(241 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guide catheter, with no mention of AI or ML capabilities.
No
The device is a guide catheter used to introduce other interventional devices, rather than directly treating a condition itself.
No
Explanation: The device is indicated for the introduction of interventional devices, facilitating access for treatment rather than diagnosis. While it uses fluoroscopy for visualization, this is for guiding the interventional device, not for diagnostic imaging of the anatomy itself.
No
The device description clearly details a physical catheter made of metal coils/braids and medical grade polymers, with a luer fitting, hydrophilic coating, and radiopaque marker. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. This is a procedural device used in vivo (within the body) to facilitate other medical procedures.
- Device Description: The description details a physical catheter designed for navigation within blood vessels. It describes its construction, features like a hydrophilic coating and radiopaque marker, and compatibility with guidewires and other devices. This is consistent with a medical device used for intervention, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This catheter does not perform any of these functions.
N/A
Intended Use / Indications for Use
The 87 NeuGlide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QJP, DQY
Device Description
The Piraeus Medical 87 NeuGlide Catheter is a single lumen guide catheter that provide access to peripheral, coronary and neuro vasculature. The catheter is comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The catheter features a hydrophilic coating to enhance tracking through tortuous vasculature and facilitate the introduction of interventional devices to the peripheral, coronary and neurovasculature. The 87 NeuGlide guide catheter is compatible with 0.035" or smaller guidewires.
The distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. The 87 NeuGlide Catheter has an inner diameter of 0.087″ (6F compatible), and a maximum outer diameter of 0.100″. The catheter is offered in working lengths of 110 and 100 cm. The 87 NeuGlide guide catheter is packaged with a loading tool to aid in insertion of the catheter into a short sheath.
Accessory devices required, but not supplied include:
- Guidewires
- Support/diagnostic catheters
- Introducer sheaths
- Rotating Hemostasis valves (RHVs) ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
peripheral, coronary, and neuro vasculature.
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)
Bench and lab testing was performed for the subject device. The following tests were performed per company approved protocols, test methods, and performance standards, and all passed:
- Visual Inspection: The catheter was examined for surface defects or extraneous matter. The distal tip was inspected to confirm the presence of smooth, tapered or rounded edges.
- Dimensional Verification: The catheter outer diameter, inner diameter, usable length, and coating length were measured.
- Delivery, Compatibility, and Retraction (Trackability): The catheter shall be able to be prepped, inserted, tracked, and retracted and removed per the IFU within a simulated use model without incurring any damage to the catheter. [ISO 10555-1, FDA guidance PTA and Specialty Catheters]
- Flexibility and Kink Resistance: There shall be no kinking of shaft (permanent deformation) after simulated use. [FDA guidance PTA and Specialty Catheters]
- Compatibility with other Devices (external): The catheter is compatible with introduction through 7F introducer (short) sheath. [ISO 10555-1, FDA guidance PTA and Specialty Catheters]
- Guidewire Compatibility: The catheter shall be able to be delivered over the maximum size guidewire indicated in the product labeling. [ISO 10555-1, FDA guidance PTA and Specialty Catheters]
- Interventional Device Compatibility (internal): The catheter shall be able to accommodate other interventional devices (e.g., support catheter, diagnostic catheter) up to the maximum size indicated in the product labeling. [ISO 10555-1, FDA guidance PTA and Specialty Catheters]
- Luer Compatibility: Devices and accessories shall be compatible with standard syringe luer fittings per ISO 80369-7 and -20.
- Accessory Compatibility: Devices shall be compatible with accessories such as RHVs and the accessory loading tool.
- Catheter Bond Strength: The catheter shall have sufficient tensile bond strengths in comparison to measured retrieval forces to remain intact throughout a procedure. [ISO 10555-1, FDA guidance PTA and Specialty Catheters]
- Freedom from Leakage - positive pressure: No liquid leakage from the hub or catheter shaft at 317 kPa (46 psi) for 30 seconds. [ISO 10555-1]
- Freedom from Leakage - negative pressure: No air leakage into a 20cc syringe when vacuum pulled for 15 seconds. [ISO 10555-1]
- Kink Resistance: There shall be no kinking of the catheter shaft (permanent deformation) after wrapping around anatomically relevant bend radii. [FDA guidance PTA and Specialty Catheters]
- Pushability: The proximal shaft of the catheter shall have sufficient stiffness that the user can easily push the catheter to the target anatomy without buckling. [ISO 10555-1, FDA guidance PTA and Specialty Catheters]
- Access Force: Catheter shall not require excessive force to safely navigate and track to the target anatomy. [ISO 10555-1, FDA guidance PTA and Specialty Catheters]
- 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.
