The QXT catheter is designed to aspirate or extract soft thrombus from arterial vasculature. It has a dual-lumen design-an extraction lumen that allows for the removal of thrombus by aspiration and a rapid-exchange guidewire lumen that accommodates ≤0.014" diameter guidewires. A Y-adapter is bonded to the catheter's proximal end that facilitates the attachment of syringes and extension lines, and there is a self-sealing straight valve bonded to one port of the Y-adapter. The purpose of the straight valve is to provide a means of inserting and removing a stiffening mandrel, that is supplied with the device, while maintaining hemostasis during use. The catheter's outer diameter is a maximum of approximately 0.063" and its working length is approximately 137cm. The catheter is compatible with ≥6F guide catheters. There is a single radiopaque marker located near the distal tip, and the catheter's shaft has non-radiopaque positioning marks printed at approximately 95cm and 105cm proximal to the distal tip. Each device is supplied with a stiffening mandrel that is placed through the self-sealing straight valve, a 30mL VakLok syringe, and a 6 inch extension line that has a one-way stopcock. The QXT catheter is provided sterile and intended for single use.

AI/ML Overview

The provided document is a 510(k) summary for the QXT Extraction Catheter, submitted to the FDA. It does not include acceptance criteria or the details of a study designed to prove the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of device characteristics and the results of bench testing for design verification.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria based on the provided document. The document explicitly states: "No QXT catheter clinical evaluations were conducted." and focuses on "Bench testing was conducted on the QXT catheter and included an assessment of the device's physical properties and its ability to achieve its intended use."

The sections below highlight what would be provided if the document contained the requested information, but given the limitation, I can only state that such information is absent.

Acceptance Criteria and Device Performance:

The document does not provide a table of acceptance criteria and reported device performance directly related to proving the device meets specific performance thresholds in a clinical or structured performance study beyond general bench testing.

Study Details (Based on available information, which is limited to bench testing, not a formal study with acceptance criteria):

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document implies that multiple units of the QXT catheter were used for each bench test listed. However, specific sample sizes (e.g., "n=X" for each test) are not provided.
- Data provenance: Not explicitly stated, but assumed to be from internal laboratory testing given it's a 510(k) submission, likely conducted in the US (where Vascular Solutions, Inc. is located). The testing is prospective for the device's design verification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. Ground truth, in the context of an expert evaluation or clinical outcome, is not established for this submission as "No QXT catheter clinical evaluations were conducted." The bench tests assess physical properties and performance against engineering specifications or established test methods, not against expert-derived ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication process is described as there were no clinical evaluations or multi-reader studies.
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. A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a medical catheter, not an AI-powered diagnostic or assistive technology.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the bench tests, the "ground truth" or reference standard would be the pre-defined engineering specifications, industry standards, or established test methods for device performance (e.g., bond strength, kink resistance, thrombus extraction efficiency under controlled conditions). It is not derived from expert consensus, pathology, or outcomes data.
The sample size for the training set:
- Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. This is a medical device, not an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 15, 2021

Vascular Solutions, Inc. Julie Tapper Sr. Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K071727

Trade/Device Name: QXT Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ

Dear Julie Tapper:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 28, 2007. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory. Oconnell(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.09.15

Gregory O'Connell Assistant Director Plaque Modification Devices Team DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2007

Vascular Solution, Inc. c/o Ms. Julie Tapper Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369

K071727 Re: QXTTM Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: August 14, 2007 Received: August 15, 2007

Dear Ms. Tapper:

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.

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Page 2 - Ms. Julie Tapper

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); 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. 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,

Sincerely yours,

R. lohmer

A 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 Statement

510(k) Number (if known): K071727

Device Name: QXTTM Extraction Catheter

Indications for Use: The QXT catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

Prescription Use X (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)

Duana R. Vahner

. Ision Sign-Off) nsion of Cardiovascular Devices

510(k) Number_K 071727

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510(k) Summary As required by 21 CFR 807.92(c)

SEP 2 8 2007

510(k) Number: Ko71727

Date Prepared June 22, 2007

Submitter Information

Submitter's Name: Address:

Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369

Contact Person:

Julie Tapper Senior Regulatory Affairs Associate

Device Information

Trade Name: QXTTM Extraction Catheter Common Name: Embolectomy catheter Class: II Classification Name: Embolectomy catheter (21CFR 870.5150, Product Code DXE)

Predicate Device(s)

Pronto™ V3 Extraction Catheter (K052232 and K063371) manufactured by Vascular Solutions, Inc.

Diver™ C.E. Catheter (K051917 and K050276) submitted by ev3.

Export® XT Extraction Catheter (K040869 and K061059) manufactured by Medtronic Vascular, Inc.

Device Description

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length is approximately 137cm. The catheter is compatible with ≥6F guide catheters. There is a single radiopaque marker located near the distal tip, and the catheter's shaft has non-radiopaque positioning marks printed at approximately 95cm and 105cm proximal to the distal tip. Each device is supplied with a stiffening mandrel that is placed through the self-sealing straight valve, a 30mL VakLok syringe, and a 6 inch extension line that has a one-way stopcock. The QXT catheter is provided sterile and intended for single use.

Intended Use/Indications for Use

The QXT catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

Summary of Testing

Bench testing was conducted on the QXT catheter and included an assessment of the device's physical properties and its ability to achieve its intended use. Bench tests were conducted as part of design verification activities and after aging the devices in simulated-aging conditions.

The results of the tests confirmed the suitability of the device for its intended use. Each bench test that was conducted is listed, below.

Visual inspection	Hub-to-proximal-shaft Bond Strength
Tortuosity	Extraction Lumen (mid-shaft) Thermal Bond
	Strength
Catheter Kink Resistance	Extraction Lumen to Distal Tip Bond Strength
Markerband visibility	Stiffening Wire Bond Strength
Thrombus extraction	Fluid Leak Under Pressure
Blood extraction	Guidewire Interface
Air Leak During Aspiration	Guide Catheter Interface

Packaging and product inspections were conducted after the devices were subjected to simulated-distribution conditions, as follows:

Pouch Visual Appearance	Product Visual Appearance
Product Containment	Labeling Legibility

Also, device biocompatibility testing was conducted, as follows:

Cytotoxicity, 929 MEM Elution	Prothrombin Time
Sensitization, Kligman Maximization	In Vitro Hemocompatibility
Intracutaneous Injection Test	Hemolysis
Systemic Toxicity	Lee & White Coagulation Assay
Material Mediated Pyrogen Test

No QXT catheter clinical evaluations were conducted.

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Statement of Equivalence

The QXT catheter is substantially equivalent to the currently marketed Pronto V3, Diver CE, and Export catheters, based on comparisons of the device classifications, indications for use, technological characteristics, and sterilization methods.

Conclusions

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).