(100 days)
Not Found
No
The device description and intended use focus solely on the physical catheter for delivering contrast media. There is no mention of any software, image processing, or AI/ML capabilities.
No
The device is described as a "diagnostic intravascular catheter" used to deliver contrast media for diagnostic imaging, not for treating a condition.
Yes
The device description explicitly states, "The IMAGER™II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters."
No
The device description clearly describes a physical catheter, a hardware component, used for delivering contrast media. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The IMAGER™II Angiographic Catheter is a device used within the vascular system to deliver contrast media. It is a tool used during a medical procedure (angiography) to visualize blood vessels. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it provides a pathway for delivering contrast media to selected sites in the vascular system. This is an in-vivo (within the living body) procedure, not an in-vitro (in glass/outside the body) test.
Therefore, based on the provided information, the IMAGER™II Angiographic Catheter is a medical device used for diagnostic imaging procedures, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IMAGER™II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system.
The IMAGER™II Angiographic Catheters are indicated for use to provide a pathway for delivering contrast media to selected sites in the vascular system.
Product codes
DQO
Device Description
The IMAGER™II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters and are available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90cm and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy.
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)
The IMAGER™II Angiographic Catheters have been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NightHawk Angiographic Catheter
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
SEP - 7 2001
Special Special 510(k)
Imager II Angiographic Catheter
May 29, 2001
Summary of Safety and Effectiveness
| General
Provisions | Trade Name: Imager™ II Angiographic Catheter
Classification Name: Diagnostic Intravascular Catheter |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate
Devices | NightHawk Angiographic Catheter |
| Classification | Class II |
| Performance
Standards | Performance Standards have not been established by FDA under Section 514
of the Food, Drug and Cosmetic Act |
| Intended Use
and Device
Description | The IMAGER™II Angiographic Catheters are designed to provide a pathway
for delivering contrast media to selected sites in the vascular system. The
IMAGER™II Angiographic Catheters are sterile, single-use diagnostic
intravascular catheters and are available in a variety of flush and selective
shapes with lengths of 40 cm, 65 cm, 90cm and 100 cm. The distal segment
of the catheter is radiopaque to aid in visualization of the device under
fluoroscopy. |
| Biocompatibility | The IMAGER™II Angiographic Catheters have been tested for
biocompatibility per ISO 10993. All data demonstrate this device is
biocompatible for its intended use. |
| Summary of
Substantial
Equivalence | The IMAGER™II Angiographic Catheters have been tested and compared to
the predicate device. All data gathered demonstrate this device as
substantially equivalent. No new issues of safety or efficacy have been
raised. |
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement. The image is in black and white.
Public Health Service
SEP = 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jodi Lynn Greenizen Boston Scientific/Medi-Tech® One Boston Scientific Place Natick, MA 01760-1537
Re: K011664
IMAGER™ II Angiographic Catheters Regulation Number: 870.1200 Regulatory Class: II (two) Product Code: DQO Dated: August 13, 2001 Received: August 14, 2001
Dear Ms. Greenizen:
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 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 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 you might
2
Page 2 - Ms. Jodi Lynn Greenizen
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 advertising 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 general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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,
Dale Teh
James E. Dillard II Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
: 上
Indications For Use
| 510(k) Number (if known) | K011664 |
|---|---|
| Device Name: | IMAGER™II Angiographic Catheters |
| Indications for Use | The IMAGER™II Angiographic Catheters are indicated for use to provide a pathway for delivering contrast media to selected sites in the vascular system. |
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| Division
| 510(k) Num | levices | |
|---|---|---|
| Prescription Use | ||
| Use | ||
| (Per 21 CFR 801.109) | OR | Over |
| (Optio | ||
| Concurrence of CDRH, Office of Device Evaluation |
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