DYNAREX STERILE LUBRICATING JELLY

K092488 · Dynarex Corporation · KMJ · Dec 18, 2009 · General Hospital

Device Facts

• Record ID: K092488
• Device Name: DYNAREX STERILE LUBRICATING JELLY
• Applicant: Dynarex Corporation
• Product Code: KMJ · General Hospital
• Decision Date: Dec 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6375
• Device Class: Class 1

Intended Use

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

Device Story

Dynarex 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 (3g, 5g) or tubes (2oz, 4oz). It is intended for use by healthcare professionals in clinical settings requiring a sterile field. The jelly facilitates device entry, potentially increasing patient comfort and reducing trauma during procedures. It is formulated with purified water, carbomer thickeners, and preservatives (methylparaben/propylparaben).

Clinical Evidence

Bench testing only. Evidence includes physical testing (viscosity, pH), preservative effectiveness testing, sterility testing, and comprehensive biocompatibility testing per ISO 10993 (in-vitro cytotoxicity, implantation, irritation, hypersensitivity, and systemic toxicity). All tests passed.

Technological Characteristics

Water-soluble gel containing purified water, carbomer thickeners, and methylparaben. Packaged in plastic/film laminate. Sterilized via gamma irradiation (ISO/AAMI 11137, Vdmax25, SAL 10^-6). Biocompatibility per ISO 10993.

Indications for Use

Indicated for use in patients requiring lubrication of body orifices to facilitate the insertion of diagnostic or therapeutic devices in settings where 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

• E-Z Lubricating Jelly (K041060)

Submission Summary (Full Text)

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K092488

## DEC 1 8 2009

### 510(K) SUMMARY (as required by 807.92(c))

| Submitter of 510(k): | Dynarex Corporation<br>10 Glenshaw Street<br>Orangeburg, NY 10972<br>USA<br>Phone: [phone]<br>Fax: [phone] | |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Daniel Consaga | |
| Date of Summary: | December 17, 2009 | |
| Trade/Proprietary Name: | Dynarex Sterile Lubricating Jelly | |
| Classification Name: | Lubricant, Patient | |
| Product Code: | KMJ | |

#### Intended Use:

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

### Device Description:

Dynarex Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly. Typical packaging configurations for the Dynarex Sterile Lubricating Jelly is 3 g or 5 g foil packs, and 2 oz or 4 oz tubes, Other sizes may become available.

#### Predicate Device:

E-Z Lubricating Jelly, 510k Number K041060 is manufactured by Chester Labs, Inc. 1900 Section Rd., Cincinnati, OH 45237.

### Substantial Equivalence:

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

#### Safety and Effectiveness of the device:

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

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### 510(K) SUMMARY (as required by 807.92(c))

### 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: Dynarex 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 physical 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 | Dynarex Lubricating Jelly | E-Z Lubricating Jelly |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Purified water | Yes | Yes |
| Carbomer thickeners | Yes | Yes |
| Methylparaben | 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 |
| Sterile | Yes | Yes |
| Physical Tests | Viscosity & pH | Viscosity & pH |
| | Preservative effectiveness | Preservative effectiveness |
| | Sterility Test Study | Sterility Test Study |
| | ISO 10993 | ISO 10993 |
| Biocompatability<br>Testing | In-Vitro Cytotoxicity - Pass* | In-Vitro Cytotoxicity - Pass |
| | Implantation - Pass | Implantation - Pass |
| | Irritation & Hypersensitivity - Pass | Irritation & Hypersensitivity - Pass |
| | Systemic Toxicity - Pass | Systemic Toxicity - Pass |
| In-Vitro Cytotoxicity -<br>Pass* Grade 2 Result<br>Response | The two preservatives (Methylparaben and Propylparaben) are well<br>known to cause this type result. Sodium Hydroxide also can cause<br>this phenomena, but the concentration in the gel of sodium<br>hydroxide is very low (less than 1%) so it is believed that its'<br>contribution to this grade 2 result is very low if any. | |

#### Sterilization:

The Dynarex 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). Method: Vdmax25 with an SAL of 10-6.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Mr. Daniel Consaga Regulatory Affairs Engineer Dynarex Corporation 10 Glenshaw Street Orangeburg, New York 10962

### DEC 1 8 3009

Re: K092488

Trade/Device Name: Dynarex Sterile Lubricating Jelly Regulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant Regulatory Class: I Product Code: KMJ Dated: October 26, 2009 Received: December 8, 2009

Dear Mr. Consaga:

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 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. Consaga

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/ResourcesforYou/Industry/default.htm.

Sincerely,

Susan Runez

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:

Dynarex Sterile Lubricating Jelly

Indications for Use:

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

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

Over-The-Counter Use _ (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)

An Stin for liz

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

510(k) Number: K 992488