(78 days)
No
The summary describes a standard intravascular ultrasound catheter and its components. There is no mention of AI, ML, or any advanced image processing that would suggest the use of such technologies. The performance studies focus on physical integrity, functionality, acoustic output, and in-vivo characteristics, not on algorithmic performance metrics typically associated with AI/ML.
No
The device is described as an "imaging catheter" intended for "intravascular ultrasound examination" and explicitly states it is for "imaging" and "diagnosis", not for therapy.
Yes
Explanation: The device is intended for "intravascular ultrasound examination of peripheral vessels," which is a diagnostic procedure to visualize the internal structure of blood vessels.
No
The device description clearly details a physical catheter with a transducer, drive cable, and connector, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "intravascular ultrasound examination of peripheral vessels only." This is a procedure performed within the body (in vivo) to visualize structures, not a test performed on samples taken from the body (in vitro).
- Device Description: The description details a catheter with an ultrasonic transducer designed to be inserted into blood vessels. This is consistent with an in-vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
The device is an intravascular ultrasound imaging catheter, which is a type of medical device used for diagnostic imaging within the body.
N/A
Intended Use / Indications for Use
The Atlantis™ 018 Peripheral Imaging Catheter is intended for intravascular ultrasound examination of peripheral vessels only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
ITX, OBJ
Device Description
The Atlantis™ 018 Peripheral Imaging Catheter is a sterile, single patient use 40MHz transducer imaging catheter, intended for intravascular ultrasound examination of peripheral vessels. This imaging catheter is designed to be operated with Boston Scientific Corporation (BSC) Intravascular Ultrasound (IVUS) Systems: iLab™ (K072517), Galaxy2/Galaxy (K980851), and Clearview™M Ultra (K921750).
The Atlantis™ 018 Peripheral Imaging Catheter consists of two main assemblies:
- . Imaging core
- . Catheter body
The catheter body comprises three sections:
- . Distal lumen
- . Proximal single lumen
- . Telescoping section
The distal lumen and proximal single lumen sections compose the "working length" of the catheter, and the telescoping section remains outside of the guiding catheter and/or introducer sheath. The telescoping shaft 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.
The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking 40 MHz ultrasonic transducer at the distal tip. An electro-mechanical connector interface at the proximal end makes the connection to the BSC IVUS System Motor Drive Unit (MDU).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intravascular Ultrasound (IVUS)
Anatomical Site
Peripheral vessels
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)
Non-Clinical Test Results:
- Bench Testing: Evaluated physical integrity and functionality of the catheter sheath and imaging core, including dimensional and functional verification. The device met or exceeded all required specifications.
- Acoustic Output: Testing was conducted as specified in the FDA guidance document "Information for Manufacturers Seeking Market Clearance of Diagnostic Ultrasound Systems and Transducers, issued in 1997." The test results were below the FDA Track 1 specified limits.
- Animal Testing: Evaluated the in-vivo deliverability and imaging characteristics of the catheter. The device performance demonstrated clinical acceptability for the intended use.
- Biocompatibility Testing: Tests were selected in accordance with Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, dated May 1, 1995. The test results demonstrate the device is acceptable for its intended use.
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.
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
§ 892.1570 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
Boston Scientific Corporation
Atlantis™ 018 Peripheral Imaging Catheter
| Submitted By | Boston Scientific Corporation |
|---|---|
| 47900 Bayside Parkway | |
| Fremont, CA 94538 |
| Contact Person | Emilly Tojima
Regulatory Affairs Specialist II
Tel: (510) 624-2546
Fax: (510) 624-2569
emilly.tojima@bsci.com |
| ---------------- | --------------------------------------------------------------------------------------------------------------------------- |
|---|
| Date Prepared | December 21, 2007 |
|---|---|
| Proprietary Name | Atlantis™ 018 Peripheral Imaging Catheter |
| Common Name(s) | Ultrasonic Diagnostic Imaging Catheter |
| Ultrasonic Diagnostic Transducers (ITX) | |
| Intravascular Ultrasound Catheter (OBJ) | |
| Classification Name(s) | 21 CFR Part 892. 1570 (ITX, OBJ) |
| Diagnostic Ultrasonic Transducer |
1
Image /page/1/Picture/1 description: The image shows a fraction with "52736.23" as the numerator and "13,265" as the denominator. The numerator is written above a horizontal line, and the denominator is written below the line. The numbers appear to be handwritten. The image is in black and white.
