(29 days)
The ZOOM Reperfusion Catheters, with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump), are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The ZOOM Aspiration Tubing is intended to connect the ZOOM Reperfusion Catheter of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.
The ZOOM Reperfusion Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source, such as the ZOOM Aspiration Pump, using the ZOOM Aspiration Tubing.
The ZOOM Reperfusion Catheter is offered in various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1 below.
The ZOOM Reperfusion Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.
The distal section of the ZOOM Reperfusion Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.
The ZOOM Reperfusion Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.
The ZOOM Aspiration Tubing is offered in one model with the features indicated in Table 2.
The ZOOM Reperfusion Tubing is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the ZOOM Reperfusion Catheter and a slip fit connector that connects to the canister on the aspiration pump. The ZOOM Aspiration tubing is made of common medical grade polymers.
The provided text describes the performance data for the ZOOM Reperfusion Catheters and ZOOM Aspiration Tubing (Gen 2), comparing it to a predicate device (Gen 1). However, it does not include information about AI/algorithm-specific acceptance criteria or studies. The documentation focuses on demonstrating substantial equivalence to a previous version of the same medical device through bench and lab testing, biocompatibility, sterilization, and shelf-life testing.
Therefore, many of the requested sections related to AI/algorithm performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this document.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally qualitative "Pass" or "Comparable to predicate/competitive products" based on the described tests. The reported performance is summarized as "Pass" for all validated attributes, indicating that the device meets its internal specifications and is comparable to the predicate.
ZOOM Reperfusion Catheter
| Test Attribute | Specification | Reported Device Performance |
|---|---|---|
| Delivery, Compatibility, & Retraction (Trackability) | The catheter shall be able to be delivered, deployed, and retracted per the IFU within 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. | Pass |
| Compatibility with other devices (external) | The catheters shall be able to be delivered through the minimum introducer sheath or guide catheter size indicated in the product labeling. | Pass |
| Guidewire compatibility | The catheters shall be able to be delivered over the guidewire size indicated in the product labeling. | Pass |
| Interventional device compatibility (internal) | 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 |
| Luer compatibility | Devices and accessories shall be compatible with standard syringe luer fittings per ISO 80369-7. | Pass |
| Accessory compatibility | Devices shall be compatible with the accessory RHV. | Pass |
| Visual | Free of kinks, breaks, separation or particulate (greater than 0.25mm^2). No exposed metal. | Pass |
| Dimensional | All defined catheter dimensions are within the specified tolerances. | Pass |
| Catheter Bond Strength | The catheter shall have sufficient bond strengths to remain intact throughout a procedure. | Pass |
| Flowrate - positive (forward) pressure | The catheter lumen shall allow for a minimum flowrate comparable to competitive products. | Pass (Comparable) |
| Flowrate – vacuum pressure | The flowrate under a vacuum shall be similar to or greater than competitive devices. | Pass (Similar/Greater) |
| Freedom from Leakage – positive pressure | No liquid leakage from the hub or catheter shaft at 46psi for 30 seconds | Pass |
| Freedom from Leakage – negative pressure | No air leakage into a 20cc syringe when vacuum pulled for 15 seconds. | Pass |
| Burst Pressure | Catheter does not burst under pressures that could be seen when performing contrast injections with a standard 10cc syringe. | Pass |
| Catheter Torque Strength | No separation of any portion of the catheter when rotated at least two (2) full rotations (720 degrees). | Pass |
| Lumen Integrity | The catheter lumen shall not collapse under vacuum after multiple passes. | Pass |
| Kink Resistance | There shall be no kinking of the catheter shaft (permanent deformation) at anatomically relevant bend radii. | Pass |
| Flexibility | The flexibility of the catheter tip shall be comparable to competitive products and allow for easily tracking the device to the desired target anatomy. | Pass (Comparable) |
