(127 days)
Not Found
No
The summary describes a physical catheter system for delivering agents and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on physical and material properties.
Yes
The device is intended to deliver "therapeutic agents" to selected sites.
No
Explanation: The device is an infusion catheter system intended for delivering radiopaque media and therapeutic agents, which are interventional and therapeutic functions, not diagnostic ones. While it mentions "Diagnostic Agent Compatibility Testing" in the performance studies, this refers to the device's compatibility with diagnostic agents, not the device itself performing diagnostic functions. Its intended use is not to diagnose a condition, but to deliver substances during an angiographic procedure.
No
The device description explicitly states it is a "two-part system comprised of an Infusion Microcatheter and a Guide Sheath," which are physical hardware components. The performance studies also detail testing on physical properties like kink, tensile, and pressure, further indicating it is not software-only.
Based on the provided information, the SUREFIRE™ INFUSION CATHETER SYSTEM is not an IVD (In Vitro Diagnostic) device.
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 device used within the body for diagnostic imaging and treatment delivery, not for testing samples outside the body.
- Device Description: The description of a "two-part system comprised of an Infusion Microcatheter and a Guide Sheath" aligns with a device used for accessing and delivering substances within the vascular system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing samples outside the body.
Therefore, the SUREFIRE™ INFUSION CATHETER SYSTEM is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Surefire™ Infusion Catheter 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 (comma separated list FDA assigned to the subject device)
DQO
Device Description
The Surefire™ Infusion Catheter System is a two-part system comprised of an Infusion Microcatheter and a Guide Sheath.
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 & Verification Testing:
- Kink Testing
- Tensile Testing
- High Pressure Injection Testing
- Hub Aspiration Testing
- Embolic Agent Infusion Compatibility Testing
- Package Integrity Testing
- Corrosion Testing
- Diagnostic Agent Compatibility Testing
- Trackability Testing
- Dimensional Inspection
- Coating Integrity
- Antegrade Flow Testing
- Infusion Efficiency
- Acute System Toxicity
Biocompatibility Testing:
- Pyrogenic- Test is conducted based on USP, General Chapter, Pyrogen Test. The procedure is recommended in ISO 10993-11
- intra-cutaneous irritation based on ISO 10993-10: Toxicity of the Paladin Catheter testing was based on International Organization for Standardization 10993-11
- Hemolysis was tested according to procedures based on ASTM F756, Standard Practices for Assessment of Hemolytic Properties of Materials and ISO 10993-4
- Sensitization was tested based on the requirements of ISO 10993-10
- Particulate USP Standards
- Cytotoxic effects were tested following the guidelines of ISO 10993-5:
- Complement System was performed
Performance/Safety: A risk/hazard analysis was conducted according to EN ISO 14971 Medical Devices- Application of Risk management to medical devices. Performance characteristic for this indication for use were determined. It was then justified that the performance of the Surefire™ Infusion Catheter System is substantially equivalent to the performance and safety of the Terumo Radifocus Glidecath. A battery of tests were performed according to protocols based on the requirements of the following standards and was shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device:
- ISO 10555-1 Sterile, single use intravascular catheters Part 1 General requirements.
- Surefire™ Infusion Catheter System Section 5-1 Premarket Notification Traditional 510(k) Submission 15 February 2011
- ISO 10555-2 Sterile, single use intravascular catheters Part 2 Angiographic catheters.
- ISO 10993-1 Biological Evaluation of medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
- ISO 11135-1 Medical Devices -Validation and Routine Control of Ethylene Oxide Sterilization.
Additional Safety Information: Manufacturing controls include visual, functional, dimensional and sterility tests. Blood contacting materials were tested in accordance with the tests recommended in the FDA General program Memorandum. Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part -1 Evaluation and testing".
Discussion of Animal Data: The animal study data is submitted in this 510(k) and is on file at Surefire Medical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
110459 Section 5-1 16 June 2011
Surefire Medical requests that the attached "Summary" for the Surefire™ Infusion Catheter System be distributed upon request under the Freedom of Information Act. This report is a summary of the information presented in this 510(k) submission.
| Owner/Manufacturer: | Surefire Medical, Inc.
8601 Turnpike Dr. Manufacturing
Suite 206
Westminster, CO 80031 | Surefire Medical, Inc.
12415 SW136Avenue
Unit 3
Miami, FL 33186 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Contact Person: | Cheryl Hastings
VP Clinical and Regulatory Affairs
303.883.5554 | |
| Date of Summary
Preparation: | 16 June 2011 | JUN 2 4 2011 |
| Trade Name: | Surefire™ Infusion Catheter System | |
| Common Name: | Intravascular Catheter | |
| Classification Name: | Intravascular Diagnostic Catheter | |
| Classification: | Class II | |
| Classification Regulation: | 21 CRF Part 870.1200 - Diagnostic intravascular catheter. | |
| Product Code: | DQO | |
| Intended Use: | The Surefire™ Infusion Catheter System is intended for use in
angiographic procedures. It delivers radiopaque media and therapeutic
agents to selected sites in the peripheral vascular system. | |
| Device Description: | The Surefire™ Infusion Catheter System is a two-part system comprised
of an Infusion Microcatheter and a Guide Sheath. | |
| Principals of Operation/
Technology: | The Surefire™ Infusion Catheter System is operated manually. | |
1
Performance Testing & Verification Testing
- Kink Testing .
