(7 days)
The Surefire® Hi-Flow Microcatheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.
The Surefire® Hi-Flow Microcatheter is an 0.027" lumen microcatheter with the Surefire Expandable Tip at the distal end. It has an outer sheath to facilitate deployment and retraction of the Surefire Expandable Tip. The infusion catheter 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), and embolic particles 700µm or less in size. The proximal end of the device features a female luer lock hub. The microcatheter has a Teflon inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The outer sheath is hydrophilically coated. The usable length of the device is 120cm. The distal soft, pliable, funnel-shaped Surefire Expandable Tip is available in two tip sizes, targeted to treat vessels of 3.0 - 4.5 mm and 4.0 - 6.0 mm.
The Surefire® Hi-Flow Microcatheter is intended for use in angiographic procedures, delivering radiopaque media and therapeutic agents to selected sites in the peripheral vascular system. The provided document details the performance testing and verification conducted to demonstrate the device's substantial equivalence to a predicate device, the Surefire Infusion Catheter System (K110459).
1. Acceptance Criteria and Reported Device Performance
The document states that a "battery of tests was performed according to protocols based on the requirements of recognized standards and was shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device." While specific numerical acceptance criteria values are not explicitly given in the provided text, the list of tests performed and the overall conclusion of substantial equivalence serve as the reported performance.
| Test Category | Specific Test | Reported Performance |
|---|---|---|
| Mechanical Performance | Kink Radius Testing | Met acceptance criteria (implied by overall conclusion of substantial equivalence). |
| Trackability Testing | Met acceptance criteria. | |
| Pull Strength Testing | Met acceptance criteria. | |
| High Pressure Injection Testing | Met acceptance criteria. | |
| Tensile Testing | Met acceptance criteria. | |
| Torque Testing | Met acceptance criteria. | |
| Fluid Dynamics/Delivery | Infusion Agent Compatibility Testing | Met acceptance criteria. Compatible with physician-specified agents, contrast agents, flush solutions, and embolic beads (specifically hydrogels ≤ 700 µm and glass beads ≤ 190 µm). |
| Antegrade Flow Testing | Met acceptance criteria. Maintains sufficient antegrade flow. | |
| Infusion Efficiency Testing | Met acceptance criteria. Increases infusion efficiency. | |
| Material/Device Integrity | Package Integrity (Pouch Bubble) Testing | Met acceptance criteria. |
| Device Corrosion Testing | Met acceptance criteria. | |
| Visual and Dimensional Inspections | Met acceptance criteria. | |
| Coating Integrity Testing | Met acceptance criteria. | |
| Particulate Testing | Met acceptance criteria. | |
| Shelf Life Testing | Met acceptance criteria. | |
| Biocompatibility | Cytotoxicity | Tested in accordance with ISO 10993-5; met acceptance criteria. |
| Sensitization | Tested in accordance with ISO 10993-10; met acceptance criteria. | |
| Intra-cutaneous irritation | Tested in accordance with ISO 10993-10; met acceptance criteria. | |
| Toxicity | Tested in accordance with ISO 10993-11; met acceptance criteria. | |
| Pyrogenicity | Tested in accordance with USP General Chapter <151> and ISO 10993-11; met acceptance criteria. | |
| Hemolysis | Tested in accordance with ASTM F756 and ISO 10993-4; met acceptance criteria. | |
| Coagulation | Tested in accordance with ASTM F2382; met acceptance criteria. | |
| Particulate (Biocompatibility) | Tested in accordance with USP 788; met acceptance criteria. | |
| Complement System Testing | Performed; met acceptance criteria. | |
| Overall Safety/Efficacy | Risk/Hazard Analysis | Conducted according to EN ISO 14971; recognized standards (ISO 10555-1, ISO 10555-2) reviewed. |
| Substantial Equivalence | Demonstrated through bench tests; device is as safe and effective as the predicate device (Surefire Infusion Catheter System, K110459). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each individual performance and biocompatibility test. It mentions that "test data provided in bench tests demonstrate that the device is as safe, as effective, and performs at least as safely and effectively as the predicate device."
