| Device Name | Sage 2-in-1 Personal Lubricant and MoisturizerTM |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | NUC (Lubricant, Personal) |
| Regulatory Class: | II |
Predicate Devices
Good Clean Love Bio-pHresh (K162207) manufactured by Good Clean Love, Inc Eugene, OR.
The predicate device has not been subject to any design-related recall.
Indications for Use
Sage 2-in-1 Personal Lubricant and Moisturizer is 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 condoms. This product is not compatible with polyisoprene or polyurethane condoms
Description of Device
Sage 2-in-1 Personal Lubricant and Moisturizer™ is a non-sterile, water-soluble personal lubricant for over-the-counter (OTC) use. The lubricant will be provided in a 1.6 oz tube and will also be supplied with a low-density polyethylene applicator. The device specifications are listed in the table below:
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| Parameter | Test Method | Specification |
|---|---|---|
| Appearance | Visual | |
| inspection | Opaque Gel | |
| Odor | Odor via | |
| smell of gel | Slight rose and sage odor | |
| pH | USP | 4.25-5.5 |
| Viscosity | USP | 3000-12000cps |
| Osmolality | USP | 240-370 mOsmo/kg |
| Antimicrobial Effectiveness | USP | Bacteria: Not less than 2.0 |
| log reduction from the | ||
| initial count at 14 days, | ||
| and no increase | ||
| from the 14 days' count at | ||
| 28 days | ||
| Yeast and Molds: No | ||
| increase at 14 and 28 | ||
| relative to initial count. | ||
| Total Aerobic Microbial Count | ||
| (TAMC) | USP |
Summary of technological characteristics compared to predicate device:
| Subject &
Predicate
Devices: | K190150
Subject Device | K162207
Predicate Device |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Device
Characteristics | | |
| Personal
Lubricant | | |
| Sponsor | Fairhaven Health LLC | Good Clean Love |
| Indication for
Use Statement | Sage 2-in-1 Personal Lubricant and
Moisturizer is 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 condoms. This product
is not compatible with polyisoprene | Good Clean Love BIO-
pHRESH 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 |
| | or polyurethane condoms. | natural rubber latex and
polyisoprene condoms. It is
not compatible with
polyurethane condoms |
| Regulation
Number
Product Code
Device Class | 884.5300 | 884.5300 |
| Condom
Compatibility | Natural rubber latex | Natural rubber latex and
polyisoprene |
| Base Type | Water based | Aloe vera (water based) |
| Formulation | Purified Water
Hypromellose (HPMC)
Carbomer
homopolymer type b
Phenethyl alcohol
Caprylyl glycol
Salvia Sclarea
Sodium Chloride
L-Lactic Acid
d-Xylose
Sodium Hydroxide
Monobasic Sodium Phosphate
anhydrous
Potassium Phosphate anhydrous | Aloe Vera
Xanthan
Potassium Sorbate
Sodium Benzonate |
| Characteristics | | |
| pH | 4.25-5.5 | - |
| Viscosity | 3000-12000 Cps | - |
| Osmolality | 240-370 mOsm/kg | - |
| Antimicrobial
Effectiveness | Bacteria: Not less than 2.0 log
reduction from the initial count
at 14 days, and no increase
from the 14 days' count at 28
days
Yeasts and Mold: No increase at 14
and 28 relative to initial count. | Category 2 (Products for
mucosal application). Bacteria
=2.0 log reduction at day 14
relative to initial count. No
increase at day 28 relative to
day-14 count. Yeasts and
Mold: No increase at 14 and
28 relative to initial count. |
| Total Microbial
Count |