(25 days)
Not Found
No
The device description and performance studies focus on mechanical, biocompatibility, and sterilization aspects of a physical introducer sheath system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an introducer sheath system intended to provide access and facilitate the introduction of other devices during diagnostic and interventional procedures, rather than directly treating a disease or condition.
No
Explanation: The device is an introducer sheath system "intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices" into arteries. While it is used "during diagnostic and interventional procedures," its function is to facilitate access for other devices, not to diagnose on its own.
No
The device description clearly outlines physical components like a sheath, dilator, valves, and tubing, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Fortress Introducer Sheath System is a medical device used to facilitate the introduction of other devices into blood vessels during diagnostic and interventional procedures. It is a tool used in the body, not for testing samples from the body.
- Intended Use: The intended use clearly states it's for providing access and facilitating the introduction of devices into arteries. This is a procedural function, not a diagnostic test performed on a specimen.
The description and intended use clearly indicate this is an invasive medical device used for accessing the vascular system, not for performing diagnostic tests on biological samples.
N/A
Intended Use / 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 arteries while maintaining hemostasis during diagnostic and interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
DYB, DRE
Device Description
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 color coded 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 introducer sheath has a hydrophobic silicone coating on the outer surface of the distal 30cm portion.
The System consists of the following components:
- A One Introducer Sheath (a) with hemostasis valve (b)
- A One dilator (c)
(a) Shaft. The coil reinforced multi-layer polymer shaft contains a tapered tip at the distal end. A continuous inner PTFE tube forms the core of the shaft and provides a circular working lumen through which devices can be passed. A single, full length polyether (Pebax) tube creates the outer cover of the shaft. A stainless-steel flat wire coil is fused between the two polymer tubes along the entire length of the shaft. Hydrophobic coating is applied along the distal 30cm of the outer layer for increased lubricity in this area. A radiopaque marker made of platinum iridium is embedded at the distal end of the shaft. At the proximal end of the shaft, a female, winged luer hub is over-molded onto the shaft to support handling and to provide for the connection for the hemostasis valve. The hub is color coded to match the French size of the device.
(b) Hemostasis valve. A removable hemostasis valve is thread onto the luer hub at the proximal end of the shaft. Inside the valve housing, a lubricated, silicone slit disc provides a seal around devices passed through the sheath, thereby preventing blood leakage through the valve. Just distal of the valve, the valve housing is connected to a side port tube leading to three-way stopcock valve. The side port is used for flushing the introducer sheath. At the proximal end of the valve housing, the color-coded housing cap provides a snap fit connection to the hub of the dilator.
(c) Dilator. The dilator made of Pebax contains a full length round lumen to allow placement over a guide wire. The distal end of the dilator is configured as a tapered tip that extends 35+/-7mm beyond the end of the sheath when the dilator is fully inserted through the sheath. An integral, color coded luer hub that is over-molded onto the proximal end of the dilator supports handling of the dilator and provides a snap fit connection to the valve housing cap at the proximal end of the sheath introducer.
The shaft and hemostasis valve are pre-assembled and packaged together with a dilator. Each shaft and each dilator are placed in a separate protection tube, the protection tubes are clamped together with clips. Products are sealed inside an inner and outer medical grade Tyvek pouch on which a product label is placed. Devices are packaged in labeled packers containing five units and one Instruction for Use (IFU) booklet.
The Fortress Introducer Sheath System is a sterile, disposable device. It is a prescription medical device that is used only in healthcare facilities or hospitals. The device is placed in patients for up to 24 hours.
Devices are sterilized using ethylene oxide (maximum levels of remaining tested sterilant residuals of EO
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 20, 2020
Contract Medical International, GmbH Marketa Shanelova Regulatory Manager Lauensteiner Strasse 37 Dresden, Saxony 01277 Germany
Re: K203179
Trade/Device Name: Fortress Introducer Sheath System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, DRE Dated: October 23, 2020 Received: October 26, 2020
Dear Marketa Shanelova:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH and -Learn (https://www.fda.gov/training-and-continuing-education/odrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203179
Device Name Fortress Introducer Sheath System
Indications for Use (Describe)
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 arteries while maintaining hemostasis during diagnostic and interventional procedures.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY 2
2.1 Submitter
| Submitter: | Contract Medical GmbH | |
|---|---|---|
| Lauensteiner Strasse 37 | ||
| 01277 Dresden | ||
| Germany | ||
| Contact Person: | Marketa Shanelova, Regulatory Manager | |
| Phone: | +420 494 949 586 | |
| Email: | marketa.shanelova@heraeus.com | |
| Date Summary Prepared: | 23 October 2020 |
2.2 Device Device Trade Name: Fortress Introducer Sheath System Device Common Name: Introducer Sheath Classification Name: Introducer Catheter, and Dilator, Vessel, For Percutaneous Catheterization Device Class: . Product Code: DYB, and DRE
2.3 Predicate Device
The predicate device is the 6F size of the Fortress Introducer Sheath System (K153197)
2.4 Device Description
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 color coded 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 introducer sheath has a hydrophobic silicone coating on the outer surface of the distal 30cm portion.
The System consists of the following components:
- A One Introducer Sheath (a) with hemostasis valve (b)
- A One dilator (c)
(a) Shaft. The coil reinforced multi-layer polymer shaft contains a tapered tip at the distal end. A continuous inner PTFE tube forms the core of the shaft and provides a circular working lumen through which devices can be passed. A single, full length polyether (Pebax) tube creates the outer cover of the shaft. A stainless-steel flat wire coil is fused between the two polymer tubes along the entire
4
length of the shaft. Hydrophobic coating is applied along the distal 30cm of the outer layer for increased lubricity in this area. A radiopaque marker made of platinum iridium is embedded at the distal end of the shaft. At the proximal end of the shaft, a female, winged luer hub is over-molded onto the shaft to support handling and to provide for the connection for the hemostasis valve. The hub is color coded to match the French size of the device.
(b) Hemostasis valve. A removable hemostasis valve is thread onto the luer hub at the proximal end of the shaft. Inside the valve housing, a lubricated, silicone slit disc provides a seal around devices passed through the sheath, thereby preventing blood leakage through the valve. Just distal of the valve, the valve housing is connected to a side port tube leading to three-way stopcock valve. The side port is used for flushing the introducer sheath. At the proximal end of the valve housing, the color-coded housing cap provides a snap fit connection to the hub of the dilator.
(c) Dilator. The dilator made of Pebax contains a full length round lumen to allow placement over a guide wire. The distal end of the dilator is configured as a tapered tip that extends 35+/-7mm beyond the end of the sheath when the dilator is fully inserted through the sheath. An integral, color coded luer hub that is over-molded onto the proximal end of the dilator supports handling of the dilator and provides a snap fit connection to the valve housing cap at the proximal end of the sheath introducer.
The shaft and hemostasis valve are pre-assembled and packaged together with a dilator. Each shaft and each dilator are placed in a separate protection tube, the protection tubes are clamped together with clips. Products are sealed inside an inner and outer medical grade Tyvek pouch on which a product label is placed. Devices are packaged in labeled packers containing five units and one Instruction for Use (IFU) booklet.
The Fortress Introducer Sheath System is a sterile, disposable device. It is a prescription medical device that is used only in healthcare facilities or hospitals. The device is placed in patients for up to 24 hours.
Devices are sterilized using ethylene oxide (maximum levels of remaining tested sterilant residuals of EO