The Surefire Guiding Catheter is intended to provide a pathway through which therapeutic devices are introduced. The Surefire Guiding Catheter is intended to be used in the peripheral vascular system.

Device Description

The Surefire Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system.

The Surefire Guiding Catheter is a single-lumen, braided, fixed-length 5F catheter with a soft distal tip and a proximal Luer-Lock hub and strain relief. The Pebax extruded polymer is filled with a radiopacifier to provide visibility of the Surefire Guiding Catheter under fluoroscopy.

The Surefire Guiding Catheters are 65 and 80 cm in length with a variety of pre-shaped tip designs (including but not limited to Axis, Simmons I and Cobra) to accommodate access and positioning in a range of peripheral vascular anatomies. The distal tip is rounded for atraumatic tracking.

The Surefire Guiding Catheter is compatible with standard 0.038" OD guide wires, Luer-Lock infusion syringes, rotating hemostatic valves (RHV), and 5F catheter sheath introducers.

The Surefire Guiding Catheter is provided sterile (EtO) for single patient use

AI/ML Overview

This document describes the Surefire Guiding Catheter, a medical device, and its acceptance criteria as demonstrated through various studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details various tests performed to demonstrate the safety and effectiveness of the Surefire Guiding Catheter and its equivalence to a predicate device. The acceptance criteria are implicitly met by the successful completion of these tests and the determination of substantial equivalence.

Acceptance Criteria Category	Specific Test / Requirement	Reported Device Performance
Biocompatibility	ISO 10993-1 (External communicating device, < 24 hours contact)	Leveraged previously completed biocompatibility testing from other Surefire devices (Surefire Infusion System (K110459), Surefire High-Flow Microcatheter (K121677), and Surefire Angiographic Catheter (K122506)) constructed of the same materials. All tests were performed in accordance with GLP by NAMSA (Northwood, OH).Specific tests conducted: - Cytotoxicity: ISO 10993-5 (ISO Elution Method - 1x Minimal Essential Media Extract)- Sensitization: ISO 10993-10 (ISO Maximization Sensitization Study - Extract - 0.9% Sodium Chloride Solution, and Sesame Oil, NF Extract)- Irritation/Intracutaneous Reactivity: ISO 10993-10 (ISO Intracutaneous Study - Extract - 0.9% Sodium Chloride Solution, and Sesame Oil, NF Extract)- Systemic Toxicity: ISO 10993-11 (ISO Systemic Toxicity Study - Extract - 0.9% Sodium Chloride Solution, Sesame Oil, NF Extract, and Pyrogen - Material Mediated - 0.9% Sodium Chloride Solution Extract)- Hemocompatibility: 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).Results: "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." Additionally, thrombogenicity testing was performed as part of the GLP Animal Study.
Performance (Bench Testing)	Specified performance requirements	"Design verification testing was performed which demonstrated that the Surefire Guiding Catheter meets its specified performance requirements, and is equivalent to the performance of the predicate device."Tests included: visual and dimensional inspection, and tests for particulates, kink, tensile strength, torque, trackability/device compatibility, high pressure injection and flow/pressure generation.
Performance (Animal Testing)	Comparative acute performance to predicate device	"A GLP animal study was performed to assess the comparative acute performance of the Surefire Guiding Catheter to the predicate device, as defined by a physician in a clinical environment. The Surefire Guiding Catheter was found to have acceptable performance. Additionally, the Surefire Guiding Catheter was found to have comparable performance to the predicate device."
Substantial Equivalence	Intended use, design, technology/principles of operation, performance	The device was found substantially equivalent to the predicate device (Medtronic Launcher Guiding Catheter K030779) in intended use (peripheral vascular system), design (single lumen, Luer-Lock hubs, shaped tip styles, similar construction materials like polymer outer extrusion with radiopacifier, stainless steel braid and polymer inner), and technology/principles of operation. Animal and bench performance data demonstrated comparable performance. The difference in indications (predicate also for coronary, new device only for peripheral) did not impact safety and effectiveness for the indicated use.

