(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 . | ||||
| "Specification" for Preservative Effectiveness per USP . | ||||
| "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 | Specification | Met pre-defined acceptance criteria |
| 1.6 | Preservative Effectiveness | USP | 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 , 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.
§ 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.