(48 days)
Not Found
Not Found
No
The summary describes a guiding catheter, a mechanical device, and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is a guiding catheter used for introducing other devices, not for therapeutic treatment itself.
No
The device is described as a "Guiding Catheter" used for the "intravascular introduction of interventional/diagnostic devices." Its purpose is to guide other devices, not to perform diagnosis itself.
No
The device is described as a "Guiding Catheter," which is a physical medical device used for intravascular introduction. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "intravascular introduction of interventional/diagnostic devices into coronary or peripheral vascular systems." This describes a device used within the body for accessing and delivering other devices, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: While the description is "Not Found," the intended use is the primary indicator.
- Other Sections: The absence of information related to image processing, AI/ML, input imaging modality, training/test sets, performance studies, and key metrics further supports that this is not an IVD, as these are common elements for devices that analyze biological samples or images.
Therefore, the Saffron NM™ Guiding Catheter is a medical device used for accessing and navigating within blood vessels, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Saffron NM™ Guiding Catheter is indicated for use for intravascular introduction of interventional/diagnostic devices into coronary or peripheral vascular systems.
Product codes
DQY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or peripheral vascular systems
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized eagle emblem. The eagle is depicted with three swooping lines forming its wings and body.
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
1
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
2
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