(150 days)
The SelectFlex 072 Neurovascular Access System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
The SelectFlex 072 Neurovascular Access System is a sterile, single-use intravascular catheter used to facilitate access target vasculature during interventional procedures. The system is composed of a the SelectFlex 072 Catheter, a 3cc Inflation Syringe, and a 7Fr Peel Away Introducer. The 072 SelectFlex Catheter has a usable length of 105cm. The SelectFlex 072 Catheter has variable stiffness along its length and has a dual mode stiffness mechanism on the distal portion of the catheter that is activated by the user allowing the device to transition between tracking and support modes. The distal end of the SelectFlex 072 Catheter has a hydrophilic coating.
This document, a 510(k) summary for the SelectFlex 072 Neurovascular Access System, describes various performance tests conducted to demonstrate the device's suitability for its intended use, rather than a clinical study evaluating an AI algorithm's performance.
Therefore, many of the requested fields regarding AI algorithm evaluation are not applicable (N/A) in this context. The document focuses on demonstrating substantial equivalence to a predicate device through physical and biological performance testing.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for each test in a table, but rather indicates that all samples "met the pre-determined acceptance criteria" or "passed" the tests. The acceptance criteria are implicitly defined by the referenced ISO/ASTM standards and internal product specifications.
| Test Description | Test Method | Reported Device Performance |
|---|---|---|
| Packaging Integrity (sterile barrier) | Tested per ISO 11607-1 and -2 | PASS All samples met the pre-determined acceptance criteria |
| Visual Surface Requirements | Visual inspection of catheter surfaces | PASS All samples met the pre-determined acceptance criteria |
| Dimensional Verification | Device dimensions were measured to confirm conformance to the product specification | PASS All samples met the pre-determined acceptance criteria |
| Liquid Leakage Under Pressure | Tested per ISO 10555-1:2013 Annex C | PASS All samples met the pre-determined acceptance criteria |
| Hub Aspiration Air Leakage | Tested per ISO 10555-1 2013 for Hub Aspiration Air Leakage | PASS All samples met the pre-determined acceptance criteria |
| Simulated Use/Usability | Evaluated in a challenging neurovascular model, including usability assessment | PASS All samples met the pre-determined acceptance criteria |
| Flex Fatigue | Tested per ISO 10555-1: 2013 for Flexural Fatigue | PASS All samples met the pre-determined acceptance criteria |
| Tip Deflection | Evaluated and compared to the predicate device | PASS All samples met the pre-determined acceptance criteria |
| Inflation Fatigue | Tested per ISO 10555-1: 2013 for Inflation Fatigue - 20 inflation cycles | PASS All samples met the pre-determined acceptance criteria |
| Burst Volume | Tested per ISO 10555-1: 2013 for Inflation Fatigue - tested to 2x inflation volume | PASS All samples met the pre-determined acceptance criteria |
| Torque Test | Tested per ISO 10555-1: 2013 for Torque Testing | PASS All samples met the pre-determined acceptance criteria |
| Flow Rate | Tested per ISO 10555-1: 2013 for Flow rate compared to the predicate device | PASS All samples met the pre-determined acceptance criteria |
| ISO 594-2: Conical Luer Fittings | Tested per ISO 594-2 for Conical Fittings | PASS All samples met the pre-determined acceptance criteria |
| Corrosion Resistance | Tested per ISO 10555-1 Annex A for corrosion resistance | PASS All samples met the pre-determined acceptance criteria |
| Particulate Count | Effluent tested per AAMI TIR42, USP 788 using multiple insertion and withdrawal cycles | PASS All samples met the pre-determined acceptance criteria |
| Coating Integrity, Lubricity, Durability | Tested in consideration of FDA CTQ for Hydrophilic Coated vascular catheters | PASS All samples met the pre-determined acceptance criteria |
| Peak Tensile Testing | Tested per ISO 10555-1 for tensile strength including all bonds/joints | PASS All samples met the pre-determined acceptance criteria |
| Device Removal in Support and Tracking Modes | Removal force in both modes compared to a reference device | PASS All samples met the pre-determined acceptance criteria |
| Radiopacity | Evaluated during simulated use testing confirming visualization under fluoroscopy | PASS All samples met the pre-determined acceptance criteria |
| Bacterial Endotoxin | Tested in accordance with USP 40, NF 35, 2017. <85> Bacterial Endotoxins Test | PASS All samples met the pre-determined acceptance criteria |
