The Aspire MAX 5 and MAX 6 Aspiration Catheters and Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

Device Description

An Aspire MAX Aspiration Catheter includes (1) Aspire MAX 6 Aspiration Catheter and (1) Aspirator 30ml. Aspire MAX Aspiration Catheters and MAX Aspiration Catheters are single-use, sterile, short-term use, and non-pyrogenic medical devices designed for use with manually operated piston syringes to remove fresh, soft emboli and thrombi from the peripheral and coronary vasculature. The Aspire MAX Aspiration Catheter operating and scientific principle is the same as predicate devices. The catheter is inserted into the body over a guidewire and through a sheath or guide catheter to the target anatomy. A piston syringe is then connected to the catheter and the aspiration is manually created with the piston syringe.

Similar to predicate devices, industry standard intravascular catheter components and materials are used:

Clear proximal polycarbonate female luer lock,
-Stainless steel braid,
Clear Pebax and Vestamid Shafts, -
-Embedded platinum iridium radiopaque marker,
Clear polycarbonate barrel piston syringe. -

Aspire MAX Aspiration Catheters do not add any new materials, manufacturing processes, colorants, or dyes to the manufacturing process.

Same as predicates, all MAX Aspiration Catheters may be connected to piston syringes including the Aspire Aspirator. Aspirators may be connected to other aspiration catheters.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the Aspire MAX Aspiration Catheter. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) device. Therefore, the information provided for acceptance criteria and study that proves the device meets the acceptance criteria is framed within the context of substantial equivalence testing and non-clinical performance, rather than a clinical study with human patients.

Based on the document, here's a breakdown of the requested information:

Acceptance Criteria and Device Performance (Non-Clinical)

The document does not present a formal table of "acceptance criteria" with specific quantitative thresholds for clinical performance metrics (e.g., sensitivity, specificity, or clinical outcome improvements). Instead, the acceptance criteria are implicit in demonstrating substantial equivalence to legally marketed predicate devices through a series of non-clinical tests and comparisons of design, materials, and operating principles.

The "Device Performance" is demonstrated by passing these non-clinical tests, indicating the device functions as intended and is comparable to predicate devices.

Table of Comparison (derived from the document):

Feature/Test Category	Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance
Science	Equivalent Scientific Principle, Mechanism of Use	"The Aspire MAX Aspiration Catheter operating and scientific principle is the same as predicate devices."
Device Construction	Equivalent Design & Dimensions, Function, Materials	"Similar to predicate devices, industry standard intravascular catheter components and materials are used: Clear proximal polycarbonate female luer lock, Stainless steel braid, Clear Pebax and Vestamid Shafts, Embedded platinum iridium radiopaque marker, Clear polycarbonate barrel piston syringe." "Aspire MAX Aspiration Catheters do not add any new materials, manufacturing processes, colorants, or dyes to the manufacturing process."
Manufacturing	Consistent with predicates (e.g., ISO compliant)	"Manufacturing extrusion, molding, and assembly in ISO 14644 Class 8 certified clean room is the same as predicates."
Device Performance (Non-Clinical Tests)	Satisfactory performance in various integrity, aspiration, and functional tests	"Non-clinical testing confirms the Aspiration Catheters and Aspirator passes all testing and meets specifications." "Subject devices passed all biocompatible tests performed by Ethox and Nelson Labs." "Subject devices passed [particulate tests] with scores significantly below an established minimum national standard."
- Bend & Torque	Acceptable performance	Confirmed by "Non-Clinical Testing" passing.
- Aspiration	Effective aspiration compared to predicates with various aspirants (low/high viscosity, Newtonian/Non-Newtonian), thrombus, in-vivo aspiration.	Passed, specifically listed tests include: "MAX Aspiration Catheters and predicates with standard syringes and aspirators with low viscosity aspirants," "MAX Aspiration Catheters and predicates with standard syringes and aspirators with high viscosity Newtonian aspirants," "MAX Aspiration Catheters and predicates with standard syringes and aspirators with high viscosity Non-Newtonian aspirants," "Thrombus aspiration," "In-vivo aspiration."
- Break strength integrity	Acceptable strength	Confirmed by "Non-Clinical Testing" passing.
- Freedom from Leakage (Aspiration/Injection)	No leakage	Confirmed by "Non-Clinical Testing" passing.
- Tracking	Acceptable tracking through vessels	Confirmed by "Non-Clinical Testing" passing.
Labeling	Equivalent Indications for Use, Intended Use, Contraindications, Instructions for Use, Warnings	"The indication and intended use is substantially equivalent other thrombus aspiration catheters manually actuated by syringes and legally marketed under the DXE product code."
Biocompatibility	Complies with ISO 10993 and FDA guidance	"Biocompatibility: Compliance with 'Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Device...' and ISO 10993. Subject devices passed all biocompatible tests performed by Ethox and Nelson Labs."
Sterilization	Validated methods	"Sterilization" methods are compared and confirmed to be the same as predicates. "AAMI/ANSI/ISO 11135:1994 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization" is cited.

