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

K Y Grosz Jelly is a water-based personal lubricant 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, and is not compatible with polyurethane condoms. Its formulation consists of Water, Propylene glycol, Hydroxyethylcellulose, Benzoic acid, Carbomer, Sodium hydroxide. KY Grosz Jelly may be packaged in 2 oz (57g) and 4 oz (113g) tubes composed of high-density polyethylene (HDPE) and linear low-density polyethylene (LLDPE), sealed with foil and fitted with a polypropylene (PP) cap. The individual tubes may be packaged in an outer cardboard carton. KY Grosz Jelly is a personal lubricant for over-the-counter (OTC) use.

AI/ML Overview

The provided text describes the regulatory review for a personal lubricant (KY Grosz Jelly), not an AI-powered medical device. Therefore, the information required to answer your specific questions about acceptance criteria, study design, expert involvement, and ground truth for an AI device is not present in the document.

The document discusses:

Product Name: KY Grosz Jelly
Regulation Number: 21 CFR § 884.5300 (Condom)
Regulatory Class: Class II
Intended Use: Penile, vaginal, and/or anal application to moisturize and lubricate, enhance intimacy, and supplement natural lubrication. Compatible with natural rubber latex and polyisoprene condoms, not with polyurethane condoms.
Predicate Device: KY Banksy Aloe
Performance Testing: Shelf life, biocompatibility (cytotoxicity, vaginal irritation, sensitization, acute systemic toxicity), and condom compatibility.

No information regarding AI/ML device performance, human reader studies (MRMC), standalone algorithm performance, or the establishment of ground truth for AI model training/testing is available in this document.

Therefore, I cannot populate the table or answer the specific questions related to AI device acceptance criteria and study design based on the provided text.

Summary

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July 30, 2020

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

Re: K201186 Trade/Device Name: KY Grosz Jelly Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 1, 2020 Received: May 1, 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.

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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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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) K201186

Device Name KY Grosz Jelly

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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510K Summary K201186 KY Grosz Jelly

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:	July 29, 2020
Trade Name:	KY Grosz Jelly
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:

Device specifications are listed in the table below.

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Property	Specification
Appearance	Clear to translucent jelly
Odor	No objectionable odor
Viscosity	40,000-100,000 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
Escherichia coli	Absent
Preservative Effectiveness Testing(PET, per EP 8.0 Section: 5.1.3)*1
Escherichia coli, Pseudomonasaeruginosa, Staphylococcus aureus	NLT 3.0 log reduction from the initial count at 7 days, and noincrease 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 noincrease from the 14 days' count at 28 days

Subject Device Specifications

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 Intended Use and Technological Characteristics of New Device in Comparison to Predicate:

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

	K201186	K183302
510(k)	Subject Device	Predicate Device
Device Name	KY Grosz Jelly	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	Clear to translucent jelly/ no objectionableodor	Homogeneous Clear Gel / Odorless
Base Type	Water	Water
Sterile	No	No
PrimaryIngredients	Water, Propylene glycol,Hydroxyethylcellulose, Benzoic acid,Carbomer, 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	1.5 years	2 years

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

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Summary of Performance Testing:

Shelf life: KY Grosz Jelly has a shelf-life of 1.5 years (18 months) in accordance with the results of an accelerated aging stability study. Results form 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 causing cell lysis or 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: 2006): There was no mortality or evidence of systemic toxicity for the subject device.

Condom Compatibility: KY Grosz Jelly 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 Jelly 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.