(80 days)
Not Found
Not Found
No
The summary describes a physical catheter and its materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is designed to deliver contrast media for diagnostic angiographic procedures, not to treat a condition or disease.
No
The device is used to deliver contrast media during an angiographic procedure, which facilitates visualization but does not directly diagnose.
No
The device description clearly details a physical catheter with multiple layers and materials, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure." This describes a device used in vivo (within the body) for a medical procedure, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a catheter designed for insertion into the vascular system. This is consistent with an in vivo device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to perform tests on specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SCIMED IMPULSE Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
Product codes (comma separated list FDA assigned to the subject device)
DOO
Device Description
The 6 French SCIMED IMPULSE Angiographic Catheters are single lumen catheters which will be available in Selective, Pigtail and Multipurpose models.
The shafts of all models utilize common biocompatible materials and consist of the following three layers: 1) The inner layer provides a smooth surface to allow for dye delivery and ease of guide wire movement. 2) The middle layer provides torque control, kink resistance and support, and 3) The outer layer provides stiffness and curve retention. Radiopaque materials are utilized in the outer layer to allow visualization of the catheter during the procedure.
A Pigtail Straightener is available to aid the physician in straightening the Pigtail curve while being introduced into the introducer sheath.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional testing consisted of pressure burst, tip bond tensile, hub tensile, dye flow, tip coefficient of friction, force transmitted by catheter tip, torque response and torque to fail. Test results verified that the 6 French IMPULSE Angiographic Catheters are adequate for their intended use. The 6 French IMPULSE Angiographic Catheters are considered substantially equivalent to angiographic catheters currently marketed by SCIMED based on a comparison of intended use, the design and the results of in-vitro testing and evaluation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 4
Summary of Safety and Effectiveness
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
FEB 2 3 1998
I. General Provisions
| Submitter's Name
and Address | SCIMED Life Systems, Inc.
One SCIMED Place
Maple Grove, Minnesota 55311 |
|---------------------------------|--------------------------------------------------------------------------------------------------------|
| Contact Person | Melanie Raska
(612) 494-2962 |
| Classification Name | Diagnostic Intravascular Catheters
(21CFR Part 870.1200) |
| Common or Usual Name | Diagnostic Intravascular Catheter |
| Proprietary Name | SCIMED® 6 French IMPULSE™
Angiographic Catheters |
| Name of Predicate Devices | SCIMED® 6 French EXPO™ Angiographic
Catheter, and SCIMED 5 French
IMPULSE™ Angiographic Catheter |
III. Device Description
II.
N
The 6 French SCIMED IMPULSE Angiographic Catheters are single lumen catheters which will be available in Selective, Pigtail and Multipurpose models.
The shafts of all models utilize common biocompatible materials and consist of the following three layers: 1) The inner layer provides a smooth surface to allow for dye delivery and ease of guide wire movement. 2) The middle layer provides torque control, kink resistance and support, and 3) The outer layer provides stiffness and curve retention. Radiopaque materials are utilized in the outer layer to allow visualization of the catheter during the procedure.
A Pigtail Straightener is available to aid the physician in straightening the Pigtail curve while being introduced into the introducer sheath.
1
Section 4
IV. Intended Use
The SCIMED IMPULSE Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
V. Summary of Technological Characteristics
The 6 French SCIMED IMPULSE Angiographic Catheters are a modification of SCIMED's currently marketed 5 French Impulse Angiographic Catheters.
VI. Non-clinical Test Summary
Functional testing consisted of pressure burst, tip bond tensile, hub tensile, dye flow, tip coefficient of friction, force transmitted by catheter tip, torque response and torque to fail. Test results verified that the 6 French IMPULSE Angiographic Catheters are adequate for their intended use. The 6 French IMPULSE Angiographic Catheters are considered substantially equivalent to angiographic catheters currently marketed by SCIMED based on a comparison of intended use, the design and the results of in-vitro testing and evaluation.
2
Image /page/2/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 a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
. ***
FEB 2 3 1998
Ms. Melanie Raska Regulatory Affairs Specialist SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, MN 55311-1566
Re: K974559 SCIMED® 6 French IMPULSE™ Angiographic Catheters Regulatory Class: II (two) Product Code: DOO Dated: December 4, 1997 Received: December 5, 1997
Dear Ms. Raska:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections; the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 2
Indications for Use
510(k) Number (if known) 1474559
Device Name: SCIMED® 6 French IMPULSE™ Angiographic Catheters
Indications for Use:
The SCIMED 6 French IMPULSE™ Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system ----------during an angiographic procedure.
(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)
Over The Counter Use
(Division Sign Off)
Division of Cardiovascular, Respirator(Optional Format 1-2-96)
and Neurological Devices
| 510(k) Number | K974559 |
|---|---|
| --------------- | --------- |