Next Generation Aspiration Catheter; Balt Aspiration Tubing Set

K234083 · Balt USA, LLC · NRY · Jul 2, 2024 · Cardiovascular

Device Facts

• Record ID: K234083
• Device Name: Next Generation Aspiration Catheter; Balt Aspiration Tubing Set
• Applicant: Balt USA, LLC
• Product Code: NRY · Cardiovascular
• Decision Date: Jul 2, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Next Generation Aspiration Catheter: The Next Generation Aspiration Catheter with a compatible aspiration pump and Balt Aspiration Tubing Set 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 symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV-tPA) or who fail IV-tPA therapy are candidates for treatment. Balt Aspiration Tubing Set: The Balt Aspiration Tubing Set is intended to connect the Next Generation Aspiration Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.

Device Story

Single-lumen, coil-reinforced, variable-stiffness composite catheter; removes thrombus from neurovasculature via aspiration. Used in clinical settings by physicians; requires connection to compatible aspiration pump and Balt Aspiration Tubing Set. Catheter features hydrophilic coating for trackability; radiopaque marker for fluoroscopic visualization. Tubing set includes flow control valve to manage aspiration. Physician navigates catheter to occlusion site; applies vacuum to aspirate thrombus. Output is visual confirmation of tip location and mechanical removal of clot. Benefits include revascularization of occluded vessels in stroke patients.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing (dimensional, mechanical, leakage, burst, vacuum, usability) and a comparative GLP animal study (porcine model) evaluating handling, clot aspiration, and vessel safety at 3 and 30 days.

Technological Characteristics

Single-lumen, coil-reinforced composite catheter; medical-grade polymers and metals; hydrophilic coating. Dimensions: 0.071"/0.074" ID. Sterilization: Ethylene Oxide (SAL 10^-6). Standards: ISO 10993 (biocompatibility), ISO 10555-1 (catheter performance), ISO 80369-7 (hub), ASTM F1980 (shelf life).

Indications for Use

Indicated for patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, M1/M2 middle cerebral, basilar, vertebral arteries) within 8 hours of symptom onset. Candidates include those ineligible for or failing IV-tPA therapy.

Regulatory Classification

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.

Predicate Devices

• ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing (K211476)

Submission Summary (Full Text)

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July 2, 2024

Balt USA, LLC Alicia Smith Senior Regulatory Affairs Specialist 29 Parker Irvine, California 92618

# Re: K234083

Trade/Device Name: Next Generation Aspiration Catheter; Balt Aspiration Tubing Set Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: May 31, 2024 Received: June 3, 2024

# Dear Alicia Smith:

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.

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).

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Your device is also subject to, among other requirements, the Quality System (OS) 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 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-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 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.

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-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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K234083

#### Device Name

Next Generation Aspiration Catheter; Balt Aspiration Tubing Set

Indications for Use (Describe)

Next Generation Aspiration Catheter:

The Next Generation Aspiration Catheter with a compatible aspiration Tubing Set 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 symptom onset.

Patients who are ineligible for intravenous tissue plasminogen activator (IV-tPA) or who fail IV-tPA therapy are candidates for treatment.

Balt Aspiration Tubing Set:

The Balt Aspiration Tubing Set is intended to connect the Next Generation Catheter to the canister of a compatible 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: K234083

| Applicant: | Balt USA, LLC<br>29 Parker<br>Irvine, CA 92618<br>Registration No.: 3014162263 |
|-----------------|--------------------------------------------------------------------------------------------|
| Contact Person: | Alicia Smith<br>Senior Specialist, Regulatory Affairs<br>Email: [e-mail] |

| Date Summary Prepared: | June 28, 2024 |
|------------------------|--------------------------------------------------------------------------|
| Trade Name: | Next Generation Aspiration Catheter; Balt Aspiration Tubing Set |
| Common Name: | Catheter, Thrombus Retriever |
| Review Panel: | Neurology |
| Product Code: | NRY |
| Regulation Number: | 21 CFR 870.1250 |
| Regulation Name: | Percutaneous Catheter |
| Device Classification: | Class II |
| Predicate Device: | ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing<br>510(k)#: K211476 |

