(175 days)
The 091 Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
The 091 Balloon Guide Catheter is a coaxial-lumen, coil-reinforced, variable stiffness catheter with a compliant balloon at the distal end to provide temporary vascular occlusion during angiographic procedures. A radiopaque marker is included at the distal end of the distal tip of the catheter) for fluoroscopic visualization. A bifurcated luer hub on the proximal end of the catheter allows attachments for flushing, and aspiration. This catheter is designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The dimensions and maximum recommended balloon inflation volume for the 091 Balloon Guide Catheter are indicated on the product label. A Peel-Away Introducer accessory is included within the packaging. It is supplied sterile, non-pyrogenic, and is intended for single use only.
This document describes the validation of the 091 Balloon Guide Catheter. Since the provided text focuses on the device's substantial equivalence to a predicate device for regulatory approval, the "acceptance criteria" and "device performance" primarily refer to engineering performance specifications and bench testing results, rather than clinical efficacy metrics for an AI/ML device. There is no mention of an AI/ML component in this premarket notification.
Therefore, the requested information specifically related to AI/ML device validation (e.g., sample sizes for training/test sets, expert ground truth adjudication, MRMC studies, standalone algorithm performance) is not applicable to this document. The document details the testing performed to ensure the device meets safety and performance standards for a medical device.
Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the "Pass" result for each test. The reported device performance is that it met all predetermined acceptance criteria for each test.
| Acceptance Criteria (Test Performed) | Reported Device Performance (Results) |
|---|---|
| Design Verification Testing | |
| Tensile Strength (per ISO 10555-1, Section 4.6 and Annex B) | Pass |
| PTFE delamination (visual inspection) | Pass |
| Torque Strength (withstand one turn of the hub) | Pass |
| Catheter Burst (per ISO10555-1, Section 4.10 and Annex F) | Pass |
| Balloon Burst (not burst below specified volume) | Pass |
| Visual Inspection (under 2.5X magnification) | Pass |
| Particulates (per USP <788>) | Pass |
| Liquid Leak Test (per ISO 10555-1, Section 4.7 and Annex C) | Pass |
| Air Leak Test (per ISO 10555-1 section 4.7.2 and Annex D) | Pass |
| Balloon Leak Test (per ISO 10555-4, section 4.4.2 and Annex B) | Pass |
| Dimensional Verification (catheter and introducer meet specs) | Pass |
| Chemical Compatibility (withstand exposure to saline, dextrose, heparin, contrast) | Pass |
| Hub Compatibility (per ISO 594-1:1986 and ISO 594-2:1998) | Pass |
| Kink Resistance (test to determine resistance to kinking) | Pass |
| Balloon Air Purge Test (acceptable level of air removed) | Pass |
| Balloon Fatigue Test (withstand specified inflation/deflation cycles) | Pass |
| Balloon Compliance Test (not exceed specified dimensions for given volume) | Pass |
| Flow Arrest (minimum occlusion time confirmed in flow model) | Pass |
| Balloon Deflation Time (time to restore flow measured) | Pass |
| Packaging Testing | |
| Pouch Leak Test (per ASTM F-1929) | Pass |
| Pouch Peel Test (per ASTM F88/F88M) | Pass |
| Packaging - Visual Inspection (perforations, nicks, cuts, punctures, seal damage) | Pass |
| Packaging - Seal Width (meet specified width) | Pass |
| Design Validation Testing | |
| In-vitro Simulated Use Study – Benchtop (performance verification by physicians) | Pass |
| Usability Testing | |
| In-vitro Simulated Use Study – Usability (IFU and labeling review, simulated use, worst-case models) | Pass |
| Biocompatibility Testing | |
| Cytotoxicity (MEM elution, 48 hr. inc., triplicate L929, 24 hr. ext.) | Pass |
| Sensitization (Magnusson-Kligman Method, 2 extracts) | Pass |
| Irritation (Intracutaneous Toxicity (ISO), 2 extracts) | Pass |
| Material mediated pyrogenicity (Material Mediated Pyrogen) | Pass |
| Acute Systemic Toxicity (Systemic Injection (ISO), 2 extracts) | Pass |
| Hemolysis (ASTM Method, indirect and direct) | Pass |
| Complement Activation (SC5b-9) | Pass |
| Dog Thrombogenicity | Pass |
| Sterilization Validation | |
| Confirmatory sterilization study (sterility, EO residual, LAL, bioburden) | Pass |
Details of the Study:
-
1. A table of acceptance criteria and the reported device performance: Provided above. All tests "Passed," indicating the device met all predetermined acceptance criteria.