- Torque Strength: The catheter was navigated through a clinically relevant tortuous path and with the distal tip secured the proximal end was rotated until failure. [FDA guidance PTA and Specialty Catheters]
- Distal Tip Flexibility: Tip flexibility was measured with a force gauge to measure the compressive force exerted by the side of the catheter at a defined distance from the distal tip when the distal tip of the catheter is deflected. Results were compared to the predicate.
- Particulate: The amount of particulate matter generated during simulated use testing was compared to the predicate. [FDA guidance PTA and Specialty Catheters]
- Coating Lubricity, Durability, and Integrity: Durability and lubricity measured the frictional forces with a pinch test. The hydrophilic coating was examined for damage after simulated use.
- Corrosion: Corrosion resistance evaluated the metallic components related to corrosion contacting the intended fluid path. [ISO 10555-1]
- Radiopacity: ASTM F640-23
- Biocompatibility Testing:
- Cytotoxicity - MEM Elution: Tested in accordance with ISO 10993-5, passed.
- Sensitization - Guinea Pig Maximization Sensitization: Tested in accordance with ISO 10993-10, passed.
- Irritation - Intracutaneous Reactivity: Tested in accordance with ISO 10993-23, passed.
- Systemic Toxicity - Acute Systemic Toxicity Test: Tested in accordance with ISO 10993-11, passed.
- Pyrogenicity - Material Mediated Pyrogenicity Test: Tested in accordance with ISO 10993-11 and USP , passed.
- Hemocompatibility - Hemolysis (Direct Contact & Extract Method): Tested in accordance with ASTM F756, and ISO 10993-4, passed.
- Hemocompatibility - Complement Activation SC5b-9 Assay: Tested in accordance with ISO 10993-4, passed.
- Hemocompatibility - In-vivo Thromboresistance: Tested in accordance with ISO 10993-4, passed.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
December 6, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The seal is a stylized depiction of an eagle and a caduceus, while the FDA acronym and name are written in blue, with the word "Administration" appearing below the acronym and name.
Piraeus Medical Kristin M. Mortenson VP Quality and Regulatory 7351 Kirkwood Lane North Suite 116 Maple Grove, Minnesota 55369
Re: K240971
Trade/Device Name: 87 NeuGlide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: November 4, 2024 Received: November 6, 2024
Dear Ms. Mortenson:
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"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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).
2
Sincerely,
Sara S. Thompson -S
for 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
3
Indications for Use
510(k) Number (if known) K240971
Device Name 87 NeuGlide Catheter
Indications for Use (Describe)
The 87 NeuGlide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
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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4
510(k) Summary, K240971
A. Submitter Information
Submitter's Name: Address:
Contact Person: Telephone: Email: Date of Preparation:
B. Correspondent Information Contact Name:
C. Subject Device
Proprietary Names: Common/Usual Name: Classification Name: Product Code: Regulation:
D. Predicate Device
Proprietary Name: Common/Usual Name: Classification Name: Product Code: Regulation: Manufacturer: 510(k) #'s:
Piraeus Medical 7351 Kirkwood Lane Maple Grove, MN 55369 Jared Hutar 507-782-0184 quality@piraeusmedical.com November 4th, 2024
Kristin Mortenson
87 NeuGlide Catheter Guide Catheter Catheter, Percutaneous, Neurovasculature QJP, DQY 21 CFR 870.1250
TracStar Large Distal Platform Guide Catheter Catheter, Percutaneous QJP, DQY 21 CFR. 870.1250 Imperative Care Inc. K203764
E. Device Description:
The Piraeus Medical 87 NeuGlide Catheter is a single lumen guide catheter that provide access to peripheral, coronary and neuro vasculature. The catheter is comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The catheter features a hydrophilic coating to enhance tracking through tortuous vasculature and facilitate the introduction of interventional devices to the peripheral, coronary and neurovasculature. The 87 NeuGlide guide catheter is compatible with 0.035" or smaller guidewires.
The distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. The 87 NeuGlide Catheter has an inner diameter of 0.087″ (6F compatible), and a maximum outer diameter of 0.100″. The catheter is offered in working lengths of 110 and 100 cm. The 87 NeuGlide guide catheter is packaged with a loading tool to aid in insertion of the catheter into a short sheath.
