(191 days)
K-Y® Brand YOURS+MINE™ is intended as a personal lubricant for penile and vaginal application compatible with latex condom.
The devices are personal lubricants compatible with latex condom.
The provided text describes a 510(k) premarket notification for a personal lubricant, K-Y® Brand YOURS+MINE™. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for a typical AI/ML medical device.
Based on the provided information, here's a breakdown of the requested elements:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly uses the "substantial equivalence" framework, meaning the device's performance should be comparable to a legally marketed predicate device. The acceptance criteria are therefore tied to demonstrating this equivalence through various tests.
| Acceptance Criteria Category | Actual Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Condom Compatibility | Demonstrates 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." |
| Lubricity | Lubricity is comparable to the predicate device. | "Lubricity of the proposed device is comparable to the lubricity of predicate device." |
| Safety (Pre-clinical/Human Use) | Shows the device is safe for use as a personal lubricant. | "The pre-clinical evaluation and testing and human use data show that the proposed device is safe for use as a personal lubricant." |
| Technological Characteristics Equivalence | Same technological characteristics as currently marketed condom compatible personal lubricants. | "The proposed device has the same technological characteristics as currently marketed condom compatible personal lubricants." |
| Indications for Use Equivalence | Similar indications for use as the predicate device. | "The proposed device and predicate device have similar indications..." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "laboratory testing, pre-clinical evaluations and testing, and human use," but does not specify the sample sizes for these tests.
The data provenance is also not specified, such as country of origin or whether it was retrospective or prospective. It infers prospective testing for "pre-clinical evaluations and testing, and human use."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. For a personal lubricant, "ground truth" would generally refer to established scientific standards for chemical and physical properties, and safety evaluations. The document does not detail who performed these evaluations or their qualifications beyond stating it was "laboratory testing" and "pre-clinical evaluations."
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of personal lubricant testing, formal adjudication methods (like 2+1 reader consensus) are typically not applicable. The evaluations likely relied on established laboratory protocols and safety assessment methodologies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not conducted as this device is a personal lubricant, not an AI/ML diagnostic tool that would involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a personal lubricant, not an algorithm or AI/ML product. Therefore, standalone performance of an algorithm is not relevant.
7. The Type of Ground Truth Used:
The ground truth for this device appears to be based on:
- Established scientific and engineering principles for condom compatibility (e.g., integrity, burst pressure).
- Biophysical measurements for lubricity.
- Safety assessments based on pre-clinical evaluations (e.g., toxicology, irritation studies) and human use data (e.g., adverse event reporting, user acceptability).
- Comparison to a legally marketed predicate device and its established performance and safety profiles.
8. The Sample Size for the Training Set:
Not applicable. This device is a personal lubricant and does not involve AI/ML that requires a training set. The term "training set" is not relevant to this submission.
9. How the Ground Truth for the Training Set was Established:
Not applicable for the same reasons as above.
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/<072421
J&J Healthcare Products, Division of McNeil – PPC, Inc.
Traditional 510(k)
:
Section 5 - 510(k) Summary
MAR - 6 2008
| Submitter | McNeil - PPC, Inc., Johnson & Johnson Healthcare Products Division199 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 | August 27, 2007 | ||
| Trade Name | K-Y® Brand YOURS+MINE™ | ||
| Common Name | Personal Lubricant | ||
| ClassificationName | NUC - Condom (21CFR 884.5300) | ||
| Statement | This proposed device consists of two personal lubricants packaged together.Each product is substantially equivalent to a K-Y® Brand product previouslycleared by the Food and Drug Administration. | ||
| Devicedescription | The devices are personal lubricants compatible with latex condom. | ||
| Intended use | The intended use of the device is as a personal lubricant compatible with latexcondom. |
[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]
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J&J Healthcare Products, Division of McNeil - PPC, Inc.
·
Section 5 - 510(k) Summary (Continued)
| Indicationsstatement | The proposed device and predicate device have similar indications, beingapplied to the vaginal or penile areas or a condom in order to enhancecomfort, ease and pleasure of intimate activity. |
|---|---|
| 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 device. Laboratory test results demonstrated that the proposeddevice is compatible with the leading commercial brands of latex condoms.Lubricity of the proposed device is comparable to the lubricity of predicatedevice. |
| The pre-clinical evaluation and testing and human use data show that theproposed 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. |
[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The caduceus in the logo is depicted with three lines forming the wings and a snake-like form at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 6 2008
J&J Consumer & Personal Products Worldwide c/o Nader Fatouhi, Ph.D. Manager. Regulatory Affairs Division of McNeil-PPC, Inc. 199 Grandview Road SKILLMAN NJ 08558
Re: K072421
Trade/Device Name: K-Y® Brand YOURS+MINE Regulation Number: 21 CFR §884,5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 28, 2008 Received: February 29, 2008
Dear Dr. Fatouhi:
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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/cdrb/industry/support/index.html,
Sincerely vours.
Nancy C. Brogdon
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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Section 4 - Indications for Use Statement
510(k) Number, if known
KO72421
Device Name: K-Y® Brand YOURS+MINE ™
Indications for Use: K-Y® Brand YOURS+MINE™ is intended as a personal lubricant 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 X
Hulen Remer
Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 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.