Study Details:

This submission relies on non-clinical testing to demonstrate substantial equivalence, not a clinical study. Therefore, some of the requested information (like expert consensus for ground truth or MRMC studies) is not applicable in this context.

Sample size used for the test set and the data provenance:
- The document does not explicitly state "sample sizes" in terms of number of devices tested for each non-clinical test. It states "Non-clinical testing confirms the Aspiration Catheters and Aspirator passes all testing and meets specifications."
- Data Provenance: The tests were conducted as part of the regulatory submission process for the device manufacturer, Control Medical Technology. The location of the testing facilities (e.g., Ethox and Nelson Labs mentioned for biocompatibility) would likely be in the US, but this is not explicitly stated as the origin of data.
- Retrospective or Prospective: The testing was prospective, specifically conducted for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical testing submission for substantial equivalence. "Ground truth" in this context refers to the defined specifications and parameters of the tests (e.g., tensile strength, aspiration volume, particulate limits) which are derived from industry standards (e.g., ISO, AAMI) and predicate device characteristics, not expert clinical consensus on patient data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As this was non-clinical testing, there was no adjudication of expert opinions. Test results are objectively measured against defined 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:
- Not applicable. This is a medical device (catheter and aspirator), not an AI/imaging device, and no clinical study was performed. The concept of "human readers" and "AI assistance" is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this 510(k) submission is established by engineering specifications, performance metrics derived from industry standards (ISO), and the characteristics of predicate devices that have already been legally marketed. For example, catheter dimensions, material properties, aspiration volume, and leak integrity are measured and compared against established parameters or the performance of predicate devices.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that involves a training set. The device design and manufacturing process are established through engineering and validated through non-clinical testing.
How the ground truth for the training set was established:
- Not applicable. No training set was involved.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 8, 2021

Control Medical Technology, LLC % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Saint Paul. Minnesota 55114

Re: K113757

Trade/Device Name: Aspire MAX Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: OEZ

Dear Mark Job:

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 February 22, 2012. Specifically, FDA is updating this SE Letter as an administrative correction 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: 2021.02.08 08:17:06 -05'00'

Gregory O'Connell Assistant Director 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image contains the text 'Public Health Service'. The text is written in a simple, sans-serif font. The words are arranged horizontally, with 'Public' on the first line, 'Health' on the second line, and 'Service' on the third line.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB 2 2 2012

Control Medical Technology c/o Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K113757

Trade/Device Name: Aspire MAX Aspiration Catheters (MAX 5 and MAX 6) Regulation Number: 21 CFR 870.5150 · Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: December 20, 2011 Received: December 21, 2011

Dear Mr. Job:

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.

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Page 2 - Mr. Mark Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat 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 or any I ederal state 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you active you.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

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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4. Indication for Use Statement

510(k) Number:

113757

Device Name:

Aspire MAX Aspiration Catheter

Indications for Use:

The Aspire MAX 5 and MAX 6 Aspiration Catheters and Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sicin-Off Division of Cardiovascular Devices 510(k) Number

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5. 510(k) Summary

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided.