### Device Description:

The Next Generation Aspiration Catheter is a single-lumen, coil reinforced, variable stiffness composite catheter that facilitates removal of thrombus from the neurovasculature when connected to a compatible aspiration pump and the Balt Aspiration Tubing Set. The Next Generation Aspiration Catheter is comprised of a hollow cylindrical tube which incorporates a standard luer fitting to allow attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter. The wall of the tube is constructed using a combination of metal coils and medical grade polymers. The distal portion of the Next Generation Aspiration Catheter has a hydrophilic coating which provides a lubricious surface during use to aid in tracking through the vasculature. The catheter includes a radiopaque marker providing the user with visual confirmation of the distal tip location under fluoroscopy. The Next Generation Aspiration Catheter is offered in various working lengths and nominal inner diameters and outer diameters.

An introducer sheath is provided in the package to support and facilitate the insertion of the Next Generation Aspiration Catheter's distal tip into an appropriate vascular sheath.

The catheter and introducer sheath are provided sterile, non-pyrogenic, and are intended for single use only.

The Balt Aspiration Tubing Set is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Next Generation Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Balt Aspiration Tubing Set is made of common medical grade polymers, is provided sterile, and is intended for single use only.

The Next Generation Aspiration Catheter and Balt Aspiration Tubing Set are intended to be used with:

- Guidewires ●

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- Guide Sheaths
- Aspiration Pump ●

### Indications for Use:

Next Generation Aspiration Catheter:

The Next Generation Aspiration Catheter with a compatible aspiration pump and Balt Aspiration Tubing Set 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 symptom onset.

Patients who are ineligible for intravenous tissue plasminogen activator (IV-tPA) or who fail IV-tPA therapy are candidates for treatment.

Balt Aspiration Tubing Set:

The Balt Aspiration Tubing Set is intended to connect the Next Generation Aspiration Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.

