The SUREFIRE™ INFUSION CATHETER SYSTEM is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

Device Description

The Surefire™ Infusion Catheter System is a two-part system comprised of an Infusion Microcatheter and a Guide Sheath.

AI/ML Overview

The Surefire™ Infusion Catheter System is a medical device intended for use in angiographic procedures to deliver radiopaque media and therapeutic agents to selected sites in the peripheral vascular system. The provided document is a 510(k) premarket notification summarizing the device's performance testing and substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Surefire™ Infusion Catheter System are based on established international standards and the performance of predicate devices. The study demonstrates the device's performance by showing it meets these acceptance criteria.

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance and Acceptance
Performance Testing	Kink Testing, Tensile Testing, High Pressure Injection Testing, Hub Aspiration Testing, Embolic Agent Infusion Compatibility Testing, Package Integrity Testing, Corrosion Testing, Diagnostic Agent Compatibility Testing, Trackability Testing, Dimensional Inspection, Coating Integrity, Antegrade Flow Testing, Infusion Efficiency	"A battery of tests were performed according to protocols based on the requirements of the following standards and was shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device: ISO 10555-1 Sterile, single-use intravascular catheters Part 1 General requirements, ISO 10555-2 Sterile, single-use intravascular catheters Part 2 Angiographic catheters." The document states that the performance characteristics were determined, and the device was proven to be "substantially equivalent to the performance and safety of the Terumo Radifocus Glidecath." Specific numerical performance values are not provided, but the statement confirms the device met the required criteria for these tests.
Biocompatibility Testing	Pyrogen Test (USP <151>, ISO 10993-11), Intra-cutaneous Irritation (ISO 10993-10), Hemolysis (ASTM F756, ISO 10993-4), Sensitization (ISO 10993-10), Particulate USP Standards, Cytotoxic Effects (ISO 10993-5), Complement System	All biocompatibility tests were conducted according to the specified international standards and demonstrated compliance. The device passed these tests, indicating it is biocompatible for its intended use. "Blood contacting materials were tested in accordance with the tests recommended in the FDA General program Memorandum. Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part -1 Evaluation and testing'."
Sterilization & Packaging	Package Integrity Testing, Ethylene Oxide Sterilization Validation and Routine Control (ISO 11135-1)	Package integrity was confirmed. Sterilization processes were validated and controlled per ISO 11135-1.
Safety and Risk Management	Risk/Hazard Analysis (EN ISO 14971), Acute System Toxicity	A risk/hazard analysis was conducted according to EN ISO 14971. The device's safety was demonstrated, and it was found substantially equivalent to predicate devices. Acute System Toxicity testing was performed.
Manufacturing Controls	Visual, Functional, Dimensional, and Sterility Tests	Manufacturing controls include visual, functional, dimensional and sterility tests. These tests are implicitly part of the acceptance criteria to ensure consistent product quality.

The primary study type is an equivalence study, specifically demonstrating substantial equivalence to predicate devices (Terumo Radifocus GLIDECATH for the Guide sheath and EmboCath Plus Infusion Microcatheter by BioSphere Medical for the Microcatheter). This is a common approach for 510(k) submissions where a new device is compared to legally marketed devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample sizes for each specific performance or biocompatibility test. However, it indicates that a "battery of tests were performed" using "protocols based on the requirements of the following standards." This implies that the sample sizes would have been determined by the requirements of the cited standards (e.g., ISO 10555-1, ISO 10555-2, ISO 10993 series, ASTM F756, USP).

The data provenance is the manufacturer's internal testing and is considered prospective as it was conducted specifically for this regulatory submission to demonstrate device performance. The country of origin of the data is implicitly the United States, where Surefire Medical, Inc. is located. The document also mentions "animal study data is submitted in this 510(k) and is on file at Surefire Medical," indicating some pre-clinical animal testing was performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This submission does not involve a "test set" in the traditional sense of a clinical diagnostic study requiring expert ground truth establishment for patient data (e.g., image interpretation). Instead, the "ground truth" for this device's performance is established by the specified acceptance criteria defined by international standards and validated engineering principles.

Therefore, there were no "experts" in the sense of clinical specialists providing interpretations. The "experts" involved would be engineers, quality assurance specialists, and regulatory professionals who designed the tests, interpreted the results against the standards, and compiled the submission. Their qualifications are inherent in their roles within a medical device company and their adherence to recognized standards.

4. Adjudication Method for the Test Set

Not applicable. As explained above, this submission does not involve a test set requiring adjudication of, for example, diagnostic interpretations or clinical outcomes by multiple experts. The "adjudication" is primarily against pre-defined engineering and biocompatibility specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to assess human reader performance with and without AI assistance. The Surefire™ Infusion Catheter System is an intravascular catheter, not a diagnostic imaging AI system. The comparison for this device is primarily against established performance benchmarks and predicate devices through physical and chemical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance assessment (in the context of an algorithm's performance without human interaction) was not done. This device is a physical, manually operated catheter system. Its performance evaluation focuses on its mechanical, material, and biological properties, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

Engineering Specifications and Performance Standards: The device's performance (e.g., kink resistance, tensile strength, flow rates, dimensions) is compared against pre-defined, acceptable ranges and thresholds derived from international standards (e.g., ISO 10555-1, ISO 10555-2).
Biocompatibility Standards: The device's biological safety is assessed against the requirements of ISO 10993 series and USP standards.
Predicate Device Performance: For substantial equivalence, the device's performance characteristics are compared to those of legally marketed predicate devices to ensure it performs as safely and effectively.
Risk/Hazard Analysis: Per EN ISO 14971, safety criteria are established based on potential risks, and the device is evaluated against these.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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110459 Section 5-1 16 June 2011

Surefire Medical requests that the attached "Summary" for the Surefire™ Infusion Catheter System be distributed upon request under the Freedom of Information Act. This report is a summary of the information presented in this 510(k) submission.

