(160 days)
Not Found
No
The description details a simple mechanical dilator and does not mention any computational or analytical capabilities, let alone AI/ML.
No.
The device is a dilator used to facilitate the introduction of other intravascular devices and does not itself treat or mitigate a disease or condition.
No
Explanation: The device is described as a dilator for introducing other intravascular devices, not for diagnosing conditions. Its function is to facilitate access to blood vessels, which is a procedural step, not a diagnostic one.
No
The device description clearly states it is a "tapered plastic tube with a hub" and "goes inside one of the StarClose sheaths," indicating it is a physical, hardware device.
Based on the provided information, the StarClose 6F Dilator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "procedures requiring percutaneous introduction of intravascular devices." This describes a device used in vivo (within the body) for accessing blood vessels.
- Device Description: The description details a physical tool used to facilitate access to blood vessels during procedures. It does not describe a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens such as blood, urine, or tissue outside the body to provide information for diagnosis, monitoring, or screening. The StarClose 6F Dilator is a procedural tool used within the body.
N/A
Intended Use / Indications for Use
The StarClose 6F Dilator is intended for use in procedures requiring percutaneous introduction of intravascular devices.
Product codes
DRE
Device Description
The Abbott Vascular StarClose 6F Dilator is a tapered plastic tube with a hub to facilitate handling and an interior channel sized to accept a 0.038 inch guidewire. The dilator goes inside one of the StarClose sheaths to provide support while gaining access to blood vessels prior to catheterization procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Non-clinical testing was conducted.
Key Metrics
Not Found
Predicate Device(s)
Encapsulon Vessel Dilators (K840641), Super Sheath Introducer Sheath (K052557)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).
0
K062 554
APPENDIX A. 510(k) SUMMARY
…
| A. Sponsor/Submitter: | Abbott Vascular Devices
400 Saginaw Drive
Redwood City, CA 94063 | FEB 6 200 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| B. Contact Person: | Daun Putnam
Regulatory Project Manager
Phone:(650) 474-3323
Fax:(650) 474-3041 | |
| Date of Submission: | August 25, 2006 | |
| Device Trade Name: | StarClose 6F Dilator | |
| Device Common Name: | Vessel Dilator | |
| Device Classification: | Class II | |
| Regulation Number: | 21 CFR 874.1310 | |
| Classification Name: | Vessel, Dilator, for Percutaneous Catheterization | |
| Product Code: | DRE | |
| Predicate Device: | Encapsulon Vessel Dilators (K840641) and Super Sheath Introducer Sheath (K052557) | |
| Intended Use: | The StarClose 6F Dilator is intended for use in procedures requiring percutaneous introduction of intravascular devices. | |
| Device Description: | The Abbott Vascular StarClose 6F Dilator is a tapered plastic tube with a hub to facilitate handling and an interior channel sized to accept a 0.038 inch guidewire. The dilator goes inside one of the StarClose sheaths to provide support while gaining access to blood vessels prior to catheterization procedures. | |
| Summary of Substantial
Equivalence: | Abbott Vascular has submitted information on indications for use, design and principle of operation, biocompatibility and performance characteristics to establish that StarClose 6F Dilator is substantially equivalent to currently marketed predicate devices.
StarClose 6F Dilator has the same intended use as the predicate devices. Results of scientific testing have ensured that all materials are biocompatible no new adverse effects were introduced and | |
1
physical properties are appropriate for the intended use. Non-clinical testing was conducted.
1 1 1
:
In conclusion, StarClose 6F Dilator has been shown to be substantially equivalent to the Class II predicate devices upon which the dilator is based.
.
2
. . .
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 6 2007
Abbott Vascular Inc. c/o Veronica Kocken 400 Saginaw Drive Redwood City, CA 94063
Re: K062554
Trade Name: Vessel Dilator Regulation Number: 21 CFR 874.1310 Regulation Name: Vessel, Catheter, for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: December 19, 2006 Received: December 20, 2006
Dear Ms. Kocken:
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.
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
3
Page 2 - Mr. Wagner
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 forth in the quality systems (OS) 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
R. lochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APPENDIX B. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K__________________________________________________________________________________________________________________________________________________ 062554
Device Name:
The StarClose 6F Dilator
Indications For Use: The StarClose 6F Dilator is intended for use in procedures requiring percutaneous introduction of intravascular devices.
× Prescription Use
OR (Per 21 CFR 801.109) (Optional Format 1-2-96) Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uma R. W. Wainer
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K062554