| Coating - 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 (Comparable) |
ZOOM Aspiration Tubing
| Test Attribute | Specification | Reported Device Performance |
|---|---|---|
| Vacuum Force at Catheter Tip | The vacuum force delivered by the aspiration tubing to the tip of the catheter should be comparable to the vacuum force delivered by the predicate aspiration tubing. | Pass (Comparable) |
| Connector Compatibility | The aspiration tubing connectors shall securely connect to the pump canister lid and standard luer fittings. | Pass |
| Lumen Collapse Test | The tubing lumen shall not collapse under vacuum. | Pass |
| Flow Control Functionality | The flow control mechanism shall allow users to start and stop flow multiple times when the connected pump is running at maximum vacuum. | Pass |
| Freedom From Leakage | The vacuum pressure delivered at the tip of the aspiration tubing shall be consistent with the pressure generated by the pump. | Pass |
| Tensile Strength | The bonds between the tubing and connectors shall be sufficiently strong to ensure the tubing remains intact during use. | Pass |
Biocompatibility Testing (ZOOM Reperfusion Catheter)
| Test | Test Method | Acceptance Criteria | Results |
|---|---|---|---|
| Cytotoxicity: ISO MEM Elution | ISO 10993-5 | Sample extracts must yield cell lysis grade 2 or lower. | Pass, Non-cytotoxic |
| Cytotoxicity: ISO MTT Assay | ISO 10993-5 | The percentage of cells exhibiting lysis should be similar for all test devices. No Significant Differences | Pass, No Significant Differences |
| Hemocompatibility: Hemolysis (Extract Method) | ASTM F 756 ISO 10993-4 | Sample extracts must be non-hemolytic (≤ 2% hemolytic index). | Pass, Non-hemolytic |
Sterilization Validation (ZOOM Reperfusion Catheter & ZOOM Aspiration Tubing)
| Requirement/Acceptance Criteria | Results | Summary |
|---|---|---|
| Positive BI controls must be positive in fractional, half and full cycles. | PASS | All positive controls in each cycle read positive. |
| Fractional cycle requirements: 1) IPCDs and EPCDs must be more difficult to sterilize than the natural product. | PASS | IPCDs and EPCDs showed more growth than natural product. |
| Fractional cycle requirements: 2) Product Sterility testing must show no growth in all samples. | PASS | The devices did not show any growth when tested per the methods in ISO 11737-2. |
| Fractional cycle requirements: 3) Bacteriostasis/Fungistasis testing must show that the product is not inhibitory for growth. | PASS | Bacteriostasis/Fungistasis Testing showed product is not inhibitory to growth when tested per the methods in ISO 11737-2. |
| Half cycle requirements: 1) IPCDs and EPCDs should show no growth for all samples. | PASS | IPCDs and EPCDs showed no growth. |
| Full cycle requirements: 1) IPCDs and EPCDs must show no growth for all samples. | PASS | IPCDs and EPCDs showed no growth. |
| Full cycle requirements: 2) The results for Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) shall meet the requirements of ISO 10993-7. | PASS | Samples passed EO residual testing. |
Packaging Validation (ZOOM Reperfusion Catheter & ZOOM Aspiration Tubing)
| Test | Test Method | T0 Results (Pass/Fail) | Shelf Life Results (Pass/Fail) |
|---|---|---|---|
| Packaging Visual Inspection | ASTM F1886 / Imperative Care Internal | Pass | Pass |
| Pouch Integrity Test - Gross Leak Detection | ASTM F2096 | Pass | Pass |
| Pouch Seal Strength – Peel Strength | ASTM F88 | Pass | Pass |
| Label Integrity | Imperative Care Internal | Pass | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document states that "The largest and smallest diameter catheters were tested for both the subject and predicate devices." Exact numerical sample sizes for each test are not specified, but the tests were performed on representative samples of the devices.
- Data Provenance: The studies were bench and lab testing. This means the tests were conducted in a laboratory setting on the physical devices themselves, not on patient data. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable in the clinical data sense. The testing was conducted by Imperative Care Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The reported studies are bench and lab testing of physical device performance, biocompatibility, sterilization, and packaging. There is no "ground truth" in the diagnostic sense or involvement of medical experts for interpreting diagnostic results. The acceptance criteria are based on engineering specifications and recognized consensus standards (e.g., ISO, ASTM).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is related to clinical interpretation or AI model output validation, which is not covered in this document.
