(78 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 technology.
Yes
The device is a personal lubricant intended to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication, which are therapeutic benefits.
No
The product is a personal lubricant intended to lubricate and moisturize, enhancing comfort during intimate sexual activity. It does not mention any diagnostic capabilities or intended use for detecting or identifying medical conditions.
No
The device is a physical personal lubricant, not a software application. The description details its physical form, packaging, and testing related to biocompatibility and condom compatibility, all of which are characteristic of a physical product.
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 and/or vaginal application, intended to lubricate and moisturize, 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.
- Device Description: The description reinforces the intended use as a "non-sterile lubricant for penile and/or vaginal application."
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or treat any disease or condition by examining specimens derived from the human body. IVDs are used to perform tests on samples like blood, urine, or tissue.
Therefore, the JO Gelato Flavored Personal Lubricants are classified as a personal lubricant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
JO Gelato Flavored Personal Lubricants are water-based personal lubricants for penile and/or vaginal application, intended to lubricate and moisturize, 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, polyurethane and polyisoprene condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
JO Gelato Flavored Personal Lubricants are clear, semi-viscous personal lubricants that are compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. The device is a non-sterile lubricant for penile and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is provided in Polyethylene Terephthalate (PET) bottles fitted with Polypropylene caps or foil sachets. The individual bottles are sealed using an induction seal constructed of aluminized mylar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Biocompatibility: Independent third-party laboratories conducted the biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing; each were performed in accordance with 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 Agarose Overlay Method, ISO 10993-5:2009), Sensitization (ISO Guinea Pig Maximization Sensitization, ISO 10993-10:2010), Vaginal Irritation (ISO Vaginal Irritation Study in Rabbits, ISO 10993-10:2010), Penile Irritation (ISO Penile Irritation Study in Rabbits, ISO 10993-10:2010), Acute Systemic Toxicity (ISO Tests for Systemic Toxicity, ISO 10993-11:2006). The results of this testing demonstrated that the subject lubricant is biocompatible.
Shelf-Life: The proposed device, JO Gelato Flavored Personal Lubricant, is a non-sterile personal lubricant with a two-year shelf-life in accordance with the results of a real time and accelerated aging study. All device specifications listed in Table 1 were tested at 0, 1 and 2 years. In addition, both versions of the device packaging were evaluated. The subject device in both versions of its packaging met the device specifications at all time points.
Condom Compatibility: The compatibility of the subject device, JO Gelato Personal Lubricant, was evaluated with natural rubber latex, polyisoprene and polyurethane condoms in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicate that the JO Gelato Flavored Personal Lubricants are compatible with natural rubber latex, polyurethane and polyisoprene 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
October 31, 2017
United Consortium Stephanie Morris RA/QA Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355
Re: K172447
Trade/Device Name: JO Gelato Flavored Personal Lubricants Regulation Number: 21 CFR$ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 10, 2017 Received: August 14, 2017
Dear Stephanie Morris:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name JO Gelato Flavored Personal Lubricants
Indications for Use (Describe)
JO Gelato Flavored Personal Lubricants are water-based personal lubricants for penile and/or vaginal application, intended to lubricate and moisturize, 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, polyurethane and polyisoprene 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)
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3
K172447 - 510(k) Summary
| 510(k) Owner: | United Consortium |
|---|---|
| Street Address: | 29000 Hancock Parkway |
| Valencia, CA 91355 | |
| Establishment Registration Number: | 3005691625 |
| Contact Person: | Stephanie Morris |
| RA/QA Specialist |
Bruce Albert
Head of Technical Services |
| Contact Numbers: | Phone: (661) 295-1700, ext. 232
Phone: (661) 295-1700, ext. 231
FAX: (661) 295-1800 |
| Summary Preparation Date: | October 27, 2017 |
| Trade Name: | JO Gelato Flavored Personal Lubricants
JO Gelato Salted Caramel Personal Lubricant
JO Gelato Crème Brulee Personal Lubricant
JO Gelato Hazelnut Espresso Personal Lubricant
JO Gelato Mint Chocolate Personal Lubricant
JO Gelato Tiramisu Personal Lubricant |
| Common Name: | Personal Lubricant |
| Device Classification: | Classification Name: Condom
Product Code: NUC (lubricant, personal)
Regulation: 21 CFR § 884.5300 (Condom)
Device Class: Class II |
| Predicate Device: | Product Name: Astroglide Sensual Strawberry
510(k) Number: K140590
Manufacturer: BioFilm, Inc.
Product Code: NUC
Device Class: Class II |
The predicate device has not been subject to a designrelated recall.
