(212 days)
The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.
The GrebSet micro-introducer kit is designed to gain access and deliver contrast media to selected vascular sites. The GrebSet catheter is compatible with ≤0.038"/.965mm guidewires. Each GrebSet kit consists of the following components:
- Access needle (21G echogenic percutaneous entry needle OR 20G echogenic Trocar . needle)
- 0.018" guidewire .
- Dilator .
- Catheter with radiopaque marker band located on distal tip ●
The provided text does not describe a study involving an AI-powered device or software. Instead, it is a 510(k) summary for a physical medical device, the "GrebSet micro-introducer kit," which is a diagnostic intravascular catheter.
Therefore, the specific information requested about acceptance criteria, study design, expert involvement, and AI performance metrics cannot be extracted from this document, as it pertains to the approval of a traditional hardware medical device through substantial equivalence to predicate devices, rather than an AI-driven one.
The "Summary of Non-Clinical Testing" section describes bench tests performed to ensure the device performs as intended, but these are engineering performance tests, not clinical studies for AI. The document explicitly states: "No clinical evaluations of this product have been conducted."
Therefore, I cannot populate the table or answer the questions with the information provided in the input.
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510(k) Summary
JAN 2 8 2009
510(k) Number: K081846
Date Prepared
September 8, 2008
Submitter Information
Submitter's Name: Address:
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369
Establishment Registration 2134812
Contact Person:
Julie Tapper, Senior Regulatory Affairs Associate jtapper@vascularsolutions.com 763-656-4300
Device Information
Trade Name: Classification Name: Product Code: Regulation:
GrebSet micro-introducer kit Diagnostic Intravascular Catheter DOO 21 CFR 870.1200
Predicate Devices
Vascular Solutions: InnerChange Micro-Introducer Catheter (K073585) Boston Scientific; AccuStick II (K unknown) Cook Medical; Neff Percutaneous Access Set (K unknown)
Device Description
The GrebSet micro-introducer kit is designed to gain access and deliver contrast media to selected vascular sites. The GrebSet catheter is compatible with ≤0.038"/.965mm guidewires. Each GrebSet kit consists of the following components:
- Access needle (21G echogenic percutaneous entry needle OR 20G echogenic Trocar . needle)
- 0.018" guidewire .
- Dilator .
- Catheter with radiopaque marker band located on distal tip ●
Intended Use/Indications for Use
The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.
Summary of Non-Clinical Testing
Testing conducted included assessments of the design verification of the GrebSet catheter along with biocompatibility assessments and shelf life testing to ensure that the device would
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perform as intended. The results of this testing confirmed the suitability of the GrebSet Catheter for its intended use. Each bench test that was conducted is listed, as follows:
| Aspiration Testing | Corrosion Resistance |
|---|---|
| Catheter Liquid Leakage Under Pressure | GrebSet Catheter Curve Retention |
| Static & Dynamic High Pressure Catheter | GrebSet Catheter Tortuosity |
| Testing | |
| Catheter Kink Testing | Hydrophilic Coating Performance |
| Fluoroscopic Visualization Test | Catheter Torque Test |
| Catheter Flow Rate Test | Force At Break |
Summary of Clinical Testing
No clinical evaluations of this product have been conducted.
Statement of Equivalence
The GrebSet micro-introducer kit has similar intended for use and functions as the predicate device.
Conclusion
Through the data and information presented, Vascular Solutions considers the GrebSet micro-introducer kit to be substantially equivalent to the predicate device. The testing performed confirms that the GrebSet Catheter will perform as intended.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head and body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vascular Solutions, Inc. c/o Ms. Julie Tapper Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369
JAN 2 8 2009
Re: K081846
Trade/Device Name: GrebSet™ Micro-introducer Kit Common Name: Diagnostic Intravascular Catheter Regulation Number: 21 CFR 870.1200 Regulatory Class: II Product Code: DQO Dated: December 23, 2008 Received: December 24, 2008
Dear Ms. Tapper:
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. Drue, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 - Ms. Julie Tapper
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0210. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
K//C/
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 Statement
510(k) Number: K081846
Device Name:
. GrebSet™ Micro-introducer Kit
Indications for Use:
The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascellar Devices 510(k) Number
Vascular Solutions, Inc. K081846 FDA Deficiency Letter Response
§ 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).