KY Grosz UltraGel

K192982 · Rb Health (Us), LLC · NUC · Apr 14, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K192982
• Device Name: KY Grosz UltraGel
• Applicant: Rb Health (Us), LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Apr 14, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

This product is intended for penile, vaginal and/or anal application 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.

Device Story

KY Grosz UltraGel is a non-sterile, water-based personal lubricant designed for over-the-counter use. It is applied topically to penile, vaginal, or anal areas to provide lubrication and enhance comfort during intimate sexual activity. The device is packaged in HDPE bottles with polypropylene caps. It is compatible with natural rubber latex and polyisoprene condoms but incompatible with polyurethane condoms. The lubricant functions by providing a physical barrier and moisture to reduce friction. It is intended for consumer self-use. The product benefits the user by supplementing natural lubrication, thereby facilitating sexual activity and reducing discomfort.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1:2009/2016 included: Cytotoxicity (ISO 10993-5:2009, non-cytotoxic), Vaginal Irritation (ISO 10993-10:2010, non-irritant), Sensitization (ISO 10993-10:2010, non-sensitizer), and Acute Systemic Toxicity (ISO 10993-11:2017, no toxicity). Condom compatibility tested per ASTM D7661-10.

Technological Characteristics

Water-based lubricant; ingredients include Water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Benzoic acid, Sodium Saccharin, Sodium Hydroxide. Viscosity 100-950 cPs; Osmolality 780-1180 mOsm/kg; pH 3.5-4.5. Packaged in HDPE bottles with PP caps. Non-sterile. Shelf life 2 years.

Indications for Use

Indicated for individuals requiring penile, vaginal, or anal lubrication to enhance comfort during sexual activity and supplement natural lubrication. Compatible with natural rubber latex and polyisoprene condoms; contraindicated for use with polyurethane condoms.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• KY Banksy Aloe (K183302)

Submission Summary (Full Text)

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April 14, 2020

RB Health (US) LLC Elizabeth Viguerie, MPH Regulatory Manager 399 Interpace Parkway Parsippany, NJ 07054

Re: K192982 Trade/Device Name: KY Grosz UltraGel Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 11, 2020 Received: March 12, 2020

Dear Elizabeth Viguerie:

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. 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 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 ([e-mail]) or phone [phone] 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) K192982

Device Name KY Grosz UltraGel

#### Indications for Use (Describe)

This product is intended for penile, vaginal and/or anal application 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.

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510K Summary K192982

### KY Grosz UltraGel

| Submitted by: | RB Health (US) LLC<br>399 Interpace Parkway<br>Parsippany NJ 07054-0224<br>973-404-2715 |
|----------------------|-----------------------------------------------------------------------------------------|
| Contact Person: | Elizabeth Viguerie<br>Regulatory Manager<br>RB Health (US) LLC<br>973-404-2715 |
| Date Prepared: | April 9th, 2020 |
| Trade Name: | KY Grosz UltraGel |
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | NUC (Lubricant, Personal) |
| Regulatory Class: | Class II |
| Predicate Device(s): | KY Banksy Aloe<br>RB Health (US) LLC<br>510(k) No.: K183302 |

The predicate device has not been subject to a design-related recall.

### Description of the Device:

KY Grosz UltraGel is a personal lubricant that is non-sterile, water-based, 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, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Benzoic acid, Sodium Saccharin, and Sodium Hydroxide. KY Grosz UltraGel is packaged in 1.5 fl. oz. (44 mL) or 4.5 fl. oz. (133 mL) bottles composed of high density polyethylene (HDPE), sealed and fitted with a polypropylene (PP) cap. The individual bottles are packaged in an outer cardboard carton. KY Grosz UltraGel is a personal lubricant for over-the-counter (OTC) use.

