(36 days)
The StarClose™ Vascular Closure System is intended for use for use to approximate vascular tissue for achieving hemostatic closure of puncture sites to aid healing in minimally invasive procedures under direct or endoscopic visualization
The StarClose™ Vascular Closure System is designed to deliver a nitinol clip to close vascular puncture sites to achieve hemostasis.
The provided text is a 510(k) summary for the Abbott Vascular Devices IVS Clip Closure System (StarClose™ Vascular Closure System) and the associated FDA approval letter. This document focuses on establishing substantial equivalence to a predicate device, rather than presenting a standalone study with specific acceptance criteria and performance metrics for the device itself.
Therefore, much of the requested information (acceptance criteria, detailed study design, sample sizes for training/test sets, ground truth methodology, expert qualifications, adjudication methods, MRMC study results, and standalone performance) is not present in the provided text. The submission is based on non-clinical testing to demonstrate equivalence, not a clinical trial to prove specific performance against pre-defined acceptance criteria in a human population.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the given text. The 510(k) summary states, "Substantial equivalence was confirmed through non-clinical testing," but does not detail the specific non-clinical tests, their acceptance criteria, or the reported performance outcomes.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the given text, as the approval is based on "non-clinical testing" which does not involve a human patient test set.
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):
This information is not provided in the given text, as the approval is based on "non-clinical testing" which does not involve human experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the given text.
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:
This information is not provided in the given text. The StarClose™ Vascular Closure System is a medical device for closing vascular puncture sites, not an AI-assisted diagnostic tool, so an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided in the given text. The StarClose™ Vascular Closure System is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided in the given text. For "non-clinical testing," ground truth would likely be established through engineering specifications, material properties, and experimental measurements against known standards, but these specifics are not detailed.
8. The sample size for the training set:
This information is not provided in the given text. The submission refers to "non-clinical testing," not machine learning model training.
9. How the ground truth for the training set was established:
This information is not provided in the given text. The submission refers to "non-clinical testing," not machine learning model training.
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051125
JUN 8 - 2005
Abbott Vascular Devices IVS Clip Closure System
APPENDIX A. 510(k) SUMMARY
| Sponsor/Submitter: | Abbott Laboratories (Perclose, Inc.)Abbott Vascular Devices400 Saginaw DriveRedwood City, CA 94063 |
|---|---|
| Contact Person: | Kim Smith-ServanceRegulatory Affairs ManagerPhone:(650) 474-3383Fax:(650) 474-3041 |
| Date of Submission: | May 2, 2005 |
| Device Trade Name: | StarClose™ Vascular Closure System |
| Device Common Name: | Vascular Closure System |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 878.430021 CFR 870.1340 |
| Classification Name: | General and Plastic Surgery Devices |
| Product Code: | FZPDYB |
| Predicate Device: | StarClose™ Vascular Closure System (K020879) |
| Intended Use: | The StarClose™ Vascular Closure System is intended for use for use toapproximate vascular tissue for achieving hemostatic closure of puncturesites to aid healing in minimally invasive procedures under direct orendoscopic visualization |
| Device Description: | The StarClose™ Vascular Closure System is designed to deliver anitinol clip to close vascular puncture sites to achieve hemostasis. |
| Summary of SubstantialEquivalence: | The StarClose™ Vascular Closure System is substantiallyequivalent to the predicate device. Substantial equivalence wasconfirmed through non-clinical testing. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with outstretched wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 8 - 2005
Ms. Kim Smith-Servance Manager, Regulatory Affairs Abbott Laboratories (Perclose, Inc.) Abbott Vascular Devices 400 Saginaw Drive Redwood City, California 94063
Re: K051125
K031123
Trade/Device Name: StarClose™ Vascular Closure System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: May 2, 2005 Received: May 10, 2005
Dear Ms. Smith-Servance:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained is substantially equivalent (for the indications felerenced above and nave decembed the acted predicate devices marketed in interstate for use stated in the encrosule) to regally manated provide in the Medical Device Ameralments, or to commerce prior to May 28, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been recultion in acceracy of of a premarket approval application (PMA). and Cosment Act (Act) that do not require approval of the general controls provisions of the Act. The You may, merelore, market the device, bacycer to the Beller of annual registration, listing of general Controls of the Hereness of the Hereas some in the manage inst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is Classified (SCC above) into existins major regulations affecting your device in the subject to successful in a FDA it may be subject to such additional concelsi - marting 21, Parts 800 to 898. In addition, FDA can be lound in the Code of Feceral rogerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dr is ibsumes or wor device complies with other requirements of the Act that IDA has made a decorminations administered by other Federal agencies. You must of ally rederal statutes and regulations and including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, moreans, and manufacturing practice requirements as set CFK Fatt 807), adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Kim Smith-Servance
This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the supply of any for heat the suice to a legal This letter will allow you to begin marketing your averale of your device of your device to a legally
premarket notification. The FDA finding of substantial end the permits premarket notification. "The FDA Intuing of bassantas - p
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
rs in the results of the most 10 15 - Alge - also - places note the requira If you desire specific advice for your device of our on the regulation entitled.
contact the Office of Compliance at (240) 276-0115 . Also, please note the regulation contact the Office of Colliptialicc at (24) 210 - 1 (21CFR Patt 807.97). You may obtain
"Misbranding by reference to premarket notification the Division of Small "Misbranding by reference to premarket nonlineation" (1) 32 oct from the Division of Small
other general information on your responsibilities under (1800 number (800) 638-204 other general information on your responsionner Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-firences Manufacturers, International and Colisuner Assistance as tos over in and and and and and and and a
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Kosi12S
Abbott Vascular Devices IVS Clip Closure System Special 510(k): Device Modification CONFIDENTIAL
APPENDIX B. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K
Device Name:
StarClose™ Vascular Closure System
Indications For Use:
The StarCloseTM Vascular Closure System is intended for use for use to The StarCloseIM Vascular Closure of actrieving hemostatic closure of puncture sites to
approximate vascular tissue for accidents and ander direct or endoscopic approximate vascular tissue for acineving nomestate became of endoscopic visualization.
Prescription Use (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)
ivision Sie - Off) Fivision of General, Restorative Nourological Devices
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§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.