| Shelf Life | Accelerated aging studies | PASS All samples met the pre-determined acceptance criteria |
| Biocompatibility Testing | ||
| Cytotoxicity | Tested in accordance with ISO 10993-5 (Neutral Red Uptake Method) | Pass Noncytotoxic according to predetermined acceptance criteria |
| Intracutaneous Irritation | Tested in accordance with ISO 10993-10 | Pass Test requirements for intracutaneous reactivity were met |
| Sensitization | Tested in accordance with ISO 10993-10 (Kligman Maximization Test) | Pass Did not elicit a sensitization response |
| Systemic Toxicity | Tested in accordance with ISO 10993-11 | Pass Test requirements for systemic toxicity were met |
| Material Mediated Pyrogenicity | Tested in accordance with ISO 10993-11 and USP 40 <151> Pyrogen Test | Pass Nonpyrogenic, met the predetermined acceptance criteria |
| Hemolysis | Tested in accordance with ASTM F756-17 and ISO 10993-4 | Pass Non-hemolytic, met the predetermined acceptance criteria |
| In Vitro Hemocompatibility | Tested in accordance with ISO 10993-4 (Direct Contact Method) | Pass Not expected to result in adverse effects in vivo |
| Complement Activation | Tested in accordance with ISO 10993-4 (SC5b-9 Complement Activation) | Pass Does not activate the complement system |
| Un-activated Partial Thromboplastin Time | Tested in accordance with ISO 10994-4 and ASTM F2382-04 | Pass Does not affect coagulation of human plasma |
| Thrombogenicity | Tested in accordance with ISO 10994-4 | Pass Demonstrates similar thromboresistance characteristics as the control device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each individual performance test (e.g., how many catheters were tested for flex fatigue). It generally states "All samples met the pre-determined acceptance criteria," implying that a sufficient number of samples were tested per the relevant standards.
- Sample Size for Test Set: Not explicitly stated for each test, but implied to be adequate for standard compliance.
- Data Provenance: Not specified. This typically refers to data like patient images or clinical records, which are not relevant to these engineering and biocompatibility tests. The tests themselves are laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: For the "Simulated Use/Usability" test, it states "a usability assessment with multiple physicians." The exact number or qualifications are not provided beyond "physicians."
- Qualifications of Experts: "Multiple physicians" for usability assessment. For other tests, "ground truth" is established by adherence to recognized international standards (e.g., ISO, ASTM, USP) and internal product specifications, carried out by qualified testing personnel, but not "experts" in the sense of clinical specialists interpreting results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving interpretation of data by multiple readers. The assessment of performance tests is based on objective measurements against pre-defined criteria in laboratory settings.
5. 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. This document pertains to the performance and safety testing of a neurovascular access system, not an AI or imaging diagnostic device. No AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the performance and biocompatibility tests, the "ground truth" is established by:
- Compliance with international standards: ISO, ASTM, AAMI, USP.
- Adherence to internal product specifications: Dimensional verification.
- Comparison to predicate/reference devices: For tip deflection, flow rate, and device removal forces.
- Usability assessment: By "multiple physicians" in a simulated environment.
No pathology or outcomes data are referenced as this is a pre-market notification for a device and not a clinical trial.
8. The sample size for the training set
Not applicable. This is not an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI training set.
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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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
September 13, 2018
Q'Apel Medical LLC % Michele Lucey President Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, New Hampshire 03255
Re: K181000
Trade/Device Name: SelectFlex 072 Neurovascular Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: August 10, 2018 Received: August 15, 2018
Dear Michele Lucey:
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
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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 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 mediation-emitting products, including information about labeling regulations, please see Device (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.
