(147 days)
Personal Lubricating Gel is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms.
Personal Lubricating Gel is a non-sterile, clear, non-staining, non-greasy, 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.
The provided document is a 510(k) Premarket Notification for a Personal Lubricating Gel. It details the device's substantial equivalence to a predicate device, its intended use, and non-clinical performance data. However, the document does NOT contain information about specific acceptance criteria related to a study that proves the device meets those criteria, nor does it describe a study involving a "device" in the context of an AI/ML algorithm or diagnostic tool.
The document focuses on:
- Substantial Equivalence: Comparing the new lubricating gel to an existing, legally marketed predicate device (K-Y Ultra Gel Personal Lubricant) based on features, chemical properties, ingredients, and perceptual qualities.
- Non-Clinical Studies: Stability and preservative effectiveness of the new lubricating gel.
- Intended Use: "designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms."
Therefore, I cannot provide the requested table and information as it pertains to AI/ML or diagnostic device studies. The document describes a medical device (personal lubricant) and its regulatory submission, which does not typically involve the types of acceptance criteria, test sets, ground truth establishment, or multi-reader studies you've asked about for AI/ML performance.
Specifically, the information requested below is not present in the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample sized used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
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510(k) Premarket Notification Qualis, Inc. Personal Lubricating Gel
Page 1 of 2
510 (k) Summary of Information Respecting Safety and 9. Effectiveness
- Legally Marketed Device. A.
Qualis Claims substantial equivalence to K-Y Ultra Gel Personal Lubricant (K020827), currently in commercial distribution by Personal Products Company Division of McNeil-PPC inc..
SEP 2 4 2004
-
Device Description. B.
Personal Lubricating Gel is a non-sterile, clear, non-staining, non-greasy, 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 Lubricating 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 Lubricating Gel and the Predicate Device K-Y Brand Ultra Gel Personal Lubricant is provided in Table 1. -
Performance Data E.
Non-Clinical Studies. -
- Stability.
Personal Lubricating Gel has successfully passed 90 day accelerated stability.
- Stability.
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510(k) Premarket Notification Qualis, Inc. Personal Lubricating Gel
Page 2 of 2
-
Preservative Effectiveness. 2.
An anti-microbial preservative challenge has been completed for Personal Lubricating Gel. The Preservative Effectiveness Study Report is in Attachment E. -
Comparison with Predicate Device. 3.
Personal Lubricating Gel was compared to K-Y Brand 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 ACTS comparison Report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with a circle around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle. The caduceus is composed of three curved lines that resemble a stylized bird or wing.
Public Health Service
FEB 2 4 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Mike Peterson Quality Assurance Manager Qualis, Inc. 4600 Park Avenue DES MOINES IA 50321
Re: K041129 Trade/Device Name: Personal Lubricating Gel Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): August 26, 2004 Received (Date on orig SE Itr): August 26, 2004
Dear Mr. Peterson:
This letter corrects our substantially equivalent letter of September 24, 2004.
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. 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
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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
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Indications for Use
510(k) Number (if known):
Device Name: Personal Lubricating Gel
Indications For Use: Personal Lubricating Gel is designed to enhance the ease and comfort indications Por 300. I 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)
David B. Sygman
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number.
Page 1 of 1
§ 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.