(147 days)
K-Y® Brand Touch Massage TM 2-in-1 Warming® body massage + Personal lubricant.
Not Found
No
The document describes a personal lubricant and massage crème and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is described as a personal lubricant for enhancing comfort during sexual activity and supplementing natural lubrication, and as a non-therapeutic body massage product. Its intended use focuses on comfort and function rather than treating or preventing disease.
No
The device is described as a personal lubricant and body massage creme, intended to enhance comfort during sexual activity and provide lubrication. Its function is to facilitate rather than diagnose.
No
The device description clearly states it is a "personal lubricant" and "body massage" product, which are physical substances, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "personal lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This is a topical application for physical comfort and lubrication, not for diagnosing a condition or analyzing a sample from the body.
- Device Description: The description reinforces this by stating it's for "non-therapeutic body massage and personal lubricant."
- Lack of Diagnostic Function: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on lubricity, condom compatibility, and safety for topical use, not on diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of this device is as a non-therapeutic body massage and personal lubricant compatible with latex condom.
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. They may also be used as a non-therapeutic body massage product.
Interections of 2-in-1 Massage Crème™ is a personal lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's in ural. lubrication.
This product is compatible with latex condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
This device is developed for non-therapeutic body massage and personal lubricant compatible with latex condom that imparts a warming sensation upon the skin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal area
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, and human use show that the proposed device performs equivalently to the predicate devices. Laboratory test results demonstrated that the proposed device is compatible with the leading commercial brands of latex condoms and provides lubricity for use as a personal lubricant. The pre-clinical evaluation and testing as well as human use data show that the proposed device is safe for use as a personal lubricant.
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 Touch Massage TM 2-in-1 Warming® body massage + 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
J&J Healthcare Products, Division of McNeil - PPC, Inc.
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1
:
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K 081236
Traditional 510(k)
| Submitter | Johnson & Johnson Healthcare Products, Division of McNeil - PPC, Inc.
199 Grandview Road
Skillman, NJ 08558 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Nader Fotouhi, Ph.D.
Manager, Regulatory Affairs
J&J Consumer & Personal Products Worldwide
199 Grandview Road
Skillman, NJ 08558
Phone: (908) 904-3730
Fax: (908) 904-3748 |
| Date | April 29, 2008 |
| Trade Name | K-Y® Brand IntrigueTM 2-in-1 Massage CrèmeTM |
| Common Name | Personal Lubricant |
| Classification
Name | NUC - condom compatible personal lubricant |
| Statement | This proposed device is substantially equivalent to predicate device, K-Y®
Brand Touch MassageTM 2-in-1 Warming® body massage + Personal lubricant. |
| Device
description | This device is developed for non-therapeutic body massage and personal
lubricant compatible with latex condom that imparts a warming sensation
upon the skin. |
| Intended use | The intended use of this device is as a non-therapeutic body massage and
personal lubricant compatible with latex condom. |
| 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. They may also be used as a non-therapeutic body massage product. |
| 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, and
human use show that the proposed device performs equivalently to the
predicate devices. Laboratory test results demonstrated that the proposed
device is compatible with the leading commercial brands of latex condoms
and provides lubricity for use as a personal lubricant.
The pre-clinical evaluation and testing as well as human use data show that
the proposed device is safe for use as a personal lubricant. |
| Conclusion | The proposed device is substantially equivalent to the currently marketed
products in technology, intended use, safety, and suitability characteristics. |
SEP 2 5 2008
[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]
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·
510(k) Summary of Safety and Effectiveness (Continued)
[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2008
Nader Fotouhi, Ph.D. Manager, Regulatory Affairs McNeil-PPC, Inc. Consumer Healthcare Products 199 Grandview Road SKILLMAN NJ 08558
Re: K081236
Trade Name: K-Y® Brand Intrigue™ 2-in-1 Massage Crème Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 17, 2008 Received: September 18, 2008
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 (PMA), 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.
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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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
loque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Consumer Healthcare Products Division of McNeil - PPC, Inc.
Section 4 - Indications for Use Statement
510(k) Number, if known
Device Name: K-Y® Brand Intrigue™ 2-in-1 Massage Crème™
Indications for Use:
Interections of 2-in-1 Massage Crème™ is a personal lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's in ural. lubrication.
This product is compatible with latex condoms.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
Hulu Remer
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K081236