Date Summary was Prepared

November 4, 2011

Submitter

Control Medical Technology 136 Heber Avenue, Suite 101 PO Box 681013 Park City, UT 84068 Phone (954) 534-9345

FDA Establishment Registration Number

3007282893

Contact

President Control Medical Technology 136 Heber Avenue, Suite 101 PO Box 681013 Park City, UT 84068 Phone (954) 534-9345

Device Information

Trade Name:
Common Name:
Classification Name:
Product Code:
Regulation:

Aspire MAX Aspiration Catheter Embolectomy or aspiration catheter and piston syringe Embolectomy catheter DXE Class II, 21 CFR 870.5150

Predicate Devices

Aspire Max Aspiration Catheters are substantially equivalent to the Medtronic Export Aspiration Catheters, Vascular Solutions Pronto Extraction Catheters, Lumen - Volcano Xtract Aspiration Catheters, and other predicate devices.

Trade Names:	Export XT Aspiration Catheters K061958 September 5, 2006Pronto Short Aspiration Catheter K051193 August 8, 2005Pronto V3 Aspiration Catheter K063371 Mar 30, 2009Xtract Aspiration Catheters K071529 August 10, 2007Xtract Aspiration Catheter K080901 October 2, 2008
Common Name:	Embolectomy or aspiration catheter and piston syringe
Classification Name:	Embolectomy catheter
Product Code:	DXE
Regulation:	Class II, 21 CFR 870.5150

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Device Description

Aspire MAX 5 Aspiration Catheter (MAX 5 Aspiration Catheter and Aspire Aspirator) Aspire MAX 6 Aspiration Catheter (MAX 6 Aspiration Catheter and Aspire Aspirator) Aspire Aspirator 30ml

An Aspire MAX Aspiration Catheter includes (1) Aspire MAX 6 Aspiration Catheter and (1) Aspirator 30ml. Aspire MAX Aspiration Catheters and MAX Aspiration Catheters are single-use, sterile, short-term use, and non-pyrogenic medical devices designed for use with manually operated piston svringes to remove fresh, soft emboli and thrombi from the peripheral and coronary vasculature. The Aspire MAX Aspiration Catheter operating and scientific principle is the same as predicate devices. The catheter is inserted into the body over a guidewire and through a sheath or guide catheter to the target anatomy. A piston syringe is then connected to the catheter and the aspiration is manually created with the piston syringe.

Similar to predicate devices, industry standard intravascular catheter components and materials are used:

Clear proximal polycarbonate female luer lock, -
-Stainless steel braid,
Clear Pebax and Vestamid Shafts, -
-Embedded platinum iridium radiopaque marker,
Clear polycarbonate barrel piston syringe. -

Aspire MAX Aspiration Catheters do not add any new materials, manufacturing processes, colorants, or dyes to the manufacturing process.

Same as predicates, all MAX Aspiration Catheters may be connected to piston syringes including the Aspire Aspirator. Aspirators may be connected to other aspiration catheters.

Indications, Intended Use and Contraindications

Indication: The Aspire MAX 6 Aspiration Catheters and Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

Intended Use: Aspire MAX Aspiration Catheters are single-use devices intended for use by physician's experienced and trained in diagnostic and interventional procedures. Techniques for placement of vascular sheaths, catheters, and guidewires may be used.

Contraindications: The removal of fibrous, adherent or calcified material (e.g., chronic clot and atherosclerotic plaque), neurovascular use, and vessels <2.0mm diameter for the Aspire MAX 5 Aspiration Catheter and <2.5mm diameter for the Aspire MAX 6 Aspiration Catheter.

The indication and intended use is substantially equivalent other thrombus aspiration catheters manually actuated by syringes and legally marketed under the DXE product code.

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Comparison to Predicate Devices

Aspire MAX Aspiration Catheters and Aspirator are substantially equivalent to predicate catheters used to remove fresh, soft thrombi/emboli. Substantial equivalence is based on equivalence in:

Science	Mechanism of Use
Scientific Principle
Device Construction	Manual Use
Design & Dimensions	Piston Syringe Driven Aspiration
Function	Manufacturing
Materials
Device Performance	Bend & Torque
Aspiration	Tracking
Break strength integrity	Freedom from Leakage Aspiration
Freedom of Leakage Injection
Labeling	Contraindications
Indication for Use & Intended Use	Instructions for Use
Warnings

Manufacturing ISO 10993 Biocompatibility

Sterilization

New device is compared to predicate device? Yes, the Aspiration Catheter is compared to the predicates against predetermined metrics and performance test criteria.

Does the new device have the same indication for use as predicate device? Yes.

