(112 days)
K-Y® Brand Intrigue™
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.
No
The device is a personal lubricant intended for penile and vaginal application, not for treating a disease or condition.
No
Explanation: A diagnostic device is used to detect, diagnose, or monitor a medical condition. This device is a personal lubricant, which is used for enhancing sexual activity and not for diagnosing any medical condition.
No
The device description explicitly states it is a personal lubricant, which is a physical substance, 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 for penile and vaginal application compatible with latex condom." This describes a device used externally on the body to facilitate sexual activity, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The device is described as a "personal lubricant compatible with latex condom." This aligns with the intended use and does not suggest any diagnostic function.
- Lack of Diagnostic Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing any kind of diagnostic result.
- Performance Studies: The performance studies focus on compatibility with condoms, lubricity, and safety for use as a personal lubricant. These are not typical performance metrics for an IVD.
IVDs are devices used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. 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.
K-Y® Brand Intrigue™ Intense Warming Sensation is intended as a personal lubricant for penile and vaginal application compatible with latex condom.
Product codes
NUC
Device Description
This device is a personal lubricant compatible with latex condom.
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
The results from laboratory testing, pre-clinical evaluations and testing, and human use 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 pre-clinical evaluation and testing and human use data show that the proposed device is safe for use as a personal lubricant.
Key Metrics
Not Found
Predicate Device(s)
K-Y® Brand Intrigue™
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K 072360
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Section 5 - 510(k) Summary
| 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 | August 20, 2007 | |
| Trade Name | K-Y® Brand Intrigue™ Intense Warming Sensation | |
| Common Name | Personal Lubricant | |
| Classification
Name | NUC - Condom (21CFR 884.5300) | |
| Statement | This proposed device is substantially equivalent to currently marketed
predicate device, K-Y® Brand Intrigue™. | |
| Device
description | This device is a personal lubricant compatible with latex condom. | |
| Intended use | The intended use of this device is as a 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.
[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL] | |
1
510(k) Summary of Safety and Effectiveness (Continued) K 072 360 2/2
| 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, and
human use 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 pre-clinical evaluation and testing and 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. |
[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]
:
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 department's name around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nader Fotouhi, Ph.D. Manager, Regulatory Affairs McNeil-PPC, Inc. Consumer Health Products 199 Grandview Road SKILLMAN NJ 08558
Re: K072360
Trade Name: K-Y® Brand Intrigue™ Intense Warming Sensation Regulation Number: 21 CFR 884.5300 Regulation Name: Personal lubricant (accessory to a condom) Regulatory Class: II Product Code: NUC Dated: October 24, 2007 Received: October 29, 2007
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.
DEC 1 2 2007
3
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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.
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 - Indications for Use Statement
510(k) Number, if known
K 072360
Device Name: K-Y® Brand Intrigue™ Intense Warming Sensation
Indications for Use:
K-Y® Brand Intrigue™ Intense Warming Sensation is intended as a personal lubricant 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 | ✓ |
|---|---|---|
| ------------------ | ------------------------- | --- |
(Division
Division of
Radioio.
| 510(k) No. | K072360 |
|---|---|
| ------------ | --------- |