Xiaolin Zheng -S
- for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181000
Device Name
SelectFlex 072 Neurovascular Access System
Indications for Use (Describe)
The SelectFlex 072 Neurovascular Access System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K181000 510(K) SUMMARY As required by 21 CFR 807.92
Submitter Information:
| Submitter's Name: | Q'Apel Medical LLC |
|---|---|
| Address: | 330 Wilshire BoulevardSanta Monica CA 90401 |
| Telephone: | 310-395-3950 |
| Fax: | 310-395-3950 |
| Contact Person: | Michele Lucey |
| Telephone: | 603-748-1374 |
| Date Prepared: | September 12, 2018 |
| Device Trade Name: | SelectFlex 072 Neurovascular Access System |
| Classification: | Class II |
| Product Code(s): | DQY |
| Regulation Number(s): | 870.1250 |
| Predicate Devices: | Penumbra Benchmark Intracranial Access System, (K142321) |
| Reference Devices: | Depuy Synthes Envoy Guiding Catheter STR (K965247, K982770)Depuy Synthes Envoy XB (Extra Backup Support) Guiding Cathete(K140307)Cook Flexor® = Shuttle Guiding Sheath (K142819) |
Indication for Use:
The SelectFlex 072 Neurovascular Access System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
Device Description
The SelectFlex 072 Neurovascular Access System is a sterile, single-use intravascular catheter used to facilitate access target vasculature during interventional procedures. The system is composed of a the SelectFlex 072 Catheter, a 3cc Inflation Syringe, and a 7Fr Peel Away Introducer. The 072 SelectFlex Catheter has a usable length of 105cm. The SelectFlex 072 Catheter has variable stiffness along its length and has a dual mode stiffness mechanism on the distal portion of the catheter that is activated by the user allowing the device to transition between tracking and support modes. The distal end of the SelectFlex 072 Catheter has a hydrophilic coating.
Performance Testing Summary:
The SelectFlex 072 Neurovascular access system has successfully completed the following relevant performance testing demonstrating that the device is suitable for its intended use.
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| Test Description | Test Method | Results |
|---|---|---|
| Packaging Integrity (sterilebarrier) | Tested per ISO 11607-1 and -2 | PASS All samples met the pre-determined acceptance criteria |
| Visual SurfaceRequirements | Visual inspection of catheter surfaces | PASS All samples met the pre-determined acceptance criteria |
| Dimensional Verification | Device dimensions were measured to confirmconformance to the product specification | PASS All samples met the pre-determined acceptance criteria |
| Liquid Leakage UnderPressure | Tested per ISO 10555-1:2013 Annex C | PASS All samples met the pre-determined acceptance criteria |
| Hub Aspiration AirLeakage | Tested per ISO 10555-1 2013 for HubAspiration Air Leakage | PASS All samples met the pre-determined acceptance criteria |
| Simulated Use/Usability | Device preparation, delivery, access, wasevaluated in a challenging neurovascularmodel. Simulated use testing includes ausability assessment with multiple physicians | PASS All samples met the pre-determined acceptance criteria |
| Flex Fatigue | Tested per ISO 10555-1: 2013 for FlexuralFatigue | PASS All samples met the pre-determined acceptance criteria |
| Tip Deflection | The amount of tip deflection under load wasevaluated and compared to the predicatedevice | PASS All samples met the pre-determined acceptance criteria |
| Inflation Fatigue | Tested per ISO 10555-1: 2013 for InflationFatigue - 20 inflation cycles | PASS All samples met the pre-determined acceptance criteria |
| Burst Volume | Tested per ISO 10555-1: 2013 for InflationFatigue - tested to 2x the inflation volume | PASS All samples met the pre-determined acceptance criteria |
| Torque Test | Tested per ISO 10555-1: 2013 for TorqueTesting | PASS All samples met the pre-determined acceptance criteria |
| Flow Rate | Tested per ISO 10555-1: 2013 for Flow ratecompared to the predicate device | PASS All samples met the pre- determined acceptance criteria |
| ISO 594-2: Conical LuerFittings | Tested per ISO 594-2 for Conical Fittings | PASS All samples met the pre-determined acceptance criteria |
| Test Description | Test Method | Results |
| Corrosion Resistance | Tested per ISO 10555-1 Annex A for corrosion resistance | PASSAll samples met the pre-determined acceptance criteria |
| Particulate Count | Effluent tested per AAMI TIR42, USP 788 using multiple insertion and withdrawal cycles | PASSAll samples met the pre-determined acceptance criteria |
