(36 days)
Cook Flexor Shuttle (K142819)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guide sheath and dilator, with no mention of AI or ML technologies.
No.
Explanation: The device is intended to introduce therapeutic devices into the vasculature, rather than being a therapeutic device itself.
No
The device description clearly states its purpose is to "introduce therapeutic devices into the vasculature". Its design features like a hydrophilic coating, marker band, and dilator are all for facilitating the insertion and positioning of other therapeutic tools, not for diagnosing conditions.
No
The device description clearly details physical components such as a sheath, dilator, radiopaque marker band, hydrophilic coating, and a stopcock. The performance studies also focus on bench tests related to the physical properties and performance of these hardware components. There is no mention of software as a component or function of this device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "introducing therapeutic devices into the vasculature". This is a direct intervention within the body, not a test performed on samples taken from the body.
- Device Description: The description details a physical device designed for insertion into blood vessels (sheath, dilator, valve, stopcock). This is consistent with a surgical or interventional tool, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural – facilitating the delivery of other therapeutic devices.
N/A
Intended Use / Indications for Use
The Guide Sheath is intended to introduce therapeutic devices into the vasculature, excluding the coronary and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Surmodics Guide Sheath is designed to perform as a guide sheath and/or introducer sheath. The sheath is braid reinforced with an embedded radiopague marker band to identify the distal tip. It also has a hydrophilic coating over the working length to provide a lubricious surface to ease insertion. The device comes packaged with a dilator, which is either .018" or .035" guidewire compatible.
This highly flexible, braid reinforced sheath is designed to resist kinking and maximize strength while keeping a minimized profile. Incorporated in the sheath is a radiopaque marker band located approximately 5mm from the distal tip. The Guide Sheath has an atraumatic tip and has a hydrophilic coating over the working length.
The dilator hub is designed to snap into the Guide Sheath cross cut valve cap. Additionally, the dilator shaft design allows for simultaneous movement of the sheath and dilator assembly. The dilator features an atraumatic tip, which is designed to extend beyond the sheath tip by approximately 5 cm. The dilator shaft is radiopaque.
The Guide Sheath features a custom designed cross cut valve that is integrated into the sheath hub and includes a 3-way stopcock with sidearm extension tubing. No assembly is required.
The sheath is packaged in a dual sterile barrier configuration. The sheath and dilator will be placed individually in high density polyethylene (HDPE) coiled hoops, which are then placed in a poly-tyvek pouch within a shelf box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature, excluding the coronary and neuro 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)
Results of design verification testing demonstrate that the technological differences identified do not raise new questions of safety or effectiveness compared to the predicate device. The Guide Sheath is substantially equivalent to the predicate device based on intended use/indications for use and technological characteristics. The subject device has been evaluated through the following bench tests:
Sheath & Dilator
- Visual inspections
- Dimensional evaluations ●
- Radiopacity, F640 ●
- Tensile strength, ISO 11070:2014 .
- Tip tensile strength ●
- Liquid Leak Test, ISO 11070:2014 ●
- Hub/Luer Connector Compatibility, . ISO 594-1:1986 and ISO 594-2:1998
- Simulated use ●
- Kink Radius, BS EN 13868:2002
- . Tracking Forces
- Torque Strength ●
- Coating Length .
- . 3 Point Bend, ASTM F2606-8
- Coating Integrity ●
- Coating Coverage .
- . Vertical Pinch Test
- Removal Force ●
- Lamination ●
- Particulate, USP 788 ●
Packaging Testing
The following packaging tests were performed in accordance with ISO 11607-1:2016/(R)2010:
- Visual Inspection per ASTM F1886-09
- Seal Strength per ASTM F88M-15 ●
- Bubble Leak per ASTM F2096-11
- Environmental Monitoring per ISTA P2A (2011)
- Distribution Simulation per ASTM D4169-16 ●
- Shelf Life ●
Biocompatibility
The following biocompatibility tests were performed in accordance with ISO 10993-1:2009:
- Cytotoxicity
- Sensitization ●
- Irritation/Intracutaneous reactivity ●
- Acute Systemic toxicity ●
- Hemolysis
- Pyrogencity ●
- Thrombogenicity ●
- Unactivated Partial Thromboplastin Time (UPTT) ●
- Complement Activation ●
All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness. The Surmodics Guide Sheath is substantially equivalent to the predicate device.
Sterilization
The results of the sterilization product testing demonstrate that the Ethylene Oxide (EtO) sterilization method for the Guide Sheath meet the requirements of ISO 11135:2014, and that the sterility of the device will be maintained over the entirety of the shelf life.
No clinical data is being submitted for the Surmodics Guide Sheath.
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 Flexor Shuttle (K142819)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 18, 2019
Surmodics, Inc. Peggy Ju Regulatory Affairs Specialist 9924 West 74th Street Eden Prairie, MN 55344
Re: K190644
Trade/Device Name: Guide Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: March 12, 2019 Received: March 13, 2019
Dear Ms. Peggy Ju:
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 (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 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,
For
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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510(K) Summary - K190644
Image /page/3/Picture/3 description: The image shows the word "SURMODICS" in a sans-serif font. To the left of the word is a blue and green geometric shape. The blue part of the shape is on top, and the green part is on the bottom.
