(61 days)
Not Found
Not Found
No
The summary describes a standard angiographic catheter and packaging updates, with no mention of AI or ML capabilities.
No
The device is designed to deliver contrast media for diagnostic imaging (angiography), not to treat a disease or condition.
No
Explanation: This device is designed to deliver contrast media for angiographic procedures, which are used to visualize the vascular system. It does not perform diagnostic analysis itself, but rather facilitates a diagnostic procedure.
No
The device description clearly states it is an angiographic catheter, which is a physical medical device, not software.
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 designed to deliver contrast media to selected sites in the vascular system during an angiographic procedure. This is an in vivo procedure, meaning it is performed within a living organism.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro).
The device's function is to facilitate a diagnostic imaging procedure performed directly on a patient, not to analyze samples in a lab setting.
N/A
Intended Use / Indications for Use
SCIMED Impulse Catheters are designed to provide a pathway to be used for SCIMED Impuise Catherers are designed is provide is provider system during an angiographic procedure.
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)
74 DQO
Device Description
The Impulse angiographic catheters and packaging materials are the same as the I he Impulse anglographic catheters and parkaging materials for all Impulse catheters currently on the market. The packaging materials for all Impulse cathelers currently on the market. "The parting of o SCIMED Angiographic catheters have recently been tested to support a 3 year shelf life.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Standard packaging testing was conducted to support a 3 year package shelf life.
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.
SCIMED® Impulse Catheters
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
AUG 23 510(k) Notification SCIMED Impulse Angiographic Catheters 3 Year Shelf Life
Summary of Safety and Effectiveness
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
I. General Provisions
Section 3
| 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® Impulse Catheters |
| Name of Predicate Devices | SCIMED® Impulse Catheters |
III. Device Description
II.
The Impulse angiographic catheters and packaging materials are the same as the I he Impulse anglographic catheters and parkaging materials for all
Impulse catheters currently on the market. The packaging materials for all Impulse cathelers currently on the market. "The parting of o
SCIMED Angiographic catheters have recently been tested to support a 3 year shelf life.
IV. Intended Use
Intended Use
SCIMED Impulse Catheters are designed to provide a pathway to be used for SCIMED Impuise Catherers are designed is provide is provider system during an angiographic procedure.
Summary of Technological Characteristics V.
Same as currently marketed Impulse catheters.
Non-clinical Test Summary VI.
Standard packaging testing was conducted to support a 3 year package shelf life.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 23 1999
Ms. Melanie Raska Boston Scientific SCIMED, Inc. One Scimed Place Maple Grove, MN 55311-1566
K992123 Re: R992123
Trade Name: SCIMED Impulse angiographic Catheters Regulatory Class: II (two) Product Code: 74 DQO Dated: June 22, 1999 Received: June 23, 1999
Dear Ms. Raska:
We have reviewed your Section 510(k) notification of intent to market We have reviewed your section 33 (), we determined the device is the device referenced above and no indications for use stated in the substantially equivalent (for the indreally is marketed in interstate
enclosure) to legally marketed predicate of the Medical enclosure) to regarly markeded promotiment date of the Medical commerce prior to May 20, 1970, const have been reclassified in Device Amendments, of to devices that notes food, Drug, and Cosmetic accordance with the provibions on arrest the device, subject to the
Act (Act). You may, therefore, market The general controls Act (Act). Tou may, choras of the Act. The general controls general controls provisions of the requirements for annual registration, and provisions of the nee moreans
listing of devices, good manufacturing practice, labeling, and fromibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special If your device Is classifica (boo abovel), it may be subject to such Controls) of Class III (Fremaines off additional controls. Existing major boy. Title 21, Parts 800 to a substantially equivalent determination assumes complance with 895. 895. A substancially equivalence as sense requirements, as set forth in the Current Good handralousing -----------------------------------------------------------------------------------------------------------------------------------------------CHE Quality System Regulation (2)
regulation (21 CFR Part 820) and that, through periodic on and manumbing regulation (21 crk rate 620) and 1604 (400) will verify such assumptions.
The Food and Drug Administration (FDA) will as momlatory che rood and Dray hamiliary GMP regulation may result in regulatory In addition, FDA may publish further announcements concerning action. action. In addreton, Ibis may range and of this response to your device in the reasing submission does not affect any obligation your premarket notification basis and submissions of the Act for devices you might have ander observed to Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Melanie Raska
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 at advertising of your device, please contact the promotion and
(301) 594-4639. Also please contact the Office of Compliance at (301) 594-4639. Also, please concace concact the office of Co.
"Misbranding by refer "Misbranding by reference to regulation entified,
"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/dsma/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
3
510(k) Notification SCIMED Impulse Angiographic Catheters 3 Year Shelf Life
Indications for Use
510(k) Number (if known) __________
Device Name: SCIMED® Impulse Angiographic Catheters
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.
Judith Danelson & Chris Sloan 9/22/9.
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
| Labels | Values |
|---|---|
| 510(k) Number | K992123 |
(PLEASE DO NOT WRITE BELOW THIS I INF. - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over The Counter Use_ ___________
(Optional Format 1-2-96)