(28 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered image analysis or interpretation. The device appears to be a standard intravascular ultrasound catheter.
No
The device is described as an "imaging catheter" intended for "ultrasound examination of coronary intravascular pathology only." This indicates a diagnostic rather than a therapeutic purpose.
Yes
The device is described as an "ultrasound examination of coronary intravascular pathology," which clearly indicates its purpose is to identify or characterize a disease state (pathology).
No
The device is described as a "Coronary Imaging Catheter," which is a physical hardware device used for intravascular ultrasound. The summary does not mention any software component as the primary or sole medical device.
Based on the provided information, the Atlantis™ SR Pro 2 Coronary Imaging Catheter 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 device used within the body for imaging, not a test performed on samples taken from the body (which is the definition of an in vitro diagnostic).
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- Input Imaging Modality: Ultrasound is an imaging technique applied to the body, not a method for analyzing biological samples.
- Anatomical Site: "Coronary intravascular" refers to the inside of coronary blood vessels, which is within the body.
IVD devices are designed to examine specimens such as blood, urine, tissue, etc., outside of the body to provide information about a person's health. This device is used for direct imaging within the body.
N/A
Intended Use / Indications for Use
The Atlantis™ SR Pro 2 Coronary Imaging 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, ITX
Device Description
Not Found
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)
Not Found
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).
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Image /page/0/Picture/1 description: The image shows the logo for Boston Scientific. The text is in a serif font, with "Boston" on the top line and "Scientific" on the bottom line. The logo is black and white.
NOV 3 v 2006
510(k) Summary of Safety and Effectiveness
Boston Scientific Corporation
Atlantis™ SR Pro 2 Coronary Imaging Catheter Atlantis™ SR Pro Coronary Imaging Catheter
Boston Scientific Corporation Submitted By: IVUS Technology Center 47900 Bayside Parkway Fremont, CA 94538
- Robert Z. Phillips Contact Person: Manager, Regulatory Affairs Tel: (510) 624-2307 Fax: (510) 624-1449 robert.phillips@bsci.com
- October 31, 2006 Date Prepared:
- Atlantis™ SR Pro 2 Coronary Imaging Catheter Proprietary Name(s): Atlantis™ SR Pro Coronary Imaging Catheter
- Ultrasound Diagnostic Imaging Catheter Common Name(s): Diagnostic Intravascular Catheter (74DQO) Diagnostic Ultrasonic Transducer (90ITX)
- Diagnostic Intravascular Catheters, 21 CFR 870.1200 (74DQ0) Classification Name(s): Diagnostic Ultrasonic Transducers, 21 CFR 892.1570 (90ITX)
- Atlantis™ SR Pro 2 and SR Pro Coronary Imaging Predicate Device(s): Catheters are substantially equivalent to the following device(s):
| Predicate | 510(k) | Clearance Date |
|---|---|---|
| Atlantis™ SR Pro 2 | ||
| Coronary Imaging | ||
| Catheter (submission | ||
| also covers SR Pro) | K050577 | March 30, 2005 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corp. c/o Robert Phillips Manager, Regulatory Affairs 47900 Bayside Parkway Fremont, CA 94538
NOV 3 0 2006
Re: K063312
Trade/Device Name: Atlantic SR Pro.2 Coronary Imaging Catheter, Atlantis SR Pro Coronary Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: DQO, ITX Dated: November 1, 2006 Received: November 2, 2006
Dear Mr. Phillips:
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, Drug, 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.
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Page 2 - Mr. Phillips
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 Office of Compliance at (240) 276- (see bottom for #s). 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.
Sincerely yours,
Duna R. Vochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the words "Boston Scientific" stacked on top of each other. The words are in a serif font and are black. The word "Boston" is on top and is slightly smaller than the word "Scientific" below it.
Indications for Use Statement
| 510(k) Number: | K063312 |
|---|---|
| Device Name: | Atlantis™ SR Pro 2 Coronary Imaging Catheter |
| Indications for Use: | The Atlantis™ SR Pro 2 Coronary Imaging 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. |
X Prescription Use_ (Part 21 CFR 801 Subpart D) Over-The-Counter Use_ (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. Lochner
(Division Sign-Off) Tivision of Cardiovascular Devices
310(k) Number K063312
Image /page/3/Picture/11 description: The image shows the word "Confidential" at the top, indicating the sensitive nature of the document. Below that, the word "Page" is written, followed by the number 256, which likely refers to the page number within the document. The text is written in a simple, clear font, and the overall layout is straightforward.