Date Prepared: 3/12/2019
Submitters Name / Contact Person
510k Submitter Address
Surmodics, Inc. 9924 W 74th St Eden Prairie MN 55344 Phone - (952) 500 -7000
Contact for Official/Routine Correspondence
Peggy Ju Regulatory Affair Associate 9924 W 74th St, Eden Prairie, MN 55344 Phone - (651) 319-3602 Fax - (763) 557-6674
| General Information | |
|---|---|
| Trade Name: | Guide Sheath |
| Common / Usual Name: | Catheter Introducer |
| Classification: | Class 2 per 21 CFR 870.1340 |
| Product Code: | DYB - Catheter Introducer |
| Predicate Device: | Cook Flexor Shuttle (K142819) |
Device Description
The Surmodics Guide Sheath is designed to perform as a guide sheath and/or introducer sheath. The sheath is braid reinforced with an embedded radiopague marker band to identify the distal tip. It also has a hydrophilic coating over the working length to provide a lubricious surface to ease insertion. The device comes packaged with a dilator, which is either .018" or .035" guidewire compatible.
This highly flexible, braid reinforced sheath is designed to resist kinking and maximize strength while keeping a minimized profile. Incorporated in the sheath is a radiopaque marker band located approximately 5mm from the distal tip. The Guide Sheath has an atraumatic tip and has a hydrophilic coating over the working length.
The dilator hub is designed to snap into the Guide Sheath cross cut valve cap. Additionally, the dilator shaft design allows for simultaneous movement of the sheath and dilator assembly. The dilator features an atraumatic tip, which is designed to extend beyond the sheath tip by approximately 5 cm. The dilator shaft is radiopaque.
The Guide Sheath features a custom designed cross cut valve that is integrated into the sheath hub and includes a 3-way stopcock with sidearm extension tubing. No assembly is required.
4
The sheath is packaged in a dual sterile barrier configuration. The sheath and dilator will be placed individually in high density polyethylene (HDPE) coiled hoops, which are then placed in a poly-tyvek pouch within a shelf box.
Indication for Use
The Guide Sheath is intended to introduce therapeutic devices into the vasculature, excluding the coronary and neuro vasculature.
Comparison of Technological Characteristics
The Surmodics Guide Sheath device is substantially similar to the legally marketed predicate device in design, intended use, principles of use, materials, sizes and sterility. The Surmodics Guide Sheath and the predicate device are intended for assisting with introduction of therapeutic devices into the peripheral anatomy. Both devices have similar dimensions and similar accessory compatibility. The devices are made from similar materials and both have a lubricious coating.
Substantial Equivalence and Summary of Studies
Results of design verification testing demonstrate that the technological differences identified do not raise new questions of safety or effectiveness compared to the predicate device. The Guide Sheath is substantially equivalent to the predicate device based on intended use/indications for use and technological characteristics. The subject device has been evaluated through the following bench tests:
Sheath & Dilator
- . Visual inspections
- Dimensional evaluations ●
- Radiopacity, F640 ●
- Tensile strength, ISO 11070:2014 .
- Tip tensile strength ●
- Liquid Leak Test, ISO 11070:2014 ●
- Hub/Luer Connector Compatibility, . ISO 594-1:1986 and ISO 594-2:1998
- Simulated use ●
- Kink Radius, BS EN 13868:2002
- . Tracking Forces
- Torque Strength ●
- Coating Length .
- . 3 Point Bend, ASTM F2606-8
- Coating Integrity ●
- Coating Coverage .
- . Vertical Pinch Test
- Removal Force ●
- Lamination ●
- Particulate, USP 788 ●
Packaging Testing
The following packaging tests were performed in accordance with ISO 11607-1:2016/(R)2010:
- Visual Inspection per ASTM F1886-09
- Seal Strength per ASTM F88M-15 ●
- Bubble Leak per ASTM F2096-11
- Environmental Monitoring per ISTA P2A (2011)
- Distribution Simulation per ASTM D4169-16 ●
- Shelf Life ●
5
Biocompatibility
The following biocompatibility tests were performed in accordance with ISO 10993-1:2009:
- Cytotoxicity
- Sensitization ●
- Irritation/Intracutaneous reactivity ●
- Acute Systemic toxicity ●
- Hemolysis
- Pyrogencity ●
- Thrombogenicity ●
- Unactivated Partial Thromboplastin Time (UPTT) ●
- Complement Activation ●
All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness. The Surmodics Guide Sheath is substantially equivalent to the predicate device.
Sterilization
The results of the sterilization product testing demonstrate that the Ethylene Oxide (EtO) sterilization method for the Guide Sheath meet the requirements of ISO 11135:2014, and that the sterility of the device will be maintained over the entirety of the shelf life.
Clinical Data
No clinical data is being submitted for the Surmodics Guide Sheath.
Conclusions
Based upon the device description, indications for use, technological characteristics & performance data it can be concluded that the Guide Sheath is substantially equivalent to the predicate device and is appropriate for the intended use.