The Surefire High Flow Angiographic Catheter (SAC) is used to facilitate advancement of the Surefire High Flow Microcatheter to the target vessel. The SAC is a single lumen, fixed length guide catheter with a Luer Lock Hub. It is compatible with standard 0.038" guide wires, Luer lock infusion syringes, and rotating hemostatic valves (RHVs). The angiographic catheter has an approximate length of 65 cm (usable length). A reinforced proximal section allows for ease of insertion and the barium sulfate filled extrusion provides clear fluoroscopic images of the shaft. A braided tungsten filled shaped tip provides visual feedback for the location of the guide catheter under fluoroscopy. The distal tip is rounded for atraumatic tracking. A shaped tip will assist to deliver the Surefire High Flow Angiographic Catheter to the desired target site. A peel-away Introducer is supplied with the SAC to insert the shaped tip into a catheter sheath introducer. The system is provided sterile (FO) for single patient use. The Angiographic Catheter is packaged in sealed sterile protective pouches and product boxes.

AI/ML Overview

The Surefire® High Flow Angiographic Catheter is intended for angiographic diagnostic use. The study relied on performance and verification testing to establish substantial equivalence to a predicate device, the Angiodynamics Soft-Vu Angiographic Catheter (K112452).

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Kink Radius Testing	No kinking that would impede device function or safe use.	Met acceptance criteria.
Trackability Testing	Device can be advanced through tortuous paths without damage.	Met acceptance criteria.
Pull Strength Testing	Device maintains integrity under specified tensile forces.	Met acceptance criteria.
High Pressure Injection Testing	Device withstands high-pressure fluid injection without failure.	Met acceptance criteria.
Infusion Agent Compatibility	Device is compatible with specified infusion agents.	Met acceptance criteria.
Package Integrity (Pouch Bubble)	Package remains sterile and undamaged.	Met acceptance criteria.
Device Corrosion Testing	No corrosion that would compromise device safety or function.	Met acceptance criteria.
Biocompatibility Testing
Cytotoxicity	No cytotoxic effects.	Met acceptance criteria (in accordance with ISO 10993-5).
Sensitization	No sensitization effects.	Met acceptance criteria (in accordance with ISO 10993-10).
Intra-cutaneous Irritation	No irritation.	Met acceptance criteria (in accordance with ISO 10993-10).
Toxicity	No systemic toxicity.	Met acceptance criteria (in accordance with ISO 10993-11).
Pyrogenicity	Apyrogenic.	Met acceptance criteria (in accordance with USP <151> and ISO 10993-11).
Hemolysis	Minimal to no red blood cell damage.	Met acceptance criteria (in accordance with ASTM F756 and ISO 10993-4).
Coagulation	Minimal impact on coagulation cascade.	Met acceptance criteria (in accordance with ASTM F2382).
Particulate	Meets particulate limits.	Met acceptance criteria (in accordance with USP 788).
Complement System Testing	Minimal activation of complement system.	Met acceptance criteria (in accordance with ISO 10993-4).
Thrombogenicity	Minimal thrombus formation.	Met acceptance criteria.
Manufacturing Controls
Visual and Dimensional Inspections	Meets specified visual and dimensional requirements.	Met acceptance criteria.
Shape Retention Testing	Device maintains intended shape during use/storage.	Met acceptance criteria.
Tensile Testing	Device maintains integrity under tensile forces.	Met acceptance criteria.
Torque Testing	Device transmits torque effectively without failure.	Met acceptance criteria.
Shelf Life Testing	Device maintains safety and performance over its shelf life.	Met acceptance criteria.

Note: The document states that a "battery of tests was performed according to protocols based on the requirements of recognized standards and was shown to meet the acceptance criteria." Specific numerical acceptance criteria were not provided in the summary.

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

The information provided specifies bench tests were conducted. Details on the specific sample sizes for each individual test (e.g., number of catheters tested for kink radius, pull strength, etc.) are not explicitly stated in the provided summary. The data provenance is from bench testing, which is performed in a controlled laboratory environment and is not tied to specific countries of origin or retrospective/prospective patient data.

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

This information is not applicable as the study involved bench testing of a medical device's physical and biological properties, not a clinical study involving experts evaluating patient data or images to establish ground truth.

4. Adjudication method for the test set

This information is not applicable for bench testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human reviewers assess data.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focuses on the physical and biocompatibility performance of a medical device, not on the effectiveness of human readers assisted by AI.

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

No, a standalone algorithm performance study was not performed. This device is a physical catheter, not an AI algorithm.

7. The type of ground truth used

For the performance and verification testing, the "ground truth" was established by recognized industry standards (ISO 10555-1, ISO 10555-2, ISO 10993 series, ASTM F756, ASTM F2382, USP <151>, USP 788) and internal protocols based on these standards. These standards define the acceptable physical properties, biocompatibility, and safety parameters for such devices.

8. The sample size for the training set

This information is not applicable as this study does not involve machine learning or a "training set."

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

This information is not applicable as there is no training set mentioned or implied in this type of device submission.

Summary

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K122506

Surefire® High Flow Angiographic Catheter Premarket Notification Traditional 510(k) Submission

ーーー.

