(77 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and user perception of a personal lubricant, with no mention of AI or ML technologies.
No.
A therapeutic device is typically intended to treat, cure, mitigate, or prevent disease. This device is a personal lubricant used to reduce friction and enhance sexual intimacy, not for therapeutic purposes.
No
Explanation: The device is a personal lubricant intended to reduce friction during sexual intercourse and enhance intimacy. Its purpose is not to diagnose any condition or disease.
No
The device description clearly indicates a physical gel 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 "Personal Lubricant For vaginal/penile and condom application during sexual intimacy." This describes a product used externally on the body for physical interaction, not for testing samples taken from the body to diagnose a condition.
- Device Description: The description focuses on its physical properties as a lubricant and its compatibility with condoms. It does not mention any diagnostic function or analysis of biological samples.
- Performance Studies: The performance studies described are related to biocompatibility, skin sensitization, and consumer perception of warmth and intimacy enhancement. These are relevant to a personal lubricant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This product does not fit that definition.
N/A
Intended Use / Indications for Use
K-Y® Brand WARMING UltraGEL is intended as personal lubricant to be used with or without a condom.
The lubricous nature of this product helps to supplement the body's own natural lubricating fluids, thereby relieving friction to help enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal, anal or penile tissues for purpose of lubrication, and moisturization and is compatible with latex condoms. K-Y® Brand WARMING UltraGEL has the additional benefit of imparting a warming sensation when applied to the genital area.
Personal Lubricant For vaginal/penile and condom application during sexual intimacy
Product codes (comma separated list FDA assigned to the subject device)
85HIS, MMS, NUC
Device Description
K-Y® Brand WARMING UltraGEL is a non-sterile, clear, non-staining, non-greasy, water soluble gel for use as a personal lubricant. This product imparts a gentle warming sensation when applied to the genitalia. This product was designed to meet a customer need for an intimate lubricant that does not feel cold when applied. K-Y® Brand Warming UltraGEL can reduce friction during sexual intercourse thereby enhancing sexual intimacy. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards as defined by ASTM D 3492. K-Y® Brand WARMING UltraGel is not a contraceptive nor spermicide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal, anal or penile tissues
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 Testing of Formulation: Biocompatibility safety studies according to International Standard ISO 10993 and General Program Memorandum G95-1 on K-Y® Brand WARMING UltraGEL were conducted by an outside laboratory, in compliance with Good Laboratory Practices (GLPs). Results form these studies, demonstrated that K-Y® Brand WARMING UltraGEL was not considered to be a contact sensitizing agent, nor was it associated with systemic toxicity.
Human Clinical Testing:
- Human Repeated Insult Patch Test (Modified Draize Procedure): Compared to the currently marketed K-Y® Warming LIQUID for its potential for contact sensitization. No evidence of contact sensitization was elicited.
- Consumer Perception Study: Evaluated male and female subjects' experience of warmth with a single application of the product to their genitals during an on-site visit. Overall 80.00% rated the product as Excellent, Very Good for "Warms on Contact" and 95.00% for "Does not feel cold when applied". No adverse events observed or reported.
- In-Home Consumer Use Study: Evaluated consumer perception of warmth during sexual activity and product tolerability through vulvo/vaginal speculum examination prior and post product use. Conducted in compliance with 21CFR Part 812 for Investigational Device Exemption and 21CFR Parts 50 and 56.
- Efficacy results: In 245 reported responses, 91.67% were positive for "Warms on Contact" and 85.01% were positive for "Enhances Intimacy". 8.6% responded positively to "experienced discomfort".
- Safety: After two weeks of home use (minimal of two sexual intercourse encounters), no serious adverse events reported. Gynecological examinations detected only one instance of mottled irregular erythema of the inner thigh area at baseline, which was not present at the return visit. Concluded that the product did not cause irritation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Consumer Perception Study:
- 80.00% Excellent/Very Good for "Warms on Contact"
- 95.00% for "Does not feel cold when applied"
In-Home Consumer Use Study:
- 91.67% positive for "Warms on Contact"
- 85.01% positive for "Enhances Intimacy"
- 8.6% responded positively to "experienced discomfort"
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 Warming 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
APR 2 8 2004
510(k) SUMMARY
KO4034D
| Submitter | Personal Products Company Division of McNeil-PPC Inc.