Owner/Manufacturer:	Surefire Medical, Inc.8601 Turnpike Dr. ManufacturingSuite 206Westminster, CO 80031	Surefire Medical, Inc.12415 SW136AvenueUnit 3Miami, FL 33186
Contact Person:	Cheryl HastingsVP Clinical and Regulatory Affairs303.883.5554
Date of SummaryPreparation:	16 June 2011	JUN 2 4 2011
Trade Name:	Surefire™ Infusion Catheter System
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™ Infusion Catheter System is intended for use inangiographic procedures. It delivers radiopaque media and therapeuticagents to selected sites in the peripheral vascular system.
Device Description:	The Surefire™ Infusion Catheter System is a two-part system comprisedof an Infusion Microcatheter and a Guide Sheath.
Principals of Operation/Technology:	The Surefire™ Infusion Catheter System is operated manually.

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Performance Testing & Verification Testing

Kink Testing .
. Tensile Testing
High Pressure Injection Testing ●
. Hub Aspiration Testing
Embolic Agent Infusion Compatibility Testing ●
Package Integrity Testing
Corrosion Testing .
. Diagnostic Agent Compatibility Testing
. Trackability Testing
. Dimensional Inspection
. Coating Integrity
. Antegrade Flow Testing
Infusion Efficiency �
Acute System Toxicity .

Biocompatibility Testing

Pyrogenic- Test is conducted based on USP, General Chapter, <151> Pyrogen Test. The . procedure is recommended in ISO 10993-11
intra-cutaneous irritation based on ISO 10993-10: Toxicity of the Paladin Catheter testing was . based on International Organization for Standardization 10993-11
Hemolysis was tested according to procedures based on ASTM F756, Standard Practices for . Assessment of Hemolytic Properties of Materials and ISO 10993-4
Sensitization was tested based on the requirements of ISO 10993-10 .
Particulate USP Standards .
Cytotoxic effects were tested following the guidelines of ISO 10993-5: .
Complement System 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 characteristic for this indication for use were determined. It was then justified that the performance of the Surefire™ Infusion Catheter System is substantially equivalent to the performance and safety of the Terumo Radifocus Glidecath. A batterv of tests were performed according to protocols based on the requirements of the following standards and was shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device:

· ISO 10555-1 Sterile, single use intravascular catheters Part 1 General requirements.
· Surefire™ Infusion Catheter System Section 5-1 Premarket Notification Traditional 510(k) Submission 15 February 2011
· ISO 10555-2 Sterile, single use intravascular catheters Part 2 Angiographic catheters.
· ISO 10993-1 Biological Evaluation of medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
· ISO 11135-1 Medical Devices -Validation and Routine Control of Ethylene Oxide Sterilization.

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Additional SafetyInformation:	Manufacturing controls include visual, functional, dimensional and sterility tests.Blood contacting materials were tested in accordance with the tests recommended in the FDA General program Memorandum. Use of InternationalStandard ISO 10993, "Biological Evaluation of Medical Devices Part -1Evaluation and testing".
Discussion ofAnimal Data:	The animal study data is submitted in this 510(k) and is on file at SurefireMedical.
SubstantialEquivalence:	The Surefire™ Infusion Catheter System is substantially equivalent in intendeduse, design, technology/principles of operation to the predicates. The Guidesheath is substantially equivalent to the Terumo Radifocus GLIDECATH,cleared under K090040. The Microcatheter is substantially equivalent to theEmboCath Plus Infusion Microcatheter by BioSphere Medical cleared underK062126. Differences between the devices do not raise any significant issues ofsafety or effectiveness.
SubmitterInformation:	Prepared by:Prepared for:Date:	Cheryl HastingsVP Clinical and Regulatory AffairsSurefire Medical, Inc.8601 Turnpike DriveSuite 206Westminster, CO 80031June 16, 2011

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Public Health Service

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

Surefire Medical, Inc. c/o Ms. Cheryl Hastings VP Clinical and Regulatory Affairs 8601 Turnpike Dr., Suite 206 Westminster, CO 80031

JUN 2 4 2011

Re: K110459

Trade/Device Name: Surefire™ Infusion Catheter System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: June 17, 2011 Received: June 20, 2011

Dear Ms. Hastings:

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

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Page 2 - Ms. Cheryl Hastings

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 go to http://www.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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

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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Surefire™ Infusion Catheter System Premarket Notification 510(k) Submission

Indication for Use

510(k) Number (if known):

K110459

Surefire™ Infusion Catheter System Device Name:

Indication for Use:

The SUREFIRE™ INFUSION CATHETER SYSTEM is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

Over-The-counter Use AND/OR Prescription Use x (21 CFR 801 Subpart C) (part 21 CFR 801 Subpart D)

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

Concurrence of CDRH,

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number 1/110459

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Indication for Use

510(k) Number (if known):	K110459
Device Name:	Surefire TM Infusion Catheter System
Indication for Use:	The SUREFIRE TM INFUSION CATHETER SYSTEM is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

AND/OR 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)

Concurrence of CDRH,

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

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).