(45 days)
Not Found
No
The device description focuses on mechanical features and user-activated modes, with no mention of AI or ML in the text or the "Mentions AI, DNN, or ML" section.
No
This device is an access system for interventional devices and does not itself treat or cure a disease or condition.
No
The device is described as an access system for introducing interventional devices, facilitating access for procedures, rather than diagnosing conditions.
No
The device description clearly outlines multiple physical components including catheters, syringes, introducers, valves, and dilators. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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 a condition.
- Device Description: The description details a catheter system designed for accessing blood vessels. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic testing being performed by the device.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely procedural access.
N/A
Intended Use / Indications for Use
The SelectFlex Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
Product codes (comma separated list FDA assigned to the subject device)
QJP, DQY
Device Description
The SelectFlex Neurovascular Access System Family consists of sterile, single-use intravascular catheters used to facilitate access to target vasculature during interventional procedures. The system is composed of a SelectFlex Neurovascular Access Catheter, a 3cc Mode Control Syringe, a 7Fr Peel Away Introducer, Luer Activated Valve and a Dilator (only for versions with a Long Hydrophilic coating to ease dermal entry). The SelectFlex Neurovascular Access Catheter comes in usable lengths of 95, 105 or 115cm. The SelectFlex Neurovascular Access 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 Neurovascular Access Catheter comes in two options of a short hydrophilic coating length of 11.5cm or a long hydrophilic coating length of 30cm.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to evaluate physical integrity, functionality, and performance of the SelectFlex Neurovascular Access System Family. Performance data includes dimensional verification, delivery and removal under simulated use conditions, bond tensile strength, and compatibility with interface devices.
- Visual Surface Requirements (catheter and dilator): Visual inspection of catheter surfaces. All samples met the pre-determined acceptance criteria.
- Dimensional Verification (catheter and dilator): Device dimensions were measured to confirm conformance to the product specification. 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. All samples met the pre-determined acceptance criteria.
- Flexion Fatigue: Tested per ISO 10555-1: 2013 for Flexural Fatigue. All samples met the pre-determined acceptance criteria.
- Inflation Fatigue: Tested per ISO 10555-1: 2013 for Inflation Fatigue - 20 inflation cycles. 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. All samples met the pre-determined acceptance criteria.
- ISO 80369-7: Small Bore Connectors for Hypodermic Applications: Tested per ISO 80369-7, dimensional, leakage by pressure decay, freedom from air leakage, positive pressure liquid leakage, sub-atmospheric pressure air leakage, stress cracking, resistance to separation from axial load, resistance to separation from unscrewing, resistance to overriding. All samples met the pre-determined acceptance criteria.
- Particulate Count: Effluent tested per AAMI TIR42, USP 788 using multiple insertion and withdrawal cycles. All samples met the pre-determined acceptance criteria.
- Peak Tensile Testing (catheter and dilator): Tested per ISO 10555-1 for tensile strength including all bonds/joints. All samples met the pre-determined acceptance criteria.
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.
SelectFlex 072 Neurovascular Access System K191664
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
§ 870.1250 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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
August 5, 2021
Q'Apel Medical Inc % Michele Lucey President Lakeshore Medical Device Consulting LLC 128 Blve Hill Landing Newbury, New Hampshire 03255
Re: K211893
Trade/Device Name: SelectFlex Neurovascular Access System Family Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: July 6, 2021 Received: July 7, 2021
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
Naira Muradyan, 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
2
Indications for Use
510(k) Number (if known) K211893
Device Name
SelectFlex Neurovascular Access System Family
Indications for Use (Describe)
The SelectFlex Neurovascular Access System Family 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
SPECIAL 510(k) SUMMARY As required by 21 CFR 807.92
Submitter Information:
| Submitter's Name: | Q'Apel Medical Inc |
|---|---|
| Address: | 46708 Lakeview Blvd |
| Fremont CA 94538 | |
| Telephone: | 510-738-6255 |
| Fax: | 510 738 6256 |
| Contact Person: | Michele Lucey |
| Telephone: | 603-748-1374 |
| Date Prepared: | August 4, 2021 |
| Device Trade Name: | SelectFlex Neurovascular Access System Family |
| Classification: | Class II |
| Product Code(s): | QJP, DQY |
| Regulation Number(s): | 870.1250 |
| Classification Name | Percutaneous Catheter |
| Predicate Devices: | SelectFlex 072 Neurovascular Access System K191664- |
| Indications for Use: |
The SelectFlex Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
Device Description
The SelectFlex Neurovascular Access System Family consists of sterile, single-use intravascular catheters used to facilitate access to target vasculature during interventional procedures. The system is composed of a SelectFlex Neurovascular Access Catheter, a 3cc Mode Control Syringe, a 7Fr Peel Away Introducer, Luer Activated Valve and a Dilator (only for versions with a Long Hydrophilic coating to ease dermal entry). The SelectFlex Neurovascular Access Catheter comes in usable lengths of 95, 105 or 115cm. The SelectFlex Neurovascular Access 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 Neurovascular Access Catheter comes in two options of a short hydrophilic coating length of 11.5cm or a long hydrophilic coating length of 30cm.