Do the differences between the new device and predicate alter the intended therapeutic or diagnostic effect as predicate device? No, the differences between the Aspire MAX Aspiration Catheter and predicates do not alter the intended use of the device.

Does the new device have the same technical characteristics, manufacturing processes as predicate? Yes, the Aspiration Catheter's manually operated aspiration principle of operation and technical characteristics are the same as predicates. Aspire MAX Aspiration Catheters and piston syringe materials including but not limited to Pebax and Vestamid shafts; 304 stainless steel wire braiding; luer lock hubs; and polycarbonate piston syringe barrels the same as predicates. Manufacturing extrusion, molding, and assembly in ISO 14644 Class 8 certified clean room is the same as predicates. No new materials or manufacturing processes.

Could the new characteristics affect safety? No.

Do new characteristics raise new types of safety and effectiveness questions? No.

Do accepted scientific methods exist for assessing effects of new characteristics? Yes, testing was based on FDA recognized standards and guidance including but not limited to:

ISO 10555-1:1997 Sterile, Single-Use, Intravascular Catheters.

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ISO 7886-1:1993(E) Sterile Hypodermic Syringe s for Single Use. رت
-AAMI/ANSI/ISO 11135:1994 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization.
ISO 10993 Biological Evaluation of Medical Devices. 集
FDA's Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical 1 Device, May 1, 1995 (G95-1)," U.S. Food and Drug Administration, Center for Devices and Radiological Health, May 1995, attachment C Biocompatibility Flow Chart for the Selection of Toxicity Test for 510(k)s.

Non-Clinical Testing

Non-clinical testing confirms the Aspiration Catheters and Aspirator passes all testing and meets specifications. Specific tests confirm functionality in the intended use, safety, demonstration of claims, and equivalence to predicate devices plus compliance with ISO recognized standards.

A. General:
- -Mold validation.
- -Visual inspection pre-packaging,
- Package sealer validation, .
- Tyvek seal test. .
- Packaging and shipping test, -
- Packaging visual appearance. .
- Label integrity and legibility, .
B. Integrity and compatibility:
- Particulate testing, -
- -Catheter corrosion resistance,
- Catheter body tensile strength integrity, =
- Catheter body to hub tensile strength integrity, _
- -Catheter tip attachment strength,
- Catheter leakage at hub integrity positive pressure, -
- Catheter leakage at hub integrity vacuum, .
- Catheter vacuum collapse integrity, .
- Catheter tracking test, .
- . Catheter torque,
- Catheter kink resistance, -
- Catheter radiopaque visibility. -
- Guidewire interface, .
- Guidecath interface, =
- Sheath interface, .
- Pulsed aspiration integrity tests, .
- . Aspiration fatigue integrity,
C. Aspiration:
- MAX Aspiration Catheters and predicates with standard syringes and aspirators . with low viscosity aspirants,
- MAX Aspiration Catheters and predicates with standard syringes and aspirators س with high viscosity Newtonian aspirants,

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MAX Aspiration Catheters and predicates with standard syringes and aspirators . with high viscosity Non-Newtonian aspirants,
= Thrombus aspiration,
In-vivo aspiration. -
Biocompatibility: Compliance with "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Device, May 1, 1995 (G95-1)," U.S. Food and Drug Administration, Center for Devices and Radiological Health. May 1995, attachment C Biocompatibility Flow Chart for the Selection of Toxicity Test for 510(k)s and ISO 10993. Subject devices passed all biocompatible tests performed by Ethox and Nelson Labs.
Particulate testing include validated light obscuration method and direct visualization tests. Subject = devices passed with scores significantly below an established minimum national standard.

Clinical testing

Not applicable.

Statement of Equivalence

Aspire MAX Aspiration Catheters are substantially equivalent to the currently marketed Pronto, Export, and Xtract aspiration systems based on comparison of the device classification, basic operating principle, indication for use, intended use, technical characteristics, packaging, and sterilization methods.

Conclusion

Aspire MAX Aspiration Catheters are substantially equivalent to the currently marketed Pronto, Export, and Xtract catheters based on comparison of the device classification, basic operating principle, indication for use, intended use, technical characteristics, packaging, and sterilization methods. Testing confirms the suitability of Aspire MAX Aspiration Catheters and Aspirator for its intended use.

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).