The Octane aspiration system is intended for the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial and deep venous system, and to infuse/deliver diagnostic or therapeutic agents.

Device Description

The Octane aspiration system consists of two components: the Octane catheter and the Octane hand pump. The Octane aspiration catheter has a working length of 115cm, is compatible with introducer sheaths ≥ 8F, guidewires ≤ 0.018" in diameter, and it is intended for use in vessels ≥ 3 mm in diameter. The catheter has a rapid exchange design and includes sliding, co-axial inner and outer lumens. The catheter inner lumen tip has three side wall slot ports and the catheter's outer lumen has a beveled radiopaque tip. To alleviate plugging of the catheter tip caused by thrombus, the actuator on the proximal end of the catheter slides the catheter's outer lumen back and forth over the inner lumen distal tip. The actuator on the proximal end of the catheter is also used to control the directionality of the torque-able catheter. Directionality is further achieved through the gradual curve in the shaft materials at the distal end. The Octane hand pump provides suction to the inner lumen of the Octane aspiration catheter and is manually operated using a spring-loaded handle. It consists of a pump handle fitted with a 30ml piston syringe, tubing, a series of one-way valves, and a 500ml collection bag. The hand pump tubing has a standard luer fitting for connection to the Octane aspiration catheter hub. The Octane aspiration system has been sterilized with ethylene oxide.

AI/ML Overview

This document is a 510(k) Summary for the Octane Aspiration System, a medical device intended for the removal of embolic material from blood vessels. The summary describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device (Pronto XL). However, it does not contain information about acceptance criteria and device performance in a format that directly addresses the user's request for AI/algorithm-related performance metrics or human reader studies.

The document specifies bench testing and biocompatibility testing to demonstrate substantial equivalence, focusing on the physical and material properties of the device, rather than the diagnostic or interpretative performance of an AI system.

Therefore, many of the requested categories related to AI performance, ground truth, expert opinions, and sample sizes for AI training/testing sets cannot be directly answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document broadly states: "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." However, it does not provide a specific table detailing the numerical acceptance criteria for each test and the corresponding reported device performance values. It only lists the tests performed.

Acceptance Criteria Category	Reported Device Performance
Bench Testing
Track force	Met specified criteria
Radiopacity	Met specified criteria
Collection bag pressure	Met specified criteria
Syringe seal attachment	Met specified criteria
Check valve crack pressure	Met specified criteria
Synthetic clot extraction	Met specified criteria
Proximal seal leak	Met specified criteria
Aspiration	Met specified criteria
Liquid leak	Met specified criteria
Bond/joint tensile	Met specified criteria
Torque capacity	Met specified criteria
Corrosion resistance	Met specified criteria
Therapeutic agent conditioning	Met specified criteria
Static pressure	Met specified criteria
Package integrity	Met specified criteria
Biocompatibility Testing
Cytotoxicity	Passed
Sensitization	Passed
Irritation	Passed
Acute systemic toxicity	Passed
Material mediated pyrogenicity	Passed
Hemolysis	Passed
Complement activation	Passed
Thrombogenicity	Passed

2. Sample size used for the test set and the data provenance:

The document does not specify sample sizes for each bench or biocompatibility test. These tests typically involve a certain number of device units.
Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided as these are bench and lab tests, not clinical or image-based studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. The studies described are physical and material tests of a medical device, not diagnostic or AI-driven interpretations requiring expert consensus for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable. These are objective engineering and laboratory tests, not subjective interpretations requiring adjudication.

5. 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 MRMC or comparative effectiveness study involving human readers or AI assistance was performed or reported in this document. The device is an aspiration catheter, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No standalone algorithm performance study was done as the device is a physical medical instrument, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the bench tests would be established by engineering specifications, physical measurements, and standardized laboratory procedures. For biocompatibility, it's defined by the ISO 10993 standards. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic would be.

8. The sample size for the training set:

Not applicable, as this device does not involve an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as this device does not involve an AI algorithm.

Summary

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December 1, 2017

Vascular Solutions Inc. Becky Astrup Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369

Re: K173266

Trade/Device Name: Octane aspiration system Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: October 10, 2017 Received: October 11, 2017

Dear Ms. Astrup:

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

for

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) K173266

Device Name Octane Aspiration System

Indications for Use (Describe)

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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K173266 510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: October 10, 2017

510(k) Number: K173266

Submitter's Name / Contact Person

Manufacturer	Contact Person
Vascular Solutions, Inc.6464 Sycamore Court NorthMinneapolis, MN 55369 USAEstablishment Registration # 2134812	Becky AstrupRegulatory Product SpecialistTel: 763-656-4300Fax: 763-656-4253

Trade Name	Octane
Common / Usual Name	Aspiration system
Classification Name	DXE - Catheter, Embolectomy, Cardiovascular
Predicate	K112571 – Pronto XL extraction catheter – Vascular Solutions(October 6, 2011)
Reference Devices	K151313 – Zelante DVT thrombectomy set – Boston Scientific(September 21, 2015)K113757 – Aspire Max aspiration catheter – Control MedicalTechnology (February 22, 2012)

Device Description

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Indications for Use

Technological Characteristics Comparison

The Octane aspiration system is similar in design and intended use to the predicate device, Pronto XL, as both are aspiration catheter systems intended for the removal of embolic material (thrombus/debris) from vessels of the arterial and deep venous system and to infuse/deliver diagnostic or therapeutic agents. The subject and predicate device are similar in size and working length. The materials used in the subject device are similar to the materials in the predicate device in that they are biocompatible, commonly utilized materials for interventional devices. The operating mechanisms of the Octane aspiration system are like those of the predicate, Pronto XL. The predicate Pronto XL device generates aspiration manually, through use of a piston syringe. Similarly, the Octane aspiration system generates aspiration manually, through use of a hand pump fitted with a piston syringe.

Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate device have been evaluated through biocompatibility and bench testing to provide evidence of Octane aspiration system substantial equivalence. The Octane aspiration system is substantially equivalent to the predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:

. Track force
o Radiopacity
Collection bag pressure .
Syringe seal attachment ●
. Check valve crack pressure
Synthetic clot extraction
Proximal seal leak
. Aspiration
Liquid leak
. Bond/joint tensile
. Torque capacity
Corrosion resistance ●
Therapeutic agent conditioning
Static pressure
Package integrity ●

Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:

Cytotoxicity
Sensitization ●
Irritation ●
. Acute systemic toxicity
Material mediated pyrogenicity ●
Hemolysis ●
Complement activation
Thrombogenicity

The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Octane aspiration system is substantially equivalent to the predicate device.

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).