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
No. This document describes the performance of a physical medical device (catheter and aspiration tubing), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This document does not describe an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for these engineering and biological tests are the established specifications, standards (e.g., ISO, ASTM), and comparison to the predicate device's performance.
8. The sample size for the training set
Not applicable. There is no AI model or training set described in this document.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set described in this document.
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September 2, 2020
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
Imperative Care Inc. Jake Wolenberg Regulatory Affairs Manager 1359 Dell Avenue Campbell, California 95008
Re: K202182
Trade/Device Name: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: July 31, 2020 Received: August 4, 2020
Dear Jake Wolenberg:
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 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
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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director (Acting) 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) K202182
Device Name
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
Indications for Use (Describe)
The ZOOM Reperfusion Catheters, with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump), are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The ZOOM Aspiration Tubing is intended to connect the ZOOM Reperfusion Catheter of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Special 510(k) Summary ZOOM™ Reperfusion Catheters and Aspiration Tubing
A. Submitter Information
Submitter's Name: Address:
Contact Person: Telephone: Email: Date of Preparation: Imperative Care Inc. 1359 Dell Avenue Campbell, CA 95008 Jake Wolenberg 248-496-0198 JWolenberg@imperativecare.com July 31, 2020
B. Subject Device
Proprietary Name:
Common/Usual Name: Classification Name: Product Code:
C. Predicate Device
Proprietary Name:
Common/Usual Name: Classification Name: Product Code: Manufacturer: 510(k) #:
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing Catheter, Thrombus Retriever Catheter, Percutaneous NRY per 21 C.F.R. 870.1250
MantaRay (071, 055, 045, 035) Reperfusion Catheters; Imperative Care Aspiration Tubing Set Catheter, Thrombus Retriever Catheter, Percutaneous NRY per 21 C.F.R. 870.1250 Imperative Care Inc. K183043
pg. 1 of 12
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D. Device Description:
The ZOOM Reperfusion Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source, such as the ZOOM Aspiration Pump, using the ZOOM Aspiration Tubing.
The ZOOM Reperfusion Catheter is offered in various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1 below.
| Product Name(Used Throughout 510k) | ModelNumber | DistalDiameter | ProximalDiameter | Nominal UsableCatheterLength | HydrophilicCoatingLength | ||
|---|---|---|---|---|---|---|---|
| ZOOM 71 | ICRC071137 | 0.071" | 0.083" | 0.071" | 0.083" | 137 cm | 35cm |
| ZOOM 55 | ICRC055137 | 0.055" | 0.069" | 0.067" | 0.080" | 137 cm | 35cm |
| ZOOM 45 | ICRC045144 | 0.045" | 0.060" | 0.064" | 0.080" | 144 cm | 65cm |
| ZOOM 35 | ICRC035158 | 0.035" | 0.051" | 0.047" | 0.061" | 158 cm | 90cm |
Table 1: ZOOM Reperfusion Catheter Sizes
The ZOOM Reperfusion Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.
The distal section of the ZOOM Reperfusion Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.
The ZOOM Reperfusion Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.
The ZOOM Aspiration Tubing is offered in one model with the features indicated in Table 2.
Table 2: ZOOM Aspiration Tubing Models
| Product Name(Used Throughout 510k) | Model Number | Tubing ID | Tubing Length |
|---|---|---|---|
| ZOOM Aspiration Tubing | TAT102B | 0.110" Minimum | 104" |
The ZOOM Reperfusion Tubing is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the ZOOM Reperfusion Catheter and a slip fit connector that connects to the canister on the aspiration pump. The ZOOM Aspiration tubing is made of common medical grade polymers.
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In addition to the accessories discussed above, the adjunctive devices and supplies listed below are intended to be used with the ZOOM Reperfusion Catheter and Aspiration Tubing.
- . Guidewires
- Support/Diagnostic Catheters
- Introducer Sheaths ●
- Aspiration Pump® ●
- Capable of achieving pressure between -20inHg to max vacuum ●
- Airflow rating of 0 23 LPM ●
- IEC 60601-1 Compliant ●
Imperative Care offers the ZOOM Aspiration Pump which meets the indicated criteria.
