(161 days)
Not Found
Not Found
No
The summary describes a diagnostic catheter for delivering contrast medium, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
Explanation: The device is described as a "Diagnostic Catheter" and is "designed to deliver radiopaque contrast medium to selected sites in the vascular system," which indicates a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" states that the device is a "Diagnostic Catheter."
No
The device description clearly identifies it as a "Diagnostic Catheter," which is a physical medical device used to deliver contrast medium. There is no mention of software as 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 is to "deliver radiopaque contrast medium to selected sites in the vascular system." This describes a device used within the body for imaging purposes, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description is for a "Diagnostic Catheter," which is consistent with a device used for in-vivo procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on the analysis of these samples.
Therefore, the Neich Modical Creation NM™ Diagnostic Catheter is a medical device used for in-vivo procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
Neich Modical Creation NM™ Diagnostic Catheters are designed to deliver radiopaque contrast thediturn to selected sites in the vascular system.
Product codes
DQO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
§ 870.1200 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).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
FEB 2 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Neich Medical (Shenzhen) Co., Ltd. c/o Mr. Raymond Lin No 1. Jinkui Road, Futian Free Trade Zone Shenzhen 518038, China
K032888 Crcation NMTM Diagnostic Catheters Regulation Number: 870.1200 Regulation Name: Catheter, Intravascular, Diagnostic Regulatory Class: Class II Product Code: DQO Dated: December 16, 2003 Received: January 13, 2004
Dear Mr. Lin:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaren o rely fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cholosure) to regars the Medical Device Amendments, or to commence print to May 20, 1978, the encordance with the provisions of the Federal Food, DNA and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costlictic Act (71ct) that to not required to the general controls provisions of the Act. The r ou may, therefore, mainte of the Act include requirements for annual registration, listing of general controls promotive, 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to saterial Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Coursements concerning your device in the Federal Register.
1
Page 2 – Mr. Raymond Lin
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a substinates with other requirements of the Act
that FDA has made a determination that your device also anancies. You must that FDA has made a determilation that your areas by other Federal agencies. You must or any Federal statutes and regulations and limited to: registration and listing (2)
comply with all the Act's requirements, including, but not be registration asset comply with all the Act S requirements, increases and manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good if applicable, the electronic CFR Part 807); labeling (21 CFX 1 all 801); good manata 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and 11, CFP 100 forth in the quality systems (QS) regulation (21-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Scellons 55 r c vice as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a l This letter will anow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, p premarket notification. The PDA initing of substantial equive and thus, permits your device to proceed to the market.
lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r the If you desire specific advice for your device of our car idocing.
contact the Office of Compliance at (301) 594-4646. Additionally, for questions of Compliance at 3 contact the Office of Compliance at (301) 59 + 10 + 1 cc the Office of Compliance at (301) 594promotion and advertising of your device, please contact the office of Complia promotion and advertising of your de reatified. "Misbranding by reference to premarket 46.39. Also, please note the regulation only obtain. Other general information on your notification" (21CFR Fall 807.97) you may obtained from the Division of Small Manufacturers, responsibilities under the Acc may of Counties (800) 638-2041 or (301) 443-6597
International and Consumer Assistance at its toll-free number (800) 443-6597
International and International and Consumer : //www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dina R. Richter
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Instructions For Use
510(K) Number: K032888
Device Name: Creation NM™ Diagnostic Catheter
Indications For Use:
.7
Neich Modical Creation NM™ Diagnostic Catheters are designed to deliver radiopaque contrast thediturn to selected sites in the vascular system,
Prescription Use (Part 21 CFR $01 Subpart D)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uma R. V. Aunes
sion Sir -Off) (Div Division of Cardiovascul Devices
510(k) Number_Ko32888