| | Predicate Device | Subject Device | |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| | ZOOM 71 Reperfusion Catheter;<br>ZOOM Aspiration Tubing<br>(K211476) | Next Generation Aspiration Catheter;<br>Balt Aspiration Tubing Set<br>(K234083) | |
| Indications for Use | The ZOOM Reperfusion Catheters,<br>with the ZOOM Aspiration Tubing<br>and ZOOM Aspiration Pump (or<br>equivalent vacuum pump), are<br>indicated for use in the<br>revascularization of patients with<br>acute ischemic stroke secondary to<br>intracranial large vessel occlusive<br>disease (within the internal carotid,<br>middle cerebral - M1 and M2<br>segments, basilar, and vertebral<br>arteries) within 8 hours of symptom<br>onset. Patients who are ineligible for<br>intravenous tissue plasminogen<br>activator (IV t-PA) or who fail IV t-<br>PA therapy are candidates for<br>treatment.<br>The ZOOM Aspiration Tubing is<br>intended to connect the ZOOM<br>Reperfusion Catheter to the ZOOM<br>Canister of the ZOOM Aspiration<br>Pump and to allow the user to<br>control the fluid flow. | Next Generation Aspiration Catheter:<br>The Next Generation Aspiration Catheter<br>with a compatible aspiration pump and Balt<br>Aspiration Tubing Set is indicated for use<br>in the revascularization of patients with<br>acute ischemic stroke secondary to<br>intracranial large vessel occlusive disease<br>(within the internal carotid, middle cerebral<br>- M1 and M2 segments, basilar, and<br>vertebral arteries) within 8 hours of<br>symptom onset.<br>Patients who are ineligible for intravenous<br>tissue plasminogen activator (IV-tPA) or<br>who fail IV-tPA therapy are candidates for<br>treatment.<br>Balt Aspiration Tubing Set:<br>The Balt Aspiration Tubing Set is intended<br>to connect the Next Generation Aspiration<br>Catheter to the canister of a compatible<br>aspiration pump and to allow the user to<br>control the fluid flow. | |
| | Predicate Device | Subject Device | |
| | ZOOM 71 Reperfusion Catheter;<br>ZOOM Aspiration Tubing<br>(K211476) | Next Generation Aspiration Catheter; | Balt Aspiration Tubing Set<br>(K234083) |
| Device<br>Classification/<br>Product Code | Class II / NRY<br>(Percutaneous Catheter) | Same as K211476 | |
| Intended Use | Revascularization of patients with<br>acute ischemic stroke. | Same as K211476 | |
| Dimensional<br>Specifications | ZOOM 71 Reperfusion Catheter | NG 071 ASP | NG 074 ASP |
| Inner Diameter | 0.071" | Same as K211476 | 0.074" |
| Outer Diameter | Proximal: 0.086"<br>Distal: 0.085" | Proximal: 0.083"<br>Distal: 0.082" | Proximal: 0.086"<br>Distal: 0.085" |
| Effective Length | 137 cm | 128 cm, 132 cm | 120 cm, 132 cm |
| Device Attributes | | | |
| Materials | Commonly used medical grade<br>plastics & metals with hydrophilic<br>coating. | Same as K211476 | |
| Coating | Hydrophilic | Same as K211476 | |
| Packaging<br>Configuration | The catheter is placed in a protective<br>polyethylene tube and then<br>mounted, along with the accessories,<br>onto a polyethylene packaging card.<br>The packaging card is inserted into a<br>Tyvek® pouch which is then sealed.<br>The sealed pouch and IFU are<br>placed in a carton box. | Same as K211476 | |
| Shelf Life | 12 months | 12 months (Next Generation Aspiration<br>Catheter)<br>6 months (Balt Aspiration Tubing Set) | |
| Sterilization | | | |
| Condition Supplied | Sterile and Single Use | Same as K211476 | |
| Method | Ethylene Oxide (EO), SAL 10-6 | Same as K211476 | |
| Accessories | | | |
| Accessories | None | Introducer Sheath | |
| Aspiration Tubing | ZOOM Aspiration Tubing | Balt Aspiration Tubing Set | |
| Dimensional | Length: 104" | Length: 114" | |
| Specifications | Inner Diameter: 0.110" Minimum | Inner Diameter: 0.110" ± 0.003" | |
| Condition Supplied | Sterile and Single Use | Same as K211476 | |
| Sterilization Method | Ethylene Oxide (EO), SAL 10-6 | Same as K211476 | |
| Flow Control<br>Mechanism | Flow Control Clamp | Flow Control Valve | |
| Aspiration Pump | • Capable of achieving pressure<br>between -20 inHg to -29.9 inHg<br>• Airflow rating of 0 – 23 LPM<br>• IEC 60601-1 Compliant | • Capable of achieving pressure<br>between -20 inHg and -25.6 inHg<br>• Airflow rating ≥ 16 LPM | |

Comparison of Technological Characteristics:

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Image /page/6/Picture/0 description: The image shows the logo for Cobalt. The logo consists of a green circle with white circles inside of it, connected to the word "balt" in a dark green sans-serif font. The circle is on the left side of the logo, and the word "balt" is on the right side.

