(90 days)
K-Y® Brand LIQUID Personal Lubricant
Not Found
No
The summary describes a personal lubricant and its physical properties and testing, with no mention of AI or ML.
Yes.
The device is a personal lubricant used to supplement natural lubrication fluids and help enhance intimacy during sexual activity, which can be considered a therapeutic purpose.
No
The device is a personal lubricant that supplements natural lubrication fluids, with an intended use to enhance intimacy. It does not perform any diagnostic function.
No
The device description clearly indicates it is a physical product (a liquid gel) and 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 as a personal lubricant to enhance intimacy and is compatible with latex condoms. This is a topical application for physical interaction, not for diagnosing a condition or examining a sample from the body.
- Device Description: The description clearly states it's a "non-sterile water-based personal lubricant designed to supplement the body's own natural lubrication fluids." This aligns with a personal care product, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The studies described focus on biocompatibility, irritation, and consumer use, which are relevant for a personal lubricant, not an IVD.
Therefore, based on the provided text, K-Y® Brand Ultra Gel™ is a personal lubricant and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Patient lubricants are devices intended to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. When used as an accessory to a condom, patient lubricants are deemed Class II Medical Devices.
K-Y® Brand Ultra Gel™ is principally intended as personal lubricant to supplement the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal, anal or penile tissue for lubrication, and moisturization purposes. It is also compatible with latex condoms.
Personal Lubricant compatible with latex condoms, helps enhance intimacy.
Product codes (comma separated list FDA assigned to the subject device)
85HIS, NUC
Device Description
K-Y® Brand Ultra Gel™ is a non-sterile water- based personal lubricant designed to supplement the body's own natural lubrication fluids. This formula is a clear, non-irritating, non-greasy, non-staining, high viscosity liquid gel. This highly lubricous product may be used with or without a latex condom during intimate sexual activity. K-Y® Brand Ultra Gel™ is not a contraceptive or spermicide. It is however, compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal, anal or penile tissue
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)
Preclinical biocompatibility studies on K-Y® Brand Ultra Gel™ Personal Lubricant were conducted by outside laboratories, in compliance with Good Laboratory Practices (GLPs). These studies demonstrated that this formulation was non-initating, did not produce any significant pharmacotoxic effects and was not associated with system toxicity.
In Human Irritation studies under conservative occluded and repetitive conditions, this formulation was non-sensitizing and only mildly irritating.
Consumer-Use Testing conducted to evaluate performance of the proposed formulation as compared to another commercially marketed vaginal moisturizer, demonstrated that the proposed formulation rated significantly higher for texture/consistency and moisturizing properties.
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.
K-Y® Brand LIQUID Personal Lubricant
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
510(k) SUMMARY
| Submitter | Personal Products Company Division of McNeil-PPC Inc.
199 Grandview Road
Skillman, New Jersey 08558-9418 |
|---------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person | Marylou Panico
Mgr. Regulatory Affairs
(908) 904-3709 telephone
(908) 904-3748 telefax |
| Date Prepared | May 29, 2002 |
| Proprietary Name | K-Y® Brand Ultra Gel™
Personal Lubricant |
| Common Name | Personal Lubricant |
| Classification Name | Condom 21CFR § 884.5300 Product Code 85HIS |
| Predicate Device | K-Y® Brand LIQUID Personal Lubricant |
Description of Device
K-Y® Brand Ultra Gel™ is a non-sterile water- based personal lubricant designed to supplement the body's own natural lubrication fluids. This formula is a clear, non-irritating, non-greasy, non-staining, high viscosity liquid gel. This highly lubricous product may be used with or without a latex condom during intimate sexual activity. K-Y® Brand Ultra Gel™ is not a contraceptive or spermicide. It is however, compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.
Intended Use
Patient lubricants are devices intended to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. When used as an accessory to a condom, patient lubricants are deemed Class II Medical Devices.
K-Y® Brand Ultra Gel™ is principally intended as personal lubricant to supplement the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal, anal or penile tissue for lubrication, and moisturization purposes. It is also compatible with latex condoms.
Technological Characteristics
K-Y® Brand Ultra Gel™ formula is proprietary. The product however, has no exceptional technological characteristics, consisting mainly of water-soluble ingredients similar to other lubricants currently on the US market.
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510(k) SUMMARY (continued)
Substantial Equivalence
This product has been shown in laboratory testing to be substantially equivalent to its predecessor, the currently marketed K-Y® Brand LIQUID Personal Lubricant. Both devices have the same intended use and similar formulations. One differentiating feature is that K-Y® Brand Ultra Gel™ contains vitamin E and is more lubricious, as demonstrated in laboratory coefficient of friction testing.
Preclinical Testing of Formulation
Preclinical biocompatibility studies on K-Y® Brand Ultra Gel™ Personal Lubricant were conducted by outside laboratories, in compliance with Good Laboratory Practices (GLPs). These studies demonstrated that this formulation was non-initating, did not produce any significant pharmacotoxic effects and was not associated with system toxicity.
Clinical Testing
In Human Irritation studies under conservative occluded and repetitive conditions, this formulation was non-sensitizing and only mildly irritating.
Consumer-Use Testing conducted to evaluate performance of the proposed formulation as compared to another commercially marketed vaginal moisturizer, demonstrated that the proposed formulation rated significantly higher for texture/consistency and moisturizing properties.
Laboratory, Preclinical and Clinical testing conducted on K-Y® Brand Ultra Gel™ Personal Lubricant has provided scientific evidence that this product is safe for its intended use and substantially equivalent to the predicate device, K-Y® Brand LIQUID Personal Lubricant.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
FEB 2 4 2014
Ms. Marylou Panico Manager, Regulatory Affairs Personal Products Company Division of McNeil-PPC, Inc. 199 Grandview Road SKILLMAN NJ 08558
Re: K020827
Trade/Device Name: K-Y® Brand Marque Ultra Gel™ Personal Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): March 12, 2002 Received (Date on orig SE ltr): March 14, 2002
Dear Ms. Panico:
This letter corrects our substantially equivalent letter of June 12, 2002.
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. Iisting 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
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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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 Small Manufacturers, International and Consumer Assistance 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours.
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
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510(k) INDICATIONS FOR USE FORM (Replica of FDA Form)
510(k) Number (if known):
Device Name: K-Y Brand ® Ultra Gel™ Personal Lubricant Indications For Use: Personal Lubricant compatible with latex condoms, helps enhance intimacy
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-the-Counter-Use V (per 21 CFR 801.109)
--
Girard G. Geyson
JUN 12 2002
02-0827
00-000003