| Coating Integrity, Lubricity, Durability | Tested in consideration of FDA CTQ for Hydrophilic Coated vascular catheters | PASSAll samples met the pre-determined acceptance criteria |
| Peak Tensile Testing | Tested per ISO 10555-1 for tensile strength including all bonds/joints | PASSAll samples met the pre-determined acceptance criteria |
| Device Removal in Support and Tracking Modes | Removal force in both modes was compared to a reference device | PASSAll samples met the pre-determined acceptance criteria |
| Radiopacity | Radiopacity was evaluated during simulated use testing confirming visualization under fluoroscopy | PASSAll samples met the pre-determined acceptance criteria |
| Bacterial Endotoxin | Testing was performed in accordance with USP 40, NF 35, 2017. <85> Bacterial Endotoxins Test | PASSAll samples met the pre-determined acceptance criteria |
| Shelf Life | Accelerated aging studies were completed to confirm the stability of the product and package | PASSAll samples met the pre-determined acceptance criteria |
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No animal or clinical studies were required to demonstrate substantial equivalence.
Biocompatibility Testing Summary
Categorized as Externally Communicating Device, Circulating Blood, Limited Contact (≤ 24 hours), per ISO 10993-1, the following testing was conducted:
| Test Name | Test Method | Results |
|---|---|---|
| Cytotoxicity | Tested in accordance with ISO 10993-5, BiologicalEvaluation of Medical Devices - Part 5: Tests for in vitrotoxicity, Neutral Red Uptake Method | PassNoncytotoxic according to thepredetermined acceptance criteria |
| Intracutaneous Irritation | Tested in accordance with ISO 10993-10, BiologicalEvaluation of Medical Devices - Part 10: Tests for Irritationand Skin Sensitization | PassTest requirements forintracutaneous reactivity weremet according to thepredetermined acceptance criteria |
| Sensitization | Tested in accordance with ISO 10993-10, BiologicalEvaluation of Medical Devices - Part 10 Tests for Irritationand Skin Sensitization, Kligman Maximization Test | Passdid not elicit a sensitizationresponse according to thepredetermined acceptance criteria |
| Systemic Toxicity | Tested in accordance with ISO 10993-11, BiologicalEvaluation of Medical Devices - Part 11: Tests for SystemicToxicity | PassTest requirements for systemictoxicity were met according to thepredetermined acceptance criteria |
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| Material MediatedPyrogenicity | Tested in accordance with ISO 10993-11, BiologicalEvaluation of Medical Devices - Part 11: Tests for SystemicToxicity and USP 40 <151> Pyrogen Test | PassNonpyrogenic, met thepredetermined acceptance criteria |
|---|---|---|
| Hemolysis | Tested in accordance with ASTM F756-17, StandardPractice for Assessment of Hemolytic Properties ofMaterials and ISO 10993-4, Biological Evaluation ofMedical Devices – Part 4: Selection of Tests for Interactionswith Blood, Tests for Hemolytic Properties, Direct andIndirect Methods | PassNon-hemolytic, met thepredetermined acceptance criteria |
| In Vitro Hemocompatibility | Tested in accordance with ISO 10993-4, BiologicalEvaluation of Medical Devices - Part 4: Selection of Testsfor Interactions with Blood, Hemocompatibility, DirectContact Method | PassNot expected to result in adverseeffects in vivo, met thepredetermined acceptance criteria |
| Complement Activation | Tested in accordance with ISO 10993-4, BiologicalEvaluation of Medical Devices - Part 4: Selection of Testsfor Interactions with Blood, SC5b-9 Complement Activation | PassDoes not activate the complementsystem, met the predeterminedacceptance criteria |
| Un-activated PartialThromboplastin Time | Tested in accordance with ISO 10994-4, BiologicalEvaluation of Medical Devices - Part 4: Selection of Testsfor Interactions with Blood and ASTM F2382-04, StandardTest Method for Assessment of Intravascular MedicalDevice Materials on Partial Thromboplastin Time (UPTT) | PassDoes not have an effect oncoagulation of human plasma, metthe predetermined acceptancecriteria |
| Thrombogenicity | Tested in accordance with ISO 10994-4, BiologicalEvaluation of Medical Devices - Part 4: Selection of Testsfor Interactions with Blood | PassDemonstrates similarthromboresistance characteristicsas the control device, met thepredetermined acceptance criteria |
Predicate Device Comparison
The following table provides a comparison of the key characteristics of the SelectFlex 072 Neurovascular Access Catheter to the predicate device.
