(192 days)
Not Found
No
The 510(k) summary describes a mechanical introducer sheath system and does not mention any AI or ML components, image processing, or data-driven performance metrics.
No.
The device is used for the introduction of interventional and diagnostic devices, not for therapeutic purposes itself.
No
The device is an introducer sheath system used to introduce other devices into the vasculature. Its intended use explicitly states it is for the "introduction of interventional and diagnostic devices," not for performing diagnosis itself.
No
The device description clearly outlines physical components (coil reinforced shaft, hemostasis valve, dilator) and performance studies focus on mechanical testing, biocompatibility, and sterilization, indicating a hardware-based device. There is no mention of software as the primary component or function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature." This describes a device used within the body for access, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a physical sheath, valve, and dilator, which are components of a device used for vascular access, not for performing in vitro tests.
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample analysis, or any other characteristics typically associated with IVD devices.
This device is a medical device used for interventional and diagnostic procedures within the body.
N/A
Intended Use / Indications for Use
The DuraSheath Introducer Sheath System is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The device is also intended to be used within a pediatric population.
Product codes (comma separated list FDA assigned to the subject device)
DYB, DRE
Device Description
The DuraSheath Introducer Sheath System is a sterile, disposable device consisting of (a) a coil reinforced shaft with an atraumatic tip at the distal end; (b) a hemostasis valve with a side port and color coded 3-way stopcock; and (c) a tapered tip dilator with snap-fit hub at the proximal end.
(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 polyurethane 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 part of the outer layer for increased lubricity in this area. The coating coverage depends on the model. 15 cm product versions have 10 cm portion of the shaft coated, while 45 cm, 60 cm and 90 cm product versions have 15 cm portion of the shaft coated. 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 TPE 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 about 2 cm 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 the hemostasis valve are pre-assembled and packaged together with one or two dilators (depending on the model), that is sealed inside a 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 device has a shelf life of three years.
The DuraSheath Introducer Sheath System 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 contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2018
Contract Medical International GmbH Jan Kloboucnik Director, Regulatory and Quality Affairs Lauensteiner Str. 37 Dresden. 01277 De
Re: K181463
Trade/Device Name: DuraSheath Introducer Sheath System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB, DRE Dated: November 7, 2018 Received: November 9, 2018
Dear Jan 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. 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 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Nicole M. Goodsell -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=2001567081,
cn=Nicole M. Goodsell -S
Date: 2018.12.13 09:10:57 -05'00'
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181463
Device Name DuraSheath Introducer Sheath System
Indications for Use (Describe)
The DuraSheath Introducer Sheath System is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The device is also intended to be used within a pediation.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary (K181463)
I. SUBMITTER
| Submitter: | Contract Medical International GmbH | |
|---|---|---|
| Lauensteiner Straße 37 | ||
| 01277 Dresden | ||
| Germany | ||
| Contact Person: | Jan Kloboucnik, Director RA/QA | |
| Phone: | +420 494 949 564 | |
| Fax: | +49 351 213 88 99 | |
| Email: | jkloboucnik@contract-medical.com | |
| Date Prepared: | 13 Dec 2018 |
II. DEVICE
| Device Trade Name: | DuraSheath Introducer Sheath System |
|---|---|
| Device Common Name: | Introducer Sheath |
| Classification Name: | Introducer, Catheter; and |
| Dilator, Vessel, For Percutaneous Catheterization | |
| Regulatory Class: | II |
| Product Code: | DYB; and |
| DRE |
III. PREDICATE DEVICE
Primary Predicate Device: DuraSheath Introducer Sheath System (K142357)
Secondary Predicate Device: Pinnacle Destination Guiding Sheath (K091329)
IV. DEVICE DESCRIPTION
The DuraSheath Introducer Sheath System is a sterile, disposable device consisting of (a) a coil reinforced shaft with an atraumatic tip at the distal end; (b) a hemostasis valve with a side port and color coded 3-way stopcock; and (c) a tapered tip dilator with snap-fit hub at the proximal end.
- (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
4
polyurethane 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 part of the outer layer for increased lubricity in this area. The coating coverage depends on the model. 15 cm product versions have 10 cm portion of the shaft coated, while 45 cm, 60 cm and 90 cm product versions have 15 cm portion of the shaft coated. 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 TPE 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 about 2 cm 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 the hemostasis valve are pre-assembled and packaged together with one or two dilators (depending on the model), that is sealed inside a 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 device has a shelf life of three years.
The DuraSheath Introducer Sheath System 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 Biocompatibility testing
Cytotoxicity test
Thromboresistance
Complement activation
Hemolysis
Pyrogenity
Acute Systemic Toxicity
Irritation
Sensitization | External Laboratory | ISO 10993-1:2009
ISO 10993-4:2017
ISO 10993-5:2009
ISO 10993-10:2010
ISO 10993-11:2017
ISO 10993-12:2012 |
| 19 | Biological Risk Assessment | Documented assessment | ISO 10993-1:2009
EN ISO 14971:2012
FDA Guidance Use of
International Standard ISO
10993-1 |
| 20 | Testing assessment 15cm | Documented assessment | Internal assessment |
| 21 | Usability evaluation | Usability Study | IEC 62366-1 |
List of Tests
9
10
The device is cleared for use in Europe (CE certification no.2017847CE05). Feedback recorded from 16 clinical cases performed in 7 centers in Germany in April and May 2014 demonstrated that the subject device performs comparably with the secondary predicate and other legally marked devices and is safe and effective. The performance is identical with the primary predicate. No clinical testing is being submitted to support review of this 510(k) premarket notification.
VIII. CONCLUSIONS
Results demonstrate that the DuraSheath Introducer Sheath System performs identically with the primary predicate, comparably with the second predicate and other legally marketed devices, and is safe and effective. The DuraSheath Introducer Sheath System is substantially equivalent to the two predicates devices in terms of intended use, design and materials, technological characteristics, and principle of operation. Any differences between the subject device and the predicates do not raise any issues of safety or effectiveness.