(27 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 ZOOMTM 71 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 71 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 71 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 71 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 comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the ZOOM 71 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 acceptance criteria and study proving the device meets them are summarized below.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Attribute | Specification (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Dimensional (Distal OD, Distal ID) | All defined catheter dimensions are within the specified tolerances. | Test results demonstrated that defined catheter dimensions were within specified tolerances. |
| Catheter Bond Strength | The catheter shall have sufficient bond strengths to remain intact throughout a procedure. | Test results demonstrated sufficient bond strengths to remain intact throughout a procedure. |
| Kink Resistance | There shall be no kinking of the catheter shaft (permanent deformation) at anatomically relevant bend radii. | Test results demonstrated no kinking of the catheter shaft (permanent deformation) at anatomically relevant bend radii. |
| Tip 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. | Test results demonstrated comparable tip flexibility to competitive products, allowing for easy tracking to the desired target anatomy. |
| Freedom from Leakage - Positive Pressure | No liquid leakage from the hub or catheter shaft at 46psi for 30 seconds. | Test results demonstrated 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. | Test results demonstrated no air leakage into a 20cc syringe when vacuum pulled for 15 seconds. |
2. Sample Size and Data Provenance:
The document does not specify the exact sample sizes used for each bench test. The data provenance is laboratory bench testing conducted by Imperative Care, Inc.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. The study involved bench testing against engineering specifications, not clinical evaluation requiring expert ground truth.
4. Adjudication Method for Test Set:
Not applicable, as this was bench testing against engineering specifications.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The data presented is from bench testing to demonstrate substantial equivalence to a predicate device.
6. Standalone Algorithm Performance:
Not applicable. This device is a reperfusion catheter and aspiration tubing, not an AI algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this study was engineering specifications and performance standards (e.g., ISO 10555-1) used for bench testing.
8. Sample Size for Training Set:
Not applicable. This device is a physical medical device, not an AI algorithm that requires a training set.
9. How Ground Truth for Training Set was Established:
Not applicable, as there is no training set for a physical medical device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 8, 2021
Imperative Care, Inc. Teri Nguyen Senior Regulatory Affairs Specialist 1359 Dell Avenue Campbell, California 95008
Re: K211476
Trade/Device Name: ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: May 11, 2021 Received: May 12, 2021
Dear Teri Nguyen:
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
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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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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) K211476
Device Name
ZOOM 71 Reperfusion Catheter; 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.
| 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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510(k) Summary
A. Submitter Information
| Submitter's Name: | Imperative Care, Inc. |
|---|---|
| Address: | 1359 Dell AvenueCampbell, CA 95008 |
| Contact Person: | Teri Nguyen |
| Telephone: | 408-833-4415 |
| Email: | vtnguyen@imperativecare.com |
| Date of Preparation: | May 28, 2021 |
B. Subject Device
| Proprietary Name: | ZOOM 71 Reperfusion Catheter; ZOOM AspirationTubing | |
|---|---|---|
| Common/Usual Name: | Catheter, Thrombus Retriever | |
| Classification Name: | Catheter, Percutaneous | |
| Product Code: | NRY | |
| Regulation: | 21 CFR 870.1250 |
C. Predicate Device
Proprietary Name:
Common/Usual Name: Classification Name: Product Code: Regulation: Manufacturer: 510(k) #:
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing Catheter, Thrombus Retriever Catheter, Percutaneous NRY 21 CFR 870.1250 Imperative Care Inc. K210996
D. Device Description:
The ZOOMTM 71 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 71 Reperfusion Catheter is offered with the features indicated in Table 1.
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| Product Name | ModelNumber | DistalDiameter | ProximalDiameter | Nominal UsableCatheterLength | HydrophilicCoatingLength | ||
|---|---|---|---|---|---|---|---|
| Inner | Outer | Inner | Outer | ||||
| ZOOM 71 | ICRC071137 | 0.071" | 0.085" | 0.071" | 0.086" | 137 cm | 35cm |
Table 1: ZOOM 71 Reperfusion Catheter
The ZOOM 71 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 71 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 71 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.
| Product Name | Model Number | Tubing ID | Tubing Length |
|---|---|---|---|
| ZOOM Aspiration Tubing | TAT102B | 0.110" Minimum | 104" |
Table 2: ZOOM Aspiration Tubing Model
The ZOOM Aspiration Tubing is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the ZOOM 71 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.
In addition to the accessories discussed above, the adjunctive devices and supplies listed below are intended to be used with the ZOOM 71 Reperfusion Catheter and Aspiration Tubing.
- . Guidewires
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- . Support/Diagnostic Catheters
- Introducer Sheaths .
- Aspiration Pump* ●
- Capable of achieving pressure between -20inHg to max vacuum o
- Airflow rating of 0 23 LPM o
- o 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.
F. Predicate Comparison:
The predicate device for the ZOOM 71 Reperfusion Catheter in this Special 510(k) is the prior generation of ZOOM 71 Reperfusion Catheter cleared under 510(k) K210996 with the same device name. Table 3 presented below provides a comparison of the subject and predicate ZOOM 71 Reperfusion Catheter. A minor change was made to the subject ZOOM 71 Reperfusion Catheter to reinforce the distal catheter shaft.
