(45 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a personal lubricant, with no mention of AI or ML.
No
The device is described as a personal lubricant designed to enhance comfort during intimate activity, which falls under the category of a consumer product rather than a medical device intended for treating or preventing disease.
No
Explanation: The device is described as a personal lubricant designed to enhance comfort during intimate activity, not to diagnose any condition.
No
The device description clearly states it is a "liquid gel," indicating 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 "to enhance the ease and comfort of intimate activity and is compatible with latex condoms." This describes a personal lubricant for external use during sexual activity.
- Device Description: The description reinforces this, calling it a "personal lubricant" used "during intimate sexual activity."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are specifically designed to perform tests on biological samples to gain diagnostic or health-related information. This personal warming gel does not fit that description.
N/A
Intended Use / Indications for Use
Personal Warming Gel is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms
Product codes (comma separated list FDA assigned to the subject device)
85 NUC
Device Description
Personal Warming Gel is a non-sterile, clear, non-staining, nongreasy, liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity.
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)
Non-Clinical Studies.
Stability.
Personal Warming Gel has successfully passed 90 day accelerated stability.
Preservative Effectiveness.
An anti-microbial preservative challenge has been completed for Personal Warming Gel.
Comparison with Predicate Device.
Personal Warming Gel was compared to K-Y Brand Warming Ultra Gel Personal Lubricant on the basis of perceptual qualities, physical and chemical properties, ingredients list review, label claims, and packaging. The result of this review was an acceptable comparison.
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.
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
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510 (k) Summary of Information Respecting Safety and 9. Effectiveness
-
Legally Marketed Device. A.
Qualis claims substantial equivalence to K-Y Warming Ultra Gel Personal Lubricant (K040340), currently in commercial distribution by Personal Products Company Division of McNeil-PPC inc.. -
Device Description. B.
Personal Warming Gel is a non-sterile, clear, non-staining, nongreasy, liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity. -
C. Intended Use.
Personal Warming Gel is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms. -
Comparison with Predicate Device. D.
A summary comparison of the features of Personal Warming Gel and the Predicate Device K-Y Brand Warming Ultra Gel Personal Lubricant is provided in Table 1. -
E. Performance Data
Non-Clinical Studies. -
Stability. 1.
Personal Warming Gel has successfully passed 90 day accelerated stability.
1
510(k) Premarket Notification Qualis, Inc. Personal Warming Gel
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-
Preservative Effectiveness. 2.
An anti-microbial preservative challenge has been completed for Personal Warming Gel. The Preservative Effectiveness Study Report is in Attachment E. -
Comparison with Predicate Device. 3.
Personal Warming Gel was compared to K-Y Brand Warming Ultra Gel Personal Lubricant on the basis of perceptual qualities, physical and chemical properties, ingredients list review, label claims, and packaging. The result of this review was an acceptable comparison. See Attachment B for the Shuster comparison Report.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2005
Mr. Mike Peterson Quality Assurance Manager Qualis Inc. 4600 Park Ave DESMOINES IA 50321
Re: K050211 Trade/Device Name: Personal Warming Gel Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 NUC Dated: January 18, 2005 Received: January 31, 2005
Dear Mr. Peterson:
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 the enolosate, to regally manthly of the Medical Device Amendments, or to devices that have been ready 20, 1770, 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 do not require upproval or wordsions of the Act. The general controls provisions of the Act device, subjor to the generation, listing of devices, good manufacturing practice, fabeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket it your do roo to subject to such additional controls. Existing major regulations affecting your Apployally, it they of salyes to at Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA device our of tound mouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I Rase be advised that i Dr rion that your device complies with other requirements of the Act or any FDA has made a decemination and your would be other Federal agencies. You must comply with all the If coclar statues and regulation but not limited to registration and listing (21 CFR Part 807); labeling ACT STEQuirements, medading, but not mixted is and (21 CFR Part 801); 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) i mis letter will anow you to begin maneting of substantial equivalence of your device to a legally prematication. The PDA mailing of Cassification 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 If you desire spective auvice for your cerres on other 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 Also, please note the regulation emiliou, "Alsociation on your responsibilities under the Act from the 807.97). You may obtain other gelleral mional 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. Hodgdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Personal Warming Gel
Indications For Use: Personal Warming Gel is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ × (21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
ive, Abdominal, Division of Reproduct and Radiological Devices 510(k) Number
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