(56 days)
The Wildcat 5F Guidewire Support Catheter is intended to support steerable guidewires in accessing discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. It may also be used to deliver saline/contrast.
The Wildcat 5F Guidewire Support Catheter is a 5F sheath and 0.014" guidewire compatible over-thewire device. It consists of a catheter shaft with handle assembly at the proximal end an atraumatic distal tip. The catheter has a working length of 140 cm. A locking luer connector at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only.
The provided text describes the nonclinical performance data for the Avinger Wildcat 5F Guidewire Support Catheter. It focuses on demonstrating equivalence to a previously cleared device (Wildcat 7F Guidewire Support Catheter) rather than establishing specific acceptance criteria with numerical targets.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of predetermined numerical acceptance criteria against which device performance is measured. Instead, it states that:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Conformance to "Sterile, single-use intravascular catheters – Part 1 – General Requirements" (ISO 10555-1) for tensile, torque strength, and coating integrity. | "All data fell well within pre-determined product specifications and external standard requirements." (This indicates that the device met the requirements of ISO 10555-1 for these parameters.) |
| Conformance to "Biological Evaluation of Medical Devices" (EN ISO 10993-1) for biocompatibility. | Device compatibility testing "was conducted according to EN ISO 10993-1" and "All data fell well within pre-determined product specifications and external standard requirements." (This indicates the device met biocompatibility requirements.) |
| Successful evaluation in a porcine animal model. | "device performance was successfully evaluated in a porcine animal model. The test model represented a discrete vascular bed in the coronary arteries under GLP-like conditions." (This indicates the device performed as intended in an in-vivo setting, though specific quantitative acceptance metrics for this performance are not provided.) |
| Substantial Equivalence to Wildcat 7F Guidewire Support Catheter. | "Based upon the product technical information, intended use, performance and biocompatibility data provided in this premarket notification, the Avinger 5F catheter has been shown to be equivalent to the currently marketed Avinger 7F catheter." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- For laboratory testing (tensile, torque, coating integrity, compatibility): Not specified.
- For porcine animal model: Not specified.
- Data Provenance: The document does not specify the country of origin of the data for either the laboratory tests or the animal study.
- Retrospective or Prospective: Not specified, but given the context of design verification testing and animal studies, it is implied to be prospective testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a medical instrument (catheter), and its performance evaluation does not involve establishing ground truth from expert interpretation in the way an AI diagnostic device would. The "ground truth" here is the physical and biological performance against established standards and in-vivo functionality.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically associated with human-read studies, particularly in the context of diagnostic AI, to resolve discrepancies in expert interpretations. This document describes physical and biological performance tests.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This document describes the nonclinical performance of a guidewire support catheter, not a diagnostic AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question refers to AI algorithm performance. This document describes the performance of a physical medical device. The "standalone performance" of the device is described as its ability to meet specifications in laboratory tests and perform successfully in an animal model.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation is primarily:
- Engineering Specifications: Pre-determined product specifications for tensile, torque strength, and coating integrity, derived from ISO 10555-1.
- Biocompatibility Standards: Requirements set forth in EN ISO 10993-1.
- In-vivo Functionality: Successful performance in a well-defined porcine animal model representing a discrete vascular bed.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; it's a physical medical instrument. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
AVINGER
Section 2: 510(k) Summary (21 CFR § 807.92)
| Submitter: | Avinger; Inc. | AUG 0,6 2010 |
|---|---|---|
| 400 Chesapeake Drive | ||
| Redwood City, CA 94063 | ||
| Contact: | Himanshu Patel | |
| Chief Technology Officer | ||
| Date Summary Prepared: | 12 July 2010 | |
| Device Trade Name: | Wildcat 5F Guidewire Support Catheter | |
| Common Name: | Guidewire Support Catheter | |
| Classification Name: | Percutaneous Catheter (21 CFR § 870.1250) | |
| Product Code: | DQY | |
| Cleared Device: | Wildcat 7F Guidewire Support Catheter (K083313) |
Device Description:
The Wildcat 5F Guidewire Support Catheter is a 5F sheath and 0.014" guidewire compatible over-thewire device. It consists of a catheter shaft with handle assembly at the proximal end an atraumatic distal tip. The catheter has a working length of 140 cm. A locking luer connector at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only.
Intended Use:
The Wildcat 5F Guidewire Support Catheter is intended to support steerable guidewires in accessing discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. It may also be used to deliver saline/contrast.
Nonclinical Performance Data:
Design verification testing was conducted. Such testing confirms that the Wildcat 5F device performs according to the stated intended use. Device evaluation consisted of laboratory testing specified in 10555-1 "Sterile, single-use intravascular catheters – Part 1 – General Requirements" and included tensile, torque strength, coating integrity and device compatibility testing was conducted according to EN ISO 10993-1 "Biological Evaluation of Medical Devices". All data fell well within pre-determined product specifications and external standard requirements. In addition, device
{1}------------------------------------------------
performance was successfully evaluated in a porcine animal model. The test model represented a discrete vascular bed in the coronary arteries under GLP-like conditions.
Comparison with Cleared Device:
The Avinger 5F catheter is very similar to the Avinger 7F catheter. Both devices are intended for use with steerable guidewires to access discrete regions of the peripheral vasculature. Additionally, both devices may be used to facilitate placement and exchange of conventional guidewires and to deliver saline or contrast. Both devices are comprised of similar materials and function according to similar operating parameters. There are two primary differences between the modified and cleared devices. First, the modified device is smaller (5F as opposed to the cleared device: Secondly, the distal tip of the modified device is comprised of a single part with atraumatic exposed wedges as opposed to the retractable wedges contained in the larger device.
Summary:
Based upon the product technical information, intended use, performance and biocompatibility data provided in this premarket notification, the Avinger 5F catheter has been shown to be equivalent to the currently marketed Avinger 7F catheter.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 0 6 2010
Avinger, Inc c/o Mr. Himanshu Patel Chief Technology Officer 400 Chesapeake Drive Redwood City, CA 94063
Re: K101647
Trade/Device Name: Wildcat 5F Guidewire Support Catheter Regulation Number: 21 CFR§ 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 14, 2010 Received: July 15, 2010
Dear Mr Patel:
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. Ilsting 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.
{3}------------------------------------------------
Page 2 - Mr. Himanshu Patel
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 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/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 yours,
una R. Vi. hiner
VBram D. Zuckerman, M.D. -Director
Division of Cardiovascular Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
AVINGER, INC.
Section 1: Statement of Indications for Use
510(k) Number if known: 780-> K10 (k) 1 1 7
Device Name: Wildcat 5F Guidewire Support Catheter
AUG 0 6 2010
Indications for Üse:
The Wildcat 5F Guidewire Support Catheter is intended to support steerable guidewires in accessing discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. It may also be used to deliver saline/contrast.
ಸ Prescription Use: (Per 21 CFR § 801, Subpart D)
AND/OR
Over-the-Counter Use _ (Per 21 CFR §807, Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (Division Sign-Jevices Page 2 CONFIDENTIAL
510(k) Number_
§ 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).