(150 days)
The Imager II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system including the carotid arteries.
The Imager II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters. These catheters are available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90 cm and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy. Clinically, flush catheters are used to deliver a bolus of contrast to a patient when obtaining an image of a large area (aorta, leg-run off, etc.). Side-holes are also added to disperse the contrast. Selective catheters are used to create images of specific areas of interest.
This is a medical device (catheter) and not an AI/ML device. The provided text is a 510(k) summary for a medical device called "Imager II Angiographic Catheters." This document describes the device, its intended use, and its equivalence to previously cleared devices. It does not contain information related to software, algorithms, or any AI/ML components. Therefore, the specific questions regarding acceptance criteria, study details, data provenance, ground truth, expert adjudication, or MRMC studies for AI/ML performance cannot be answered from this document.
The document states:
- Technological Characteristics: "Same as currently marketed Imager II Angiographic Catheter cleared for marketing under K011664 (September 7, 2001) and K022621 (September 4, 2002)."
- Non-Clinical Test Summary: "Same as currently marketed Imager II Angiographic Catheter cleared for marketing under K011664 (September 7, 2001) and K022621 (September 4, 2002)."
This indicates that the device's clearance is based on its substantial equivalence to a predicate device, meaning it has the same technological characteristics and similar non-clinical test performance. There is no study described within this document that "proves the device meets the acceptance criteria" in the context of an AI/ML device's performance. The "acceptance criteria" for this type of medical device would typically relate to physical performance characteristics (e.g., tensile strength, flow rates, biocompatibility, radiopacity, etc.) established through non-clinical bench testing, which are only summarized as being "same as" the predicate.
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KOSO863
P. Lot L
510(k) Summary
per 21 CFR §807.92
| Submitter's Nameand Address | Boston Scientific Corporation (BSC)Two Scimed PlaceMaple Grove, MN 55311 | ||
|---|---|---|---|
| Contact Name andInformation | Diane BrinzaSpecialist, Regulatory AffairsPhone: 763-694-3061Fax: 763-694-6966e-mail: brinzad@bsci.com | ||
| Date Prepared | April 4, 2005 | ||
| ProprietaryName(s) | Imager II Angiographic Catheters | ||
| Common Name | Diagnostic Intravascular Catheter | ||
| Product Code | DQO | ||
| Classification ofDevice | Class II, 21 CFR Part 870.1200 | ||
| Predicate Device | Imager™ II AngiographicCatheter | K011664K022621 | 9/07/20019/04/2002 |
| DeviceDescription | The Imager II Angiographic Catheters are sterile, single-usediagnostic intravascular catheters. These catheters are availablein a variety of flush and selective shapes with lengths of 40 cm,65 cm, 90 cm and 100 cm. The distal segment of the catheter isradiopaque to aid in visualization of the device underfluoroscopy. Clinically, flush catheters are used to deliver abolus of contrast to a patient when obtaining an image of a largearea (aorta, leg-run off, etc.). Side-holes are also added todisperse the contrast. Selective catheters are used to createimages of specific areas of interest. | ||
| Intended Use ofDevice | The Imager II Angiographic Catheters are designed to provide apathway for delivering contrast media to selected sites in thevascular system including the carotid arteries. | ||
| TechnologicalCharacteristics | Same as currently marketed Imager II Angiographic Cathetercleared for marketing under K011664 (September 7, 2001) andK022621 (September 4, 2001). | ||
| Non-Clinical TestSummary | Same as currently marketed Imager II Angiographic Cathetercleared for marketing under K011664 (September 7, 2001) andK022621 (September 4, 2001). |
SEP 0 2 2005
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three abstract shapes resembling flowing fabric or wings extending from the figure's back.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 0 2 2005
Boston Scientific Corporation c/o Ms. Diane Brinza Regulatory Affairs Specialist One Boston Scientific Pl. Natick, MA 01760
Re: K050863
Imager™ II Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheters
Regulation Name: Diagnostic Intravascular Catheters Regulatory Class: Class II Product Code: DQO Dated: August 22, 2005 Received: August 23, 2005
Dear Ms. Brinza:
We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section 5 U(K) prematics in the muivalent (for the indications for the indications for the indications for referenced above and have determined the devices marketed in interstate commence
use stated in the enclosure) to legally marketed predicate devices that use stated in the enclosure) to legally marketed predicals of to devices that the enteres that prior to May 28, 1976, the enactment adte of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal Food, Drug, have been reclassified in accordance with the provisions of the Spolication (PMA). You may,
Act (Act) that do not require approval of a premarket approval application (PMA). Act (Act) that do not require approval of a premater apply on approvinsions of the general
therefore, market the device, subject to the eneral controls provisions of the gene therefore, market the device, subject to the general controls provisitation, listing of devices, good
controls provisions of the Act include requirements for annual registrat controls provisions of the Act include requirements for annual regularions and adulteration.
manufacturing practice, labeling, and prohibitions against misbranding and adulte
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into eliner class in (special ons after ing your device can be
may be subject to such additional controls. Existing major regulation may be subject to such additional controls. Existilly Internations and only government
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, found in the Code of Federal Regarations, Schools, Schools, Schools, Schools, School
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Page 2 - Ms. Diane Brinza
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DX 3 issualled of a louice complies with other requirements of the Act or that FDA has made a decemination and Joistered by other Federal agencies. You must comply with CEP Page 200 ally rederal statutes and regulations and limited to: registration and listing (21 CFR Part 807); an the Act s requirements, morading, our crice requirements as set forth in the quality labeling (21 CFR Part 001), good managale, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. control provisions (Scotons 551-512-81-21-21-21-21-21-2017 device as described in your Section 510(k) I mis letter will anow you to ogain maing of substantial equivalence of your device to a legally premarket notification: "The I Driving of basification 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), please If you desire specific acries ion Jour 2017 2012 . Also, please note the regulation entitled, Comact the Office of Compilance aarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your responsibilities at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K050863 |
|---|---|
| Device Name: | ImagerTM II Angiographic Catheter |
| Indications For Use: | The Imager II Angiographic Catheters are designed toprovide a pathway for delivering contrast media to selectedsites in the vascular system including the carotid arteries |
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | 14050863 |
Pagege 1 of __
§ 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).