Grosz Play Feel 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. Grosz Play Feel is compatible with natural rubber latex and polyisoprene condoms. Grosz Play Feel is not compatible with polyurethane condoms.

Device Description

Grosz Play Feel 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, Propylene Glycol, Xanthan Gum, Carbomer, Benzoic Acid, and Sodium Hydroxide. Grosz Play feel is packaged in 50 mL bottles composed of High Density Polyethylene (HDPE) and fitted with a Polypropylene (PP) cap. The bottle is packaged in an outer cardboard carton. Grosz Play Feel is a personal lubricant for over-the-counter (OTC) use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Grosz Play Feel" personal lubricant. This document details the device's technical specifications and the testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Grosz Play Feel personal lubricant are primarily derived from its device specifications and performance testing. The reported device performance is indicated by the results of these tests.

Property	Acceptance Criteria	Reported Device Performance
Device Specifications (Table 1)		(Implied to meet these specifications as per the submission)
Appearance	Viscous, clear gel	Viscous, clear gel
Odor	Odorless	Odorless
Viscosity	3,400 - 10,000 cPs	Within the range of 3,400 - 10,000 cPs
pH	3.5 - 4.5	Within the range of 3.5 - 4.5
Osmolality	663 - 1,063 mOsm/kg	Within the range of 663 - 1,063 mOsm/kg
Total Yeast and Mold Count (TYMC)	<100 cfu/g (per EP 8.0 Section: 2.6.12)	Meets the specification of <100 cfu/g
Total Aerobic Microbial Count (TAMC)	<10 cfu/g (per EP 8.0 Section: 2.6.12)	Meets the specification of <10 cfu/g
Presence of Pathogens (per EP 8.0 Section: 2.6.13)	Pseudomonas aeruginosa: Absent/g Staphylococcus aureus: Absent/g Candida albicans: Absent/g Escherichia coli: Absent/g	Pseudomonas aeruginosa: Absent/g Staphylococcus aureus: Absent/g Candida albicans: Absent/g Escherichia coli: Absent/g
Preservative Effectiveness Testing (PET)	For 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. For 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. (per EP 8.0 Section: 2.6.13)	Meets the specified log reduction and non-increase criteria for all tested microorganisms.
Biocompatibility	Non-cytotoxic, non-irritating (vaginal), non-sensitizing, and non-systemically toxic, in accordance with ISO 10993-1, -5, -10, -11.	The results of the testing demonstrated that Grosz Play Feel is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.
Shelf-Life	Maintain specifications (Table 1) over a 30-month shelf-life.	Results from accelerated testing demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of its 30-month shelf-life.
Condom Compatibility	Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms, as tested per ASTM D7661-10.	Was determined to be compatible with natural rubber latex and polyisoprene condoms. Was determined not to be compatible with polyurethane condoms.

Study Proving Acceptance Criteria are Met

The document describes several non-clinical performance tests conducted to demonstrate that the Grosz Play Feel personal lubricant meets the acceptance criteria and is substantially equivalent to the predicate device.

Sample size used for the test set and the data provenance:
- The document does not explicitly state the specific sample sizes for each test. For chemical and physical properties (appearance, odor, viscosity, pH, osmolality), standard quality control batch testing would be performed, but the exact number of batches or individual samples isn't given.
- For microbiological tests (TYMC, TAMC, Pathogens, PET), these are typically performed on representative samples from production lots.
- For biocompatibility, shelf-life, and condom compatibility tests, these would likely involve multiple samples or replicates to ensure robustness.
- Data Provenance: The studies were non-clinical performance tests, likely conducted in a laboratory setting by RB Health (US) LLC or a contract research organization. There is no mention of country of origin for data specifically, but the company is based in the US. These appear to be prospective tests conducted for the purpose of this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of submission. The "ground truth" for a medical device like a personal lubricant is established by international standards (e.g., ISO, ASTM, European Pharmacopoeia, USP) and regulatory guidance, not by expert consensus on individual cases or images.
- The tests described (e.g., pH, viscosity, microbiological assays, biocompatibility, condom compatibility) have objective, quantifiable outcomes measured against established physical, chemical, or biological criteria defined by the relevant standards. There are no human "experts" required to interpret complex data akin to radiographic images or clinical diagnoses to establish a "ground truth."
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers are interpreting subjective data (like medical images) and their interpretations need to be reconciled to form a ground truth. For the objective, laboratory-based tests described, there is no need for such adjudication. The results are typically quantitative or qualitative outcomes that either meet or do not meet a predefined specification.
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 question is not applicable. MRMC studies are associated with AI/CAD software used in image interpretation by human readers. This submission is for a personal lubricant, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This submission is for a physical medical device (personal lubricant), not an algorithm or AI software, so the concept of "standalone" algorithmic performance does not apply.
The type of ground truth used:
- The "ground truth" for the performance of the Grosz Play Feel device is based on International Standards (e.g., ISO 10993 series for biocompatibility, ASTM D7661-10 for condom compatibility), European Pharmacopoeia (EP) standards (e.g., EP 8.0 Sections 2.6.12, 2.6.13, and 5.1.3 for microbiological testing), and internal device specifications (e.g., appearance, odor, viscosity, pH, osmolality) that are deemed appropriate for the intended use and safety of the product. These standards represent scientifically validated methodologies and widely accepted performance benchmarks for medical devices.
The sample size for the training set:
- This question is not applicable. A "training set" refers to data used to train machine learning models. This submission is for a physical medical device, which does not involve any machine learning algorithms requiring a training set.
How the ground truth for the training set was established:
- This question is not applicable, as there is no training set for this type of device.

