(50 days)
No
The description focuses on the physical characteristics and mechanical performance of a guiding catheter, with no mention of AI or ML capabilities.
No
The device is described as providing a pathway for other therapeutic devices, not as a therapeutic device itself. Its function is to facilitate the introduction and advancement of other devices.
No
The device is described as a "Guiding Catheter" intended to "provide a pathway through which therapeutic devices are introduced." It facilitates the advancement of other devices, rather than acquiring information for diagnosis.
No
The device description clearly outlines a physical catheter made of polymer with a radiopacifier, a Luer-Lock hub, and various tip shapes. It also mentions compatibility with physical components like guide wires and syringes. The performance studies involve physical testing (tensile strength, torque, trackability) and an animal study, all indicative of a hardware device.
Based on the provided information, the Surefire Guiding Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "provide a pathway through which therapeutic devices are introduced" and to be used "in the peripheral vascular system." This describes a device used within the body for a procedural purpose, not for testing samples outside the body.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. It mentions features like a lumen, braiding, tip designs, and compatibility with other interventional devices. This aligns with an in-vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any form of testing or diagnostic analysis performed on samples outside the body.
In summary, the Surefire Guiding Catheter is an in-vivo medical device used for facilitating procedures within the peripheral vascular system, not an IVD device used for testing samples.
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, braided, fixed-length 5F catheter with a soft distal tip and a proximal Luer-Lock hub and strain relief. The Pebax extruded polymer is filled with a radiopacifier to provide visibility of the Surefire Guiding Catheter under fluoroscopy.
The Surefire Guiding Catheters are 65 and 80 cm in length with a variety of pre-shaped tip designs (including but not limited to Axis, Simmons I and Cobra) to accommodate access and positioning in a range of peripheral vascular anatomies. The distal tip is rounded for atraumatic tracking.
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
Fluoroscopy
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)
Biocompatability Testing: Biocompatibility testing of the patient-contact materials used in the construction of the catheter was 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 following biocompatibility testing was conducted on the Surefire Infusion System (K110459), Surefire High-Flow Microcatheter (K121677), and Surefire Angiographic Catheter (K122506) which are constructed of the same materials as the Surefire Guiding Catheter. The biocompatibility test requirements for the Surefire Guiding Catheter were met by leveraging previously completed biocompatibility testing. The results of all 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.
Performance Testing: Design verification testing was performed which demonstrated that the Surefire Guiding Catheter meets its specified performance requirements, and is equivalent to the performance of the predicate device. Testing included visual and dimensional inspection, and tests for particulates, kink, tensile strength, torque, trackability/device compatibility, high pressure injection and flow/pressure generation.
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)
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
K140034 p. I of 3
FEB 2 6 2014
510(K) SUMMARY
(Date Prepared: February 21, 2014)
Device Name
Surefire Guiding Catheter
Manufacturer Name and Address
Surefire Medical, Inc. 12415 SW 136 Ave., Unit 3 Miami FL 33186 Establishment Registration Number: 3009428975
Submitter Contact Information
Surefire Medical, Inc. 8601 Turnpike Drive, Suite 206 Westminster, CO 8003 1 Contact: Lynne Aronson, Director Regulatory Affairs 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
Medtronic Launcher 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, braided, fixed-length 5F catheter with a soft distal tip and a proximal Luer-Lock hub and strain relief. The Pebax extruded polymer is filled with a radiopacifier to provide visibility of the Surefire Guiding Catheter under fluoroscopy.
The Surefire Guiding Catheters are 65 and 80 cm in length with a variety of pre-shaped tip designs (including but not limited to Axis, Simmons I and Cobra) to accommodate access and positioning in a range of peripheral vascular anatomies. The distal tip is rounded for atraumatic tracking.
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
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.
1
Biocompatability Testing
Biocompatibility testing of the patient-contact materials used in the construction of the catheter was 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 following biocompatibility testing was conducted on the Surefire Infusion System (K110459), Surefire High-Flow Microcatheter (K121677), and Surefire Angiographic Catheter (K122506) which are constructed of the same materials as the Surefire Guiding Catheter. The biocompaibility test requirements for the Surefire Guiding Catheter were met by leveraging previously completed biocompatibility testing.
| 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 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 Intracutaneous Study - Extract - Sesame Oil, NF Extract | ||
| Systemic Toxicity | ISO 10993-11 | ISO Systemic Toxicity Study - Extract - 0.9% Sodium Chloride |
| Solution Extract | ||
| ISO Systemic Toxicity Study - Extract - Sesame Oil, NF Extract | ||
| Pyrogen - Material Mediated - 0.9% Sodium Chloride Solution | ||
| Extract | ||
| Hemocompatability | ISO 10993-4 | ASTM Hemolysis - CMF-PBS Extract |
| C3a Complement Assay - Normal Human Serum Extract | ||
| SC5b-9 Complement Assay - Normal Human Serum Extract | ||
| Coagulation - ASTM Partial Thromboplastin Time |
All testing was performed in accordance with GLP by NAMSA (Northwood, OH).
Additionally, testing for thrombogenicity was performed on the Surefire Guiding Catheter as a part of the GLP Animal Study.
The results of all 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.
Performance Testing
Design verification testing was performed which demonstrated that the Surefire Guiding Catheter meets its specified performance requirements, and is equivalent to the performance of the predicate device. Testing included visual and dimensional inspection, and tests for particulates, kink, tensile strength, torque, trackability/device compatibility, high pressure injection and flow/pressure generation.
2
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.
Substantial Equivalence
The Surefire Guiding Catheter is substantially equivalent in intended use, design, and technology/principles of operation to the predicate.
Comparative Summary: Design / Technological Characteristics
The Surefire Guiding Catheter and predicate device are single lumen catheters with Luer-Lock hubs and a variety of shaped tip styles. They have similar constructions consisting of a polymer outer extrusion with radiopacifier, stainless steel braid and polymer inner.
The Surefire Guiding Catheter and predicate device have similar dimensions, with inner and outer diameters that are consistent with a 5F sized catheters are available in a range of lengths. The predicate device is available in a longer length to accommodate use in the coronary application.
Comparative Summary: Indications for Use
The indication statement of the Surefire Guiding Catheter is the same as that of the predicate device with the exception that the predicate device is indicated for use in both the coronary and peripheral vascular system and the Surefire Guiding Catheter indication is limited to use in only the peripheral vascular system. As both devices are indicated for use in the peripheral vascular system, this difference in indications for use does not impact the safety and effectiveness of the Surefire Guiding Catheter when used as indicated.
Comparative Summary: Performance
Animal and bench performance test data demonstrate that the Surefire Guiding Catheter performance is comparable to the predicate device.
Differences between the devices do not raise any issues of safety or effectiveness.
3
Image /page/3/Picture/1 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 an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
February 26, 2014
Surefire Medical, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K140034
Trade/Device Name: Surefire Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 4, 2014 Received: February 5, 2014
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
4
·· 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,
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
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140034
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) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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