(199 days)
No
The summary does not mention AI, ML, or any related concepts, and the device description focuses on standard ultrasound functionality.
No
The device is described as a diagnostic ultrasound transducer used for imaging and providing information about blood flow, which are diagnostic functions, not therapeutic.
Yes
The 'Intended Use / Indications for Use' section states, "The INT13 is a diagnostic ultrasound intraoperative transducer for use in abdominal surgery." Additionally, the 'Input Imaging Modality' is listed as "Diagnostic Ultrasound."
No
The device description explicitly states it is a "transducer," which is a hardware component used in ultrasound imaging.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The INT13 is a diagnostic ultrasound transducer used during abdominal surgery to image anatomy and blood flow within the body. It directly interacts with the patient's internal tissues and vessels.
- Intended Use: The intended use clearly states it's for "diagnostic ultrasound intraoperative transducer for use in abdominal surgery" and to "image abdominal anatomy during abdominal surgical procedures." This is an in-vivo (within the living body) diagnostic method.
Therefore, the INT13 falls under the category of an in-vivo diagnostic device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The INT13 is a diagnostic ultrasound intraoperative transducer for use in abdominal surgery. The transducer can be used to image abdominal anatomy during abdominal surgical procedures. In Doppler mode, the transducer can provide information about blood flow in abdominal vessels.
Product codes
Not Found
Device Description
The Esaote INT13 intraoperative transducer is designed and intended to be used in open (open as opposed to laparoscopic used with a trocar) abdominal surgical procedures. More specifically, the transducer is intended to be used to image abdominal anatomy during open surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intraoperative / Abdominal surgical procedures
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)
Hitachi Intraoperative Ultrasound Transducer EUP - 033J K884644
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Safety and Effectiveness Summary INT13 Intraoperative Diagnostic Ultrasound Transducer Biosound, Inc.
MAR - 1 1996
Safety and Effectivene
1770
1978
1 · 110 / V
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: 08-09-95
807.92(a)(2)
Trade Name: INT 13 Intraoperative Transducer
Common Name: Diagnostic Ultrasound Transducers
Classification Name(s): Transducer, Ultrasonic, Diagnostic 892.1570
807.92(a)(3)
Predicate Device(s)
- . Hitachi Intraoperative Ultrasound Transducer EUP - 033J K884644
1
K 953819
P-2q3
Safety and Effectiveness Summary INT13 Intraoperative Diagnostic Ultrasound Transchicer Biosound, Inc.
807.92(a)(4)
DEVICE DESCRIPTION
The Esaote INT13 intraoperative transducer is designed and intended to be used in open (open as opposed to laparoscopic used with a trocar) abdominal surgical procedures. More specifically, the transducer is intended to be used to image abdominal anatomy during open surgical procedures. The table below provides further descriptive information about the INT13 transducer
SPECIFICATIONS
| Operating Temperature | +5 to +35 C° |
|---|---|
| Storing Temperature | -5 to +45 C° |
| Weight | 0.3 Kg |
| Safety Requirement | IEC 601-1 (CEI62-5) |
| Operating Modes and Frequencies | |
| B - Mode | 7.5 - 10.0 Mhz |
| M - Mode | 7.5 - 10.0 Mhz |
| PW - Mode | 3.5 - 4.7 - 7.0 Mhz |
| CFM | 3.5 - 4.7 - 7.0 Mhz |
| Intended Use | Intraoperative, Abdominal |
| Technology | Linear Array |
| Cable Length | 2.5 Meters |
MATERIALS
Esaote has chosen to construct the INT13 transducer with the same materials they used in constructing the LP12 Laparoscopic probe. The LP12 device is currently under review with FDA under K941935 Esaote has received FDA's letter stating that all requirements have been satisfied for part one of K941935 (two-part submission), and that FDA is awaiting only acoustic output data. The materials for the laparoscopic probe described in K941935, and those used for the subject device, INT13, are:
PVC, Putnam Plastics Ultem, General Electric Plastics FDA, TRA-Bond Epoxy
Both probes will be used in the same type of application; abdominal intraoperative imaging
STERILIZATION
The INT13 transducer can be sterilized with Cidex™ solutions. The procedure for sterilizing the INT13 transducer is provided in the operator's manual.
2
Image /page/2/Picture/0 description: The image shows handwritten text. The first line reads "K953819". The second line reads "P. 3 of 3". The text appears to be a combination of a code or identifier and a page number.
Safety and Effectiveness Summary INT13 Intraoperative Diagnostic Ultrasound Transducer Biosound, Inc.
807.92(a)(5)
Intended Use(s)
The INT13 is a diagnostic ultrasound intraoperative transducer for use in abdominal surgery. The transducer can be used to image abdominal anatomy during abdominal surgical procedures. In Doppler mode, the transducer can provide information about blood flow in abdominal vessels.
807.92(a)(6)
Substantial Equivalence
SUBSTANTIAL EQUIVALENCE COMPARISON TABLE
| Characteristic | Esaote INT13 | Hitachi EUP 088 J
K884644 |
|-----------------|---------------------------|------------------------------|
| Intended Use | Abdominal, Intraoperative | Abdominal, Intraoperative |
| Technology | Linear Array | Linear Array |
| Frequencies Mhz | 7.5 - 10.0 | 7.5 |
| Operating Modes | B, PW, M, CFM | B, PW, M, CFM |
| Cable length | 2.5 meters | 2.2 meters |
| Safety Standard | IEC 601-1 | IEC 601-1 |
The table above illustrates the equivalence of the compared devices. The intended use, and imaging characteristics of the compared products are equivalent. The Esaote product offers more frequencies than the Hitachi product which enhances the clinical utility of the Esaote product. Based on the comparison table above, we believe the two products are substantially equivalent.