(27 days)
SCIMED® EXPO and Impulse Angiographic Catheters
Not Found
No
The summary describes a simple modification to the hub material of an existing angiographic catheter and does not mention any software, image processing, or AI/ML capabilities.
No
The device is designed to deliver contrast media for diagnostic angiographic procedures, not to treat a condition. While it provides a pathway, its primary role is diagnostic imaging.
No
The device is designed to deliver contrast media for an angiographic procedure, which is a method of imaging, rather than diagnosing on its own. While imaging assists in diagnosis, the device itself is a delivery tool.
No
The device description explicitly states it is a catheter, which is a physical hardware device. The modifications are to the hub material, further indicating a hardware component. 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 contrast media to selected sites in the vascular system during an angiographic procedure. This is an in-vivo procedure performed directly on a patient, not an in-vitro test performed on samples outside the body.
- Device Description: The device is a catheter, which is a tool used within the body.
- 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 designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural (delivering contrast) within the body.
N/A
Intended Use / Indications for Use
The SCIMED EXPO and 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
DQO
Device Description
The modified SCIMED EXPO and Impulse angiographic catheters are the same as the SCIMED EXPO and Impulse angiographic catheters currently on the market with the exception of the new hub material.
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 was conducted to verify the integrity of the modified hub. Biocompatibility testing was conducted on the new hub material.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SCIMED® EXPO and Impulse Angiographic Catheters
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
K992M2
JUL 2 1 ਰਿਰੋਰੇ Special 510(k) : Device Modification SCIMED Angiographic Catheters Hub Material Change
Section 4
Summary of Safety and Effectiveness
.. ...
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
I. General Provisions
| Submitter's Name
and Address | Boston Scientific SCIMED, 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® EXPO and Impulse
Angiographic Catheters |
| Name of Predicate Devices | SCIMED® EXPO and Impulse
Angiographic Catheters |
II. Device Description
The modified SCIMED EXPO and Impulse angiographic catheters are the same as the SCIMED EXPO and Impulse angiographic catheters currently on the market with the exception of the new hub material.
III. Intended Use
SCIMED EXPO and 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.
IV. Summary of Technological Characteristics
Same as currently marketed EXPO and Impulse angiographic catheters.
V. Non-clinical Test Summary
Functional testing was conducted to verify the integrity of the modified hub. Biocompatibility testing was conducted on the new hub material.
1
Image /page/1/Picture/1 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, possibly representing health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 1999
Ms. Melanie Raska Regulatory Affairs Specialist Boston Scientific SCIMED, Inc. One Scimed Place Maple Grove, MN 55311-1566
Re: K992142 SCIMED EXPO and Impulse Angiographic Catheters Trade Name: Requlatory Class: II Product Code: DQO Dated: June 23, 1999 June 24, 1999 Received:
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 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). 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 regulation 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
2
Page 2 - Ms. Melanie Raska
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.
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) 594-4586. Additionally, for questions on the promotion and advertisinq 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 807.97). Other qeneral 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callshan
Thomas J. Callaha Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Special 510(k) : Device Modification SCIMED Angiographic Catheters Hub Material Change
Section 3
Indications for Use
510(k) Number (if known)
Device Name: SCIMED® EXPO and Impulse Angiographic Catheters
Indications for Use:
The SCIMED EXPO and 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 _ OR Over The Counter Use _
(Per 21 CFR 801.109)
(Division Sign Off) (Optional Format 1-2-96)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K99 2142