(23 days)
Not Found
No
The description focuses on the physical components and materials of an intravascular ultrasound catheter and its compatibility with existing imaging systems. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as an imaging catheter for ultrasound examination of coronary intravascular pathology, specifically for diagnostic purposes, not for treating any condition.
Yes
Explanation: The device is described as an "intravascular ultrasound imaging catheter" intended for "ultrasound examination of coronary intravascular pathology," which clearly designates it for diagnostic purposes.
No
The device description clearly details a physical catheter with various components (imaging core, catheter body, transducer, drive shaft, etc.) and mentions bench and biological safety testing, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "ultrasound examination of coronary intravascular pathology ONLY." This describes a procedure performed within the body (in vivo) using imaging, not a test performed on a sample taken from the body (in vitro).
- Device Description: The description details a catheter with an ultrasonic transducer designed to be inserted into coronary vessels. This is consistent with an in vivo imaging device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis based on analysis of biological samples
The device is an intravascular ultrasound imaging catheter, which is a medical device used for diagnostic imaging within the body.
N/A
Intended Use / Indications for Use
The Atlantis SR Pro2 catheter is intended for ultrasound examination of coronary intravascular pathology ONLY. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Product codes
DQO, DQO
Device Description
The catheters included in the Atlantis™ family of intravascular ultrasound coronary imaging catheters (i.e., SR, SR Plus, SR Pro, and SR Pro') are designed to be used with the Clearview® Ultra with High Frequency (HF) option, Galaxy™ or Galaxy™ 2 intravascular ultrasound imaging instruments. These catheters are comprised of two main assemblies:
- . Imaging core
- . Catheter body
The catheter body is comprised of three sections:
- Distal lumen .
- Proximal lumen .
- . Telescoping section
The imaging core is composed of a hi-torque, flexible, rotating drive shaft with a radially-looking 40 MHz ultrasonic transducer at the distal tip. An electromechanical connector interface at the proximal end makes the connection to the Motor Drive Unit (MDU) which is in turn connected to the imaging system (e.g., Galaxy™ system). The MDU-Catheter interface consists of an integrated mechanical drive hub and an electrical connection.
The catheter body has a distal guidewire lumen with proximal exit port at approximately 1.5 cm from the distal end. The catheter body is attached to the telescope section via a male/female luer connection. A radiopaque (RO) marker is embedded in the catheter body at 0.5 cm from the distal tip. In addition, an insertion depth indicator is located on the catheter body at 105 cm, corresponding to femoral insertions.
Within the catheter body, the distal lumen and proximal lumen sections comprise the "working length" of the catheter, and the telescoping section remains outside of the quiding catheter. The telescoping section allows the imaging core to be advanced and retracted for 15 cm of linear movement. The corresponding movement of the transducer occurs from the proximal end of the wire exit port, to the proximal end of the distal lumen.
A flush port with a one-way valve is used to displace air near the transducer. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The oneway valve helps retain saline in the catheter during use.
The Atlantis SR Pro2 catheter modifications are being implemented to improve performance and functionality of the catheter. The Atlantis™ SR Pro2 catheter is the same as the Atlantis™ SR Plus catheter, except for the following changes:
- Inclusion of a hydrophilic coating (Bioslide™) to the distal 230mm portion of . the catheter sheath. The purpose of the hydrophilic-coating is to improve catheter lubricity, thus reducing catheter frictional resistance during introduction into the coronary vessel.
