(39 days)
No
The description focuses on the mechanical and electrical components of an ultrasound imaging catheter and its compatibility with existing imaging systems. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as an "Imaging Catheter" for "ultrasound examination of peripheral pathology only" and its intended use is for "intravascular ultrasound imaging." These descriptions align with diagnostic rather than therapeutic purposes.
Yes
The device is intended for "ultrasound examination of peripheral pathology only" and "intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures," which describes a diagnostic purpose.
No
The device description clearly details a physical catheter with a transducer, drive cable, and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, the Atlantis™ PV Imaging Catheter is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states "ultrasound examination of peripheral pathology only" and "Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures." This describes a device used in vivo (within the living body) for imaging, not a device used in vitro (outside the living body) to examine specimens derived from the body.
- Device Description: The description details a catheter designed to be inserted into blood vessels for imaging. This is consistent with an in vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or performing tests on specimens outside the body, which are hallmarks of IVD devices.
Therefore, the Atlantis™ PV Imaging Catheter is an in vivo imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Atlantis™ PV Imaging Catheter is intended for ultrasound examination of peripheral pathology 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™ PV imaging catheter (H749364560) is a sterile, single use, over-the-wire (OTW) imaging catheter with a 8F distal crossing profile and a transducer capable of producing a frequency of 15MHz and a 8F distal crossing profile. This imaging catheter is designed to be operated with Boston Scientific Corporation (BSC) Intravascular Ultrasound Imaging Systems: iLab™ (K072517), Galaxy2/Galaxy™ (K980851), and Clearview™ Ultra (K921750).
The Atlantis™ PV catheter consists of two main assemblies:
- . Catheter body
- Imaging Core .
The catheter body is comprised of two sections:
- . Dual lumen
- Telescoping section (shaft) .
The dual lumen section is the "working length" of the catheter. The dual lumen is an over-the-wire (OTW) design containing an imaging core lumen and a guidewire lumen. The telescoping section remains outside of the introducer sheath. The telescoping shaft allows the imaging core to be advanced and retracted for 25 cm of linear movement. The corresponding movement of the transducer occurs inside the imaging core lumen. The catheter body is attached to the telescope shaft via a y-manifold with male/female luer connection. The straight leg of the y-manifold is the guidewire exit port with a female luer thread. The luer thread allows flushing of the guidewire lumen.
The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking ultrasonic transducer at the distal tip. The distal ends of the imaging core and the catheter body are radiopaque for visualization of the imaging plane and the catheter tip. An electro-mechanical connector interface at the proximal end makes the connection to the Motor Drive Unit (MDU) / Instrument. The MDU-catheter interface consists of an integrated mechanical drive hub and electrical connection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Peripheral pathology, 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)
The performance test results for bench, biocompatibility and sterility testing of the Atlantis™ PV Imaging Catheter demonstrate that the device meets or exceeds the performance requirements for the specified 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.
K072517, K980851, K921750, K022860, K041727, K050684
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
CONFIDENTIAL
MAR 1 1 2008
510(k) Summary of Safety and Effectiveness
Boston Scientific Corporation
Atlantis™ PV Imaging Catheter
| Submitted By | Boston Scientific Corporation
49700 Bayside Parkway
Fremont, CA 94538 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Janice Brown
Director, Regulatory Affairs
Tel: (510) 624-2582
Fax: (510) 624-2569
janice.brown@bsci.com |
| Date Prepared | January 31, 2008 |
| Proprietary Name | AtlantisTM PV Imaging Catheter |
| Common Name(s) | Ultrasonic Diagnostic Transducer
Ultrasonic Intravascular Catheter |
| Classification
Name(s) | 21 CFR 892.1570 (ITX)
Transducer, Ultrasonic, Diagnostic
21 CFR 870.1200 (OBJ)
Catheter, Ultrasound Intravascular |
Predicate Device
.
