(243 days)
No
The provided text describes a medical device (catheter system) for stroke treatment, outlining its physical components and intended use. There is no mention of data processing, analytical functions, or any terms related to AI, machine learning, or deep learning within the description.
Yes
The device is used for revascularization in patients with acute ischemic stroke, which is a medical treatment aimed at restoring blood flow to an organ or tissue.
No
This device is used for revascularization and removal of thrombus/clot in patients with acute ischemic stroke, which is a treatment, not a diagnostic purpose.
No
The device is a physical medical device (catheter system) designed for mechanical thrombectomy. The description explicitly details physical components like catheters, tubing, and a pump, and refers to physical procedures. It does not mention any software components or functionality as the primary or sole purpose of the device.
No.
This device is an aspiration catheter system used for mechanical thrombectomy in acute ischemic stroke. It is used directly on the patient to remove a thrombus, not to perform analysis on in vitro specimens.
N/A
Intended Use / Indications for Use
The Zoom 7X Catheter, with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing, and the Zoom Aspiration Pump (or equivalent vacuum pump), is 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 last known well.
Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.
The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (7X, 71, 55, 45, 35) Catheter and the TracStar LDP Large Distal Platform, the Zoom 88 Large Distal Platform, or the Zoom 88 Large Distal Platform Support to the Zoom Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.
Product codes
NRY
Device Description
The Zoom™ 7X 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 or the Zoom POD Aspiration Tubing.
The Zoom 7X 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 7X 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 7X Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is intended to be attached to the proximal hub of the catheter and used to control hemostasis during use with other devices. The Zoom 7X Catheter is also packaged with two (2) introducer sheath accessories. The introducer is intended to assist with insertion of the Zoom 7X Catheter into the RHV or the guide catheter.
The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Zoom 7X 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 could be used with the Zoom 7X Catheter, Zoom Aspiration Tubing, and Zoom POD Aspiration Tubing.
- Guidewires
- Support/Diagnostic Catheters
- Aspiration Pump*
- Capable of achieving pressure between -20inHg to max vacuum (-29.9 inHg)
- Airflow rating of 0 – 23 LPM
- IEC 60601-1 Compliant
*Imperative Care offers the Zoom Aspiration Pump which meets the indicated criteria.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Bench Testing:
- Delivery, Compatibility, and 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. Results: Pass.
- Compatibility with Other Devices (External): The catheter shall be able to be delivered through the minimum introducer sheath or guide catheter size indicated in the product labeling. Results: Pass.
- Guidewire Compatibility: The catheter shall be able to be delivered over the maximum size guidewire indicated in the product labeling. Results: Pass.
- Microcatheter / Intermediate Catheter Compatibility: The catheter shall be able to accommodate a microcatheter/intermediate catheter up to the maximum size indicated in the product labeling. Results: Pass.
- Tip Flexibility: The catheter distal tip flexibility shall be comparable to the predicate. Results: Pass.
- Visual Inspection: The catheter shall meet visual inspection criteria. The printing on the strain relief must be legible. Results: Pass.
- Dimensional (ID, Distal OD, Tip Length): All defined catheter dimensions are within the specified tolerances. Results: Pass.
- Catheter Bond Strength: The catheter shall have sufficient bond strength to remain intact throughout a procedure. Results: Pass.
- Dynamic Burst: The catheter must withstand pressure testing under dynamic flow conditions. Results: Pass.
- Static Burst: The catheter shall meet criteria for static burst pressure testing. Results: Pass.
- Catheter Torque Strength: With the catheter tip constrained from movement, the proximal end was rotated until failure. The catheter shall not be damaged when rotated at least two (2) full rotations (720 degrees). Results: Pass.
- Kink Resistance: There shall be no kinking of the catheter shaft around respective clinically relevant minimum bend radii in distal tip, medial and proximal locations. Results: Pass.
- Flexibility: The catheter needs to have acceptable flexure values for tracking in the vasculature. Results: Pass.
- Luer Compatibility: Device and accessories shall be compatible with standard syringe luer fittings per ISO 80369-7. Results: Pass.
- Accessory Compatibility: Device shall be compatible with an RHV. Results: Pass.
