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 5F catheter with a soft distal tip and a Luer-Lock hub and strain relief. The Surefire Guiding Catheter has a three-layer construction, consisting of a Teflon inner liner, metal mid-layer, and a polymer outer shaft jacket. The polymer is filled with a radiopacifier agent, to provide visibility of the catheter under fluoroscopy.

The Surefire Guiding Catheter is available in 65 cm and 80 cm lengths with a variety of pre-shaped tip designs (including but not limited to Axis and Sim1) to accommodate access and positioning in a range of peripheral vascular anatomies.

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

The provided text describes a 510(k) summary for the Surefire Guiding Catheter, which is seeking substantial equivalence to a predicate device. This submission focuses on engineering and biocompatibility testing for a modified device, rather than a study on an AI/ML algorithm's performance meeting acceptance criteria. Therefore, most of the information requested in your prompt (1-9) about AI device performance and ground truth establishment is not available in the given document.

The document does describe acceptance criteria and performance data for the catheter device itself. I will provide the available information based on the document, noting where the requested AI-specific information is not present.

Acceptance Criteria and Device Performance (for the physical device, not AI):

The document states that the design verification/validation tests performed on the modified Surefire Guiding Catheter demonstrated that it "meets the same performance specifications and acceptance criteria as the predicate device." This implies a direct comparison to the previously cleared predicate device's established performance. The specific quantitative acceptance criteria and their corresponding reported device performance values are not explicitly listed in a table, but rather implied by statements of "meeting" or "comparable" performance.

Detailed Breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Biocompatibility	No significant biological reaction affecting the patient due to contact with materials.	All biocompatibility testing results (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Hemocompatibility) did not indicate any significant biological reaction.
Performance Testing	Meet same performance specifications as predicate device.	Modified device meets the same performance specifications and acceptance criteria as the predicate device for: Visual Inspection/Distal Kink, Dimensional Inspection, Proximal Kink, Pull Strength, Trackability/Device Compatibility, Torque, High Pressure Injection (Burst), Corrosion, Particulate.
Animal Testing	Acceptable performance as defined by a physician in a clinical environment; comparable to predicate device.	Modified device was found to have acceptable performance and comparable performance to the predicate device.

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

For Biocompatibility: The document refers to "testing" and "studies" but does not explicitly state sample sizes for each test type (e.g., number of cells for cytotoxicity, number of animals for sensitization/irritation). The "previously completed biocompatibility testing" was leveraged from the predicate device (K140034).
For Performance Testing (Bench Tests): No specific sample sizes for each bench test are provided. It states these tests were performed and results demonstrate the device meets criteria.
For Animal Testing: A "GLP animal study was performed," but the number of animals used is not specified.
Data Provenance: The biocompatibility testing was conducted by NAMSA (Northwood, OH) and Toxicon (Bedford MA). The animal study was also a GLP study; the location is not specified, but it's implied to be a controlled environment for generating data for regulatory submission. All data would be prospective for the purpose of this submission, though some biocompatibility data was leveraged from previous testing of the predicate device.

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

Not Applicable. This information is relevant for AI/ML device studies where experts define the "correct" diagnostic or classification outcome. For this physical catheter device, "ground truth" relates to objective physical and biological properties measured via standardized tests and potentially assessed by "a physician" in the animal study. The qualifications of the "physician" are not detailed.

4. Adjudication method for the test set:

Not Applicable. Again, this is typically for AI/ML studies involving human interpretation disagreements. For this device, standard testing protocols are followed, and performance is measured against established specifications or comparison to a predicate device.

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:

Not Applicable. This is an AI/ML specific question. No MRMC study was conducted as this is a physical medical device (guiding catheter).

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

Not Applicable. This is an AI/ML specific question. No algorithm is involved in this device.

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

For Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and observation of biological reactions (e.g., no significant cytotoxicity, no sensitization, no irritation, no systemic toxicity, acceptable hemocompatibility). This is essentially data derived from standard biological assays.
For Performance Testing (Bench Tests): Ground truth is based on engineering specifications and direct physical measurements (e.g., visual inspection, dimensional checks, force measurements for pull strength, burst pressure).
For Animal Study: Ground truth involves "acceptable performance" as defined by a physician's assessment in a clinical environment during the study, and comparison to the predicate device. This is a form of expert assessment of device function in vivo.

8. The sample size for the training set:

Not Applicable. There is no training set for a physical catheter device. This is an AI/ML specific question.

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

Not Applicable. There is no training set for a physical catheter device. This is an AI/ML specific question.

In summary, the provided document describes a regulatory submission for a physical medical device (Surefire Guiding Catheter) and focuses on demonstrating substantial equivalence to a predicate device through engineering (bench) tests, biocompatibility testing, and an animal study. It does not involve an AI/ML algorithm, and therefore the details requested about AI performance, ground truth, and study design for AI are not present.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle with three human profiles incorporated into its design. The profiles are facing to the right.

