(218 days)
BioGenesis Fertility 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. BioGenesis Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
BioGenesis Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
BioGenesis Fertility Lubricant is water-based formula with ingredients including lactic acid, hydroxyethylcellulose, sodium chloride, potassium sorbate, sodium benzoate, potassium chloride, sorbic acid, magnesium chloride, and calcium chloride. The product is provided in a tube container and has a gel consistency. Its specifications are listed in Table 1 below. The lubricant is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. It is also compatible with compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples.
This document is an FDA 510(k) summary for the BioGenesis Fertility Lubricant (K190872). It describes the acceptance criteria and performance data used to demonstrate its substantial equivalence to a predicate device (BabyDance Fertility Lubricant, K162319).
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and reported device performance:
| Property | Acceptance Criteria (Specification) | Reported Performance |
|---|---|---|
| Appearance | Gel | Gel |
| Color | Clear | Clear |
| Odor | Characteristic | Characteristic |
| Viscosity | 1,200-10,000 cps | 1,200-10,000 cps (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Osmolality | 300–400 mOsm/kg | 300–400 mOsm/kg (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| pH at 25 °C | 3.8-4.2 | 3.8-4.2 (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Endotoxin | < 0.5 EU/mL | < 0.5 EU/mL (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Human Sperm Survival | ≥ 70% after 24 hours | Compatible with sperm and does not inhibit sperm motility (Specific quantitative result of ≥ 70% after 24 hours is implied to have been met by the statement "compatible with sperm and does not inhibit sperm motility" and the inclusion of HSSA testing.) |
| Total Aerobic Microbial Count (USP <61>) | <100 cfu/g | <100 cfu/g (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Total Yeast & Mold Count (USP <61>) | <10 cfu/g | <10 cfu/g (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Absence of Pathogenic Organisms (USP <62>) | Absent | Absent (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Pseudomonas aeruginosa | Absent | Absent (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Staphylococcus aureus | Absent | Absent (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Candida albicans | Absent | Absent (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Escherichia coli, Salmonella, Clostridium | Absent | Absent (Implied, as this is the specification, and the product is reported to maintain specifications over shelf life) |
| Antimicrobial Effectiveness (E. coli, P. aeruginosa, S. aureus) | NLT a 2.0 log reduction from initial count at 14 days and no increase from the 14-day count at 28 days | Meets criteria (Implied, as per "Antimicrobial Effectiveness (USP<51>)" testing and statement the product maintains specifications over shelf life) |
| Antimicrobial Effectiveness (C. albicans, A. niger) | No increase from the initial calculated count at 14 and 28 days | Meets criteria (Implied, as per "Antimicrobial Effectiveness (USP<51>)" testing and statement the product maintains specifications over shelf life) |
| Biocompatibility | Meets ISO 10993-5:2009, human repeat insult patch testing (sensitization and irritation), and ISO 10993-11:2006 | Device is biocompatible (tested per ISO 10993-5:2009, human repeat insult patch testing, and ISO 10993-11:2006) |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms | BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms (tested per ASTM D7661-10) |
| Shelf Life | 12 months | BioGenesis Fertility Lubricant maintains its specifications over the duration of its proposed shelf life of twelve months (demonstrated through accelerated aging shelf-life testing) |
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes for each non-clinical performance test (e.g., number of replicates for viscosity, number of samples for microbial counts, number of individuals for biocompatibility, etc.). It only mentions that testing was conducted.
- The data provenance is non-clinical laboratory data. There is no indication of country of origin for the data provided, but given the FDA submission, it would adhere to US regulatory standards for testing. The data is retrospective in the sense that the tests were completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to this type of device and study. The "ground truth" here is established by validated laboratory test methods and industry standards (e.g., USP, ISO, ASTM). There are no human experts "adjudicating" diagnostic images or clinical outcomes in this context. The experts involved would be those performing the lab tests, who are qualified by their adherence to the specified test methods.
4. Adjudication method for the test set:
- This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly in medical imaging, where multiple human readers assess data and their interpretations need to be reconciled to form a ground truth. For this type of non-clinical device, "adjudication" is replaced by standardized laboratory procedures and validated analytical methods, where a clear pass/fail or specification adherence is determined by the test results themselves.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not performed, nor is it relevant for this non-clinical device. MRMC studies are used to evaluate the impact of a diagnostic aid (like AI) on human reader performance for tasks such as disease detection or diagnosis. This submission focuses on the chemical and physical properties, and biological compatibility of a lubricant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This concept is not applicable to the BioGenesis Fertility Lubricant. This is not an AI/algorithm-based medical device. The "performance" is the inherent chemical, physical, and biological properties of the lubricant itself as measured by laboratory tests.