- Coating - Particulate: The amount of particulate matter generated during simulated use testing shall be determined and comparable to competitive products. Results: Pass.
- Coating – Lubricity, Durability, and Integrity: Coating must be lubricious with a specified average pull force. There were no coating anomalies or significant wear observed post simulated use. Results: Pass.
- Clot Retrieval: The device shall be able to aspirate a variety of clot types in a range of vessel diameters. Results: Pass.
Performance tests for the Zoom POD Aspiration Tubing:
- Visual Inspection: The Zoom POD Aspiration Tubing shall meet visual inspection criteria. Results: Pass.
- Dimensional (Working Length): The working length is within the specified tolerances. Results: Pass.
- 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. Results: Pass.
- Connector Compatibility: The aspiration tubing connectors shall securely connect to the pump canister lid and standard luer fittings. Results: Pass.
- Lumen Collapse Test: The tubing lumen shall not collapse under vacuum. Results: 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. Results: 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. Results: Pass.
- Tensile Strength: The bonds between the tubing and connectors shall be sufficiently strong to ensure the tubing remains intact during use. Results: Pass.
- Clot Filter Functionality (Zoom POD only): The clot filter should be able to be opened and closed without causing leak. Results: Pass.
Biocompatibility Test Summary – Introducer Sheath:
- Cytotoxicity (ISO 10993-5): Test article extracts must yield grade 2 or lower. Results: Pass, Non-cytotoxic.
- Sensitization (ISO 10993-10): Test article extracts must yield grade 0. Results: Pass, Non-sensitizing.
- Intracutaneous Reactivity (ISO 10993-23): Test article extracts must yield a difference between the test extract overall mean score and corresponding control overall mean score of 1.0 or less. Results: Pass, Non-irritating.
- Acute Systemic Toxicity (ISO 10993-11): None of the animals treated with the test article extracts must show a significantly greater reactivity than animals treated with the control article. Results: Pass, Non-toxic (acute systemic).
- Material-Mediated Pyrogenicity (ISO 10993-11): Test article extract must yield
§ 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).
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 28, 2025
Imperative Care, Inc.
Michael Wong
Lead Regulatory Affairs Specialist
1359 Dell Avenue
Campbell, California 95008
Re: K243047
Trade/Device Name: Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: NRY
Dated: April 29, 2025
Received: April 29, 2025
Dear Michael Wong:
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 (the 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 available 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.
Page 2
K243047 - Michael Wong Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K243047 - Michael Wong Page 3
assistance/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 -S
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243047
Device Name: Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
Indications for Use (Describe)
The Zoom 7X Catheter, with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing, and the Zoom Aspiration Pump (or equivalent vacuum pump), is 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 last known well.
Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.
The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (7X, 71, 55, 45, 35) Catheter and the TracStar LDP Large Distal Platform, the Zoom 88 Large Distal Platform, or the Zoom 88 Large Distal Platform Support to the Zoom Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
K243047 – 510(k) Summary
I. SUBMITTER
Submitter's Name: Imperative Care, Inc.
Address: 1359 Dell Avenue
Campbell, CA 95008
Contact Person: Michael Wong
Telephone: 925-337-1530
Email: mwong@imperativecare.com
Date of Preparation: May 23, 2025
II. DEVICE
Proprietary Names: Zoom™ 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
Common/Usual Name: Catheter, Thrombus Retriever
Classification Name: Percutaneous Catheter
Regulatory Class: II
Product Code: NRY
Regulation: 21 CFR 870.1250
III. PREDICATE DEVICE
Proprietary Name: ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing
Common/Usual Name: Catheter, Thrombus Retriever
Classification Name: Percutaneous Catheter
Product Code: NRY
Regulation: 21 CFR 870.1250
Manufacturer: Imperative Care, Inc.
510(k) #: K211476
IV. DEVICE DESCRIPTION
The Zoom™ 7X 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 or the Zoom POD Aspiration Tubing.
The Zoom 7X 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 7X Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel
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K243047 Page 2 of 11
branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.
The Zoom 7X Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is intended to be attached to the proximal hub of the catheter and used to control hemostasis during use with other devices. The Zoom 7X Catheter is also packaged with two (2) introducer sheath accessories. The introducer is intended to assist with insertion of the Zoom 7X Catheter into the RHV or the guide catheter.