Comparison of Technological Characteristics
The SelectFlex Neurovascular Access System Family incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those contained in the SelectFlex 072 Neurovascular Access System (K191664). The following table provides a comparison of the subject device to the predicate device:
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| Comparison Table to Demonstrate Substantial Equivalence | |||
|---|---|---|---|
| Subject Device | Predicate Device | ||
| Feature | SelectFlex | ||
| Neurovascular | |||
| Access System | |||
| Family | SelectFlex 072 | ||
| Neurovascular | |||
| Access System | Comparison | ||
| Regulatory | |||
| Clearance/Approval | |||
| Reference | Pending | K191664 | NA |
| FDA Classification | Class II | Class II | Same |
| Product Code(s) | QJP, 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 | 95, 105, and 115cm | 105cm | Similar, additional |
| lengths are consistent | |||
| with catheters of this | |||
| type, this difference | |||
| does not raise new | |||
| questions regarding | |||
| safety of effectiveness | |||
| 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 | ||
| Comparison Table to Demonstrate Substantial Equivalence | |||
| Subject Device | Predicate Device | ||
| Feature | SelectFlex | ||
| Neurovascular | |||
| Access System | |||
| Family | SelectFlex 072 | ||
| Neurovascular | |||
| Access System | Comparison | ||
| Coating | Hydrophilic Coating | ||
| – Distal Portion | |||
| 11.5cm and 30cm | Hydrophilic Coating | ||
| – Distal Portion | |||
| 11.5cm | Similar, difference does | ||
| not raise new questions | |||
| regarding safety and | |||
| effectiveness | |||
| 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. | |||
| & | |||
| Two user-selectable | |||
| variable stiffness | |||
| modes of the distal | |||
| 10cm by application | |||
| of fluid into the | |||
| distal scaffold | |||
| chamber of the | |||
| catheter wall. Fluid | |||
| pressure enables the | |||
| more flexible | |||
| tracking mode; fluid | |||
| withdrawal switches | |||
| to a less flexible and | |||
| more supportive | |||
| mode. | 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. | |||
| & | |||
| Two user-selectable | |||
| variable stiffness | |||
| modes of the distal | |||
| 10cm by application | |||
| of fluid into the | |||
| distal scaffold | |||
| chamber of the | |||
| catheter wall. Fluid | |||
| pressure enables the | |||
| more flexible | |||
| tracking mode; fluid | |||
| withdrawal switches | |||
| to a less flexible and | |||
| more supportive | |||
| mode. | Same | ||
| Comparison Table to Demonstrate Substantial Equivalence | |||
| Feature | Subject Device | Predicate Device | Comparison |
| Distal End Segment | |||
| Length | SelectFlex | ||
| Neurovascular | |||
| Access System | |||
| Family | SelectFlex 072 | ||
| Neurovascular | |||
| Access System | Comparison | ||
| Distal End Segment | |||
| Length | 17, 22, and 27cm | 17cm | Similar, difference does |
| not raise new questions | |||
| regarding safety and | |||
| effectiveness | |||
| Tip Stiffness | 0.12 N (tracking and | ||
| support mode) | 0.12 N (tracking and | ||
| support mode) | Same | ||
| Accessories | |||
| Supplied | 7 Fr Introducer | ||
| Sheath | |||
| 3cc syringe | |||
| Luer Activated | |||
| Valve | |||
| Dilator (only | |||
| included with | |||
| catheters that have a | |||
| Long Hydrophilic | |||
| Coating) | 7 Fr Introducer | ||
| Sheath | |||
| 3cc syringe | |||
| Hub Extension Line | Similar, 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 |
5
6
Substantial Equivalence:
This summary demonstrates that the SelectFlex Neurovascular Access System Family and the predicate device have the same intended use, similar technological characteristics, materials, and principles of operation. It can therefore be concluded that the SelectFlex Neurovascular Access System Family is substantially equivalent to the predicate device.
7
Nonclinical Performance Data:
Determination of substantial equivalence is based on an assessment of non-clinical performance bench test data.
Bench Testing:
Bench testing was performed to evaluate physical integrity, functionality, and performance of the SelectFlex Neurovascular Access System Family. Performance data includes dimensional verification, delivery and removal under simulated use conditions, bond tensile strength, and compatibility with interface devices. A summary of all tests performed is provided in the following table:
| Test Description | Test Method | Results |
|---|---|---|
| Visual Surface | ||
| Requirements | ||
| (catheter and dilator) | Visual inspection of catheter | |
| surfaces | PASS | |
| All samples met the pre- | ||
| determined acceptance | ||
| criteria | ||
| Dimensional Verification | ||
| (catheter and dilator) | Device dimensions were measured to | |
| confirm conformance to the product | ||
| specification | 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 | ||
| Flexion Fatigue | Tested per ISO 10555-1: 2013 for | |
| Flexural Fatigue | 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 | ||
| ISO 80369-7: Small Bore | ||
| Connectors for | ||
| Hypodermic Applications | Tested per ISO 80369-7, dimensional, | |
| leakage by pressure decay, freedom from air | ||
| leakage, positive pressure liquid leakage, | ||
| sub-atmospheric pressure air leakage, stress | ||
| cracking, resistance to separation from axial | ||
| load, resistance to separation from | ||
| unscrewing, resistance to overriding | PASS | |
| All samples met the pre- | ||
| determined acceptance | ||
| criteria | ||
| Test Description | Test Method | Results |
| Particulate Count | Effluent tested per AAMI TIR42, USP | |
| 788 using multiple insertion and | ||
| withdrawal cycles | PASS | |
| All samples met the pre- | ||
| determined acceptance | ||
| criteria | ||
| Peak Tensile Testing | ||
| (catheter and dilator) | Tested per ISO 10555-1 for tensile | |
| strength including all bonds/joints | PASS | |
| All samples met the pre- | ||
| determined acceptance | ||
| criteria |
8
The results of these tests provide reasonable assurance that the 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 substantially equivalent to the predicate device.
Biocompatibility:
The subject device is primarily comprised of the same materials used in the predicate device. Where there are minor differences, biocompatibility has been demonstrated through company testing of other devices with the same tissue contact categorization. No additional biocompatibility testing was performed.
Conclusion:
Based on the indications for use, technological characteristics, and performance testing, the SelectFlex Neurovascular Access System Family has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the SelectFlex 072 Neurovascular Access System, K191664.