The tests are described as "bench tests," indicating they were conducted in a laboratory setting rather than involving human or animal subjects. The data provenance is industrial/laboratory testing conducted by the manufacturer, Surefire Medical, Inc. The country of origin for the data is not explicitly stated, but the manufacturer has addresses in Westminster, CO, and Miami, FL, implying the testing was done in the USA. The nature of these tests (bench tests) means they are prospective for the purpose of regulatory clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable (N/A) for this device and study. The Surefire® Hi-Flow Microcatheter is a medical device, not an AI/software device that requires expert human interpretation to establish ground truth for image analysis or similar diagnostic tasks. The "ground truth" for this device is established by meeting engineering specifications, biocompatibility standards, and demonstrating functional performance through objective physical tests, rather than expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is N/A for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or interpretations. The tests described for the microcatheter are objective physical and chemical tests, not involving human interpretation that would require adjudication.
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
This section is N/A. The Surefire® Hi-Flow Microcatheter is a physical medical device, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with or without AI assistance was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is N/A. The device is a physical microcatheter, not an algorithm or AI system. Its performance is inherent in its design and manufacturing, tested objectively through bench tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the Surefire® Hi-Flow Microcatheter is established by objective engineering performance specifications, recognized industry standards (e.g., ISO, ASTM, USP), and regulatory requirements. For example:
- Mechanical Integrity: Ground truth is defined by the physical limits the device must withstand (e.g., pull strength, high pressure injection) without failure, as per engineering design and relevant standards.
- Biocompatibility: Ground truth is defined by the absence of toxic, irritating, sensitizing, or thrombogenic reactions when tested against established biological safety standards (e.g., ISO 10993 series, ASTM, USP).
- Functional Performance: Ground truth for infusion efficiency and antegrade flow is defined by the device's ability to perform its intended function within specified parameters, typically benchmarked against predicate device performance or clinical needs.
8. The sample size for the training set
This section is N/A. The device is a physical medical device, not a machine learning model, and therefore does not have a "training set" in the context of AI or algorithm development.
9. How the ground truth for the training set was established
This section is N/A, as there is no training set for this physical device.
{0}------------------------------------------------
ﺮ ﺍ
Section 5: 510(k) Summary 26 April 2012
. '
JUN 1 4 2012
K
| Owner/Manufacturer: | OwnerSurefire Medical, Inc.8601 Turnpike Dr.Suite 206Westminster, CO 80031 | ManufacturerSurefire Medical, Inc.12415 SW136 AvenueUnit 3Miami, FL 33186 |
|---|---|---|
| Contact Person: | Mario ArbesuDirector, Quality Assurance and Regulatory Affairs305.378.2651 | |
| Date of SummaryPreparation: | 26 April 2012 | |
| Trade Name: | Surefire® Hi-Flow Microcatheter | |
| 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® Hi-Flow Microcatheter is intended for use inangiographic procedures. It delivers radiopaque media andtherapeutic agents to selected sites in the peripheral vascularsystem. | |
| Device Description: | The Surefire® Hi-Flow Microcatheter is an 0.027" lumenmicrocatheter with the Surefire Expandable Tip at the distalend. It has an outer sheath to facilitate deployment andretraction of the Surefire Expandable Tip. The infusioncatheter serves as the conduit for physician-specified agentssuch as contrast agents, flush solutions, and embolic beads.It is compatible with standard 0.018" guide wires, infusionsyringes, rotating hemostatic valves (RHVs), and embolicparticles 700µm or less in size. The proximal end of thedevice features a female luer lock hub. The microcatheterhas a Teflon inner liner to provide a lubricious surface forpassage of physician-specified agents and other accessory.devices. The outer sheath is hydrophilically coated. Theusable length of the device is 120cm. The distal soft,pliable, funnel-shaped Surefire Expandable Tip is available |
-21-
l
t
{1}------------------------------------------------
in two tip sizes, targeted to treat vessels of 3.0 - 4.5 mm and 4.0 - 6.0 mm.
