(19 days)
The Surefire Spark Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.
The Surefire Spark Infusion System is a 0.021" lumen microcatheter with a seff-expanding tip at the distal end. The Surefire Spark serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires up to 0.018", and embolic hydrogel particles 500um or less in size and glass microspheres 110um or less in size. The Surefire Spark has a PTFE 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, self-expanding tip is sized for use in vessels of 1.5-3.5mm.
There are two radiopaque markers located at the distal end of the Surefire Spark to aid in positioning of the self-expanding tip. When in correct position, the self-expanding tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in various size vessels.
The Surefire Spark Infusion System is provided sterile (EtO) for single patient use.
The Surefire Infusion Systems will be available in the following sizes:
Inner Diameter: 0.021 inch, Length: 120 cm, Tip / Vessel Size: 1.5 - 3.5 mm
Inner Diameter: 0.021 inch, Length: 150 cm, Tip / Vessel Size: 1.5 - 3.5 mm
The Surefire Spark Infusion System is a medical device and the provided text describes its 510(k) premarket notification to the FDA. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional clinical study with quantifiable acceptance criteria for diagnostic performance metrics like sensitivity or specificity.
Therefore, many of the requested categories for a study proving device acceptance (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this type of device and regulatory submission as described in the provided text. The device is an intravascular catheter designed for delivering agents, not for diagnosis or image interpretation.
Instead, the acceptance criteria and performance evaluation for this device revolve around engineering and physical performance tests, and a comparative animal study against a predicate device.
Here's the information that can be extracted and inferred from the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Surefire Spark Infusion System are implicitly defined by meeting the same performance specifications as its predicate device and demonstrating comparable performance in various physical and functional tests. The study demonstrates that the device met these criteria.
| Acceptance Criteria Category | Reported Device Performance and Study Findings |
|---|---|
| Physical/Mechanical Tests | The Surefire Spark Infusion System met the same performance specifications for: - Visual and Dimensional (Implicitly met comparable dimensions) - Tensile (Pull) Strengths - Kink Radius - Torque Resistance - Burst Pressure - Coating Frictional Force - Base Catheter Insertion/Retraction Force - Corrosion Resistance - Hub Solvent Compatibility - Coating Durability and Uniformity - Particulates - Pouch Integrity - Pouch Seal Strength Overall: The test results demonstrate that the Surefire Spark Infusion System meets the same performance specifications and acceptance criteria as the predicate device. |
| Functional Compatibility | The Surefire Spark Infusion System met the same performance specifications for: - Diagnostic Agent Compatibility - Embolic Agent Compatibility - Hub Aspiration - Antegrade Flow - Infusion Efficiency Overall: The test results demonstrate that the Surefire Spark Infusion System meets the same performance specifications and acceptance criteria as the predicate device. |
| Biocompatibility | No direct new biocompatibility testing was performed on the subject device. Testing was leveraged from previously cleared predicate devices (Surefire High Flow Microcatheter K121677, Surefire Guiding Catheter K162359, and Surefire Precision Infusion System K171355), implying that the materials are deemed biocompatible based on prior assessments. |
| Thrombogenicity | Testing for thrombogenicity was performed on the Surefire Spark Infusion System Catheter as a part of an Animal Study. (Specific results are not detailed, but the overall conclusion of the animal study indicates acceptability). |
| Sterilization Residuals | EtO Residuals testing was leveraged from previous testing of the predicate device. |
| Acute Performance (Animal Study) | "An animal study was performed to assess the comparative acute performance of the Surefire Spark Infusion System to the predicate device, as defined by physicians in a simulated clinical environment. The Surefire Spark Infusion System was found to be acceptable in all evaluated categories, met the defined user needs, and performed comparably to the predicate device." |
Study Details (Based on available information)
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each bench test. For the animal study, the sample size is not specified beyond "An animal study was performed."
- Data Provenance: The bench tests and animal study were performed by the manufacturer to support the 510(k) submission. No country of origin is specified for the data, but the manufacturer is based in Westminster, CO, USA. The study would be considered prospective for the purpose of demonstrating equivalence for this specific device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Bench Tests: Not applicable in the sense of expert review for ground truth on performance specifications. These are objective engineering measurements against defined criteria.
- Animal Study: The acute performance was "defined by physicians in a simulated clinical environment." The number and qualifications of these "physicians" are not specified. Their role was to assess performance, not establish ground truth in a diagnostic sense.
-
Adjudication method for the test set:
- Not applicable as the tests involve objective measurements (bench tests) or physician assessment (animal study) rather than diagnostic interpretation requiring adjudication.
-
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 an intravascular catheter for substance delivery, not an AI-powered diagnostic tool, so such a study is not relevant to its regulatory approval in this context.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench tests, the "ground truth" is defined by established engineering and material performance specifications which the device must meet or perform comparably to the predicate.
