(121 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a catheter sheath and dilator, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is an introducer sheath designed to provide a conduit for inserting other diagnostic or endovascular devices, not to provide therapy itself.
No
Explanation: The device description clearly states that the Sentrant Introducer Sheath is intended to "provide a conduit for the insertion of diagnostic or endovascular devices" and "minimize blood loss." It does not perform any diagnostic function itself. It acts as an access tool for other devices, some of which may be diagnostic.
No
The device description clearly outlines physical components like a catheter, dilator, sheath, and valves, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and minimize blood loss associated with such insertions." This describes a device used during a medical procedure to facilitate the delivery of other devices, not a device used to perform a diagnostic test on a sample taken from the body.
- Device Description: The description details a physical catheter, dilator, and associated components designed for insertion into blood vessels. It does not mention any reagents, assays, or components used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, which is the core function of an IVD. The device's purpose is mechanical and procedural.
Therefore, the Sentrant Introducer Sheath with Hydrophilic Coating is a medical device used in interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sentrant Introducer Sheath with Hydrophilic Coating is intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and minimize blood loss associated with such insertions.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Sentrant Sheath is a single-use, disposable, hydrophilic-coated catheter designed to provide a flexible and hemostatic conduit for the insertion of endovascular devices and to minimize blood loss associated with vascular procedures. The system is comprised of a dilator and an introducer sheath. The system accommodates a 0.035 in (0.89 mm) guidewire and is available in 28 and 64 cm lengths and in sizes from 12 to 26 Fr in 2 French increments.
The dilator is radiopaque and has a tapered, flexible tip that facilitates atraumatic tracking through the vasculature. A female luer taper fitting is located on the distal end of the dilator grip. The proximal end of the dilator grip is threaded to allow the dilator to be secured to the sheath seal housing.
The introducer sheath is comprised of a hydrophilic, coil-reinforced catheter that is attached to a rigid seal housing containing the hemostatic valve assembly. A sideport extension with a 3way valve is attached to the seal housing. A radiopaque markerband is located at the distal tip of the sheath. The device also has a suture loop for attaching it to the patient and a strain relief to minimize kinking of the catheter where it joins to the seal housing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing Performance Data:
The Sentrant Sheath was tested through a series of physical, mechanical and bench tests, listed below, to evaluate its performance and verify that it meets the required performance specifications. All of the predetermined acceptance criteria were met and results passed.
- OD of Sheath Tubing ●
- OD of Dilator .
- . Sheath Working Length
- . Dilator Working Length
- . Hydrophilic Coating Length .
- . Guidewire Acceptance
- . Grip to Dilator Tensile Strength
- . Seal Housing to Sheath Tubing Tensile Test
- Seal Cap to Seal Housing Tensile Strength
- . Atraumatic Tip (A-Tip) Lamination Tensile Strength
- Sideport Torque Test ●
- . Leak Test
- Kink Test .
- . Test for Liquid Leakage Under Pressure
Biocompatibility Testing:
The following Biocompatibility testing was performed on the Sentrant Sheath per the requirements of ISO10993-1. All of the predetermined acceptance criteria were met and results passed.
- . ISO MEM Elution, Cytotoxicity
- ISO Maximization Sensitization .
- . ISO Intracutaneous Reactivity
- ISO Acute Systemic Toxicity .
- . USP Material Mediated Pyrogen
- . ASTM In-vitro Hemolysis
- Complement Activation C3a and SC5b-9 .
- ASTM Partial Thromboplastin Time .
- . In-vivo Thromboresistance
- Inductively Coupled Plasma Spectroscopy .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cook Extra Large Check-Flo® Introducer (K902469), GORE Dry Seal Sheath (K093791)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
510(k) Summary Page 1 of 3 +
510(k) Summary – K123990
| Submitter: | Medtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
(707) 591-2091
(707) 566-1432 | APR 26 2013 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Kelley Lamke
Regulatory Affairs Specialist
3576 Unocal Place
Santa Rosa, CA 95403
(707) 543-5043
(707) 566-1245
kelley.lamke@medtronic.com | |
| Date Prepared: | December 21, 2012 | |
| Device Trade Name: | Sentrant Introducer Sheath with Hydrophilic
Coating | |
| Device Classification: | Class II | |
| Classification Name: | Catheter Introducer | |
| Regulation Number: | 21 CFR 870.1340 | |
| Classification Product Code: | DYB | |
| Classification Panel: | Cardiovascular | |
| Predicate Devices: | Cook Extra Large Check-Flo® Introducer (K902469)
GORE Dry Seal Sheath (K093791) | |
1
Device Description:
The Sentrant Sheath is a single-use, disposable, hydrophilic-coated catheter designed to provide a flexible and hemostatic conduit for the insertion of endovascular devices and to minimize blood loss associated with vascular procedures. The system is comprised of a dilator and an introducer sheath. The system accommodates a 0.035 in (0.89 mm) guidewire and is available in 28 and 64 cm lengths and in sizes from 12 to 26 Fr in 2 French increments.