4
Device Description:
JO Gelato Flavored Personal Lubricants are clear, semi-viscous personal lubricants that are compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. The device is a non-sterile lubricant for penile and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is provided in Polyethylene Terephthalate (PET) bottles fitted with Polypropylene caps or foil sachets. The individual bottles are sealed using an induction seal constructed of aluminized mylar.
The device specifications are listed in the table below:
Table 1: Device Specifications for JO Gelato Flavored Personal Lubricants
| Property | Specification |
|---|---|
| Appearance | Clear, semi-viscous liquid |
| Color | Clear |
| Odor | Sweet/Characteristic |
| Viscosity (cps) | 2000 cps to 3700 cps |
| Specific Gravity | 0.900 to 1.050 |
| pH | 5.0 to 6.0 |
| Osmolality | 1350 to 1550 mOsm/kg |
| Antimicrobial effectiveness per USP | Meets US acceptance criteria for Category 2 |
| products | |
| Total aerobic microbial count (TAMC) per USP | |
| and | Less than 10 cfu/g |
| Total yeast and mold count (TYMC) per USP | |
| and | Less than 10 cfu/g |
| Presence of Pathogens per USP | Specification |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Salmonella | Absent |
| Escherichia coli | Absent |
| Candida albicans | Absent |
Indications for Use:
JO Gelato Flavored Personal Lubricants are water-based personal lubricants for penile and/or vaginal application, intended to lubricate and moisturize, 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, polyurethane and polyisoprene condoms.
Predicate Device Comparison:
The table below lists the comparative intended use and technological characteristics of the subject and predicate device.
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| Feature | JO Gelato Flavored Personal Lubricants | Astroglide Sensual Strawberry
(K140590) |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| Intended Use | JO Gelato Flavored Personal Lubricants
are water-based personal lubricants for
penile and/or vaginal application,
intended to lubricate and moisturize, 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, polyurethane and
polyisoprene condoms. | The BioFilm, Inc. Astroglide
Sensual Strawberry is a personal
lubricant for penile and/or
vaginal application, intended 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, polyisoprene and
polyurethane condoms. |
| Water soluble | Yes | Yes |
| Contains water | Yes | Yes |
| Primary ingredients | Water (Aqua), Glycerin, Potassium
Sorbate, Hydroxyethylcellulose, Flavor
(Aroma), Sodium Chloride, Sucralose,
Citric Acid | Water (Aqua), Glycerin,
Propylene Glycol,
Hydroxyethylcellulose, Natural
and Artificial Strawberry Flavor,
Sodium Gluconate, Sodium
Saccharin, Methylparaben,
Sodium Benzoate, Citric Acid |
| Over the counter use | Yes | Yes |
| Sterile | No | No |
| Condom Compatibility | Latex, Polyisoprene, Polyurethane | Latex, Polyisoprene,
Polyurethane |
| Biocompatibility Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
Table 2: Comparator Table for Subject Device – JO Gelato Flavored Personal Lubricants and Predicate Device Astroglide Sensual Strawherry
The subject and predicate device have the same intended use - for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The subject and predicate device have different technological characteristics, including different formulation. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions. All personal lubricants must independently demonstrate they are biocompatible, compatible with condoms, and can maintain their specifications for their expected shelf life.
6
Summary of Performance Data:
Biocompatibility
Independent third-party laboratories conducted the biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing; each were performed in accordance with 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 Agarose Overlay Method, ISO 10993-5:2009) ●
- Sensitization (ISO Guinea Pig Maximization Sensitization, ISO 10993-10:2010) ●
- Vaginal Irritation (ISO Vaginal Irritation Study in Rabbits, ISO 10993-10:2010)
- Penile Irritation (ISO Penile Irritation Study in Rabbits, ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO Tests for Systemic Toxicity, ISO 10993-11:2006)
The results of this testing demonstrated that the subject lubricant is biocompatible.
Shelf-Life:
The proposed device, JO Gelato Flavored Personal Lubricant, is a non-sterile personal lubricant with a two-year shelf-life in accordance with the results of a real time and accelerated aging study. All device specifications listed in Table 1 were tested at 0, 1 and 2 years. In addition, both versions of the device packaging were evaluated. The subject device in both versions of its packaging met the device specifications at all time points.
Condom Compatibility:
The compatibility of the subject device, JO Gelato Personal Lubricant, was evaluated with natural rubber latex, polyisoprene and polyurethane condoms in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicate that the JO Gelato Flavored Personal Lubricants are compatible with natural rubber latex, polyurethane and polyisoprene condoms.
Conclusion:
The results of the performance testing described above demonstrate that the JO Gelato Flavored Personal Lubricants are safe and effective as the predicate device and supports a determination of substantial equivalence.