(25 days)
The intended use of this device is as a personal lubricant compatible with latex condom.
K-Y® Brand Warming Liquid is intended as a personal lubricant compatible with latex condom.
This device is a condom compatible personal lubricant that has been specifically developed to produce a warming sensation when in contact with moist skin and mucosal membrane.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:
Device: K-Y® Brand Warming Liquid (Personal Lubricant)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Claim | Reported Device Performance |
|---|---|
| Condom compatibility | "The proposed device is compatible with the leading commercial brands of latex condoms." |
| Lubricity | "Lubricity of the proposed device is comparable to the lubricity of predicate device." |
| Safety (Ingredients) | "The ingredients used in the formulation... are generally recognized as safe (GRAS) and the pre-clinical evaluation... has determined that they are safe for use in personal lubricant products." |
| Warming claim | "The consumer use test has shown that the product meets its warming claim." |
| Non-sensitizing | "The human RIPT shows that the proposed device is non-sensitizing." |
| Overall substantial equivalence | "The proposed device is substantially equivalent to the currently marketed products in technology, intended use, safety, and suitability characteristics." |
2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for the "test set" in terms of specific numbers of condoms, consumers for the use test, or participants for the RIPT.
- Condom Compatibility: Tested with "leading commercial brands of latex condoms." (No specific number mentioned). Data provenance is from "laboratory testing."
- Lubricity: Compared to the "predicate device." Data provenance is from "laboratory testing."
- Warming Claim: Assessed via a "consumer use test." Data provenance is from human participants. No country of origin is specified, nor whether it was retrospective or prospective, but "consumer use test" typically implies prospective.
- Non-sensitizing: Assessed via "human RIPT" (Repeat Insult Patch Test). Data provenance is from human participants. No country of origin is specified, nor whether it was retrospective or prospective, but an RIPT is a prospective clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of medical device evaluation (e.g., radiologists interpreting images). The evaluations are based on:
- Laboratory testing for physical properties (condom compatibility, lubricity).
- Pre-clinical evaluations for ingredient safety.
- Consumer self-reporting for the warming claim (implied from "consumer use test").
- Medical/Toxicological experts for interpreting RIPT results (implied by "human RIPT shows that the proposed device is non-sensitizing," but no specific number or qualifications are provided).
4. Adjudication Method for the Test Set:
No specific adjudication method (like 2+1 or 3+1) is described for any of the tests. The results seem to be direct outcomes of laboratory measurements, pre-clinical assessments, and consumer feedback/RIPT results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices where multiple human readers evaluate cases with and without AI assistance to measure improvement in diagnostic performance. The K-Y® Brand Warming Liquid is a personal lubricant, not a diagnostic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is not an algorithm or AI-driven system. The "performance data" refers to the physical and biological characteristics of the lubricant itself.
7. The Type of Ground Truth Used:
The "ground truth" for this device's evaluation is based on a combination of:
- Objective Laboratory Data: For condom compatibility and lubricity.
- Pre-clinical Safety Data: For ingredient safety.
- Subjective Human Perception/Response: For the warming claim (consumer use test) and non-sensitization (RIPT, which has objective endpoints but measures a biological response in humans).
- Comparison to Predicate Device: Many of the claims are based on "comparable" or "equivalent" performance to legally marketed predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve a "training set" in the context of an AI/ML algorithm. The product formulation and testing are based on traditional chemical and biological safety/efficacy assessments.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an algorithm.
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Personal Product Company Division of McNeil - PPC, Inc.
(Appendix A)
Special 510(k) Device Modification
MAR 2 3 2007
510(k) Summary of Safety and Effectiveness Personal Products Company Submitter Division of McNeil - PPC, Inc. 199 Grandview Road Skillman, NJ 08558 Nader Fotouhi, Ph.D. Contact Manager, Regulatory Affairs J&J Consumer & Personal Products Worldwide 199 Grandview Road Skillman, NJ 08558 Phone: (908) 904-3730 Fax: (908) 904-3748 February 23, 2007 Date Trade Name K-Y® Brand Warming Liquid Common Name Personal Lubricant Classification NUC Condom (21CFR 884.5300) Name This modification of the device is substantially equivalent to currently Statement marketed predicate devices, K-Y® Brand Warming Liquid. Device This device is a condom compatible personal lubricant that has been description specifically developed to produce a warming sensation when in contact with moist skin and mucosal membrane.
[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]
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Personal Product Company Division of McNeil - PPC, Inc.
510(k) Summary of Safety and Effectiveness (Continued)
| Intended use | The intended use of this device is as a personal lubricant compatible with latex condom. |
|---|---|
| Indications statement | This device and predicate devices have similar indications, by being applied to the vaginal area or a condom in order to enhance comfort and ease of intimate activity. |
| Technological characteristics | The device has the same technological characteristics as the currently marketed condom compatible personal lubricants. |
| Performance data | The results from laboratory testing, pre-clinical evaluations, human RIPT and use test show that the proposed device performs equivalently to the predicate devices. Laboratory test results demonstrated that the proposed device is compatible with the leading commercial brands of latex condoms. Lubricity of the proposed device is comparable to the lubricity of predicate device. |
| The ingredients used in the formulation of the proposed device are generally recognized as safe (GRAS) and the pre-clinical evaluation of the ingredients has determined that they are safe for use in personal lubricant products. The consumer use test has shown that the product meets its warming claim. The human RIPT shows that the proposed device is non-sensitizing. | |
| Conclusion | The proposed device is substantially equivalent to the currently marketed products in technology, intended use, safety, and suitability characteristics. |
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of three human profiles facing right, arranged in a vertical stack. The profiles are black and silhouetted against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Nader Fotouhi, Ph.D. Manager, Regulatory Affairs J&J Consumer & Personal Products Worldwide Division of McNeil-PPC, Inc. 199 Grandview Road SKILLMAN NJ 08558-9418
Re: K070545
Trade/Device Name: K-Y0 Brand WARMING LIOUID Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 23, 2007 Received: February 26, 2007
Dear Dr. Fotouhi:
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.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "FDA Centennial" in the center. The letters "FDA" are prominently displayed in a bold, sans-serif font. Three stars are arranged below the word "Centennial". The logo is surrounded by text that follows the circular shape.
Protecting and Promoting Public Health
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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.
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
http://www.lda.gov/rcam/industry/support/index.html
Sincerely yours,
Nancy C. Broydon
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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Personal Product Company Division of McNeil - PPC, Inc.
(Appendix C)
Indications for Use Statement
510(k) Number, if known
K070 545
Device Name: K-Y® Brand WARMING LIQUID
Indications for Use: K-Y® Brand Warming Liquid is intended as a personal lubricant compatible with 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
OR Over-the-Counter Use
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number.
[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL ]
41
§ 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.