Imperative Care Radial 088 Access System

K220807 · Imperative Care, Inc. · QJP · May 17, 2022 · Cardiovascular

Device Facts

• Record ID: K220807
• Device Name: Imperative Care Radial 088 Access System
• Applicant: Imperative Care, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: May 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Imperative Care Radial 088 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Device Story

The Imperative Care Radial 088 Access System is a single-lumen, braid and coil reinforced catheter with a 6F dilator, designed for transradial access (TRA) to peripheral, coronary, and neuro vasculature. The system is used by clinicians under fluoroscopic guidance to provide a conduit for interventional devices. The catheter features a hydrophilic coating for trackability, an atraumatic angled tip, and a radiopaque marker for visualization. The dilator facilitates initial access. The system is used in clinical settings; the clinician advances the catheter over a guidewire to the target site, then uses it as a pathway for other interventional tools. By providing a stable, low-friction conduit, the device enables minimally invasive access to complex vascular anatomy, potentially improving procedural efficiency and patient outcomes.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included dimensional inspection, delivery/trackability in simulated neurological models, flexibility, kink resistance, torque strength, luer/guidewire/accessory compatibility, and coating integrity. Biocompatibility testing for the 6F dilator confirmed non-cytotoxicity, non-sensitization, non-irritation, and non-toxicity. Hemocompatibility testing (thromboresistance, hemolysis, complement activation) and material-mediated pyrogenicity testing were successfully completed.

Technological Characteristics

Single-lumen catheter; braid and coil reinforced; variable stiffness; medical grade polymers; hydrophilic coating on distal section; radiopaque distal marker. Dimensions: 0.088" ID, 0.107"-0.110" OD. 6F dilator included. Sterilization: Ethylene Oxide (EtO) per ISO 11135. Standards: ISO 10555-1 (catheter performance), ISO 80369-7 (luer compatibility), ASTM F1980-16 (accelerated aging), ASTM F1886/F2096/F88 (packaging).

Indications for Use

Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Regulatory Classification

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.

Predicate Devices

• TracStar™ LDP Large Distal Platform (K212224)

Submission Summary (Full Text)

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Imperative Care, Inc. Kristin Ellis, RAC Associate Director, Regulatory Affairs 1359 Dell Avenue Campbell, California 95008

Re: K220807

Trade/Device Name: Imperative Care Radial 088 Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: March 16. 2022 Received: March 18, 2022

Dear Kristin Ellis:

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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K220807

Device Name Imperative Care Radial 088 Access System

Indications for Use (Describe)

The Imperative Care Radial 088 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

| 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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# K220807: 510(k) Summary

#### A. Submitter Information

Submitter's Name: Address:

Contact Person: Telephone: Email: Date of Preparation:

#### B. Subject Device

Proprietary Name: Common/Usual Name: Classification Name: Product Code:

Regulation:

#### C. Predicate Device

Proprietary Name:

Common/Usual Name: Classification Name: Product Code:

Regulation: Manufacturer: 510(k):

Imperative Care, Inc. 1359 Dell Avenue Campbell, CA 95008 Kristin Ellis, RAC [phone] [e-mail] May 12, 2022

Imperative Care Radial 088 Access System Guide Catheter Catheter, Percutaneous, Neurovasculature OJP DQY 21 CFR 870.1250

TracStar™ LDP Large Distal Platform Zoom™ 88 Large Distal Platform Guide Catheter Catheter, Percutaneous, Neurovasculature OJP DQY 21 CFR. 870.1250 Imperative Care, Inc. K212224

## D. Device Description:

The Imperative Care Radial 088 Access System (Radial 088 Access System) consists of a single lumen catheter (Radial 088 Access Catheter) and a 6F Dilator intended to provide ease of access to the peripheral, coronary and neuro vasculature using a transradial access (TRA) approach.

The Radial 088 Access Catheter consists of a single lumen, braid and coil reinforced, variable stiffness catheter constructed using medical grade polymers. The catheter features include a standard luer hub on the proximal end and an atraumatic angled tip on the distal end. The distal section is covered in a lubricious hydrophilic coating for ease of tracking through tortuous vasculature to reach the target location. The distal tip has a radiopaque marker to provide the user with visual confirmation of the distal tip location during

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tracking and placement under fluoroscopy.

