(150 days)
K-Y® Brand Touch Massage® 2-in-1 Tingling™ is intended as a body massage + personal IN-1 - Drain For penile and vaginal application compatible with latex condom.
This device is a body massage + personal lubricant compatible with latex condom that has been specifically developed produce a tingling sensation and a minty scent.
The provided text is a 510(k) Summary of Safety and Effectiveness for a personal lubricant and body massage product. It does not describe an AI medical device or a study involving acceptance criteria and device performance in the way a typical AI medical device submission would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through laboratory testing and pre-clinical evaluations.
Therefore, many of the requested categories (such as sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance, and ground truth type) are not applicable to this particular submission.
Here's a breakdown of the relevant information from the provided text according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Condom Compatibility (Technical Performance) | The proposed device is compatible with leading commercial brands of latex condoms. |
| Lubricity (Technical Performance) | Lubricity of the proposed device is comparable to the lubricity of the predicate device. |
| Safety of Ingredients (Pre-clinical/Formulation Review) | The ingredients used in the formulation are generally recognized as safe (GRAS). Pre-clinical evaluation of ingredients and testing of prototypes determined it is safe for use in personal lubricant products. |
| Non-sensitizing (Human RIPT - Repeat Insult Patch Test) | The human RIPT shows that the proposed device is non-sensitizing. |
| Equivalence to Predicate Device | The results from laboratory testing, pre-clinical evaluations and testing, human RIPT, and use tests show that the proposed device performs equivalently to the predicate device. The proposed device has the same technological characteristics, intended use, safety, and suitability characteristics as currently marketed condom compatible personal lubricants (specifically K-Y® Brand ULTRA GEL™). |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated as a single "test set" in the context of an AI device. The submission mentions "laboratory testing, pre-clinical evaluations and testing, human RIPT and use test." Specific sample sizes for each of these tests are not provided.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI device relying on expert-defined ground truth for image interpretation or diagnosis. The "ground truth" here is based on chemical and physical properties testing, and human safety testing.
4. Adjudication method for the test set:
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable, as this is not an AI medical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable, as this is not an AI medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" or basis for claims in this submission is derived from:
- Laboratory testing: For properties like condom compatibility and lubricity.
- Pre-clinical evaluations: For ingredient safety.
- Human Repeat Insult Patch Test (RIPT): For skin sensitization.
- Use test: Implied for overall performance and user experience, but details are not provided.
8. The sample size for the training set:
- Not applicable, as this is not an AI medical device.
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI medical device.
Summary of the Study (as described for this device):
The study to "prove the device meets acceptance criteria" involved a series of laboratory tests, pre-clinical evaluations, and human safety tests.
- Laboratory Testing: Demonstrated compatibility with leading commercial latex condoms and confirmed lubricity comparable to the predicate device.
- Pre-clinical Evaluations: Assessed the safety of the ingredients, noting they are "generally recognized as safe (GRAS)" and that prototype testing confirmed overall safety for use in personal lubricant products.
- Human RIPT (Repeat Insult Patch Test): Concluded that the device is non-sensitizing.
- Use Test: Mentioned generally as contributing to the equivalency demonstration.
The overall conclusion was that these tests collectively demonstrate the proposed device is substantially equivalent to the predicate device (K-Y® Brand ULTRA GEL™) in terms of technology, intended use, safety, and suitability characteristics.
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062535
Personal Product Company Division of McNeil - PPC, Inc.
(Appendix A)
Traditional 510(k)
510(k) Summary of Safety and Effectiveness
JAN 2 6 2007
| Submitter | Personal Products CompanyDivision of McNeil - PPC, Inc.199 Grandview RoadSkillman, NJ 08558 |
|---|---|
| Contact | Nader Fotouhi, Ph.D.Manager, Regulatory AffairsPersonal Product CompanyDivision of McNeil - PPC, Inc.199 Grandview RoadSkillman, NJ 08558Phone: (908) 904-3730Fax: (908) 904-3748 |
| Date | August 28, 2006 |
| Trade Name | K-Y® Brand Touch Massage® 2-in-1 Tingling™ |
| Common Name | Personal Lubricant |
| ClassificationName | HIS - Condom (21CFR 884.5300)MMS - Patient Lubricant (21CFR 880.6375) |
| Statement | This proposed device is substantially equivalent to currently marketedpredicate device, K-Y® Brand ULTRA GEL™ |
| Devicedescription | This device is a body massage + personal lubricant compatible with latexcondom that has been specifically developed produce a tingling sensation anda minty scent. |
[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]
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510(k) Summary of Safety and Effectiveness (Continued)
| Intended use | The intended use of this device is as a personal lubricant compatible withlatex condom. It may also be used as a body massage product. |
|---|---|
| Indicationsstatement | This device and predicate device have similar indications, by being applied tothe vaginal area or a condom in order to enhance comfort and ease of intimateactivity. |
| Technologicalcharacteristics | The proposed device has the same technological characteristics as currentlymarketed condom compatible personal lubricants. |
| Performancedata | The results from laboratory testing, pre-clinical evaluations and testing,human RIPT and use test show that the proposed device performsequivalently to the predicate device. Laboratory test results demonstrated thatthe proposed device is compatible with the leading commercial brands oflatex condoms. Lubricity of the proposed device is comparable to thelubricity of predicate device.The ingredients used in the formulation of the proposed device are generallyrecognized as safe (GRAS) and the pre-clinical evaluation of ingredients, aswell as, testing of prototypes of the proposed device have determined that it issafe for use in personal lubricant products. The human RIPT shows that theproposed device is non-sensitizing. |
| Conclusion | The proposed device is substantially equivalent to the currently marketedproducts in technology, intended use, safety, and suitability characteristics. |
. . . . . .
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Nader Fotouhi, Ph.D. Manager, Regulatory Affairs Personal Products Company Division of McNeil-PPC, Inc. 199 Grandview Road SKILLMAN NJ 08558-9418
JAN 2 6
Re: K062535
Trade/Device Name: K-Y® Brand Touch Massage® 2-in-1 Tingling™ Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulation Number: 21 CFR §880.6375 Regulation Name: Patient lubricant Regulatory Class: II
Product Code: NUC Dated: December 14, 2006 Received: December 18, 2006
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/11 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Three stars are arranged below the word "Centennial". The logo is surrounded by text that appears to be part of a circular border.
Protesting and Promoting Public Health
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Page 2 -
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy Chogdon
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
KO62535
Device Name: K-Y® Brand Touch Massage® 2-in-1 Tingling™
Indications for Use:
indications for Use.
K-Y® Brand Touch Massage® 2-in-1 Tingling™ is intended as a body massage + personal IN-1 - Drain For penile and vaginal application 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 B. hayes
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]
Page 42 of 47
§ 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.