(65 days)
The SUREFIRE® GUIDE SHEATH is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.
The Surefire® Guide Sheath is designed to act as a conduit for diagnostic agents and facilitates deployment at the desired treatment location. The Guide Sheath is a 0.035" guide wire compatible, single lumen, fixed length catheter body with a luer lock hub.
The document describes the performance testing for the Surefire® Guide Sheath. Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that a "battery of tests was performed according to protocols based on the requirements of the international standards and was shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device." However, specific numerical acceptance criteria (e.g., "tensile strength must be > X N") and the exact numerical performance results are not detailed in the provided text for most tests.
The document lists various tests under "Performance Testing & Verification Testing" and states that "The following series of tests have been provided in this submission:" and "Testing listed below was provided in the original submission."
| Test Category | Acceptance Criteria (Stated in Document) | Reported Device Performance (Stated in Document) |
|---|---|---|
| Performance Testing | "meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device" | A battery of tests was performed and was shown to meet the acceptance criteria. (Specific results not provided). |
| Biocompatibility Testing | Recommended tests in FDA General Program Memorandum, "Biological Evaluation of Medical Devices Part -1 Evaluation and testing" (ISO 10993). Specific standards mentioned: ASTM F756 and ISO 10993-4 (Hemolysis), ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Intra-cutaneous Irritation, Sensitization), ISO 10993-11 (Pyrogenicity), USP Standards (Particulate), Complement System evaluation. | All listed biocompatibility tests were performed and presumably met the acceptance criteria as the device was cleared. (Specific results not provided). |
| Risk/Hazard Analysis (EN ISO 14971) | "Performance characteristics for this indication for use were determined." Justified that "the performance of the Surefire® Guide Sheath is substantially equivalent to the performance and safety of the Surefire® Infusion System." | A risk/hazard analysis was conducted, and it was justified that the performance is substantially equivalent to the predicate. (Specific risk levels or performance metrics not provided). |
| Additional Safety Mfg. Controls | Visual, functional, dimensional, and sterility tests. | These additional controls were performed to ensure safety. (Specific results not provided). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for any of the performance or biocompatibility tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective, as these are typically bench-top or lab-based tests for medical devices of this nature, not clinical studies.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
This information is not applicable to the type of device and testing described. The Surefire® Guide Sheath is an intravascular catheter, and its performance is evaluated through engineering and biocompatibility bench testing, not through human expert assessment of data like in image-based diagnostic AI.
4. Adjudication Method for the Test Set:
This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are used in clinical trials or expert consensus studies, which are not described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI algorithms comparing human performance with and without AI assistance. The Surefire® Guide Sheath is a physical medical device (catheter), not an AI diagnostic tool.
6. If a Standalone (Algorithm Only) Performance Study Was Done:
No, a standalone (algorithm only) performance study was not done. This is relevant for AI algorithms without human intervention. The Surefire® Guide Sheath is a physical device that is used by a human operator. Its performance is assessed through bench tests of its physical properties and biocompatibility.
7. The Type of Ground Truth Used:
The "ground truth" for the performance testing of the Surefire® Guide Sheath is primarily defined by international standards and engineering specifications.
- Engineering Specifications: For tests like Kink Testing, Tensile Testing, High-Pressure Injection, Trackability, Torque, and Dimensional Inspection, the ground truth is established by predetermined engineering specifications and functional requirements for the device. For example, a certain force must be withstood in a tensile test, or a specific pressure must be tolerated during injection.
- International Standards (Biocompatibility): For biocompatibility, the ground truth is established by well-defined tests and pass/fail criteria outlined in standards such as ASTM F756, ISO 10993 series, and USP Standards. These standards provide methodologies and acceptable limits for biological responses.
8. The Sample Size for the Training Set:
This information is not applicable. The Surefire® Guide Sheath is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for a physical medical device.
