(97 days)
ScanLube is an in vivo biocompatible and biodegradable sterile ultrasound couplant that will be used in coniunction with hydrogel pads, such as Sonotech's ScanTac Pad, during medical diagnostic ultrasound imaging to couple ultrasound waves between the patient and medical imaging electronics.
ScanLube converts an adhesive hydrogel surface into a lubricous surface by hydrogen bonding with the ScanTac Pad, which then facilitates scanning with an ultrasound transducer.
ScanLube is intended for use with the ScanTac Strip and ScanTac Pad in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, and within a protective sheath (probe cover) for intraoperative and endocavity ultrasound imaging.
ScanLube, when swabbed or similarly applied to the exposed surface of a hydrogel strip, such as the ScanTac Strip, when attached to the face of a transducer, converts the exposed hydrogel adhesive surface to lubricous, thus enabling the easy insertion of the hydrogel covered transducer into a transducer cover or sheath, or for scanning the patient using direct contact of the lubricous hydrogel surface.
ScanLube is unit dose packaged, sterilized and intended for use as a couplant and lubricant in all diagnostic ultrasound procedures which currently use an ultrasound coupling gel or fluid alone or in combination with a latex, polyurethane or polyethylene transducer cover where sterility and in vivo biocompatibility are required.
ScanLube may be used to lubricate the exterior surface of endocavity transducer sheaths or covers prior to insertion into the vagina or rectum. In this application, ScanLube serves both as an ultrasound couplant and instrument lubricant.
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This document is a 510(k) clearance letter from the FDA for a device named ScanLubeTM. It primarily focuses on the regulatory approval for this device as a substantially equivalent product to existing ones, rather than providing a detailed study report with specific acceptance criteria and performance data.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not available in the provided text.
Here's what can be inferred or stated based on the document's content:
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A table of acceptance criteria and the reported device performance:
- Not available. The document is a clearance letter, not a study report. It states that the device is "substantially equivalent" to legally marketed predicate devices, implying it met certain regulatory requirements, but it does not detail specific performance metrics or acceptance criteria for those metrics.
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not available. The document does not describe any specific test set or clinical study details.
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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 available. Ground truth establishment related to a test set is not discussed.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not available. Adjudication methods are not mentioned as no test set details are provided.
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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/Not available. ScanLubeTM is an ultrasonic couplant and lubricant, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this product.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not available. As above, this device is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not available. The document does not describe clinical study ground truth. The basis for substantial equivalence would likely rely on physical/chemical properties and biocompatibility testing, not diagnostic ground truth as understood for imaging algorithms.
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The sample size for the training set:
- Not applicable/Not available. This device is not an AI algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable/Not available. This device is not an AI algorithm requiring a training set.
Summary of available information related to equivalence:
- Device Name: ScanLubeTM
- Regulation Number: 21 CFR 892.1570
- Regulation Name: Diagnostic ultrasonic transducer (ScanLube is an accessory to this)
- Regulatory Class: II
- Product Code: 90 MUI
- Indication For Use: ScanLube is an in vivo biocompatible and biodegradable sterile ultrasound couplant and lubricant. It is used in conjunction with hydrogel pads (e.g., Sonotech's ScanTac Pad) during medical diagnostic ultrasound imaging to couple ultrasound waves, convert adhesive hydrogel surfaces to lubricous surfaces for easier scanning with an ultrasound transducer, and facilitate insertion of hydrogel-covered transducers into sheaths or for direct contact scanning. It is unit-dose packaged, sterilized, and intended for use in diagnostic ultrasound procedures where sterility and in vivo biocompatibility are required, including lubricating the exterior surface of endocavity transducer sheaths.
- Predicate Device: The letter states the device is substantially equivalent to "legally marketed predicate devices." Specific predicate device names are not provided in this excerpt.
- Basis for Approval: Substantial equivalence to existing predicate devices. This implies that the properties, indications for use, and performance characteristics (e.g., acoustical coupling, lubrication, sterility, biocompatibility) were demonstrated to be acceptable and similar to those of previously cleared devices. However, the exact tests and their acceptance criteria are not detailed here.
§ 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.