(70 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 to target vasculature during interventional procedures. The system is composed of a the SelectFlex 072 Catheter, a 3cc Inflation Syringe, a 7Fr Peel Away Introducer, and Hub Extension Line. 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.
The provided document is a 510(k) summary for the SelectFlex 072 Neurovascular Access System, asserting its substantial equivalence to a predicate device (SelectFlex 072 Neurovascular Access System K181000). The summary focuses on comparing the new device to the predicate and presenting nonclinical bench test data. It does not detail a study proving the device meets acceptance criteria for an AI/ML-based medical device. The documentation pertains to a traditional medical device (a catheter system), not an AI-enabled device.
Therefore, the following information cannot be extracted from the provided text for an AI/ML-based device:
- A table of acceptance criteria and the reported device performance: The document lists bench tests and states "PASS" for all, meaning all samples met "pre-determined acceptance criteria," but it does not specify the numerical or qualitative acceptance criteria for each test in a detailed table that would be typical for an AI/ML performance summary (e.g., sensitivity, specificity, AUC thresholds). The acceptance criteria for the new device are implicitly that they perform equivalently to the predicate device in the listed bench tests.
- Sample size used for the test set and the data provenance: No information on test set sample size or data provenance in the context of an AI/ML study is provided. The bench tests would have their own sample sizes, but these are not for an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML study requiring expert-derived ground truth.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
However, based on the document, I can provide information relevant to a traditional medical device's nonclinical performance evaluation:
1. Table of Acceptance Criteria and Reported Device Performance (Nonclinical Bench Testing):
The document states that all tests resulted in "PASS," meaning all samples met "pre-determined acceptance criteria." The specific numerical acceptance criteria themselves are not listed in this summary, only the outcome.
| Test Description | Test Method | Reported Device Performance (Result against unspecified acceptance criteria) |
|---|---|---|
| Packaging Integrity | 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 | Device preparation, delivery, access, was evaluated in a challenging neurovascular model. Simulated use testing includes a usability assessment with multiple physicians. | 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 | The amount of tip deflection under load was 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 the 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 80369-7: Small Bore Connectors | Tested per ISO 80369-7 (dimensional, leakage, resistance to separation, etc.) | 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 | Removal force in both modes was compared to a reference device | PASS (All samples met the pre-determined acceptance criteria) |
| Radiopacity | Radiopacity was evaluated during simulated use testing confirming visualization under fluoroscopy | PASS (All samples met the pre-determined acceptance criteria) |
| Shelf Life | Accelerated aging studies were completed to confirm the stability of the product and package. All testing noted above was performed on aged product to support the shelf life claim | PASS (All samples met the pre-determined acceptance criteria) |
| Cytotoxicity | Tested in accordance with ISO 10993-5, Neutral Red Uptake Method | Pass (Noncytotoxic according to the 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 (direct and indirect methods) | 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 have an effect on coagulation of human plasma) |
| Thrombogenicity | Tested in accordance with ISO 10994-4 | Pass (Demonstrates similar thromboresistance characteristics as control) |
| Bacterial Endotoxin | Tested in accordance with USP 40, NF 35, 2017. <85> Bacterial Endotoxins Test | PASS (All samples met the pre-determined acceptance criteria) |
2. Sample sized used for the test set and the data provenance:
The document mentions "All samples met the pre-determined acceptance criteria" for various bench tests, but does not specify the sample size (n) for each test set used in the nonclinical bench testing. Data provenance is not applicable in the context of clinical data for an AI/ML device, as these are bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
For the "Simulated Use/Usability" test, the document states it "includes a usability assessment with multiple physicians." The specific number and qualifications of these physicians are not provided. This is not establishing "ground truth" in an AI/ML context, but rather assessing usability.
4. Adjudication method for the test set:
Not applicable in the context of bench testing for a traditional medical device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, this type of study was not conducted as this is a non-AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used:
Not applicable, as this is not an AI/ML device. For the bench tests, the "ground truth" is defined by established international and national standards (e.g., ISO, ASTM, USP) and the device's own specifications.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
August 30, 2019
O'Apel Medical % Michele Lucey President Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, New Hampshire 03255
Re: K191664
Trade/Device Name: SelectFlex 072 Neurovascular Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: July 30, 2019 Received: August 1, 2019
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.
