(28 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 body surface, endocavity, and intra-operative 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 body surface, endocavity and intra-operative diagnostic ultrasound. 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.
This document is a 510(k) summary for a Transducer Probe Cover. It primarily discusses the equivalence of the subject device to a predicate device, focusing on an expanded indication for use. Therefore, the information provided does not describe a study to prove the device meets acceptance criteria in the typical sense of performance metrics for an AI/algorithm-based device.
Instead, the document asserts substantial equivalence based on the device's characteristics and the performance of its predicate, along with additional biocompatibility testing for the expanded use.
Here's an analysis based on the provided text, addressing your questions where applicable and noting where the information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not detail specific acceptance criteria for performance as would be expected for an AI/algorithm. Instead, it compares the subject device's technological characteristics to predicate devices to establish substantial equivalence. The "performance" here refers to the device's characteristics fulfilling its intended purpose (acting as a barrier and not impairing ultrasound imaging).
| Characteristic | Subject Device (K241615) | Predicate Device (K221278) | Conclusion (compared to Predicate) |
|---|---|---|---|
| Product Code | ITX | ITX | Same |
| Regulation No. | 21 CFR 892.1570 | 21 CFR 892.1570 | Same |
| Class | II | II | Same |
| Intended Use/Indication for Use | Transducer Probe Cover for body surface, endocavity, and intra-operative diagnostic ultrasound. Helps prevent transfer of microorganisms, body fluids, particulate material, and maintains sterile field. | Transducer Probe Cover for external intact skin diagnostic ultrasound. Helps prevent transfer of microorganisms, body fluids, particulate material, and maintains sterile field. | Expanded scope (endocavity, intra-operative) |
| Materials & Construction | Polyurethane, tubular, sealed | Polyurethane, tubular, sealed | Same |
| Model | Various Size | Various Size | Same |
| Microbial Barrier | Meets requirements of ASTM F1671-13 for prevention of blood-borne pathogens | Meets requirements of ASTM F1671-13 for prevention of blood-borne pathogens | Same |
| Acoustic Performance | Acoustic Impedance: 1.60 x 10^6^ Pa s/m; Acoustic Velocity: 1594 m/s; Acoustic Attenuation: 0.01dB/(cm-MHZ) | Acoustic Impedance: 1.60 x 10^6^ Pa s/m; Acoustic Velocity: 1594 m/s; Acoustic Attenuation: 0.01dB/(cm-MHZ) | Same |
| Sterile | EO sterilization, SAL 10^-6^ | EO sterilization, SAL 10^-6^ | Same |
| Disposable, Single Use Only | Yes | Yes | Same |
| Shelf Life | 3 years | 3 years | Same |
| Biocompatibility | Conform with ISO10993-1 (ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11) - Additionally, Thrombogenicity and Complement Activation Testing per ISO 10993-4 were performed due to expanded contact level. | Conform with ISO10993-1 (ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11). Biocompatibility test results for predicate also valid and support proposed device. | Additional tests performed due to expanded indication |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. This submission is for a physical medical device (transducer probe cover), not an AI/algorithm. Therefore, there isn't a "test set" in the context of data for an algorithm. The evaluation is based on non-clinical testing of the physical properties and biological compatibility of the device.
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)
This information is not applicable and not provided. As this is a physical device, not an AI, there is no "ground truth" establishment by experts for a test set of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. As this is a physical device, not an AI, there is no "adjudication method" for a test set of data.
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
This information is not applicable and not provided, as this is a physical device and not an AI or AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided, as this is a physical device and not an AI/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. For this physical device, "ground truth" would refer to established standards for material properties, sterilization efficacy, biocompatibility, and barrier function, which are evaluated through standardized non-clinical tests (e.g., ASTM F1671-13 for microbial barrier, ISO 10993 for biocompatibility).
8. The sample size for the training set
This information is not applicable and not provided. As this is a physical device, not an AI/algorithm, there is no "training set" in the data science context.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As this is a physical device, not an AI/algorithm, there is no "ground truth" establishment for a "training set."
Summary of the Study and Acceptance Criteria (as interpreted for this device type):
The "study" presented here is a pre-market notification (510(k)) submission seeking to demonstrate substantial equivalence to a previously cleared predicate device (K221278), with an expanded indication for use.
The primary "acceptance criterion" for this submission is that the device is as safe, as effective, and performs as well as the legally marketed predicate device and raises no new questions of safety or effectiveness.
The "study" to prove this involves:
- Technological Characteristic Comparison: Detailed comparison of the subject device's design, materials, manufacturing, and performance characteristics (e.g., microbial barrier, acoustic properties, sterilization, shelf life) to the predicate device. The conclusion is that these characteristics are largely identical.
- Non-Clinical Testing Confirmation: Because there were no changes in materials, structure, dimensions, or performance that were deemed to impact the previous clearance, no new performance bench testing was considered necessary, except for additional biocompatibility evaluation related to the expanded indications for use.
- Biocompatibility Testing: For the expanded scope to include endocavity and intra-operative diagnostic ultrasound, additional biocompatibility tests (Thrombogenicity and Complement Activation Testing per ISO 10993-4) were conducted. The results of these tests, along with the previously reviewed biocompatibility data for the predicate, were deemed valid and supportive.
In essence, the "study" is a comparative analysis and targeted supplementary testing demonstrating that the changes (expanded indications) do not introduce new hazards and that the device remains substantially equivalent to market predicates under the new conditions of use.
§ 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.