(150 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML capabilities.
No.
The device is indicated for the "introduction of interventional devices" and is described as a "catheter used to facilitate access target vasculature during interventional procedures." It acts as a conduit for other devices rather than providing a direct therapeutic effect itself.
No
Explanation: The device is indicated for the "introduction of interventional devices" and is described as an "intravascular catheter used to facilitate access target vasculature during interventional procedures." This indicates an interventional/therapeutic purpose rather than a diagnostic one.
No
The device description explicitly lists physical components like a catheter, syringe, and introducer, and the performance studies focus on physical properties and biocompatibility, indicating it is a hardware-based medical device.
Based on the provided information, the SelectFlex 072 Neurovascular Access System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of interventional devices into the peripheral and neurovasculature. This describes a device used within the body for a procedural purpose, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details an intravascular catheter used to facilitate access during interventional procedures. This is consistent with a device used for accessing blood vessels, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other components typically associated with IVD testing.
In summary, the SelectFlex 072 Neurovascular Access System is a medical device used for accessing blood vessels during interventional procedures, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The SelectFlex 072 Neurovascular Access System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
Product codes
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neurovasculature
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
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.
- Packaging Integrity (sterile barrier): Tested per ISO 11607-1 and -2. Results: PASS All samples met the pre-determined acceptance criteria
- Visual Surface Requirements: Visual inspection of catheter surfaces. Results: PASS All samples met the pre-determined acceptance criteria
- Dimensional Verification: Device dimensions were measured to confirm conformance to the product specification. Results: PASS All samples met the pre-determined acceptance criteria
- Liquid Leakage Under Pressure: Tested per ISO 10555-1:2013 Annex C. Results: PASS All samples met the pre-determined acceptance criteria
- Hub Aspiration Air Leakage: Tested per ISO 10555-1 2013 for Hub Aspiration Air Leakage. Results: 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. Results: PASS All samples met the pre-determined acceptance criteria
- Flex Fatigue: Tested per ISO 10555-1: 2013 for Flexural Fatigue. Results: 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. Results: PASS All samples met the pre-determined acceptance criteria
- Inflation Fatigue: Tested per ISO 10555-1: 2013 for Inflation Fatigue - 20 inflation cycles. Results: 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. Results: PASS All samples met the pre-determined acceptance criteria
- Torque Test: Tested per ISO 10555-1: 2013 for Torque Testing. Results: 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. Results: PASS All samples met the pre- determined acceptance criteria
- ISO 594-2: Conical Luer Fittings: Tested per ISO 594-2 for Conical Fittings. Results: PASS All samples met the pre-determined acceptance criteria
- Corrosion Resistance: Tested per ISO 10555-1 Annex A for corrosion resistance. Results: PASS All samples met the pre-determined acceptance criteria
- Particulate Count: Effluent tested per AAMI TIR42, USP 788 using multiple insertion and withdrawal cycles. Results: PASS All samples met the pre-determined acceptance criteria
- Coating Integrity, Lubricity, Durability: Tested in consideration of FDA CTQ for Hydrophilic Coated vascular catheters. Results: PASS All samples met the pre-determined acceptance criteria
- Peak Tensile Testing: Tested per ISO 10555-1 for tensile strength including all bonds/joints. Results: PASS All 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. Results: PASS All samples met the pre-determined acceptance criteria
- Radiopacity: Radiopacity was evaluated during simulated use testing confirming visualization under fluoroscopy. Results: PASS All samples met the pre-determined acceptance criteria
- Bacterial Endotoxin: Testing was performed in accordance with USP 40, NF 35, 2017. Bacterial Endotoxins Test. Results: 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. Results: PASS All samples met the pre-determined acceptance criteria