- . Tensile Testing
- High Pressure Injection Testing ●
- . Hub Aspiration Testing
- Embolic Agent Infusion Compatibility Testing ●
- Package Integrity Testing
- Corrosion Testing .
- . Diagnostic Agent Compatibility Testing
- . Trackability Testing
- . Dimensional Inspection
- . Coating Integrity
- . Antegrade Flow Testing
- Infusion Efficiency �
- Acute System Toxicity .
Biocompatibility Testing
- Pyrogenic- Test is conducted based on USP, General Chapter, Pyrogen Test. The . procedure is recommended in ISO 10993-11
- intra-cutaneous irritation based on ISO 10993-10: Toxicity of the Paladin Catheter testing was . based on International Organization for Standardization 10993-11
- Hemolysis was tested according to procedures based on ASTM F756, Standard Practices for . Assessment of Hemolytic Properties of Materials and ISO 10993-4
- Sensitization was tested based on the requirements of ISO 10993-10 .
- Particulate USP Standards .
- Cytotoxic effects were tested following the guidelines of ISO 10993-5: .
- Complement System was performed .
Performance/Safety: A risk/hazard analysis was conducted according to EN ISO 14971 Medical Devices- Application of Risk management to medical devices. Performance characteristic for this indication for use were determined. It was then justified that the performance of the Surefire™ Infusion Catheter System is substantially equivalent to the performance and safety of the Terumo Radifocus Glidecath. A batterv of tests were performed according to protocols based on the requirements of the following standards and was shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device:
- · ISO 10555-1 Sterile, single use intravascular catheters Part 1 General requirements.
- · Surefire™ Infusion Catheter System Section 5-1 Premarket Notification Traditional 510(k) Submission 15 February 2011
- · ISO 10555-2 Sterile, single use intravascular catheters Part 2 Angiographic catheters.
- · ISO 10993-1 Biological Evaluation of medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
- · ISO 11135-1 Medical Devices -Validation and Routine Control of Ethylene Oxide Sterilization.
2
| Additional Safety
Information: | Manufacturing controls include visual, functional, dimensional and sterility tests.
Blood contacting materials were tested in accordance with the tests re
commended in the FDA General program Memorandum. Use of International
Standard ISO 10993, "Biological Evaluation of Medical Devices Part -1
Evaluation and testing". | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Discussion of
Animal Data: | The animal study data is submitted in this 510(k) and is on file at Surefire
Medical. | |
| Substantial
Equivalence: | The Surefire™ Infusion Catheter System is substantially equivalent in intended
use, design, technology/principles of operation to the predicates. The Guide
sheath is substantially equivalent to the Terumo Radifocus GLIDECATH,
cleared under K090040. The Microcatheter is substantially equivalent to the
EmboCath Plus Infusion Microcatheter by BioSphere Medical cleared under
K062126. Differences between the devices do not raise any significant issues of
safety or effectiveness. | |
| Submitter
Information: | Prepared by:
Prepared for:
Date: | Cheryl Hastings
VP Clinical and Regulatory Affairs
Surefire Medical, Inc.
8601 Turnpike Drive
Suite 206
Westminster, CO 80031
June 16, 2011 |
:
:
:
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Surefire Medical, Inc. c/o Ms. Cheryl Hastings VP Clinical and Regulatory Affairs 8601 Turnpike Dr., Suite 206 Westminster, CO 80031
JUN 2 4 2011
Re: K110459
Trade/Device Name: Surefire™ Infusion Catheter System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: June 17, 2011 Received: June 20, 2011
Dear Ms. Hastings:
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
4
Page 2 - Ms. Cheryl Hastings
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Surefire™ Infusion Catheter System Premarket Notification 510(k) Submission
Indication for Use
510(k) Number (if known):
Surefire™ Infusion Catheter System Device Name:
Indication for Use:
The SUREFIRE™ INFUSION CATHETER SYSTEM is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.
Over-The-counter Use AND/OR Prescription Use x (21 CFR 801 Subpart C) (part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH,
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number 1/110459
6
Indication for Use
| 510(k) Number (if known): | K110459 |
|---|---|
| Device Name: | Surefire TM Infusion Catheter System |
| Indication for Use: | The SUREFIRE TM INFUSION CATHETER SYSTEM is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system. |
AND/OR Prescription Use × (part 21 CFR 801 Subpart D)
Over-The-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH,
i
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number