(143 days)
Desnuda Reflect 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.
Desnuda Reflect 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, hydroxyethyl cellulose, xanthan gum, hyaluronic acid, Zemea propanediol, sodium benzoate, potassium sorbate, and DL lactic acid. Desnuda Reflect is packaged in 2 fl. oz high-density polyethylene pump bottles. Desnuda Reflect is a personal lubricant for over-the-counter (OTC) use.
The provided text describes the 510(k) premarket notification for a medical device called "Desnuda Reflect," a personal lubricant. It does not contain information about an AI-powered device or a study involving human readers and AI assistance for medical imaging, which is what your query is geared towards.
Therefore, I cannot provide the detailed information requested in points 1-9 of your prompt, as the document concerns a physical product (personal lubricant) and its testing for safety and effectiveness as a lubricant, not a digital AI medical device.
The document discusses various performance tests relevant to a personal lubricant, such as:
- Biocompatibility testing: Cytotoxicity, sensitization, irritation, and acute systemic toxicity.
- Condom Compatibility testing: Adherence to ASTM D7661-18 for natural rubber latex and polyisoprene condoms.
- Shelf-life testing: Accelerated aging study to confirm maintenance of specifications over one year.
- Device Specifications (Table 1): Appearance, color, odor, viscosity, osmolality, pH, microbial counts (TAMC, TYMC), absence of specific pathogens, and antimicrobial effectiveness.
These tests establish the safety and effectiveness of the lubricant but are not related to the acceptance criteria or study design for an AI medical imaging device.
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November 18, 2021
Good Clean Love, Inc. % Abhishek Gurnani Partner Amin Talati Wasserman, LLP 100 S. Wacker Drive Suite 2000 Chicago, IL 60606
Re: K211998 Trade/Device Name: Desnuda Reflect 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 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.
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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
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Indications for Use
510(k) Number (if known) K211998
Device Name Desnuda Reflect
Indications for Use (Describe)
Desnuda Reflect 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)
| Regulation Under Part 81 CFR 221 (Select One) | ☑ |
|---|---|
| Serve The Convention of Part 81 CFR 221 (Select One) | ☐ |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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K211998 Page 1 of 5
510(k) Summary K211998 Desnuda Reflect
| Submitter: | Good Clean Love, Inc.207 West 5th AvenueEugene, OR 97401Contact: Wendy StrgarPhone: 541 344 4483Email: Wendy@GoodCleanLove.com |
|---|---|
| Contact Person: | Abhishek K. GurnaniAmin Talati Wasserman, LLP100 South Wacker Drive, Suite 2000Chicago, IL 60606Phone: 312 327 3325Fax: 312 884 7352Email: Abhishek@AminTalati.com |
| Summary Prepared: | November 16, 2021 |
| Trade Name:Common Name:Regulation Number:Regulation Name:Regulatory Class:Product Code: | Desnuda ReflectPersonal Lubricant21 CFR 884.5300CondomClass IINUC (lubricant, personal) |
| Predicate Device: | K150883, HyaloGYN® Vaginal Hydrating GelFidia Farmaceutici, S.p.A. |
The predicate device has not been subject to a design-related recall.
Device Description: Desnuda Reflect 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, hydroxyethyl cellulose, xanthan gum, hyaluronic acid, Zemea propanediol, sodium benzoate, potassium sorbate, and DL lactic acid. Desnuda Reflect is packaged in 2 fl. oz high-density polyethylene pump bottles. Desnuda Reflect is a personal lubricant for over-the-counter (OTC) use.
Device specifications are listed in Table 1 below.
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| Property | Specifications |
|---|---|
| Appearance | Gel |
| Color | Clear to 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 <61>) | <100 cfu/g |
| Total Yeast & Mold Count(TYMC, per USP <61>) | <10 cfu/g |
| Presence of Pathogens per USP <62> | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella | Absent |
| Escherichia coli | Absent |
| Clostridium Species | Absent |
| Candida albicans | Absent |
| Antimicrobial Effectiveness Testing(per USP <51>) | Specification |
| Bacteria | Meets USP <51> criteria for category 2. No lessthan 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 14and 28 days |
Table 1: Device Specifications for Desnuda Reflect
Indications for Use Statement: Desnuda Reflect 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.
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| Subject Device(K211998) | Predicate(K150883) | |
|---|---|---|
| Sponsor | Desnuda Reflect | HyaloGYN® Vaginal Hydrating Gel |
| RegulationNumber | 844.5300 | 844.5300 |
| Product CodeDevice Class | NUCII | NUCII |
| Indications forUse | Desnuda Reflect is apersonal lubricant, forpenile and/or vaginalapplication, intended tomoisturize and lubricate,to enhance the ease andcomfort of intimate sexualactivity and supplementthe body's naturallubrication. This productis compatible with naturalrubber latex andpolyisoprene condoms.This product is notcompatible withpolyurethane condoms. | HyaloGYN® is a personal lubricantfor vaginal application intended tomoisturize and lubricate, to enhancethe ease and comfort of intimatesexual activity and supplement thebody's natural lubrication. Thisproduct is compatible withpolyisoprene condoms. |
| Rx/OTC | OTC | OTC |
| Water-based | Yes | Yes |
| Ingredients | WaterHyaluronic AcidHydroxyethylcelluloseXanthan GumZemea PropanediolSodium BenzoatePotassium SorbateDL Lactic Acid | WaterHyaluronic AcidPropylene GlycolCarbomerPreservativesSodium Hydroxide |
| Sterile | No | No |
| Applicator | No | Yes |
| CondomCompatibility | Natural Rubber Latex andPolyisoprene Condoms | Polyisoprene Condoms |
| Shelf life | 1 year | 3 years |
| Biocompatibility | Yes | Yes |
| Tested | ||
| Microbiology | Yes | Yes |
| Tested (absenceof pathogenicorganisms,TAMC, andTYMC) | ||
| Osmolality | Yes | Yes |
| Tested | ||
| pH Tested | Yes | Yes |
| PhysicalCharacteristics | Yes | Yes |
| Tested(appearance,color, and odor) | ||
| Antimicrobial | Yes | Yes |
| Tested |
Table 2. Intended Use and Technological Characteristics of Desnuda Reflect as Compared to the Predicate
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The subject and predicate device have similar indications for use, and the intended use of the subject and predicate device is the same, i.e., provides lubrication during intimate sexual activity. As noted in the table above, the subject and predicate device have different technological characteristics, including formulations, condom compatibility, use of an applicator, and shelflife. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.
Summary of Performance Data:
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 Desnuda Reflect is non-cytotoxic, non-sensitizing, nonirritating, and non-systemically toxic.
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Condom Compatibility: The compatibility of the subject device with condoms was evaluated in accordance with ASTM D7661-18 "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: Desnuda Reflect 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.
Conclusion: The results of the performance testing described above demonstrate that Desnuda Reflect is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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.