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Device specifications are listed in Table 1 below.

| Property | Specification |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Appearance | Colorless to slightly yellow, clear to translucent liquid |
| Odor | No objectionable odor |
| Viscosity | 100-950 cPs |
| Osmolality | 780-1180 mOsm/kg |
| pH | 3.5 - 4.5 |
| Total Yeast and Mold Count (TYMC, per EP 8.0 Section: 2.6.12)* | < 10 cfu/g |
| Total Aerobic Microbial Count (TAMC, per EP 8.0 Section: 2.6.12)* | < 100 cfu/g |
| Total Specified Organisms (per EP 8.0 Section: 2.6.13)* | |
| | Pseudomonas aeruginosa Absent |
| | Staphylococcus aureus Absent |
| | Candida albicans Absent |
| Preservative Effectiveness Testing (PET, per EP 8.0 Section: 5.1.3)* | |
| | Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus NLT 3.0 log reduction from the initial count at 7 days, and no increase from the 7 days' count at 28 days |
| | Candida albicans, Aspergillus niger (A. brasiliensis) 2.0 log reduction from the initiation count at 14 days, and no increase from the 14 days' count at 28 days |

* European Pharmacopoeia (EP) standards EP 8.0 Sections 2.6.12, 2.6.13, and 5.1.3 have harmonized with or have comparable specifications to USP standards USP <61>, <62>, and <51>, respectively.

Indications of Use Statement: This product is intended for penile, vaginal and/or anal application 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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Summary of Technological Characteristics of New Device in Comparison to Predicate:

Comparison of the technological features of the subject and predicate devices is provided in Table 2 below:

| | K192982<br>Subject Device | K183302<br>Predicate Device |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | | |
| Device Name | KY Grosz UltraGel | KY Banksy Aloe |
| Indications for<br>Use | This product is intended for penile, vaginal<br>and/or anal application to moisturize and<br>lubricate, to enhance the ease and comfort of<br>intimate sexual activity and supplement the<br>body's natural lubrication. This product is<br>compatible with natural rubber latex and<br>polyisoprene condoms. This product is not<br>compatible with polyurethane condoms. | This product is intended for penile, vaginal<br>and/or anal application to moisturize and<br>lubricate, to enhance the ease and comfort of<br>intimate sexual activity and supplement the<br>body's natural lubrication. This product is<br>compatible with natural rubber latex and<br>polyisoprene condoms. This product is not<br>compatible with polyurethane condoms. |
| Rx/OTC | OTC | OTC |
| Physical Features | Colorless to slightly yellow, clear to<br>translucent liquid/Odorless | Homogeneous Clear Gel / Odorless |
| Base Type | Water | Water |
| Sterile | No | No |
| Primary<br>Ingredients | Water, Glycerin, Propylene Glycol,<br>Hydroxyethylcellulose, Benzoic acid,<br>Sodium Saccharin, Sodium Hydroxide | Water, Propanediol, Xanthan Gum, Benzoic<br>Acid, Aloe Barbadensis Leaf Juice, Potassium<br>Lactate, Lactic Acid |
| Biocompatibility<br>Tested | Yes | Yes |
| Antimicrobial<br>Tested | Yes | Yes |
| Condom<br>Compatibility | Compatible with natural rubber latex and<br>polyisoprene condoms. Not compatible with<br>polyurethane condoms. | Compatible with natural rubber latex and<br>polyisoprene condoms. Not compatible with<br>polyurethane condoms. |
| Shelf Life | 2 years | 2 years |

## Table 2: Technological Characteristics of Subject Device Compared to Predicate

The subject device and predicate devices have different technological characteristics, including their formulation. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

### Summary of Performance Testing:

Shelf life: KY Grosz UltraGel has a shelf-life of 2 years 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.

Biocompatibility: Biocompatibility studies were performed 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" and ISO 10993- 1:2009 as follows:

- Cytotoxicity (ISO 10993-5: 2009): The subject device test article showed no evidence of ● cytotoxicity to L-929 cells and therefore is not cytotoxic.

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- Vaginal Irritation (ISO 10993-10: 2010): The Irritation Index for the subject device test article ● was 0. Macroscopically, the vaginal tissue was found to be normal. Therefore, the subject device was considered a non-irritant to vaginal tissue of the rabbit
- Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010): The subject device test article ● solution showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test.
- . Acute Systemic Toxicity (ISO 10993-11: 2017): There was no mortality or evidence of systemic toxicity for the subject device.

Condom Compatibility: KY Grosz UltraGel was tested 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. It was determined not to be compatible with polyurethane condoms.

Conclusion: The results of the performance testing described above demonstrate that the KY Grosz UltraGel is as safe and effective as the predicate device and supports a determination of substantial equivalence.