(247 days)
No
The device description and performance studies focus on the mechanical and physical properties of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is intended to guide and support interventional devices and provide a conduit for various agents, including therapeutic ones, but it does not directly administer therapy itself. It acts as an accessory for therapeutic procedures rather than a therapeutic device.
No
The device is described as an "over-the-wire percutaneous catheter" intended to "guide and support interventional devices," "traverse discrete portions of the vasculature," "allow for interventional device exchanges," and "provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents." While it can deliver diagnostic contrast agents, its primary function is not to diagnose but to facilitate interventional procedures. It is an access and support tool rather than a diagnostic tool in itself.
No
The device description clearly describes a physical catheter with specific dimensions, materials, and mechanical properties. It undergoes mechanical, performance, and biocompatibility testing, which are characteristic of hardware medical devices, not software-only devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) during interventional procedures. It guides and supports other devices, allows for exchanges, and provides a conduit for delivering fluids directly into the vasculature.
- Device Description: The description details a physical catheter designed to be inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs typically involve analyzing blood, urine, tissue, or other bodily fluids outside the body.
This device is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Boosting Catheter is intended for use in conjunction with guiding catheters or sheaths during coronary and peripheral interventional procedures to guide and support interventional devices, traverse discrete portions of the vasculature, allow for interventional device exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents.
Product codes
DQY
Device Description
The Boosting Catheter is an over-the-wire percutaneous catheter with an atraumatic tip. The catheter has an effective length of 150cm and available in four (4) diameter models; each compatible with various guiding catheters or sheaths as shown in the following table:
| Catalog
Number | Model
Number | Catheter
I.D. | Catheter
O.D. | Compatible
Guiding Catheter | Compatible
Sheath |
|-------------------|-----------------|------------------|------------------|--------------------------------|------------------------|
| BC52-150 | 9005-001 | 0.052" | 0.064" | 6 Fr (0.066" MIN ID) | 5 Fr (0.066" MIN ID) |
| BC57-150 | 9005-002 | 0.057" | 0.068" | 6 Fr (0.070" MIN ID) | 5.5 Fr (0.072" MIN ID) |
| BC63-150 | 9005-003 | 0.063" | 0.076" | 7 Fr (0.078" MIN ID) | 6 Fr (0.079" MIN ID) |
| BC72-150 | 9005-004 | 0.072" | 0.086" | 8 Fr (0.088" MIN ID) | 7 Fr (0.092" MIN ID) |
The Boosting Catheter is constructed with a proximal manipulation shaft connected to a distal tube or guiding catheter segment. The manipulation shaft is used to advance the distal tube segment over a guidewire and through a guiding catheter (or sheath) to a desired location in the coronary or peripheral vasculature. Once positioned, diagnostic or interventional devices (including guidewires) may be delivered or exchanged though the guiding catheter and the Boosting Catheter distal tube segment. Further, procedural fluids (such as saline, contrast agents or therapeutic agents) can be delivered through the guiding catheter and the distal tube segment to a desired location in the coronary or peripheral vasculature. The distal tube segment has two (2) radiopaque markers to facilitate fluoroscopic guidance and a lubricious outer coating to assist with catheter advancement. The manipulation shaft has a molded handle and strain relief to assist with handling. The strain relief is printed with the catheter dimensional information. The device is supplied sterile and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary and peripheral vasculature
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 Boosting Catheter underwent mechanical, performance, and biocompatibility assessments to support a determination of substantial equivalence. These tests provide reasonable assurance that the device meets the established performance criteria and will perform as intended.
The mechanical and performance tests performed on the Boosting Catheter included: Visual inspections, Dimensional evaluations, Device compatibility, Guiding catheter/sheath compatibility, Device support, Catheter stiffness & flexibility, Device retraction & insertion, Catheter fatigue, Catheter kink resistance, Corrosion resistance, Torque strength, Tensile strength, Simulated use, Coating adherence, Particulate evaluation, Fluoroscopic visualization, Fluid delivery, Shelf life testing, Package integrity, Shipping/distribution testing, Environmental conditioning.
The biocompatibility tests performed on the Boosting Catheter included: Cytotoxicity, Sensitization, Irritation / Intracutaneous reactivity, Systemic toxicity (acute), Genotoxicity, Hemolysis, Immunology (complement activation), In Vivo Thromboresistance, Pyrogenicity (material mediated), Physicochemical tests.
