(296 days)
No
The 510(k) summary describes a simple personal lubricant and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The primary intended use of Lubrease is to moisturize and lubricate for enhancing comfort during sexual activity, which is not considered a therapeutic function. Therapeutic devices are typically used for diagnosis, cure, mitigation, treatment, or prevention of disease.
No
Explanation: The device is a personal lubricant intended to moisturize and lubricate for enhancing intimate sexual activity. Its stated purpose is not to diagnose any condition or disease.
No
The device description clearly states it is a physical product (lubricating gel and applicator) and does not mention any software component.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of Lubrease is for personal lubrication during sexual activity. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a lubricant gel in an applicator. It does not contain reagents or components designed to detect or measure substances in biological samples.
- Lack of Diagnostic Information: The document does not mention any diagnostic purpose, analysis of biological samples, or providing information about a patient's health status.
IVDs are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. Lubrease does not fit this description.
N/A
Intended Use / Indications for Use
Lubrease is intended to be used for immediate lubrication of vaginal dryness and relief from intimate discomfort. It is intended for discreet vaginal use as a moisturiser and lubricant immediately prior to sexual intercourse.
Lubrease is a personal lubricant for vaginal application, intended to moisturise and lubricate to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
This product is NOT compatible with latex or synthetic condoms
Product codes
NUC
Device Description
Lubrease is a single use applicator containing 1.6ml water based lubricating gel. The applicator is designed to lock after the gel has been applied to prevent inadvertent re-use of the applicator.
The Lubrease gel is presented in a patented single use applicator. The formulation of the gel is proprietary but it consists of 95% water and the other ingredients are similar to those of the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Curves Limited has not performed any clinical trials on Lubrease and there are consequently no financial implications to be considered in accordance with 21 CFR 54.
Key Metrics
Not Found
Predicate Device(s)
Aquagel (K951431), Rephresh (K021737)
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
510(k) SUMMARY
FEB 2 4 2010
| Applicant: | Curves Limited
2 High Road
Eastcote
Pinner
Middlesex
HA5 2EW |
| ------------ | ----------------------------------------------------------------------------- |
|---|
Contact name: Nilufer Smith Managing Director Tel: +44 (0) 20 7371 6062
- Date prepared: 20th March 2009
- Proprietary name: Lubrease Female Lubricant
Common name: Personal lubricant
Classification name: Condom Regulation Number (21 CFR 884.5300) Procode (NUC)
Predicate devices:
Lubrease is considered to be substantially equivalent to Aquagel (K951431) and Rephresh (K021737).
Description of device:
Lubrease is a single use applicator containing 1.6ml water based lubricating gel. The applicator is designed to lock after the gel has been applied to prevent inadvertent re-use of the applicator.
Indications for Use:
Lubrease is intended to be used for immediate lubrication of vaginal dryness and relief from intimate discomfort. It is intended for discreet vaginal use as a moisturiser and lubricant immediately prior to sexual intercourse.
Technological characteristics:
The Lubrease gel is presented in a patented single use applicator. The formulation of the gel is proprietary but it consists of 95% water and the other ingredients are similar to those of the predicate devices.
1
8. Financial statement:
.
Curves Limited has not performed any clinical trials on Lubrease and there are consequently no financial implications to be considered in accordance with 21 CFR 54.
9. Submission statement:
I, Nilufer Smith, of Curves Limited, 2 High Road, Eastcote, Pinner, Middlesex, HA5 2EW, confirm that I believe, to the best of my knowledge, that all data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted.
Signed: Nilufer Smith milli
Date: 22nd February 2010
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a sphere. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
FEB 2 4 2014
Mr. Nilufer Smith Managing Director Curves Limited 2 High Road Eastcote Pinner, Middlesex HAS 2EW UNITED KINGDOM
Re: K091298 Trade/Device Name: Lubrease Female Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): February 10, 2010 Received (Date on orig SE ltr): February 12, 2010
Dear Mr. Smith.
This letter corrects our substantially equivalent letter of February 24, 2010.
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. Iisting 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): K091298
Device Name: Lubrease Female Lubricant
Indications for Use:
Lubrease is a personal lubricant for vaginal application, intended to moisturise and lubricate to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
This product is NOT compatible with latex or synthetic condoms
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use V (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hels Remen
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(Division Sign-Off) Division of Reproductive, Abdomina Radiological Devices 510(k) Number