DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A

• K Number: K953530
• Device Name: DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A
• Manufacturer: BIOSOUND, INC.
• Date Cleared: 1996-04-08 ( 256 days)
• Product Code: IYO
• Regulation Number: 892.1560
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: K896356 , K902515

Intended Use

The intended use is specific for each transducer: P12A - Vascular PT10A - Transcranial P10A - Cardiac PA11A - Cardiac/ Transcranial

Device Description

The subject devices are diagnostic ultrasound transducers described in the following tables.

AI/ML Overview

The provided text is a summary for diagnostic ultrasound transducers and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It primarily focuses on:

• Submitter Information: Company details and contact person.
• Device Identification: Trade names, common names, and classification names.
• Predicate Devices: Listing of previously cleared devices considered substantially equivalent.
• Device Description: Technical specifications of the P10A, P12A, PT10A, and PA11-A transducers, including modes, frequencies, physical characteristics, and safety requirements.
• Intended Uses: Specific applications for each transducer (Vascular, Transcranial, Cardiac).

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document serves as a 510(k) summary, which is typically a high-level overview for regulatory submission, rather than a detailed report of performance studies or acceptance criteria.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.