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 Liquid is a 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, PEG-400, Propylene glycol, Xanthan Gum, Carbomer, Benzoic acid, Sodium saccharin, and Sodium hydroxide. KY Grosz Liquid may be 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 Liquid is a personal lubricant for over-the-counter (OTC) use.

AI/ML Overview

This document describes the premarket notification (510(k)) for the KY Grosz Liquid, a personal lubricant. It details the device's characteristics, intended use, and the studies conducted to demonstrate its safety and effectiveness in comparison to a predicate device, KY Banksy Aloe.

Here's the breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria	Reported Device Performance (KY Grosz Liquid)
Appearance	Clear to translucent	Clear to translucent
Odor	No objectionable odor	No objectionable odor
Viscosity	200-1200 cPs	(Not explicitly stated if within range, but implied satisfactory)
Osmolality	690-1090 mOsm/kg	(Not explicitly stated if within range, but implied satisfactory)
pH	3.5 - 4.5	(Not explicitly stated if within range, but implied satisfactory)
Total Yeast and Mold Count (TYMC)	< 10 cfu/g (per EP 8.0 Section 2.6.12)	(Not explicitly stated if within range, but implied satisfactory)
Total Aerobic Microbial Count (TAMC)	< 100 cfu/g (per EP 8.0 Section 2.6.12)	(Not explicitly stated if within range, but implied satisfactory)
Pseudomonas aeruginosa	Absent (per EP 8.0 Section 2.6.13)	Absent
Staphylococcus aureus	Absent (per EP 8.0 Section 2.6.13)	Absent
Candida albicans	Absent (per EP 8.0 Section 2.6.13)	Absent
Preservative Effectiveness - 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 (per EP 8.0 Section 5.1.3)	(Implied satisfactory performance)
Preservative Effectiveness - 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)	(Implied satisfactory performance)
Cytotoxicity	No evidence of cytotoxicity	No evidence of cytotoxicity
Vaginal Irritation	Non-irritant to vaginal tissue	Non-irritant to vaginal tissue
Sensitization	No evidence of delayed dermal contact sensitization	Not considered a sensitizer
Acute Systemic Toxicity	No mortality or evidence of systemic toxicity	No mortality or evidence of systemic toxicity
Condom Compatibility	Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms	Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms
Shelf Life	Maintain specifications over 2 years	2 years (based on accelerated aging stability study)

Study Information

The document describes several performance tests conducted for the KY Grosz Liquid. However, it does not provide all the granular details requested regarding specific sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, or training set specifics for AI/algorithm-related studies. This is expected as the product is a personal lubricant, not an AI/ML-based medical device.

1. Sample sizes used for the test set and the data provenance:

Shelf Life: The document states that stability studies were performed, but does not provide the specific sample size of product units tested or the duration of the accelerated aging study. Data provenance is implied to be from the manufacturer's internal testing.
Biocompatibility Studies (Cytotoxicity, Vaginal Irritation, Sensitization, Acute Systemic Toxicity):
- Cytotoxicity: Tested on L-929 cells. Sample size of cells or test replicates not specified.
- Vaginal Irritation: Tested on rabbits. The number of rabbits is not specified.
- Guinea Pig Maximization Sensitization Test: Tested on guinea pigs. The number of guinea pigs is not specified.
- Acute Systemic Toxicity: Tested on an unspecified animal model. The number of animals is not specified.
- Data provenance for biocompatibility studies is implied to be from testing conducted according to ISO standards.
Condom Compatibility: Tested according to ASTM D7661-10. The number of condoms or test replicates is not specified. Data provenance is implied to be from testing conducted according to ASTM standards.
Microbial Purity and Preservative Effectiveness: Sample sizes for these microbial tests (cfu/g measurements, log reductions) are not specified. Data provenance is implied to be from testing conducted according to European Pharmacopoeia (EP) standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The tests performed are laboratory-based and do not involve human expert interpretation for "ground truth" in the way an AI/ML diagnostic device would. For example, cytotoxicity is determined by cell viability assays, and irritation by pathological assessment after animal exposure, not by expert consensus on image interpretation.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation or clinical trial endpoints involving human judgment. The tests for a personal lubricant involve standardized laboratory procedures.

4. 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 device.

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

Not applicable. This is not an AI/algorithm-based device.

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

The "ground truth" for the various tests corresponds to established scientific and regulatory standards:
- Physical/Chemical Properties (Appearance, Odor, Viscosity, Osmolality, pH): Measured against defined numerical and descriptive specifications.
- Microbial Purity & Preservative Effectiveness: Defined by colony-forming units (cfu/g) and log reduction thresholds established in European Pharmacopoeia (EP) standards.
- Biocompatibility: Determined by standardized biological responses (e.g., cell viability in cytotoxicity, histological assessment in irritation, dermal response in sensitization, animal health in systemic toxicity) according to ISO 10993 series.
- Condom Compatibility: Assessed using the standardized test method ASTM D7661-10.
- Shelf Life: Determined by the ability of the device to maintain its physical, chemical, and microbial specifications over time under accelerated aging conditions.

7. The sample size for the training set:

Not applicable. This is not an AI/ML device; there is no "training set."

8. How the ground truth for the training set was established:

Not applicable. Since there's no AI/ML component, there's no training set or associated ground truth.

Summary

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April 20, 2020

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

Re: K193032 Trade/Device Name: KY Grosz Liquid 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, MPH:

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) K193032

Device Name KY Grosz Liquid

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510K Summary K193032

KY Grosz Liquid

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 17th, 2020
Trade Name:	KY Grosz Liquid
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	Clear to translucent
Odor	No objectionable odor
Viscosity	200-1200 cPs
Osmolality	690-1090 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 8.0Section: 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 8.0Section: 5.1.3)*
Escherichia coli, Pseudomonas aeruginosa,Staphylococcus aureus	NLT 3.0 log reduction from the initialcount at 7 days, and no increase from the 7days' count at 28 days
Candida albicans, Aspergillus niger (A. brasiliensis)	2.0 log reduction from the initiation countat 14 days, and no increase from the 14days' 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>, 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 Intended Use and Technological Characteristics of the New Device in Comparison to Predicate:

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

	K193032	K183302
510(k)	Subject Device	Predicate Device
Device Name	KY Grosz Liquid	KY Banksy Aloe
Indications for Use	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	Clear to translucent/ no odor	Homogeneous Clear Gel / Odorless
Base Type	Water	Water
Sterile	No	No
PrimaryIngredients	Water, PEG-400, Propylene glycol, XanthanGum, Carbomer, Benzoic acid, Sodiumsaccharin, Sodium hydroxide	Water, Propanediol, Xanthan Gum, BenzoicAcid, Aloe Barbadensis Leaf Juice,Potassium Lactate, 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 and predicate device have identical indications for use statements and have the same intended use.

The subject device and predicate devices have different technological characteristics, including a different 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 Liquid 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:

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