The dilator is radiopaque and has a tapered, flexible tip that facilitates atraumatic tracking through the vasculature. A female luer taper fitting is located on the distal end of the dilator grip. The proximal end of the dilator grip is threaded to allow the dilator to be secured to the sheath seal housing.
The introducer sheath is comprised of a hydrophilic, coil-reinforced catheter that is attached to a rigid seal housing containing the hemostatic valve assembly. A sideport extension with a 3way valve is attached to the seal housing. A radiopaque markerband is located at the distal tip of the sheath. The device also has a suture loop for attaching it to the patient and a strain relief to minimize kinking of the catheter where it joins to the seal housing.
Statement of Intended Use:
The Sentrant Introducer Sheath with Hydrophilic Coating is intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and minimize blood loss associated with such insertions.
Substantial Equivalence:
The documentation provided includes mechanical test results that demonstrate the Sentrant Sheath is substantially equivalent to the Cook Extra Large Check-Flo Introducer (K902469) and the GORE Dry Seal Sheath (K093791).
Bench Testing Performance Data:
The Sentrant Sheath was tested through a series of physical, mechanical and bench tests, listed below, to evaluate its performance and verify that it meets the required performance specifications. All of the predetermined acceptance criteria were met and results passed.
- OD of Sheath Tubing ●
- OD of Dilator .
- . Sheath Working Length
- . Dilator Working Length
- . Hydrophilic Coating Length .
- . Guidewire Acceptance
- . Grip to Dilator Tensile Strength
- . Seal Housing to Sheath Tubing Tensile Test
- Seal Cap to Seal Housing Tensile Strength
- . Atraumatic Tip (A-Tip) Lamination Tensile Strength
- Sideport Torque Test ●
- . Leak Test
- Kink Test .
- . Test for Liquid Leakage Under Pressure
Medtronic Vascular Sentrant Introducer Sheath with Hydrophilic Coating K123990 Traditional 510(k) Submission
2
510(k) Summary K123990, Page 3 of 3
Biocompatibility Testing:
The following Biocompatibility testing was performed on the Sentrant Sheath per the requirements of ISO10993-1. All of the predetermined acceptance criteria were met and results passed.
- . ISO MEM Elution, Cytotoxicity
- ISO Maximization Sensitization .
- . ISO Intracutaneous Reactivity
- ISO Acute Systemic Toxicity .
- . USP Material Mediated Pyrogen
- . ASTM In-vitro Hemolysis
- Complement Activation C3a and SC5b-9 .
- ASTM Partial Thromboplastin Time .
- . In-vivo Thromboresistance
- Inductively Coupled Plasma Spectroscopy .
Conclusion:
The Sentrant Introducer Sheath is substantially equivalent in intended use, technological characteristics and performance of the predicate introducer catheters, the Cook Extra Large Check-Flo® Introducer (K902469) and the GORE DrySeal Sheath (K093791).
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2013
Medtronic Vascular C/O Kelley Lamke, Regulatory Affairs Specialist 3576 Unocal Place Santa Rosa, CA 95403
Re: K123990
Trade/Device Name: Sentrant Introducer Sheath with Hydrophilic Coating Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: March 12, 2013 Received: March 13, 2013
Dear Ms. Kelley Lamke:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth 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.
4
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours,
Matthew G Hillebrenner
Bra
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K123990
Device Name: Sentrant Introducer Sheath with Hydrophilic Coating
Indications for Use:
The Sentrant Introducer Sheath with Hydrophilic Coating is intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and minimize blood loss associated with such insertions.
Prescription Use X
(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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Matthew G퀘咖lebrenner
Page 1 of 1
Medtronic Vascular Sentrant Introducer Sheath K123990 Traditional 510(k)