(256 days)
Not Found
No
The document describes diagnostic ultrasound transducers and does not mention AI, ML, or any related image processing or analytical capabilities.
No
The device is described as "diagnostic ultrasound transducers" with an "Intended Use / Indications for Use" focused on different anatomical sites (Vascular, Transcranial, Cardiac), explicitly stating its diagnostic purpose. There is no mention of treating or preventing diseases or conditions.
Yes
The "Device Description" explicitly states, "The subject devices are diagnostic ultrasound transducers." Additionally, the predicate devices are listed as "Diagnostic Ultrasound Transducer."
No
The device description explicitly states the subject devices are "diagnostic ultrasound transducers," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound transducers" for imaging various anatomical sites (Vascular, Transcranial, Cardiac). This is consistent with medical imaging devices used to visualize internal structures, not devices used to examine specimens (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: The description confirms they are "diagnostic ultrasound transducers."
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any other elements typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is used to generate images of the body directly.
N/A
Intended Use / Indications for Use
P12A - Vascular
PT10A - Transcranial
P10A - Cardiac
PA11A - Cardiac/ Transcranial
Product codes (comma separated list FDA assigned to the subject device)
FI 33
Device Description
The subject devices are diagnostic ultrasound transducers described in the following tables.
PA11-A
MODES: B mode, M mode, PW mode, CW mode, CFM mode, Power Color
CHARACTERISTICS:
Frequency: 2.5/3.5 MHz (B/M mode), 2.3/2.8 MHz (PW/CW/CFM mode)
Elevation & Focal Point: 80 mm
Angle: 30-90 deg.
Depth: 55.3 + 260 mm
Connector: Both Electronical connectors
Cable length: 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
P10A, P12A, PT10A
MODE: CW
P10A:
Frequency: 2.5 MHz
Connector: Both Mechanical connectors
Cable length (meters): 1850 mm
Operating Temperature (deg.C): from +10 to +40
Storing temperature (deg.C): from -5 to +45
Weight (Kg): 200 G.
Safety Requirements: IEC 601-1(CEI62-5)
Application: Cardiac
P12A:
Frequency: 5.0 MHz
Connector: Both Mechanical connectors
Cable length (meters): 1850 mm
Operating Temperature (deg.C): from +10 to +40
Storing temperature (deg.C): from -5 to +45
Weight (Kg): 200 G.
Safety Requirements: IEC 601-1(CEI62-5)
Application: Vascular
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic Ultrasound
Anatomical Site
Vascular, Transcranial, Cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Safety and Effectiveness Summary Diagnostic Ultrasound Transducers, PIOA, PIZA, PTI0A, PAH-A Biosound, Inc.
Image /page/0/Picture/1 description: The image shows the logo for BIOSOUND, which is written in all caps and in a bold, sans-serif font. Below the logo, it says "AN ISAIALI COMPANY". Above the logo, there is a handwritten number that appears to be K9535-30.
APR - 8 1996
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
FI 33
Biosound, Inc. - An I saure Gompany 7990 Gastleway Urive - Indianapoles. IN 46250 317 8491793 800 - 428 4374 - 1AX 217 - 841 8516
1
1
Safety and Effectiveness Summary Diagnostic Ultrasound Transducers, PIOA, PI2A, PT10A, PA11-A Brosound, Inc.
^^7 92(a)(3)
Predicate Device(s)
- Esaote P10 Diagnotic Ultrasound Transducer K896356 .
- Esaote P12 Diagnotic 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 |
| 10A | 2.3 | P10 | 2.5 | Cardiac |
| ESAOTE AU4 | Frequency MHz | Predicate Device | Frequency MHz | Application |
|---|---|---|---|---|
| PT10A | 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..
| 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 Electronical 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 |
PA11-A
3
Safety and Effectiveness Summary Diagnostic Ultrasound Transducers, P10A, P12A, PT10A, PA11-A Brosound, 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