Accessory devices required, but not supplied include:
- Guidewires
- Support/diagnostic catheters
- Introducer sheaths
- Rotating Hemostasis valves (RHVs) ●
5
F. Indications for Use:
The 87 NeuGlide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
G. Principles of Operation:
The 87 NeuGlide Catheter may be used with support catheters to assist in accessing the target vasculature. Use of the 87 NeuGlide Catheter relies on standard percutaneous interventional techniques, including access site preparation, introducing the catheter portion of the device, advancing the catheter under fluoroscopy, withdrawing the catheter, and closing the access site. Predicate Comparison:
The predicate device is the Imperative Care TracStar Large Distal Platform cleared under K204764. The predicate and subject devices share intended use, basic technology characteristics, and the same performance characteristics, demonstrated through bench and laboratory testing as shown in Table 1.
| Device Attribute | Predicate device (K203764) | Subject Device (K240971) |
|---|---|---|
| FDA Product Classification | Class II, QJP and DQY, 21 CFR | |
| 870.1250 | Same | |
| Product Name | TracStar Large Distal Platform | 87 NeuGlide Catheter |
| Indications for Use | The TracStar Large Distal Platform is | |
| indicated for the introduction of | ||
| interventional devices into the | ||
| peripheral, coronary, and neuro | ||
| vasculature. | The 87 NeuGlide Catheter is | |
| indicated for the introduction of | ||
| interventional devices into the | ||
| peripheral, coronary, and neuro | ||
| vasculature. | ||
| Condition Supplied | Sterile and Single Use | Same |
| Sterilization Method | Ethylene Oxide (EO), SAL 10-6 | Same |
| Inner Diameter (Distal) | 0.088" | 0.087" |
| Outer Diameter (Distal) | 0.106" | 0.100" |
| Inner Diameter (Proximal) | 0.088" | 0.087" |
| Outer Diameter (Proximal) | 0.110" | 0.100" |
| Effective Length | 80 - 110cm | 100 - 110cm |
| Tip Design | Beveled distal edge, soft, flexible, | |
| atraumatic tip | Straight atraumatic tip | |
| Coating | Hydrophilic coating | Same |
| Materials | Commonly used medical grade | |
| plastics & metals with hydrophilic | ||
| coating. | Same | |
| Packaged Accessories | Rotating Hemostasis Valve (RHV) | Loading Tool |
| Packaging Configuration | The catheters are placed in a | |
| protective polyethylene tube, | ||
| mounted with accessory RHV onto a | ||
| polyethylene packaging card, placed | ||
| into a pouch, sealed and labeled. | ||
| The sealed pouch and IFU are placed | ||
| in a labeled shelf carton box. | The catheter is placed in a protective | |
| polyethylene tube, mounted with | ||
| accessory loading tool onto a | ||
| polyethylene packaging card, placed | ||
| into a pouch, sealed and labeled. | ||
| The sealed pouch and IFU are placed | ||
| in a labeled shelf carton box. |
Table 1: Comparison of Predicate and Subject Device
6
H. Performance Data Supporting Substantial Equivalence:
A summary of the supportive data is presented in Table 2. These tests were performed per company approved protocols, test methods, and performance standards.
| Test | Test Method Summary [standard and/or guidance] | Results |
|---|---|---|
| Visual Inspection | The catheter was examined for surface defects or extraneous matter. The distal tip was inspected to confirm the presence of smooth, tapered or rounded edges | Pass |
| Dimensional Verification | The catheter outer diameter, inner diameter, usable length, and coating length were measured. | Pass |
| Delivery, Compatibility, and Retraction (Trackability) | The catheter shall be able to be prepped, inserted, tracked, and retracted and removed per the IFU within a simulated use model without incurring any damage to the catheter. [ISO 10555-1, FDA guidance PTA and Specialty Catheters] | Pass |
| Flexibility and Kink Resistance | There shall be no kinking of shaft (permanent deformation) after simulated use. [FDA guidance PTA and Specialty Catheters] | Pass |
| Compatibility with other Devices (external) | The catheter is compatible with introduction through 7F introducer (short) sheath. [ISO 10555-1, FDA guidance PTA and Specialty Catheters] | Pass |
| Guidewire Compatibility | The catheter shall be able to be delivered over the maximum size guidewire indicated in the product labeling. [ISO 10555-1, FDA guidance PTA and Specialty Catheters] | Pass |
| Interventional Device Compatibility (internal) | The catheter shall be able to accommodate other interventional devices (e.g., support catheter, diagnostic catheter) up to the maximum size indicated in the product labeling. [ISO 10555-1, FDA guidance PTA and Specialty Catheters] | Pass |
| Luer Compatibility | Devices and accessories shall be compatible with standard syringe luer fittings per ISO 80369-7 and -20. | Pass |
| Accessory Compatibility | Devices shall be compatible with accessories such as RHVs and the accessory loading tool. | Pass |
