(29 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guiding catheter, with no mention of AI or ML capabilities.
No.
The device's intended use explicitly states it is a pathway through which therapeutic devices are introduced, not a therapeutic device itself.
No
Explanation: The device description and intended use state that the Surefire Guiding Catheter provides a pathway for therapeutic devices to be introduced, and helps facilitate their advancement. It does not mention any diagnostic function such as identifying or analyzing medical conditions or states.
No
The device description clearly details a physical catheter with specific material construction, dimensions, and compatibility with other physical medical devices. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Surefire Guiding Catheter Function: The Surefire Guiding Catheter is a medical device used within the body (in vivo) to facilitate the introduction of other therapeutic devices into the peripheral vascular system. It's a tool for delivering treatments, not for analyzing biological samples.
The description clearly outlines its use as a pathway for introducing devices during a medical procedure, which is a therapeutic or interventional function, not a diagnostic one based on in vitro analysis.
N/A
Intended Use / Indications for Use
The Surefire Guiding Catheter is intended to provide a pathway through which therapeutic devices are introduced. The Surefire Guiding Catheter is intended to be used in the peripheral vascular system.
Product codes
DQY
Device Description
The Surefire Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system.
The Surefire Guiding Catheter is a single-lumen 5F catheter with a soft distal tip and a Luer-Lock hub and strain relief. The Surefire Guiding Catheter has a three-layer construction, consisting of a Teflon inner liner, metal mid-layer, and a polymer outer shaft jacket. The polymer is filled with a radiopacifier agent, to provide visibility of the catheter under fluoroscopy.
The Surefire Guiding Catheter is available in 65 cm and 80 cm lengths with a variety of pre-shaped tip designs (including but not limited to Axis and Sim1) to accommodate access and positioning in a range of peripheral vascular anatomies.
The Surefire Guiding Catheter is compatible with standard 0.038" OD guide wires, Luer-Lock infusion syringes, rotating hemostatic valves (RHV), and 5F catheter sheath introducers.
The Surefire Guiding Catheter 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
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:
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 Guiding Cathater meets the same performance specifications and acceptance criteria as the predicate device.
- Visual Inspection / Distal Kink
- Dimensional Inspection
- Proximal Kink
- Pull Strength
- Trackability/ Device Compatibility
- Torque
- High Pressure Injection (Burst)
- Corrosion
- Particulate
The following testing was leveraged from previous testing of the predicate device:
- Packaging and Labeling Visuals
- Packaging Integrity (Pouch Bubble)
- Pouch Seal Strength
- Diagnostic Agent Compatibility
- Hub Aspiration
- Flow Rates and Associated Pressures
Animal Testing:
A GLP animal study was performed to assess the comparative acute performance of the Surefire Guiding Catheter to the predicate device, as defined by a physician in a clinical environment. The Surefire Guiding Catheter was found to have acceptable performance. Additionally, the Surefire Guiding Catheter was found to have comparable performance to the predicate device.
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(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 & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle with three human profiles incorporated into its design. The profiles are facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2016
Surefire Medical, Inc. % Mark Job Responsible Third Party Official Regulatory Technical Services, LLC 1394 25th Street NW Buffalo, MN 55313
Re: K162359
Trade/Device Name: Surefire Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Procode: DQY Dated: August 19, 2016 Received: August 23, 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
1
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 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,
Brian D. Pullin -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) K162359
Device Name Surefire Guiding Catheter
Indications for Use (Describe)
The Surefire Guiding Catheter is intended to provide a pathway through which therapeutic devices are introduced. The Surefire Guiding Catheter is intended to be used 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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(DATE PREPARED: AUGUST 9, 2016)
510(K) SUMMARY
Device Name
Surefire Guiding Catheter
Manufacturer Name and Address
Surefire Medical, Inc. 6272 W. 91st Avenue Westminster, CO 80031 Owner Operator Number: 10038066
Submitter Contact Information
Surefire Medical. Inc. Surefire Medical, Inc. 6272 W. 91st Avenue Westminster. CO 80031 Contact: Contact: Lynne Aronson, VP Regulatory Affairs and Quality Assurance Phone: 303-426-1222 Fax: 303-426-1223
Common, Classification & Proprietary Names
| Common Name: | Guiding Catheter |
|---|---|
| Classification Name: | Percutaneous Catheter |
| Proprietary Name: | Surefire Guiding Catheter |
| Classification: | Class II |
| Classification Panel: | Cardiovascular Devices |
| Classification Regulation: | 21 CFR 870.1250 |
| Product Code: | DQY |
Predicate Device
Surefire Guiding Catheter
Device Description
The Surefire Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system.
The Surefire Guiding Catheter is a single-lumen 5F catheter with a soft distal tip and a Luer-Lock hub and strain relief. The Surefire Guiding Catheter has a three-layer construction, consisting of a Teflon inner liner, metal mid-layer, and a polymer outer shaft jacket. The polymer is filled with a radiopacifier agent, to provide visibility of the catheter under fluoroscopy.
The Surefire Guiding Catheter is available in 65 cm and 80 cm lengths with a variety of pre-shaped tip designs (including but not limited to Axis and Sim1) to accommodate access and positioning in a range of peripheral vascular anatomies.
The Surefire Guiding Catheter is compatible with standard 0.038" OD guide wires, Luer-Lock infusion syringes, rotating hemostatic valves (RHV), and 5F catheter sheath introducers.
The Surefire Guiding Catheter is provided sterile (EtO) for single patient use.
4
Indications for Use
The Surefire Guiding Catheter is intended to provide a pathway through which therapeutic devices are introduced. The Surefire Guiding Catheter is intended to be used in the peripheral vascular system.
Biocompatability Testing
The patient contact materials and colorants used to fabricate the proximal section (hub and shaft) of the modified Surefire Guiding Catheter are identical to the Surefire Guiding Catheter as it was cleared in 510(k) K140034 (cleared February 26, 2014) 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 proximal section (hub and shaft) of the modified Surefire Guiding Catheter 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). Therefore, the biocompatibility test requirements for the proximal section (hub and shaft) of the modified Surefire Guiding Catheter were met by leveraging the previously completed biocompatibility testing.
Biocompatibility testing of the patient contact materials used to fabricate the modified distal tip was performed in accordance with GLP (NAMSA, Northwood, OH) and ISO 10993-1 for external communicating devices in contact with circulating blood with a limited duration of less than 24 hours.
Biocompatibility testing of the material used to jacket the catheter shaft was completed by the material manufacturer in accordance with GLP (Toxicon, Bedford MA) and ISO 10993-1 for external communicating devices in contact with circulating blood with a limited duration of less than 24 hours.
Additionally, testing for thrombogenicity was performed on the modified Surefire Guiding Catheter as a part of an Animal Study.
| Biocompatibility Testing | ||
|---|---|---|
| ISO 10993-1 for external communicating devices in contact with circulating blood, duration |