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.

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:

CatalogNumber	ModelNumber	CatheterI.D.	CatheterO.D.	CompatibleGuiding Catheter	CompatibleSheath
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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Boosting Catheter." It is a regulatory submission to the FDA demonstrating that the new device is substantially equivalent to legally marketed predicate devices, and therefore does not require a premarket approval application (PMA).

Here's an analysis of the provided text with respect to acceptance criteria and supporting studies:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a pass/fail format, which is typical for a detailed engineering report. Instead, it states that the device underwent various non-clinical tests to demonstrate substantial equivalence. The overall "acceptance criteria" can be inferred as meeting the performance that allows for a substantial equivalence determination to the predicate devices.

The "reported device performance" is summarized in general terms under the "Summary of Non-Clinical Testing" section. The document claims that these tests "provide reasonable assurance that the device meets the established performance criteria and will perform as intended."

Inferred Acceptance Criteria & Reported Performance (from the document):

Acceptance Criteria (Inferred from tests performed)	Reported Device Performance (Summary)
Visual inspections satisfactory	Tests performed and passed (implied)
Dimensional evaluations within specification	Tests performed and passed (implied)
Device compatibility maintained	Tests performed and passed (implied)
Guiding catheter/sheath compatibility	Tests performed and passed (implied)
Device support adequate	Tests performed and passed (implied)
Catheter stiffness & flexibility within range	Tests performed and passed (implied)
Device retraction & insertion smooth	Tests performed and passed (implied)
Catheter fatigue resistance	Tests performed and passed (implied)
Catheter kink resistance	Tests performed and passed (implied)
Corrosion resistance	Tests performed and passed (implied)
Torque strength adequate	Tests performed and passed (implied)
Tensile strength adequate	Tests performed and passed (implied)
Simulated use acceptable	Tests performed and passed (implied)
Coating adherence	Tests performed and passed (implied)
Particulate evaluation	Tests performed and passed (implied)
Fluoroscopic visualization	Tests performed and passed (implied)
Fluid delivery capability	Tests performed and passed (implied)
Shelf life testing met	Tests performed and passed (implied)
Package integrity maintained	Tests performed and passed (implied)
Shipping/distribution testing	Tests performed and passed (implied)
Environmental conditioning	Tests performed and passed (implied)
Biocompatibility (Cytotoxicity, Hemolysis, etc.)	Tests performed and passed (implied to ensure safety)

Specific Information Requested and Located:

A table of acceptance criteria and the reported device performance: As described above, an explicit table is not provided. The document lists the types of tests performed (mechanical, performance, and biocompatibility) and states that the device "meets the established performance criteria and will perform as intended."
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: This information is not provided in the document for any of the non-clinical tests.
- Data Provenance: This information is not specified for the non-clinical tests. Since it's a device submission, the testing would typically be conducted by the manufacturer or a contracted lab.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document describes non-clinical, laboratory-based testing (mechanical, performance, biocompatibility). These types of tests do not typically involve human experts establishing "ground truth" in the way a clinical study or image interpretation study would. Ground truth for these tests is based on objective measurements and established scientific/engineering methodologies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept typically applies to clinical studies where expert consensus is needed for diagnoses or outcome assessments. For non-clinical device testing, results are usually objectively measured and compared against specifications.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The device is a "Boosting Catheter" (a physical medical device, not an AI or imaging device).
- No AI component is mentioned, so improvement with AI assistance is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This question is not applicable as the device is a physical catheter, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests (mechanical, performance, biocompatibility), the "ground truth" refers to objective physical and chemical measurements compared against predefined engineering specifications and regulatory standards. For example, tensile strength would be measured by a machine and compared to a specified minimum strength. Biocompatibility would be assessed against ISO 10993 standards and measured cytotoxicity, hemolysis, etc.
The sample size for the training set:
- Not applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning model.
How the ground truth for the training set was established:
- Not applicable. As stated above, there is no training set mentioned for this device.

Summary

{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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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:

CatalogNumber	ModelNumber	CatheterI.D.	CatheterO.D.	CompatibleGuiding Catheter	CompatibleSheath
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)

Intended Use/Indications for Use:

{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 (< 24 h) and intended anatomical location (coronary and peripheral vasculature). Additionally, the Boosting Catheter and the predicate devices are technologically similar with regards to the following characteristics:

Construction, including over-the-wire configuration ●
Materials
Design and manufacturing techniques
Hydrophilic coating
Radiopaque tip
Dimensions (ID, OD, overall length)
Guidewire, sheath and guiding catheter compatibility
Packaging
Sterilization

The differences between the Boosting Catheter and the predicate devices are:

Guidewire lumen configuration and length ●
Addition of some materials common to other cardiovascular catheters .

The test data presented in this submission demonstrate substantial equivalence of the Boosting Catheter.

Summary of Non-Clinical Testing:

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:

Mechanical and Performance Test Summary
Visual inspections	Torque strength
Dimensional evaluations	Tensile strength
Device compatibility	Simulated use
Guiding catheter/sheath compatibility	Coating adherence
Device support	Particulate evaluation
Catheter stiffness & flexibility	Fluoroscopic visualization

{6}------------------------------------------------

Mechanical and Performance Test Summary
Device retraction & insertion	Fluid delivery
Catheter fatigue	Shelf life testing
Catheter kink resistance	Package integrity
Corrosion resistance	Shipping/distribution testing
	Environmental conditioning

The biocompatibility tests performed on the Boosting Catheter included:

Biocompatibility Test Summary
Cytotoxicity	Hemolysis
Sensitization	Immunology (complement activation)
Irritation / Intracutaneous reactivity	In Vivo Thromboresistance
Systemic toxicity (acute)	Pyrogenicity (material mediated)
Genotoxicity	Physicochemical tests

Clinical Testing

Clinical evaluation was not required for this device.

Substantial Equivalence Comparison Summary

Based on a comparison of the intended use/indications for use, principle of use, intended anatomical location, and technological characteristics, along with the results from a series of non-clinical tests, the Boosting Catheter has been shown to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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).