(2 days)
No
The description focuses on the mechanical and material properties of a microcatheter and its expandable tip for delivering agents. There is no mention of data processing, algorithms, or learning capabilities.
Yes
The device is intended to deliver "therapeutic agents" to selected sites in the peripheral vascular system, indicating a therapeutic purpose.
No
This device is described as an infusion system used to deliver agents (radiopaque media, therapeutic agents, contrast agents, flush solutions, embolic beads) during angiographic procedures, not to diagnose conditions.
No
The device description clearly details a physical medical device (microcatheter with an expandable tip, luer lock hub, etc.) and describes performance testing related to its physical properties and function within the body. There is no mention of software as the primary or sole component.
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 procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a catheter system used for delivering substances within the body. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic and imaging delivery system used directly within the patient's vascular system.
N/A
Intended Use / Indications for Use
The Surefire Infusion System 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 modified Surefire Infusion System is a 0.027" lumen coaxial microcatheter with the Surefire Expandable Tip at the distal end. The Surefire Infusion System has a female luer lock hub on the proximal end of the catheter and has a catheter shaft length of 150 cm.
The modified Surefire Infusion System 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/Tuohy Borsts), and embolic hydrogel particles 700um or less in size and glass microspheres 190um or less in size. The Surefire Infusion System, serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. The Surefire 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 soft, pliable, funnel-shaped Surefire Expandable Tip is sized for use in vessels of 4 mm to 6 mm.
The Surefire 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 Infusion System is provided sterile (EtO) for single patient use.
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
physician
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
Bench performance test data. Animal study performed to assess the comparative acute performance of the modified Surefire Infusion System to the predicate device, as defined by physicians in a simulated clinical environment. The modified Surefire Infusion System was found to be acceptable in all evaluated categories, met the defined user needs, and performed comparably to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Surefire Infusion System 021 (marketed as Surefire Precision Infusion System) K143588
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, with three faces in profile overlapping each other. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2016
Surefire Medical, Inc. c/o Mark Job Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K160662
Trade/Device Name: Surefire Infusion System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Dated: March 7, 2016 Received: March 9, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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,
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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Indications for Use
510(k) Number (if known) K160662
Device Name Surefure Infusion System
Indications for Use (Describe)
The Surefire 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 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 Infusion System |
| Classification: | Class II |
| Classification Panel: | Cardiovascular Devices |
| Classification Regulation: | 21 CFR 870.1200 |
| Product Code: | DQO |
Predicate Device
- Surefire Infusion System 021 ■ (marketed as Surefire Precision Infusion System)
Device Description
The modified Surefire Infusion System is a 0.027" lumen coaxial microcatheter with the Surefire Expandable Tip at the distal end. The Surefire Infusion System has a female luer lock hub on the proximal end of the catheter and has a catheter shaft length of 150 cm.
The modified Surefire Infusion System 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/Tuohy Borsts), and embolic hydrogel particles 700um or less in size and glass microspheres 190um or less in size. The Surefire Infusion System, serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. The Surefire 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 soft, pliable, funnel-shaped Surefire Expandable Tip is sized for use in vessels of 4 mm to 6 mm.
The Surefire 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.
4
The Surefire Infusion System is provided sterile (EtO) for single patient use.
Indications for Use
The Surefire 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
All of the patient-contact materials used to fabricate the modified Surefire Infusion System are identical to the predicate Surefire Infusion System as it was approved in 510(k) K143588 (cleared January 12, 2015) 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 modified Surefire Infusion System 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).
As the modified Surefire Infusion System is constructed of the same materials as the predicate Surefire Infusion System, the biocompatibility test requirements for the modified Surefire Infusion System were met by leveraging the previously completed biocompatibility testing listed below.
Additionally, testing for thrombogenicity was performed on the modified Surefire 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 10993-10 | ISO Maximization Sensitization Study - Extract - Sesame Oil, NF Extract | |
| Irritation or | ||
| Intracutaneous | ||
| Reactivity | ISO 10993-10 | ISO Intracutaneous Study - Extract - 0.9% Sodium Chloride Solution Extract |
| ISO 10993-10 | 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 10993-11 | ISO Systemic Toxicity Study - Extract - Sesame Oil, NF Extract | |
| ISO 10993-11 | Pyrogen - Material Mediated – 0.9% Sodium Chloride Solution Extract | |
| Hemocompatability | ISO 10993-4 | ASTM Hemolysis – CMF-PBS Extract |
| ISO 10993-4 | C3a Complement Assay - Normal Human Serum Extract | |
| ISO 10993-4 | SC5b-9 Complement Assay - Normal Human Serum Extract | |
| ISO 10993-4 | Coagulation - ASTM Partial Thromboplastin Time |
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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 Infusion System meets the same performance specifications and acceptance criteria as the predicate device.
- l Visual/Dimensional Inspections
- . Pull Force
- Infusion Efficiency
- . Particulates
- . Device Compatibility
- Kink Resistance
- Antegrade Flow
- Torque Resistance (catheter body)
- Trackability
The following testing was leveraged from previous testing of the predicate device:
- . Packaging seal strength and integrity
- . Hub Aspiration
- . Corrosion
- Pull Force (handle components) 트
- 트 Hydrophilic Coating Lubricity and Wear
- Diagnostic Infusion Agent Compatibility ■
Burst Pressure
- Embolic Agent Compatibility
- . Torque (handle components)
Animal Testing
An animal study was performed to assess the comparative acute performance of the modified Surefire Infusion System to the predicate device, as defined by physicians in a simulated clinical environment. The modified Surefire 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 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 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 Infusion System and the predicate device are constructed of the same materials utilizing similar construction and manufacturing processes.
The modified Surefire Infusion System is a larger version of the predicate device. The predicate device has an inner lumen diameter of .021", length of 120 cm, and a Surefire Expandable Tip sized for use in vessels 1.5 - 3.5 mm. The modified device has an inner lumen diameter of .027", lengths of 150 cm, and a Surefire Expandable Tip sized for use in vessels 4-6 mm.
The modified Surefire Infusion System and predicate device are provided in identical packaging, sterilized by ethylene oxide, and labeled for single use only.
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Comparative Summary: Indications for Use
The modified Surefire 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 Infusion System performance is comparable to the predicate device.
In summary, the modified Surefire Infusion 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 Infusion System performance is comparable to the predicate device. Differences between the devices do not raise any issues of safety or effectiveness.