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:
- Cytotoxicity: Tested in accordance with ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for in vitro toxicity, Neutral Red Uptake Method. Results: Pass Noncytotoxic according to the predetermined acceptance criteria
- Intracutaneous Irritation: Tested in accordance with ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization. Results: Pass Test requirements for intracutaneous reactivity were met according to the predetermined acceptance criteria
- Sensitization: Tested in accordance with ISO 10993-10, Biological Evaluation of Medical Devices - Part 10 Tests for Irritation and Skin Sensitization, Kligman Maximization Test. Results: Pass did not elicit a sensitization response according to the predetermined acceptance criteria
- Systemic Toxicity: Tested in accordance with ISO 10993-11, Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity. Results: Pass Test requirements for systemic toxicity were met according to the predetermined acceptance criteria
- Material Mediated Pyrogenicity: Tested in accordance with ISO 10993-11, Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity and USP 40 Pyrogen Test. Results: Pass Nonpyrogenic, met the predetermined acceptance criteria
- Hemolysis: Tested in accordance with ASTM F756-17, Standard Practice for Assessment of Hemolytic Properties of Materials and ISO 10993-4, Biological Evaluation of Medical Devices – Part 4: Selection of Tests for Interactions with Blood, Tests for Hemolytic Properties, Direct and Indirect Methods. Results: Pass Non-hemolytic, met the predetermined acceptance criteria
- In Vitro Hemocompatibility: Tested in accordance with ISO 10993-4, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood, Hemocompatibility, Direct Contact Method. Results: Pass Not expected to result in adverse effects in vivo, met the predetermined acceptance criteria
- Complement Activation: Tested in accordance with ISO 10993-4, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood, SC5b-9 Complement Activation. Results: Pass Does not activate the complement system, met the predetermined acceptance criteria
- Un-activated Partial Thromboplastin Time: Tested in accordance with ISO 10994-4, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood and ASTM F2382-04, Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (UPTT). Results: Pass Does not have an effect on coagulation of human plasma, met the predetermined acceptance criteria
- Thrombogenicity: Tested in accordance with ISO 10994-4, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood. Results: Pass Demonstrates similar thromboresistance characteristics as the control device, met the predetermined acceptance criteria
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K965247, K982770, K140307, K142819
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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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3
K181000 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: | 310-395-3950 |
| 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.
4
| Test Description | Test Method | Results |
|---|---|---|
| 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 | 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 594-2: Conical Luer | ||
| Fittings | 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 | 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 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 | ||
| Bacterial Endotoxin | Testing was performed in accordance with USP 40, NF 35, 2017. Bacterial Endotoxins Test | 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 | PASS |
| All samples met the pre-determined acceptance criteria |
5
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, Biological | |
| Evaluation of Medical Devices - Part 5: Tests for in vitro | ||
| toxicity, Neutral Red Uptake Method | Pass | |
| Noncytotoxic according to the | ||
| predetermined acceptance criteria | ||
| Intracutaneous Irritation | Tested in accordance with ISO 10993-10, Biological | |
| Evaluation of Medical Devices - Part 10: Tests for Irritation | ||
| and Skin Sensitization | Pass | |
| Test requirements for | ||
| intracutaneous reactivity were | ||
| met according to the | ||
| predetermined acceptance criteria | ||
| Sensitization | Tested in accordance with ISO 10993-10, Biological | |
| Evaluation of Medical Devices - Part 10 Tests for Irritation | ||
| and Skin Sensitization, Kligman Maximization Test | Pass | |
| did not elicit a sensitization | ||
| response according to the | ||
| predetermined acceptance criteria | ||
