(88 days)
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.
Yes.
The device 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," which describes a therapeutic purpose to alleviate dryness and discomfort.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to diagnose a condition or disease.
No
The device description clearly states it is a personal lubricant, a physical substance, and details its chemical composition and packaging. There is no mention of software as part of the device itself.
Based on the provided information, Grosz Play Feel is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is 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 comfort and function, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description clearly states it is a "personal lubricant" and lists its ingredients and packaging. This aligns with a personal care product, not a diagnostic test kit.
- Lack of Diagnostic Function: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a person's health status or disease.
- Performance Studies: The performance studies focus on biocompatibility, shelf-life, and condom compatibility, which are relevant to a personal lubricant, not a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Grosz Play Feel does not fit this definition.
N/A
Intended Use / Indications for Use
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.
Product codes
NUC
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.
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
Biocompatibility studies were performed 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)
- 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.
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.
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.
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.
0
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.
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 -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
2
Indications for Use
510(k) Number (if known) K211088
Device Name Grosz Play Feel
Indications for Use (Describe)
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.
| 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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3
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
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-thecounter (OTC) use. Device specifications are listed in Table 1 below.
Table 1: Device Specifications for Grosz Play Feel
4
| 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)* | , , and , respectively. |
7. Indications for Use
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.
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 Feel
K211088
Subject Device | KY Banksy Aloe
K183302
Predicate Device |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Indications for Use | 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. | 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. |
5
| | Grosz Play Feel is compatible with
natural rubber latex and polyisoprene
condoms. Grosz Play Feel is not
compatible with polyurethane condoms | This product is compatible with
natural rubber latex and polyisoprene
condoms. This product is not
compatible with polyurethane
condoms. |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical Features | Homogeneous Clear Gel | Homogeneous Clear Gel |
| Base type | Water | Water |
| Primary ingredients | Water, Propylene Glycol, Xanthan Gum,
Carbomer, Benzoic Acid, and Sodium
Hydroxide | Water, Propanediol, Xanthan Gum,
Benzoic Acid, Aloe Barbadensis Leaf
Juice, Potassium Lactate, Lactic Acid |
| Rx/OTC | OTC | OTC |
| Sterile | No | No |
| Condom Compatibility | Compatible with natural rubber latex and
polyisoprene | Compatible with natural rubber latex
and polyisoprene |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Effectiveness
Tested | 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.
6
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.