Study that Proves the Device Meets the Acceptance Criteria:

The document describes a series of studies rather than a single unifying study, all aimed at demonstrating the safety, effectiveness, and substantial equivalence of the Surefire Guiding Catheter to its predicate device. This approach is typical for 510(k) submissions.

Summary of Studies:

Biocompatibility Testing: Performed per ISO 10993-1, leveraging data from other Surefire products with similar materials. This included various in-vitro tests for cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility.
Performance Testing (Bench Studies): Design verification tests including visual/dimensional inspection, particulates, kink, tensile strength, torque, trackability/device compatibility, high pressure injection, and flow/pressure generation.
Animal Testing (GLP): A comparative acute performance study against the predicate device.

Detailed Information Regarding the Studies:

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

Biocompatibility Testing: The specific sample sizes for each in-vitro test (Elution, Maximization, Intracutaneous, Systemic Toxicity, Hemolysis, Complement Assays, Coagulation) are not explicitly stated in the provided text.
- Data Provenance: The tests were performed by NAMSA (Northwood, OH). This suggests in-vitro laboratory testing. The leveraging of data from other Surefire devices implies the materials were sourced from the manufacturer for these devices.
Performance Testing (Bench Studies): Sample sizes for the various bench tests (visual/dimensional, kink, tensile, torque, etc.) are not explicitly stated in the provided text.
- Data Provenance: These were likely performed at a manufacturing or testing facility, but the specific location is not mentioned.
Animal Testing: The number of animals used for the GLP animal study is not explicitly stated.
- Data Provenance: The study was a "GLP animal study," meaning it followed Good Laboratory Practices. The location and type of animal are not specified, nor is the country of origin. This would be a prospective study.

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

Biocompatibility Testing: Not applicable. Ground truth for these in-vitro tests is adherence to established international standards (ISO 10993) and scientific principles of toxicology and material science. The tests were performed by NAMSA.
Performance Testing (Bench Studies): Not applicable. Ground truth for these engineering tests is meeting predefined specifications and equivalence to the predicate device's performance.
Animal Testing: The text mentions the study assessed performance "as defined by a physician in a clinical environment." This implies at least one, and likely more, physician experts were involved in defining the performance criteria and potentially assessing the outcomes during the animal study. Their specific qualifications (e.g., years of experience, specialization) are not explicitly stated.

4. Adjudication Method for the Test Set

Biocompatibility Testing: Not applicable in the sense of expert adjudication. The results are interpreted against established acceptance criteria defined by ISO standards.
Performance Testing (Bench Studies): Not applicable in the sense of expert adjudication. Results are compared against specifications and predicate device performance.
Animal Testing: The method for "defining" acceptable and comparable performance by the physician(s) is not detailed. It's possible there was an internal review panel or a sole physician's assessment, but no formal adjudication method (e.g., 2+1, 3+1) is described.

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 study was done. This device is a guiding catheter, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable.

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

No standalone algorithm performance study was done. This device is a physical medical instrument, not an algorithm. Therefore, this question is not applicable.

7. The Type of Ground Truth Used

Biocompatibility Testing: The ground truth is derived from established international standards (ISO 10993 series) for biological evaluation of medical devices. The "ground truth" is that the materials are not biologically reactive, cytotoxic, sensitizing, irritating, systematically toxic, or highly thrombogenic.
Performance Testing (Bench Studies): The ground truth is based on engineering specifications and comparative performance data from the predicate device. The "ground truth" is that the device can withstand specific forces, pressures, and demonstrates appropriate mechanical behavior for its intended use, comparable to the predicate.
Animal Testing: The ground truth is based on direct observation and assessment of the device's acute performance and safety within a living biological system (animal model), as evaluated by a physician. This is a form of outcomes data (observed physiological responses, device functionality in-vivo) within a controlled experimental setting, benchmarked against a predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is hardware and does not involve AI or machine learning models that require training sets. The "training" for this device would be its design, manufacturing, and preclinical testing phases.

