(90 days)
BioNourish 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
BioNourish Lubricant is a personal lubricant that is non-sterile, contains hyaluronic acid, 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, hyaluronic acid, carrageenan, sodium chloride, xanthan gum, lactic acid, potassium sorbate, sodium benzoate, ceratonia siliqua (carob) gum, and calcium chloride. BioNourish is packaged in 2 fl. oz plastic tubes. The device is packaged with a low-density polyethylene (LDPE) applicator. BioNourish lubricant is a personal lubricant for over-the-counter (OTC) use.
The provided document is a 510(k) Pre-market Notification for a medical device (BioNourish Lubricant). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device's performance is measured against predefined acceptance criteria for clinical efficacy or diagnostic accuracy. Therefore, the information requested in the prompt, which pertains to a clinical or diagnostic study design, such as sample size for test sets and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, is not available in this type of regulatory submission.
However, I can extract the acceptance criteria for the device's physical, chemical, and microbiological properties and the reported performance based on non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Specification) | Reported Device Performance (Implied by meeting spec) |
|---|---|---|
| Appearance | Clear and transparent | Clear and transparent |
| Odor | Characteristic | Characteristic |
| Viscosity | 5,000 – 28,000 cps | Within 5,000 – 28,000 cps |
| Osmolality | 250 – 400 mOsm/kg | Within 250 – 400 mOsm/kg |
| pH at 25 °C | 3.8-4.2 | Within 3.8-4.2 |
| Total Aerobic Microbial Count (USP<61>) | <100 cfu/g | <100 cfu/g |
| Total Yeast & Mold Count (USP <61>) | <10 cfu/g | <10 cfu/g |
| Pseudomonas aeruginosa | Absent | Absent |
| Staphylococcus aureus | Absent | Absent |
| Candida albicans | Absent | Absent |
| Escherichia coli, Salmonella, Clostridium Species | Absent | Absent |
| Antimicrobial Effectiveness (USP<51>) | Initial count at 14 days and no increase from the 14-day count at 28 days for bacteria and no increase from the initial calculated count at 14 and 28 days for yeasts/molds. | Met criteria |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility (Sensitization) | Non-sensitizing | Non-sensitizing |
| Biocompatibility (Irritation) | Non-irritating | Non-irritating |
| Biocompatibility (Acute systemic toxicity) | Not acutely-systemically toxic | Not acutely-systemically toxic |
| Condom Compatibility (Natural rubber latex) | Compatible | Compatible |
| Condom Compatibility (Polyisoprene) | Compatible | Compatible |
| Condom Compatibility (Polyurethane) | Not compatible | Not compatible |
| Shelf Life | 1 year (maintaining specifications) | 1 year (specifications maintained) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes pre-market testing to ensure the device meets specified physical, chemical, microbiological, and biocompatibility standards, not a clinical trial with a "test set" in the context of diagnostic performance or clinical efficacy. The data described appears to be from in-vitro and laboratory tests rather than human studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document does not describe a study involving expert-established ground truth for a test set, as it is not a clinical or diagnostic performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is mentioned as this document does not describe a study that would require such a method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a personal lubricant, not an algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the physical, chemical, and microbiological properties, the "ground truth" or reference standard would be the established scientific and regulatory methods (e.g., USP standards for microbial count, ASTM standards for condom compatibility, ISO standards for biocompatibility). For biocompatibility, the "ground truth" is derived from the results of standardized assays.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an algorithm-based device that requires machine learning training.
9. How the ground truth for the training set was established
Not applicable. This information is not relevant to the nature of the device and the studies presented.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets its acceptance criteria involved a series of non-clinical, laboratory-based tests. These included:
- Biocompatibility Testing: Conducted in accordance with the 2016 FDA guidance document "Use of International Standard ISO 10993-1." Specific tests included:
- Cytotoxicity (per ISO 10993-5: 2009)
- Sensitization and Irritation (using human repeated insult patch testing, an alternative to ISO 10993-10:2010)
- Acute systemic toxicity (per ISO 10993-11:2017)
- Results: The device was determined to be non-cytotoxic, non-sensitizing, non-irritating, and not acutely-systemically toxic.
