DYNACOR LUBRICATION GEL

K103718 · Medline Industries, Inc. · KMJ · May 10, 2011 · General Hospital

Device Facts

• Record ID: K103718
• Device Name: DYNACOR LUBRICATION GEL
• Applicant: Medline Industries, Inc.
• Product Code: KMJ · General Hospital
• Decision Date: May 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6375
• Device Class: Class 1

Intended Use

The gel is intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

Device Story

Lubrication Gel (Sterile) is a patient lubricant used to facilitate the insertion of diagnostic or therapeutic devices into body orifices. It is intended for over-the-counter use. The gel reduces friction during medical procedures, potentially increasing patient comfort and easing device entry for clinicians or patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile patient lubricant gel. Class II device under 21 CFR 880.6375. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for lubrication of body orifices to facilitate entry of diagnostic or therapeutic devices in patients requiring such procedures.

Regulatory Classification

Identification

A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

Submission Summary (Full Text)

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Image /page/0/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 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Matt Clausen Regulatory Affairs Medline Industries, Incorporated One Medline Place Mundelein, Illinois 60060

MAY 1 0 2011

Re: K103718

Trade/Device Name: Lubrication Gel (Sterile) Regulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant Regulatory Class: II Product Code: KMJ Dated: April 15, 2011 Received: April 21, 2011

Dear Mr. Clausen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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Page 2 - Mr. Clausen

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); medical device reprting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regilation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

hh for

Anthony Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): Κιο3718

Device Name:

Dynacor Lubrication Gel (Sterile)

Indications for Use:

The gel is intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off)

Division of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K103718