Clinical evaluation was not required for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a series of lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
QXMédical, LLC Fernando Di Caprio Chief Technology Officer 2820 Patton Road Roseville, Minnesota 55113
Re: K160561
Trade/Device Name: Boosting Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 30, 2016 Received: October 3, 2016
Dear Fernando Di Caprio:
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 devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160561
Device Name Boosting Catheter
Indications for Use (Describe)
The Boosting Catheter is intended for use in conjunction with guiding catheters or sheaths during coronary and peripheral interventional procedures to guide and support interventional devices, traverse discrete portions of the vasculature, allow for interventional device exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary - K160561
Date Prepared: October 27, 2016
Submitter Information:
| Submitter's Name/Address | Contact Person |
|---|---|
| QXMédical, LLC | Fernando Di Caprio, |
| 2820 Patton Road | Chief Technical Officer |
| Roseville, MN 55113 | Phone: (651) 842-2053 |
| Email: fernando.dicaprio@qxmedical.com |
Device Information:
| Device Trade Name | Boosting Catheter™ |
|---|---|
| Device Common Name | Guiding Catheter |
| Device Classification Name | Catheter, Percutaneous (per 21 CFR 870.1250) |
| Classification Product Code | DQY |
| Regulatory Classification | Class II (per 21 CFR 870.1250) |
| Review Panel | Cardiovascular |
Performance Standards:
No performance standards applicable to this product have been developed under Section 514 of the Act.
Predicate Devices:
| Predicate Device | 510(k) Status |
|---|---|
| Access and Support Catheter | K123311 |
| Concierge Guiding Catheter | K132409 |
Reference Devices:
| Reference Device | 510(k) Status |
|---|---|
| Guidezilla Catheter | K123765 |
| CrossBoss Catheter | K091841 |
4
Device Description:
The Boosting Catheter is an over-the-wire percutaneous catheter with an atraumatic tip. The catheter has an effective length of 150cm and available in four (4) diameter models; each compatible with various guiding catheters or sheaths as shown in the following table:
| Catalog
Number | Model
Number | Catheter
I.D. | Catheter
O.D. | Compatible
Guiding Catheter | Compatible
Sheath |
|-------------------|-----------------|------------------|------------------|--------------------------------|------------------------|
| BC52-150 | 9005-001 | 0.052" | 0.064" | 6 Fr (0.066" MIN ID) | 5 Fr (0.066" MIN ID) |
| BC57-150 | 9005-002 | 0.057" | 0.068" | 6 Fr (0.070" MIN ID) | 5.5 Fr (0.072" MIN ID) |
| BC63-150 | 9005-003 | 0.063" | 0.076" | 7 Fr (0.078" MIN ID) | 6 Fr (0.079" MIN ID) |
| BC72-150 | 9005-004 | 0.072" | 0.086" | 8 Fr (0.088" MIN ID) | 7 Fr (0.092" MIN ID) |
The Boosting Catheter is constructed with a proximal manipulation shaft connected to a distal tube or guiding catheter segment. The manipulation shaft is used to advance the distal tube segment over a guidewire and through a guiding catheter (or sheath) to a desired location in the coronary or peripheral vasculature. Once positioned, diagnostic or interventional devices (including guidewires) may be delivered or exchanged though the guiding catheter and the Boosting Catheter distal tube segment. Further, procedural fluids (such as saline, contrast agents or therapeutic agents) can be delivered through the guiding catheter and the distal tube segment to a desired location in the coronary or peripheral vasculature. The distal tube segment has two (2) radiopaque markers to facilitate fluoroscopic guidance and a lubricious outer coating to assist with catheter advancement. The manipulation shaft has a molded handle and strain relief to assist with handling. The strain relief is printed with the catheter dimensional information. The device is supplied sterile and intended for single use only.
Intended Use/Indications for Use:
The Boosting Catheter is intended for use in conjunction with guiding catheters or sheaths during coronary and peripheral interventional procedures to guide and support interventional devices, including guidewires, traverse discrete portions of the vasculature, allow for interventional device exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents.
5
Comparison of Technological Characteristics with the Predicate Devices:
The Boosting Catheter has similar intended use as the predicate devices along with similar principle of use, body contact duration (