The comparison between the subject ZOOM 71 Reperfusion Catheter and predicate ZOOM 71 Reperfusion Catheter demonstrates that the subject ZOOM 71 Reperfusion Catheter is substantially equivalent to the predicate ZOOM 71 Reperfusion Catheter and that there are no new safety or effectiveness concerns. This conclusion is based on the devices sharing the same intended use, basic technological characteristics, and performance characteristics.
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| Device Attribute | ZOOM 71 Reperfusion Catheter(Predicate Device – K210996) | ZOOM 71 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 | 0.071" | Same |
| Max DistalOuter Diameter | 0.085" | Same |
| Nominal ProximalInner Diameter | 0.071" | Same |
| Max ProximalOuter Diameter | 0.086" | Same |
| Effective Length | 137cm | Same |
| Tip Design | Beveled edge, soft, flexible, andatraumatic | Same |
| Tip Length | 0.5 - 0.8mm | Same |
| Distal CatheterShaft | Reinforced with metals and polymers | Additional polymer reinforcement |
| 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. | Same |
| Device Attribute | ZOOM 71 Reperfusion Catheter(Predicate Device – K210996) | ZOOM 71 Reperfusion Catheter(Subject Device) |
| The packaging card is inserted into aTyvek® pouch which is then sealed.The sealed pouch and IFU are placed ina carton box. | ||
| Aspiration Pump | ZOOM Aspiration Pump | Same |
| Shelf Life | 12 months | Same |
| Device Attribute | ZOOM Aspiration Tubing | ZOOM Aspiration Tubing |
| 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 | 104" | Same |
| Flow ControlMechanism | Flow Control Clamp | Same |
Table 3: Subject and Predicate Device Comparison
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G. Performance Data Supporting Substantial Equivalence:
Bench testing was completed to evaluate the differences between the subject ZOOM 71 Reperfusion Catheter and predicate ZOOM 71 Reperfusion Catheter. Performance specifications and test methods were based primarily on catheter performance standard ISO 10555-1 and a summary of the evaluated performance specifications is presented in Table 4 below.
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The test results were reviewed and found to demonstrate that the differences between the subject ZOOM 71 Reperfusion Catheter and predicate ZOOM 71 Reperfusion Catheter do not significantly impact any performance parameters that would negatively affect the safety or effectiveness of the subject ZOOM 71 Reperfusion Catheter.
| Test Attribute | Specification |
|---|---|
| Dimensional(Distal OD, Distal ID) | 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. |
| Kink Resistance | There shall be no kinking of the catheter shaft (permanent deformation) at anatomically relevant bend radii. |
| Tip 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. |
| 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. |
Table 4: Tests and Performance Specifications for ZOOM 71 Reperfusion Catheter
There were no changes to the ZOOM Aspiration Tubing or ZOOM Aspiration Pump and no changes to the subject and predicate ZOOM 71 Reperfusion Catheter that would impact compatibility with these components. Therefore, no additional performance testing was required for the ZOOM Aspiration Tubing or ZOOM Aspiration Pump.
H. Biocompatibility Testing:
There are no changes to materials compared to the predicate device. Therefore, testing in support of the predicate device applies to the subject device and additional biocompatibility testing was not required.
I. Sterilization:
The ZOOM 71 Reperfusion Catheter and Aspiration Tubing are both sterilized using validated Ethylene Oxide (EO) processes with a sterility assurance level of 1x106. The sterilization processes were validated per the overkill method described in the recognized consensus standard ISO 11135, "Sterilization Of Health-Care
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Products - Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices." There were no changes to the ZOOM 71 Reperfusion Catheter that would impact the validated EO process.
J. Shelf Life and Packaging:
Accelerated aging testing based on ASTM F1980 was previously conducted to verify packaged device performance. A minimum shelf life was established based on this testing and is indicated by the expiration date provided on the product labeling. There were no changes to packaging compared to the predicate ZOOM 71 Reperfusion Catheter. In addition, there were no changes to the ZOOM 71 Reperfusion Catheter that would impact the packaging validation.
K. Conclusions:
Where differences were identified between the subject ZOOM 71 Reperfusion Catheter and predicate ZOOM 71 Reperfusion Catheter, a risk assessment was completed to determine if the difference would result in new safety or effectiveness concerns. As appropriate, previous bench and laboratory testing were evaluated for applicability and either the rationale for no impact was documented or verification and validation was repeated as required. The results of design verification and validation did not raise different questions of safety and effectiveness.
Based on the results of the risk assessments and associated bench and laboratory testing, the subject ZOOM 71 Reperfusion Catheter and predicate ZOOM 71 Reperfusion Catheter are substantially equivalent and there are no new safety or effectiveness concerns. The subject ZOOM 71 Reperfusion Catheter and predicate ZOOM 71 Reperfusion Catheter share the same intended use, basic technological characteristics, and equivalent performance characteristics.
§ 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).