(21 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.
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 Aspiration 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 document describes the acceptance criteria and a study conducted for the ZOOM Reperfusion Catheters and ZOOM Aspiration Tubing (K210996).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Attribute | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Visual | Free of kinks, breaks, separation or particulate (greater than $0.25mm^2$). No exposed metal. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. (Implies performance met this and other specifications by not negatively impacting safety/effectiveness). |
| Dimensional (Effective Length) | All defined catheter dimensions are within the specified tolerances. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
| Catheter Bond Strength | The catheter shall have sufficient bond strengths to remain intact throughout a procedure. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
| Flowrate - Positive (Forward) Pressure | The catheter lumen shall allow for a minimum flowrate comparable to competitive products. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
| Flowrate – Vacuum Pressure | The flowrate under a vacuum shall be similar to or greater than competitive devices. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
| Freedom from Leakage – Positive Pressure | No liquid leakage from the hub or catheter shaft at 46psi for 30 seconds. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
| Freedom from Leakage – Negative Pressure | No air leakage into a 20cc syringe when vacuum pulled for 15 seconds. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
| Dynamic Burst Pressure | Catheter does not burst under pressures that could be seen when performing contrast injections with a standard 10cc syringe. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
| 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. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
| Corrosion Resistance | No visible corrosion present on devices after saline immersion followed by 30 minutes in boiling water followed by 48 hours in 37°C water bath. | The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness. |
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 primarily describes bench testing to evaluate differences between the subject and predicate devices. No information about sample sizes for a clinical test set is provided in this submission summary, nor details about data provenance (country of origin, retrospective/prospective). This type of submission (510(k) Special) largely relies on demonstrating substantial equivalence through engineering and performance testing.
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. The study described is bench testing, not a clinical study involving experts to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was bench testing, not a clinical study requiring adjudication.
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. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for medical devices (catheters and tubing), not an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" was the predefined performance specifications and test methods based primarily on catheter performance standard ISO 10555-1. The devices were tested against these engineering and functional standards.
8. The sample size for the training set
Not applicable. This is a medical device submission based on bench testing of physical products, not an AI or machine learning model that would require a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML submission.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 23, 2021
Imperative Care, Inc. Kristin Ellis Regulatory Affairs Manager 1359 Dell Avenue Campbell, California 95008
Re: K210996
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: April 1, 2021 Received: April 2, 2021
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 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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) K210996
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.
| 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: Address:
Contact Person: Telephone: Email: Date of Preparation: 1359 Dell Avenue Campbell, CA 95008 Kristin Ellis 408-857-0934 kellis@imperativecare.com April 1, 2021
Imperative Care, Inc.
B. Subject Device
Proprietary Name:
Common/Usual Name: Classification Name: Product Code: Regulation:
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing Catheter, Thrombus Retriever Catheter, Percutaneous NRY 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. K202182
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.
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| Product Name | 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" | 160 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 Model
| Product Name | Model Number | Tubing ID | Tubing Length |
|---|---|---|---|
| ZOOM Aspiration Tubing | TAT102B | 0.110" Minimum | 104" |
The ZOOM Aspiration 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 o
- Airflow rating of 0 23 LPM O
- 0 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 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) K202182 with the same device names. Table 3 presented below provides a comparison of the similarities and differences between the subject and predicate ZOOM Reperfusion Catheter and Aspiration Tubing.
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The comparison between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters demonstrates that the subject ZOOM Reperfusion Catheters is substantially equivalent to the predicate ZOOM Reperfusion Catheters and that there are no new safety or effectiveness concerns. This conclusion is based on all devices sharing the same intended use, basic technological characteristics, and performance characteristics.
| Device Attribute | ZOOM Reperfusion Catheters(Predicate Device – K202182) | ZOOM Reperfusion Catheters(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" | Same |
| Effective Length | 137 - 158cm | 137 - 160cm |
| Tip Design | Beveled edge, soft, flexible, andatraumatic | Same |
| Tip Length | 0.5 - 0.8cm | Same |
| Coating | Hydrophilic coating | Same |
| Materials | Commonly used medical grade plastics& metals with hydrophilic coating. | Same |
| Device Attribute | ZOOM Reperfusion Catheters(Predicate Device – K202182) | ZOOM Reperfusion Catheters(Subject Device) |
| 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 | ZOOM Aspiration Tubing(Predicate Device – K202182) | 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 | 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 Reperfusion Catheters and predicate ZOOM Reperfusion Catheters. Performance specifications and test methods were based primarily on catheter performance standard ISO
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10555-1 and a summary of the evaluated performance specifications is presented in Table 4 below.
The test results were reviewed and found to demonstrate that the differences between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters do not significantly impact any performance parameters that would negatively affect the safety or effectiveness of the subject ZOOM Reperfusion Catheters and Aspiration Tubing.
| Test Attribute | Specification |
|---|---|
| Visual | Free of kinks, breaks, separation or particulate (greater than $0.25mm^2$ ). No exposed metal. |
| Dimensional(Effective Length) | All defined catheter dimensions are within the specifiedtolerances. |
| Catheter Bond Strength | The catheter shall have sufficient bond strengths to remain intactthroughout a procedure. |
| Flowrate - Positive(Forward) Pressure | The catheter lumen shall allow for a minimum flowratecomparable to competitive products. |
| Flowrate – VacuumPressure | The flowrate under a vacuum shall be similar to or greater thancompetitive devices. |
| Freedom from Leakage– Positive Pressure | No liquid leakage from the hub or catheter shaft at 46psi for 30seconds |
| Freedom from Leakage– Negative Pressure | No air leakage into a 20cc syringe when vacuum pulled for 15seconds. |
| Dynamic Burst Pressure | Catheter does not burst under pressures that could be seen whenperforming contrast injections with a standard 10cc syringe. |
| Tip Flexibility | The flexibility of the catheter tip shall be comparable tocompetitive products and allow for easily tracking the device tothe desired target anatomy. |
| Corrosion Resistance | No visible corrosion present on devices after saline immersionfollowed by 30 minutes in boiling water followed by 48 hours in37°C water bath. |
Table 4: Tests and Performance Specifications for ZOOM Reperfusion Catheter
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There were no changes to the Zoom Aspiration Tubing or Zoom Aspiration Pump and no changes to the subject and predicate ZOOM Reperfusion Catheters 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, the original testing on the predicate devices applies to the subject devices and additional biocompatibility testing was not required.
I. Sterilization:
The ZOOM Reperfusion Catheters and Aspiration Tubing are both sterilized using validated EO processes with a sterility assurance level of 1x106 The sterilization processes were validated per the overkill method described in 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." There were no changes to the ZOOM Reperfusion Catheters 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 Reperfusion Catheters. In addition, there were no changes to the ZOOM Reperfusion Catheters that would impact the packaging validation.
K. Conclusions:
Where differences were identified between the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters, 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 was evaluated for applicability and either the
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rationale for no impact was documented or verification and validation was repeated as required. As appropriate, bench and laboratory testing were conducted to support this assessment.
Based on the results of the risk assessments and associated bench and laboratory testing, the subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters are substantially equivalent and there are no new safety or effectiveness concerns. The subject ZOOM Reperfusion Catheters and predicate ZOOM Reperfusion Catheters 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).