Predicate Devices
The Atlantis™ 018 Peripheral Imaging Catheter is substantially equivalent to the following devices:
| Product | 510(k) | Clearance Date |
|---|---|---|
| Atlantis™ SR Pro Coronary Imaging | ||
| Catheter | K063312 | November 30, 2006 |
| Sonicath Ultra™ Imaging Catheter | ||
| (3.2F) | K060947 | April 19, 2006 |
Description of the Device
The Atlantis™ 018 Peripheral Imaging Catheter is a sterile, single patient use 40MHz transducer imaging catheter, intended for intravascular ultrasound examination of peripheral vessels. This imaging catheter is designed to be operated with Boston Scientific Corporation (BSC) Intravascular Ultrasound (IVUS) Systems: iLab™ (K072517), Galaxy2/Galaxy (K980851), and Clearview™M Ultra (K921750).
The Atlantis™ 018 Peripheral Imaging Catheter consists of two main assemblies:
- . Imaging core
- . Catheter body
The catheter body comprises three sections:
- . Distal lumen
- . Proximal single lumen
- . Telescoping section
The distal lumen and proximal single lumen sections compose the "working length" of the catheter, and the telescoping section remains outside of the guiding catheter and/or introducer sheath. The telescoping shaft section allows the imaging core to be advanced and retracted for 15 cm of linear movement. The corresponding movement
2
of the transducer occurs from the proximal end of the wire exit port to the proximal end of the distal lumen.
The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking 40 MHz ultrasonic transducer at the distal tip. An electro-mechanical connector interface at the proximal end makes the connection to the BSC IVUS System Motor Drive Unit (MDU).
Intended Use / Indications for Use
The Atlantis™ 018 Peripheral Imaging Catheter is intended for intravascular ultrasound examination of peripheral vessels only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Device Technology Characteristics and Comparison to Predicate Device
The Atlantis™ 018 Peripheral Imaging Catheter and the predicate devices are comprised of a catheter body and an imaging core. The Atlantis™ 018 Peripheral Imaging Catheter is equivalent in terms of design, operational characteristics, and material composition to the Atlantis™ SR Pro Coronary Imaging Catheter.
In terms of intended use and operational characteristics, the Atlantis™ 018 Peripheral Imaging Catheter is equivalent to the Sonicath Ultra™ 3.2F Peripheral Imaging Catheter. The use of the device in intravascular ultrasound imaging is the same among the 2 predicate devices and Atlantis™ 018; however both Atlantis™ 018 and Sonicath Ultra™ 3.2F are indicated for peripheral use, while Atlantis™ SR Pro is indicated for coronary use.
3
Non-Clinical Test Results
The performance test results of the Atlantis™ 018 Peripheral Imaging Catheter demonstrate the device meets or exceeds the performance requirements for the specified intended use. Bench, acoustic output, animal, and biocompatibility tests were conducted on the device.
Bench Testing
Bench testing was conducted to evaluate the physical integrity and functionality of the catheter sheath and imaging core. The testing consisted of dimensional and functional verification. The Atlantis™ 018 Peripheral Imaging Catheter met or exceeded all required specifications.
Acoustic Output
Acoustic output testing was conducted as specified in the FDA guidance document Information for Manufacturers Seeking Market Clearance of Diagnostic Ultrasound Systems and Transducers, issued in 1997. The Atlantis™ 018 Peripheral Imaging Catheter test results are below the FDA Track 1 specified limits.
Animal Testing
The Atlantis™ 018 Peripheral Imaging Catheter was evaluated through animal testing to assess the in-vivo deliverability and imaging characteristics of the catheter. The device performance demonstrated clinical acceptability for the intended use.
Biocompatibility Testing
Biocompatibility tests were selected in accordance with Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, dated May 1, 1995. The biocompatibility test results demonstrate the device is acceptable for its intended use.
4
Conclusion
The Atlantis™ 018 Peripheral Imaging Catheter is substantially equivalent to the Atlantis™ SR Pro Coronary Imaging Catheter and the Sonicath Ultra™ 3.2F Peripheral Imaging Catheter. The Atlantis™ 018 Peripheral Imaging Catheter test results support the determination of substantial equivalence to predicate devices, and confirm the device is safe and effective for its intended use.
5
Public Health Service
Image /page/5/Picture/11 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2008
Boston Scientific Corporation c/o Ms. Emilly Tojima Regulatory Affairs Specialist II 47900 Bayside Parkway Fremont, CA 94538
Re: K073623
Trade Name: Atlantis 018 Peripheral Imaging Catheter Regulation Number: 21 CFR 892.1570 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Codes: ITX, OBJ Date: December 21, 2007 Received: December 26, 2007
Dear Ms. Tojima:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Trug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
6
Page 2 -- Ms. Emilly Tojima
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Bfommemasfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
510(k) Number: K073623
Device Name: Atlantis™ 018 Peripheral Imaging Catheter
Indications for Use:
The Atlantis™ 018 Peripheral Imaging Catheter is intended for intravascular ultrasound examination of peripheral vessels only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummer
n Sian-Off Vices 510