# Performance Testing Summary:

## Biocompatibility:

The following biocompatibility testing was conducted for the Next Generation Aspiration Catheter:

| Test | Test Method Summary | Conclusion |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Cytotoxicity - MEM Elution | Tested in accordance with ISO<br>10993-5 | Pass<br>The test article is considered non-<br>cytotoxic. |
| Hemocompatibility -<br>Hemolysis (Direct Contact<br>& Extract Method) | Tested in accordance with ISO<br>10993-4 | Pass<br>The test article is considered non-<br>hemolytic. |
| Hemocompatibility -<br>Complement Activation<br>SC5b-9 Assay | Tested in accordance with ISO<br>10993-4 | Pass<br>Requirements have been met by<br>the test article. |
| Hemocompatibility - Partial<br>Thromboplastin Time (PTT) | Tested in accordance with ASTM<br>F2382-18 | Pass<br>Requirements have been met by<br>the test article. |
| Hemocompatibility – Blood<br>Platelet and Leukocyte<br>Count (PLC) | Tested in accordance with ASTM<br>F2888-19 | Pass<br>Requirements have been met by<br>the test article. |
| Hemocompatibility -<br>Comparative Surface<br>Assessment | The test article was visually<br>inspected at more than 40x<br>magnification. | Pass<br>Requirements have been met by<br>the test article. |
| Hemocompatibility -<br>Thrombogenicity in a<br>Canine Model | Tested in accordance with ISO<br>10993-4 | Pass<br>The test article performed<br>similarly to the comparator. |
| Pyrogenicity - Material-<br>Mediated Rabbit Pyrogen | Tested in accordance with USP<br><151> | Pass<br>Requirements have been met by<br>the test article. |
| Sensitization - Guinea Pig<br>Maximization Sensitization | Tested in accordance with ISO<br>10993-10 | Pass<br>The test article did not elicit a<br>sensitization response. |
| Systemic Toxicity - Acute<br>Systemic Injection | Tested in accordance with ISO<br>10993-11 | Pass<br>Requirements have been met by<br>the test article. |
| Irritation - Intracutaneous<br>Reactivity | Tested in accordance with ISO<br>10993-23 | Pass<br>Requirements have been met by<br>the test article. |

The following biocompatibility testing was conducted for the Balt Aspiration Tubing Set:

| Test | Test Method Summary | Conclusion |
|--------------|------------------------------------------|-----------------------------------------------------------|
| Cytotoxicity | Tested in accordance with ISO<br>10993-5 | Pass<br>The test article is considered non-<br>cytotoxic. |

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| Test | Test Method Summary | Conclusion |
|---------------|-------------------------------------------|----------------------------------------------------------------------|
| Sensitization | Tested in accordance with ISO<br>10993-10 | Pass<br>The test article did not elicit a<br>sensitization response. |
| Irritation | Tested in accordance with ISO<br>10993-23 | Pass<br>Requirements have been met by<br>the test article. |

# Performance Data – Bench:

| | | | | | The following performance bench testing was conducted for the Next Generation Aspiration Catheter: | |
|--|--|--|--|--|----------------------------------------------------------------------------------------------------|--|
| | | | | | | |

| Test | Test Method Summary | Results |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Dimensional<br>Verification | The catheter outer diameter, inner diameter, usable length, tip<br>length, and coating length were measured. | Pass |
| Surface<br>Contamination | Visual inspection completed for surface defects. | Pass |
| Tensile Strength | The peak tensile force was evaluated per ISO 10555-1 after<br>preconditioning in a simulated use model. | Pass |
| Kink Resistance | Kink resistance was evaluated after preconditioning in a<br>simulated use model. | Pass |
| Liquid Leakage | The device was exposed to a liquid pressure for 30 seconds. The<br>device was inspected for leakage per ISO 10555-1. | Pass |
| Air Leakage | The device was tested for air leakage into the hub per ISO<br>10555-1. | Pass |
| Dynamic Burst | Tests to verify the device can withstand internal liquid pressure<br>under dynamic flow conditions with the distal end open. | Pass |
| Torque Strength | The device was evaluated for torque strength by measuring the<br>number of catheter rotations until failure after preconditioning in<br>a simulated use model and compared to the predicate. | Pass |
| Hub Validation<br>Testing | The device shall meet the established acceptance criteria per ISO<br>80369-7. | Pass |
| Particulate<br>Matter | The catheter underwent simulated use testing and particulate<br>testing was conducted including a reference device for<br>comparison. | Pass |
| Tip Buckling | The maximum force to cause catheter tip buckling while<br>constrained at varying distances was measured. | The tip stiffness<br>was comparable<br>to the predicate<br>and other cleared<br>aspiration<br>catheters. |
| Corrosion | Corrosion tested per ISO 10555-1. | No evidence of<br>corrosion and met<br>requirements per<br>ISO 10555-1. |
| Static Burst | The distal tip of the catheter was blocked, and fluid was injected<br>into the lumen at increasing pressure until the catheter burst per<br>ISO 10555-1 and the static burst pressure was compared with the<br>maximum pressure generated with manual syringe injection. | Pass |

