(94 days)
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No
The description focuses on mechanical function (pull back, speed selection) and does not mention any computational analysis, image processing, or learning algorithms.
No
The device is described as a "pull back accessory" for imaging catheters and is used to withdraw the catheter from the vessel. It does not directly treat a disease or condition.
No
The device is described as a "pull back accessory" for an intravascular ultrasound imaging catheter, withdrawing it from the vessel. Its function is mechanical (pulling back the catheter at a uniform speed) rather than involving the generation, processing, or interpretation of diagnostic information. It facilitates a diagnostic procedure but does not perform diagnosis itself.
No
The device description explicitly states it is a "battery powered device" and describes physical components and functions like "linear travel distance" and "pull back rate," indicating it is a hardware device with software control, not a software-only device.
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.
- Device Function: The Endosonics Automatic PBD is a mechanical device used to physically withdraw an intravascular ultrasound imaging catheter. It is an accessory to an imaging system.
- No Sample Analysis: The device does not analyze any biological samples from the patient. Its function is purely mechanical and related to the positioning of an imaging tool.
Therefore, the device's purpose and operation do not align with the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Endosonics Automatic PBD is intended for use as a pull back accessory to the Endosonics Intravascular Ultrasound Imaging catheters. The Automatic Pull Back Device withdraws the imaging catheter from the vessel through the guide catheter.
Product codes
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Device Description
The Automatic PBD is a battery powered device that is used in the catheterization laboratory during intravascular ultrasound assessment. The Automatic PBD has a nominal linear travel distance of approximately 12 cm and provides a uniform, slow pull back rate of the catheter's imaging element. The speed is selectable between 1 mm/sec or 0.5mm/sec. The Auto PBD has no direct or indirect patient contact. The device is constructed of materials common to the medical industry for both patient and non-patient contact devices and equipment
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
catheterization laboratory
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
ENDOSONICS Automatic Pull Back Device
SEP 16 '1996
As an accessory, the Automatic Pull Back Device (PBD) does not affect the safe and effective use of the Endosonics Intravascular Ultrasonic Imaging System or the Endosonics Imaging catheters.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The Automatic PBD is substantially equivalent in intended use and technologic characteristics to cardiovascular accessory devices: the CVIS Catheter Pull-Back Device and the Intertherapy Interpret Catheter Linear Translator. These predicate devices are legally commercially available.
COMPANY AND CONTACT PERSON
Endosonics Corporation 3078-B Prospect Park Drive Rancho Cordova, CA 95670
Adam Savakus Vice President, Clinical and Regulatory Affairs 916-638-8008
DEVICE NAME
Automatic Pull Back Device
PREDICATE DEVICE(S)
- CVIS Catheter Pull-Back Device 1.
- Intertherapy Interpret Catheter Linear Translator 2.
1
DESCRIPTION OF DEVICE
The Automatic PBD is a battery powered device that is used in the catheterization laboratory during intravascular ultrasound assessment. The Automatic PBD has a nominal linear travel distance of approximately 12 cm and provides a uniform, slow pull back rate of the catheter's imaging element. The speed is selectable between 1 mm/sec or 0.5mm/sec. The Auto PBD has no direct or indirect patient contact. The device is constructed of materials common to the medical industry for both patient and non-patient contact devices and equipment
STATEMENT OF INTENDED USE OF THE DEVICE
The Endosonics Automatic PBD is intended for use as a pull back accessory to the Endosonics Intravascular Ultrasound Imaging catheters. The Automatic Pull Back Device withdraws the imaging catheter from the vessel through the guide catheter.
INTENDED USE OF PREDICATE DEVICE
- The Auto PBD is intended to be used as a pull-back accessory to CVIS intravascular 1. ultrasound catheters. The Auto PBD pulls back the imaging element inside the catheter while the outer catheter body is stationary in the vessel.
- The CVIS Catheter Pull-Back Device is intended to be used for uniform, slow velocity 2. pull-back of intravascular ultrasound catheters.
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- The Intertherapy Interpret Catheter Linear Translator is intended to be used for uniform. slow velocity pull-back of intravascular ultrasound catheters.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE
The Automatic PBD and the predicate devices have substantially equivalent technological characteristics (materials, design, specifications, and mode of operation). These accessory devices have no patient contact. The devices are designed so catheters will attach to a movable carriage. The Automatic PBD incorporates pull-back rates comparable to predicate devices.