Section 5: 510(k) Summary 16 July 2012

Owner/Manufacturer:	OwnerSurefire Medical, Inc.8601 Turnpike Dr.Suite 206Westminster, CO 80031	ManufacturerSurefire Medical, Inc.12415 SW136 AvenueUnit 3Miami, FL 33186	SEP 2 0 2012
Contact Person:	Mario ArbesuDirector, Quality Assurance and Regulatory Affairs305.378.2651
Date of SummaryPreparation:	16 July 2012
Trade Name:	Surefire® High Flow Angiographic Catheter
Common Name:	Intravascular Catheter
Classification Name:	Intravascular Diagnostic Catheter
Classification:	Class II
Classification Regulation:	21 CRF Part 870.1200 - Diagnostic intravascular catheter.
Product Code:	DQO
Intended Use:	The Surefire® High Flow Angiographic Catheter is intended foruse where angiographic diagnosis is indicated.
Device Description:	The Surefire High Flow Angiographic Catheter (SAC) isused to facilitate advancement of the Surefire High FlowMicrocatheter to the target vessel. The SAC is a singlelumen, fixed length guide catheter with a Luer Lock Hub. Itis compatible with standard 0.038" guide wires, Luer lockinfusion syringes, and rotating hemostatic valves (RHVs).The angiographic catheter has an approximate length of 65cm (usable length). A reinforced proximal section allowsfor ease of insertion and the barium sulfate filled extrusionprovides clear fluoroscopic images of the shaft. A braidedtungsten filled shaped tip provides visual feedback for thelocation of the guide catheter under fluoroscopy. The distaltip is rounded for atraumatic tracking. A shaped tip willassist to deliver the Surefire High Flow AngiographicCatheter to the desired target site. A peel-away Introduceris supplied with the SAC to insert the shaped tip into acatheter sheath introducer. The system is provided sterile(FO) for single patient use. The Angiographic Catheter is

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Surefire® High Flow Angiographic Catheter Premarket Notification Traditional 510(k) Submission

Section 5: 510(k) Summary 16 July 2012

packaged in sealed sterile protective pouches and product boxes.

Principals of Operation/

Technology:

The Surefire® High Flow Angiographic Catheter is operated manually.

Performance Testing & Verification Testing

· Kink Radius Testing
· Trackability Testing
· Pull Strength Testing
· High Pressure Injection Testing
· Infusion Agent Compatibility Testing
· Package Integrity (Pouch Bubble) Testing
· Device Corrosion Testing

Biocompatibility Testing

· Cytotoxicity Tested in accordance with ISO 10993-5
· Sensitization Tested in accordance with ISO 10993-10
· Intra-cutancous irritation Tested in accordance with ISO 10993-10
· Toxicity Tested in accordance with ISO 10993-11
· Pyrogenicity Tested in accordance with USP General Chapter < 151> Pyrogen Test recommended in ISO 10993-11
· Hemolysis Tested in accordance with ASTM F756 and ISO 10993-4
· Coagulation ~ Tested in accordance with ASTM F2382
· Particulate Tested in accordance with USP 788
· Complement System Testing was performed in accordance with ISO 10993-4
· Thrombogenicity Testing Testing was performed

Performance/Safety: A risk/hazard analysis was conducted according to EN ISO 14971

(Medical Devices-Application of Risk management to medical devices). Performance characteristics for this indication for use were identified which included a review of both ISO 10555-1 (Intravascular catheters -Sterile and single-use catheters - Part 1: General requirements) and ISO 10555-2 (Sterile, single-use intravascular catheters - Part 2: Angiographic catheters). It was then determined that the performance of the Surefire High Flow Angiographic Catheter is substantially equivalent to the performance and safety of the Angiodynamics Soft-Vu Angiographic Catheter. A battery of tests was performed according to protocols based on the requirements of recognized standards and was shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device.

Additional Safety Information:

Manufacturing controls include visual, functional, dimensional and sterility tests. Blood contacting materials were tested in accordance with

· Visual and Dimensional Inspections
· Shape Retention Testing
· Particulate Testing
· Tensile Testing
· Torque Testing
· Shelf Life Testing

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	Surefire® High Flow Angiographic CatheterPremarket Notification Traditional 510(k) Submission	Section 5: 510(k) Summary16 July 2012
		the tests recommended in the FDA General program Memorandum.Biocompatibility testing was conducted in accordance with InternationalStandard ISO 10993, "Biological Evaluation of Medical Devices Part -1Evaluation and testing".
SubstantialEquivalence:	The Surefire® High Flow Angiographic Catheter is substantiallyequivalent in intended use, design, and technology/principles of operationto the predicate. Both devices share the same Indications for Use. Bothdevices have a 5F outer diameter. The tip of both the predicate and theproposed device have an equivalent geometry. Both products are designedto be compatible with 0.038" guidewires. The Microcatheter issubstantially equivalent to the Angiodynamics Soft-Vu AngiographicCatheter, cleared under K112452. Differences between the devices do notraise any issues of safety or effectiveness.
		Test data provided in bench tests demonstrate that the device is as safe, aseffective, and performs at least as safely and effectively as the predicatedevice.
SubmitterInformation:	Prepared by:	Mario ArbesuDirector, Quality Assurance and Regulatory Affairs
	Prepared for:	Surefire Medical, Inc.12415 SW 136 AvenueUnit 3Miami, FL 33186
	Date:	July 16, 2012

।

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

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

April 11, 2013

Surefire Medical, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K122506

Trade/Device Name: Surefire® High Flow Angiographic Catheter Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: June 8, 2012 Received: August 16, 2012

Dear Mr. Job:

This letter corrects our substantially equivalent letter of September 20, 2012.

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

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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Matthew G. Hillebrenner

for

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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-9-

Indication for Use

510(k) Number (if known):

Device Name:

Indication for Use:

Surefire® High Flow Angiographic Catheter

The SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER is intended for use where angiographic diagnosis is indicated.

X Prescription Use (part 21 CFR 801 Subpart D) Over-The-counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Le

(Dhisicri 9:7):1. Off) Division in Cardiovascular Devices 122506 510:-., Number

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.