(193 days)
ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing K211476
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a catheter and tubing set for aspiration, with no mention of AI or ML capabilities.
Yes
This device is a therapeutic device because its intended use is for the revascularization of patients with acute ischemic stroke by facilitating the removal of thrombus from neurovasculature, which directly treats a medical condition.
No
The device is an aspiration catheter system designed for the revascularization of patients with acute ischemic stroke by removing thrombus. It is a therapeutic device, not a diagnostic one.
No
The device description clearly details physical components like a catheter, tubing set, and introducer sheath, all made of medical-grade polymers and metal coils. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Next Generation Aspiration Catheter and Balt Aspiration Tubing Set are used directly within the patient's body to physically remove blood clots from blood vessels. They are therapeutic devices, not diagnostic ones.
- Intended Use: The intended use clearly states "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease," which is a treatment procedure.
- Device Description: The description details a catheter designed for insertion into the vasculature and connection to an aspiration pump for physical removal of material.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens in vitro (outside the body) for diagnostic purposes.
Therefore, this device falls under the category of a therapeutic medical device used for intervention within the body, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NRY
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
- Guide Sheaths
- Aspiration Pump
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)
Biocompatibility:
- Cytotoxicity - MEM Elution: Tested in accordance with ISO 10993-5, Conclusion: Pass, The test article is considered non-cytotoxic.
- Hemocompatibility - Hemolysis (Direct Contact & Extract Method): Tested in accordance with ISO 10993-4, Conclusion: Pass, The test article is considered non-hemolytic.
- Hemocompatibility - Complement Activation SC5b-9 Assay: Tested in accordance with ISO 10993-4, Conclusion: Pass, Requirements have been met by the test article.
- Hemocompatibility - Partial Thromboplastin Time (PTT): Tested in accordance with ASTM F2382-18, Conclusion: Pass, Requirements have been met by the test article.
- Hemocompatibility – Blood Platelet and Leukocyte Count (PLC): Tested in accordance with ASTM F2888-19, Conclusion: Pass, Requirements have been met by the test article.
- Hemocompatibility - Comparative Surface Assessment: The test article was visually inspected at more than 40x magnification, Conclusion: Pass, Requirements have been met by the test article.
- Hemocompatibility - Thrombogenicity in a Canine Model: Tested in accordance with ISO 10993-4, Conclusion: Pass, The test article performed similarly to the comparator.
- Pyrogenicity - Material-Mediated Rabbit Pyrogen: Tested in accordance with USP , Conclusion: Pass, Requirements have been met by the test article.
- Sensitization - Guinea Pig Maximization Sensitization: Tested in accordance with ISO 10993-10, Conclusion: Pass, The test article did not elicit a sensitization response.
- Systemic Toxicity - Acute Systemic Injection: Tested in accordance with ISO 10993-11, Conclusion: Pass, Requirements have been met by the test article.
- Irritation - Intracutaneous Reactivity: Tested in accordance with ISO 10993-23, Conclusion: Pass, Requirements have been met by the test article.
Biocompatibility for Balt Aspiration Tubing Set:
- Cytotoxicity: Tested in accordance with ISO 10993-5, Conclusion: Pass, The test article is considered non-cytotoxic.
- Sensitization: Tested in accordance with ISO 10993-10, Conclusion: Pass, The test article did not elicit a sensitization response.
- Irritation: Tested in accordance with ISO 10993-23, Conclusion: Pass, Requirements have been met by the test article.
Performance Data – Bench (Next Generation Aspiration Catheter):
- Dimensional Verification: The catheter outer diameter, inner diameter, usable length, tip length, and coating length were measured, Results: Pass.
- Surface Contamination: Visual inspection completed for surface defects, Results: Pass.
- Tensile Strength: The peak tensile force was evaluated per ISO 10555-1 after preconditioning in a simulated use model, Results: Pass.
- Kink Resistance: Kink resistance was evaluated after preconditioning in a simulated use model, Results: Pass.
- Liquid Leakage: The device was exposed to a liquid pressure for 30 seconds. The device was inspected for leakage per ISO 10555-1, Results: Pass.
- Air Leakage: The device was tested for air leakage into the hub per ISO 10555-1, Results: Pass.
- Dynamic Burst: Tests to verify the device can withstand internal liquid pressure under dynamic flow conditions with the distal end open, Results: Pass.
- Torque Strength: The device was evaluated for torque strength by measuring the number of catheter rotations until failure after preconditioning in a simulated use model and compared to the predicate, Results: Pass.
- Hub Validation Testing: The device shall meet the established acceptance criteria per ISO 80369-7, Results: Pass.
- Particulate Matter: The catheter underwent simulated use testing and particulate testing was conducted including a reference device for comparison, Results: Pass.
- Tip Buckling: The maximum force to cause catheter tip buckling while constrained at varying distances was measured, Results: The tip stiffness was comparable to the predicate and other cleared aspiration catheters.
- Corrosion: Corrosion tested per ISO 10555-1, Results: No evidence of corrosion and met requirements per ISO 10555-1.