The Radial 088 Access Catheter is offered in working lengths of 95 cm, 105 cm, and 110 cm. The catheter has a proximal and distal inner diameter (ID) of 0.088" and is compatible with ≤ 0.038" diameter guidewires and 6F interventional devices having a minimum device length of 120 cm. The catheter has a distal outer diameter (OD) of 0.107" (2.7 mm) and a proximal OD of 0.110" (2.8 mm): the luer hub on the proximal end is compatible with Rotating Hemostasis Valves (RHVs) having a standard luer connector.

The 6F Dilator is a single lumen dilator with a tapered tip constructed of medical grade polymers. The 6F Dilator includes a standard luer hub on the proximal end which is compatible with standard luer lock devices (e.g., syringes). The 6F Dilator has an ID of 0.039" minimum, an OD of 0.083"-0.086" and is offered in a working length of 130 cm (± 2 cm).

Accessories and supplies required, but not supplied, include:

- Rotating Hemostatic Value (RHV) ●
- . Guidewires
- Support/diagnostic catheters .
- Heparinized saline ●

## E. Indications for Use:

The Imperative Care Radial 088 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

## F. Principles of Operation:

Use of the Radial 088 Access System relies on standard percutaneous interventional techniques, including access site preparation, introducing the catheter portion of the device, advancing the catheter under fluoroscopy, withdrawing the catheter, and closing the access site.

During use, the male luer of an ancillary RHV is attached to the proximal luer of the Radial 088 Access Catheter to create a continuous lumen through the catheter and to the RHV ports. The female luer of an ancillary RHV is typically connected to a saline drip line while an < 0.038" guidewire and other ancillary devices (such as support catheters) are used to gain vascular access facilitating advancement of the Radial 088 Access Catheter through the vasculature. Under fluoroscopy, the Radial 088 Access Catheter is advanced to the desired position, where it is used as a conduit to access the target site.

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# G. Predicate Comparison:

As shown in Table 1, the subject and predicate devices share the same intended use.

The differences in technological characteristics compared to the predicate device, for ease of tracking through tortuous vasculature, a range of working lengths designed to reach target anatomy, and the addition of the dilator, do not raise new questions of safety and effectiveness.

| Device Attribute | Subject Device | Predicate Device |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Imperative Care Radial 088 Access<br>System | TracStar LDP Large Distal Platform |
| 510(k) Number | K220807 | K212224 |
| Device Classification | Class II | Same |
| Regulation Number<br>and Name | 21 CFR §870.1250<br>Percutaneous Catheter | Same |
| Product Code | DQY, QJP | Same |
| Indications for Use | The Imperative Care Radial 088<br>Access System is indicated for the<br>introduction of interventional devices<br>into the peripheral, coronary, and<br>neuro vasculature. | The TracStar LDP Large Distal<br>Platform is indicated for the<br>introduction of interventional<br>devices into the peripheral, coronary,<br>and neuro vasculature. |
| Condition Supplied | Provided sterile, for single use only. | Same |
| Sterilization Method | Ethylene Oxide (EtO) gas | Same |
| Catheter Effective<br>Working Length | 95 cm<br>105 cm<br>110 cm | 80 cm<br>90 cm<br>95 cm<br>105 cm |
| Catheter Inner<br>Diameter (Distal and<br>Proximal) | 0.088" | Same |
| Catheter Outer<br>Diameter (Distal) | 0.107" | Same |
| Catheter Outer<br>Diameter (Proximal) | 0.110" | Same |
| Catheter Tip<br>Configuration | Atraumatic, angled tip | Same |
| Shaft Lumen | Single-lumen, braid and coil<br>reinforced shaft, variable stiffness | Same |

