(253 days)
Transducer Probe Cover placed over diagnostic ultrasound transducer/ probe scan head instruments. The cover allows use of the transducer in scanning and needle guided procedures for external intact skin diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer. The cover also provides a means for maintenance of a sterile field. Transducer Probe Cover are furnished sterile; single use patient/procedure, disposable.
The subject device is composed of transparent thin-walled polyurethane sleeve, rubber ring and (or) tape strip. A conventional 0.05mm thin, 49 GSM (Grams per Square Meter), transparent high strength polyurethane film tube shape, in various dimensions with heat sealed distal end to be applied over a transducer probe to provide a Transducer Cover that can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required. The Transducer Probe Cover is utilized by applying sterile transmission, coupling, or lubricating gel onto the transducer face or into closed end of cover, inserting ultrasound transducer into closed end of cover and unrolling cover over length of the transducer as desired, and securing open end of cover with bands as necessary the removal process is accomplished by pulling the cover off the transducer in a reverse method from the application. The subject device is furnished in sterile condition, for single use patient/procedure use, disposable. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.
The provided text describes the performance and acceptance criteria for a medical device called "Transducer Probe Cover". Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Viral Penetration | To validate the ability to withstand viral penetration per ASTM F1671-13. | Meets requirements of ASTM F1671 for prevention of blood-borne pathogens, and the material has been tested and proven to be a viral barrier for microbes 25 nanometers and larger in size. |
| Tensile | The maximum tensile force for longitudinal breaking of the membrane of the Transducer Probe Cover shall be no less than 20N, the maximum tensile force for transverse breaking shall not be less than 10N, and the elongation at break of the membrane of the disposable ultrasonic inspection sheath shall not be less than 100%. | Meets requirements of ISO 527-3:1995. Tensile strength: 37.41N/25mm, longitudinal tensile strength: 39.25N/25mm, elongation at break: 517.51% |
| Tear resistance | Under the specified conditions, test the tearing strength of the disposable ultrasonic inspection sheath is not less than 5N | Meets requirements of ISO 9073-4-2021. Longitudinal crack resistance: 16.64N, Lateral crack resistance: 17.64N |
| Water resistance | To determine the resistance of the materials to the penetration of water by impact. The time that can withstand 500mm hydrostatic pressure should not be less than 300s. | Met the requirements |
| Acoustic properties | Sound Attenuation: Measured at 35°C, Sound Attenuation shall be ≤0.1dB/(cm·MHz); Acoustic Impedance: Measured at 35°C, Acoustic Impedance shall be 1.5x10^6 - 1.7x10^6 Pa·s/m; Sound Velocity: Measured at 35°C, the Sound Velocity (Acoustic Velocity) shall be 1520-1620m/s. | Acoustic Velocity: 1594.4 m/s; Acoustic Attenuation: 0.01dB/(cm·MHz); Acoustic Impedance: 1.60 Pa·s/m. The Transducer Probe Cover does not affect the acoustic properties of the ultrasound device. |
| Force at Break and Tear Resistance Properties | To demonstrate material breaking force property and tear resistance property per ISO 527-3:2018 | Meets requirements of ISO 527-3:2018: Force at break: 28.85 N/25mm; Tear resistance: 515%. |
| Water Leakage | Watertightness Test for Detection of Holes. The subject probe cover shall be free of pinhole | No Water Leakage |
| Airburst pressure and Volume | To demonstrate the mechanical strength and durability. The Airburst Pressure shall not be less than 1.0 kpa and the volume shall be not less than 28 dm³ for cover with a mid-body width greater than or equal to 65,0 mm and less than 75,0 mm | The document states "To demonstrate the mechanical strength and |
| durability. The Airburst Pressure shall not be less | ||
| than 1.0 kpa and the volume shall be not less than | ||
| 28 dm³ for cover with a mid-body width greater | ||
| than or equal to 65,0 mm and less than 75,0 mm" but does not explicitly state the results. However, given that all other tests explicitly state "Meets requirements" or "Met the requirements", it can be inferred that this criterion was also met for the purpose of regulatory acceptance. | ||
| Ultrasound imaging effect | Ultrasound imaging is not impaired by use of the cover as it is intended | Meets requirements; The image is clear. |
2. Sample Size Used for the Test Set and the Data Provenance
The document details performance testing for various physical and acoustic properties. It does not explicitly state the sample sizes for each specific test (e.g., how many covers were tested for tensile strength). The data provenance is from bench testing conducted by Hony Medical Co., Ltd. in China. The studies described are non-clinical tests, not involving human subjects, and therefore are inherently prospective in their setup (designed and executed to prove compliance).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The tests performed are bench tests evaluating physical properties and acoustic effects of the device. There's no mention of human experts defining "ground truth" for these types of engineering and material science evaluations. The ground truth for these tests is defined by established international standards (e.g., ASTM, ISO).
4. Adjudication Method for the Test Set
Not applicable. As noted above, these are bench tests against defined international standards. There is no human interpretation or adjudication beyond the direct measurement of physical properties against a set threshold.
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. The document explicitly states: "No clinical study is included in this submission." This device is a transducer probe cover, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, as this is not an algorithm-based device. The "standalone" performance refers to the physical and acoustic properties of the cover itself.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests is established by:
- International Consensus Standards: For example, ASTM F1671-13 for viral penetration, ISO 527-3:1995 for tensile properties, ISO 9073-4-2021 for tear resistance, ISO 10993 for biocompatibility, etc.
- Defined Physical and Acoustic Parameters/Thresholds: The acceptance criteria for acoustic properties (sound attenuation, impedance, velocity) and physical properties (force at break, tear resistance, water resistance, airburst pressure) serve as the ground truth.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this 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.