7. The type of ground truth used:
- The ground truth for this device is based on established scientific and technical standards, laboratory assays, and relevant consensus standards (e.g., ISO, ASTM, USP). It is not clinical "outcomes data" or "expert consensus" in the sense of medical diagnosis. Specifically:
- Chemical and Physical Properties: Defined by specific ranges and characteristics (e.g., viscosity, pH, appearance).
- Microbiological Purity/Effectiveness: Defined by USP standards and specified microbial limits.
- Biocompatibility: Defined by ISO 10993 series of standards.
- Sperm Compatibility: Defined by Human Sperm Survival Assay (HSSA) and lubricant barrier assay, with a specific quantitative acceptance criterion identified (≥ 70% sperm survival).
- Condom Compatibility: Defined by ASTM D7661-10.
- Shelf Life: Defined by accelerated aging studies demonstrating maintenance of all other listed specifications over time.
8. The sample size for the training set:
- This refers to the development of an AI algorithm. Since BioGenesis Fertility Lubricant is a physical product (a lubricant) and not an AI/software device, the concept of a "training set" for an algorithm is not applicable. The product's formulation and manufacturing processes are developed through traditional chemical and pharmaceutical engineering, not machine learning.
9. How the ground truth for the training set was established:
- As stated above, this question is not applicable as there is no AI training set for this device. The "ground truth" for the device's formulation and manufacturing would be established through chemical principles, quality control standards, and iterative product development/testing.
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November 7, 2019
Good Clean Love, Inc. Abhishek Gurnani Partner Amin Talati Wasserman, LLP 100 South Wacker Drive, Suite 2000 Chicago, IL 60606
Re: K190872
Trade/Device Name: BioGenesis Fertility Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB Dated: October 7, 2019 Received: October 8, 2019
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.
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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 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 (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 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,
Monica D. Garcia, Ph.D. Acting 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) K190872
Device Name BioGenesis Fertility Lubricant
Indications for Use (Describe)
BioGenesis Fertility 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. BioGenesis Fertility Lubricant is compatible with sperm, oocytes, and ean be used by trying to conceive couples. BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
BioGenesis Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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and
510(k) Summary - K190872
This summary uses the format provided in 21 CFR 807.92:
| (1) | Submitter/Owner: | Good Clean Love, Inc.207 West 5th AvenueEugene, OR 97401Contact: Wendy StrgarPhone: 541-344-4483Fax: 541-685-1335Email: wendy@goodcleanlove.com |
|---|---|---|
| Preparer/Contact: | 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 7, 2019 | |
| (2) | Trade Name: | BioGenesis Fertility Lubricant |
| Common Name: | Personal Lubricant | |
| Regulation Number: | 21 CFR 884.5300 | |
| Regulation Name: | Condom | |
| Regulatory Class: | Class II | |
| Product Code: | PEB (lubricant, personal, gamete, fertilization,embryo compatible) |
(3) Identification of Predicate Device: BabyDance Fertility Lubricant (K162319)
The predicate device has not been subject to a design-related recall.
(4) Device Description: BioGenesis Fertility Lubricant is water-based formula with ingredients including lactic acid, hydroxyethylcellulose, sodium chloride, potassium sorbate, sodium benzoate, potassium chloride, sorbic acid, magnesium chloride, and calcium chloride. The product is provided in a tube container and has a gel consistency. Its specifications are listed in Table 1 below. The lubricant is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is
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not compatible with polyurethane condoms. It is also compatible with compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples.
