The Surefire Infusion System 021 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 System 021 is a 0.021" lumen coaxial microcatheter with the Surefire Expandable Tip at the distal end. It has an outer sheath to facilitate expanding and collapsing the Surefire Expandable Tip. The Surefire 021, serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard 0.018" guide wires, infusion syringes, rotating hemostatic valves (RHVs/Tuohy Borsts), and embolic hydrogel particles 500um or less in size and glass microspheres 110um or less in size. The Surefire 021 has a Teflon inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The device is hydrophilically coated. The soft, pliable, funnel-shaped Surefire Expandable Tip is sized for use in vessels of 1.5mm to 4 mm.

There are two radiopaque markers located just proximal and distal to the Surefire Expandable Tip. The Tip can be expanded or collapsed up to 3 times for re-positioning an interventional procedure by simply retracting or advancing the inner microcatheter while holding the outer sheath stationary. When expanded, the Expandable Tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in various size vessels.

The Surefire Infusion System 021 is provided sterile (EtO) for single patient use.

AI/ML Overview

The document provided is a 510(k) premarket notification letter and summary for the Surefire Infusion System 021. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

Based on the provided text, the device is the Surefire Infusion System 021, and the study described is a comparison to a predicate device (Surefire Infusion System, K121677) to demonstrate substantial equivalence, rather than a study defining specific acceptance criteria for a novel AI or diagnostic algorithm and its performance against those criteria. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies for an AI/diagnostic device is not directly applicable or available in this document.

However, I can extract the information that is relevant to the performance testing and comparison made in this submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal, quantitative table of acceptance criteria with specific thresholds for performance metrics. Instead, it states that the device "meets its specified performance requirements" and "is comparable to the performance of the predicate device."

Criterion Category	Acceptance Criteria (general statement)	Reported Device Performance (general statement)
Design Verification	Meets specified performance requirements.	"demonstrated that the Surefire Infusion System 021 meets its specified performance requirements, and is equivalent to the performance of the predicate device."
Mechanical Strength & Performance	Comparable to the predicate device.	"The Surefire Infusion System 021 meets its specifications and is comparable in mechanical strength and performance to the predicate Surefire Infusion System."
Acute Performance (Clinical Simulation)	Acceptable performance, comparable to the predicate device.	"The Surefire Infusion System 021 was found to have acceptable performance. Additionally, the Surefire Infusion System 021 was found to have comparable performance to the predicate device." (from animal study)
Biocompatibility	No significant biological reaction that would affect the patient.	"The results of all of the biocompatibility testing did not indicate any significant biological reaction that would affect the patient due to contact with the materials used in the device construction." (leveraging predicate device testing, and additional thrombogenicity testing)

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

Test Set Description: The "test set" in this context refers to the samples used for design verification (bench testing) and the animal study.
Bench Testing: No specific sample sizes are provided for the various bench tests (visual/dimensional inspection, lubricity, wear, particulates, burst pressure, tensile strength, kink resistance, torque resistance, trackability, infusion/embolic agent compatibility, antegrade flow, infusion efficiency). The document only states "Design verification testing was performed."
Animal Study: The document states "An animal study was performed," but does not provide the number of animals or specifically state the country of origin.
Data Provenance: Not explicitly stated for either bench or animal testing, beyond "NAMSA (Northwood, OH)" for biocompatibility (which was leveraged from the predicate device). The animal study involved a "simulated clinical environment," suggesting a controlled experimental setting rather than retrospective patient data.

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

This document does not describe the use of "experts" to establish ground truth in the context of diagnostic performance for a test set. The animal study assessed "comparative acute performance... as defined by physician's in a simulated clinical environment," implying physician observation and assessment, but no specific number or qualifications are given for these "physicians."

4. Adjudication method for the test set

No adjudication method is described. The performance assessments are generally stated as being "met" or "comparable."

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 comparative effectiveness study was conducted. This device is an infusion system (catheter), not an AI or diagnostic imaging device that would typically involve human readers interpreting cases.

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

Not applicable. This is a medical device (catheter) and does not involve an algorithm for standalone performance evaluation in the way an AI diagnostic device would.

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

The "ground truth" for the performance claims comes from:
- Bench Test Specifications: The device met its internal specified performance requirements.
- Predicate Device Performance: Performance was compared to that of the predicate device.
- Animal Study Observations: Physicians' assessments in a simulated clinical environment were used for acute performance.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

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

In summary: This FDA submission focuses on demonstrating substantial equivalence for a physical medical device (catheter) through bench testing, biocompatibility testing (leveraging existing data), and an animal study. It does not involve the types of testing, acceptance criteria, or ground truth establishment typically associated with AI-powered diagnostic devices or software that require human expert review and large datasets.

Summary

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

June 11, 2015

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

Re: K143588

Trade/Device Name: Surefire Infusion System 021 Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: December 17, 2014 Received: December 18, 2014

Dear Mr. Job:

This letter corrects our substantially equivalent letter of January 12, 2015.

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

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Page 2 - Mr. Mark Job

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 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

for

Sincerely yours,

Kenneth J. Cavanaugh -S

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)

Device Name Surefire Infusion System 021

Indications for Use (Describe)

The Surefire Infusion System 021 is intended for use in angiographic procedures.