- A change is made to switch from Dymax adhesive 1-20271-G to Dymax . adhesive 191 M-T in the Female Telescope assembly. The Dymax adhesive 191 M-T is currently being used within the same product for the Male Telescope assembly. The reason for the change is to reduce material variability in manufacturing of the catheter, and to limit the types of adhesives used in the device. The change is being implemented based on acceptable results from verification testing, in which the bond strength met the acceptance criteria. The female telescope assembly is a section of catheter that remains external to the patient during the application of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Coronary intravascular
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)
Bench and biological safety testing demonstrate that the Atlantis™ SR Pro2 imaging catheter meets or exceeds the performance requirements and is safe and effective for its intended use. Bench testing was performed to evaluate the physical integrity and functionality of the catheter. This testing included dimensional testing, sheath bond tensile testing, and a variety of functional and performance testing of the sheath assembly, the telescope assembly, and the final sterile device. The results demonstrated that the device satisfies all performance, physical, and functional requirements. The Atlantis™ Pro2 catheter was subjected to a series of biocompatibility tests per ISO 10993, bioburden, endotoxin, sterility assurance, and latex testing. The results of the biocompatibility testing demonstrate that the catheter is acceptable for its intended use. Acoustic Output testing was not required for the Atlantis™ SR Pro2, as the addition of hydrophilic coating to the distal sheath of the catheter will not change the Acoustic Output measurement of the transducer, thus undetectable to the performance of the catheter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
MAR 3 0 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Boston Scientific/Scimed (BSS) Atlantis™ SR Pro2 Coronary Imaging Catheter
| Submitted by: | Boston Scientific/Scimed
IVUS Technology Center
47900 Bayside Parkway
Fremont, CA 94538 | | | | | | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Contact Person: | Veronica M. Kocken
Regulatory Affairs Specialist II
Tel: (510) 624-1431
Fax: (510) 624-1449
kockenv@bsci.com | | | | | | |
| Date prepared: | March 4, 2005 | | | | | | |
| Proprietary Name: | BSS Atlantis™ SR Pro² Coronary Imaging
Catheter | | | | | | |
| Common Name(s): | Ultrasound Diagnostic Imaging Catheter
Diagnostic Intravascular Catheter (74DQO)
Diagnostic Ultrasonic Transducers (90ITX) | | | | | | |
| Classification Name(s): | Diagnostic Intravascular Catheter, 21 CFR Part
870.1200 (74DQO)
Diagnostic Ultrasonic Transducer, 21 CFR Part
892.1570 (90ITX) | | | | | | |
| Predicate Device(s): | The BSS Atlantis™ SR Pro² Coronary Imaging
Catheter is substantially equivalent to the
following device:
Product 510(k) Clearance
Date Atlantis™ SR Plus
Coronary Imaging K010707 March 29,
2001 | | | | | | |
.
Coronary Imaging Catheter
1
Description of the Device:
The catheters included in the Atlantis™ family of intravascular ultrasound coronary imaging catheters (i.e., SR, SR Plus, SR Pro, and SR Pro') are designed to be used with the Clearview® Ultra with High Frequency (HF) option, Galaxy™ or Galaxy™ 2 intravascular ultrasound imaging instruments. These catheters are comprised of two main assemblies:
- . Imaging core
- . Catheter body
The catheter body is comprised of three sections:
- Distal lumen .
- Proximal lumen .
- . Telescoping section
The imaging core is composed of a hi-torque, flexible, rotating drive shaft with a radially-looking 40 MHz ultrasonic transducer at the distal tip. An electromechanical connector interface at the proximal end makes the connection to the Motor Drive Unit (MDU) which is in turn connected to the imaging system (e.g., Galaxy™ system). The MDU-Catheter interface consists of an integrated mechanical drive hub and an electrical connection.
The catheter body has a distal guidewire lumen with proximal exit port at approximately 1.5 cm from the distal end. The catheter body is attached to the telescope section via a male/female luer connection. A radiopaque (RO) marker is embedded in the catheter body at 0.5 cm from the distal tip. In addition, an insertion depth indicator is located on the catheter body at 105 cm, corresponding to femoral insertions.
Within the catheter body, the distal lumen and proximal lumen sections comprise the "working length" of the catheter, and the telescoping section remains outside
2
of the quiding catheter. The telescoping section allows the imaging core to be advanced and retracted for 15 cm of linear movement. The corresponding movement of the transducer occurs from the proximal end of the wire exit port, to the proximal end of the distal lumen.