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.

July 9, 2021

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

Re: K211088

Trade/Device Name: Grosz Play Feel Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: April 9, 2021 Received: April 12, 2021

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 -S

Monica D. Garcia, Ph.D. 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) K211088

Device Name Grosz Play Feel

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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K211088 Page 1 of 4

510(k) Summary K211088 Grosz Play Feel

1. Submitter Information

Applicant:	RB Health (US) LLC
Address:	399 Interpace Parkway Parsippany NJ, 07054-0224

2. Correspondent Information

Contact:	Elizabeth Viguerie,Regulatory Manager
Address:	399 Interpace Parkway Parsippany NJ,07054-0224
Phone:	(862) 702-6117
Email:	Elizabeth.Viguerie@rb.com

3. Date prepared: July 7, 2021

4. Device Information

Device Name:	Grosz Play Feel
Common Name:	Personal Lubricant
Regulation Number:	21 CFR 884.5300
Regulation Name:	Condom
Product Code:	NUC (lubricant, personal)
Regulatory Class:	Class II

5. Predicate Device Information

Device Name:	KY Banksy Aloe
510(k) Number:	K183302
Manufacturer:	RB Health (US) LLC

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

6. Device Description

The bottle is packaged in an outer cardboard carton. Grosz Play Feel is a personal lubricant for over-thecounter (OTC) use. Device specifications are listed in Table 1 below.

Table 1: Device Specifications for Grosz Play Feel

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Property	Specification
Appearance	Viscous, clear gel
Odor	Odorless
Viscosity	3,400 - 10,000 cPs
pH	3.5 - 4.5
Osmolality	663 - 1,063 mOsm/kg
Total Yeast and Mold Count (TYMC, per EP 8.0 Section: 2.6.12)*	<100 cfu/g
Total Aerobic Microbial Count (TAMC, per EP 8.0 Section: 2.6.12)*	<10 cfu/g
Presence of Pathogens (per EP 8.0 Section: 2.6.13)*	Specification
Pseudomonas aeruginosa	Absent/g
Staphylococcus aureus	Absent/g
Candida albicans	Absent/g
Escherichia coli	Absent/g
Preservative Effectiveness Testing (PET, per EP 8.0 Section: 2.6.13)*	Specification
Escherichia coli, Pseudomonas aeruginosa,Staphylococcus aureus	NLT 3.0 log reduction from the initial count at7 days, and no increase from the 7 days' countat 28 days
Candida albicans, Aspergillus niger (A. brasiliensis)	2.0 log reduction from the initiation count at 14days, and no increase from the 14 days' countat 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.

7. Indications for Use

8. Comparison of Intended Use and Technological Characteristics with the Predicate Device

The table below compares the intended use and technological characteristics of the subject and predicate device.

Table 2: Comparator Table for Subject and Predicate Device

	Grosz Play FeelK211088Subject Device	KY Banksy AloeK183302Predicate Device
Device Classification Name	Lubricant, Personal	Lubricant, Personal
Indications for Use	Grosz Play Feel is intended for penile,vaginal and/or anal application tomoisturize and lubricate, to enhance theease and comfort of intimate sexualactivity and supplement the body'snatural lubrication.	This product is intended for penile,vaginal and/or anal application tomoisturize and lubricate, to enhancethe ease and comfort of intimatesexual activity and supplement thebody's natural lubrication.

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	Grosz Play Feel is compatible withnatural rubber latex and polyisoprenecondoms. Grosz Play Feel is notcompatible with polyurethane condoms	This product is compatible withnatural rubber latex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms.
Physical Features	Homogeneous Clear Gel	Homogeneous Clear Gel
Base type	Water	Water
Primary ingredients	Water, Propylene Glycol, Xanthan Gum,Carbomer, Benzoic Acid, and SodiumHydroxide	Water, Propanediol, Xanthan Gum,Benzoic Acid, Aloe Barbadensis LeafJuice, Potassium Lactate, Lactic Acid
Rx/OTC	OTC	OTC
Sterile	No	No
Condom Compatibility	Compatible with natural rubber latex andpolyisoprene	Compatible with natural rubber latexand polyisoprene
Biocompatibility Tested	Yes	Yes
Antimicrobial EffectivenessTested	Yes	Yes
Shelf life	2.5 years	2 years

The subject and predicate device indications for use have a minor difference in wording; however, the intended use of the subject and predicate devices is the same (i.e., provides lubrication during intimate sexual activity).

The subject and predicate device have different technological characteristics included a different formulation and different shelf life as shown in the table above. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

9. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility studies were performed in accordance with the 2020FDA 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)
Sensitization (ISO 10993-10:2010) ●
Vaginal Irritation (ISO 10993-10:2010) ●
Acute Systemic Toxicity (ISO 10993-11:2017) ●

The results of this testing demonstrated that Grosz Play Feel is non-cytotoxic, non-irritating, nonsensitizing, and non-systemically toxic.

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Shelf-Life

The subject device has a shelf-life of 30-months. Results from accelerated testing demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of its shelf-life.

Condom Compatibility

Grosz Play Feel 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.

10. Conclusion

The results of the performance testing described above demonstrate that Grosz Play Feel 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.