(48 days)
The Saffron NM™ Guiding Catheter is indicated for use for intravascular introduction of interventional/diagnostic devices into coronary or peripheral vascular systems.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Saffron NM™ Guiding Catheter." It is not a study demonstrating the device meets acceptance criteria.
The 510(k) process is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving individual performance metrics in the same way a clinical trial for a new drug or a novel AI algorithm would.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not present in this document. This letter simply states that the FDA has determined the device is "substantially equivalent" to predicate devices for its stated indications for use.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2003
Neich Medical (Shenzhen) Co., Ltd. Mr. Raymond Lin Manager, Regulatory Affairs No. 1 Jinkui Road Futian Free Trade Zone Shezhen 518038, China
Re: K030715
Trade/Device Name: Saffron NM™ Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: April 14, 2003 Received: April 16, 2003
Dear Mr. Lin:
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. Iisting 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.
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
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Page 2 - Mr. Raymond Lin
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,
V. Qalln T.M.
B. Zaleski, M.D.
ckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 3 – Indications for Use
: 上一篇:
The Saffron NM™ Guiding Catheter is indicated for use for intravascular introduction of interventional/diagnostic devices into coronary or peripheral vascular systems.
Prescription Use Only
Koffler
(Division Sian-Division of Cardiovascular Devices
510(k) Number K030745
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).