(16 days)
Not Found
Not Found
No
The 510(k) summary describes a personal lubricant and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as a personal lubricant intended to supplement natural lubrication and enhance comfort during sexual activity. It is explicitly stated as not a contraceptive or spermicide. Its function addresses comfort and ease, not the treatment or prevention of a medical condition, which are characteristic of therapeutic devices.
No
Explanation: The intended use of this device is as a personal lubricant to enhance intimate sexual activity, not to diagnose any condition.
No
The device description clearly states it is a "homogenous blend of fluids" and a "liquid gel," indicating it 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 clearly stated as a personal lubricant to enhance intimate sexual activity. This is a topical application for physical comfort and ease, not for diagnosing a condition or analyzing a sample from the human body.
- Device Description: The description focuses on the physical properties of the lubricant and its compatibility with condoms. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, "The Art of Intimacy Response" ™ Liquid Personal lubricant falls under the category of a medical device, but specifically a personal lubricant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Art of Intimacy Response ™ Liquid Personal lubricant is principally intended as personal lubricant to supplement the body's natural lubricating fluids, and to enhance the ease and comfort of intimate sexual activity with or without a latex condom.
Product codes
NUC
Device Description
The Art of Intimacy Response™ is a horners on fluids. It is specifically formulated to be a clear, supplement the body s own hatural lubriscosity liquid gel and is compatible for use with or non-intalling, non-starting, mgn-hectivity as evidenced by condom compatibility williout a latex condom daning intimate contraceptive or spermicide, nor does it contain any such component
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 product was tested by independent laboratories for condom compatibility, biocompatibility and preservative enectiveness. Thia results from the identified industry standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
0
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K05/668
Page 1 of 2
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) [21 CFR 807.87(H)]
The Art of Intimacy Response ™ Personal Lubricant
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe In accordance with the Food and Drug Auministration new York, this information Medical Devices ACt of 1990 and in officitions with of Intimacy Response ™ Personal Lubricant
| Submitted By:
Date:
Contact Person: | Goodmark USA, Inc.
March 8, 2005
Boston Talbert
Project Manager |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | The Art of Intimacy Response ™ |
| Common Name: | Personal Lubricant |
| Classification Name: | The General Hospital and Personal Use Device section of
the General Medical Devices Panel within the FDA's
Center for Medical Device & Radiological Health considers
patient lubricants (21 CFR §880.6375, Class I) to be
Class II devices when promoted as being compatible for
use with condoms (21 CFR §884.5300) |
| Intended Use: | The Art of Intimacy Response ™ Liquid Personal lubricant
is principally intended as personal lubricant to supplement
the body's natural lubricating fluids, and to enhance the
ease and comfort of intimate sexual activity with or without
a latex condom. |
Device Description
Device Description The Art of millings of Rosponso - 16 a horners on fluids. It is specifically formulated to be a clear, supplement the body s own hatural lubriscosity liquid gel and is compatible for use with or non-intalling, non-starting, mgn-hectivity as evidenced by condom compatibility williout a latex condom daning intimate contraceptive or spermicide, nor does it contain any such component
Summary of Technological Characteristics
The Art of Intimacy Response ™ Liquid Personal lubricant contains ingredients that are The Art of Intimaty Acoponos - used in the manufacture of the predicate devices. The ingredients meet specifications defined in the United State Pharmacopoeia (USP) or National ingrediction most openized as safe for their intended use" (21 CFR 172.515).
1
Kosibos
Page 2 of 2
The product was tested by independent laboratories for condom compatibility, biocompatibility The product was tested by independent laboratorious for only the devices and preservative enectiveness. Thia results from the identified industry standards.
Substantial Equivalence Information:
Substantial Equivalence Information:
The intended use, ingredients, and application of the proposed device are substantially The intended use, ingledients, and application of the proposatial equivalence, the Art of equivalent to those of the predicate device. "In acteming as ally marketed device to which the Sponsor claims substantial equivalence.
2
Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird in flight, with three curved lines representing its body and wings. The word "DEPARTMENT" is written vertically along the left side of the logo, following the curve of the bird's wing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL = 8 2005
Goodmark USA, Inc. c/o Mr. Mark Job Regulatory Technology Services, Inc. 1394 25th Street, NW BUFFALO MN 55313
Re: K051668
Trade/Device Name: The Art of Intimacy Response™ Personal Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 18, 2005 ري جي جي Received: June 22, 2005
Dear Mr. Job:
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.
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.
3
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.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" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification The Art of Intimacy Response ™ Liquid Personal Lubricant
Indications For Use
Page _________________________________________________________________________________________________________________________________________________________________________ of 1 510(k) Number (if known):
Device Name: The Art of Intimacy Response™ Personal Lubricant
Indications for Use:
"The Art of Intimacy Response" ™ Liquid Personal lubricant is principally intended as personal lubricant to supplement the body's natural lubricating fluids, and to enhance the ease and comfort of intimate sexual activity with or without a 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 (Per 21 CFR 801.109) Over-The Counter Use
(Optional Format 1-2-96)
David W. Lynn
(Division Sign-Off)
Division of Reproductive, Abdomi
and Radiological Devices
510(k) Number
Ko