(222 days)
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.
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.
This document describes the 510(k) premarket notification for Sion Biotext Medical's Lubricating Jelly. It is a Class I medical device intended to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a table of tests performed and relevant standards. The reported device performance is a general statement that "All tested devices met the tests' requirements and pre-defined acceptance criteria."
| No. | Test Name | Per Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| 1. | Chemical and Microbiological along Shelf Life: | "Specification" for Appearance, Weight, pH, Viscosity. "Specification" for Sterility and GPT per ISO 11737-2, USP <71>. "Specification" for Preservative Effectiveness per USP <51>. "Specification" for Dye Test per ASTM 1929. | Met pre-defined acceptance criteria | |
| 1.1 | Appearance | Specification | Specification | Met pre-defined acceptance criteria |
| 1.2 | Weight | Specification | Specification | Met pre-defined acceptance criteria |
| 1.3 | pH | Specification | Specification | Met pre-defined acceptance criteria |
| 1.4 | Viscosity | Specification | Specification | Met pre-defined acceptance criteria |
| 1.5 | Sterility and GPT | ISO 11737-2, USP <71> | Specification | Met pre-defined acceptance criteria |
| 1.6 | Preservative Effectiveness | USP <51> | Specification | Met pre-defined acceptance criteria |
| 1.7 | Dye Test | ASTM 1929 | Specification | Met pre-defined acceptance criteria |
| 2. | Biocompatibility: | 10993-1 (General) | "Specification" for Cytotoxicity per 10993-5. "Specification" for Sensitization per 10993-10. "Specification" for Irritation - Mucosal (Vaginal) per 10993-10. "Specification" for Acute Systemic Toxicity per 10993-11. | Met pre-defined acceptance criteria |
| 2.1 | Cytotoxicity | 10993-5 | Specification | Met pre-defined acceptance criteria |
| 2.2 | Sensitization | 10993-10 | Specification | Met pre-defined acceptance criteria |
| 2.3 | Irritation - Mucosal (Vaginal) | 10993-10 | Specification | Met pre-defined acceptance criteria |
| 2.4 | Acute Systemic Toxicity | 10993-11 | Specification | Met pre-defined acceptance criteria |
| 3. | Gamma Sterilization Validation | ISO 11137-2, AAMI TIR 33 | "Specification" | Met pre-defined acceptance criteria |
| 4. | Sterile Packaging Integrity | ISO 11607-1 | "Specification" | Met pre-defined acceptance criteria |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes for each test mentioned. It only states that "All tested devices met the tests' requirements." The data provenance is implied to be from Sion Biotext Medical Ltd. in Israel, as the company is based there and would conduct its own testing for device clearance. The studies appear to be prospective, designed to evaluate the physical and biological properties of the device against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is generally not applicable to laboratory or performance testing of a lubricating jelly. The "ground truth" for these tests is established by adhering to widely accepted international standards (e.g., ISO, USP, ASTM) and internal specifications, not by expert consensus on clinical interpretation. The tests are objective measurements of physical, chemical, and biological properties.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. The tests are typically pass/fail based on predetermined specifications or standard requirements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and their performance with and without AI assistance is evaluated. This is a lubricating jelly, and its performance is assessed through laboratory testing, not human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone performance tests of the device itself, without any human-in-the-loop evaluation of its performance in a diagnostic or interpretive capacity. The "algorithm" in this context would be the physical and chemical formulation of the jelly and the manufacturing process, and its performance is evaluated against predefined specifications.
7. The Type of Ground Truth Used
The ground truth for the device's performance is based on established industry standards (e.g., ISO 11737-2, USP <71>, ASTM 1929, ISO 10993 series, ISO 11137-2, AAMI TIR 33, ISO 11607-1) and internal specifications set by Sion Biotext Medical. These standards and specifications define the acceptable ranges for properties like pH, viscosity, sterility, biocompatibility, etc.
8. The Sample Size for the Training Set
Not applicable. This device is a medical product (lubricating jelly), not an AI algorithm that requires a "training set" for learning. The development process would involve formulation and optimization, but there isn't a "training set" in the sense used for machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device. The formulation and characteristics of the lubricating jelly were likely developed based on scientific principles of chemistry and materials science, aiming to meet the performance criteria and safety standards required for medical devices.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: 972-4-6956201, Fax: 972-4-6956202 E-mail:sbmedical@sb-medical.com
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
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 PRAStaff@fda.hhs.gov.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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 "smedical@sb-medical.com".
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: +972-4-6956201, Fax: +972-4-6956202, E-mail: sbmedical@sb-medical.com.
Contact person:
Ms. Tali Hazan – RA Consultant Phone: +972-(0)50-5292-304 Fax: +972-(0)722448981 Email: tali.hazan@talmed.co.il
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 sbmedical@sb-medical.com.
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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 Microbiologicalalong 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,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 SterilizationValidation | ISO 11137-2,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 sbmedical@sb-medical.com 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.
§ 880.6375 Patient lubricant.
(a)
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.(b)
Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.