(50 days)
Exact Medical Manufacturing Ultrasonic Transducer Cover 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. This product is not intended for use of probes with endocavity or intraoperative use. The Exact Medical Manufacturing Ultrasonic Transducer Cover are also sold as bulk non-sterile, single use items, to repackager/ relabeler establishments for further packaging and ethylene oxide sterilization.
A 0.05mm thin, 50 GSM (Grams per Square Meter), translucent high strength polyurethane film tube shape, nominally 48" x 6" 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. This product is not intended for use of probes with endocavity or intraoperative use. The Exact Medical Manufacturing Ultrasonic Transducer Cover are also sold as bulk non-sterile, single use items, to repackager/relabeler/kit packers establishments for further packaging and ethylene oxide sterilization.
The provided text describes the acceptance criteria and performance of the EMM Ultrasonic Transducer Cover, which is a medical device.
1. A table of acceptance criteria and the reported device performance:
| Test Performed & Description of test | Acceptance Criteria | Reported Device Performance / Result Summary | Conclusion |
|---|---|---|---|
| Water Resistance: Impact Penetration Test, Level 3 | Blotter weight gain of no more than 1.0 g | Accept, 32 samples ≤ 1.0g (all samples = 0.0 g) | Ability of a protective product to resist the penetration of liquids and liquid-borne microorganisms according to AAMI PB70, Level 3. Substantially equivalent barrier property compared to the predicate device. |
| Water Resistance: Hydrostatic Pressure Level 3 | Hydrostatic resistance of at least 50 cm | Accept, 32 samples > 50cm (all samples ≥ 180cm) | Ability of a protective product to resist the penetration of liquids and liquid-borne microorganisms according to AAMI PB70, Level 3. Substantially equivalent barrier property compared to the predicate device. |
| Flammability of Clothing Textiles (16CFR1610) | Burn Time ≥ 3.5 seconds | Accept, 5 samples DNI (Did Not Ignite) | Able to meet and claim flammability Class 1 rating in accordance with 16CFR1610. Exceeds predicate device based upon predicate device has not been tested for this attribute. |
| Tensile properties — Part 3: Test conditions for films and sheets (ISO 527-3) | Tensile strength minimum 40N in machine direction, minimum 34N in cross direction. Elongation 108 % minimum in machine direction, 119% minimum in cross direction. | Accept, all samples passed acceptance criteria in accordance with statistical sampling plan per ISO2859-1 (otherwise, material is rejected). | Specification confirmation of tensile and elongation properties of plastic films or sheets less than 1 mm thick to assure compliant device barrier performance. Substantially equivalent tensile and elongation property compared to material specification. |
| Lint and other particles generation in the dry state (ISO 9073-10) | IPM =/≤ 3.5 (Index for Particle Matter) | Accept, IPM 1.3 (outside), IPM 0.72 (inside) | Material does not significantly generate lint or particles that may shed during an ultrasonic scan procedure. Exceeds predicate device based upon predicate device has not been tested for this attribute. |
| Acoustic Output Measurement Standard for Diagnostic Ultrasound (NEMA UD 2-2004) | Negligible effect on the transmission of ultrasound signal and does not degrade signal or image. | Accept, Speed of sound = 1698 m/sec, Acoustic Attenuation = 0.51 dB, Acoustic Impedance = 1.63 MRayl. | Based on the acoustic testing results, it was concluded that EMM's transducer/probe cover has negligible effect on the transmission of ultrasound signal and that EMM's transducer/probe cover does not degrade signal or image. Exceeds predicate device based upon predicate device has not been tested for this attribute. |
| Compatibility of ultrasonic coupling gel with polyurethane (ASTM D543-20) | (Acceptance Criteria Not Defined) | Accept, Color N=9 Pass, Dimension N=9 Pass, Weight N=9 Pass, Coordinates N=9 Pass, Mechanical Properties N=9 Pass. | Confirmation that device polyurethane material is not negatively affected by the acoustic coupling gel during an ultrasonic scanning procedure. Exceeds predicate device based upon predicate device does not provide compatibility evaluation of acoustic coupling gel with their device. |
| Ethylene Oxide Residuals (ISO 10993-7:2008) | Tolerable contact limit (TCL) for EO at 10ug/cm2 and ECH at 5mg/cm2 | Accept, Actual results for EO Residuals at Time 0 hours = 8.67ug/cm2. Actual results for ECH residuals at Time 0 hours = Not detected (within the limits of detection of 3.7ug/g). | Confirmation of maximum allowable residues for ethylene oxide (EO) within the submission device sterilized with EO and to ensure that the levels of residual EO, ethylene chlorohydrin (ECH), and ethylene glycol (EG) pose a minimal risk to the patient in normal product use. Substantially equivalent to predicate device based upon acceptable testing results that comply with testing standard. |
| In Vitro Cytotoxicity Test (ISO 10993-5;2009) | Viability is reduced |
§ 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.