(164 days)
Select Hybrid 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Select Pure Silicone Personal 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
The Select Hybrid Personal Lubricant and Select Pure Silicone Personal Lubricant are nonsterile, over the counter, personal lubricants. These devices are 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. Both lubricants are not compatible with natural rubber latex, polyisoprene, and polyurethane condoms. These lubricants are neither a contraceptive nor a spermicide.
The Select Hybrid Personal Lubricant formulation consists of distilled water, cyclopentasiloxane, dimethicone, dimethiconol, methylparaben, Cellosize™ hydroxyethyl cellulose PEG-10, and propylene glycol. The Select Pure Silicone Personal Lubricant formulation consists of cyclopentasiloxane, dimethicone, and dimethiconol.
Both subject devices are packaged in high density polyethylene bottles (2oz., 40z., 80z., 160z., 32 oz., 64oz., and 128 oz.) with low density polyethylene caps or polypropylene/polyethylene/stainless steel combination pumps. The bottle closure/pumps are covered with a heat shrink polyethylene terephthalate glycol sleeve film.
This document describes the 510(k) premarket notification for two personal lubricants, "Select Hybrid Personal Lubricant" and "Select Pure Silicone Personal Lubricant," by Select Labs, LLC. This is not a study about an AI/ML powered device, therefore the request can't be fulfilled.
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June 7, 2024
Lucida Scientific and Regulatory Consulting, LLC Om Singh Principal Regulatory Consultant 9667 Norfolk Ave. Laurel, Maryland 20723
Re: K234099
Trade/Device Name: Select Hybrid Personal Lubricant and Select Pure Silicone Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 9, 2024 Received: May 10, 2024
Dear Om Singh:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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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,
Michael T. Bailey -S
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) K234099
Device Name
Select Hybrid Personal Lubricant and Select Pure Silicone Personal Lubricant
Indications for Use (Describe)
Select Hybrid 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Select Pure Silicone Personal 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 not compatible with natural rubber latex, polyurethane, and polyisoprene 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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510(k) Summary Select Labs, LLC Select Hybrid Personal Lubricant and Select Pure Silicone Personal Lubricant
| Company Name: | Select Labs, LLC |
|---|---|
| Company Address: | 4236 Wilkinson Blvd.Charlotte, NC 28208, USA |
| Contact Number: | Phone: 704-399-4400Fax: 704-399-5781 |
| Contact Person: | Brent Fox, CEOE-mail: bfox@selectlabsllc.com |
| Submission Correspondent: | Om V. Singh, Ph.D.Principal Regulatory ConsultantLucida Scientific and Regulatory Consulting, LLC9667 Norfolk Ave.Laurel, MD 20723Tel: (443) 253-2104E-mail: om.singh@lsrconsultancy.com |
| Summary Preparation Date: | June 5, 2024 |
| Device Trade Names: | Select Hybrid Personal LubricantSelect Pure Silicone Personal Lubricant |
| Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Product Code: | NUC (lubricant, personal) |
| Device Class: | II |
Table 1: Predicate Devices
| Select Hybrid Personal | Select Pure Silicone | |
|---|---|---|
| Lubricant | Lubricant | |
| Predicate 510(k) Number | K191480 | K212260 |
| Predicate Trade Name | Wet® Water Based Personal Lubricant | Sensuva Premium Silicone Personal Lubricant |
| Predicate Manufacturer | TRIGG Laboratories, Inc. | Valencia Naturals, Inc. |
The predicate devices identified above have not been subject to design-related recalls.
Device Description
The Select Hybrid Personal Lubricant and Select Pure Silicone Personal Lubricant are nonsterile, over the counter, personal lubricants. These devices are for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of
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intimate sexual activity and supplement the body's natural lubrication. Both lubricants are not compatible with natural rubber latex, polyisoprene, and polyurethane condoms. These lubricants are neither a contraceptive nor a spermicide.
The Select Hybrid Personal Lubricant formulation consists of distilled water, cyclopentasiloxane, dimethicone, dimethiconol, methylparaben, Cellosize™ hydroxyethyl cellulose PEG-10, and propylene glycol. The Select Pure Silicone Personal Lubricant formulation consists of cyclopentasiloxane, dimethicone, and dimethiconol.
Both subject devices are packaged in high density polyethylene bottles (2oz., 40z., 80z., 160z., 32 oz., 64oz., and 128 oz.) with low density polyethylene caps or polypropylene/polyethylene/stainless steel combination pumps. The bottle closure/pumps are covered with a heat shrink polyethylene terephthalate glycol sleeve film.
