(48 days)
Not Found
No
The summary describes a physical catheter device for delivering contrast media and does not mention any software, algorithms, or data processing capabilities that would suggest AI/ML. The performance studies focus on mechanical and biocompatibility testing.
No.
The device is used to deliver contrast media during an angiographic procedure, which is a diagnostic imaging procedure, not a therapeutic intervention.
No
The device is designed to deliver contrast media during an angiographic procedure. While angiography is a diagnostic procedure, the catheter itself is not performing the diagnostic function (i.e., it's not analyzing the data or making a diagnosis). It's a tool used in the process.
No
The device description clearly details physical components like polymer layers, stainless steel braid, atraumatic tip, and a polymer hub, indicating it is a hardware device. The performance studies also focus on mechanical and material properties.
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 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." This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a physical catheter designed for insertion into the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD. The testing described (mechanical, biocompatibility) is typical for medical devices used in vivo, not for diagnostic tests performed on samples.
Therefore, the Impulse™ and Expo™ Angiographic Catheters are medical devices used for a procedure within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Impulse™ and Expo™ 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 Impulse™ and Expo™ Angiographic Catheters are single Jumen catheters offered in three distal curve shapes: Selective, Pigtail and Multi-Purpose. The Expo Catheter is offered in 5F, 6F, and 7F outer diameter, and the Impulse Catheter is offered in 5F and 6F outer diameter. The device shafts have multiple polymer layers with a stainless steel braid embedded between the layers, and an atraumatic tip that does not contain a braid. The proximal end consists of an insert molded polymer hub on all models, and a strain relief on all models except the 7F Expo.
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)
Design verification testing, including mechanical bench testing was performed to verify that the performance of the proposed Impulse™ and Expo™ Angiographic Catheters remain substantially equivalent to the predicate devices. Biocompatibility, and packaging testing were also performed to verify the overall safety and efficacv of the device.
Specifically the following design verification was performed:
- . Shaft Integrity: Burst Pressure
- Hub Leakage
- Tensile Test .
- Gauging Test ●
- Liquid Leakage
- Air Leakage ●
- Unscrewing Torque .
- Ease of Assembly .
- Stress Cracking .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a cascading manner. The profiles are rendered in a dark color, creating a sense of depth and unity. Encircling the profiles is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2015
Boston Scientific Corporation Mac McKeen Fellow, Regulatory Affairs One Scimed Place Maple Grove, MN 55311
Re: K152605
Trade/Device Name: Impulse™ and Expo™ Angiographic Guide Catheters Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Dated: October 12, 2015 Received: October 13, 2015
Dear Mr. Mac McKeen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm_ Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Willemen
for
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Form
510(k) Number (if known): K152605
Device Name: Impulse™ and Expo™ Angiographic Catheter
Indications for Use:
The Impulse™ and Expo™ Anqiographic 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.
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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)
3
510(k) Summary
per 21 CFR $807.92
| Sponsor: | Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752 USA |
|-------------------|-----------------------------------------------------------------------------------------|
| Contact Person: | Mac McKeen, mac.mckeen@bsci.com |
| Phone Number: | 763-494-1409 Fax: 763-494-2222 |
| Prepared: | 10 September 2015 |
| Trade Name: | Impulse™ and Expo™ Angiographic Catheter |
| Common Name: | Diagnostic Intravascular Guide Catheter |
| Classification: | II |
| Product Code: | DQO, 21 CFR 870.1200 |
| Predicate Device: | Impulse: K120495 (21 May 2012) Expo: K120495 (21 May 2012) |
Device Description:
The Impulse™ and Expo™ Angiographic Catheters are single Jumen catheters offered in three distal curve shapes: Selective, Pigtail and Multi-Purpose. The Expo Catheter is offered in 5F, 6F, and 7F outer diameter, and the Impulse Catheter is offered in 5F and 6F outer diameter. The device shafts have multiple polymer layers with a stainless steel braid embedded between the layers, and an atraumatic tip that does not contain a braid. The proximal end consists of an insert molded polymer hub on all models, and a strain relief on all models except the 7F Expo.
Intended Use
The Impulse™ and Expo™ Angiographic Catheters are intended for use in general intravascular applications to provide a pathway through which contrast media may be introduced.
Substantial Equivalence
Modified Impulse™ and Expo™ Angiographic Catheter designs, materials, manufacturing processes and intended use are substantially equivalent to the predicate Impulse™ and Expo™ Angiographic Catheters.
Summary of Non-Clinical Testing
Design verification testing, including mechanical bench testing was performed to verify that the performance of the proposed Impulse™ and Expo™ Angiographic Catheters remain substantially equivalent to the predicate devices. Biocompatibility, and packaging testing were also performed to verify the overall safety and efficacv of the device.
Specifically the following design verification was performed:
- . Shaft Integrity: Burst Pressure
- Hub Leakage
- Tensile Test .
- Gauging Test ●
- Liquid Leakage
- Air Leakage ●
- Unscrewing Torque .
- Ease of Assembly .
- Stress Cracking .
Summary of Clinical Testing
Clinical Evaluation was not required for these devices.
- Biocompatibility Testing
- A Cytotoxicity
- A Hemolysis
-
Inductively Coupled Plasma - Mass Spectrometry (ICP-MS)
- A FTIR
-
Nonvolatile Residue (NVR)