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Surefire® Guide Sheath Premarket Notification Special 510(k
Section 6: 510(k) Summary 24 January 2012
| Owner/Manufacturer: | OwnerSurefire Medical, Inc.8601 Turnpike Dr.Suite 206Westminster, CO 80031 | ManufacturerSurefire Medical, Inc.12415 SW 136 AvenueUnit 3Miami, FL 33186 | FEB 2 3 2012 |
|---|---|---|---|
| Contact Person: | Mario ArbesuDirector, Quality Assurance and Regulatory Affairs305.378.2651 | ||
| Date of SummaryPreparation: | 24 January 2012 | ||
| Trade Name: | Surefire® Guide Sheath | ||
| 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® Guide Sheath is intended for use in angiographicprocedures. It delivers radiopaque media and therapeutic agents toselected sites in the peripheral vascular system. | ||
| Device Description: | The Surefire® Guide Sheath is designed to act as a conduit fordiagnostic agents and facilitates deployment at the desiredtreatment location. The Guide Sheath is a 0.035" guide wirecompatible, single lumen, fixed length catheter body with a luerlock hub. | ||
| Principals of Operation/Technology: | The Surefire® Guide Sheath is operated manually. |
Performance Testing & Verification Testing
The following series of tests have been provided in this submission:
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- Kink Testing
- · Tensile Testing
- · High Pressure Injection Testing
- · Trackability Testing
- · Torque Testing
- Dimensional Inspection
Testing listed below was provided in the original submission. The modifications in this device have no impact on these characteristics:
- · Kink Testing
- · Hub Aspiration Testing
- · Embolic Agent Infusion Compatibility Testing
- · Package Integrity Testing
- · Corrosion Testing
- · Diagnostic Agent Compatibility Testing
- · Coating Integrity
- · Antegrade Flow Testing
- · Infusion Efficiency
- Biocompatability
- -Hemolysis - ASTM F756 and ISO 10993-4
- Cytotoxicity ISO 10993-5 -
- Intra-cutaneous Irritation ISO 10993-10 -
- -Sensitization - ISO 10993-10
- -Pyrogenicity - ISO 10993-11
- -Particulate - USP Standards
- Complement System was performed -
| Performance/Safety: A risk/hazard analysis was conducted according to EN ISO 14971 MedicalDevices- Application of Risk management to medical devices. Performancecharacteristics for this indication for use were determined. It was then justifiedthat the performance of the Surefire® Guide Sheath is substantially equivalent tothe performance and safety of the Surefire® Infusion System. A battery of testswas performed according to protocols based on the requirements of theinternational standards and was shown to meet the acceptance criteria that weredetermined to be applicable to the safety and efficacy of the device. |
|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Additional Safety Manufacturing controls include visual, functional, dimensional and sterility tests. Information: 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". Substantial The Surefire Guide Sheath is substantially equivalent in intended use, design, Equivalence: technology/principles of operation to the predicate. The Guide sheath is substantially equivalent to the Surefire Infusion System, cleared under K110459.
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Differences between the devices do not raise any significant issues of safety or effectiveness. ·
| SubmitterInformation: | Prepared by: | Mario ArbesuDirector, Quality Assurance and Regulatory Affairs |
|---|---|---|
| Prepared for: | Surefire Medical, Inc.12415 SW. 136 AvenueUnit 3Miami, FL 33186 | |
| Date: | January 24, 2012 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
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 Mr. Mario Arbesu Director, Quality Assurance and Regulatory Affairs 8601 Turnpike Drive Suite 206 Westminster. CO 80031
Re: K113737
Trade Name: Surefire® Guide Sheath Regulation Number: 21 CFR 870.1200 Regulation Name: Intravascular Diagnostic Catheter Regulatory Class: II (two) Product Code: DQO Dated: January 24, 2012 Received: January 26, 2012
Dear Mr. Arbesu:
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 for use stated in the encreated of 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, de floos mat have over require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelove, manot of the Act include requirements for annual registration, listing of general ocurities proficturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Thead now now ver, 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.
FEB 2 3 2012
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Page 2 – Mr. Mario Arbesu
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 or any I cuttar buttates and entrements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical (21 OFF 1 ar 607) : accessed (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" (21) CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
10gallanon (21 Cr N 1 ar 500), prices/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,
M. A. Hillebert
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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Surefire® Guide Sheath
Premarket Notification Special 510(k) Submission
Indication for Use
510(k) Number (if known):
Device Name:
Indication for Use:
K113737
Surefire® Guide Sheath
The SUREFIRE® GUIDE SHEATH is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.
Prescription Use X (part 21 CFR 801 Subpart D)
AND/OR
Over-The-counter Use (21 CFR 801 Subpart C).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
M.S. Welle Concurrence of CDRH,
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ KII3737
§ 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).