The Surefire Precision Infusion 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 Precision Infusion Systems are coaxial microcatheters with a female luer lock hub at the proximal end, and the Surefire Expandable Tip at the distal end that is sized for use in various sized vessels. The Surefire Precision Infusion System, serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires up to 0.018", and embolic hydrogel particles ≤500μm, and glass microspheres ≤110μm (0.021" lumen) or <150um (0.025" lumen). The Surefire Precision Infusion System 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 Surefire Precision Infusion System has an outer sheath to facilitate expanding and collapsing the Surefire Expandable Tip. There are three radiopaque markers located just proximal and distal to the Surefire Expandable Tip. The Tip can be expanded or collapsed for re-positioning during 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 the vessel. The Surefire Precision Infusion System is provided sterile (EtO) for single patient use.

AI/ML Overview

The Surefire Precision Infusion System is a medical device and the provided text describes its 510(k) summary, focusing on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "device performance" are not presented in the context of a diagnostic AI algorithm with specific metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are the performance specifications and the "device performance" refers to the results of the verification and validation tests, which show the device meets these specifications and performs comparably to the predicate.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a medical device (intravascular catheter) and not an AI algorithm, the "acceptance criteria" refer to established performance specifications for device function, and "reported device performance" refers to the successful demonstration that the device met these specifications during testing. The document does not provide a quantitative table of specific numerical acceptance criteria and their corresponding results but rather states that the device "meets the same performance specifications and acceptance criteria as the predicate device" and that "performance is comparable to the predicate device."

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Did not indicate any significant biological reaction that would affect the patient due to contact with materials. Thrombogenicity testing was also performed and found acceptable.
Design Verification/Validation (Material Modifications)	Met the same performance specifications and acceptance criteria as the predicate device for all tests performed, including: Tensile (Pull) Strengths (distal tip), Kink Radius, Torque Resistance, Infusion Efficiency, Antegrade Flow, Particulates, Embolic Agent Compatibility, Burst Pressure, Coating Durability and Uniformity, Frictional Force, Base Catheter Insertion/Retraction Force, Visual and Dimensional, EtO Residuals.
Comparative Acute Performance (Animal Study)	Acceptable in all evaluated categories, met defined user needs, and performed comparably to the predicate device in a simulated clinical environment.
Substantial Equivalence	Found to be substantially equivalent in intended use, design, and technology/principles of operation to the predicate device. Differences do not raise issues of safety or effectiveness.

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

Test Set Description: The "test set" here refers to the samples used in the performance testing and animal study for the physical device, not a dataset for an AI model.
Sample Size: The document does not specify the exact numerical sample sizes for each performance test (e.g., number of catheters tested for burst pressure). It only generically states that various tests were performed. For the animal study, the sample size (number of animals) is not disclosed.
Data Provenance: The biocompatibility testing was conducted by NAMSA (Northwood, OH), indicating US-based data. The performance testing (bench testing) was likely conducted in-house or by a contracted lab. The animal study was also performed to assess comparative acute performance. The general provenance is therefore related to device manufacturing and testing processes, not patient data from a specific country or whether it was retrospective/prospective in the AI sense.

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

This question is not directly applicable in the context of this traditional medical device submission. Ground truth, in the sense of expert consensus on diagnostic imaging, is not relevant here. The "ground truth" for the device's performance is established by objective engineering and biological testing against predefined specifications and comparison to the predicate device's established performance.

However, for the animal study, it notes that the performance was "as defined by physicians in a simulated clinical environment." This implies that physicians (experts) observed and evaluated the device's performance in the animal model. The number and qualifications of these physicians are not specified.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI studies where disagreements among experts need to be resolved. This is not applicable to a traditional medical device's performance testing. Device performance is determined by objective measurements and observations against acceptance criteria.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance, which is not the subject of this 510(k) submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this question is not applicable as the Surefire Precision Infusion System is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is defined by:

Objective Performance Specifications: These are engineering standards and safety requirements that the device must meet (e.g., tensile strength, burst pressure, coating durability).
Predicate Device Performance: The "ground truth" for comparative performance is the established safe and effective performance of the legally marketed predicate device. The new device must demonstrate comparable performance.
Biocompatibility Standards: Compliance with ISO 10993 series standards establishes the biological "ground truth" for material safety.
Physician Assessment (Animal Study): In the animal study, the "ground truth" for acceptability and comparability was a qualitative assessment by physicians based on "defined user needs" in a simulated clinical environment.

8. The Sample Size for the Training Set

This question is not applicable as the Surefire Precision Infusion System is a physical medical device and does not involve AI model training.

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

This question is not applicable as the Surefire Precision Infusion System is a physical medical device and does not involve AI model training or a training set.