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

September 21, 2016

Surefire Medical, Inc. % Mark Job Responsible Third Party Official Regulatory Technical Services, LLC 1394 25th Street NW Buffalo, MN 55313

Re: K162359

Trade/Device Name: Surefire Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Procode: DQY Dated: August 19, 2016 Received: August 23, 2016

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

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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/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 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 yours,

Brian D. Pullin -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) K162359

Device Name Surefire Guiding Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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(DATE PREPARED: AUGUST 9, 2016)

510(K) SUMMARY

Device Name

Surefire Guiding Catheter

Manufacturer Name and Address

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

Submitter Contact Information

Surefire Medical. Inc. Surefire Medical, Inc. 6272 W. 91st Avenue Westminster. CO 80031 Contact: Contact: Lynne Aronson, VP Regulatory Affairs and Quality Assurance 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

Surefire Guiding Catheter

K140034

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.

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Indications for Use

Biocompatability Testing

The patient contact materials and colorants used to fabricate the proximal section (hub and shaft) of the modified Surefire Guiding Catheter are identical to the Surefire Guiding Catheter as it was cleared in 510(k) K140034 (cleared February 26, 2014) in formulation, processing, and sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.). Biocompatibility testing of the patient-contact materials used in the construction of the proximal section (hub and shaft) of the modified Surefire Guiding Catheter were previously 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). Therefore, the biocompatibility test requirements for the proximal section (hub and shaft) of the modified Surefire Guiding Catheter were met by leveraging the previously completed biocompatibility testing.

Biocompatibility testing of the patient contact materials used to fabricate the modified distal tip was performed in accordance with GLP (NAMSA, Northwood, OH) and ISO 10993-1 for external communicating devices in contact with circulating blood with a limited duration of less than 24 hours.

Biocompatibility testing of the material used to jacket the catheter shaft was completed by the material manufacturer in accordance with GLP (Toxicon, Bedford MA) and ISO 10993-1 for external communicating devices in contact with circulating blood with a limited duration of less than 24 hours.

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

Biocompatibility Testing
ISO 10993-1 for external communicating devices in contact with circulating blood, duration < 24 hours
Category	Standard	Test Method
Cytotoxicity	ISO 10993-5	Cytotoxicity Study Using the ISO Elution Method – 1x Minimal EssentialMedia Extract
Sensitization	ISO 10993-10	ISO Maximization Sensitization Study – Extract– 0.9% Sodium Chloride Solution Extract– Sesame Oil, NF Extract
Irritation orIntracutaneousReactivity	ISO 10993-10	ISO Intracutaneous Study – Extract– 0.9% Sodium Chloride Solution Extract– Sesame Oil, NF Extract
Systemic Toxicity	ISO 10993-11	ISO Systemic Toxicity Study – Extract– 0.9% Sodium Chloride Solution Extract– Sesame Oil, NF Extract
Hemocompatability	ISO 10993-4	Pyrogen – Material Mediated – 0.9% Sodium Chloride Solution ExtractASTM Hemolysis – CMF-PBS ExtractC3a Complement Assay – Normal Human Serum ExtractSC5b-9 Complement Assay – Normal Human Serum ExtractCoagulation – ASTM Partial Thromboplastin Time

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

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

트 Visual Inspection / Distal Kink
Dimensional Inspection
Proximal Kink
트 Pull Strength
Trackability/ Device Compatibility

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

트 Packaging and Labeling Visuals
트 Packaging Integrity (Pouch Bubble)
- Pouch Seal Strength
Diagnostic Agent Compatibility
Hub Aspiration
트 Flow Rates and Associated Pressures

Animal Testing

트

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 device.

Comparative Summary: Design / Technological Characteristics

The modified Surefire Guiding Catheter and predicate devices are single-lumen 5F catheters with a soft distal tip and a Luer-Lock hub and strain relief. Both the modified and predicated devices have a multi-layer construction, consisting of a Teflon inner liner, metal mid-layer, and a polymer outer shaft jacket filled with a radiopacifier agent.

Both the modified and predicate Surefire Guiding Catheters are available in 65 cm and 80 cm lengths with a variety of pre-shaped tip designs, and are compatible with standard 0.038" OD guide wires, Luer-Lock infusion syringes, rotating hemostatic valves (RHV), and 5F catheter sheath introducers.

Both the modified and predicate Surefire Guiding Catheter are provided in identical packaging, sterilized by ethylene oxide, and labeled for single use only.

Comparative Summary: Indications for Use

The indication statement of the modified Surefire Guiding Catheter is the same as that of the predicate device. Both devices are intended to provide a pathway through which therapeutic devices are introduced in the peripheral vascular system.

Torque
High Pressure Injection (Burst)
트 Corrosion
Particulate ■

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Comparative Summary: Performance

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

In summary, the modified Surefire Guiding Catheter 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 Guiding Catheter performance is comparable to the predicate device. Differences between the devices do not raise any issues of safety or effectiveness.

Regulation Number and Section

§ 870.1250 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).