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ence determination does not mean that FDA
Page 2
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 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-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-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-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 Xiaolin Zheng, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191664
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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SPECIAL 510(K) SUMMARY As required by 21 CFR 807.92
Submitter Information:
| Submitter's Name: | Q'Apel Medical LLC |
|---|---|
| Address: | 330 Wilshire Boulevard |
| Santa Monica CA 90401 | |
| Telephone: | 310-395-3950 |
| Fax: | 310-395-1122 |
| Contact Person: | Michele Lucey |
| Telephone: | 603-748-1374 |
| Date Prepared: | August 30, 2019 |
| Device Trade Name: | SelectFlex 072 Neurovascular Access System |
| Classification: | Class II |
| Product Code(s): | DQY |
| Regulation Number(s): | 870.1250 |
| Classification Name | Percutaneous Catheter |
| Predicate Devices: | SelectFlex 072 Neurovascular Access System K181000 |
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 to target vasculature during interventional procedures. The system is composed of a the SelectFlex 072 Catheter, a 3cc Inflation Syringe, a 7Fr Peel Away Introducer, and Hub Extension Line. 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.
Comparison of Technological characteristics
The 072 Neurovascular Access System incorporates substantially equivalent design, packaging. fundamental technology, manufacturing processes, sterilization process and intended use as those contained in the 072 Neurovascular Access System (K181000). The following table provides a comparison of the subject device to the predicate device:
| Comparison Table to Demonstrate Substantial Equivalence | |||
|---|---|---|---|
| Feature | Subject Device | Predicate Device | Comparison |
| SelectFlex 072 NeurovascularAccess System | SelectFlex 072Neurovascular AccessSystem | ||
| RegulatoryClearance/ | Pending | K181000 | NA |
| Comparison Table to Demonstrate Substantial Equivalence | |||
| Feature | Subject Device | Predicate Device | Comparison |
| Approval Reference | |||
| FDA Classification | Class II | Class II | Same |
| Product Code(s) | DQY | DQY | Same |
| Regulation Number | 870.1250 | 870.1250 | Same |
| Material | Commonly used medical grade plastics, stainless steel, nitinol | Commonly used medical grade plastics, stainless steel, nitinol | Similar, difference does not raise new questions regarding safety and efficacy |
| Outer Diameter | .095-in | .095-in | Same |
| Inner dimension | .072-in | .072-in | Same |
| Fr Designation | 7 Fr | 7 Fr | Same |
| Effective length | 105cm | 105cm | Same |
| Tip Shape | Straight | Straight | Same |
| Injection Port | Yes | Yes | Same |
| Radiopaque | Distal Tip has a radiopaque marker band, stainless steel reinforcement and nitinol scaffold in the catheter shaft renders the shaft visible on fluoroscopy | Distal Tip has a radiopaque marker band, stainless steel reinforcement and nitinol scaffold in the catheter shaft renders the shaft visible on fluoroscopy | Same |
| Coating | Hydrophilic Coating - Distal Portion (11.5cm) | Hydrophilic Coating - Distal Portion (10cm) | Similar, difference does not raise new questions regarding safety and efficacy |
| Reinforced Shaft | Stainless steel reinforced shaft | Stainless steel reinforced shaft | Same |
| Variable Stiffness Mechanism | Variable durometer catheter shaft construction to deliver a flexible distal tip and transition to a stiffer proximal section; ten transition segments between the distal tip and proximal shaft. & | Variable durometer catheter shaft construction to deliver a flexible distal tip and transition to a stiffer proximal section; ten transition segments between the distal tip and proximal shaft. & | Same |
| Comparison Table to Demonstrate Substantial Equivalence | |||
| Feature | Subject DeviceSelectFlex 072 NeurovascularAccess System | Predicate DeviceSelectFlex 072Neurovascular AccessSystem | Comparison |
| stiffness modes of the distal10cm by application of fluidinto the distal scaffoldchamber of the catheter wall.Fluid pressure enables themore flexible tracking mode;fluid withdrawal switches to aless flexible and moresupportive mode. | Two user-selectablevariable stiffness modes ofthe distal 10cm byapplication of fluid into thedistal scaffold chamber ofthe catheter wall. Fluidpressure enables the moreflexible tracking mode;fluid withdrawal switchesto a less flexible and moresupportive mode. | ||
| Tip Stiffness | 0.12 N (tracking and supportmode) | Ranges from 0.12-0.16 N(tracking and supportmode) | Similar,difference doesnot raise newquestionsregarding safetyand efficacy |
| AccessoriesSupplied | 7 Fr Introducer Sheath3cc syringeHub Extension Line | 7 Fr Introducer Sheath3cc syringe | Similar,difference doesnot raise newquestionsregarding safetyand efficacy |
| GuidewireCompatibility | 0.035 - 0.038-in | 0.035 - 0.038-in | Same |
| How Supplied | Sterile, single use | Sterile, single use | Same |
| SterilizationMethod | EtO | EtO | Same |
| Sterility AssuranceLevel | 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.
