(434 days)
Other-Sonic™ Transmission Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination. The product is indicated for prescription use only.
Other-Sonic™ Transmission Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals. It is packaged in 5L Cubitainers and 250 mL bottles.
The device under review is "Other-Sonic™ Transmission Gel," which is a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. The device is compared to a predicate device, "Sonishield™ 100 Antimicrobial Ultrasound Gel," and an additional reference device, "Ecogel 100 Ultrasound Gel."
Here's the breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for each performance metric but rather presents a comparison of technological and non-clinical characteristics between the subject device and the predicate/reference devices to demonstrate substantial equivalence. The "performance" column below reflects the characteristics of the "Other-Sonic™ Transmission Gel" and the "Acceptance Criteria" column indicates that its performance should be substantially equivalent or similar to the predicate/reference devices for these characteristics.
| Acceptance Criteria (Compared to Predicate/Reference) | Reported Device Performance (Other-Sonic™ Transmission Gel) |
|---|---|
| Acoustic Performance: | |
| Sound velocity similar to predicate | 1601 ms-1 at 22.5°C (Predicate: 1497 ms-1 at 30°C) |
| Density similar to predicate | 1033 kg/ m3 at 22.5°C (Predicate: 1023 kg/ m3 at 30°C) |
| Acoustic impedance similar to predicate | 1.65 MRayls at 22.5°C (Predicate: 1.53 MRayls at 30°C) |
| Attenuation coefficient similar to predicate | 0.19 + 0.0000105 $f^{2.974}$ (Predicate: 0.04 ± 0.0042 $f$) |
| Antimicrobial Effectiveness: | |
| Pass USP (Category 2) log reductions | Passed with log reductions > 5 for bacteria, yeasts and molds decreased |
| Biocompatibility: | |
| Non-sensitizing | Non-sensitizing |
| Non-irritating | Non-irritating |
| In Vitro Cytotoxicity: | |
| Not considered cytotoxic (per ISO 10993-5:2009) | Not considered cytotoxic |
| Physical/Chemical Properties: | |
| Salt free | Salt free |
| Alcohol free | Alcohol free |
| Formaldehyde free | Formaldehyde free |
| pH range (comparable to predicate) | 6.80 ± 0.25 |
| Density (g/mL) (comparable to predicate) | 1.033 |
| Viscosity (comparable to predicate) | 966,000 ± 483,000 CPS |
| Boiling Point (comparable to predicate) | > 200° C |
| Water soluble high MW polymers | Water soluble high MW polymers |
| No irritation | No irritation |
| Other: | |
| External Use | External |
| Pediatric and adult Target Population | Pediatric and adult |
| Multiple Uses | Multiple uses |
| Hospital Environment of Use | Hospital |
2. Sample Size Used for the Test Set and Data Provenance:
- Acoustic Testing: The document does not specify a separate "test set" sample size for acoustic testing. The acoustic properties are reported as values for "Other-Sonic™ Transmission Gel" and "Sonishield™ 100 Antimicrobial Ultrasound Gel." It implicitly compares the characteristics of the gel rather than a study on a specific number of instances.
- Antimicrobial Effectiveness Testing: The sample size is not explicitly stated as a number of distinct gel samples. However, the test was performed according to USP (Category 2) using standard microbial challenges: Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027, Aspergillus brasiliensis ATCC 16404, and Candida albicans ATCC 10231. These represent specific strains used in lab testing.
- Biocompatibility (Skin Irritation and Sensitization): The document states "Animal tests" were conducted, referring to "Skin Irritation and Skin Sensitization." The number of animals or specific experimental setup (e.g., number of patches, individual subjects) is not provided.
- In Vitro Cytotoxicity: The test was conducted according to ISO 10993-5:2009. The sample size refers to the cell cultures used in the in vitro test, but specific numbers are not given.
- Data Provenance: The document does not specify the country of origin for the non-clinical test data. These tests are typically conducted in laboratory settings (i.e., in vitro or in vivo animal studies) rather than using retrospective or prospective human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable. The evaluations conducted for this device (acoustic properties, antimicrobial effectiveness, biocompatibility, cytotoxicity) are non-clinical laboratory tests. They do not involve expert interpretation of images or clinical data to establish a "ground truth" in the way a diagnostic algorithm might. The "ground truth" for these tests comes from established scientific methodologies and standards (e.g., USP , ISO 10993).
4. Adjudication Method for the Test Set:
This section is not applicable as the studies were non-clinical laboratory tests that do not involve human adjudication of results in the context of diagnostic interpretation.
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:
No MRMC comparative effectiveness study was done. This device is an ultrasound transmission gel, not an AI-powered diagnostic tool requiring human reader assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No standalone (algorithm-only) performance was done because this is a physical medical device (ultrasound transmission gel), not an algorithm or AI software.
7. The Type of Ground Truth Used:
The "ground truth" for the performance claims comes from:
- Acoustic Properties: Direct physical measurements of the gel's sound velocity, density, acoustic impedance, and attenuation coefficient.
- Antimicrobial Effectiveness: Quantitative microbial count reductions as measured by standard microbiological assays (USP ).
- Biocompatibility: Results from standardized animal (in vivo) irritation and sensitization tests (ISO 10993-10).
- In Vitro Cytotoxicity: Results from standardized cell culture tests (ISO 10993-5:2009) to assess cell viability.
8. The Sample Size for the Training Set:
This section is not applicable. This device is a physical product (ultrasound transmission gel) and does not involve AI or machine learning algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable as there is no training set for this type of device.
§ 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.