(28 days)
Not Found
No
The description focuses on the physical characteristics and function of a catheter for delivering contrast media, with no mention of AI/ML or image processing.
No
The device is described as a "diagnostic intravascular catheter" designed to deliver "contrast media to selected sites in the vascular system" to aid in visualization, indicating a diagnostic rather than therapeutic purpose.
Yes
The "Device Description" explicitly states, "The IMAGER™II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters."
No
The device description clearly states it is a physical catheter, a hardware device, designed to be inserted into the vascular system.
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 Catheters are designed to deliver contrast media into the vascular system for imaging purposes (angiography). They are used in vivo (within the living body), not in vitro (outside the living body).
- Lack of Sample Analysis: The device itself does not analyze any biological samples. Its function is purely mechanical – providing a pathway for delivery.
Therefore, based on the provided information, the IMAGER™ II Angiographic Catheter is a medical device used for diagnostic imaging procedures, but it does not fit the definition of an In Vitro Diagnostic.
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.
Product codes (comma separated list FDA assigned to the subject device)
74 DQO
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™ Angiographic Catheters are sterile, single-use diagnostic intravascular catheters and are available in a variety of flush and selective curve styles 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)
Functional testing consisted of dimensional verification, guidewire compatibility, tensile strength, torque response, insertion force, static burst strength, and flow rate. Biocompatibility and product shelf life testing were previously conducted on the predicate devices. Test results verified that the 4F Selective Imager™ Angiographic Catheters are adequate for the intended use.
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.
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
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
General Provisions 6.1
| Submitter's Name
and Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, Minnesota 55311 |
|---------------------------------|-------------------------------------------------------------------------------------|
| Contact Person | Heidi M. Erickson
(763) 494-2564 |
| Classification Name | Diagnostic Intravascular
Catheters (21CFR Part 970.1200) |
| Common or Usual Name | Angiographic Catheter |
| Proprietary Name | Boston Scientific Imager™ II 4F Selective
Angiographic Catheter |
| Name of Predicate Device | Boston Scientific Imager™ II 4F, 5F Flush
and 5F Selective Angiographic Catheter |
6.3 Device Description
6.2.1
The IMAGER™II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system. The IMAGER™ Angiographic Catheters are sterile, single-use diagnostic intravascular catheters and are available in a variety of flush and selective curve styles 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.
6.4 Intended Use
The IMAGER™ II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system.
1
Section 6: Summary of Safety and Effectiveness
KO22621
Summary of Technological Characteristics 6.5
Same as currently marketed Imager™ II Angiographic Catheters, cleared for market under K011664, September 7, 2001.
6.6 Non-clinical Test Summary
Functional testing consisted of dimensional verification, guidewire compatibility, tensile strength, torque response, insertion force, static burst strength, and flow rate. Biocompatibility and product shelf life testing were previously conducted on the predicate devices. Test results verified that the 4F Selective Imager™ Angiographic Catheters are adequate for the intended use. The 4F Selective Imager™ II Angiographic Catheters are considered substantially equivalent to the currently marketed 4F and 5F Flush and 5F Selective Imager™ Angiographic catheters based on a comparison of the intended use, the device design, and the results of testing and evaluation.
2
Public Health Service
4 2002 SEP
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation c/o Ms. Heidi M. Erickson One Scimed Place Maple Grove, MN 55311
Re: K022621
Boston Scientific Imager™ II 4F Selective Angiographic Catheter Regulation Number: 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: 74 DQO Dated: August 6, 2002 Received: August 7, 2002
Dear Ms. Erickson:
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 such 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.
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);
3
Page 2 - Ms. Heidi M. Erickson
labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 Part 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,
Da Teln
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
022621
Section 4:
Indications for Use
510(k) Number (if known) _______________
Device Name: 4F Selective Imager™ II Angiogaphic Catheter
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.
(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)
OR
Over The Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)