(143 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 described as a personal lubricant intended to moisturize and lubricate for enhancing sexual activity and supplementing natural lubrication, not for therapeutic purposes like treating a disease or condition.
No
Explanation: The device is described as a personal lubricant intended to moisturize and lubricate to enhance comfort during intimate sexual activity, without any mention of diagnosing a condition or disease.
No
The device is a personal lubricant, which is a physical substance (a chemical formulation) and not a software program. The description details its ingredients, packaging, and physical properties, not software functionalities.
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 one.
- Device Description: The description details a water-based personal lubricant with specific ingredients. There is no mention of it being used to test or analyze biological samples for diagnostic purposes.
- Performance Studies: The performance studies focus on biocompatibility, condom compatibility, and shelf life. These are relevant to a personal lubricant's safety and efficacy for its intended use, not for diagnosing a condition.
- Lack of Diagnostic Elements: There are no mentions of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for the diagnosis of a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
Medley 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
Medley is a water-based personal lubricant that is non-sterile and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, hydroxyethylcellulose, xanthan gum, hyaluronic acid, Zemea propanediol, glycerin water, dimethicone, hydrogenated lecithin, sodium benzoate, potassium sorbate, and DL lactic acid. Medley is packaged in 2 fl. oz high-density polyethylene pump bottles. Medley 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: Biocompatibility studies 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." The following testing was conducted:
- Cytotoxicity per ISO 10993-5:2009
- Sensitization and irritation testing using the human repeat insult patch test, an alternative test method to ISO 10993-10:2010
- Acute systemic toxicity testing per ISO 10993-11:2017
The results of testing demonstrate that Medley is non-sensitizing, non-irritating, and non-systemically toxic.
Condom Compatibility: The compatibility of the subject device with condoms was evaluated in accordance with ASTM D7661-8 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and was determined to be compatible with natural rubber latex and polyisoprene condoms. The subject device was determined not to be compatible with polyurethane condoms.
Shelf Life: Medley has a one-year shelf-life. Results from an accelerated aging study demonstrated that the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life.
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 shows 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.
November 18, 2021
Good Clean Love, Inc. % Abhishek K. Gurnani Partner Amin Talati Wasserman, LLP 100 S. Wacker Drive Suite 2000 Chicago, IL 60606
Re: K212000 Trade/Device Name: Medley Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: October 14, 2021 Received: October 19, 2021
Dear Abhishek K. Gurnani:
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) K212000
Device Name Medley
Indications for Use (Describe)
Medley 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 K212000 Medley
| Submitter: | Good Clean Love, Inc.
207 West 5th Avenue
Eugene, OR 97401
Contact: Wendy Strgar
Phone: 541 344 4483
Email: Wendy@GoodCleanLove.com |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Abhishek K. Gurnani
Amin Talati Wasserman, LLP
100 South Wacker Drive, Suite 2000
Chicago, IL 60606
Phone: 312 327 3325
Fax: 312 884 7352
Email: Abhishek@AminTalati.com |
| Summary Prepared: | November 16, 2021 |
| Trade Name: | Medley |
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Regulatory Class: | Class II |
| Product Code: | NUC (lubricant, personal) |
| Predicate Device: | K191480, WET Water Based Personal Lubricant (additionally
branded as WET Platinum Houston, Elite Water-Based Hybrid)
Trigg Laboratories, Inc, D/B/A Wet International |
The predicate device has not been subject to a design-related recall.
Device Description: Medley is a water-based personal lubricant that is non-sterile and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, hydroxyethylcellulose, xanthan gum, hyaluronic acid, Zemea propanediol, glycerin water, dimethicone, hydrogenated lecithin, sodium benzoate, potassium sorbate, and DL lactic acid. Medley is packaged in 2 fl. oz high-density polyethylene pump bottles. Medley is a personal lubricant for over-the-counter (OTC) use.
Device specifications are listed in Table 1 below.
4
| Property | Specifications |
|---|---|
| Appearance | Gel |
| Color | Colorless to Slightly Yellow and Cloudy |
| Odor | Characteristic |
| Viscosity | 12,500 – 25,000 cps |
| Osmolality | 250 – 400 mOsm/kg |
| pH | 3.5-4.0 |
| Total Aerobic Microbial Count | |
| (TAMC, per USP ) | ) |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella | Absent |
| Escherichia coli | Absent |
| Clostridium Species | Absent |
| Candida albicans | Absent |
| Antimicrobial Effectiveness Testing | |
| (per USP ) | Specification |
| Bacteria | Meets USP criteria for category 2. No less |
| than 2.0 log reduction from initial count at 14 days, | |
| and no increase from the 14-day count at 28 days | |
| Yeast and molds | No increase from the initial calculated count at 14 |
| and 28 days |
Table 1: Subject Device Specifications
Indications for Use Statement: Medley 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.
Comparison of Intended Use and Technological Characteristics:
The table below compares the intended use and technological characteristics of the subject and predicate device.
5
| | Subject Device
(K212000) | Predicate
(K191480) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | Medley | WET Water Based Personal
Lubricant (additionally
branded as WET Platinum Houston,
Elite Water-Based Hybrid) |
| Regulation
Number | 844.5300 | 844.5300 |
| Product Code | NUC | NUC |
| Device Class | II | II |
| Indications for
Use | Medley 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. | The Wet Water Based Personal
Lubricant (additionally, branded as
WET Platinum Houston, Elite
Water-Based Hybrid) is a personal
lubricant for penile, anal 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. |
| Rx/OTC | OTC | OTC |
| Water-based | Yes | Yes |
| Ingredients | Water
Hydroxyethylcellulose
Xanthan Gum
Hyaluronic Acid
Zemea Propanediol
Glycerin Water
Dimethicone
Hydrogenated Lecithin
Sodium Benzoate
Potassium Sorbate | Propylene Glycol
Water
Dimethicone
Cyclopentasiloxane
PEG/PPG 18/18 Dimethicone
Caprylhydroxamic Acid
1,2-Hexanediol
Propanediol
Sodium Polyacrylate
Trideceth-6
Hydroxyethylcellulose
Sodium Acetate |
Table 2. Intended Use and Technological Characteristics of Medley as Compared to the Predicate
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| DL Lactic Acid | Cellulose | |
|---|---|---|
| Sterile | No | No |
| Appearance/Color | Gel, Colorless to Slightly Yellow and Cloudy | Slightly Cloudy |
| Odor | Characteristic | Odorless |
| Viscosity | 12,500-25,000 cps | 5,000-13,000 cps |
| pH | 3.5-4.0 | 6.0-7.5 |
| Osmolality | 250-400 mOsm.kg | 3,691-6,140 mOsm/kg |
| Total Aerobic | ||
| Microbial Count | ||
| (TAMC) |