K Number
K213400
Device Name
Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry
Manufacturer
Date Cleared
2022-03-01

(134 days)

Product Code
Regulation Number
884.5300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry are personal lubricants 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. They are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.
Device Description
Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry are water-based personal lubricants 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. The products are compatible with natural rubber latex and polyisoprene condoms. The products are not compatible with polyurethane condoms. They are for over-the-counter (OTC) use. The formula consists of water, propylene glycol. xanthan gum, carbomer, benzoic acid, sodium hydroxide, sodium saccharin and flavor. Grosz Play Aloe, Grosz Play Ylang, and Grosz Play Guarana are packaged in a 200 mL polyethylene terephthalate (PET) bottle fitted with a polypropylene (PP) cap. Grosz Play Cherry and Grosz Play Strawberry are packaged in a 50 mL high density polyethylene (HDPE) bottle fitted with a polypropylene (PP) cap. The bottle and cap feature a tamper evident shrink seal label. The individual bottles may be packaged in an outer cardboard carton.
More Information

Not Found

No
The device description and performance studies focus on the physical and chemical properties of a personal lubricant, with no mention of AI or ML technology.

Yes
The device is described as a personal lubricant intended to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication, which are therapeutic claims. Furthermore, it undergoes biocompatibility testing, a common requirement for therapeutic devices.

No

Explanation: The device is a personal lubricant intended to moisturize and lubricate for enhancing sexual activity. Its stated purpose is not to diagnose any condition.

No

The device is a physical product (personal lubricant) composed of chemical ingredients and packaged in bottles. It is not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that these products are "personal lubricants 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 describes a topical application for physical lubrication during sexual activity.
  • IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Lack of Diagnostic Function: The provided description does not mention any diagnostic function. The device does not analyze samples from the body to provide information about a person's health status.
  • Device Description: The device description details the physical form and ingredients of a lubricant, not a diagnostic test kit or instrument.

Therefore, based on the provided information, this device falls under the category of a personal lubricant, which is not an IVD.

N/A

Intended Use / Indications for Use

Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry are personal lubricants 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. They are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.

Product codes (comma separated list FDA assigned to the subject device)

NUC

Device Description

Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry are water-based personal lubricants 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. The products are compatible with natural rubber latex and polyisoprene condoms. The products are not compatible with polyurethane condoms. They are for over-the-counter (OTC) use. The formula consists of water, propylene glycol. xanthan gum, carbomer, benzoic acid, sodium hydroxide, sodium saccharin and flavor. Grosz Play Aloe, Grosz Play Ylang, and Grosz Play Guarana are packaged in a 200 mL polyethylene terephthalate (PET) bottle fitted with a polypropylene (PP) cap. Grosz Play Cherry and Grosz Play Strawberry are packaged in a 50 mL high density polyethylene (HDPE) bottle fitted with a polypropylene (PP) cap. The bottle and cap feature a tamper evident shrink seal label. The individual bottles may be packaged in an outer cardboard carton.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

penile, vaginal and/or anal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Shelf life: Grosz Play Aloe, Grosz Play Cherry, and Grosz Play Strawberry have a proposed shelf-life of 2 years (24 months). Grosz Play Ylang and Grosz Play Guarana have a proposed shelf-life of 1.5 years (18 months). All device specifications listed in the device specifications table above were tested based on accelerated aging conditions per ASTM F1980-16. Results from testing demonstrated that the device can maintain its specifications over the duration of its shelf life.

Biocompatibility: Biocompatibility studies were performed for all variants of the subject device in accordance with the 2020 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)
  • . Vaginal Irritation (ISO 10993-10: 2010)
  • Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010) ●
  • Acute Systemic Toxicity (ISO 10993-11: 2006) ●
    The results of this testing demonstrated that the subject lubricants are non-cytotoxic, non-irritating, nonsensitizing, and not systemically toxic.

Condom Compatibility: Grosz Play Aloe, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry 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 Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K211088

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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

March 1, 2022

RB Health (US) Lisa Burns Sr. Manager Regulatory Affairs 399 Interpace Parkway Parsippany, NJ 07054

Re: K213400

Trade/Device Name: Grosz Play Aloe, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 19, 2022 Received: January 27, 2022

Dear Lisa Burns:

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.

1

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. 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) K213400

Device Name

Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry

Indications for Use (Describe)

Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry are personal lubricants 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. They are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.