The Atlantis™ PV Imaging Catheter is substantially equivalent to the following predicate device:
| Name | Manufacturer | 510(k) Number |
|---|---|---|
| Atlantis™ PV Imaging | ||
| Catheter | Boston Scientific Corporation | K050684 |
1
Description of the Device
The Atlantis™ PV imaging catheter (H749364560) is a sterile, single use, over-the-wire (OTW) imaging catheter with a 8F distal crossing profile and a transducer capable of producing a frequency of 15MHz and a 8F distal crossing profile. This imaging catheter is designed to be operated with Boston Scientific Corporation (BSC) Intravascular Ultrasound Imaging Systems: iLab™ (K072517), Galaxy2/Galaxy™ (K980851), and Clearview™ Ultra (K921750).
The Atlantis™ PV catheter consists of two main assemblies:
- . Catheter body
- Imaging Core .
The catheter body is comprised of two sections:
- . Dual lumen
- Telescoping section (shaft) .
The dual lumen section is the "working length" of the catheter. The dual lumen is an over-the-wire (OTW) design containing an imaging core lumen and a guidewire lumen. The telescoping section remains outside of the introducer sheath. The telescoping shaft allows the imaging core to be advanced and retracted for 25 cm of linear movement. The corresponding movement of the transducer occurs inside the imaging core lumen. The catheter body is attached to the telescope shaft via a y-manifold with male/female luer connection. The straight leg of the y-manifold is the guidewire exit port with a female luer thread. The luer thread allows flushing of the guidewire lumen.
The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking ultrasonic transducer at the distal tip. The distal ends of the imaging core and the catheter body are radiopaque for visualization of the imaging plane and the catheter tip. An electro-mechanical connector interface at the proximal end makes the connection to the Motor Drive Unit (MDU) / Instrument. The MDU-catheter interface consists of an integrated mechanical drive hub and electrical connection.
Intended Use/Indications for Use
The Atlantis™ PV Imaging Catheter is intended for ultrasound examination of peripheral pathology 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™ PV Imaging Catheter and its predicate device are comprised of a catheter body and an imaging core. They are similar in terms of their intended use, fundamental technology, operating principle, and catheter design. Modifications to the Atlantis™ PV
2
Boston Scientific Corporation
Imaging Catheter, the subject of this submission, include design, material, and labeling changes.
Non-Clinical Test Results
The performance test results for bench, biocompatibility and sterility testing of the Atlantis™ PV Imaging Catheter demonstrate that the device meets or exceeds the performance requirements for the specified intended use.
Conclusion
The modified Atlantis™ PV Imaging Catheter is substantially equivalent to its predicate device. The test results support the determination that the two devices are substantially equivalent, and confirm the device is safe and effective for its intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 2008
Boston Scientific Corporation c/o Ms. Janice Brown Director, Regulatory Systems IVUS Technology Center 47900 Bayside Parkway Fremont, CA 94538-6515
Re: K080272
Atlantis PV Imaging Catheter Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasound Transducer Regulatory Class: Class II (two) Product Code: ITX, OBJ Dated: January 31, 2008 Received: February 1, 2008
Dear Ms. Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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, Drug, and Cosmetic Act (Act). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the iLab™, Galaxy2/Galaxy™, and Clearview™™ Ultra Intravascular Ultrasound Imaging Systems, as described in your premarket notification:
Atlantis TM PV Imaging Catheter, Model H749364560
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
4
Page 2 -- Ms. Janice Brown
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.
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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, vou submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your 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 market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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
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Page 3 – Ms. Janice Brown
If you have any questions regarding the content of this letter, please contact Lisa E. Leveille at (240) 276-4095.
Sincerely yours,
Pam D. Zuckerman, M.D.
am D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number: Ko80272
Device Name: Atlantis™ PV Imaging Catheter
Indications for Use:
The Atlantis™ PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Prescription Use ਨ (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)
Devices 51000 Numbe
Traditional 510(k) Atlantis ™ PV Imaging Catheter January 31, 2008
7
Attachment 2.0 Diagnostic Indications for Use Form Atlantis™ PV Imaging Catheter
Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the human body as follows:
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color Velocity
Imaging | Combined
(specify) | Other
(specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|---------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
(specify) | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | P | | | | | | | | |
| Peripheral
Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = New indication; P = Previously cleared by FDA; E = Added under Appendix E Additional Comments: Cleared under K022860 (November 21, 2002), K041727 (cleared July 23, 2004) and K050684 (cleared May 20, 2005)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Traditional 510(k) Atlantis ™ PV Imaging Catheter January 31, 2008