It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

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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510(K) SUMMARY

Device Name

Surefire Infusion System 021

Manufacturer Name and Address

Surefire Medical, Inc. 6272 W. 91st Avenue Westminster, CO 80031 Owner Operator Number: 10038066

Submitter Contact Information

Surefire Medical, Inc. 6272 W. 91st Avenue Westminster, CO 80031 Lynne Aronson. VP Regulatory Affairs and Quality Assurance Contact: Contact: Phone: Phone: 303-426-1222 Fax: 303-426-1223

Common, Classification & Proprietary Names

Common Name:	diagnostic intravascular catheter
Classification Name:	diagnostic intravascular catheter
Proprietary Name:	Surefire Infusion System 021
Classification:	Class II
Classification Panel:	Cardiovascular Devices
Classification Regulation:	21 CFR 870.1200
Product Code:	DQO

Predicate Device

Surefire Infusion System 트

K121677

Device Description

The Surefire Infusion System 021 is provided sterile (EtO) for single patient use.

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Indications for Use

The Surefire Infusion System 021 is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

Biocompatability Testing

Biocompatibility testing of the patient-contact materials used in the construction of the catheter was performed in accordance with ISO 10993-1 for an external communicating device in contact with circulating blood with a limited duration of less than 24 hours. The following testing was conducted in accordance with GLP by NAMSA (Northwood, OH).

The following biocompatibility testing was conducted on the Surefire Infusion System (K121677) which are constructed of the same materials as the Surefire Infusion System 021. Therefore, the biocompatibility test requirements for the Surefire Infusion System (21 were met by leveraging previously completed biocompatibility testing.

Category	Standard	Test Method
Cytotoxicity	ISO 10993-5	Cytotoxicity Study Using the ISO Elution Method - 1x MinimalEssential Media Extract
Sensitization	ISO 10993-10	ISO Maximization Sensitization Study - Extract - 0.9% SodiumChloride Solution Extract
		ISO Maximization Sensitization Study - Extract – Sesame Oil, NFExtract
Irritation orIntracutaneousReactivity	ISO 10993-10	ISO Intracutaneous Study - Extract - 0.9% Sodium Chloride SolutionExtract
		ISO Intracutaneous Study - Extract - Sesame Oil, NF Extract
Systemic Toxicity	ISO 10993-11	ISO Systemic Toxicity Study - Extract - 0.9% Sodium ChlorideSolution Extract
		ISO Systemic Toxicity Study - Extract - Sesame Oil, NF Extract
		Pyrogen – Material Mediated – 0.9% Sodium Chloride SolutionExtract
Hemocompatability	ISO 10993-4	ASTM Hemolysis – CMF-PBS Extract
		C3a Complement Assay - Normal Human Serum Extract
		SC5b-9 Complement Assay - Normal Human Serum Extract
		Coagulation - ASTM Partial Thromboplastin Time

Additionally, testing for thrombogenicity was performed on the Surefire Infusion System 021 Catheter as a part of an Animal Study.

The results of all of the biocompatibility testing did not indicate any significant biological reaction that would affect the patient due to contact with the materials used in the device construction.

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Performance Testing

Design verification testing was performed which demonstrated that the Surefire Infusion System 021 meets its specified performance requirements, and is equivalent to the performance of the predicate device. Testing included visual and dimensional inspection, and tests for hydrophilic coating lubricity and wear, particulates, high pressure injection (burst pressure), tensile strength, kink resistance, torque resistance, trackability, infusion agent compatibility, embolic agent compatibility, antegrade flow and infusion efficiency.

The results of testing demonstrated that the Surefire Infusion System 021 meets its specifications and is comparable in mechanical strength and performance to the predicate Surefire Infusion System.

Animal Testing

An animal study was performed to assess the comparative acute performance of the Surefire Infusion System 021to the predicate device, as defined by physician's in a simulated clinical environment. The Surefire Infusion System 021was found to have acceptable performance. Additionally, the Surefire Infusion System 021was found to have comparable performance to the predicate device.

Substantial Equivalence

The Surefire Infusion System 021is substantially equivalent in intended use, design, and technology/principles of operation to the predicate.

Comparative Summary: Design / Technological Characteristics

The Surefire Infusion System 021 and predicate device are coaxial microcatheters with the Surefire Expandable Tip at the distal end. Both infusion systems have an outer catheter to facilitate expanding and collapsing the Surefire Expandable Tip.

The Surefire Infusion System 021 and the predicate device are constructed of similar materials utilizing similar construction and manufacturing processes.

The Surefire Infusion System 021 and predicate device have similar dimensions, with the Surefire Infusion System 021 having smaller outer and inner diameters. Both catheters are 120 cm in length. Due to the smaller inner lumension, the maximum sized embolic beads that are compatible with the Surefire Infusion System 021 are smaller than with the predicate device.

The Surefire Infusion System 021 and predicate device are provided in identical packaging, sterilized by ethylene oxide, and labeled for single use only.

Comparative Summary: Indications for Use

The Surefire Infusion System 021 has the same indications for use as the predicate device. Both devices are intended for use in angiographic procedures to deliver radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

Comparative Summary: Performance

Animal and bench performance test data demonstrate that the Surefire Infusion System 021 performance is comparable to the predicate device.

In summary, the Surefire Infusion System 021 is substantially equivalent in intended use, design, and technology/principles of operation to the predicate. Animal and bench performance test data demonstrate that the Surefire Infusion System 021 performance is comparable to the predicate device. Differences between the devices do not raise any issues of safety or effectiveness.

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).