Device specifications are provided in Tables 2 and 3.
| Physical Specification Test | Specification |
|---|---|
| Appearance | White Opaque Liquid |
| Color | White |
| Odor | Characteristic |
| Viscosity per USP <912> | 15,000 - 16,500 cP |
| pH per USP <791> | 5.62 - 6.07 |
| Osmolality per USP <785> | 744 – 783 mOsm/kg |
| Antimicrobial effectiveness perUSP <51> | Category 2 product: bacteria should show not less than2.0 log reduction at 14 days and no increase from 14-daycount at the 28-day count. Yeast and molds should showno increase from the initial calculated count at 14 and 28days. |
| Total Aerobic Microbial Count(TAMC) per USP <61> and<1111> | <20 CFU/g |
| Total Yeast and Mold Count(TYMC) per USP <61> and<1111> | <10 CFU/g |
| Absence of Pathogens per USP<62> | Absence of Staphylococcus aureus, Pseudomonasaeruginosa, and Candida albicans |
Table 2. Device Specifications for the Select Hybrid Personal Lubricant
Table 3. Device Specifications for the Select Pure Silicone Personal Lubricant
| Physical Specification Test | Specification |
|---|---|
| Appearance | Clear Liquid |
| Color | Colorless |
| Odor | Characteristic |
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| Viscosity per USP <912> | 247 – 305 сР |
|---|---|
| Total Aerobic Microbial Count (TAMC)per USP <61> and <1111> | <100 CFU/g |
| Total Yeast and Mold Count (TYMC)per USP <61> and <1111> | <10 CFU/g |
| Absence of Pathogens per USP <62> | Absence of Staphylococcus aureus , Pseudomonas aeruginosa , and Candida albicans |
Indication for Use
Select Hybrid Personal 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Select Pure Silicone Personal 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Comparison of Intended Use and Technological Characteristics with the Predicate Device
The tables below compare the intended use and technological characteristics of the subject and predicate devices.
| Parameter | Subject DeviceSelect Hybrid PersonalLubricant | Predicate device (K191480)Wet® Water Based PersonalLubricant | Comparison |
|---|---|---|---|
| Manufacturer | Select Labs, LLC | TRIGG Laboratories, Inc. | N/A |
| Indications forUse | Select Hybrid PersonalLubricant is a personallubricant, for penile and/orvaginal application, intendedto moisturize and lubricate,to enhance the ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication.This product is notcompatible with naturalrubber latex, polyurethane,and polyisoprene condoms. | The Wet Water Based PersonalLubricant (additionally, brandedas WET Platinum Houston, EliteWater-Based Hybrid) is apersonal lubricant for penile,anal and/or vaginal application,intended to moisturize andlubricate, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication. Thisproduct is compatible withnatural rubber latex andpolyisoprene condoms. Thisproduct is not compatible withpolyurethane condoms. | Not identical |
| Table 4. Comparison Table for Subject Device Select Hybrid Personal Lubricant and Predicate | |
|---|---|
| Device Wet® Water Based Personal Lubricant |
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| Base Type | Hybrid | Hybrid | Same |
|---|---|---|---|
| Ingredients | Water, Cyclopentasiloxane,Dimethicone, Dimethiconol,Methylparaben, Cellosize™Hydroxyethyl CellulosePEG-10, Propylene Glycol | Water, Dimethicone,Cyclopentasiloxane, PEG/PPG18/18 Dimethicone,Propylene Glycol,Caprylhydroxamic Acid, 1,2-Hexanediol, Propanediol,Sodium Polyacrylate, Trideceth-6, Hydroxyethylcellulose,Sodium Acetate, Cellulose | Different |
| Rx/OTC | OTC | OTC | Same |
| Sterile | No | No | Same |
| Appearance | While Opaque liquid | Hazy | Similar |
| Color | White | Slightly Cloudy (Hazy) | Similar |
| Odor | Characteristic | Characteristic | Same |
| Viscosity | 15,000 - 16,500 cp | 5,000 - 13,000 ср | Different |
| pH | 5.62 - 6.07 | 6.0 - 7.5 | Different |
| Osmolality | 744 – 786 mOsm/kg | 3,691 – 6,140 mOsm/kg | Different |
| Total yeast andmold (TYMC) | <10 CFU/g | <10 CFU/g | Same |
| Total aerobicmicrobial count(TAMC) | <20 CFU/g | <10 CFU/g | Different |
| Absence ofPathogenicOrganisms | Absent | Absent | Same |
| AntimicrobialEffectivenessTested per USP<51> | Meets USP <51> acceptancecriteria for Category 2products | Meets USP <51> acceptancecriteria for Category 2 products | Same |
| CondomCompatibility | Not compatible with naturalrubber latex, polyisoprene,and polyurethane condoms. | Compatible with natural rubberlatex and polyisoprene condoms.Not compatible withpolyurethane condoms. | Different |
| Biocompatibility | Yes | Yes | Same |
| Shelf Life | 2 years | 1.5 Years | Different |
The subject and predicate device indications are not that the predicate device is also indicated for anal use and compatibility with natural rubber latex and polyisoprene condoms. These differences do not represent a new intended use, which is the same for both the predicate and subject devices (i.e., intended to provide lubrication during intimate sexual activity), but rather a more limited indications for use for the subject device. The subject and predicate devices also have differences in technological characteristics, including different formulations, specifications, compatibility with condoms, and shelf-life duration. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.
