(147 days)
Interections of 2-in-1 Massage Crème™ is a personal lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's in ural. lubrication. This product is compatible with latex condoms.
This device is developed for non-therapeutic body massage and personal lubricant compatible with latex condom that imparts a warming sensation upon the skin.
The provided document is a 510(k) premarket notification for a medical device: K-Y® Brand IntrigueTM 2-in-1 Massage CrèmeTM. This is a personal lubricant, and the submission primarily focuses on demonstrating its substantial equivalence to a predicate device, K-Y® Brand Touch MassageTM 2-in-1 Warming® body massage + Personal lubricant.
The information provided does not describe a study involving an AI or algorithm-driven device. Instead, it outlines the regulatory submission for a physical personal lubricant. Therefore, I cannot provide details on acceptance criteria and a study that proves an AI device meets these criteria based on the input text.
However, I can extract information related to the performance data presented for this physical device, which addresses some aspects of your request, even though it's not for an AI.
Here's the relevant information based on the provided text, structured to align with your request where applicable, but noting its non-relevance for AI:
1. A table of acceptance criteria and the reported device performance
Since this is not an AI device, there are no specific quantitative acceptance criteria like sensitivity, specificity, or AUC that would typically be reported for an AI. Instead, the "acceptance criteria" are implied by the safety and performance standards for personal lubricants, particularly condom compatibility and lubricity.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compatibility with leading commercial brands of latex condoms | "Laboratory test results demonstrated that the proposed device is compatible with the leading commercial brands of latex condoms." |
| Provides lubricity for use as a personal lubricant | "Laboratory test results demonstrated that the proposed device...provides lubricity for use as a personal lubricant." |
| Safety for use as a personal lubricant | "The pre-clinical evaluation and testing as well as human use data show that the proposed device is safe for use as a personal lubricant." |
| Equivalence in performance to predicate devices | "The results from laboratory testing, pre-clinical evaluations and testing, and human use show that the proposed device performs equivalently to the predicate devices." (Predicate: K-Y® Brand Touch MassageTM 2-in-1 Warming® body massage + Personal lubricant) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "laboratory testing, pre-clinical evaluations and testing, and human use data." However, it does not provide specific sample sizes for these tests. The provenance (e.g., country of origin, retrospective/prospective) is also not detailed in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device submission. Ground truth, in the context of AI, usually refers to labeled data for diagnostic purposes. For a personal lubricant, "ground truth" would be established through physical and chemical testing, and human sensory evaluation, not through expert consensus in the diagnostic sense. The document does not specify the number or qualifications of individuals conducting "pre-clinical evaluation" or participating in "human use data collection."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a diagnostic AI device requiring adjudication of interpretations.
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. This is not an AI device, and no MRMC study involving human readers and AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" for its performance characteristics would be based on:
- Laboratory test results: For condom compatibility and lubricity (e.g., measuring force, friction, integrity).
- Pre-clinical evaluation and testing: Likely involving various biological and chemical assays to assess safety.
- Human use data: Direct experience and feedback from individuals using the product to confirm safety and performance (e.g., absence of irritation, desired lubricity).
8. The sample size for the training set
Not applicable, as there is no training set for an AI algorithm here.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI algorithm here.
In summary, the provided document is a regulatory submission for a physical medical device (personal lubricant) and does not concern an AI or algorithm-driven device. Therefore, most of the questions regarding AI-specific criteria are not applicable. The information describes standard laboratory, pre-clinical, and human use testing to demonstrate the safety and performance of a physical product.
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J&J Healthcare Products, Division of McNeil - PPC, Inc.
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K 081236
Traditional 510(k)
| Submitter | Johnson & Johnson Healthcare Products, Division of McNeil - PPC, Inc.199 Grandview RoadSkillman, NJ 08558 |
|---|---|
| Contact | Nader Fotouhi, Ph.D.Manager, Regulatory AffairsJ&J Consumer & Personal Products Worldwide199 Grandview RoadSkillman, NJ 08558Phone: (908) 904-3730Fax: (908) 904-3748 |
| Date | April 29, 2008 |
| Trade Name | K-Y® Brand IntrigueTM 2-in-1 Massage CrèmeTM |
| Common Name | Personal Lubricant |
| ClassificationName | NUC - condom compatible personal lubricant |
| Statement | This proposed device is substantially equivalent to predicate device, K-Y®Brand Touch MassageTM 2-in-1 Warming® body massage + Personal lubricant. |
| Devicedescription | This device is developed for non-therapeutic body massage and personallubricant compatible with latex condom that imparts a warming sensationupon the skin. |
| Intended use | The intended use of this device is as a non-therapeutic body massage andpersonal lubricant compatible with latex condom. |
| 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. They may also be used as a non-therapeutic body massage product. |
| 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, andhuman use show that the proposed device performs equivalently to thepredicate devices. Laboratory test results demonstrated that the proposeddevice is compatible with the leading commercial brands of latex condomsand provides lubricity for use as a personal lubricant.The pre-clinical evaluation and testing as well as human use data show thatthe proposed device is safe for use as a personal lubricant. |
| Conclusion | The proposed device is substantially equivalent to the currently marketedproducts in technology, intended use, safety, and suitability characteristics. |
SEP 2 5 2008
[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]
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510(k) Summary of Safety and Effectiveness (Continued)
[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2008
Nader Fotouhi, Ph.D. Manager, Regulatory Affairs McNeil-PPC, Inc. Consumer Healthcare Products 199 Grandview Road SKILLMAN NJ 08558
Re: K081236
Trade Name: K-Y® Brand Intrigue™ 2-in-1 Massage Crème Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 17, 2008 Received: September 18, 2008
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 (PMA), 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.
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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.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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
loque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Consumer Healthcare Products Division of McNeil - PPC, Inc.
Section 4 - Indications for Use Statement
510(k) Number, if known
Device Name: K-Y® Brand Intrigue™ 2-in-1 Massage Crème™
Indications for Use:
Interections of 2-in-1 Massage Crème™ is a personal lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's in ural. lubrication.
This product is compatible with latex condoms.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
Hulu Remer
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K081236
§ 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.