(340 days)
The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while while maintaining hemostasis during diagnostic and interventional procedures.
The Fortress Introducer Sheath System consists of an introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and Luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic 3-way stopcock valve. The side port is used for flushing the introducer sheath. The introducer sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The Fortress Introducer Sheath System consists of the following components: - One: introducer sheath - Two: dilators
The provided text is a 510(k) summary for the Fortress Introducer Sheath System. It focuses on establishing substantial equivalence to predicate devices and does not detail specific acceptance criteria or a study proving its performance against such criteria in the way described in the request. The document describes the device, its intended use, and its technological characteristics but lacks information related to clinical performance studies, ground truth establishment, or expert evaluation for decision-making regarding device efficacy.
Therefore, for each requested point:
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A table of acceptance criteria and the reported device performance
- Not provided. The document does not list specific performance acceptance criteria or report performance against them. It relies on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and technological characteristics.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. No information about a specific test set, its sample size, or data provenance is mentioned as this is not a clinical study report.
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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/Not provided. Since no specific test set requiring ground truth establishment is described, this information is not present.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. There is no mention of an adjudication process for a test set.
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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/Not provided. This device is an introducer sheath system, a physical medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is irrelevant and not mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. As stated above, this is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No clinical ground truth is established or discussed in this document. The "ground truth" for this 510(k) submission is the pre-existing safety and effectiveness profile of the predicate devices.
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The sample size for the training set
- Not applicable/Not provided. This is not an AI or machine learning device, so there is no concept of a training set.
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How the ground truth for the training set was established
- Not applicable/Not provided. As there is no training set, this information is not relevant or present.
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SECTION 1. 510(K) SUMMARY
| Submission Owner / Correspondent: | Jan KloboucnikDirector, RA/QAContract Medical, GmbHZur Wetterwarte 5001109 Dresden, Germany | FEB 25 2011 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Phone: +420 494949564 .Fax: +420 494949565Email: jkloboucnik@contract-medical.comContact: Jan Kloboucnik | ||||||||||
| Device Manufacturer | Contract Medical Intl. GmbHZur Wetterwarte 50House 302Dresden, GERMANY 01109Registration Number: 3003637635 | |||||||||
| Date summary prepared: | December 22, 2010 (supersedes original summary from March 18, 2010) | |||||||||
| Device trade name: | Fortress Introducer Sheath System | |||||||||
| Device common name: | Introducer Sheath | |||||||||
| Device classification name: | Catheter IntroducerDYB, Class II per 21 CFR 870.1340, andDilator, Vessel, For Percutaneous CatheterizationDRE, class II at 21 CFR Part 870.1310 | |||||||||
| Legally marketed device to which the device is substantially equivalent: | ManufacturerDevice Name510(k) NumberMerit Medical Systems, Inc.Prelude and Prelude Pro Sheath IntroducersK073035Terumo Medical CorporationPinnacle Destination Peripheral Guiding SheathsK091329 | Manufacturer | Device Name | 510(k) Number | Merit Medical Systems, Inc. | Prelude and Prelude Pro Sheath Introducers | K073035 | Terumo Medical Corporation | Pinnacle Destination Peripheral Guiding Sheaths | K091329 |
| Manufacturer | Device Name | 510(k) Number | ||||||||
| Merit Medical Systems, Inc. | Prelude and Prelude Pro Sheath Introducers | K073035 | ||||||||
| Terumo Medical Corporation | Pinnacle Destination Peripheral Guiding Sheaths | K091329 | ||||||||
| Description of the device: | The Fortress Introducer Sheath System consists of an introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and Luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic 3-way stopcock valve. The side port is used for flushing the introducer sheath. The introducer sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The Fortress Introducer Sheath System consists of the following components:- One: introducer sheath- Two: dilators |
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Intended use of the device: The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while while maintaining hemostasis during diagnostic and interventional procedures. The device is designed to facilitate easier access to the femoral, popliteal and infrapopliteal arteries by means of the crossover approach, which would otherwise be difficult or impossible to access by conventional means, as exemplified in patients with damaged, occluded or blocked vessels. The Fortress Introducer Sheath System is intended to be used by physicians trained in performing arterial catheterizations, primarily in hospital environment. Technological The proposed device has the same technological characteristics characteristics: as the predicate devices. Conclusions: The results of the comparison of design, materials, intended use and technological characteristics demonstrate that the device is as substantially equivalent to the legally marketed predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Contract Medical GmbH c/o Ms. Jan Kloboucnik Director, RA/OA Zur Wetterwarte 50 01109 Dresden, Germany
FEB 2 5 231
Re: K100799
Trade/Device Name: Fortress Introducer Sheath System Model 358813, 358814 and 358815 Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: December 22, 2010 Received: December 29, 2010
Dear Ms. Kloboucnik:
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 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 - Ms. Jan Kloboucnik
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 (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.
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/CDRH0ffices/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Tom Brake M.P.
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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SECTION 4. INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K100799 |
|---|---|
| Device Name: | Fortress Introducer Sheath System |
| Indications for Use: | The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while while maintaining hemostasis during diagnostic and interventional procedures |
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.S.
scular Devices
510(k) number K10074
§ 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).