(172 days)
Not Found
No
The document describes a personal lubricant with a simple chemical formulation and does not mention any computational or analytical capabilities that would suggest the use of AI or ML. The performance studies focus on shelf life, biocompatibility, and condom compatibility, which are standard tests for this type of device and do not involve AI/ML.
No.
A therapeutic device is typically used to prevent, diagnose, or treat a disease, or to affect the structure or function of the body in a medical way. This device is a personal lubricant used to enhance comfort and ease during intimate sexual activity and moisturize/lubricate, which is not considered a therapeutic function.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during intimate sexual activity, not to diagnose a medical condition.
No
The device description clearly states it is a personal lubricant with a specific chemical formulation and is packaged in physical bottles. This indicates it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 product applied to the body for physical lubrication and comfort during sexual activity.
- Device Description: The device is described as a "personal lubricant" that is "non-sterile, water-based, and provides lubrication during intimate sexual activity."
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition. IVDs are specifically designed to be used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnostic purposes.
The information provided clearly indicates that this is a personal lubricant intended for physical application and comfort, not for diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
KY Grosz UltraGel 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, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Benzoic acid, Sodium Saccharin, and Sodium Hydroxide. KY Grosz UltraGel is 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 UltraGel 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 application
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Shelf life: KY Grosz UltraGel 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:
- Cytotoxicity (ISO 10993-5: 2009): The subject device test article showed no evidence of 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 UltraGel 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 UltraGel is as safe and effective as the predicate device and supports a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
April 14, 2020
RB Health (US) LLC Elizabeth Viguerie, MPH Regulatory Manager 399 Interpace Parkway Parsippany, NJ 07054
Re: K192982 Trade/Device Name: KY Grosz UltraGel 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:
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) K192982
Device Name KY Grosz UltraGel
Indications for Use (Describe)
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.
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510K Summary K192982
KY Grosz UltraGel
| Submitted by: | RB Health (US) LLC
399 Interpace Parkway
Parsippany NJ 07054-0224
973-404-2715 |
|----------------------|-----------------------------------------------------------------------------------------|
| Contact Person: | Elizabeth Viguerie
Regulatory Manager
RB Health (US) LLC
973-404-2715 |
| Date Prepared: | April 9th, 2020 |
| Trade Name: | KY Grosz UltraGel |
| 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 Aloe
RB Health (US) LLC
510(k) No.: K183302 |
The predicate device has not been subject to a design-related recall.
Description of the Device:
KY Grosz UltraGel 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, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Benzoic acid, Sodium Saccharin, and Sodium Hydroxide. KY Grosz UltraGel is 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 UltraGel is a personal lubricant for over-the-counter (OTC) use.
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Device specifications are listed in Table 1 below.
| Property | Specification |
|---|---|
| Appearance | Colorless to slightly yellow, clear to translucent liquid |
| Odor | No objectionable odor |
| Viscosity | 100-950 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)* | , , and , 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 Technological Characteristics of New Device in Comparison to Predicate:
Comparison of the technological features of the subject and predicate devices is provided in Table 2 below:
| | K192982
Subject Device | K183302
Predicate Device |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | | |
| Device Name | KY Grosz UltraGel | KY Banksy Aloe |
| Indications for
Use | 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. | 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. |
| Rx/OTC | OTC | OTC |
| Physical Features | Colorless to slightly yellow, clear to
translucent liquid/Odorless | Homogeneous Clear Gel / Odorless |
| Base Type | Water | Water |
| Sterile | No | No |
| Primary
Ingredients | Water, Glycerin, Propylene Glycol,
Hydroxyethylcellulose, Benzoic acid,
Sodium Saccharin, Sodium Hydroxide | Water, Propanediol, Xanthan Gum, Benzoic
Acid, Aloe Barbadensis Leaf Juice, Potassium
Lactate, Lactic Acid |
| Biocompatibility
Tested | Yes | Yes |
| Antimicrobial
Tested | Yes | Yes |
| 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 | 2 years | 2 years |
Table 2: Technological Characteristics of Subject Device Compared to Predicate
The subject device and predicate devices have different technological characteristics, including their 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 UltraGel 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:
- Cytotoxicity (ISO 10993-5: 2009): The subject device test article showed no evidence of ● cytotoxicity to L-929 cells and therefore is not cytotoxic.
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- 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 UltraGel 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 UltraGel is as safe and effective as the predicate device and supports a determination of substantial equivalence.