Table 1: Comparison of Subject and Predicate Devices

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| Device Attribute | Subject Device | Predicate Device |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Hydrophilic Coating | Distal portion of the catheter<br>contains a hydrophilic coating to<br>reduce friction during use. | Same |
| Accessories Provided<br>in Product Package | 6F Dilator | Rotating Hemostasis Valve (RHV) |
| Dilator Effective Length | $130 cm \pm 2 cm$ | N/A |
| Dilator ID | 0.039" minimum | N/A |
| Dilator OD | 0.083"-0.086" | N/A |
| Dilator Tip Configuration | Atraumatic, taper | N/A |
| Packaging<br>Configuration | The catheters are placed in a<br>protective polyethylene tube (which<br>is attached to the packaging card),<br>then the 6F Dilator is mounted onto a<br>polyethylene packaging card | The catheters are placed in a<br>protective polyethylene tube and<br>then mounted, along with the RHV,<br>onto a polyethylene packaging card. |
| | The packaging card is inserted into a<br>Tyvek® pouch which is then sealed. | The packaging card is inserted into<br>a Tyvek® pouch which is then<br>sealed. |
| | The sealed pouch and Instructions<br>for Use (IFU) are placed in a shelf<br>carton. | The sealed pouch and IFU are placed<br>in a shelf carton. |

# H. Performance Data Supporting Substantial Equivalence:

Bench and Laboratory (in-vitro) testing was completed to evaluate the differences between the subject device, Radial 088 Access System, and the predicate. Performance specifications and test methods were based primarily on catheter performance standard ISO 10555-1. A summary of the evaluated performance tests and specifications is presented in Table 2 and Table 3.

The test results were reviewed and found to demonstrate that the differences between the subject Radial 088 Access Catheter and predicate TracStar LDP catheters do not significantly impact any performance parameters that would adversely affect the safety or effectiveness of the subject Radial 088 Access System.

| Test Attribute | Specification | Results |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Dimensional Inspection | All defined catheter dimensions are within the<br>specified tolerances. | Pass |
| Test Attribute | Specification | Results |
| Delivery, Compatibility,<br>and Retraction<br>(Trackability) | The catheter shall be able to be delivered and<br>retracted per the IFU using radial access in a<br>simulated neurological model without<br>incurring any damage to the catheter. | Pass |
| Flexibility and Kink<br>Resistance | There shall be no kinking of shaft (permanent<br>deformation) after simulated use. Catheter<br>remains patent after removal of the dilator. | Pass |
| Catheter Torque Strength | No separation of any portion of the catheter<br>when rotated at least two (2) full rotations (720<br>degrees).<br>No damage to the catheter when hand rotated<br>during insertion. | Pass |
| Luer Compatibility | Devices shall be compatible with standard<br>syringe luer fittings per ISO 80369-7. | Pass |
| Guidewire Compatibility | The catheters shall be able to be delivered over<br>the maximum size guidewire indicated in the<br>product labeling. | Pass |
| Dilator Compatibility | The catheter should remain patent after<br>removal of the dilator to allow for the<br>introduction of interventional devices. | Pass |
| Interventional Device<br>Compatibility | The catheters shall be able to accommodate<br>other interventional devices (e.g., support<br>catheter, diagnostic catheter) up to the<br>maximum size indicated in the product<br>labeling. | Pass |
| Direct Puncture | The catheter with dilator can be inserted<br>without incurring any damage to the catheter<br>or causing catheter tip roll back. | Pass |
| Accessory Compatibility | Devices shall be compatible with an RHV. | Pass |
| Stability | The catheter provides enough support to<br>maintain its position when interventional<br>device is advanced to target location. | Pass |
| Pushability | The proximal shaft of the catheters shall have<br>sufficient stiffness that the user can easily push<br>the catheter to the target anatomy without<br>buckling. | Pass |
| Access Force | Catheters shall not require excessive force to<br>safely navigate and track to the target anatomy. | Pass |
| Coating<br>Integrity/Particulate | The amount of particulate matter that comes<br>off the hydrophilic coated shaft during<br>simulated use testing shall be determined and<br>compared to competitive products and<br>techniques. | Pass |

Table 2: Catheter Tests and Performance Specifications

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| Test Attribute | Specification | Results |
|-------------------------|--------------------------------------------------------------------------------------------------------------------|---------|
| Dimensional Inspection | All defined dilator dimensions are within the<br>specified tolerances. | Pass |
| Radiopacity | The distal tip of dilator can be seen under<br>fluoroscopy during use. | Pass |
| Dilator Bond Strength | The dilator shall have sufficient bond strength to<br>remain intact throughout a procedure. | Pass |
| Luer Compatibility | The dilator shall be compatible with<br>standard luer lock fittings per ISO 80369-<br>7. | Pass |
| Guidewire Compatibility | The dilator shall be able to be delivered over<br>the maximum size guidewire indicated in the<br>product labeling. | Pass |
| Direct Puncture | The dilator can be inserted without incurring any<br>damage. | Pass |

