(175 days)
No
The 510(k) summary describes a physical medical device (a catheter) and its mechanical properties and performance. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is a guide catheter used to facilitate the insertion and guidance of other intravascular catheters and to provide temporary vascular occlusion. It does not directly treat a disease or condition.
No.
The device facilitates the insertion and guidance of catheters and provides temporary vascular occlusion; it does not gather or interpret data about a patient's health status to make a diagnosis.
No
The device description clearly details a physical catheter with a balloon, lumens, and a hub, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for facilitating the insertion and guidance of intravascular catheters and providing temporary vascular occlusion within the body (peripheral and neuro vascular systems). This is an in vivo procedure.
- Device Description: The description details a physical catheter with a balloon designed for use inside blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is used inside the body for a procedural purpose.
N/A
Intended Use / Indications for Use
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.
Product codes
DQY, QJP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral and neuro vascular systems
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)
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.
Study types include:
Design Verification Testing: Tensile Strength, PTFE delamination, Torque Strength, Catheter Burst, Balloon Burst, Visual Inspection, Particulates, Liquid Leak Test, Air Leak Test, Balloon Leak Test, Dimensional Verification, Chemical Compatibility, Hub Compatibility, Kink Resistance, Balloon Air Purge Test, Balloon Fatigue Test, Balloon Compliance Test, Flow Arrest, Balloon Deflation Time, Packaging - Pouch Leak Test, Packaging - Pouch Peel Test, Packaging - Visual Inspection, Packaging - Seal Width. All tests passed.
Design Validation Testing: In-vitro Simulated Use Study – Benchtop (Pass), Usability Testing (Pass), In-vitro Simulated Use Study - Useability (including Label Content - Product IFU) (Pass).
Biocompatibility testing: Cytotoxicity (Pass), Sensitization (Pass), Irritation (Pass), Material mediated pyrogenicity (Pass), Acute Systemic Toxicity (Pass), Hemocompatibility (Hemolysis, Complement Activation, Dog Thrombogenicity) (Pass).
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.
No clinical studies were required to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Concentric Balloon Guide Catheter K112404
Reference Device(s)
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 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
1
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
2
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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3
510(k) Summary
| Date Summary Prepared | July 21, 2022 |
|---|---|
| Submitter | InNeuroCo, Inc. |
| 19700 Stirling Road, Suite 1 | |
| Pembroke Pines, FL 33332 | |
| Primary Submission Contact | Garry Koroshec |
| Senior Design Quality Engineer / Regulatory Affairs |
InNeuroCo, Inc.
19700 Stirling Road, Suite 1
Pembroke Pines, FL 33332
Telephone: 1-954-254-5003
Facsimile: 1-954-742-5989
E-Mail: garry@inneuroco.com |
| Secondary Submission Contacts | Ming Cheng Chew
Regulatory Consultant
Libra Medical Inc.
8401 73rd Avenue North, Suite 63
Brooklyn Park, MN 55428
Telephone: 763-232-3701
E-Mail: mcchew@libramed.com
Marianne Grunwaldt
Senior Director of Regulatory Affairs and Quality Assurance
InNeuroCo, Inc.
19700 Stirling Road, Suite 1
Pembroke Pines, FL 33332
Telephone: 1-954-703-5271
Facsimile: 1-954-742-5989
E-Mail: marianne@inneuroco.com |
| Trade Name | 091 Balloon Guide Catheter |
| Regulation Number | 21 CFR 870.1250 |
| Device Common or Classification
Name | Percutaneous Catheter, Neurovasculature |
| Product Class | Class II |
| Product Panel | Cardiovascular, Neurology |
| Product Codes | DQY, QJP |
| Predicate Device | Concentric Balloon Guide Catheter
K112404 |
4
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 Device
Concentric Balloon Guide Catheter
(K112404) | Subject Device
091 Balloon Guide Catheter
(K220331) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Concentric Balloon Guide Catheter is
indicated 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
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 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. |
| Anatomical
Location | Peripheral and neuro vasculature | Peripheral and neuro vasculature |
| Product Code | DQY | DQY, QJP |
| Classification | Class II | Class II |
| Regulation
Number | 870.1250 | 870.1250 |
| Catheter
Material | Outer Jacket: Pebax
Inner Lumen: PTFE and Pebax
Distal Tip: Pebax | Outer Jacket: PTFE and Polyethylene
Inner Lumen: PTFE, Pebax, and Nylon
Distal Tip: Chronoflex and Polyolefin |
| Reinforcement
Layer | Stainless Steel Braid | Stainless Steel Coil |
| Radiopaque
Marker Band | Platinum/Iridium | Platinum/Iridium |
Table 6.1 Technological Comparison of the 091 Balloon Guide Catheter and Concentric Balloon Guide Catheter (K112404)
5
| Parameter | Predicate Device
Concentric Balloon Guide Catheter
(K112404) | Subject Device
091 Balloon Guide Catheter
(K220331) |
|--------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|
| Coating | None | None |
| Internal
Construction | Co-axial Lumen | Co-axial Lumen |
| Hub | Polyurethane | Polycarbonate |
| Strain Relief | Polyolefin | Silicone |
| Balloon Material | Silicone | Polyurethane elastomer |
| Working Length | 80cm, 95cm | 95cm |
| Max Outer
Diameter | 0.088, 0.104, and 0.116 inches | 0.125 inches |
| Shaft Inner
Diameter | 0.059, 0.078, and 0.085 inches | 0.0905 inches |
| Accessories
Supplied | Dilator | Peel Away Introducer |
| Packaging | Polyethylene Tube and HDPE Packaging
Card
Tyvek/PE/PET Pouch | Polyethylene Tube and HDPE Packaging
Card
Tyvek/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 and | |
| Annex B. | Pass | |
| PTFE delamination | PTFE liner was visually inspected to ensure that | |
| delamination 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 4.10 | |
| and Annex F. | Pass | |
| Balloon Burst | The constrained balloon must not burst below the | |
| specified volume. | Pass | |
| Visual Inspection | Samples were visually inspected under 2.5X magnification | |
| to ensure acceptance criteria were met. | Pass | |
| Particulates | Testing was completed per USP . Testing was also | |
| performed in comparison to the predicate. | Pass | |
| Liquid Leak Test | Testing was conducted per ISO 10555-1, Section 4.7 and | |
| Annex C. | Pass | |
| Air Leak Test | Testing was conducted per ISO 10555-1 section 4.7.2 and | |
| Annex D. | Pass | |
| Balloon Leak Test | Testing was conducted per ISO 10555-4, section 4.4.2 | |
| and Annex B. | Pass |
Table 6.2 – Performance Bench Tests Performed on the 091 Balloon Guide Catheter
6
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.
7
| Biological Effect | Test | Results |
|---|---|---|
| Cytotoxicity | MEM elution, 48 hr. inc., | |
| triplicate L929, 24 hr. ext. | ||
| (nonimplant) | 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 | |
| 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.