Principals of Operation/ Technology:
The Surefire® Hi-Flow Microcatheter is operated manually.
Performance Testing & Verification Testing
- · Kink Radius Testing
- · Trackability Testing
- · Pull Strength Testing ·
- · High Pressure Injection Testing
- · Infusion Agent Compatibility Testing
- · Package Integrity (Pouch Bubble) Testing
- · Device Corrosion Testing
- · Antegrade Flow Testing
- · Infusion Efficiency Testing
- · Visual and Dimensional Inspections
- · Coating Integrity Testing
- · Particulate Testing
- · Tensile Testing
- · Torque Testing
- · Shelf Life Testing
Biocompatibility Testing
- · Cytotoxicity Tested in accordance with ISO 10993-5
- · Sensitization Tested in accordance with ISO 10993-10
- · Intra-cutaneous irritation Tested in accordance with ISO 10993-10
- · Toxicity Tested in accordance with ISO 10993-11
- · Pyrogenicity Tested in accordance with USP General Chapter <151> Pyrogen Test recommended in ISO 10993-11
- · Hemolysis Tested in accordance with ASTM F756 and ISO 10993-4
- · Coagulation Tested in accordance with ASTM F2382
- · Particulate Tested in accordance with USP 788
- · Complement System Testing 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 characteristics for this indication for use were identified which included a review of both ISO 10555-1 (Intravascular catheters -Sterile and single-use catheters - Part 1: General requirements) and ISO 10555-2 (Sterile, single-use intravascular catheters - Part 2: Angiographic catheters). It was then determined that the performance of the Surefire® Hi-Flow Microcatheter is substantially equivalent to the performance and safety of the Surefire Infusion Catheter System. A battery of tests was performed according to protocols based on the requirements of recognized standards and was shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device.
Additional Safety Information:
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
{2}------------------------------------------------
Substantial
Equivalence:
of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part -1 Evaluation and testing".
The Surefire® Hi-Flow Microcatheter is substantially equivalent in intended use, design, and technology/principles of operation to the predicate. Both devices share the same Indications for Use. Both devices make use of the Surefire Expandable Tip at the distal end of the microcatheter to increase the infusion efficiency of the device while maintaining sufficient antegrade flow. Both systems are compatible with solutions containing embolic agents, specifically hydrogels ≤ 700 µm and glass beads ≤ 190 um. Both devices include configurations intended for use in vessels of 4.0 - 6.0 mm in diameter. The proposed device contains an additional configuration for use in vessels of 3.0 - 4.5 mm in diameter. The Microcatheter is substantially equivalent to the Surefire® Infusion Catheter System, cleared under K110459. Differences between the devices do not raise any issues of safety or effectiveness.
Test data provided in bench tests demonstrate that the device is as safe, as effective, and performs at least as safely and effectively as the predicate device.
| SubmitterInformation: | Prepared by: Mario ArbesuDirector, Quality Assurance and Regulatory Affairs | |
|---|---|---|
| Prepared for: Surefire Medical, Inc.12415 SW 136 AvenueUnit 3Miami, FL 33186 | ||
| Date: | April 26, 2012 |
-23-
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 4 2012
Surefire Medical, Inc. c/o Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K121677
Trade/Device Name: Surefire Hi-Flow Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (Two) Product Code: DQO Dated: June 6, 2012 Received: June 7, 2012
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.
{4}------------------------------------------------
Page 2 - Mr. Mark Job
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 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 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 yours.
W.g. Hilleben
fa Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Section 4 Indication for Use 26 April 2012
Indication for Use
510(k) Number (if known):
Device Name:
Indication for Use:
Surefire® Hi-Flow Microcatheter
The SUREFIRE® HI-FLOW MICROCATHETER is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.
Prescription Use X (part 21 CFR 801 Subpart D) AND/OR
t
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, Office of Device Evaluation (ODE)
M9f Killeben
(Division Sign-Off) Division of Cardiovascular Devices
K121677 510(k) Number
§ 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).