Summary

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Public Health Service

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May 17, 2017

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

Surefire Medical, Inc. % Mark Job Official Correspondent Regulatory Technology Services. LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K171355

Trade/Device Name: Surefire Precision Infusion System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DOO Dated: March 6, 2017 Received: May 9, 2017

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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" (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.

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.

Sincerely.

Fernando
Aguel
Fernando
Aguel-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)

K171355

Device Name Surefire Precision Infusion System

Indications for Use (Describe)

The Surefire Precision Infusion System 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 Precision Infusion System

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: 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 Precision Infusion System
Classification:	Class II
Classification Panel:	Cardiovascular Devices
Classification Regulation:	21 CFR 870.1200
Product Code:	DQO

Predicate Device

	■ Surefire Infusion System 021	K143588
	■ Surefire Infusion System(marketed as Surefire Precision Infusion System)	K160662

Device Description

Catalog Number	Inner Diameter	Length	Tip / Vessel Size
SPS-21120-35	0.021 inch	120 cm	1.5 - 3.5 mm
SPS-21150-35	0.021 inch	150 cm	1.5 - 3.5 mm
SPS-25120-40	0.025 inch	120 cm	2 - 4 mm
SPS-25150-40	0.025 inch	150 cm	2 - 4 mm
SPS-25120-60	0.025 inch	120 cm	4 - 6 mm
SPS-25150-60	0.025 inch	150 cm	4 - 6 mm

The Surefire Precision Infusion System, serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires up to 0.018", and embolic hydrogel particles ≤500μm, and glass microspheres ≤110μm (0.021" lumen) or <150um (0.025" lumen). The Surefire Precision Infusion System 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.

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The Surefire Precision Infusion System has an outer sheath to facilitate expanding and collapsing the Surefire Expandable Tip. There are three radiopaque markers located just proximal and distal to the Surefire Expandable Tip. The Tip can be expanded or collapsed for re-positioning during 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 the vessel.

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

Indications for Use

The Surefire Precision Infusion System 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 (listed below) of the patient-contact materials used in the construction of the modified Surefire Precision Infusion System were 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 testing was conducted in accordance with GLP by NAMSA (Northwood, OH).

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

The results 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.

Category	Standard	Test Method
Cytotoxicity	ISO 10993-5	Cytotoxicity Study Using the ISO Elution Method – 1x Minimal Essential Media Extract
Sensitization	ISO 10993-10	ISO Maximization Sensitization Study – Extract – 0.9% Sodium Chloride Solution Extract
		ISO Maximization Sensitization Study – Extract – Sesame Oil, NF Extract
Irritation orIntracutaneous Reactivity	ISO 10993-10	ISO Intracutaneous Study – Extract – 0.9% Sodium Chloride Solution Extract
		ISO Intracutaneous Study – Extract – Sesame Oil, NF Extract
Systemic Toxicity	ISO 10993-11	ISO Systemic Toxicity Study – Extract – 0.9% Sodium Chloride Solution Extract
		ISO Systemic Toxicity Study – Extract – Sesame Oil, NF Extract
		Pyrogen – Material Mediated – 0.9% Sodium Chloride Solution Extract
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

Performance Testing

The following design verification / validation tests were performed as a result of the risk analysis assessment of the material modifications. The test results demonstrate that the modified Surefire Precision Infusion System meets the same performance specifications and acceptance criteria as the predicate device.

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Tensile (Pull) Strengths (distal tip) ■
Kink Radius
트 Torque Resistance
. Infusion Efficiency
. Antegrade Flow
. Particulates
트 Embolic Agent Compatibility
Burst Pressure
Coating Durability and Uniformity
Frictional Force
Base Catheter Insertion/Retraction Force
I Visual and Dimensional
. EtO Residuals

The following testing was leveraged from previous testing of the predicate device:

I Tensile (Pull) Strengths (proximal hub/handle)
Corrosion
I Diagnostic Agent Compatibility
. Packaging & Labeling Visual Inspection
. Package Seal Strength
. Package Integrity

Animal Testing

An animal study was performed to assess the comparative acute performance of the modified Surefire Precision Infusion System to the predicate device, as defined by physicians in a simulated clinical environment. The modified Surefire Precision Infusion System was found to be acceptable in all evaluated categories, met the defined user needs, and performed comparably to the predicate device.

Substantial Equivalence

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

Comparative Summary: Design / Technological Characteristics

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

The predicate and modified are available in the same range of sizes: inner diameters 021" to 025". lengths 120 cm to 150 cm, and tip/vessel size 1.5 mm to 6 mm.

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

Comparative Summary: Indications for Use

The modified Surefire Precision Infusion System 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 modified Surefire Precision Infusion System performance is comparable to the predicate device.

In summary, the modified Surefire Precision System is substantially equivalent in intended use, design, and technology/principles of operation to the predicate device. Animal and bench performance test data demonstrate that the modified Surefire Precision Infusion System 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).