(95 days)
The StarClose™ Introducer Set is intended for use in procedures requiring percutaneous introduction of intravascular devices.
The StarClose™ Introducer Set consists of a 6F Introducer, a Dilator and a "J"-tip guidewire and is for use in gaining access to blood vessels for diagnostic and interventional procedures.
The provided text describes the Abbott Vascular StarClose Introducer Set (K060902) but does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than detailed clinical performance studies with specific acceptance criteria.
Therefore, I cannot fulfill your request for the tables and study details based on the provided input. The information you are seeking (acceptance criteria, device performance, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) is not present in this regulatory submission document.
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Abbott Vascular StarClose Introducer Set
APPENDIX A: 510(k) SUMMARY
| Sponsor/Submitter: | Abbott LaboratoriesAbbott Vascular Inc.400 Saginaw DriveRedwood City, CA 94063 | JUL - 7 2006 |
|---|---|---|
| Contact Person: | Daun PutnamRegulatory AffairsPhone: 650-474-3323Fax: 650-474-3041 | |
| Date of Submission: | March 31, 2006 | |
| Device Trade Name: | StarClose™ Introducer Set | |
| Device Common Name: | Introducer Set | |
| Device Classification: | Class II | |
| Regulation Number: | 21 CFR 870.1340 | |
| Classification Name: | Catheter Introducer | |
| Product Code: | DYB | |
| Predicate Device: | StarClose™ Introducer Set (K030723) | |
| Intended Use: | The StarClose™ Introducer Set is intended for use inprocedures requiring percutaneous introduction ofintravascular devices. | |
| Device Description: | The StarClose™ Introducer Set consists of a 6F Introducer,a Dilator and a "J"-tip guidewire and is for use in gainingaccess to blood vessels for diagnostic and interventionalprocedures. | |
| Summary of SubstantialEquivalence: | The StarClose™ Introducer Set is substantially equivalentto the predicate device. Substantial equivalence wasconfirmed through non-clinical testing. |
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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human profiles. The profiles are stacked on top of each other, representing the department's focus on health and human well-being. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2006
Abbott Vascular, Inc. c/o Mr. Daun Putnam Coordinator, Regulatory Affairs 400 Saginaw Drive Redwood City, CA 94063
Re: K060902
Trade Name: StarClose™ Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II (two) Product Code: DYB Dated: June 8, 2006 Received: June 9, 2006
Dear Mr. Putnam:
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.
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Page 2 – Mr. Daun Putnam
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Drinas intatutes and regulations administered by other Federal agencies. You must or any I vith 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 CFN 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. product radiation contact provises (site of the station your device as described in your Section 510(k) This letter will and in your finding of substantial equivalence of your device to a legally premarket notification on "carsification 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 If you active 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 other general informational 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,
Meffey Map
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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APPENDIX B: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K 060902
Device Name:
StarClose™ Introducer Set
Indications for Use: The StarClose™ Introducer Set is intended for use in procedures requiring percutaneous introduction of intravascular devices.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use______________ OR (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mefferson
Division of Nuclear Devices
(Divis. of Cardio:ascular Devices)
Division of
510(k) Number K060902
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).