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

Prescription Use (Part 21 CFR 801 Subpart D)Over The Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------------------------------------------------

_ | Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510K Summary K213400

Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry

| Submitted by: | RB Health (US) LLC
399 Interpace Parkway
Parsippany NJ 07054-0224
973-404-2715 |
|----------------------|----------------------------------------------------------------------------------------------------|
| Contact Person: | Lisa Burns
Regulatory Sr.
Manager RB
Health (US) LLC
862-325-0012 |
| Date Prepared: | February 25, 2022 |
| Device/Trade Name: | Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry,
Grosz Play Strawberry |
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | NUC (Lubricant, Personal) |
| Regulatory Class: | II |
| Predicate Device(s): | Grosz Play Feel |
| Device Name: | RB Health (US) LLC |
| Manufacturer: | K211088 |
| 510(k) Number: | |

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

Description of the Device:

Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry are water-based personal lubricants 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. The products are compatible with natural rubber latex and polyisoprene condoms. The products are not compatible with polyurethane condoms. They are for over-the-counter (OTC) use. The formula consists of water, propylene glycol. xanthan gum, carbomer, benzoic acid, sodium hydroxide, sodium saccharin and flavor. Grosz Play Aloe, Grosz Play Ylang, and Grosz Play Guarana are packaged in a 200 mL polyethylene terephthalate (PET) bottle fitted with a polypropylene (PP) cap. Grosz Play Cherry and Grosz Play Strawberry are packaged in a 50 mL high density polyethylene (HDPE) bottle fitted with a polypropylene (PP) cap. The bottle and cap feature a tamper evident shrink seal label. The

4

individual bottles may be packaged in an outer cardboard carton.

Subject Device Specifications:

| Specification | ALOE | YLANG | GUARANA | CHERRY | STRAW-
BERRY |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Appearance | Clear to slightly translucent, colourless to slightly yellow colour homogeneous gel and free from particulate matter | Clear to slightly translucent, colourless to slightly yellow colour homogeneous gel and free from particulate matter | Clear to slightly translucent, colourless to slightly yellow colour homogeneous gel and free from particulate matter | Colorless, transparent gel, free from lumps and particulate matter | Colorless, transparent gel, free from lumps and particulate matter |
| Odor | No objectional odor | No objectional odor | No objectional odor | Characteristic of cherry | Characteristic of strawberry |
| Viscosity (cps) | 3,300 - 10,000 | 3,300 - 10,000 | 3,300 - 10,000 | 3,400 - 10,000 | 3,400 - 10,000 |
| Osmolality (mOsm/kg) | 695 - 1,095 | 720 - 1,120 | 710 - 1,110 | 683-1,083 | 742 - 1,143 |
| Benzoic Acid | 0.15-0.22 %w/w | 0.15-0.22 %w/w | 0.15-0.22 %w/w | 0.15-0.22 %w/w | 0.15-0.22 %w/w |
| pH at 25°C | 3.5 - 4.5 | 3.5 - 4.5 | 3.5 - 4.5 | 3.5 - 4.5 | 3.5 - 4.5 |
| Total Yeast and Mold
Count (TYMC)* | , and , respectively.

Indications for Use Statement: Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry are personal lubricants 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. They are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.

Comparison of Intended Use and Technological Characteristics with the Predicate Device: A comparison of the technological features of the subject and predicate devices is provided in the table below:

| 510(k) | K2134000
Subject Device | K211088
Predicate Device |
|-------------|--------------------------------------------------------------------------------------------|-----------------------------|
| Device Name | Grosz Play Aloe, Grosz Play
Ylang, Grosz Play Guarana,
Grosz Play Cherry, Grosz Play | Grosz Play Feel |

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Strawberry
Indications for
UseGrosz Play Aloe, Grosz Play Ylang,
Grosz Play Guarana, Grosz Play Cherry,
and Grosz Play Strawberry are personal
lubricants 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. They are compatible with
natural rubber latex and polyisoprene
condoms. They are not compatible with
polyurethane condoms.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.
Rx/OTCOTCOTC
Physical
FeaturesHomogenous transparent gelHomogeneous clear gel
Base TypeWaterWater
SterileNoNo
Primary
IngredientsWater, Propylene Glycol, Xanthan
Gum, Carbomer, Benzoic Acid,
Sodium Hydroxide, Sodium
Saccharin, Flavor.Water, Propylene Glycol, Xanthan Gum,
Carbomer, Benzoic Acid, Sodium
Hydroxide.
Biocompatibility
TestedYesYes
Antimicrobial
TestedYesYes
Condom
CompatibilityCompatible 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 LifeGrosz Play Aloe, Grosz Play
Cherry, Grosz Play Strawberry: 2
years
Grosz Play Ylang, Grosz Play
Guarana: 1.5 years2.5 years

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 different formulations and shelf-life. 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: Grosz Play Aloe, Grosz Play Cherry, and Grosz Play Strawberry have a proposed shelf-life of 2 years (24 months). Grosz Play Ylang and Grosz Play Guarana have a proposed shelf-life of 1.5 years (18 months). All device specifications listed in the device specifications table above were tested based on accelerated aging conditions per ASTM F1980-16. Results from testing demonstrated that the device can maintain its specifications over the duration of its shelf life

Biocompatibility: Biocompatibility studies were performed for all variants of the subject device in

6

accordance with the 2020 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)
  • . Vaginal Irritation (ISO 10993-10: 2010)
  • Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010) ●
  • Acute Systemic Toxicity (ISO 10993-11: 2006) ●

The results of this testing demonstrated that the subject lubricants are non-cytotoxic, non-irritating, nonsensitizing, and not systemically toxic.

Condom Compatibility: Grosz Play Aloe, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry 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 Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry is as safe and effective as the predicate device and supports a determination of substantial equivalence.