(218 days)
Not Found
No
The device is a personal lubricant and the description focuses on its chemical composition, physical properties, and biocompatibility, with no mention of AI or ML.
No
The device is described as a personal lubricant intended to enhance comfort and supplement natural lubrication during sexual activity. While it can be used with "diagnostic and therapeutic devices," it is not itself a therapeutic device. Its primary function is lubrication and moisturization, not the treatment or diagnosis of a condition.
No.
The document states that BioGenesis Fertility Lubricant "can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices," meaning it aids in the use of diagnostic devices, but it is not a diagnostic device itself.
No
The device description clearly states it is a water-based formula with specific ingredients and is provided in a tube container with a gel consistency. This indicates a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is as a personal lubricant for sexual activity and to facilitate the use of diagnostic and therapeutic devices during fertility interventions. While it mentions facilitating the use of diagnostic devices, the lubricant itself is not performing a diagnostic function on a sample taken from the body.
- Device Description: It's a water-based lubricant with a gel consistency. It doesn't contain reagents or components designed to detect or measure substances in a biological sample.
- Performance Studies: The performance studies focus on biocompatibility, sperm compatibility, condom compatibility, and shelf life. These are relevant to a personal lubricant and a device used in fertility procedures, but not to the analytical performance of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
While it is used in the context of fertility interventions which may involve diagnostic procedures, the lubricant's role is purely functional (lubrication) rather than diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
PEB
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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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3
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 Avenue
Eugene, OR 97401
Contact: Wendy Strgar
Phone: 541-344-4483
Fax: 541-685-1335
Email: wendy@goodcleanlove.com |
|-----|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Preparer/Contact: | 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 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
4
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 | ) |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Candida albicans | Absent |
| Escherichia coli, Salmonella, Clostridium | |
| Species | Absent |
| Antimicrobial Effectiveness (USP) | |
| Escherichia coli, Pseudomonas aeruginosa, | |
| Staphylococcus aureus | NLT a 2.0 log reduction from initial |
| count at 14 days and no increase | |
| from the 14-day count at 28 days | |
| Candida albicans, Aspergillus niger | No increase from the initial |
| calculated 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:
5
| | BioGenesis Fertility
Lubricant
K190872 | BabyDance Fertility
Lubricant
K162319 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device |
| Sponsor | Good Clean Love Inc. | Fairhaven Health, LLC |
| Indications for Use | 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. | BabyDance 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.
BabyDance Fertility
Lubricant is compatible with
sperm, oocytes, and embryos
and can be used by trying to
conceive couples.
BabyDance Fertility
Lubricant is compatible with
natural rubber latex and
polyurethane condoms.
BabyDance 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. |
| Regulation Number | 884.5300 | 884.5300 |
Table 2. Technological Characteristics of BioGenesis Fertility Lubricant as Compared to the Predicate Device
6
| Product Code | PEB | PEB |
|---|---|---|
| Device Class | II | II |
| Base Type | Water | Water |
| Primary Ingredients | Water | |
| Hydroxyethylcellulose | ||
| Sodium Chloride | ||
| Potassium Chloride | ||
| Calcium Chloride | ||
| Magnesium Chloride | ||
| Potassium Benzoate | ||
| Sodium Benzoate | ||
| Sorbic Acid | ||
| Lactic Acid | Water | |
| Cetyl Hydroxyethylcellulose | ||
| Hypromellose | ||
| Carbomer Homopolymer | ||
| Monobasic Sodium | ||
| Phosphate | ||
| Dibasic Potassium Phosphate | ||
| Sodium Chloride | ||
| D-Xylose | ||
| Sodium Hydroxide | ||
| Phenethyl Alcohol | ||
| Caprylyl Glycol | ||
| Salvia Sclarea | ||
| Over the Counter Use | Yes | Yes |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
| Condom Compatibility | Natural Rubber Latex | |
| Polyisoprene | Natural Rubber Latex | |
| Polyurethane | ||
| 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.
7
- 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.