E. Indications for Use:
The ZOOM Reperfusion Catheters, with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump), are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The ZOOM Aspiration Tubing is intended to connect the ZOOM Reperfusion Catheter to the ZOOM Canister of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.
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Predicate Comparison: F.
The predicate device for the ZOOM Reperfusion Catheter and Aspiration Tubing in this Special 510(k) is the prior generation of ZOOM Reperfusion Catheter and Aspiration Tubing cleared under 510(k) K183043 with device name MantaRay (071, 055, 045, 035) Reperfusion Catheters; Imperative Care Aspiration Tubing Set. For ease of review the subject device is referred to as "Gen 2" and the predicate device cleared under 510(k) K183043 is referred to as "Gen 1" throughout the rest of this 510(k) Summary. Table 3 presented below provides a comparison of the similarities and differences between the Gen 1 and Gen 2 ZOOM Reperfusion Catheter and Aspiration Tubing.
The comparison between the subject and predicate devices demonstrates that Gen 2 ZOOM Reperfusion Catheter and Aspiration Tubing are substantially equivalent to the predicate Gen 1 versions of these devices and that there are no new safety or effectiveness concerns. This conclusion is based on all devices sharing the same intended use, basic technology characteristics, and performance characteristics, as demonstrated through bench and lab testing.
| Device Attribute | Gen 1 ZOOM Reperfusion Catheter(Predicate Device) | Gen 2 ZOOM Reperfusion Catheter(Subject Device) |
|---|---|---|
| FDA ProductClassification | Class II, NRY, 21 CFR 870.1250 | Same |
| Intended Use | Revascularization of patients with acuteischemic stroke. | Same |
| Indications for Use | See Section E. | Same |
| ConditionSupplied | Sterile and Single Use | Same |
| SterilizationMethod | Ethylene Oxide (EO), SAL 10-6 | Same |
| Nominal DistalInner Diameter | 0.035" - 0.071" | Same |
| Max DistalOuter Diameter | 0.053" - 0.085" | Same |
| Nominal ProximalInner Diameter | 0.047" - 0.071" | Same |
| Max ProximalOuter Diameter | 0.062" - 0.085" | Increased by 0.001" for all sizes |
| Effective Length | 137 - 158cm | Same |
| Tip Design | Beveled edge, soft, flexible, andatraumatic | Same |
| Tip Length | 0.5 - 1.5cm | 0.5 - 0.8cm |
| Device Attribute | Gen 1 ZOOM Reperfusion Catheter(Predicate Device) | Gen 2 ZOOM Reperfusion Catheter(Subject Device) |
| Coating | Hydrophilic coating | Same |
| Materials | Commonly used medical grade plastics& metals with hydrophilic coating. | Same |
| PackagedAccessories | Rotating Hemostasis Valve (RHV) | Same |
| PackagingConfiguration | The catheter is placed in a protectivepolyethylene tube and then mounted,along with the accessories, onto apolyethylene packaging card.The packaging card is inserted into aTyvek® pouch which is then sealed.The sealed pouch and IFU are placed ina carton box. | Same |
| Aspiration Pump | ZOOM Aspiration Pump | Same |
| Device Attribute | Gen 1 ZOOM Aspiration Tubing(Predicate Device) | Gen 2 ZOOM Aspiration Tubing(Subject Device) |
| Indications for Use | See Section E | Same |
| ConditionSupplied | Sterile and Single Use | Same |
| SterilizationMethod | Ethylene Oxide (EO), SAL 10-6 | Same |
| Tubing ID | 0.110" Minimum | Same |
| Tubing Length | 112" | 104" |
| Flow ControlMechanism | Flow Control Switch | Flow Control Clamp |
Table 3: Subject and Predicate Device Comparison
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G. Performance Data Supporting Substantial Equivalence:
Bench testing was conducted to evaluate the similarities and differences between the subject and predicate devices. The largest and smallest diameter catheters were tested for both the subject and predicate devices.