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| Test | Test Method Summary | Results |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Coating Integrity | The coating integrity was inspected before and after preconditioning through a simulated use model. | No evidence of surface damage or coating defects. |
| Saline and<br>Contrast<br>Exposure | After the device was used to deliver saline and contrast media, the device was inspected for damage, and dimensional attributes were measured. | No visual evidence of damage or dimensional changes. |
| Radiopacity<br>(Visibility) | The device was tested to demonstrate acceptable radiopacity. | Marker radiopacity is comparable to the predicate. |
| Design<br>Validation<br>/Usability | The subject and predicate devices were prepared in accordance with their respective instructions for use and tested for device usability in a clinically relevant anatomical model. | Device preparation, introduction, trackability, and retrieval were comparable to the predicate. |
| Lumen Collapse | Tested to verify that the catheter lumen does not collapse at maximum vacuum pressure for a duration of 6 minutes. | Pass |
| Vacuum Pressure | Tested to verify the vacuum pressure at the aspiration pump and distal tip of the catheter. | Pass |

### The following performance bench testing was conducted for the Balt Aspiration Tubing Set:

| Test | Test Method Summary | Results |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------|
| Dimensional Verification | The total length, inner diameter, and outer diameter were measured. | Pass |
| Surface Contamination | Surface contamination testing was performed in alignment with ISO 10555-1. | Pass |
| Lumen Collapse | Tested to verify that the aspiration tubing lumen does not collapse at maximum vacuum pressure for a duration of 6 minutes. | Pass |
| Tensile Strength | Testing was adopted from EN ISO 10555-1. | Pass |
| Tubing to Pump | The tubing to pump pressure was measured. | Pass |
| On/Off Functionality | The On/Off functionality of the tubing set was measured. | Pass |
| Tubing Hub Compatibility | The tubing hub compatibility was evaluated. | Pass |

### Sterilization and Shelf Life:

The Next Generation Aspiration Catheter and Balt Aspiration Tubing Set are sterilized using an ethylene oxide sterilization cycle that was verified to a sterility assurance level of 1 x 10th in accordance with ISO 11135. Accelerated aging testing for the Next Generation Catheter and Balt Aspiration Tubing

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Set based on ASTM F1980 have established that the subject device and packaging remain functional for the labeled expiration date. Aging studies for packaging integrity, seal strength, and device functionality were performed and met the acceptance criteria.

### Performance Data - Animal:

The safety and performance of the Next Generation Catheter and Balt Aspiration Tubing Set were evaluated in a comparative animal study conducted under Good Laboratory Practices in a porcine model in the internal maxillary artery (IMAX), superficial cervical artery (SCA), renal artery, femoral artery, and lingual vessels against the control (ZOOM 71 Reperfusion Catheter and Tubing Set). Assessments included performance and handling, aspiration of experimental soft and firm clots, and application of maximum vacuum with the device in a wedged position against the vessel wall. Both the subject and the control devices were evaluated at subacute (3 days) and chronic (30 days) time points. Performance and handling, soft and firm clot aspiration, and wedge assessment results were comparable between the test and control devices. Angiographic and histological evaluations concluded the devices were comparable at all time points.

### Performance Data - Clinical…