(45 days)
Personal Warming Jelly is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms.
Personal Warming Jelly is a non-sterile, clear, non-staining, I ersonal walling Jelly used as a personal lubricant. This non groups, inquily lubricous and may be used with or without a latex condom during intimate sexual activity.
The provided text describes a 510(k) premarket notification for "Personal Warming Jelly," a personal lubricant. The submission focuses on demonstrating substantial equivalence to a predicate device, K-Y Brand Warming Jelly Personal Lubricant, rather than establishing de novo performance criteria against a disease or condition. Therefore, many of the typical elements of acceptance criteria and study design for medical devices that involve clinical performance or diagnostic accuracy are not applicable here.
This submission is for a Class II medical device (Condom, Product Code: 85 NUC), which aligns with the general controls and special controls applied to such devices. The performance data presented is primarily non-clinical, focusing on stability and preservative effectiveness, as well as a direct comparison to the predicate device’s physical and chemical properties and warming loss.
Here's a breakdown based on the provided text, indicating where information is not applicable for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Stability | Successful completion of accelerated stability testing. | "Personal Warming Jelly has successfully passed 90 day accelerated stability." |
| Preservative Effectiveness | Demonstrated anti-microbial preservative challenge effectiveness. | "An anti-microbial preservative challenge has been completed on Qualis Personal Warming Jelly. The Preservative Effectiveness Study Report is in Attachment E." (Implied successful given the substantial equivalence determination) |
| Comparison to Predicate Device | Acceptable comparison to K-Y Brand Warming Jelly Personal Lubricant based on warming loss, physical/chemical properties, ingredients, label claims, and packaging. | "The result of this review was an acceptable comparison." |
| Intended Use | Designed to enhance the ease and comfort of intimate activity and compatible with latex condoms. | Verified as substantially equivalent to a device with the same intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. For non-clinical studies (stability, preservative challenge), the "sample size" would refer to the number of batches or units tested, which is not specified in this summary. For the comparative analysis, this was a review of characteristics rather than a test on a specific patient population.
- Data Provenance: Not applicable in the context of clinical data (e.g., country of origin, retrospective/prospective). The studies are non-clinical (laboratory-based).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This submission does not involve diagnostic accuracy or interpretation of medical images/data by experts. Ground truth, in this context, refers to objective laboratory measurements and comparisons.
4. Adjudication Method for the Test Set
- Not applicable. There is no expert adjudication process for this type of non-clinical product comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for diagnostic devices interpreting medical images or data. This is a personal lubricant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an AI-powered algorithm or diagnostic device.
7. The Type of Ground Truth Used
- For Stability: Laboratory measurements of physical, chemical, and functional properties over time.
- For Preservative Effectiveness: Laboratory challenge tests using specified microorganisms and methods.
- For Comparison with Predicate Device: Direct comparison of product specifications, physical and chemical properties, ingredients lists, label claims, and packaging characteristics against the established predicate device's information.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. (See #8)
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (which are fundamentally criteria for demonstrating substantial equivalence to a legally marketed predicate device) consists of:
- Non-Clinical Stability Study: "Personal Warming Jelly has successfully passed 90 day accelerated stability." This demonstrates the product maintains its properties and safety over a simulated shelf life.
- Preservative Effectiveness Study: An "anti-microbial preservative challenge has been completed on Qualis Personal Warming Jelly." This study, detailed in Attachment E (not provided in the excerpt), ascertains the product's ability to resist microbial contamination during storage and use.
- Comparison Report (Shuster comparison Report in Attachment B): This report outlines a direct comparison of Personal Warming Jelly to the predicate device (K-Y Brand Warming Jelly Personal Lubricant). The comparison was based on:
- Warming loss characteristics.
- Physical and chemical properties.
- Ingredients list review.
- Label claims.
- Packaging.
The outcome of these studies, particularly the comparison report, led to the conclusion that "The result of this review was an acceptable comparison," which substantiated the claim of equivalence. The FDA, in its decision letter, concurred with this assessment, stating they "determined the device is substantially equivalent... for the indications for use stated above."
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K050212 MAR 17 2005
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 Warming Jelly Qualis claims cant (K040164), currently in commercial I Crsonal Lucrican on Products Company Division of McNeil-PPC inc .. -
Device Description. B.
Personal Warming Jelly is a non-sterile, clear, non-staining, I ersonal walling Jelly used as a personal lubricant. This non groups, inquily lubricous and may be used with or without a latex condom during intimate sexual activity. -
Intended Use. C.
Personal Warming Jelly 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 Jelly and the Predicate Device K-Y Brand Warming Jelly Personal Lubricant is provided in Table 1. -
Performance Data E.
Non-Clinical Studies. -
Stability. 1.
Personal Warming Jelly has successfully passed 90 day accelerated stability.
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510(k) Premarket Notification Qualis, Inc. Personal Warming Jelly
Kogawa 212
Page 242
Preservative Effectiveness. 2.
An anti-microbial preservative challenge has been An and International Warming Jelly. The Preservative Effectiveness Study Report is in Attachment E.
- Comparison with Predicate Device. 3.
Personal Warming Jelly was compared to K-Y Brand Warming Jelly Personal Lubricant on the basis of warming loss, 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 17 2005
Mr. Mike Peterson Quality Assurance Manager Oualis Inc. 4600 Park Ave DESMOINES IA 50321
Re: K050212 Trade/Device Name: Personal Warming Jelly 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 we have levice your becared your becally equivalent (for the indications for use stated in above and nave decemined the ad predicate devices marketed in interstate commerce prior to the enclosure) to regary marketed predical Device Amendments, or to devices that have been May 26, 1770, the charantenedato of the Federal Food, Drug, and Cosmetic Act (Act) that recrassified in accordance with the proval application (PMA). You may, therefore, market the do not require approval of a premanel approvisions of the Act. The general controls provisions of the Act device, subject to the general controls prove, 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 11 your device is classified (600 above) and controls. Existing major regulations affecting your Apploval), It ifay of subject to such aceral Regulations, Title 21, Parts 800 to 898. In addition, FDA ucvice can be round in the coments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Flease oc advised mar 1 27 i in that your device complies with other requirements of the Act or any FDA has made a decemination and your rederal agencies. You must comply with all the I cuean statues and regulations as a limited to registration and listing (21 CFR Part 807); labeling ACL S requirements, morading, but not a more a cause as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your artice of your device of your device of your device to a legally
premarket notification. The FDA finding of substantial eq premarket notification. The FDA Inting of substantial of 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 specific advice for your device on our labering regarances.
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 Also, please note the regulation entitled, "Misoranians" of tressnonibilities under the Act from the 807.97). You may obtain other general information on your respections of its toll-free number (800)
Division of Small Manufacturers, International and Consumer Assistance at DIVISion of (301) 443-6597 or at its Internet address 058-2041 or (901) v/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
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Indications for Use
510(k) Number (if known): Ko50212
Device Name: Personal Warming Jelly
Indications For Use: Personal Warming Jelly is designed to enhance the ease and comfort mulcations For SSC. Forechants of Scottan Processor of intimate activity and imm
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)
Division of Revenductive, Abde and Radiological Devices minal, 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.