K-Y BRAND SENSUAL MIST

K053397 · Mcneil-Ppc, Inc. · NUC · Feb 17, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K053397
• Device Name: K-Y BRAND SENSUAL MIST
• Applicant: Mcneil-Ppc, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Feb 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

K-Y® Brand SENSUAL MIST™ is intended as a personal lubricant (for penile and vaginal application) compatible with latex condom.

Device Story

K-Y® Brand SENSUAL MIST™ is a personal lubricant designed for penile and vaginal application to enhance comfort during intimate activity. It is compatible with latex condoms. The device is delivered via a non-aerosol spray pump mechanism. It is intended for over-the-counter use. The formulation uses ingredients generally recognized as safe (GRAS). The spray mechanism is designed such that particle size analysis indicates inhalation is unlikely to reach the alveolar region of the lungs. The device provides lubrication comparable to existing liquid lubricants, assisting users in intimate activities.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing and pre-clinical evaluations. Laboratory testing confirmed compatibility with leading latex condom brands and lubricity comparable to the predicate. Pre-clinical evaluation of ingredients confirmed safety (GRAS). Human RIPT demonstrated the device is non-sensitizing. Particle size analysis confirmed that spray inhalation is unlikely to reach the alveolar region.

Technological Characteristics

Personal lubricant formulation delivered via non-aerosol spray pump. Ingredients are GRAS. Particle size analysis performed to assess inhalation safety. Device is compatible with latex condoms.

Indications for Use

Indicated for use as a personal lubricant for penile and vaginal application to enhance comfort and ease of intimate activity; compatible with latex condoms.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• K-Y® Brand Liquid

Submission Summary (Full Text)

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Personal Product Company Division of McNeil - PPC, Inc.

Special 510(k) Device Modification

#### (Appendix A) FEB 1 7 2006 510(k) Summary of Safety and Effectiveness -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------and the same of the same of the same of the same of the same of the same of the same of the same of the same of the seat of the seat of the seat of the seat of the seat of th Personal Products Company Submitter Division of McNeil - PPC, Inc. 199 Grandview Road Skillman, NJ 08558 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Nader Fotouhi, Ph.D. Contact Manager, Regulatory Affairs Personal Product Company Division of McNeil - PPC, Inc. 199 Grandview Road Skillman, NJ 08558 Phone: [phone] Fax: [phone] December 5, 2005 Date K-Y® Brand SENSUAL MIST™ Trade Name Personal Lubricant Common Name HIS - Condom (21CFR 884.5300) Classification MMS - Patient Lubricant (21CFR 880.6375) Name This modification of the device is substantially equivalent to currently Statement marketed predicate devices, K-Y® Brand Liquid. This device is a condom compatible personal lubricant that has been Device specifically developed to be delivered via a non-aerosol spray pump. description ート - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

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Special 510(k) Device Modification

K053 397

# 510(k) Summary of Safety and Effectiveness (Continued)

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| Intended use | The intended use of this device is as a personal lubricant compatible with<br>latex condom. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>statement | This device and predicate devices have similar indications, by being applied<br>to the vaginal area or condom in order to enhance comfort and ease of<br>intimate activity. |
| Technological<br>characteristics | The device has the same technological characteristics as the currently<br>marketed condom compatible personal lubricants. |
| Performance<br>data | The results from laboratory testing, pre-clinical evaluations, and human RIPT<br>show that the proposed device performs equivalently to the predicate device.<br>Laboratory test results demonstrated that the proposed device is compatible<br>with the leading commercial brands of latex condoms. Lubricity of the<br>proposed device is comparable to the lubricity of predicate device. |
| | The ingredients used in the formulation of the proposed device are generally<br>recognized as safe (GRAS) and the pre-clinical evaluation of the ingredients<br>has determined that they are safe for use in personal lubricant products.<br>The particle size analysis data suggest that any inhalation of the product is not<br>likely to reach the deep lung (i.e., alveolar region). The alveolar region<br>represents the region of the respiratory tract where the most potentially<br>serious health consequences may occur. The human RIPT shows that the<br>proposed device is non-sensitizing. |
| Conclusion | The proposed device is substantially equivalent to the currently marketed<br>products in technology, intended use, safety, and suitability characteristics. |

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 2006

Nader Fotouhi, Ph.D. Manager, Regulatory Affairs Personal Products Company Division of McNeil-PPC, Inc. 199 Grandview Road SKILLMAN NJ 08558

Re: K053397

Trade/Device Name: K-Y® Brand SENSUAL MIST Regulation.Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 30, 2006 Received: February 2, 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.

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 clectronic 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 anow you'to obgh mationing of substantial equivalence of your device to a legally premaired nothoution: " Presults 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 If you desire specific active for your de received in 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, prease note the regulation entires, formation on your responsibilities under the Act from the 007.77). Tou may obtain other gamer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/industrv/support/index.html

Sincerely vours.

T. Nancy C. Brigdon

Naney 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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## (Appendix C)

## Indications for Use Statement

510(k) Number, if known

K053397

Device Name: K-Y® Brand SENSUAL MIST™

Indications for Use:

indications for USe:
K-Y® Brand SENSUAL MIST™ 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)

OR Over-the-Counter Use Prescription Use_

Gaird A. Bergman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

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