- Condom Compatibility Testing: Evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms."
- Results: The device was compatible with natural rubber latex and polyisoprene condoms, but not compatible with polyurethane condoms.
- Shelf Life Testing: An accelerated aging stability study was performed to determine the shelf life.
- Results: The study demonstrated a 1-year shelf life, with the device maintaining all its specified properties (as listed in Table 1) over this duration.
- Device Specifications Testing: Various tests were conducted to confirm the physical (appearance, odor, viscosity), chemical (pH, osmolality), and microbiological (total aerobic microbial count, total yeast & mold count, absence of pathogenic organisms, antimicrobial effectiveness) properties met the defined specifications in "Table 1: Subject Device Specifications."
- Results: All specified properties were met.
The conclusion of these tests was that the BioNourish Lubricant is as safe and effective as the predicate device, supporting its substantial equivalence determination.
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March 12, 2020
Good Clean Love, Inc. % Abhishek Gurnani Partner Amin Talati Wasserman, LLP 100 South Wacker Drive, Suite 2000 Chicago, IL 60606
Re: K193448 Trade/Device Name: BioNourish Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: December 11, 2019 Received: December 13, 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 control's 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. You must comply with all the Act's
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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 (OS) 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,
For Sharon M. Andrews 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) K193448
Device Name BioNourish Lubricant
Indications for Use (Describe)
BioNourish 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 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) | |
|---|---|
| Production Use (21 CFR 201. Select Program) | On-The-Contract Use (21 CFR 201. Select Contract) |
__ 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 - K193448
| 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: | March 10, 2020 |
| Trade Name: | BioNourish Lubricant |
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulatory Name: | Condom |
| Regulatory Class: | Class II |
| Product Code: | NUC (lubricant, personal) |
Identification of Predicate Device: Hyalo Gyn Personal Lubricant (K094039)
The predicate device has not been subject to a design related recall.
Device Description: BioNourish Lubricant is a personal lubricant that is non-sterile, contains hyaluronic acid, 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, hyaluronic acid, carrageenan, sodium chloride, xanthan gum, lactic acid, potassium sorbate, sodium benzoate, ceratonia siliqua (carob) gum, and calcium
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chloride. BioNourish is packaged in 2 fl. oz plastic tubes. The device is packaged with a low-density polyethylene (LDPE) applicator. BioNourish lubricant is a personal lubricant for over-the-counter (OTC) use.
Device specifications are listed in Table 1 below.
| Table 1: Subject Device Specifications | |||
|---|---|---|---|
| -- | -- | -- | ---------------------------------------- |
| Property | Specification |
|---|---|
| Appearance | Clear and transparent |
| Odor | Characteristic |
| Viscosity | 5,000 – 28,000 cps |
| Osmolality | 250 – 400 mOsm/kg |
| pH at 25 °C | 3.8-4.2 |
| Total Aerobic Microbial Count (USP<61>) | <100 cfu/g |
| Total Yeast & Mold Count (USP <61>) | |
| Absence of Pathogenic Organisms (USP<62>) | |
| Pseudomonas aeruginosa | |
| Staphylococcus aureus | Absent |
| Candida albicans | Absent |
| Escherichia coli, Salmonella, ClostridiumSpecies | Absent |
| Antimicrobial Effectiveness (USP<51>) | |
| initial count at 14 days and no increase | |
| from the 14-day count at 28 days for | |
| bacteria and no increase from the initial | |
| calculated count at 14 and 28 days for | |
| yeasts/molds. |
Indications for Use Statement: BioNourish 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
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| K193448 | K094039 | Comparison | |
