(34 days)
The Atlantis™ SR and Atlantis™ SR PLUS Imaging Catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound is indicated in patients who are candidates for transluminal coronary interventional procedures.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Boston Scientific Corporation for their Atlantis™ SR and Atlantis™ SR PLUS Imaging Catheters. This letter approves the marketing of the device based on substantial equivalence to a legally marketed predicate device.
Crucially, this document does NOT contain a study or data proving the device meets specific acceptance criteria.
The 510(k) process in 2004 primarily relied on demonstrating substantial equivalence to a predicate device, meaning it's as safe and effective as a device already on the market. It often does not require detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) would.
Therefore, I cannot provide the requested information from the given text because the text does not include a study or its results. It is simply an FDA clearance letter.
To fully answer your prompt, I would need a document detailing the studies conducted, their methodology, and results, which are typically found in the 510(k) submission itself, not the FDA's clearance letter.
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2004
Boston Scientific Corporation c/o Mr. Robert Z. Phillips Manager, Regulatory Affairs Ivus Technology Center 47900 Bayside Parkway Fremont, CA 94538
Re: K040776
Ro40770
Trade Name: Atlantis ™ SR and Atlantis ™ SR PLUS Imaging Catheters Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II (two) Product Code: DQO Dated: March 24, 2004 Received: March 26, 2004
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. Robert Z. Phillips
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 Office of Compliance at (301) 594-4648. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dona R. Lochner
A 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
KO40776 510(k) Number: Atlantis™ SR and Atlantis™ SR PLUS Imaging Catheters Device Name: The Atlantis™ SR and Atlantis™ SR PLUS Imaging Indications for Use: Catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound is indicated in patients who are candidates for transluminal coronary interventional procedures.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dana R. LaClines
(Division Sian-Off Division of Cardiovascular Devices
510(k) Number K040776
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801. 109)
Confidential
§ 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).