(137 days)
Not Found
No
The summary describes a standard angiographic catheter and does not mention any AI or ML components or functionalities.
No
The device is described as being used for delivering radiopaque media for diagnostic procedures, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures." This indicates its role in facilitating diagnostic processes.
No
The device description clearly states it is a physical catheter, a hardware component, and does not mention any software functionality.
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 media to selected sites in the vascular system for diagnostic procedures and potentially for anatomical measurements. This is a procedure performed within the body (in vivo) to visualize structures, not a test performed outside the body (in vitro) on samples like blood, urine, or tissue.
- Device Description: The device is a catheter designed to be inserted into the vascular system.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This angiography catheter does not fit that description.
N/A
Intended Use / Indications for Use
Angiography catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.
Product codes
DQO
Device Description
The Impress® Angiographic Catheters with hydrophilic coating are single lumen catheters offered in 4F and 5F sizes and 40cm to 125cm. The outer surface of the distal segment of the catheter shaft is coated with a hydrophilic coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, testing was performed demonstrating that the subject device met the acceptance criteria determined to demonstrate the safety and efficacy of the device.
Key Metrics
Not Found
Predicate Device(s)
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
:
| Section 5 | |||
|---|---|---|---|
| 510(k) Summary | FEB 12 2010 | ||
| General | |||
| Provisions | Submitter Name: | ||
| Address: | |||
| Telephone Number: | |||
| Fax Number: | |||
| Contact Person: | |||
| Date of Preparation: | |||
| Registration Number: | Merit Medical Systems, Inc. | ||
| 1600 West Merit Parkway | |||
| South Jordan, UT 84095 | |||
| (801) 208-4196 | |||
| (801) 253-6932 | |||
| Michaela Rivkowich | |||
| September 25, 2009 | |||
| 1721504 | |||
| Subject | |||
| Device | Trade Name: | ||
| Common/Usual Name: | |||
| Classification Name: | Impress® Angiographic Catheter with | ||
| Hydrophilic Coating | |||
| Angiographic Catheter | |||
| Diagnostic Intravascular Catheter | |||
| Predicate | |||
| Device | Trade Name: | ||
| Classification Name: | |||
| Premarket Notification: | |||
| Manufacturer: | Impress® Angiographic Catheter | ||
| Diagnostic Intravascular Catheter | |||
| K053171 | |||
| Merit Medical Systems, Inc. | |||
| Predicate | |||
| Device | Trade Name: | ||
| Classification Name: | |||
| Premarket Notification: | |||
| Manufacturer: | Radifocus® Glidecath™ | ||
| Diagnostic Intravascular Catheter | |||
| K915414 | |||
| Terumo Corporation | |||
| Classification | Class II | ||
| 21 CFR § 870.1200, 74 DQO | |||
| Division of Cardiovascular Devices | |||
| Intended Use | Angiography catheters are designed to be used for delivering | ||
| radiopaque media to selected sites in the vascular system in | |||
| conjunction with routine diagnostic procedures. Angiographic | |||
| catheters with marker bands may also be used for anatomical | |||
| measurements. |
and the control of the county of
1
| Device
Description | The Impress® Angiographic Catheters with hydrophilic coating are
single lumen catheters offered in 4F and 5F sizes and 40cm to
125cm. The outer surface of the distal segment of the catheter shaft
is coated with a hydrophilic coating. |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | Technological characteristics of the subject Impress catheter with
hydrophilic coating are substantially equivalent to those of the
predicate devices, the Impress Angiographic Catheter (K053171)
and the Radifocus Glidecath Angiographic Catheter (K915414). |
| Safety &
Performance
Tests | No performance standards have been established under Section 514
of the Food, Drug and Cosmetic Act for these devices. However,
testing was performed demonstrating that the subject device met the
acceptance criteria determined to demonstrate the safety and
efficacy of the device. |
| Summary of
Substantial
Equivalence | Based on the indications for use, design, safety and performance
testing, the subject Impress® Angiographic Catheter with hydrophilic
coating is substantially equivalent to the predicate devices, the
Impress® Angiographic Catheter, manufactured by Merit Medical
Systems, Inc., and the Radifocus Glidecath Angiographic Catheter,
manufactured by Terumo Corporation. |
. . .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a logo for the Department of Health & Human Services - CSA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - CSA" arranged around the top half of the circle. In the center of the circle is an abstract image of three human profiles facing to the right, which is a common symbol used by the Department of Health and Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Merit Medical Systems, Inc. c/o Ms. Michaela Rivkowich Regulatory Affairs Specialist III 1600 West Merit Parkway South Jordan, UT 84095
FEB 1 2 2010
Re: K093004
Trade/Device Name: Impress® Angiographic Catheter with Hydrophilic Coating Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DQO Dated: January 28, 2010 Received: January 29, 2010
Dear Ms. Rivkowich:
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 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.
3
Page 2 – Ms. Michaela Rivkowich
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
una R. Viilunen
Image /page/3/Picture/8 description: The image shows a signature. The signature is written in black ink on a white background. The signature appears to be a stylized version of the letters 'S' and 'M' connected together with a horizontal line underneath.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4
Indications for Use
510(k) Number (if known):
Device Name: Impress® Angiographic Catheter with Hydrophilic Coating
KO93004
Indications for Use:
Angiography catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Vi
Division Sign-Off) Division Sign-Off)
Division Sign-Off)
Tivision of Cardiovascular 0.0 % 0.0 % % % 0(k) Number Kong 300 R