| Catheter Bond Strength | The catheter shall have sufficient tensile bond strengths in comparison to measured retrieval forces to remain intact throughout a procedure. [ISO 10555-1, FDA guidance PTA and Specialty Catheters] | Pass |
| Freedom from Leakage - positive pressure | No liquid leakage from the hub or catheter shaft at 317 kPa (46 psi) for 30 seconds. [ISO 10555-1] | Pass |
| Freedom from Leakage - negative pressure | No air leakage into a 20cc syringe when vacuum pulled for 15 seconds. [ISO 10555-1] | Pass |
| Kink Resistance | There shall be no kinking of the catheter shaft (permanent deformation) after wrapping around anatomically relevant bend radii. [FDA guidance PTA and Specialty Catheters] | Pass |
| Pushability | The proximal shaft of the catheter shall have sufficient stiffness that the user can easily push the catheter to the target anatomy without buckling. [ISO 10555-1, FDA guidance PTA and Specialty Catheters] | Pass |
| Access Force | Catheter shall not require excessive force to safely navigate and track to the target anatomy. [ISO 10555-1, FDA guidance PTA and Specialty Catheters] | Pass |
| Static Burst | The distal tip of the catheter was blocked, and fluid was | Pass |
| Table 2: Tests and Performance Specifications | |
|---|---|
7
| Test | Test Method Summary [standard and/or guidance] | Results |
|---|---|---|
| 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. | ||
| Torque Strength | The catheter was navigated through a clinically relevant | |
| tortuous path and with the distal tip secured the proximal end | ||
| was rotated until failure. [FDA guidance PTA and Specialty | ||
| Catheters] | Pass | |
| Distal Tip Flexibility | Tip flexibility was measured with a force gauge to measure the | |
| compressive force exerted by the side of the catheter at a | ||
| defined distance from the distal tip when the distal tip of the | ||
| catheter is deflected. Results were compared to the predicate. | Pass | |
| Particulate | The amount of particulate matter generated during simulated | |
| use testing was compared to the predicate. [FDA guidance PTA | ||
| and Specialty Catheters] | Pass | |
| Coating Lubricity, | ||
| Durability, and Integrity | Durability and lubricity measured the frictional forces with a | |
| pinch test. The hydrophilic coating was examined for damage | ||
| after simulated use. | Pass | |
| Corrosion | Corrosion resistance evaluated the metallic components | |
| related to corrosion contacting the intended | ||
| fluid path. [ISO 10555-1] | Pass | |
| Radiopacity | ASTM F640-23 | Pass |
Biocompatibility Testing l.
The following biocompatibility testing was conducted for the 87 NeuGlide Catheter:
| Test | Test Method Summary | Results |
|---|---|---|
| Cytotoxicity - MEM Elution | Tested in accordance with ISO 10993-5 | Pass |
| The test article is considered | ||
| non-cytotoxic. | ||
| Sensitization - Guinea Pig | ||
| Maximization Sensitization | Tested in accordance with ISO 10993-10 | Pass |
| The test article is considered | ||
| non-sensitizing. | ||
| Irritation - Intracutaneous | ||
| Reactivity | Tested in accordance with ISO 10993-23 | Pass |
| Requirements have been met | ||
| by the test article. | ||
| Systemic Toxicity - Acute | ||
| Systemic Toxicity Test | Tested in accordance with ISO 10993-11 | Pass |
| Requirements have been met | ||
| by the test article. | ||
| Pyrogenicity - Material | ||
| Mediated Pyrogenicity Test) | Tested in accordance with ISO 10993-11 | |
| and USP | Pass | |
| Requirements have been met | ||
| by the test article. | ||
| Hemocompatibility - | ||
| Hemolysis (Direct Contact & | ||
| Extract Method) | Tested in accordance with ASTM F756, | |
| and 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 - | ||
| In-vivo Thromboresistance | Tested in accordance with ISO 10993-4 | Pass |
| The test article performed | ||
| similarly to the control article. |
8
J. Sterilization:
The 87 NeuGlide Catheter is sterilized using a validated EO process with a sterility assurance level of 1x10 validated per the overkill method in accordance with ISO 11135, "Sterilization of Health-Care Products - Ethylene Oxide - Requirements for The Development, Validation and Routine Control of A Sterilization Process For Medical Devices".
K. Shelf Life and Packaging:
Accelerated aging testing based on ASTM F1980 was conducted to verify packaged device performance to support a 6-month shelf-life claim. Device and package performance was verified by functional and performance testing.
L. Conclusions:
As confirmed through the results of bench and lab testing, the subject device and predicate device share the same intended use, basic technological characteristics, and performance characteristics. Based on the results of bench performance testing, the subject and predicate devices are substantially equivalent.