Lubricating Jelly

K142473 · Sion Biotext Medical , Ltd. · KMJ · Apr 13, 2015 · General Hospital

Device Facts

• Record ID: K142473
• Device Name: Lubricating Jelly
• Applicant: Sion Biotext Medical , Ltd.
• Product Code: KMJ · General Hospital
• Decision Date: Apr 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6375
• Device Class: Class 1

Intended Use

The Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when either sterile or non-sterile fields are required.

Device Story

Lubricating jelly; clear, greaseless, odorless, water-soluble, non-irritating. Used to lubricate body orifices; facilitates entry of diagnostic/therapeutic devices (catheters, endoscopes, surgical instruments). Applied by clinicians in medical settings. Provided in sterile or non-sterile formats; packaged in bacterial barrier tubes or sealed laminated sachets. Benefits patient by reducing friction during medical device insertion, minimizing tissue irritation. No complex processing or software involved.

Clinical Evidence

Bench testing only. Evaluated via physical, chemical, and microbiological performance tests: appearance, weight, pH, viscosity, sterility (ISO 11737-2, USP <71>), preservative effectiveness (USP <51>), dye test (ASTM 1929), and biocompatibility (ISO 10993-1, -5, -10, -11). Sterilization validated per ISO 11137-2 and AAMI TIR 33; packaging integrity per ISO 11607-1. All tests met pre-defined acceptance criteria.

Technological Characteristics

Composition: water, carbomer thickeners, methylparaben, propylparaben, sodium hydroxide, and lubricator. Form factor: tubes or laminated sachets. Sterilization: Gamma radiation (for sterile version). Biocompatibility evaluated per ISO 10993-1:2009.

Indications for Use

Indicated for lubrication of body orifices to facilitate insertion of diagnostic or therapeutic devices (e.g., catheters, endoscopes, surgical instruments) 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.

Predicate Devices

• Dynarex Sterile Lubricating Jelly (K092488)

Submission Summary (Full Text)

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

April 13, 2015

Sion Biotext Medical, Limited c/o Ms. Tali Hazan Talmed Ltd. M.P Upper Galilee Ramont Naftali, Ha Zafon 1383000 Israel

Re: K142473

Trade/Device Name: Lubricating Jelly Regulation Number: 21 CFR 880.6375 Regulation Name: Patient Lubricant Regulatory Class: I Product Code: KMJ Dated: March 5, 2015 Received: March 11, 2015

Dear Ms. Hazan:

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 - Ms. Tali Hazan

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for Sion Biotext Medical Ltd. The logo is in blue and teal colors. The address Hagoshrim, 12225, ISRAEL is printed at the bottom left and the website www.sb-medical.com is printed at the bottom right.

Tel: [phone], Fax: [phone] E-mail:[e-mail]

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
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Indications for Use

| 510(k) Number (if known) | K142473 |
|--------------------------|-------------------|
| Device Name | Lubricating Jelly |

Indications for Use (Describe) The Lubricating Jelly is a medical device intended for medical purposes, to lubricate body onlices to facilitate entry of diagnostic or therapeutic devices when either sterile or non-sterile fields are required.

Image /page/2/Figure/4 description: This image shows a section of the FDA form 3881 (1/14). The section is for FDA use only and includes a digital signature by Mary E. Brooks -S, dated 2015.04.01. The form indicates that it applies to the requirements of the Paperwork Reduction Act of 1995 and provides contact information for the PRA Staff at [e-mail].

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Sion Biotext Medical Ltd 510(k) Lubricating Jelly

.............................................................................................................................................................................. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------July 30, 2014 4-1

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Image /page/3/Picture/0 description: The image shows the logo for Sion Biotext Medical Ltd. The logo features the company name in bold, dark blue letters, with "Sion Biotext" on the top line and "Medical Ltd." on the second line. Below the company name, there is contact information, including the address "Hagoshrim, 12225, ISRAEL," the website "www.sb-medical.com," the telephone number "972-4-8956201," the fax number "972-4-8956202," and the email address "[e-mail]".

# 510(K) SUMMARY FOR SION BIOTEXT MEDICAL'S LUBRICATING JELLY Device

## DATE PREPARED: JULY 25, 2014

#### 510(K) OWNER NAME 1.

Sion Biotext Medical Ltd. Kibbutz Hagoshrim Upper Galilee Zip Code: 12225, Israel Phone: [phone], Fax: [phone], E-mail: [e-mail].