| Property | Specification |
|---|---|
| Appearance | Gel |
| Color | Clear |
| Odor | Characteristic |
| Viscosity | 1,200-10,000 cps |
| Osmolality | 300–400 mOsm/kg |
| pH at 25 °C | 3.8-4.2 |
| Endotoxin | < 0.5 EU/mL |
| Human Sperm Survival | ≥ 70% after 24 hours |
| Total Aerobic Microbial Count (USP <61>) | <100 cfu/g |
| Total Yeast & Mold Count (USP <61>) | <10 cfu/g |
| Absence of Pathogenic Organisms (USP <62>) | Absent |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Candida albicans | Absent |
| Escherichia coli, Salmonella, ClostridiumSpecies | Absent |
| Antimicrobial Effectiveness (USP<51>) | |
| Escherichia coli, Pseudomonas aeruginosa,Staphylococcus aureus | NLT a 2.0 log reduction from initialcount at 14 days and no increasefrom the 14-day count at 28 days |
| Candida albicans, Aspergillus niger | No increase from the initialcalculated count at 14 and 28 days |
Table 1: Subject Device Specifications
- (5) Indications for Use Statement: BioGenesis Fertility 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. BioGenesis Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
BioGenesis Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
(6) Substantial Equivalence Discussion
The table below compares the intended use and technological characteristics of the subject and predicate devices:
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| BioGenesis FertilityLubricantK190872 | BabyDance FertilityLubricantK162319 | |
|---|---|---|
| Subject Device | Predicate Device | |
| Sponsor | Good Clean Love Inc. | Fairhaven Health, LLC |
| Indications for Use | BioGenesis FertilityLubricant is a personallubricant for penileand/or vaginalapplication, intended tomoisturize andlubricate, to enhancethe ease and comfort ofintimate sexual activityand supplement thebody's naturallubrication. BioGenesisFertility Lubricant iscompatible with sperm,oocytes, and embryosand can be used bytrying to conceivecouples. BioGenesisFertility Lubricant iscompatible with naturalrubber latex andpolyisoprene condoms.It is not compatiblewith polyurethanecondoms.BioGenesis FertilityLubricant can be usedto lubricate genitaltissues and devices tofacilitate use ofdiagnostic andtherapeutic devicesduring fertilityinterventions andreproductive medicine. | BabyDance FertilityLubricant 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.BabyDance FertilityLubricant is compatible withsperm, oocytes, and embryosand can be used by trying toconceive couples.BabyDance FertilityLubricant is compatible withnatural rubber latex andpolyurethane condoms.BabyDance FertilityLubricant can be used tolubricate genital tissues anddevices to facilitate use ofdiagnostic and therapeuticdevices during fertilityinterventions andreproductive medicine. |
| Regulation Number | 884.5300 | 884.5300 |
Table 2. Technological Characteristics of BioGenesis Fertility Lubricant as Compared to the Predicate Device
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| Product Code | PEB | PEB |
|---|---|---|
| Device Class | II | II |
| Base Type | Water | Water |
| Primary Ingredients | WaterHydroxyethylcelluloseSodium ChloridePotassium ChlorideCalcium ChlorideMagnesium ChloridePotassium BenzoateSodium BenzoateSorbic AcidLactic Acid | WaterCetyl HydroxyethylcelluloseHypromelloseCarbomer HomopolymerMonobasic SodiumPhosphateDibasic Potassium PhosphateSodium ChlorideD-XyloseSodium HydroxidePhenethyl AlcoholCaprylyl GlycolSalvia Sclarea |
| Over the Counter Use | Yes | Yes |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Condom Compatibility | Natural Rubber LatexPolyisoprene | Natural Rubber LatexPolyurethane |
| Shelf-Life | 12 Months | 9 Months |
The subject and predicate devices have the same indications for use statements and have the same intended use. As noted in the table above, the subject and predicate device have different technological characteristics, including a different formulation and a different shelf life. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.
(7) Summary of Performance Data:
As part of demonstrating substantial equivalence to the predicate device, the following non-clinical performance tests were conducted.
- . Biocompatibility. BioGenesis Fertility Lubricant has undergone biocompatibility testing including cytotoxicity per ISO 10993-5:2009, human repeat insult patch testing (sensitization and irritation), and acute systemic toxicity testing per ISO 10993-11:2006. The testing found that BioGenesis Fertility Lubricant is biocompatible.
- Non-clinical Performance Testing. Human sperm survival assay (HSSA), and . lubricant barrier assay testing was conducted and indicates that BioGenesis Fertility Lubricant is compatible with sperm and does not inhibit sperm motility.
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- Condom Compatibility. BioGenesis Fertility Lubricant was tested for condom compatibility per ASTM D7661-10: Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicate that BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. BioGenesis Fertility Lubricant is not compatible with polyurethane condoms.
- Shelf Life. The results of accelerated aging shelf-life testing demonstrated that . BioGenesis Fertility Lubricant maintains its specifications over the duration of its proposed shelf life of twelve months.
Conclusion (8)
The results of performance testing described above demonstrate that the BioGenesis Fertility Lubricant 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.