(8 days)
No
The device description focuses on mechanical components and their function in delivering agents. There is no mention of AI, ML, image processing, or data analysis for decision-making or control.
No.
The device delivers therapeutic agents to selected sites, but it is not itself a therapeutic agent or a device that performs therapy. It is described as a "conduit for physician-specified agents."
No
The device is described as an infusion system for delivering radiopaque media and therapeutic agents during angiographic procedures. It acts as a conduit for agents like contrast agents, flush solutions, and embolic beads. Its primary function is therapeutic delivery, not diagnosis. While contrast agents are used for diagnostic imaging, the device itself is a delivery mechanism for these agents and not a diagnostic tool per se.
No
The device description clearly details a physical medical device (coaxial microcatheters, luer lock hub, expandable tip, inner liner, outer sheath, radiopaque markers) and its hardware components. 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 delivering radiopaque media and therapeutic agents to selected sites in the peripheral vascular system during angiographic procedures. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a catheter system designed for physical delivery of substances into the body. It does not describe a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed for testing samples outside of the body to gain information about a person's health. This device is designed for direct intervention within the body.
N/A
Intended Use / Indications for Use
The Surefire Precision 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 Surefire Precision Infusion Systems are coaxial microcatheters with a female luer lock hub at the proximal end, and the Surefire Expandable Tip at the distal end that is sized for use in various sized vessels. The Surefire Precision Infusion System 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 ≤500μm, and glass microspheres ≤110μm (0.021" lumen) or
§ 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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other.
May 17, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Surefire Medical, Inc. % Mark Job Official Correspondent Regulatory Technology Services. LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K171355
Trade/Device Name: Surefire Precision Infusion System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DOO Dated: March 6, 2017 Received: May 9, 2017
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/ResourcesforYou/Industry/default.htm. 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.
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.
Fernando
Aguel
Fernando
Aguel-S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Surefire Precision Infusion System
Indications for Use (Describe)
The Surefire Precision 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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3
510(K) SUMMARY
Device Name
Surefire Precision 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 Precision Infusion System |
| Classification: | Class II |
| Classification Panel: | Cardiovascular Devices |
| Classification Regulation: | 21 CFR 870.1200 |
| Product Code: | DQO |
Predicate Device
| ■ Surefire Infusion System 021 | K143588 | |
|---|---|---|
| ■ Surefire Infusion System | ||
| (marketed as Surefire Precision Infusion System) | K160662 |
Device Description
The Surefire Precision Infusion Systems are coaxial microcatheters with a female luer lock hub at the proximal end, and the Surefire Expandable Tip at the distal end that is sized for use in various sized vessels. The Surefire Precision Infusion Systems are currently available in the following sizes:
| Catalog Number | Inner Diameter | Length | Tip / Vessel Size |
|---|---|---|---|
| SPS-21120-35 | 0.021 inch | 120 cm | 1.5 - 3.5 mm |
| SPS-21150-35 | 0.021 inch | 150 cm | 1.5 - 3.5 mm |
| SPS-25120-40 | 0.025 inch | 120 cm | 2 - 4 mm |
| SPS-25150-40 | 0.025 inch | 150 cm | 2 - 4 mm |
| SPS-25120-60 | 0.025 inch | 120 cm | 4 - 6 mm |
| SPS-25150-60 | 0.025 inch | 150 cm | 4 - 6 mm |
The Surefire Precision Infusion System, 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 ≤500μm, and glass microspheres ≤110μm (0.021" lumen) or