(28 days)
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.
Not Found
The provided text is a 510(k) summary for the Boston Scientific Atlantis™ SR Pro 2 Coronary Imaging Catheter. It does not contain information about acceptance criteria, device performance, specifics of a study proving those criteria, ground truth establishment, or human-in-the-loop performance. It primarily focuses on regulatory information, such as predicate devices, classification, and indications for use.
Therefore, I cannot extract the requested information from the provided text. The document is a regulatory filing, not a scientific study report describing performance metrics or validation methodologies.
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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 2Coronary ImagingCatheter (submissionalso covers SR Pro) | K050577 | March 30, 2005 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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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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 isintended for ultrasound examination of coronaryintravascular pathology only. Intravascular ultrasoundimaging is indicated in patients who are candidates fortransluminal 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
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§ 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).