The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Zoom 7X 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 could be used with the Zoom 7X Catheter, Zoom Aspiration Tubing, and Zoom POD Aspiration Tubing.
- Guidewires
- Support/Diagnostic Catheters
- Aspiration Pump*
- Capable of achieving pressure between -20inHg to max vacuum (-29.9 inHg)
- Airflow rating of 0 – 23 LPM
- IEC 60601-1 Compliant
*Imperative Care offers the Zoom Aspiration Pump which meets the indicated criteria.
V. INDICATIONS FOR USE
The Zoom 7X Catheter, with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing, and the Zoom Aspiration Pump (or equivalent vacuum pump), is 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 last known well.
Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.
The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (7X, 71, 55, 45, 35) Catheter and the TracStar LDP Large Distal Platform, the Zoom 88 Large Distal Platform, or the Zoom 88 Large Distal Platform Support to the Zoom Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
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K243047 Page 3 of 11
The predicate device is the Imperative Care ZOOM 71 Reperfusion Catheter and ZOOM Aspiration Tubing cleared under K211476. The predicate and subject devices share the same intended use, basic technological characteristics, and equivalent performance characteristics, demonstrated through bench testing. Table 1 provides a comparison of the subject Zoom 7X Catheter and the predicate ZOOM 71 Reperfusion Catheter. Table 2 provides a comparison of the subject Zoom Aspiration Tubing and Zoom POD Aspiration Tubing and the predicate ZOOM Aspiration Tubing.
Table 1: Comparison of Technological Characteristics with Predicate Device – Zoom 7X Catheter
| Device Attribute | Predicate Device | Subject Device |
|---|---|---|
| FDA Product Classification | Class II Product Code: NRY 21 CFR 870.1250 | Same as Predicate |
| Product Name | ZOOM 71 Reperfusion Catheter | Zoom 7X Catheter |
| 510(k) Number | K211476 | K243047 |
| Manufacturer | Imperative Care, Inc. | Same |
| Intended Use | Revascularization of patients with acute ischemic stroke. | Same |
| 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 7X Catheter, with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing, and the Zoom Aspiration Pump (or equivalent vacuum pump), is 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 last known well. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. |
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K243047 Page 4 of 11
| Device Attribute | Predicate Device | Subject Device |
|---|---|---|
| Condition Supplied | Sterile, Single Use Only | Same |
| Sterilization Method | Ethylene Oxide (EO), Sterility Assurance Level (SAL) 10⁻⁶ | Same |
| One (1) EO cycle | Up to two (2) EO cycles | |
| Nominal Distal Inner Diameter | 0.071" | Same |
| Maximum Distal Outer Diameter | 0.085" | Same |
| Nominal Proximal Inner Diameter | 0.071" | Same |
| Maximum Proximal Outer Diameter | 0.086" | Same |
| Effective Working Length | 137 cm | Same |
| Tip Design | Beveled edge, soft, flexible, atraumatic | Pre-shaped tip, beveled edge, soft, flexible, atraumatic |
| Tip Length | 0.5 – 0.8 mm (point to point) 0.4 – 0.7 mm (line to line) | Same |
| Distal Catheter Shaft | Reinforced with metals and polymers | Same |
| Coating | Hydrophilic coating | Same |
| Materials | Commonly used medical grade plastics and metals with hydrophilic coating | Same |
| Packaged Accessories | One (1) Rotating Hemostasis Valve (RHV) | One (1) RHV Two (2) Introducer sheaths |
| Packaging Configuration | The catheter is placed in a protective polyethylene tube and then mounted, along with the accessories, onto a polyethylene packaging card. The packaging card is inserted into a Tyvek® pouch which is then sealed. The sealed pouch and IFU are placed in a shelf carton. | Same |
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K243047 Page 5 of 11
| Device Attribute | Predicate Device | Subject Device |
|---|---|---|
| Aspiration Pump | Zoom Aspiration Pump or equivalent | Same |
| Shelf Life | 12 Months (1 Year) | Same |
Table 2: Comparison of Technological Characteristics with Predicate Device – Zoom and Zoom POD Aspiration Tubing
| Device Attribute | Predicate Device (K211476) | Subject Device (K243047) |
|---|---|---|
| Product Name | ZOOM Aspiration Tubing | Zoom Aspiration Tubing; Zoom POD Aspiration Tubing |
| Indications for Use | 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. | The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (7X, 71, 55, 45, 35) Catheter and the TracStar LDP Large Distal Platform, the Zoom 88 Large Distal Platform, or the Zoom 88 Large Distal Platform Support to the Zoom Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow. |
