(60 days)
The Imperative Care Radial 088 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
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 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).
The provided text describes a 510(k) summary for the "Imperative Care Radial 088 Access System." The document extensively outlines the device, its intended use, comparison to a predicate device, and performance data supporting its substantial equivalence. However, it does not describe the acceptance criteria and study that proves the device meets the acceptance criteria in terms of clinical performance measures such as sensitivity, specificity, accuracy, or diagnostic effectiveness.
The document focuses on engineering and material-based performance tests commonly used for medical devices like catheters, ensuring they meet specified physical and material properties. It does not involve a study with a "test set" in the context of diagnostic or AI-driven medical devices (which would typically involve patient data and expert ground truth). Therefore, many of the requested items, particularly those related to diagnostic performance and AI studies, cannot be extracted from this document.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Test Attribute | Specification | Results |
|---|---|---|
| Catheter Tests | ||
| Dimensional Inspection | All defined catheter dimensions are within the specified tolerances. | Pass |
| Delivery, Compatibility, and Retraction (Trackability) | The catheter shall be able to be delivered and retracted per the IFU using radial access in a simulated neurological model without incurring any damage to the catheter. | Pass |
| Flexibility and Kink Resistance | There shall be no kinking of shaft (permanent deformation) after simulated use. Catheter remains patent after removal of the dilator. | Pass |
| Catheter Torque Strength | No separation of any portion of the catheter when rotated at least two (2) full rotations (720 degrees). No damage to the catheter when hand rotated during insertion. | Pass |
| Luer Compatibility | Devices shall be compatible with standard syringe luer fittings per ISO 80369-7. | Pass |
| Guidewire Compatibility | The catheters shall be able to be delivered over the maximum size guidewire indicated in the product labeling. | Pass |
| Dilator Compatibility | The catheter should remain patent after removal of the dilator to allow for the introduction of interventional devices. | Pass |
| Interventional Device Compatibility | The catheters shall be able to accommodate other interventional devices (e.g., support catheter, diagnostic catheter) up to the maximum size indicated in the product labeling. | Pass |
| Direct Puncture | The catheter with dilator can be inserted without incurring any damage to the catheter or causing catheter tip roll back. | Pass |
| Accessory Compatibility | Devices shall be compatible with an RHV. | Pass |
| Stability | The catheter provides enough support to maintain its position when interventional device is advanced to target location. | Pass |
| Pushability | The proximal shaft of the catheters shall have sufficient stiffness that the user can easily push the catheter to the target anatomy without buckling. | Pass |
| Access Force | Catheters shall not require excessive force to safely navigate and track to the target anatomy. | Pass |
| Coating Integrity/Particulate | The amount of particulate matter that comes off the hydrophilic coated shaft during simulated use testing shall be determined and compared to competitive products and techniques. | Pass |
| Dilator Tests | ||
| Dimensional Inspection | All defined dilator dimensions are within the specified tolerances. | Pass |
| Radiopacity | The distal tip of dilator can be seen under fluoroscopy during use. | Pass |
| Dilator Bond Strength | The dilator shall have sufficient bond strength to remain intact throughout a procedure. | Pass |
| Luer Compatibility | The dilator shall be compatible with standard luer lock fittings per ISO 80369-7. | Pass |
| Guidewire Compatibility | The dilator shall be able to be delivered over the maximum size guidewire indicated in the product labeling. | Pass |
| Direct Puncture | The dilator can be inserted without incurring any damage. | Pass |
| Biocompatibility Testing (6F Dilator) | ||
| Cytotoxicity (ISO MEM Elution) | No reactivity. (Conclusion: Non-cytotoxic) | Non-cytotoxic |
| Sensitization (Magnusson-Klingman Method) | Extracts elicited no reaction at the challenge following the induction phase. (Conclusion: Non-sensitizer) | Non-sensitizer |
| Irritation/Intracutaneous Reactivity | Test article sites did not show any significantly greater biological reaction than control sites. Differences in mean test and control scores were less than 1.0. (Conclusion: Non-irritant) | Non-irritant |
| Acute Systemic Toxicity | None of the animals treated with sample extracts showed a significantly greater biological reaction than animals treated with control extracts. (Conclusion: Non-toxic) | Non-toxic |
| Hemocompatibility (Complement Activation) | Statistically similar SC5b-9 concentrations when compared to the predicate device and negative controls. (Conclusion: Pass) | Pass |