The test results were reviewed and found to demonstrate that the differences between the subject and predicate devices do not significantly impact any performance parameters that would negatively affect the safety or effectiveness of the subject Gen 2 ZOOM Reperfusion Catheter and Aspiration Tubing.
A summary of the tests and performance specifications that were evaluated is presented in Tables 4 and 5. These tests were performed per company approved protocols and test methods based primarily on catheter performance standard ISO 10555-1.
| Test Attribute | Specification |
|---|---|
| Delivery, Compatibility,and Retraction(Trackability) | The catheter shall be able to be delivered, deployed, and retractedper the IFU within a simulated neurological model withoutincurring any damage to the catheter. |
| Flexibility and KinkResistance | There shall be no kinking of shaft (permanent deformation) aftersimulated use. |
| Compatibility with otherdevices (external) | The catheters shall be able to be delivered through the minimumintroducer sheath or guide catheter size indicated in the productlabeling. |
| Guidewire compatibility | The catheters shall be able to be delivered over the guidewire sizeindicated in the product labeling. |
| Interventional devicecompatibility (internal) | The catheters shall be able to accommodate other interventionaldevices (e.g., support catheter, diagnostic catheter) up to themaximum size indicated in the product labeling. |
| Luer compatibility | Devices and accessories shall be compatible with standard syringeluer fittings per ISO 80369-7. |
| Accessory compatibility | Devices shall be compatible with the accessory RHV. |
| Visual | Free of kinks, breaks, separation or particulate (greater than0.25mm^2). No exposed metal. |
| Test Attribute | Specification |
| Dimensional | All defined catheter dimensions are within the specified tolerances. |
| Catheter Bond Strength | The catheter shall have sufficient bond strengths to remain intact throughout a procedure. |
| Flowrate - positive(forward) pressure | The catheter lumen shall allow for a minimum flowrate comparable to competitive products. |
| Flowrate – vacuumpressure | The flowrate under a vacuum shall be similar to or greater than competitive devices. |
| Freedom from Leakage– positive pressure | No liquid leakage from the hub or catheter shaft at 46psi for 30 seconds |
| Freedom from Leakage– negative pressure | No air leakage into a 20cc syringe when vacuum pulled for 15 seconds. |
| Burst Pressure | Catheter does not burst under pressures that could be seen when performing contrast injections with a standard 10cc syringe. |
| Catheter TorqueStrength | No separation of any portion of the catheter when rotated at least two (2) full rotations (720 degrees). |
| Lumen Integrity | The catheter lumen shall not collapse under vacuum after multiple passes. |
| Kink Resistance | There shall be no kinking of the catheter shaft (permanent deformation) at anatomically relevant bend radii. |
| Flexibility | The flexibility of the catheter tip shall be comparable to competitive products and allow for easily tracking the device to the desired target anatomy. |
| Coating - 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. |
Table 4: Tests and Performance Specifications for ZOOM Reperfusion Catheter
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| Test Attribute | Specification |
|---|---|
| Vacuum Force atCatheter Tip | The vacuum force delivered by the aspiration tubing to the tip ofthe catheter should be comparable to the vacuum force deliveredby the predicate aspiration tubing. |
| ConnectorCompatibility | The aspiration tubing connectors shall securely connect to thepump canister lid and standard luer fittings. |
| Lumen Collapse Test | The tubing lumen shall not collapse under vacuum. |
| Flow ControlFunctionality | The flow control mechanism shall allow users to start and stopflow multiple times when the connected pump is running atmaximum vacuum. |
| Freedom From Leakage | The vacuum pressure delivered at the tip of the aspiration tubingshall be consistent with the pressure generated by the pump. |
| Tensile Strength | The bonds between the tubing and connectors shall be sufficientlystrong to ensure the tubing remains intact during use. |
Table 5: Tests and Performance Specifications for ZOOM Aspiration Tubing
In addition to the above tests which support that the Gen 2 ZOOM Reperfusion Catheter and Aspiration Tubing perform as intended when used with the ZOOM Aspiration Pump, general performance testing was also completed for the accessory ZOOM Aspiration Pump as documented in 510(k) K190105.
