(222 days)
Not Found
No
The device description and performance studies focus on the physical, chemical, and biological properties of a lubricating jelly, with no mention of AI or ML technologies.
No
The device is a lubricating jelly used to facilitate the entry of other diagnostic or therapeutic devices, not a therapeutic device itself.
No
Explanation: The device is a lubricating jelly used to facilitate the entry of other medical devices. Its function is purely facilitative, not diagnostic. It does not provide any information about a patient's medical condition.
No
The device description clearly indicates a physical product (lubricating jelly) and details its physical properties, packaging, and biocompatibility testing, which are characteristic of a hardware or material-based medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "lubricate body orifices to facilitate entry of diagnostic or therapeutic devices". This describes a physical function to aid in procedures, not a diagnostic test performed in vitro (outside the body) on samples like blood, urine, or tissue.
- Device Description: The description reinforces the lubricating function and lists examples of devices it facilitates the insertion of (catheters, endoscopes, surgical instruments, etc.). It focuses on the physical properties of the jelly.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing in vitro.
Therefore, this lubricating jelly is a medical device used to facilitate medical procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
KMJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body orifices
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 | |
| 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, |
| USP | ||
| 1.6 | Preservative Effectiveness | USP |
| 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 | |
| Validation | ISO 11137-2, | |
| AAMI TIR 33 | ||
| 4. | Sterile Packaging Integrity | ISO 11607-1 |
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national affiliation.
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.
1
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 SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See 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
3
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 |
4
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.
રે
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.
5
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 | |
| 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, |
| USP | ||
| 1.6 | Preservative Effectiveness | USP |
| 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 | |
| Validation | ISO 11137-2, | |
| AAMI TIR 33 | ||
| 4. | Sterile Packaging Integrity | ISO 11607-1 |
6
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.