(150 days)
K-Y® Brand ULTRA GEL™
Not Found
No
The device description and performance studies focus on the physical properties and safety of a personal lubricant, with no mention of AI or ML technology.
No.
The intended use describes it as a body massage and personal lubricant, which are not therapeutic functions.
No
The intended use describes the device as a personal lubricant and body massage product for penile and vaginal application, not for diagnosing a medical condition.
No
The device description clearly states it is a body massage + personal lubricant, which 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 body massage and personal lubrication for penile and vaginal application. This is a topical application for physical interaction, not for testing samples of human origin in vitro (outside the body).
- Device Description: The description confirms it's a body massage and personal lubricant.
- 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 condition.
IVDs are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of this device is as a personal lubricant compatible with latex condom. It may also be used as a body massage product.
This device and predicate device have similar indications, by being applied to the vaginal area or a condom in order to enhance comfort and ease of intimate activity.
K-Y® Brand Touch Massage® 2-in-1 Tingling™ is intended as a body massage + personal IN-1 - Drain For penile and vaginal application compatible with latex condom.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
This device is a body massage + personal lubricant compatible with latex condom that has been specifically developed produce a tingling sensation and a minty scent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal area, penile and 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)
The results from laboratory testing, pre-clinical evaluations and testing, human RIPT and use test show that the proposed device performs equivalently to the predicate device. Laboratory test results demonstrated that the proposed device is compatible with the leading commercial brands of latex condoms. Lubricity of the proposed device is comparable to the lubricity of predicate device.
The ingredients used in the formulation of the proposed device are generally recognized as safe (GRAS) and the pre-clinical evaluation of ingredients, as well as, testing of prototypes of the proposed device have determined that it is safe for use in personal lubricant products. The human RIPT shows that the proposed device is non-sensitizing.
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 ULTRA GEL™
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
062535
Personal Product Company Division of McNeil - PPC, Inc.
(Appendix A)
Traditional 510(k)
510(k) Summary of Safety and Effectiveness
JAN 2 6 2007
| Submitter | Personal Products Company
Division of McNeil - PPC, Inc.
199 Grandview Road
Skillman, NJ 08558 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Nader Fotouhi, Ph.D.
Manager, Regulatory Affairs
Personal Product Company
Division of McNeil - PPC, Inc.
199 Grandview Road
Skillman, NJ 08558
Phone: (908) 904-3730
Fax: (908) 904-3748 |
| Date | August 28, 2006 |
| Trade Name | K-Y® Brand Touch Massage® 2-in-1 Tingling™ |
| Common Name | Personal Lubricant |
| Classification
Name | HIS - Condom (21CFR 884.5300)
MMS - Patient Lubricant (21CFR 880.6375) |
| Statement | This proposed device is substantially equivalent to currently marketed
predicate device, K-Y® Brand ULTRA GEL™ |
| Device
description | This device is a body massage + personal lubricant compatible with latex
condom that has been specifically developed produce a tingling sensation and
a minty scent. |
[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]
1
510(k) Summary of Safety and Effectiveness (Continued)
| Intended use | The intended use of this device is as a personal lubricant compatible with
latex condom. It may also be used as a body massage product. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
statement | This device and predicate device have similar indications, by being applied to
the vaginal area or a condom in order to enhance comfort and ease of intimate
activity. |
| Technological
characteristics | The proposed device has the same technological characteristics as currently
marketed condom compatible personal lubricants. |
| Performance
data | The results from laboratory testing, pre-clinical evaluations and testing,
human RIPT and use test show that the proposed device performs
equivalently to the predicate device. Laboratory test results demonstrated that
the proposed device is compatible with the leading commercial brands of
latex condoms. Lubricity of the proposed device is comparable to the
lubricity of predicate device.
The ingredients used in the formulation of the proposed device are generally
recognized as safe (GRAS) and the pre-clinical evaluation of ingredients, as
well as, testing of prototypes of the proposed device have determined that it is
safe for use in personal lubricant products. The human RIPT shows that the
proposed device is non-sensitizing. |
| Conclusion | The proposed device is substantially equivalent to the currently marketed
products in technology, intended use, safety, and suitability characteristics. |
. . . . . .
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 stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Nader Fotouhi, Ph.D. Manager, Regulatory Affairs Personal Products Company Division of McNeil-PPC, Inc. 199 Grandview Road SKILLMAN NJ 08558-9418
JAN 2 6
Re: K062535
Trade/Device Name: K-Y® Brand Touch Massage® 2-in-1 Tingling™ Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulation Number: 21 CFR §880.6375 Regulation Name: Patient lubricant Regulatory Class: II
Product Code: NUC Dated: December 14, 2006 Received: December 18, 2006
Dear Dr. Fotouhi:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/11 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Three stars are arranged below the word "Centennial". The logo is surrounded by text that appears to be part of a circular border.
Protesting and Promoting Public Health
3
Page 2 -
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Personal Product Company Division of McNeil - PPC, Inc.
(Appendix C)
Indications for Use Statement
510(k) Number, if known
KO62535
Device Name: K-Y® Brand Touch Massage® 2-in-1 Tingling™
Indications for Use:
indications for Use.
K-Y® Brand Touch Massage® 2-in-1 Tingling™ is intended as a body massage + personal IN-1 - Drain For penile and vaginal application compatible with latex condom.
(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 _
David B. hayes
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]
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