DUKAL LUBRICATING JELLY

K113689 · Dukal Corporation · KMJ · May 4, 2012 · General Hospital

Device Facts

• Record ID: K113689
• Device Name: DUKAL LUBRICATING JELLY
• Applicant: Dukal Corporation
• Product Code: KMJ · General Hospital
• Decision Date: May 4, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6375
• Device Class: Class 1

Intended Use

The Dukal Sterile Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic devices when a sterile field is required.

Device Story

Dukal Sterile Lubricating Jelly is a clear, greaseless, water-soluble lubricant. It is applied to body orifices to reduce friction during the insertion of diagnostic or therapeutic medical devices. The product is provided in sterile foil packs (2.7g or 5g) or tubes (2oz or 4oz). It is intended for use in clinical or home settings where a sterile lubricant is required to facilitate medical procedures. The device benefits patients by minimizing discomfort and potential trauma during device insertion.

Clinical Evidence

No clinical data. Safety and effectiveness are supported by bench testing, including biocompatibility testing (in-vitro cytotoxicity, implantation, irritation, hypersensitivity, and systemic toxicity) per ISO 10993, and validation of gamma irradiation sterilization per ISO/AAMI 11137.

Technological Characteristics

Water-soluble jelly containing purified water, carbomer thickeners, and methylparabens. Packaged in plastic/film laminate containers. Sterilized via gamma irradiation validated to ISO/AAMI 11137 (SAL 10^-6).

Indications for Use

Indicated for use as a patient lubricant to facilitate the insertion of diagnostic and therapeutic devices into body orifices when a sterile field is required.

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.

Predicate Devices

• Dynarex Sterile Lubricating Jelly (K092488)

Submission Summary (Full Text)

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K113689

MAY - 4 2012

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## 510(k) Summary (as required by 807.92(c)

| Submitter of 510(k): | Dukal Corporation<br>2 Fleetwood Court<br>Ronkonkoma, NY 11779 |
|-------------------------|----------------------------------------------------------------|
| Contact Person: | Patrick J. Lamb<br>VP International/Operations Manager |
| Date of Summary: | December 5, 2011 |
| Trade/Proprietary Name: | Dukal Sterile Lubricating Jelly |
| Classification Name: | Lubricant, Patient |
| Product Code: | KMJ |

#### Intended Use:

. The Dukal Sterile Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic devices when a sterile field is required.

#### Device Description:

The Dukal Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly.

#### Device Packaging:

A typical packaging configuration for the Dukal Sterile Lubricating Jelly ls a 2.7g or 5gm foil packs and 2oz or 4oz tubes. Other sizes may become available.

#### Predicate Device:

Dynarex Sterile Lubricating Jelly, 510(k) K092488 is manufactured for Dynarex 10 Glenshaw St. Orangeburg, NY 10962.

#### Substantial Equivalence:

The Dukal Sterile Lubricating Jelly provides effective lubrication during the insertion of diagnostic and therapeutic devices into the body orifices. Its function and performance are similar to the predicate device as presented in this 510(k).

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## Safety and Effectiveness of the device:

This device is as safe and effective as the predicate device cited above based on the following:

Summary comparing technological characteristics with other predicate device: Dukal Sterile Lubricating Jelly is similar in terms of intended use and technological characteristics to predicate devices reviewed as a lubricating jelly to facilitate the entry of a diagnostic or therapeutic device. The device is substantially equivalent with respect to indications for use and other characteristics to predicate devices in terms of section 510(k) substantial equivalency.

Please find below a tabulated comparison supporting that this device is substantially equivalent to the predicate device in commercial distribution.

| Technological<br>Characteristics | Dukal | Dynarex |
|---------------------------------------|----------------------------------------|-------------------------------------|
| Purified Water | Yes | Yes |
| Carbomer Thickeners | Yes | Yes |
| Methylparabens | Yes | Yes |
| Labeled Water Soluble | Yes | Yes |
| Labeled Non Staining | Yes | Yes |
| Labeled Alcohol and<br>fragrance free | Yes | Yes |
| Container Material | Plastic/Film Laminate | Plastic/Film Laminate |
| Sterile | Yes | Yes |
| Physical Tests | | |
| Biocompatibility<br>Testing | ISO 10993 | ISO 10993 |
| | In-Vitro Cytotoxicity -Pass | In-Vitro Cytotoxicity -Pass |
| | Implantation-Pass | Implantation-Pass |
| | Irritation & Hypersensitivity<br>-Pass | Irritation & Hypersensitivity -Pass |
| | Systemic Toxicity - Pass | Systemic Toxicity - Pass |

#### Comparative Chart

#### Sterilization:

The Dukal Sterile Lubricating Jelly is sterilized by gamma irradiation under parameters that have been validated according to ISO/AAMI 11137 requirements (sterilization of health care products - requirements for validation and routine control radiation sterilization) with SAL of 10°

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Patrick J. Lamb Vice President International/Operations Manager Dukal Corporation 2 Fleetwood Court Ronkonkoma, New York 11779

MAY - 4 2012

Re: K113689

Trade/Device Name: Dukal Sterile Lubricating Jelly Regulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant Regulatory Class: II Product Code: KMJ Dated: April 17, 2012 Received: April 25, 2012

Dear Mr. Lamb:

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. Lamb

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 reporting (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 regulation (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.

Wh for

Anthony D. 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)

Device Name:

Dukal Sterile Lubricating Jelly

## Indications for use:

The Dukal Sterile Lubricating Jelly is a medical device intended for medical purposes, to l he banal other of acilitate entry of diagnostic devices when a sterile field is required.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

# PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:_

All Ch 5/3/12

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K113689