-
2. Sample size used for the test set and the data provenance: The document states that "Some of the tests were also conducted on the predicate device to help establish substantial equivalence." However, specific sample sizes for each test are not explicitly detailed in this summary. The data provenance is from bench testing and simulated use, conducted to support a regulatory submission in the United States. It is not patient data, so "retrospective or prospective" is not applicable.
-
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the context of an AI/ML device. For the "In-vitro Simulated Use Study – Benchtop," it states "A simulated interventional procedure was performed by physicians." For "Usability Testing," it mentions "Evaluators representative of the intended user population shall review... then attempt to use the catheters and accessories along with the expected compatible products in a simulated use environment, using worst-case neurovascular models." The specific number or qualifications of these physicians/evaluators are not detailed.
-
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML device with image interpretation or complex diagnostic outputs requiring expert adjudication. Performance was assessed against pre-defined engineering and functional criteria.
-
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical medical device (catheter), not an AI/ML diagnostic or assistive tool.
-
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (catheter), not an AI/ML algorithm.
-
7. The type of ground truth used:
- Engineering/Performance Specifications: For most tests (e.g., Tensile Strength, Torque Strength, Burst, Leak tests, Dimensional Verification), the "ground truth" is defined by established engineering and materials standards (e.g., ISO 10555-1, USP <788>, ASTM F-1929, ISO 594-1:1986).
- Simulated Use/Usability: For these tests, the "ground truth" is the successful and safe performance of the device by intended users in a simulated clinical environment, meeting pre-defined operational criteria.
- Biocompatibility: The "ground truth" is compliance with ISO 10993-1 and specific biological test methodologies (e.g., MEM elution, Magnusson-Kligman Method, ASTM Method for Hemolysis) to ensure the device is not harmful to biological systems.
-
8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML device trained on data.
-
9. How the ground truth for the training set was established: Not applicable.
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July 29, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
InNeuroCo, Inc. Garry Koroshec Senior Design Quality Engineer / Regulatory Affairs 19700 Stirling Road, Suite 1 Pembroke Pines, Florida 33332
Re: K220331
Trade/Device Name: 091 Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: June 30, 2022 Received: July 1, 2022
Dear Garry Koroshec:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220331
Device Name 091 Balloon Guide Catheter
Indications for Use (Describe)
The 091 Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
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) |
|---|---|
| ☑ | ☐ |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date Summary Prepared | July 21, 2022 |
|---|---|
| Submitter | InNeuroCo, Inc.19700 Stirling Road, Suite 1Pembroke Pines, FL 33332 |
| Primary Submission Contact | Garry KoroshecSenior Design Quality Engineer / Regulatory AffairsInNeuroCo, Inc.19700 Stirling Road, Suite 1Pembroke Pines, FL 33332Telephone: 1-954-254-5003Facsimile: 1-954-742-5989E-Mail: garry@inneuroco.com |
| Secondary Submission Contacts | Ming Cheng ChewRegulatory ConsultantLibra Medical Inc.8401 73rd Avenue North, Suite 63Brooklyn Park, MN 55428Telephone: 763-232-3701E-Mail: mcchew@libramed.comMarianne GrunwaldtSenior Director of Regulatory Affairs and Quality AssuranceInNeuroCo, Inc.19700 Stirling Road, Suite 1Pembroke Pines, FL 33332Telephone: 1-954-703-5271Facsimile: 1-954-742-5989E-Mail: marianne@inneuroco.com |
| Trade Name | 091 Balloon Guide Catheter |
| Regulation Number | 21 CFR 870.1250 |
| Device Common or ClassificationName | Percutaneous Catheter, Neurovasculature |
| Product Class | Class II |
| Product Panel | Cardiovascular, Neurology |
| Product Codes | DQY, QJP |
| Predicate Device | Concentric Balloon Guide CatheterK112404 |
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6.1 Device Description
The 091 Balloon Guide Catheter is a coaxial-lumen, coil-reinforced, variable stiffness catheter with a compliant balloon at the distal end to provide temporary vascular occlusion during angiographic procedures. A radiopaque marker is included at the distal end of the distal tip of the catheter) for fluoroscopic visualization. A bifurcated luer hub on the proximal end of the catheter allows attachments for flushing, and aspiration. This catheter is designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The dimensions and maximum recommended balloon inflation volume for the 091 Balloon Guide Catheter are indicated on the product label. A Peel-Away Introducer accessory is included within the packaging. It is supplied sterile, non-pyrogenic, and is intended for single use only.