H. Biocompatibility Testing:
While there are no new patient contacting materials for the Gen 2 ZOOM Reperfusion Catheters, a subset of supporting biocompatibility testing was completed per Imperative Care's risk management and change control procedures to confirm that the Gen 2 design and manufacturing updates did not result in any significant changes to the biocompatibility of the ZOOM Reperfusion Catheters.
The changes made to the Gen 2 ZOOM Aspiration Tubing were also reviewed and it was determined that no new biocompatibility testing was necessary to implement these changes as the aspiration tubing is non-patient contacting and there were no manufacturing process updates associated with the changes that were made.
The test results for the Gen 2 ZOOM Reperfusion Catheter were compared against the test results for the Gen 1 ZOOM Reperfusion Catheter, as summarized below in Table 6 and no significant differences were noted that would negatively impact the biocompatibility of the Gen 2 ZOOM Reperfusion Catheters.
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| Test | Test Method | ExtractionMethods/Conditions | Acceptance Criteria | Results |
|---|---|---|---|---|
| Cytotoxicity: ISOMEM* Elution | ISO 10993-5 | Test device extracted inMEM with 5% serum at 37 ± yield cell lysis grade 2 or1 °C for 24 ± 2 hours | Sample extracts mustlower. | Pass, Non-cytotoxic |
| Cytotoxicity: ISOMTT* Assay | ISO 10993-5 | Test device extracted inMTT* Assay Media at 37 ±1 ℃ for 24 ± 2 hours | The percentage of cellsexhibiting lysis should be Significantsimilar for all test devices. Differences | Pass, No |
| Hemocompatibility:Hemolysis (ExtractMethod) | ASTM F 756ISO 10993-4 | Test device extracted in PBSat 50 ± 2℃ for 72 ± 2 hours. Sample extracts must beExtract exposed to blood cell honhemolytic (≤ 2%suspension. % hemolysis ismeasured. | hemolytic index). | Pass, Non-hemolytic |
Table 6: Biocompatibility Test Summary
*MEM=Minimal Essential Media,
MTT Assay = (3-(4,5-Dimethylthiazol-2-yl)-2,5-Diphenyltetrazolium Bromide)
NS = Normal Saline
PBS=Phosphate Buffered Saline
I. Sterilization:
The ZOOM Reperfusion Catheter and Aspiration Tubing are both sterilized using validated EO processes with a sterility assurance level of 1x10 6. The sterilization processes were validated per the overkill method described recognized consensus standard ISO 11135, "Sterilization Of Health-Care Products - Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices." A summary of the completed testing is presented below in Tables 7 and 8.
Table 7: Sterilization Validation Summary - ZOOM Reperfusion Catheter
| Requirement/Acceptance Criteria | Results | Summary |
|---|---|---|
| Positive BI controls must be positive infractional, half and full cycles. | PASS | All positive controls in each cycle readpositive. |
| Fractional cycle requirements:1) IPCDs and EPCDs must be more difficultto sterilize than the natural product. | PASS | 1) IPCDs and EPCDs showed moregrowth than natural product. |
| 2) Product Sterility testing must show nogrowth in all samples. | PASS | 2) The devices did not show anygrowth when tested per the methodsin ISO 11737-2. |
| 3) Bacteriostasis/Fungistasis testing mustshow that the product is not inhibitory forgrowth. | PASS | 3) Bacteriostasis/Fungistasis Testingshowed product is not inhibitory togrowth when tested per the methodsin ISO 11737-2. |
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| Requirement/Acceptance Criteria | Results | Summary |
|---|---|---|
| Half cycle requirements:1) IPCDs and EPCDs should show no growthfor all samples. | PASS | 1) IPCDs and EPCDs showed nogrowth. |
| Full cycle requirements:1) IPCDs and EPCDs must show no growthfor all samples.2) The results for Ethylene Oxide (EO) andEthylene Chlorohydrin (ECH) shall meetthe requirements of ISO 10993-7. | PASS | 1) IPCDs and EPCDs showed nogrowth.2) Samples passed EO residual testing. |
Table 8: Sterilization Validation Summary – ZOOM Aspiration Tubing