| Hemocompatibility (ASTM Hemolysis, Direct Contact) | Difference between hemolytic indexes of test sample and negative control equals 0 percent. (Conclusion: Non-hemolytic) | Non-hemolytic |
| Hemocompatibility (ASTM Hemolysis, Extract Method) | Difference between hemolytic indexes of test sample and negative control equals 0.15 percent. (Conclusion: Non-hemolytic) | Non-hemolytic |
| Hemocompatibility (in-vitro Blood Loop Assay) | Acceptable thrombus formation scores. (Conclusion: Thromboresistant) | Thromboresistant |
| Material Mediated Pyrogenicity | No individual temperature rise of ≥ 0.5°C at observed time points. (Conclusion: Non-pyrogenic) | Non-pyrogenic |
| Shelf Life & Packaging | ||
| Packaging Visual Inspection | Pass (T=0) / Pass (T=1 year) | Pass |
| Pouch Integrity Test - Gross Leak Detection | Pass (T=0) / Pass (T=1 year) | Pass |
| Pouch Seal Strength - Peel Strength | Pass (T=0) / Pass (T=1 year) | Pass |
| Label Integrity | Pass (T=0) / Pass (T=1 year) | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes bench and laboratory (in-vitro) testing. It does not involve a "test set" of patient data in the sense of a clinical or AI diagnostic study. The testing was conducted in a simulated neurological model for trackability. No specific sample sizes for these bench tests are provided, nor is the country of origin or whether it was retrospective/prospective in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a catheter, and its performance evaluation involves engineering and biocompatibility testing, not expert-adjudicated ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is a catheter, and its performance evaluation involves engineering and biocompatibility testing, not expert adjudication on patient data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a catheter, not an AI-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a catheter, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on established engineering standards (e.g., ISO 10555-1 for catheter performance, ISO 80369-7 for luer compatibility, ASTM F1980-16 for accelerated aging) and biocompatibility testing guidelines. It's about meeting physical, chemical, and biological specifications rather than a diagnostic 'truth.'
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI algorithm that would have a "training set."
9. How the ground truth for the training set was established
Not applicable. This document describes a physical medical device, not an AI algorithm.
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Image /page/0/Picture/0 description: The image shows the date May 17, 2022. The month is spelled out, followed by the day and year. The text is in a clear, sans-serif font and is easy to read. The date is likely part of a document or calendar.
Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
{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
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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 (408) 857-0934 kellis@imperativecare.com 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 AccessSystem | TracStar LDP Large Distal Platform |
| 510(k) Number | K220807 | K212224 |
| Device Classification | Class II | Same |
| Regulation Numberand Name | 21 CFR §870.1250Percutaneous Catheter | Same |
| Product Code | DQY, QJP | Same |
| Indications for Use | The Imperative Care Radial 088Access System is indicated for theintroduction of interventional devicesinto the peripheral, coronary, andneuro vasculature. | The TracStar LDP Large DistalPlatform is indicated for theintroduction of interventionaldevices into the peripheral, coronary,and neuro vasculature. |
| Condition Supplied | Provided sterile, for single use only. | Same |
| Sterilization Method | Ethylene Oxide (EtO) gas | Same |
| Catheter EffectiveWorking Length | 95 cm105 cm110 cm | 80 cm90 cm95 cm105 cm |
| Catheter InnerDiameter (Distal andProximal) | 0.088" | Same |
| Catheter OuterDiameter (Distal) | 0.107" | Same |
| Catheter OuterDiameter (Proximal) | 0.110" | Same |
| Catheter TipConfiguration | Atraumatic, angled tip | Same |
| Shaft Lumen | Single-lumen, braid and coilreinforced 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 cathetercontains a hydrophilic coating toreduce friction during use. | Same |
| Accessories Providedin 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 |
| PackagingConfiguration | The catheters are placed in aprotective polyethylene tube (whichis attached to the packaging card),then the 6F Dilator is mounted onto apolyethylene packaging card | The catheters are placed in aprotective polyethylene tube andthen mounted, along with the RHV,onto a polyethylene packaging card. |
| The packaging card is inserted into aTyvek® pouch which is then sealed. | The packaging card is inserted intoa Tyvek® pouch which is thensealed. | |
| The sealed pouch and Instructionsfor Use (IFU) are placed in a shelfcarton. | The sealed pouch and IFU are placedin 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 thespecified tolerances. | Pass |