6.2 Indications for Use
The 091 Balloon Guide Catheter is in facilitating the insertion and quidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
6.3 Technological Characteristics and Basis for Substantial Equivalence
| Parameter | Predicate DeviceConcentric Balloon Guide Catheter(K112404) | Subject Device091 Balloon Guide Catheter(K220331) |
|---|---|---|
| Indications forUse | The Concentric Balloon Guide Catheter isindicated for use in facilitating the insertionand guidance of an intravascular catheterinto a selected blood vessel in theperipheral and neuro vascular systems. Theballoon provides temporary vascularocclusion during these and otherangiographic procedures. The BalloonGuide Catheter is also indicated for use asa conduit for Retrieval devices. | The 091 Balloon Guide Catheter is indicatedfor use in facilitating the insertion andguidance of intravascular catheters into aselected blood vessel in the peripheral andneuro vascular systems. The balloon providestemporary vascular occlusion during theseand other angiographic procedures. TheBalloon Guide Catheter is also indicated foruse as a conduit for Retrieval devices. |
| AnatomicalLocation | Peripheral and neuro vasculature | Peripheral and neuro vasculature |
| Product Code | DQY | DQY, QJP |
| Classification | Class II | Class II |
| RegulationNumber | 870.1250 | 870.1250 |
| CatheterMaterial | Outer Jacket: PebaxInner Lumen: PTFE and PebaxDistal Tip: Pebax | Outer Jacket: PTFE and PolyethyleneInner Lumen: PTFE, Pebax, and NylonDistal Tip: Chronoflex and Polyolefin |
| ReinforcementLayer | Stainless Steel Braid | Stainless Steel Coil |
| RadiopaqueMarker Band | Platinum/Iridium | Platinum/Iridium |
Table 6.1 Technological Comparison of the 091 Balloon Guide Catheter and Concentric Balloon Guide Catheter (K112404)
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| Parameter | Predicate DeviceConcentric Balloon Guide Catheter(K112404) | Subject Device091 Balloon Guide Catheter(K220331) |
|---|---|---|
| Coating | None | None |
| InternalConstruction | Co-axial Lumen | Co-axial Lumen |
| Hub | Polyurethane | Polycarbonate |
| Strain Relief | Polyolefin | Silicone |
| Balloon Material | Silicone | Polyurethane elastomer |
| Working Length | 80cm, 95cm | 95cm |
| Max OuterDiameter | 0.088, 0.104, and 0.116 inches | 0.125 inches |
| Shaft InnerDiameter | 0.059, 0.078, and 0.085 inches | 0.0905 inches |
| AccessoriesSupplied | Dilator | Peel Away Introducer |
| Packaging | Polyethylene Tube and HDPE PackagingCardTyvek/PE/PET Pouch | Polyethylene Tube and HDPE PackagingCardTyvek/PE/PET Pouch |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Number of Uses | Single Use | Single Use |
6.4 Performance Data
Design verification and validation were performed to ensure that the 091 Balloon Guide Catheter meets its performance specifications and demonstrates substantial equivalence to the predicate device. The list of the performance testing conducted is presented below in Table 6.2.
Some of the tests were also conducted on the predicate device to help establish substantial equivalence. All predetermined acceptance criteria were met.