| Condition Supplied | Sterile and Single Use | Same |
| Sterilization Method | EO, SAL 10⁻⁶ | Same |
| Nominal Tubing Inner Diameter | 0.110" | Same |
| Nominal Working Length | 104" | Zoom Aspiration Tubing: 104" Zoom POD Aspiration Tubing: 117" |
| Flow Control Mechanism | External Pinch Clamp | Same |
| Clot Filter | N/A – does not have a clot filter | Zoom Aspiration Tubing: N/A Zoom POD Aspiration Tubing: in-line clot filter |
| Packaging Configuration | The Zoom Aspiration Tubing is coiled and placed inside a labeled pouch and sealed. The sealed pouch and IFU are placed in a labeled shelf carton box. | Same |
| Shelf Life | 43 months | Same |
VII. PERFORMANCE DATA
The following performance data was provided in support of the substantial equivalence determination.
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K243047 Page 6 of 11
Non-Clinical Bench Testing
A summary of the evaluated design and performance specifications for the Zoom 7X Catheter is listed below. Performance specifications and test methods were based primarily on catheter performance standard ISO 10555-1. The test results were reviewed and found to demonstrate that the differences between the subject device and predicate device do not significantly impact any performance parameters that would negatively affect the safety or effectiveness of the subject device.
Table 3: Performance Tests for the Zoom 7X Catheter
| Test Attribute | Acceptance Criterion | Results |
|---|---|---|
| Delivery, Compatibility, and 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 |
| Compatibility with Other Devices (External) | The catheter shall be able to be delivered through the minimum introducer sheath or guide catheter size indicated in the product labeling. | Pass |
| Guidewire Compatibility | The catheter shall be able to be delivered over the maximum size guidewire indicated in the product labeling. | Pass |
| Microcatheter / Intermediate Catheter Compatibility | The catheter shall be able to accommodate a microcatheter/intermediate catheter up to the maximum size indicated in the product labeling. | Pass |
| Tip Flexibility | The catheter distal tip flexibility shall be comparable to the predicate. | Pass |
Page 11
K243047 Page 7 of 11
| Test Attribute | Acceptance Criterion | Results |
|---|---|---|
| Visual Inspection | The catheter shall meet visual inspection criteria. The printing on the strain relief must be legible. | Pass |
| Dimensional (ID, Distal OD, Tip Length) | All defined catheter dimensions are within the specified tolerances. | Pass |
| Catheter Bond Strength | The catheter shall have sufficient bond strength to remain intact throughout a procedure. | Pass |
| Dynamic Burst | The catheter must withstand pressure testing under dynamic flow conditions. | Pass |
| Static Burst | The catheter shall meet criteria for static burst pressure testing. | Pass |
| Catheter Torque Strength | With the catheter tip constrained from movement, the proximal end was rotated until failure. The catheter shall not be damaged when rotated at least two (2) full rotations (720 degrees). | Pass |
| Kink Resistance | There shall be no kinking of the catheter shaft around respective clinically relevant minimum bend radii in distal tip, medial and proximal locations. | Pass |
| Flexibility | The catheter needs to have acceptable flexure values for tracking in the vasculature. | Pass |
| Luer Compatibility | Device and accessories shall be compatible with standard syringe luer fittings per ISO 80369-7. | Pass |
| Accessory Compatibility | Device shall be compatible with an RHV. | Pass |
Page 12
K243047 Page 8 of 11
| Test Attribute | Acceptance Criterion | Results |
|---|---|---|
| Coating - Particulate | The amount of particulate matter generated during simulated use testing shall be determined and comparable to competitive products. | Pass |
| Coating – Lubricity, Durability, and Integrity | Coating must be lubricious with a specified average pull force. There were no coating anomalies or significant wear observed post simulated use. | Pass |
| Clot Retrieval | The device shall be able to aspirate a variety of clot types in a range of vessel diameters. | Pass |
The performance of the Zoom Aspiration Tubing is supported by testing conducted in K211476. A summary of the key performance specifications for the Zoom POD Aspiration Tubing is listed below. The test results were reviewed and found to demonstrate that the differences between the subject device and predicate device do not significantly impact any performance parameters that would negatively affect the safety or effectiveness of the subject device.