| Test Attribute | Specification | Results |
| Delivery, Compatibility,and Retraction(Trackability) | The catheter shall be able to be delivered andretracted per the IFU using radial access in asimulated neurological model withoutincurring any damage to the catheter. | Pass |
| Flexibility and KinkResistance | There shall be no kinking of shaft (permanentdeformation) after simulated use. Catheterremains patent after removal of the dilator. | Pass |
| Catheter Torque Strength | No separation of any portion of the catheterwhen rotated at least two (2) full rotations (720degrees).No damage to the catheter when hand rotatedduring insertion. | Pass |
| Luer Compatibility | Devices shall be compatible with standardsyringe luer fittings per ISO 80369-7. | Pass |
| Guidewire Compatibility | The catheters shall be able to be delivered overthe maximum size guidewire indicated in theproduct labeling. | Pass |
| Dilator Compatibility | The catheter should remain patent afterremoval of the dilator to allow for theintroduction of interventional devices. | Pass |
| Interventional DeviceCompatibility | The catheters shall be able to accommodateother interventional devices (e.g., supportcatheter, diagnostic catheter) up to themaximum size indicated in the productlabeling. | Pass |
| Direct Puncture | The catheter with dilator can be insertedwithout incurring any damage to the catheteror causing catheter tip roll back. | Pass |
| Accessory Compatibility | Devices shall be compatible with an RHV. | Pass |
| Stability | The catheter provides enough support tomaintain its position when interventionaldevice is advanced to target location. | Pass |
| Pushability | The proximal shaft of the catheters shall havesufficient stiffness that the user can easily pushthe catheter to the target anatomy withoutbuckling. | Pass |
| Access Force | Catheters shall not require excessive force tosafely navigate and track to the target anatomy. | Pass |
| CoatingIntegrity/Particulate | The amount of particulate matter that comesoff the hydrophilic coated shaft duringsimulated use testing shall be determined andcompared to competitive products andtechniques. | Pass |
Table 2: Catheter Tests and Performance Specifications
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| Test Attribute | Specification | Results |
|---|---|---|
| Dimensional Inspection | All defined dilator dimensions are within thespecified tolerances. | Pass |
| Radiopacity | The distal tip of dilator can be seen underfluoroscopy during use. | Pass |
| Dilator Bond Strength | The dilator shall have sufficient bond strength toremain intact throughout a procedure. | Pass |
| Luer Compatibility | The dilator shall be compatible withstandard luer lock fittings per ISO 80369-7. | Pass |
| Guidewire Compatibility | The dilator shall be able to be delivered overthe maximum size guidewire indicated in theproduct labeling. | Pass |
| Direct Puncture | The dilator can be inserted without incurring anydamage. | 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(ISO MEM* Elution) | The test article had no reactivity. | Non-cytotoxic |
| Sensitization(Magnusson-KlingmanMethod) | The extracts of the test article elicited noreaction at the challenge following theinduction phase. | Non-sensitizer |
| Irritation/IntracutaneousReactivity(ISO IntracutaneousIrritation Test) | The test article sites did not show anysignificantly greater biological reaction thanthe sites injected with the control article.The differences in the mean test and controlscores of the dermal observations were lessthan 1.0. | Non-irritant |
| Acute Systemic Toxicity(ISO Acute SystemicInjection Test) | None of the animals treated with sampleextracts of the test article showed asignificantly greater biological reaction thananimals treated with sample extracts of thecontrol article. | Non-toxic |
Table 4: Biocompatibility Testing – 6F Dilator
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| Test | Results | Conclusion |
|---|---|---|
| Hemocompatibility(Complement Activation) | The test device had statistically similarSC5b-9 concentrations when compared tothe predicate device and negative controls. | Pass |
| Hemocompatibility(ASTM Hemolysis, DirectContact Method) | The difference between the hemolyticindexes of the test sample and the negativecontrol equals 0 percent. | Non-hemolytic |
| Hemocompatibility(ASTM Hemolysis, ExtractMethod) | The difference between the hemolyticindexes of the test sample and the negativecontrol equals 0.15 percent. | Non-hemolytic |
| Hemocompatibility(in-vitro Blood LoopAssay) | The test device received acceptablethrombus formation scores. | Thromboresistant |
| Material MediatedPyrogenicity(ISO Material MediatedRabbit Pyrogen) | No individual temperature rise of ≥ 0.5°C atthe 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 VisualInspection | ASTM F1886 | Pass | Pass |
| Pouch Integrity Test -Gross Leak Detection | ASTM F2096 | Pass | Pass |
| Pouch Seal Strength -Peel Strength | ASTM F88 | Pass | Pass |
| Label Integrity | ImperativeCare 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.
§ 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).