(25 days)
The ANGIODYNAMICS Accu-Vu Sizing Catheter is for use where angiographic diagnosis is indicated.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to AngioDynamics, Inc. It confirms that the AngioDynamics Accu-Vu Sizing Angiographic Catheter is substantially equivalent to legally marketed predicate devices.
*However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details typically found in a study report proving a device meets acceptance criteria.
The 510(k) letter is a regulatory approval document based on a submitted application, not the study report itself. To answer your request, I would need access to the actual 510(k) submission (Design History File Number 506), specifically the sections detailing the studies performed to demonstrate substantial equivalence.
Therefore, I cannot fill in the table or provide the requested information based solely on the text you provided.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 6 2003
AngioDynamics, Inc. c/o Teri Jucketti Regulatory Affairs Manager 603 Queensbury Avenue Queensbury, NY 12804
K032376 Re:
AngioDynamics Accu-Vu Sizing Angiographic Catheter Regulation Number: 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: July 30, 2003 Received: August 4, 2003
Dear Ms. Juckett:
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 - Ms. Teri Jucketti
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) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,
2
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
510(k) Application: Special 510(k) Device Modification
ANGIODYNAMICS Accu-Vu Sizing Angiographic Catheter Device Name:
Indications for Use:
The ANGIODYNAMICS Accu-Vu Sizing Catheter is for use where angiographic diagnosis is indicated.
Please do not write below this line - continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | ----------------------------------------- |
OR
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |
(Division Sign-Off)
Division of Cardiovascular Device:
| 510(k) Number | 14032376 |
|---|---|
| --------------- | ---------- |
4F Accu-Vu Sizing Catheter 510k Submission Design History File Number506 Page 7 of 23
§ 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).