|---|---|---|---|
| Subject Device | Predicate | ||
| Sponsor | BioNourish Lubricant | Hyalo Gyn PersonalLubricant | |
| RegulationNumberProduct CodeDevice Class | 844.5300NUCII | 844.5300NUCII | |
| Indications forUse | BioNourish Lubricantis a personal lubricant,for penile and/orvaginal application,intended to moisturizeand lubricate, toenhance the ease andcomfort of intimatesexual activity andsupplement the body'snatural lubrication.This product iscompatible withnatural rubber latexand polyisoprenecondoms. This productis not compatible withpolyurethane condoms. | Hyalo gyn is a personallubricant for penile and/or vaginal applicationintended to moisture andlubricate, to enhance theease and comfort ofintimate sexual activityand supplement the body'snatural lubricant. Thisproduct is compatiblewith condoms;lubricated/nonlubricatedlatex, lubricatedpolyurethane, lubricatednatural skin. | Similar |
| Physical | Clear liquid | Clear liquid | Same |
| Water-based | Yes | Yes | Same |
| PrimaryIngredients | Water,Hydroxyethylcellulose,Hyaluronic Acid,Carrageenan, SodiumChloride, Lactic Acid,Potassium Sorbate,Sodium Benzoate,Ceratonia Siliqua(Carob) Gum,Xanthan Gum, andCalcium Chloride | Water, Hydeal-D,Propylene Glycol,Carbomer, Methyl p-hydroxybenzoate, Propylp-hydroxybenzoate,Sodium Hydroxide | Different: The subject andpredicate devices havedifferences in ingredients.These differences do notraise different questions ofsafety and effectiveness(S&E). |
| pH | 3.8-4.2 | 5.5-6.5 | Different: The subjectdevice has a lower pH thanthe predicate. Thisdifference does not raisedifferent questions of S&E. |
| Osmolality | 250-400 mOsm/kg | Not known | Different: The osmolality ofthe predicate device is notknown. This difference doesnot raise different questionsof S&E. Additionally, theosmolality of the subjectdevice is comparable to othercleared personal lubricantproducts. |
| Viscosity | 5,000-28,000 cps | Not known | Different: The viscosity ofthe predicate device is notknown. This difference doesnot raise different questionsof S&E. |
| Sterile | No | No | Same |
| CondomCompatibility | Natural Rubber Latexand Polyisoprene | Natural Rubber Latex,Polyurethane, and NaturalSkin Condoms | Different: The subject andpredicate devices havedifferences in condomcompatibility. Thisdifference does not raisedifferent questions of S&E. |
| BiocompatibilityTested | Yes | Yes | Same |
| AntimicrobialTested | Yes | Yes | Same |
| Shelf-Life | One year | Three years | Different: This differencedoes not raise differentquestions of S&E. |
Table 2. Technological Characteristics of BioNourish as Compared to the Predicate
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The subject and predicate devices have similar indications for use statements and the same intended use (i.e., lubrication during intimate sexual activity). As noted in the table above, the subject and predicate device have different technological characteristics, including differences in formulations, specifications, condom compatibility and shelf-life. The differences in technological characteristics between the subject and predicate device do not
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raise different questions of safety and effectiveness.
Summary of Performance Data
Biocompatibility: BioNourish Lubricant has undergone biocompatibility testing in accordance with the 2016 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." Testing included:
- Cytotoxicity per ISO 10993-5: 2009 ●
- Sensitization and Irritation testing using the human repeat insult patch testing, an . alternative test method to ISO 10993-10:2010
- Acute systemic toxicity testing per ISO 10993-11:2017. ●
The testing demonstrate that BioNourish Lubricant is non-cytotoxic, non-sensitizing, non-irritating, and not acutely-systemically toxic.
Condom Compatibility: The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 "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 polvurethane condoms.
Shelf Life: BioNourish Lubricant has a 1-year shelf life in accordance with the results of an accelerated aging stability study. Results from testing demonstrated that the device can maintain 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 the BioNourish 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.