| Test performed | Test Summary | Results |
|---|---|---|
| Design Verification Testing | ||
| Tensile Strength | Testing was completed per ISO 10555-1, Section 4.6 andAnnex B. | Pass |
| PTFE delamination | PTFE liner was visually inspected to ensure thatdelamination of the liner was not present. | Pass |
| Torque Strength | The device must withstand one turn of the hub. | Pass |
| Catheter Burst | Testing was completed per ISO10555-1, Section 4.10and Annex F. | Pass |
| Balloon Burst | The constrained balloon must not burst below thespecified volume. | Pass |
| Visual Inspection | Samples were visually inspected under 2.5X magnificationto ensure acceptance criteria were met. | Pass |
| Particulates | Testing was completed per USP <788>. Testing was alsoperformed in comparison to the predicate. | Pass |
| Liquid Leak Test | Testing was conducted per ISO 10555-1, Section 4.7 andAnnex C. | Pass |
| Air Leak Test | Testing was conducted per ISO 10555-1 section 4.7.2 andAnnex D. | Pass |
| Balloon Leak Test | Testing was conducted per ISO 10555-4, section 4.4.2and Annex B. | Pass |
Table 6.2 – Performance Bench Tests Performed on the 091 Balloon Guide Catheter
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InNeuroCo, Inc. 091 Balloon Guide Catheter Traditional 510(k) K220331
| Test performed | Test Summary | Results |
|---|---|---|
| Dimensional Verification | The catheter and introducer must meet dimensional specifications. | Pass |
| Chemical Compatibility | The device shall withstand exposure to saline, dextrose, heparin, and contrast. | Pass |
| Hub Compatibility | Catheter luers shall be tested per ISO 594-1:1986 and ISO 594-2:1998. | Pass |
| Kink Resistance | After conditioning, two sections of each test sample were wrapped around progressively smaller diameter mandrels until a kink was observed. | Pass |
| Balloon Air Purge Test | The balloon shall be capable of having an acceptable level of air removed. | Pass |
| Balloon Fatigue Test | The balloon shall withstand the specified number of inflation/deflation cycles. | Pass |
| Balloon Compliance Test | The balloon shall not exceed the specified dimensions for a given inflation volume. | Pass |
| Flow Arrest | The balloon was inflated within a clinically relevant flow model and a minimum occlusion time (aka time of effective flow arrest) was confirmed. | Pass |
| Balloon Deflation Time | The balloon was inflated within a clinically relevant flow model, the time to restore flow (deflation) was measured. | Pass |
| Packaging - Pouch Leak Test | Testing was conducted per ASTM F-1929. | Pass |
| Packaging - Pouch Peel Test | Testing was conducted per ASTM F88/F88M. | Pass |
| Packaging - Visual Inspection | Packaging was visually inspected to determine if any perforations, nicks, cuts, or punctures on the pouch were present. All pouch seals were also visually inspected to verify that seals were not damaged or peeled, and that all seals were intact. | Pass |
| Packaging - Seal Width | The seals should meet the specified width. | Pass |
| Design Validation Testing | ||
| In-vitro Simulated Use Study – Benchtop | The 091 Balloon Guide Catheter was prepared per the instructions for use (IFU). A simulated interventional procedure was performed by physicians in order to verify the product's performance. | Pass |
| Usability Testing | ||
| In-vitro Simulated Use Study -Useability(including Label Content -Product IFU) | Evaluators representative of the intended user population shall review the 091 Balloon Guide Catheter IFU and labeling, then attempt to use the catheters and accessories along with the expected compatible products in a simulated use environment, using worst-case neurovascular models | Pass |
No clinical studies were required to demonstrate substantial equivalence.
6.5 Biocompatibility testing
The 091 Balloon Guide Catheter was assessed for biocompatibility in accordance with ISO 10993-1, "Biological evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process." The subject device is considered an externally communicating medical device with circulating blood contact for less than 24 hours. The biological effects tests performed are summarized in Table 6.3.
The results of the testing demonstrate the biocompatibility of the 091 Balloon Guide Catheter for its indicated use.
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| Biological Effect | Test | Results |
|---|---|---|
| Cytotoxicity | MEM elution, 48 hr. inc.,triplicate L929, 24 hr. ext.(nonimplant) | Pass |
| Sensitization | Magnusson-KligmanMethod, 2 extracts | Pass |
| Irritation | Intracutaneous Toxicity(ISO), 2 extracts | Pass |
| Material mediatedpyrogenicity | Material Mediated Pyrogen | Pass |
| Acute Systemic Toxicity | Systemic Injection (ISO), 2extracts | Pass |
| Hemocompatibility | Hemolysis, ASTM Method,indirect (human blood) | Pass |
| Hemolysis, ASTM Method,direct contact (human blood) | Pass | |
| Complement Activation,SC5b-9 | Pass | |
| Dog Thrombogenicity | Pass |
Table 6.3 Summarv of Biocompatibility Testing
6.6 Sterilization Validation
A confirmatory sterilization study was conducted to verify that the subject device can be adopted into the previously validated ethylene oxide (EO) sterilization cycle. The device passed all sterility, EO residual, limulus amebocyte lysate (LAL), and bioburden testing.
6.7 Conclusion
The review of the verification and validation test results as well as the comparison of the device classification, indications for use, operating principles, technological characteristics, sterility, and biocompatibility, demonstrate that the subject device, the 091 Balloon Guide Catheter, is substantially equivalent to the Concentric Balloon Guide Catheter (K112404). The differences between the subject and the predicate devices do not raise new questions of safety and effectiveness.
§ 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).