- Static Burst: The distal tip of the catheter was blocked, and fluid was injected into the lumen at increasing pressure until the catheter burst per ISO 10555-1 and the static burst pressure was compared with the maximum pressure generated with manual syringe injection, Results: Pass.
- Coating Integrity: The coating integrity was inspected before and after preconditioning through a simulated use model, Results: No evidence of surface damage or coating defects.
- Saline and Contrast Exposure: After the device was used to deliver saline and contrast media, the device was inspected for damage, and dimensional attributes were measured, Results: No visual evidence of damage or dimensional changes.
- Radiopacity (Visibility): The device was tested to demonstrate acceptable radiopacity, Results: Marker radiopacity is comparable to the predicate.
- Design Validation/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, Results: 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, Results: Pass.
- Vacuum Pressure: Tested to verify the vacuum pressure at the aspiration pump and distal tip of the catheter, Results: Pass.
Performance Data – Bench (Balt Aspiration Tubing Set):
- Dimensional Verification: The total length, inner diameter, and outer diameter were measured, Results: Pass.
- Surface Contamination: Surface contamination testing was performed in alignment with ISO 10555-1, Results: Pass.
- Lumen Collapse: Tested to verify that the aspiration tubing lumen does not collapse at maximum vacuum pressure for a duration of 6 minutes, Results: Pass.
- Tensile Strength: Testing was adopted from EN ISO 10555-1, Results: Pass.
- Tubing to Pump: The tubing to pump pressure was measured, Results: Pass.
- On/Off Functionality: The On/Off functionality of the tubing set was measured, Results: Pass.
- Tubing Hub Compatibility: The tubing hub compatibility was evaluated, Results: 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 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 (porcine model):
- Study Type: Comparative animal study conducted under Good Laboratory Practices.
- Assessments: 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. Angiographic and histological evaluations.
- Sample Size: Not specified, but multiple anatomical sites were used (internal maxillary artery (IMAX), superficial cervical artery (SCA), renal artery, femoral artery, and lingual vessels).
- Key Results: 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 (subacute (3 days) and chronic (30 days)).
Performance Data - Clinical:
- A determination of substantial equivalence is based upon successful completion of nonclinical bench and animal testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing K211476
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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).
1
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 (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
2
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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3
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510(k) Summary: K234083
| Applicant: | Balt USA, LLC
29 Parker
Irvine, CA 92618
Registration No.: 3014162263 |
|-----------------|--------------------------------------------------------------------------------------------|
| Contact Person: | Alicia Smith
Senior Specialist, Regulatory Affairs
Email: alicia.smith@baltgroup.com |
| 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 |
| 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; | |||
| ZOOM Aspiration Tubing | |||
| (K211476) | Next Generation Aspiration Catheter; | ||
| Balt Aspiration Tubing Set | |||
| (K234083) | |||
| 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. | 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;
ZOOM Aspiration Tubing
(K211476) | Next Generation Aspiration Catheter; | Balt Aspiration Tubing Set
(K234083) |
| Device
Classification/
Product Code | Class II / NRY
(Percutaneous Catheter) | Same as K211476 | |
| Intended Use | Revascularization of patients with
acute ischemic stroke. | Same as K211476 | |
| Dimensional
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"
Distal: 0.085" | Proximal: 0.083"
Distal: 0.082" | Proximal: 0.086"
Distal: 0.085" |
| Effective Length | 137 cm | 128 cm, 132 cm | 120 cm, 132 cm |
| Device Attributes | | | |
| Materials | Commonly used medical grade
plastics & metals with hydrophilic
coating. | Same as K211476 | |
| Coating | Hydrophilic | Same as K211476 | |
| 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 carton box. | Same as K211476 | |
| Shelf Life | 12 months | 12 months (Next Generation Aspiration
Catheter)
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
Mechanism | Flow Control Clamp | Flow Control Valve | |
| Aspiration Pump | • Capable of achieving pressure
between -20 inHg to -29.9 inHg
• Airflow rating of 0 – 23 LPM
• IEC 60601-1 Compliant | • Capable of achieving pressure
between -20 inHg and -25.6 inHg
• Airflow rating ≥ 16 LPM | |
Comparison of Technological Characteristics:
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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 | |
| 10993-5 | Pass | |
| The test article is considered non- | ||
| cytotoxic. | ||
| Hemocompatibility - | ||
| Hemolysis (Direct Contact | ||
| & Extract Method) | Tested in accordance with ISO | |
| 10993-4 | Pass | |
| The test article is considered non- | ||
| hemolytic. | ||
| Hemocompatibility - | ||
| Complement Activation | ||
| SC5b-9 Assay | Tested in accordance with ISO | |
| 10993-4 | Pass | |
| Requirements have been met by | ||
| the test article. | ||
| Hemocompatibility - Partial | ||
| Thromboplastin Time (PTT) | Tested in accordance with ASTM | |
| F2382-18 | Pass | |
| Requirements have been met by | ||
| the test article. | ||
| Hemocompatibility – Blood | ||
| Platelet and Leukocyte | ||
| Count (PLC) | Tested in accordance with ASTM | |
| F2888-19 | Pass | |
| Requirements have been met by | ||
| the test article. | ||
| Hemocompatibility - | ||
| Comparative Surface | ||
| Assessment | The test article was visually | |
| inspected at more than 40x | ||
| magnification. | Pass | |
| Requirements have been met by | ||
| the test article. | ||
| Hemocompatibility - | ||
| Thrombogenicity in a | ||
| Canine Model | Tested in accordance with ISO | |
| 10993-4 | Pass | |
| The test article performed | ||
| similarly to the comparator. | ||
| Pyrogenicity - Material- | ||
| Mediated Rabbit Pyrogen | Tested in accordance with USP |
| Pass
Requirements have been met by
the test article. |
| Sensitization - Guinea Pig
Maximization Sensitization | Tested in accordance with ISO
10993-10 | Pass
The test article did not elicit a
sensitization response. |
| Systemic Toxicity - Acute
Systemic Injection | Tested in accordance with ISO
10993-11 | Pass
Requirements have been met by
the test article. |
| Irritation - Intracutaneous
Reactivity | Tested in accordance with ISO
10993-23 | Pass
Requirements have been met by
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 | |
| 10993-5 | Pass | |
| The test article is considered non- | ||
| cytotoxic. |
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Image /page/7/Picture/0 description: The image shows the logo for Cobalt. The logo consists of a green circle with two smaller white circles attached to it. The word "balt" is written in green lowercase letters to the right of the circle. The logo is simple and modern.