| Requirement/Acceptance Criteria | Results | Summary |
|---|---|---|
| Positive BI controls must be positive infractional, half and full cycles. | PASS | All positive controls in each cycle readpositive. |
| Fractional cycle requirements:1) IPCDs and EPCDs must be more difficultto sterilize than the natural product. | PASS | 1) IPCDs and EPCDs showed moregrowth than natural product. |
| 2) Product Sterility testing must show nogrowth in all samples. | PASS | 2) The devices did not show anygrowth when tested per the methodsin ISO 11737-2. |
| 3) Bacteriostasis/Fungistasis testing mustshow that the product is not inhibitory forgrowth. | PASS | 3) Bacteriostasis/Fungistasis Testingshowed product is not inhibitory togrowth when tested per the methodsin ISO 11737-2. |
| Half cycle requirements:1) IPCDs and EPCDs should show nogrowth for all samples. | PASS | 1) IPCDs and EPCDs showed nogrowth. |
| Full cycle requirements:1) IPCDs and EPCDs must show no growthfor all samples. | PASS | 1) IPCDs and EPCDs showed nogrowth. |
| 2) The results for Ethylene Oxide (EO) andEthylene Chlorohydrin (ECH) shall meetthe requirements of ISO 10993-7. | PASS | 2) Samples passed EO residual testing. |
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Shelf Life and Packaging: J.
Accelerated aging testing based on ASTM F1980 was conducted to verify device, accessory, and packaging performance. A minimum shelf life was established based on this testing and is indicated by the expiration date provided on the product labeling.
Device and accessory performance was verified by repeating the functional tests previously presented in Section G of this 510(k) summary.
Packaging and sterile barrier integrity through transportation has been verified for the packaging configurations used for the ZOOM Reperfusion Catheter and ZOOM Aspiration Tubing. Aging testing has also been performed that supports the sterile barrier integrity following aging. A summary of the completed packaging tests is presented below in Tables 9 and 10.
Table 9: Packaging Validation Summary - ZOOM Reperfusion Catheter
| Test | Test Method | T0 Results(Pass/Fail) | Shelf Life Results(Pass/Fail) |
|---|---|---|---|
| Packaging VisualInspection | ASTM F1886Imperative CareInternal | Pass | Pass |
| Pouch Integrity Test -Gross Leak Detection | ASTM F2096 | Pass | Pass |
| Pouch Seal Strength– Peel Strength | ASTM F88 | Pass | Pass |
| Label Integrity | Imperative CareInternal | Pass | Pass |
Table 10: Packaging Validation Summary - ZOOM Aspiration Tubing
| Test | Test Method | T0 Results(Pass/Fail) | Shelf Life Results(Pass/Fail) |
|---|---|---|---|
| Packaging VisualInspection | ASTM F1886TWBM Internal | Pass | Pass |
| Pouch Integrity Test -Gross Leak Detection | ASTM F2096 | Pass | Pass |
| Pouch Seal Strength– Peel Strength | ASTM F88 | Pass | Pass |
| Label Integrity | TWBM Internal | Pass | Pass |
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K. Conclusions:
Where differences were identified between the subject Gen 2 ZOOM Reperfusion Catheter and Aspiration Tubing and the predicate Gen 1 ZOOM Reperfusion Catheter and Aspiration Tubing, a risk assessment was completed to determine if the difference would result in new safety or effectiveness concerns regarding the use of the device. As appropriate, bench and lab testing were conducted to support this assessment.
Based on the results of the completed risk assessments and associated testing, it is concluded that the subject Gen 2 ZOOM Reperfusion Catheter and Aspiration Catheter is substantially equivalent to the predicate Gen 1 ZOOM Reperfusion Catheter and Aspiration Tubing and that there are no new safety or effectiveness concerns associated with the identified differences. This conclusion is supported by the subject and predicate devices sharing the same intended use, basic technology characteristics, and equivalent performance characteristics, as confirmed through well-designed bench and lab testing.
§ 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).