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| Parameter | Subject Device: SelectPure Silicone PersonalLubricant | Predicate device (K212260)Sensuva Premium SiliconePersonal Lubricant | Comparison |
|---|---|---|---|
| Manufacturer | Select Labs, LLC | Valencia Naturals, Inc. | N/A |
| Indications forUse | Select Pure SiliconePersonal Lubricant is apersonal lubricant, forpenile and/or vaginalapplication, intended tomoisturize and lubricate, toenhance the ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication.This product is notcompatible with naturalrubber latex, polyurethane,and polyisoprene condoms. | Sensuva Premium SiliconePersonal Lubricant is a silicone-based personal lubricant forpenile, anal and/or vaginalapplication, intended tomoisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubberlatex, polyisoprene andpolyurethane condoms. | Not identical |
| Base Type | Silicone | Silicone | Same |
| Ingredients | Cyclopentasiloxane,Dimethicone, Dimethiconol | Cyclopentasiloxane,Dimethicone, Dimethiconol | Same |
| Rx/OTC | OTC | OTC | Same |
| Sterile | No | No | Same |
| Appearance | Clear liquid | Clear liquid | Same |
| Color | Colorless | Colorless | Similar |
| Odor | Characteristic | Characteristic | Same |
| Viscosity (USP<912>) | 247 - 305 cp | 300 - 630 cps | Different |
| Total yeast andmold (TYMC,10CFU/g perUSP <61> and<1111>) | <10 CFU/g | <10 CFU/g | Same |
| Total aerobicmicrobial count(TAMC < 100CFU/g per USP<61> and<1111>) | <100 CFU/g | <100 CFU/g | Same |
| Absence ofPathogenicOrganisms perUSP <62> | Absent | Absent | Same |
| CondomCompatibility | Not compatible with naturalrubber latex, polyisoprene,and polyurethane condoms | Compatible with natural rubberlatex, polyisoprene, andpolyurethane condoms | Different |
| Biocompatibility | Yes | Yes | Same |
| Shelf-Life | 2 years | 8.4 Months | Different |
Table 5. Comparison Table for Subject Device Select Pure Silicone Personal Lubricant and Predicate Device Sensuva Premium Silicone Personal Lubricant
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The subject and predicate device indications are not that the predicate device is also indicated for anal use and compatibility with natural rubber latex, polyisoprene, and polyurethane condoms. These differences do not represent a new intended use, which is the same for both the predicate and subject devices (i.e., intended to provide lubrication during intimate sexual activity), but rather a more limited indications for the subject device. The subject and predicate devices also have differences in technological characteristics, including different viscosity specifications, compatibility with condoms, and shelf-life durations. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.
Summary of Non-Clinical Performance Data
Biocompatibility
Biocompatibility studies were performed on both subject lubricants in accordance with the 2023 FDA guidance 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 10993-11:2017)
The results of this testing demonstrated that the subject lubricants are non-cytotoxic, non-irritating, non-sensitizing, and not acutely systemically toxic.
Condom Compatibility
The condom compatibility of the subject device was not tested against any condom type. Therefore, the subject device is not claimed to be condom compatible.
Shelf-Life Testing
The subject devices have a shelf-life of 2 years based on the results of accelerated aging studies. The shelf-life studies evaluated all device specifications listed in Tables 2 and 3 of the Device Specifications. The subject devices met all device specifications over the stated shelf-life duration.
Conclusion
The results of performance testing described above demonstrate the Select Hybrid Personal
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Lubricant and Select Pure Silicone Personal Lubricant are as safe and effective as the predicate devices and support 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.