199 Grandview Road
Skillman, New Jersey 08558-9418 |
|---------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person | Marylou P. Carlson
Mgr. Regulatory Affairs
(908) 904-3709 phone (908) 904-3748 fax |
| Date Prepared | February 02, 2004 |
| Proprietary Name | K-Y® Brand
WARMING UltraGEL Personal Lubricant |
| Common Name | Personal Lubricant |
| Classification Name | Condom: 21CFR § 884.5300 Product Code 85HIS
Patient Lubricant: 21CFR 880.6375 Product Code MMS |
| Predicate Device | K-Y® Brand Warming LIQUID Personal Lubricant |
Description of Device
K-Y® Brand WARMING UltraGEL is a non-sterile, clear, non-staining, non-greasy, water soluble gel for use as a personal lubricant. This product imparts a gentle warming sensation when applied to the genitalia. This product was designed to meet a customer need for an intimate lubricant that does not feel cold when applied. K-Y® Brand Warming UltraGEL can reduce friction during sexual intercourse thereby enhancing sexual intimacy. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards as defined by ASTM D 3492. K-Y® Brand WARMING UltraGel is not a contraceptive nor spermicide.
Intended Use
K-Y® Brand WARMING UltraGEL is intended as personal lubricant to be used with or without a condom.
The lubricous nature of this product helps to supplement the body's own natural lubricating fluids, thereby relieving friction to help enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal, anal or penile tissues for purpose of lubrication, and moisturization and is compatible with latex condoms. K-Y® Brand WARMING UltraGEL has the additional benefit of imparting a warming sensation when applied to the genital area.
Regulatory Status
Per 21CFR, 880.6375, Patient lubricant is defined as a Class I medical device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. Patient lubricants are not exempt from 510(k) clearance. Additionally when used as an accessory to a condom, (a Class II medical device) the lubricant is considered, by FDA, as a Class II Medical Device requiring 510(k) clearance.
1
510(k) SUMMARY (continued)
Technological Characteristics
The K-Y® Brand WARMING UltraGEL Personal Lubricant formula is proprietary. The product, has no exceptional technological characteristics and consists mainly of safe watersoluble GRAS status ingredients somewhat similar to other K-Y® Brand personal lubricants currently on the market.
Substantial Equivalence
K-Y® Brand WARMING UltraGEL Personal Lubricant has been shown, in laboratory tests, to be substantially equivalent to the currently marketed K-Y® Brand Warming LIQUID Personal Lubricant. Both devices have the same intended use with a variation in formula ingredients. The gentle warming technology is the special feature of the K-Y® Brand WARMING lubricant products.
Preclinical Testing of Formulation
Biocompatibility safety studies according to International Standard ISO 10993 and General Program Memorandum G95-1 on K-Y® Brand WARMING UltraGEL were conducted by an outside laboratory, in compliance with Good Laboratory Practices (GLPs). Results form these studies, demonstrated that K-Y® Brand WARMING UltraGEL was not considered to be a contact sensitizing agent, nor was it associated with systemic toxicity.
Human Clinical Testing
In a Human Repeated Insult Patch Test (Modified Draize Procedure), this product was compared to the currently marketed K-Y® Warming LIQUID for its potential for contact sensitization. Under the conditions of this test no evidence of contact sensitization was elicited.
A Consumer Perception Study evaluated both male and female subjects' experience of warmth with a single application of the product to their genitals during an on-site visit. Overall 80.00% of the participants rated the product as Excellent, Very Good for "Warms on Contact" and 95.00% for "Does not feel cold when applied" There were no adverse events observed or reported during the course of this study.
An In-Home Consumer Use Study was conducted to evaluate both consumer perception of warmth during sexual activity as well as the tolerability of the product through vulvo/vaginal speculum examination prior and post product use. Consented female subjects received gynecological examinations at baseline and following the last coital episode. The study was conducted in compliance with 21CFR Part 812 for Investigational Device Exemption and 21CFR Parts 50 and 56. Efficacy results for this study concluded that in 245 reported responses, 91.67% were positive for "Warms on Contact" and 85.01% were positive for "Enhances Intimacy" and 8.6% responded positively to "experienced discomfort". Additionally, after two weeks of home use, (with a minimal of two sexual intercourse encounters) there were no serious adverse events reported. Gynecological examinations detected only one instance of mottled irregular erythema of the inner thigh area at baseline, which was not present at the return visit. It was concluded that the product did not cause irritation as determined by final gynecological examination.
Preclinical and Clinical testing have provided scientific evidence that this product is safe for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing another, possibly representing care and support.
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) Carlson Manager, Regulatory Affairs Personal Products Company Division of McNeil-PPC, Inc. 199 Grandview Road SKILLMAN NJ 08558
Re: K040340
Trade/Device Name: K-Y® Brand Warming UltraGel Personal Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): February 6, 2004 Received (Date on orig SE ltr): February 11, 2004
Dear Ms. Carlson:
This letter corrects our substantially equivalent letter of April 28, 2004.
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
3
Page 2 -
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
4
Indications for Use
510(k) Number (if known): K040340
Device Name: K-Y® Brand Warming Ultra Gel
Indications For Use:
Personal Lubricant For vaginal/penile and condom application during sexual intimacy
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David H. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
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