Table 3: Dilator Tests and Performance Specifications

#### Biocompatibility Testing: I.

There are no changes to patient contacting materials of the catheter component of the Radial 088 Access System, compared to the predicate device. Therefore, the original testing on the predicate devices applies to the Radial 088 Access Catheter and additional biocompatibility testing was not required. Biocompatibility testing was successfully completed to support the biological safety of the 6F Dilator component of the Radial 088 Access System.

| Test | Results | Conclusion |
|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Cytotoxicity<br>(ISO MEM* Elution) | The test article had no reactivity. | Non-cytotoxic |
| Sensitization<br>(Magnusson-Klingman<br>Method) | The extracts of the test article elicited no<br>reaction at the challenge following the<br>induction phase. | Non-sensitizer |
| Irritation/Intracutaneous<br>Reactivity<br>(ISO Intracutaneous<br>Irritation Test) | The test article sites did not show any<br>significantly greater biological reaction than<br>the sites injected with the control article.<br>The differences in the mean test and control<br>scores of the dermal observations were less<br>than 1.0. | Non-irritant |
| Acute Systemic Toxicity<br>(ISO Acute Systemic<br>Injection Test) | None of the animals treated with sample<br>extracts of the test article showed a<br>significantly greater biological reaction than<br>animals treated with sample extracts of the<br>control article. | Non-toxic |

Table 4: Biocompatibility Testing – 6F Dilator

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| Test | Results | Conclusion |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Hemocompatibility<br>(Complement Activation) | The test device had statistically similar<br>SC5b-9 concentrations when compared to<br>the predicate device and negative controls. | Pass |
| Hemocompatibility<br>(ASTM Hemolysis, Direct<br>Contact Method) | The difference between the hemolytic<br>indexes of the test sample and the negative<br>control equals 0 percent. | Non-hemolytic |
| Hemocompatibility<br>(ASTM Hemolysis, Extract<br>Method) | The difference between the hemolytic<br>indexes of the test sample and the negative<br>control equals 0.15 percent. | Non-hemolytic |
| Hemocompatibility<br>(in-vitro Blood Loop<br>Assay) | The test device received acceptable<br>thrombus formation scores. | Thromboresistant |
| Material Mediated<br>Pyrogenicity<br>(ISO Material Mediated<br>Rabbit Pyrogen) | No individual temperature rise of ≥ 0.5°C at<br>the observed time points. | Non-pyrogenic |

*MEM=Minimal Essential Media

## J. Sterilization:

The Radial 088 Access System is sterilized using a validated EtO process with a sterility assurance level (SAL) of 10 validated per the overkill method in accordance with ISO 11135, "Sterilization of Health-Care Products - Ethylene Oxide - Requirements for The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices".

# K. Shelf Life and Packaging:

Accelerated aging testing based on ASTM F1980-16 was conducted to verify packaged device performance. The devices were exposed to accelerated aging conditions equivalent to 13 months real time aging to support a 1-year shelf life. Device performance was verified by functional and performance testing. A summary of the completed packaging tests is presented below in Table 5.

| Test | Test Method | T=0 Results | T=1 year Results |
|------------------------------------------------|-----------------------------|-------------|------------------|
| Packaging Visual<br>Inspection | ASTM F1886 | Pass | Pass |
| Pouch Integrity Test -<br>Gross Leak Detection | ASTM F2096 | Pass | Pass |
| Pouch Seal Strength -<br>Peel Strength | ASTM F88 | Pass | Pass |
| Label Integrity | Imperative<br>Care Internal | Pass | Pass |

Table 5. Packaging Validation Summary

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## L. Conclusions:

The differences between the subject device and the predicate devices do not raise new questions of safety and effectiveness.

Imperative Care has completed comprehensive design verification and validation testing to evaluate the differences and to ensure that the Radial 088 Access System is biocompatible, performs as intended, meets all necessary performance attributes, and performs consistently throughout the device shelf life.

Based on the results of the risk assessments and associated bench and laboratory testing, the subject device described in this submission is substantially equivalent to the predicate device.