(7 days)
Not Found
No
The description focuses on the mechanical and material properties of a microcatheter and does not mention any software, algorithms, or data processing capabilities that would suggest AI/ML.
Yes
The "Intended Use / Indications for Use" section states that the device "delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system."
No
Explanation: The device is described as a microcatheter intended for delivering radiopaque media and therapeutic agents during angiographic procedures. Its function is to facilitate the administration of substances, not to provide diagnostic information about the patient's condition.
No
The device description clearly details a physical microcatheter with various material and mechanical components, and the performance studies focus on physical properties and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "angiographic procedures" to "deliver radiopaque media and therapeutic agents to selected sites in the peripheral vascular system." This describes a device used within the body for diagnostic imaging and therapeutic delivery, not for testing samples outside the body.
- Device Description: The description details a microcatheter designed for insertion into blood vessels. It describes its physical characteristics, compatibility with other medical devices used in interventional procedures, and how it functions to deliver substances. This aligns with an in-vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate procedures performed directly on the patient's vascular system.
N/A
Intended Use / Indications for Use
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.
Product codes
DQO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part -1 Evaluation and testing".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
ﺮ ﺍ
Section 5: 510(k) Summary 26 April 2012
. '
JUN 1 4 2012
K
| Owner/Manufacturer: | Owner
Surefire Medical, Inc.
8601 Turnpike Dr.
Suite 206
Westminster, CO 80031 | Manufacturer
Surefire Medical, Inc.
12415 SW136 Avenue
Unit 3
Miami, FL 33186 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Contact Person: | Mario Arbesu
Director, Quality Assurance and Regulatory Affairs
305.378.2651 | |
| Date of Summary
Preparation: | 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 in
angiographic procedures. It delivers radiopaque media and
therapeutic agents to selected sites in the peripheral vascular
system. | |
| Device Description: | 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 | |
-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 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.
| Submitter
Information: | | Prepared by: Mario Arbesu
Director, Quality Assurance and Regulatory Affairs |
|---------------------------|-------|------------------------------------------------------------------------------------------|
| | | Prepared for: Surefire Medical, Inc.
12415 SW 136 Avenue
Unit 3
Miami, FL 33186 |
| | Date: | April 26, 2012 |
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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