- For the animal study, the "ground truth" for acute performance was based on "user needs" defined by physicians in a simulated clinical environment and comparison to the predicate device's performance.
-
The sample size for the training set:
- Not applicable. This device does not involve a training set as it is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- Not applicable as there is no training set mentioned or implied.
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April 3, 2018
Surefire Medical, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K180677
Trade/Device Name: Surefire Spark Infusion System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: March 13, 2018 Received: March 15, 2018
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 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K180677
Device Name Surefire Spark Infusion System
Indications for Use (Describe)
The Surefire Spark 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)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
K180677
Device Name Surefire® Spark™ 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 Contact: Lynne Aronson, VP Regulatory Affairs and Quality Assurance 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® Spark™ Infusion System |
| Classification: | Class II |
| Classification Panel: | Cardiovascular Devices |
| Classification Regulation: | 21 CFR 870.1200 |
| Product Code: | DOO |
Predicate Device
- Surefire Precision Infusion System (also marketed as Surefire Infusion System)
K171355
Device Description
The Surefire Spark Infusion System is a 0.021" lumen microcatheter with a seff-expanding tip at the distal end. The Surefire Spark serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires up to 0.018", and embolic hydrogel particles 500um or less in size and glass microspheres 110um or less in size. The Surefire Spark has a PTFE 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, self-expanding tip is sized for use in vessels of 1.5-3.5mm.
There are two radiopaque markers located at the distal end of the Surefire Spark to aid in positioning of the self-expanding tip. When in correct position, the self-expanding tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in various size vessels.
The Surefire Spark Infusion System is provided sterile (EtO) for single patient use.
The Surefire Infusion Systems will be available in the following sizes:
| Inner Diameter | Length | Tip / Vessel Size |
|---|---|---|
| 0.021 inch | 120 cm | 1.5 - 3.5 mm |
| 0.021 inch | 150 cm | 1.5 - 3.5 mm |
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Indications for Use
The Surefire Spark Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.
Substantial Equivalence
The Surefire Spark Infusion System is substantially equivalent in intended use, design, and technology/principles of operation to the predicate.
Comparative Summary: Design / Technological Characteristics
The Surefire Spark Infusion System is similar in design to the predicate device. Both devices are microcatheters with an expandable tip on the distal end. The Surefire Spark is a single microcatheter, whereas the predicate device is a coaxial (dual) microcatheter. The Surefire Spark has a selfexpanding tip, in comparison to the predicate device which has a manual mechanism in the device handle to expand and collapse the tip. An introducer on the Surefire Spark is used to collapse the tip so that it can be introduced into the guide catheter.
The Surefire Spark Infusion System and the predicate device are constructed of similar materials utilizing similar construction and manufacturing processes.
The Surefire Spark Infusion System and the predicate device have similar dimensions.
The Surefire Spark Infusion System and predicate device are provided in identical packaging, sterilized by ethylene oxide, and labeled for single use only.
Comparative Summary: Indications for Use
The Surefire Spark 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 Surefire Spark Infusion System performance is comparable to the predicate device.
Biocompatibility Testing
Biocompatibility testing was not conducted on the subject device. Testing was leveraged from the Surefire High Flow Microcatheter (K121677), Surefire Guiding Catheter (K162359), and Surefire Precision Infusion System (K171355). Testing for thrombogenicity was performed on the Surefire Spark Infusion System Catheter as a part of an Animal Study.
Performance Testing
The following design verification / validation tests were performed. The test results demonstrate that the Surefire Spark Infusion System meets the same performance specifications and acceptance criteria as the predicate device.
- I Visual and Dimensional
- Tensile (Pull) Strengths
- l Kink Radius
- Torque Resistance
- . Burst Pressure
- l Coating Frictional Force
- Base Catheter Insertion/Retraction Force
- l Diagnostic Agent Compatibility
- l Embolic Agent Compatibility
- . Infusion Efficiency
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- Hub Aspiration
- Corrosion Resistance
- Hub Solvent Compatibility
- I Coating Durability and Uniformity
- Antegrade Flow ■
- l Particulates
- Pouch Integrity
- I Pouch Seal Strength
The following testing was leveraged from previous testing of the predicate device:
- EtO Residuals
Animal Testing
An animal study was performed to assess the comparative acute performance of the Surefire Spark Infusion System to the predicate device, as defined by physicians in a simulated clinical environment. The Surefire Spark Infusion System was found to be acceptable in all evaluated categories, met the defined user needs, and performed comparably to the predicate device.
Conclusion
In summary, the Surefire Spark 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 Surefire Spark Infusion System performance is comparable to the predicate device. Differences between the devices do not raise different questions of safety and effectiveness.
§ 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).