### Contact person:

Ms. Tali Hazan – RA Consultant Phone: [phone] Fax: [phone] Email: [e-mail]

#### DEVICE NAME AND CLASSIFICATION 2.

Common/Usual Name: Lubricating Jelly (Sterile or Non-Sterile) Proprietary/Trade name: Lubricating Jelly Classification: Sion Biotext Medical's Lubricating Jelly device has been classified as

Class I device under the following classification names:

| Classification Name | Product Code | 21 CFR Ref. | Review Panel |
|---------------------|--------------|-------------|------------------|
| Lubricant, Patient | KMJ | 880.6375 | General Hospital |

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Image /page/4/Picture/0 description: The image shows the logo for Sion Biotext Medical Ltd. The logo features the company name in a bold, blue font, with "Medical Ltd." in a smaller font size. Below the logo, the address "Hagoshrim, 12225, ISRAEL" is printed, along with the website address "www.sb-medical.com" and contact information including the telephone number 972-4-6956201, fax number 972-4-8956202, and email address [e-mail].

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Sion Biotext Medical's Lubricating Jelly device is substantially equivalent to the following Predicate Device:

Dynarex Sterile Lubricating Jelly (by Dynarex Corporation) cleared under 510(k) number K092488 on December 18, 2009.

#### 4. DEVICE DESCRIPTION

Sion's Lubricating Jelly is used to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when either sterile or non-sterile fields are required. Typical uses of the lubricating jelly include (but not limited) insertion of catheters, endoscopes surgical instruments, gynecological, rectal, oral and rubber or plastic etc. The lubricating jelly is clear, greaseless, odorless, water soluble and non-irritating to the skin, tissue and mucous membranes.

Both product types (sterile and non-sterile) are packed in a bacterial barrier tubes or sealed laminated sachets.

Sion's Lubricating Jelly is a body contact material and was evaluated for biocompatibility with accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2009.

#### 5. INTENDED USE

The Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when either sterile or non-sterile fields are required.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Lubricating jelly is composed of water, carbomer thickeners, methylparaben, propylparaben, sodium hydroxide and lubricator. These ingredients are the same as those used for the predicate device and formulation is nearly the same. Sion's Lubricating jelly is substantially equivalence to the predicate since it has the very same indication for use; it performs the same and has the same properties and labeling claims. It is intended to be used for the same patients' population.

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The only differences between Sion's proposed device and Dynarex cleared device are that Sion provides the device as both 'sterile' and 'non-sterile' while Dynarex provides the product in sterile state only. Minor changes in the formulation were assessed and they do not affect the final device substantial equivalency determination.

#### PERFORMANCE DATA 7.

Sion's Lubricating Jelly has been successfully tested for physical non-clinical performances' tests. These non-clinical testing data performed to evaluate device performances:

| No. | Test Name | Per Standard |
|-----|---------------------------------------------------|-----------------------------|
| 1. | Chemical and Microbiological<br>along Shelf Life: | |
| 1.1 | Appearance | Specification |
| 1.2 | Weight | Specification |
| 1.3 | pH | Specification |
| 1.4 | Viscosity | Specification |
| 1.5 | Sterility and GPT | ISO 11737-2,<br>USP <71> |
| 1.6 | Preservative Effectiveness | USP <51> |
| 1.7 | Dye Test | ASTM 1929 |
| 2. | Biocompatibility: | 10993-1 (General) |
| 2.1 | Cytotoxicity | 10993-5 |
| 2.2 | Sensitization | 10993-10 |
| 2.3 | Irritation - Mucosal (Vaginal) | 10993-10 |
| 2.4 | Acute Systemic Toxicity | 10993-11 |
| 3. | Gammy Sterilization<br>Validation | ISO 11137-2,<br>AAMI TIR 33 |
| 4. | Sterile Packaging Integrity | ISO 11607-1 |

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Image /page/6/Picture/0 description: The image shows the logo for Sion Biotext Medical Ltd. The logo is in blue and teal colors. The address Hagoshirm, 12225, ISRAEL, the website www.sb-medical.com, the telephone number 972-4-6956201, the fax number 972-4-6956202, and the email address [e-mail] are also included in the image.

All tested devices met the tests' requirements and pre-defined acceptance criteria. Therefore it was concluded that under normal use, the device will performed according to its specifications and intended uses.

Performance tests' results supported Sion's labeling claims and the determination of substantial equivalence with predicate device.

#### 8. SUBSTANTIAL EQUIVALENCE

Sion's Lubricating Jelly is substantially equivalent to the predicate device selected in terms of indication for use, technology, performances, physical characterization, sterile product's sterility method of use, target patient population and nature of body contact.

#### 9. CONCLUSIONS

As above described, the evaluation of our device performances demonstrates that it is equivalent and as safe and as effective as the predicate device.