Nonclinical Performance Data:
Determination of substantial equivalence is based on an assessment of non-clinical performance bench test data.
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Bench Testing:
Bench testing was performed to evaluate physical integrity, functionality and performance of the 072 Neurovascular Access System. Performance data includes dimensional, delivery and removal under simulated use conditions, bond tensile strength, tip flexibility, hub aspiration and leakage under pressure, torque, biocompatibility and compatibility with interface devices. A summary of all tests performed is provided in the following table:
| Test Description | Test Method | Results |
|---|---|---|
| Packaging Integrity(sterile barrier) | Tested per ISO 11607-1 and -2 | PASSAll samples met the pre-determined acceptance criteria |
| Visual SurfaceRequirements | Visual inspection of cathetersurfaces | PASSAll samples met the pre-determined acceptance criteria |
| DimensionalVerification | Device dimensions were measuredto confirm conformance to theproduct specification | PASSAll samples met the pre-determined acceptance criteria |
| Liquid Leakage UnderPressure | Tested per ISO 10555-1:2013Annex C | PASSAll samples met the pre-determined acceptance criteria |
| Hub Aspiration AirLeakage | Tested per ISO 10555-1 2013 forHub Aspiration Air Leakage | PASSAll samples met the pre-determined acceptance criteria |
| SimulatedUse/Usability | Device preparation, delivery,access, was evaluated in achallenging neurovascular model.Simulated use testing includes ausability assessment with multiplephysicians | PASSAll samples met the pre-determined acceptance criteria |
| Flex Fatigue | Tested per ISO 10555-1: 2013 forFlexural Fatigue | PASSAll samples met the pre-determined acceptance criteria |
| Tip Deflection | The amount of tip deflection underload was evaluated and comparedto the predicate device | PASSAll samples met the pre-determined acceptance criteria |
| Inflation Fatigue | Tested per ISO 10555-1: 2013 forInflation Fatigue - 20 inflationcycles | PASSAll samples met the pre-determined acceptance criteria |
| Test Description | Test Method | Results |
| Burst Volume | Tested per ISO 10555-1: 2013 forInflation Fatigue - tested to 2x theinflation volume | PASSAll samples met the pre-determined acceptance criteria |
| Torque Test | Tested per ISO 10555-1: 2013 forTorque Testing | PASSAll samples met the pre-determined acceptance criteria |
| Flow Rate | Tested per ISO 10555-1: 2013 forFlow rate compared to thepredicate device | PASSAll samples met the pre-determined acceptance criteria |
| ISO 80369-7 : SmallBore Connectors forHypodermicApplications | Tested per ISO 80369-7,dimensional, leakage by pressuredecay, freedom from air leakage,positive pressure liquid leakage,sub-atmospheric pressure airleakage, stress cracking, resistanceto separation from axial load,resistance to separation fromunscrewing, resistance tooverriding | PASSAll samples met the pre-determined acceptance criteria |
| Corrosion Resistance | Tested per ISO 10555-1 Annex Afor corrosion resistance | PASSAll samples met the pre-determined acceptance criteria |
| Particulate Count | Effluent tested per AAMI TIR42,USP 788 using multiple insertionand withdrawal cycles | PASSAll samples met the pre-determined acceptance criteria |
| Coating Integrity,Lubricity, Durability | Tested in consideration of FDACTQ for Hydrophilic Coatedvascular catheters | PASSAll samples met the pre-determined acceptance criteria |
| Peak Tensile Testing | Tested per ISO 10555-1 for tensilestrength including all bonds/joints | PASSAll samples met the pre-determined acceptance criteria |
| Device Removal inSupport and TrackingModes | Removal force in both modes wascompared to a reference device | PASSAll samples met the pre-determined acceptance criteria |
| Radiopacity | Radiopacity was evaluated duringsimulated use testing confirmingvisualization under fluoroscopy | PASSAll samples met the pre-determined acceptance criteria |
| Test Description | Test Method | Results |
| Shelf Life | Accelerated aging studies werecompleted to confirm the stabilityof the product and package. Alltesting noted above was performedon aged product to support theshelf life claim | PASSAll samples met the pre-determined acceptance criteria |
