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 Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the KY Grosz UltraGel, structured to answer your specific questions.

1. A table of acceptance criteria and the reported device performance

Property	Acceptance Criteria (Specification)	Reported Device Performance
Physical/Chemical Properties
Appearance	Colorless to slightly yellow, clear to translucent liquid	"can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this, though no direct measured value is given in summary)
Odor	No objectionable odor	"can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this)
Viscosity	100-950 cPs	"can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this)
Osmolality	780-1180 mOsm/kg	"can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this)
pH	3.5 - 4.5	"can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this)
Microbiological Purity
Total Yeast and Mold Count (TYMC)	< 10 cfu/g (per EP 8.0 Section: 2.6.12)	"can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this)
Total Aerobic Microbial Count (TAMC)	< 100 cfu/g (per EP 8.0 Section: 2.6.12)	"can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this)
Specified Organisms (per EP 8.0 Section: 2.6.13)	Pseudomonas aeruginosa AbsentStaphylococcus aureus AbsentCandida albicans Absent	"can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this)
Preservation Effectiveness
Preservative Effectiveness Testing (PET)	E. coli, P. aeruginosa, S. aureus: NLT 3.0 log reduction from initial count at 7 days, no increase from 7 days' count at 28 days.C. albicans, A. niger: 2.0 log reduction from initial count at 14 days, no increase from 14 days' count at 28 days (per EP 8.0 Section: 5.1.3).	"can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this)
Biocompatibility
Cytotoxicity (ISO 10993-5: 2009)	No evidence of cytotoxicity	"showed no evidence of cytotoxicity to L-929 cells and therefore is not cytotoxic."
Vaginal Irritation (ISO 10993-10: 2010)	Irritation Index of 0 / Non-irritant	"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."
Sensitization (ISO 10993-10: 2010)	No evidence of causing delayed dermal contact sensitization / Not considered a sensitizer	"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)	No mortality or evidence of systemic toxicity	"There was no mortality or evidence of systemic toxicity for the subject device."
Condom Compatibility
Natural Rubber Latex Condoms	Compatible (per ASTM D7661-10)	"determined to be compatible with natural rubber latex...condoms."
Polyisoprene Condoms	Compatible (per ASTM D7661-10)	"determined to be compatible with...polyisoprene condoms."
Polyurethane Condoms	Not compatible (per ASTM D7661-10)	"It was determined not to be compatible with polyurethane condoms." (This is a performance characteristic rather than an "acceptance criteria" for passing, but it is a stated outcome of the test that defines its use).
Shelf Life	2 years with maintained specifications	"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."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify exact sample sizes for each test within the biocompatibility, microbiological, or condom compatibility studies. It refers to standard methods (e.g., ISO, ASTM, EP) which typically implicitly define sample size requirements. For the animal studies (vaginal irritation, sensitization, acute systemic toxicity), these typically involve small numbers of animals (e.g., guinea pigs, rabbits, mice).
Data Provenance: Not explicitly stated. The studies are described as "performance testing" and "biocompatibility studies were performed." There's no mention of the country of origin of the data or whether it was retrospective or prospective, though performance testing for device clearance is typically prospective for the device under evaluation.

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)

This section is not applicable to this device. The KY Grosz UltraGel is a personal lubricant, not an AI/imaging device requiring expert interpretation for ground truth. Its performance is evaluated through physical, chemical, microbiological, and biological compatibility tests, not by expert review of data sets.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the same reason as point 3. Adjudication methods are relevant for subjective interpretations, especially in medical imaging. The tests for this device involve objective measurements and standardized protocols without a need for expert adjudication in this context.

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

This section is not applicable. This is not an AI-assisted diagnostic or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, "ground truth" refers to the established scientific and regulatory standards and methods by which its properties are evaluated.

Physical/Chemical Properties (Appearance, Odor, Viscosity, Osmolality, pH): Ground truth is established by analytical chemistry and physical testing methods against defined specifications.
Microbiological Purity & Preservative Effectiveness: Ground truth is established by standard microbiological plating and challenge tests (e.g., European Pharmacopoeia standards) with specific thresholds for bacterial, yeast, and mold counts, and log reductions.
Biocompatibility (Cytotoxicity, Irritation, Sensitization, Systemic Toxicity): Ground truth is established by international standards (ISO 10993 series) using in vitro cell line tests and in vivo animal models, with defined endpoints (e.g., cell viability, irritation index, absence of reaction).
Condom Compatibility: Ground truth is established by standardized material testing methods (e.g., ASTM D7661-10) that assess the degradation or impact of the lubricant on condom materials.
Shelf Life: Ground truth is established by accelerated aging stability studies which project long-term stability based on short-term data under stressed conditions, confirming retention of all specified properties over time.

8. The sample size for the training set

This section is not applicable. This device does not use machine learning or AI that requires a "training set."

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

Summary

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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (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) K192982

Device Name KY Grosz UltraGel

Indications for Use (Describe)

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) LLC399 Interpace ParkwayParsippany NJ 07054-0224973-404-2715
Contact Person:	Elizabeth ViguerieRegulatory ManagerRB Health (US) LLC973-404-2715
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 AloeRB Health (US) LLC510(k) No.: K183302

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

Description of the Device:

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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:

	K192982Subject Device	K183302Predicate Device
510(k)
Device Name	KY Grosz UltraGel	KY Banksy Aloe
Indications forUse	This product is intended for penile, vaginaland/or anal application to moisturize andlubricate, to enhance the ease and comfort ofintimate sexual activity and supplement thebody's natural lubrication. This product iscompatible with natural rubber latex andpolyisoprene condoms. This product is notcompatible with polyurethane condoms.	This product is intended for penile, vaginaland/or anal application to moisturize andlubricate, to enhance the ease and comfort ofintimate sexual activity and supplement thebody's natural lubrication. This product iscompatible with natural rubber latex andpolyisoprene condoms. This product is notcompatible with polyurethane condoms.
Rx/OTC	OTC	OTC
Physical Features	Colorless to slightly yellow, clear totranslucent liquid/Odorless	Homogeneous Clear Gel / Odorless
Base Type	Water	Water
Sterile	No	No
PrimaryIngredients	Water, Glycerin, Propylene Glycol,Hydroxyethylcellulose, Benzoic acid,Sodium Saccharin, Sodium Hydroxide	Water, Propanediol, Xanthan Gum, BenzoicAcid, Aloe Barbadensis Leaf Juice, PotassiumLactate, Lactic Acid
BiocompatibilityTested	Yes	Yes
AntimicrobialTested	Yes	Yes
CondomCompatibility	Compatible with natural rubber latex andpolyisoprene condoms. Not compatible withpolyurethane condoms.	Compatible with natural rubber latex andpolyisoprene condoms. Not compatible withpolyurethane 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.

Regulation Number and Section

§ 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.