A flush port with a one-way valve is used to displace air near the transducer. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The oneway valve helps retain saline in the catheter during use.
Atlantis SR Pro2 catheter
The Atlantis SR Pro2 catheter modifications are being implemented to improve performance and functionality of the catheter. The Atlantis™ SR Pro2 catheter is the same as the Atlantis™ SR Plus catheter, except for the following changes:
- Inclusion of a hydrophilic coating (Bioslide™) to the distal 230mm portion of . the catheter sheath. The purpose of the hydrophilic-coating is to improve catheter lubricity, thus reducing catheter frictional resistance during introduction into the coronary vessel.
- A change is made to switch from Dymax adhesive 1-20271-G to Dymax . adhesive 191 M-T in the Female Telescope assembly. The Dymax adhesive 191 M-T is currently being used within the same product for the Male Telescope assembly. The reason for the change is to reduce material variability in manufacturing of the catheter, and to limit the types of adhesives used in the device. The change is being implemented based on acceptable results from verification testing, in which the bond strength met the acceptance criteria. The female telescope assembly is a section of catheter that remains external to the patient during the application of the device.
3
Intended Use/Indications:
The Atlantis SR Pro2 catheter is intended for ultrasound examination of coronary intravascular pathology ONLY. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Device Technology Characteristics an Comparison to Predicate Device:
The BSS Atlantis™ SR Pro2 Coronary Imaging Catheter utilizes the same basic catheter design as the predicate device, the BSS Atlantis™ SR Plus Coronary Imaging Catheter, cleared in March 29, 2001, and the current Atlantis™ SR Pro, cleared via internal documentation (letter-to-file dated, February 14, 2003 and January 27, 2004). These devices have the same intended use, use the same operating principal, incorporate that same basic catheter design, have the same shelf life, and are packaged using the same materials and processes. The two modifications from the Atlantis™ SR Pro to the Atlantis™ SR Pro2, is the addition of lubricous hydrophilic coating (Bioslide™) to distal segment (230mm minimum) of the catheter sheath, and the use of Dymax 191 M-T adhesive on the telescope assembly.
Non-clinical Test Results:
Bench and biological safety testing demonstrate that the Atlantis™ SR Pro2 imaging catheter meets or exceeds the performance requirements and is safe and effective for its intended use.
Bench Testing:
Bench testing was performed to evaluate the physical integrity and functionality of the catheter. This testing included dimensional testing, sheath bond tensile testing, and a variety of functional and performance testing of the sheath assembly, the telescope assembly, and the final sterile device. The results demonstrated that the device satisfies all performance, physical, and functional requirements.
4
Biological Safety Testing:
The Atlantis™ Pro2 catheter was subjected to a series of biocompatibility tests per ISO 10993, bioburden, endotoxin, sterility assurance, and latex testing. The results of the biocompatibility testing demonstrate that the catheter is acceptable for its intended use.
Acoustic Output Testing:
Acoustic Output testing was not required for the Atlantis™ SR Pro2, as the addition of hydrophilic coating to the distal sheath of the catheter will not change the Acoustic Output measurement of the transducer, thus undetectable to the performance of the catheter.
Per the FDA Guidance, Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 30 1997), Acoustic Output measurements for the Atlantis™ SR Pro2 catheter remains unchanged from its predicate device, the Atlantis™ SR Plus catheter and the Atlantis™ SR Pro catheter for which a letter-to-file was documented.
Table 2 of this submission provides the Acoustic Output equivalency comparison, followed by a rationale for not conducting Acoustic Output testing on the Atlantis™ SR Pro2 coronary catheter.
Conclusion:
The BSS Atlantis™ SR Pro2 Coronary Imaging Catheter utilizes the same design features and has the same intended use as the predicate device, the Atlantis™ SR Plus Coronary Imaging Catheter. The tests support a determination of substantial equivalence of the modified device, the Atlantis™ SR Pro2 Coronary Imaging Catheter to its predicate device.