| Test Name | Test Method | Results |
| Cytotoxicity | Tested in accordance with ISO 10993-5,Biological Evaluation of Medical Devices- Part 5: Tests for in vitro toxicity,Neutral Red Uptake Method | PassNoncytotoxic according to thepredetermined acceptancecriteria |
| IntracutaneousIrritation | Tested in accordance with ISO 10993-10,Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and SkinSensitization | PassTest requirements forintracutaneous reactivity weremet according to thepredetermined acceptancecriteria |
| Sensitization | Tested in accordance with ISO 10993-10,Biological Evaluation of Medical Devices- Part 10 Tests for Irritation and SkinSensitization, Kligman Maximization Test | Passdid not elicit a sensitizationresponse according to thepredetermined acceptancecriteria |
| Systemic Toxicity | Tested in accordance with ISO 10993-11,Biological Evaluation of Medical Devices- Part 11: Tests for Systemic Toxicity | PassTest requirements for systemictoxicity were met according tothe predetermined acceptancecriteria |
| Material MediatedPyrogenicity | Tested in accordance with ISO 10993-11,Biological Evaluation of Medical Devices- Part 11: Tests for Systemic Toxicity andUSP 40 <151> Pyrogen Test | PassNonpyrogenic, met thepredetermined acceptancecriteria |
| Hemolysis | Tested in accordance with ASTM F756-17, Standard Practice for Assessment ofHemolytic Properties of Materials andISO 10993-4, Biological Evaluation ofMedical Devices - Part 4: Selection ofTests for Interactions with Blood, Testsfor Hemolytic Properties, Direct andIndirect Methods | PassNon-hemolytic, met thepredetermined acceptancecriteria |
| In VitroHemocompatibility | Tested in accordance with ISO 10993-4,Biological Evaluation of Medical Devices- Part 4: Selection of Tests forInteractions with Blood,Hemocompatibility, Direct ContactMethod | PassNot expected to result in adverseeffects in vivo , met thepredetermined acceptancecriteria |
| ComplementActivation | Tested in accordance with ISO 10993-4,Biological Evaluation of Medical Devices- Part 4: Selection of Tests forInteractions with Blood, SC5b-9Complement Activation | PassDoes not activate thecomplement system, met thepredetermined acceptancecriteria |
| Un-activated PartialThromboplastinTime | Tested in accordance with ISO 10994-4,Biological Evaluation of Medical Devices- Part 4: Selection of Tests forInteractions with Blood and ASTMF2382-04, Standard Test Method forAssessment of Intravascular MedicalDevice Materials on PartialThromboplastin Time (UPTT) | PassDoes not have an effect oncoagulation of human plasma,met the predeterminedacceptance criteria |
| Thrombogenicity | Tested in accordance with ISO 10994-4,Biological Evaluation of Medical Devices- Part 4: Selection of Tests forInteractions with Blood | PassDemonstrates similarthromboresistance characteristicsas the control device, met thepredetermined acceptancecriteria |
| Bacterial Endotoxin | Testing was performed in accordance withUSP 40, NF 35, 2017. <85> BacterialEndotoxins Test | PASSAll samples met the pre-determined acceptance criteria |
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The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing; therefore, this device is considered to be substantially equivalent to the predicate device.
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Biocompatibility Testing Summary:
Categorized as Externally Communicating Device, Circulating Blood, Limited Contact (≤ 24 hours), per ISO 10993-1, the following testing was conducted and results were acceptable:
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The biocompatibility and hemocompatibility testing summarized in the table above yielded acceptable (passing) results for all tests conducted. This information demonstrating acceptable biocompatibility and hemocompatibility properties support the claim of substantial equivalence to the predicate device.
Conclusion:
Based on the indications for use, technological characteristics, and performance testing, the SelectFlex 072 Neurovascular Access System has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the SelectFlex 072 Neurovascular Access System, K181000.
§ 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).