Table 4: Performance Tests for the Zoom POD Aspiration Tubing
| Test Attribute | Acceptance Criterion | Results |
|---|---|---|
| Visual Inspection | The Zoom POD Aspiration Tubing shall meet visual inspection criteria. | Pass |
| Dimensional (Working Length) | The working length is within the specified tolerances. | Pass |
| 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 |
| 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 |
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| Test Attribute | Acceptance Criterion | Results |
|---|---|---|
| Clot Filter Functionality (Zoom POD only) | The clot filter should be able to be opened and closed without causing leak. | Pass |
Sterilization
The subject Zoom 7X Catheter, Zoom Aspiration Tubing, and Zoom POD Aspiration Tubing are sterilized using validated EO processes with a sterility assurance level of 10⁻⁶. The sterilization processes were 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."
Packaging and Shelf Life
Accelerated aging testing based on ASTM F1980 was conducted to verify packaged device performance of the subject Zoom 7X Catheter, Zoom Aspiration Tubing, and Zoom POD Aspiration Tubing. A minimum shelf life was established based on the testing and is indicated by the expiration date provided on the product labeling. Verification testing of the subject devices followed the same test methods as the predicate device.
Packaging and sterile barrier integrity following a transportation challenge has been verified for the packaging configuration used for the Zoom 7X Catheter, Zoom Aspiration Tubing, and Zoom POD Aspiration Tubing. Aging testing has also been performed that supports the sterile barrier integrity following aging.
Biocompatibility
With the exception of the minor modifications to the Zoom 7X Catheter distal shaft, there are no changes to the patient contacting materials, including raw materials, manufacturing processes and manufacturing aids of the subject Zoom 7X Catheter compared to the predicate ZOOM 71 Reperfusion Catheter. Following a risk assessment, it was determined that the original testing on the predicate (K211476) device applies to the subject Zoom 7X Catheter and additional biocompatibility testing of the Zoom 7X Catheter was not required.
To further support the safety of the new introducer sheath accessory, biocompatibility tests were completed for this component categorized as an external communicating device with indirect blood contact for a limited (≤ 24 hour) duration, in accordance with the FDA guidance document, "Use of International Standard ISO 10993- 1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"," and International Standard ISO 10993-1, "Biological Evaluation of Medical Devices − Part 1: Evaluation and Testing Within a Risk Management Process".
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Table 5: Biocompatibility Test Summary – Introducer Sheath
| Test | Test Method | Extraction Methods/Conditions | Acceptance Criteria | Results |
|---|---|---|---|---|
| Cytotoxicity | ISO 10993-5 | Test device extracted with MEM with 5% serum at 37°C for 24 hours. | Test article extracts must yield grade 2 or lower. | Pass, Non-cytotoxic |
| Sensitization | ISO 10993-10 | Test device extracted with both NS and SSO at 50°C for 72 hours. | Test article extracts must yield grade 0. | Pass, Non-sensitizing |
| Intracutaneous Reactivity | ISO 10993-23 | Test device extracted with both NS and SSO at 50°C for 72 hours. | Test article extracts must yield a difference between the test extract overall mean score and corresponding control overall mean score of 1.0 or less. | Pass, Non-irritating |
| Acute Systemic Toxicity | ISO 10993-11 | Test device extracted with both NS and SSO at 50°C for 72 hours. | None of the animals treated with the test article extracts must show a significantly greater reactivity than animals treated with the control article. | Pass, Non-toxic (acute systemic) |
| Material-Mediated Pyrogenicity | ISO 10993-11 | Test device extracted with NS at 50°C for 72 hours. | Test article extract must yield |