| Substantial Equivalence Comparison Chart | |||
|---|---|---|---|
| Feature | Subject Device | Predicate device | Comparison |
| Feature | SelectFlex 072Neurovascular AccessSystem | PenumbraBenchmark™Intracranial AccessSystem | Comparison |
| Material | Commonly usedmedical grade plastics,stainless steel, nitinol | Commonly usedmedical grade plasticsand stainless steel | Similar, difference doesnot raise new questionsregarding safety andefficacy |
| Outer Diameter | .095-in | 0.081-0.083-in | Similar, Reference devicesinclude a diameter rangeabove and below thesubject device. |
| Inner Dimension | .072-in | 0.070-in | Similar, Reference devicesinclude a diameter rangeabove and below thesubject device. |
| Fr Designation | 7 Fr | 6 Fr | Similar, Reference devicesincludes a diameter rangeabove and below thesubject device. |
| Usable Length | 105cm | 95cm, 105cm | Same |
| Tip Shape | Straight | Straight &Multipurpose | Same |
| Injection Port | Yes | Yes | Same |
| Substantial Equivalence Comparison Chart | |||
| Subject Device | Predicate device | ||
| Feature | SelectFlex 072Neurovascular AccessSystem | PenumbraBenchmark™Intracranial AccessSystem | Comparison |
| Radiopaque | Distal Tip has aradiopaque markerband, stainless steelreinforcement andnitinol scaffold in thecatheter shaft rendersthe shaft visible onfluoroscopy | Distal Tip has aradiopaque markerband, stainless steelreinforcement in thecatheter shaft rendersthe shaft visible onfluoroscopy | Same |
| Coating | Hydrophilic Coating -Distal Portion | Hydrophilic Coating -Distal Portion | Same |
| Reinforced Shaft | Stainless steelreinforced shaft | Stainless steelreinforced shaft | Same |
| Variable StiffnessMechanism | Variable durometercatheter shaftconstruction to delivera flexible distal tip andtransition to a stifferproximal section; tentransition segmentsbetween the distal tipand proximal shaft.&User selected trackingand support modes | Variable durometercatheter shaftconstruction to deliver aflexible distal tip andtransition to a stifferproximal section; tentransition segmentsbetween the distal tipand proximal shaft. | Similar, the range incatheter stiffness for thesubject device isencompassed in thecombined range reportedfor the predicate devicesand reference devices withthe same intended use.Difference in mechanismdoes not raise newquestions regarding safetyand effectiveness. |
| Accessories Supplied | 7 Fr Introducer Sheath3cc syringe | 5F Penumbra SelectCatheter - offeringincludes option forBenchmark and SelectIntroducer Device as akit. | Different, there are nospecial accessoriesrequired for use with thepredicate device.Difference does not raisenew questions regardingsafety and effectiveness. |
| Guidewire Compatibility | 0.035 - 0.038-in | 0.035 - 0.038-in | Same |
| How Supplied | Sterile, single use | Sterile, single use | Same |
| Sterilization Method | ETO | ETO | Same |
| Sterility Assurance Level | 10-6 | 10-6 | Same |
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Substantial Equivalence:
This summary demonstrates that the SelectFlex 072 Neurovascular Access System and the predicate device have the same intended use, similar technological characteristics, materials, and principals of operation. It can therefore be concluded that the SelectFlex 072 Neurovascular Access System is substantially equivalent to the predicate device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).