| Test | Test Method Summary | Conclusion |
|---|---|---|
| Sensitization | Tested in accordance with ISO | |
| 10993-10 | Pass | |
| The test article did not elicit a | ||
| sensitization response. | ||
| Irritation | Tested in accordance with ISO | |
| 10993-23 | Pass | |
| Requirements have been met by | ||
| 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 | ||
| Verification | The catheter outer diameter, inner diameter, usable length, tip | |
| length, and coating length were measured. | Pass | |
| Surface | ||
| Contamination | Visual inspection completed for surface defects. | Pass |
| Tensile Strength | The peak tensile force was evaluated per ISO 10555-1 after | |
| preconditioning in a simulated use model. | Pass | |
| Kink Resistance | Kink resistance was evaluated after preconditioning in a | |
| simulated use model. | Pass | |
| Liquid Leakage | The device was exposed to a liquid pressure for 30 seconds. The | |
| device was inspected for leakage per ISO 10555-1. | Pass | |
| Air Leakage | The device was tested for air leakage into the hub per ISO | |
| 10555-1. | Pass | |
| Dynamic Burst | Tests to verify the device can withstand internal liquid pressure | |
| under dynamic flow conditions with the distal end open. | Pass | |
| Torque Strength | The device was evaluated for torque strength by measuring the | |
| number of catheter rotations until failure after preconditioning in | ||
| a simulated use model and compared to the predicate. | Pass | |
| Hub Validation | ||
| Testing | The device shall meet the established acceptance criteria per ISO | |
| 80369-7. | Pass | |
| Particulate | ||
| Matter | The catheter underwent simulated use testing and particulate | |
| testing was conducted including a reference device for | ||
| comparison. | Pass | |
| Tip Buckling | The maximum force to cause catheter tip buckling while | |
| constrained at varying distances was measured. | The tip stiffness | |
| was comparable | ||
| to the predicate | ||
| and other cleared | ||
| aspiration | ||
| catheters. | ||
| Corrosion | Corrosion tested per ISO 10555-1. | No evidence of |
| corrosion and met | ||
| requirements per | ||
| ISO 10555-1. | ||
| Static Burst | The distal tip of the catheter was blocked, and fluid was injected | |
| into the lumen at increasing pressure until the catheter burst per | ||
| ISO 10555-1 and the static burst pressure was compared with the | ||
| maximum pressure generated with manual syringe injection. | Pass |
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Image /page/8/Picture/0 description: The image shows the logo for "balt". The logo consists of a green circle with three smaller white circles inside, connected to the word "balt" in a dark green sans-serif font. The circle is connected to the word by a thin, curved line.
| 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 | ||
| Contrast | ||
| 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 | ||
| (Visibility) | The device was tested to demonstrate acceptable radiopacity. | Marker radiopacity is comparable to the predicate. |
| Design | ||
| Validation | ||
| /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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Image /page/9/Picture/0 description: The image shows the logo for Cobalt. The logo consists of a green circle with three smaller white circles inside, connected to the word "balt" in green lowercase letters. The circle and the word are connected by a green line that splits into two before connecting to the "b" in "balt."
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:
A determination of substantial equivalence is based upon successful completion of nonclinical bench and animal testing.
Conclusion:
The Next Generation Aspiration Catheter and Balt Aspiration Tubing Set have the same intended use as the predicate device. The differences in technological characteristics in comparison to the predicate device do not raise different or new questions of safety and effectiveness. The successful completion of nonclinical bench, biocompatibility, sterilization, shelf life, and animal testing supports that the subject device is substantially equivalent to the predicate device.