← Product Code [IYO](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO) · K953530 # DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A (K953530) _Biosound, Inc. · IYO · Apr 8, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO/K953530 ## Device Facts - **Applicant:** Biosound, Inc. - **Product Code:** [IYO](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO.md) - **Decision Date:** Apr 8, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1560 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The intended use is specific for each transducer: P12A - Vascular PT10A - Transcranial P10A - Cardiac PA11A - Cardiac/ Transcranial ## Device Story Diagnostic ultrasound transducers (P10A, P12A, PT10A, PA11-A) used for medical imaging. Devices convert electrical signals into ultrasonic waves and receive reflected echoes to produce diagnostic images or measurements. Operated by clinicians in clinical settings. PA11-A supports B-mode, M-mode, PW, CW, CFM, and Power Color modes; P10A, P12A, and PT10A are CW transducers. Output displayed on compatible ultrasound systems to assist in clinical diagnosis of cardiac, vascular, and transcranial structures. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Diagnostic ultrasound transducers with operating frequencies ranging from 2.0 to 5.0 MHz. PA11-A features electronic connectors; P10A, P12A, and PT10A feature mechanical connectors. Safety requirements meet IEC 601-1 (CEI 62-5). Operating temperature range +10 to +40°C. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Esaote P10 Diagnostic Ultrasound Transducer ([K896356](/device/K896356.md)) - Esaote P12 Diagnostic Ultrasound Transducer ([K896356](/device/K896356.md)) - Esaote SMA26 Diagnostic Ultrasound Transducer ([K944485](/device/K944485.md)/S3) - Acuson S228 Diagnostic Ultrasound Transducer ([K902515](/device/K902515.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Safety and Effectiveness Summary Diagnostic Ultrasound Transducers, P10A, P12A, PT10A, PA11-A Biosound, Inc. APR - 8 1995 K953530 BIOSOUNI AN ISADIE COMPANY # Safety and Effectiveness Summary The following safety and effectiveness summary has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR ¶807.92(a). 807.92(a)(1) ## Submitter Information Wayne Nethercutt Director, Regulatory Affairs 7990 Castleway Drive Indianapolis, IN 46250 Phone: (317) 849-1793 Facsimile: (317) 841-8616 Contact Person: Wayne Nethercutt Date: 07-18-95 807.92(a)(2) Trade Name: P10A, P12A, PT10A, PA11-A Common Name: Diagnostic Ultrasound Transducers Classification Name(s): Transducer, Ultrasonic, Diagnostic 892.1570 Biosound, Inc. - An Isadie Company 7990 Castleway Drive - Indianapolis, IN 46250 317 849 1793 800 429 4374 FAX 317 841 8616 {1} Safety and Effectiveness Summary Diagnostic Ultrasound Transducers, P10A, P12A, PT10A, PA11-A Biosound, Inc. 7.92(a)(3) # Predicate Device(s) - Esaote P10 Diagnostic Ultrasound Transducer K896356 - Esaote P12 Diagnostic Ultrasound Transducer K896356 - Esaote SMA26 Diagnostic Ultrasound Transducer K944485/S3 - Acuson S228 Diagnostic Ultrasound Transducer K902515 Additional Substantial Equivalence information is provided in the attached Substantial Equivalence Comparison Table. 807.92(a)(6) ## SUBSTANTIAL EQUIVALENCE COMPARISON TABLE | ESAOTE AU4 | Frequency MHz | Predicate Device | Frequency MHz | Application | | --- | --- | --- | --- | --- | | | | Esaote AU530 510 (k): 896356 | | | | P12A | 4.7 | P12 | 5.0 | Vascular | | 1OA | 2.3 | P1O | 2.5 | Cardiac | | ESAOTE AU4 | Frequency MHz | Predicate Device | Frequency MHz | Application | | --- | --- | --- | --- | --- | | PT1OA | 2.0 | Acuson Probe S228 Cleared via K902515 | 2.0 | Transcranial | | ESAOTE AU4 Code | Frequency MHz | Predicate Device | Frequency MHz | Application | | --- | --- | --- | --- | --- | | PA11-A | 2.5 - 3.5 B-Mode 2.3 - 2.8 PW/CFM/CW | Esaote Probe: SMA26 Cleared via K944485/S3 | 2.5 - 3.5 | Cardiac | | | 2.5 - 3.5 B-Mode 2.3 - 2.8 PW/CFM/CW | Acuson Probe S228 Cleared via K902515 | 2.0 - 2.5 | Transcranial | {2} Safety and Effectiveness Summary Diagnostic Ultrasound Transducers, P10A, P12A, PT10A, PA11-A Biosound, Inc. 807.92(a)(4) # Device Description The subject devices are diagnostic ultrasound transducers described in the following tables. ## PA11-A | MODES | CHARACTERISTICS | | --- | --- | | B mode | 2.5/3.5 MHz | | M mode | 2.5/3.5 MHz | | PW mode | 2.3/2.8 MHz | | CW mode | 2.3/2.8 MHz | | CFM mode | 2.3/2.8 MHz | | Power Color | 2.3/2.8 MHz | | Elevation & Focal Point | 80 mm | | Angle | 30-90 deg. | | Depth | 55.3 ÷ 260 mm | | Connector | Both Electronic connectors | | Cable length (meters) | 2.00 mt. | | Operating Temperature (deg.C) | from +10 to +40 | | Storing temperature (deg.C) | from -5 to +45 | | Weight (Kg) | 500 G. | | Safety Requirements | IEC 601-1(CEI62-5) | | Application | Cardiac Transcranial | {3} Safety and Effectiveness Summary Diagnostic Ultrasound Transducers, P10A, P12A, PT10A, PA11-A Biosound, Inc. # P10A, P12A, PT10A | MODES | P10A | P12A | | --- | --- | --- | | MODE | CW | CW | | Frequency | 2.5 MHz | 5.0 MHz | | Connector | Both Mechanical connectors | Both Mechanical connectors | | Cable length (meters) | 1850 mm | 1850 mm | | Operating Temperature (deg.C) | from +10 to +40 | from +10 to +40 | | Storing temperature (deg.C) | from -5 to +45 | from -5 to +45 | | Weight (Kg) | 200 G. | 200 G. | | Safety Requirements | IEC 601-1(CEI62-5) | IEC 601-1(CEI62-5) | | Application | Cardiac | Vascular | 807.92(a)(5) ## Intended Use(s) The intended use is specific for each transducer: P12A - Vascular PT10A - Transcranial P10A - Cardiac PA11A - Cardiac/ Transcranial --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO/K953530](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYO/K953530) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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