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

Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for a training set does not apply here. The "ground truth" for the device's design and manufacturing is established through quality systems, design controls, material specifications, and regulatory standards.

Summary

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K140034 p. I of 3

FEB 2 6 2014

510(K) SUMMARY

(Date Prepared: February 21, 2014)

Device Name

Surefire Guiding Catheter

Manufacturer Name and Address

Surefire Medical, Inc. 12415 SW 136 Ave., Unit 3 Miami FL 33186 Establishment Registration Number: 3009428975

Submitter Contact Information

Surefire Medical, Inc. 8601 Turnpike Drive, Suite 206 Westminster, CO 8003 1 Contact: Lynne Aronson, Director Regulatory Affairs Phone: 303-426-1222 Fax: 303-426-1223

Common, Classification & Proprietary Names

Common Name:	Guiding Catheter
Classification Name:	Percutaneous Catheter
Proprietary Name:	Surefire Guiding Catheter
Classification:	Class II
Classification Panel:	Cardiovascular Devices
Classification Regulation:	21 CFR 870.1250
Product Code:	DQY

Predicate Device

Medtronic Launcher Guiding Catheter

K030779

Device Description

The Surefire Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system.

The Surefire Guiding Catheter is compatible with standard 0.038" OD guide wires, Luer-Lock infusion syringes, rotating hemostatic valves (RHV), and 5F catheter sheath introducers.

The Surefire Guiding Catheter is provided sterile (EtO) for single patient use

Indications for Use

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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 biocompatibility testing was conducted on the Surefire Infusion System (K110459), Surefire High-Flow Microcatheter (K121677), and Surefire Angiographic Catheter (K122506) which are constructed of the same materials as the Surefire Guiding Catheter. The biocompaibility test requirements for the Surefire Guiding Catheter 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

All testing was performed in accordance with GLP by NAMSA (Northwood, OH).

Additionally, testing for thrombogenicity was performed on the Surefire Guiding Catheter as a part of the GLP 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.

Performance Testing

Design verification testing was performed which demonstrated that the Surefire Guiding Catheter meets its specified performance requirements, and is equivalent to the performance of the predicate device. Testing included visual and dimensional inspection, and tests for particulates, kink, tensile strength, torque, trackability/device compatibility, high pressure injection and flow/pressure generation.

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Animal Testing

A GLP animal study was performed to assess the comparative acute performance of the Surefire Guiding Catheter to the predicate device, as defined by a physician in a clinical environment. The Surefire Guiding Catheter was found to have acceptable performance. Additionally, the Surefire Guiding Catheter was found to have comparable performance to the predicate device.

Substantial Equivalence

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

Comparative Summary: Design / Technological Characteristics

The Surefire Guiding Catheter and predicate device are single lumen catheters with Luer-Lock hubs and a variety of shaped tip styles. They have similar constructions consisting of a polymer outer extrusion with radiopacifier, stainless steel braid and polymer inner.

The Surefire Guiding Catheter and predicate device have similar dimensions, with inner and outer diameters that are consistent with a 5F sized catheters are available in a range of lengths. The predicate device is available in a longer length to accommodate use in the coronary application.

Comparative Summary: Indications for Use

The indication statement of the Surefire Guiding Catheter is the same as that of the predicate device with the exception that the predicate device is indicated for use in both the coronary and peripheral vascular system and the Surefire Guiding Catheter indication is limited to use in only the peripheral vascular system. As both devices are indicated for use in the peripheral vascular system, this difference in indications for use does not impact the safety and effectiveness of the Surefire Guiding Catheter when used as indicated.

Comparative Summary: Performance

Animal and bench performance test data demonstrate that the Surefire Guiding Catheter performance is comparable to the predicate device.

Differences between the devices do not raise any issues of safety or effectiveness.

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Public Health Service

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

February 26, 2014

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

Re: K140034

Trade/Device Name: Surefire Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 4, 2014 Received: February 5, 2014

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 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

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·· 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/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 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,

Kenneth J. Cavanaugh -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140034

Device Name Surefire Guiding Catheter

Indications for Use (Describe)

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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Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).