| Systemic Toxicity | Tested in accordance with ISO 10993-11, Biological | |
| Evaluation of Medical Devices - Part 11: Tests for Systemic | ||
| Toxicity | Pass | |
| Test requirements for systemic | ||
| toxicity were met according to the | ||
| predetermined acceptance criteria |
6
| Material Mediated
Pyrogenicity | Tested in accordance with ISO 10993-11, Biological
Evaluation of Medical Devices - Part 11: Tests for Systemic
Toxicity and USP 40 Pyrogen Test | Pass
Nonpyrogenic, met the
predetermined acceptance criteria |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Hemolysis | Tested in accordance with ASTM F756-17, Standard
Practice for Assessment of Hemolytic Properties of
Materials and ISO 10993-4, Biological Evaluation of
Medical Devices – Part 4: Selection of Tests for Interactions
with Blood, Tests for Hemolytic Properties, Direct and
Indirect Methods | Pass
Non-hemolytic, met the
predetermined acceptance criteria |
| In Vitro Hemocompatibility | Tested in accordance with ISO 10993-4, Biological
Evaluation of Medical Devices - Part 4: Selection of Tests
for Interactions with Blood, Hemocompatibility, Direct
Contact Method | Pass
Not expected to result in adverse
effects in vivo, met the
predetermined acceptance criteria |
| Complement Activation | Tested in accordance with ISO 10993-4, Biological
Evaluation of Medical Devices - Part 4: Selection of Tests
for Interactions with Blood, SC5b-9 Complement Activation | Pass
Does not activate the complement
system, met the predetermined
acceptance criteria |
| Un-activated Partial
Thromboplastin Time | Tested in accordance with ISO 10994-4, Biological
Evaluation of Medical Devices - Part 4: Selection of Tests
for Interactions with Blood and ASTM F2382-04, Standard
Test Method for Assessment of Intravascular Medical
Device Materials on Partial Thromboplastin Time (UPTT) | Pass
Does not have an effect on
coagulation of human plasma, met
the predetermined acceptance
criteria |
| Thrombogenicity | Tested in accordance with ISO 10994-4, Biological
Evaluation of Medical Devices - Part 4: Selection of Tests
for Interactions with Blood | Pass
Demonstrates similar
thromboresistance characteristics
as the control device, met the
predetermined 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 072 | ||
| Neurovascular Access | |||
| System | Penumbra | ||
| Benchmark™ | |||
| Intracranial Access | |||
| System | Comparison | ||
| Material | Commonly used | ||
| medical grade plastics, | |||
| stainless steel, nitinol | Commonly used | ||
| medical grade plastics | |||
| and stainless steel | Similar, difference does | ||
| not raise new questions | |||
| regarding safety and | |||
| efficacy | |||
| Outer Diameter | .095-in | 0.081-0.083-in | Similar, Reference devices |
| include a diameter range | |||
| above and below the | |||
| subject device. | |||
| Inner Dimension | .072-in | 0.070-in | Similar, Reference devices |
| include a diameter range | |||
| above and below the | |||
| subject device. | |||
| Fr Designation | 7 Fr | 6 Fr | Similar, Reference devices |
| includes a diameter range | |||
| above and below the | |||
| subject 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 072 | ||
| Neurovascular Access | |||
| System | Penumbra | ||
| Benchmark™ | |||
| Intracranial Access | |||
| System | Comparison | ||
| 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 in the | |||
| catheter shaft renders | |||
| the shaft visible on | |||
| fluoroscopy | Same | ||
| Coating | Hydrophilic Coating - | ||
| Distal Portion | Hydrophilic Coating - | ||
| Distal Portion | Same | ||
| 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. | |||
| & | |||
| User selected tracking | |||
| and support modes | 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. | Similar, the range in | ||
| catheter stiffness for the | |||
| subject device is | |||
| encompassed in the | |||
| combined range reported | |||
| for the predicate devices | |||
| and reference devices with | |||
| the same intended use. | |||
| Difference in mechanism | |||
| does not raise new | |||
| questions regarding safety | |||
| and effectiveness. | |||
| Accessories Supplied | 7 Fr Introducer Sheath | ||
| 3cc syringe | 5F Penumbra Select | ||
| Catheter - offering | |||
| includes option for | |||
| Benchmark and Select | |||
| Introducer Device as a | |||
| kit. | Different, there are no | ||
| special accessories | |||
| required for use with the | |||
| predicate device. | |||
| Difference does not raise | |||
| new questions regarding | |||
| safety 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 |
7
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.