(87 days)
Lubricano is an in vivo biocompatible and bioexcretable sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications.
Lubricano is used to couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavitary medical diagnostic ultrasound imaging procedures, such as transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, intracavity ultrasound imaging, and gel infusion sonography.
Lubricano is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterility, in vivo biocompatibility and bioelimination are required.
Lubricano® Sterile Gel is a sterile, water-soluble gel composed of hydroxyethylcellulose, glycerol, and purified water, which is contained in a 10 mL syringe. Lubricano Sterile Gel is free from fats, latex, disinfectants and preservatives. Lubricano Sterile Gel ensures that catheters and instruments move easily, and it adheres well to the mucosa.
The provided text describes the 510(k) summary for Lubricano® Sterile Gel - Ultrasound. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through outlining the device's composition, intended use, and safety profile based on in vivo and in vitro testing.
Crucially, this document does NOT contain information about acceptance criteria or a study designed to evaluate the device's performance against specific numerical acceptance criteria for diagnostic accuracy or effectiveness in a clinical context. It is for an ultrasound coupling gel, not an AI/algorithm-based diagnostic device. Therefore, many of the typical acceptance criteria points you requested for AI/algorithm studies (like sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, or standalone performance) are not applicable or provided in this type of submission.
The "study" referenced in the document is a series of in vivo and in vitro tests to establish the safety profile of the device.
Here's a breakdown of the relevant information from the provided text, addressing only the points that can be answered:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the "acceptance criteria" appear to be related to the safety profile and the ability to demonstrate substantial equivalence to predicate devices. The performance is reported in terms of safety attributes.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-toxic | Established as non-toxic through in vivo and in vitro testing. |
| Non-irritating | Established as non-irritating through in vivo and in vitro testing. |
| Non-sensitizing | Established as non-sensitizing through in vivo and in vitro testing. |
| Comparable to Predicate Devices | Performance is comparable to the predicate devices (SonoTech UltraBio, Farco-Pharma Lubricano® Gel). |
| Sterile | Described as sterile. |
| Water-soluble | Described as water-soluble gel. |
| Free from fats, latex, disinfectants, preservatives | Explicitly stated to be free from these substances. |
| Ensures easy movement of catheters/instruments | Stated as a characteristic. |
| Adheres well to mucosa | Stated as a characteristic. |
| In vivo biocompatible | Stated as an intended property and confirmed by testing. |
| Bioexcretable (or Bioeliminated) | Stated as an intended property and confirmed by testing. |
| Unit dose packaged | Described as unit dose packaged. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The document refers to "results of in vivo and in vitro testing," but does not detail the number of subjects or samples used in these tests.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the tests were retrospective or prospective. Given the submitter's address in Germany, it's possible testing occurred there, but this is not stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This device is an ultrasound coupling gel, not an AI or diagnostic imaging device that requires expert interpretation for ground truth establishment. The "ground truth" for this device relates to its material properties and biological safety (e.g., toxicity, irritation).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See response for point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI/algorithm-based device. An MRMC study is not relevant to an ultrasound coupling gel.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an AI/algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device relies on objective measurements from in vivo (e.g., animal or human safety studies) and in vitro (e.g., lab tests) assessments of its biological and physical properties (toxicity, irritation, sensitization, sterility, chemical composition). It's based on scientific protocols for toxicology and biocompatibility testing, not clinical "ground truth" like pathology or expert consensus for diagnostic accuracy.
8. The sample size for the training set
- Not Applicable. This is not an AI/algorithm-based device. There is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/algorithm-based device. There is no "training set."
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.