(179 days)
No
The device description and intended use focus on the mechanical and material properties of a balloon catheter for temporary vascular occlusion and infusion. There is no mention of AI or ML in the provided text.
No.
The device is a catheter used for temporary occlusion and delivery of other diagnostic or therapeutic devices, rather than being a therapeutic device itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is indicated for "the infusion of diagnostic agents, such as contrast media," in both peripheral and neurovascular applications.
No
The device description clearly details a physical catheter with lumens, a balloon, radiopaque markers, and a hydrophilic coating, indicating it is a hardware device, not software-only.
Based on the provided information, the ECLIPSE 2L is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in the blood vessels) for temporary occlusion, infusion of diagnostic agents (like contrast media), and delivery of therapeutic devices. This is an in vivo application.
- Device Description: The description details a catheter with a balloon designed for inflation within blood vessels, radiopaque markers for visualization during procedures, and a hydrophilic coating for insertion. These are characteristics of a device used directly on or within a living organism.
- IVD Definition: In Vitro Diagnostic devices are defined as those intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The ECLIPSE 2L does not perform this function.
The ECLIPSE 2L is a medical device used for interventional procedures within the vascular system.
N/A
Intended Use / Indications for Use
The ECLIPSE 2L is indicated for use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired. These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms.
ECLIPSE 2L is indicated for use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic devices, such as embolization coils.
ECLIPSE 2L is also indicated for neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic devices, such as DMSO based embolization materials, that have been approved for use in the neurovasculature and are compatible with the diameter of the ECLIPSE 2L.
Product codes (comma separated list FDA assigned to the subject device)
MJN, DQY
Device Description
ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in a parallel configuration. The guidewire lumen or the working lumen is DMSO compatible and can be used for infusion/delivery of diagnostic and therapeutic devices. The inflation lumen is used for the inflation and deflation of the balloon. The inflation of the balloon can be achieved independently of the presence of the guidewire. ECLIPSE 2L balloon catheter is equipped with a non-detachable low inflation pressure super compliant balloon welded to the distal end of the catheter.
The ECLIPSE 2L balloon catheter incorporates 3-4 radiopaque markers. The radiopaque marker bands are located at the distal end of the working lumen and at either end of the balloon to facilitate fluoroscopic visualization during procedure. The short nose (SN) variant has an additional proximal marker located 3 cm from the distal tip of the catheter to aid in positioning detachable coils. The ECLIPSE 2L also has distal purge air from the balloon prior to use. The catheter and the outer surface of the balloon is coated with hydrophilic coating to reduce friction and increase lubricity. An introducer sheath is provided with the device as an accessory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels of the peripheral and neurovasculature
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)
Performance Bench Testing and Animal Testing: Results of the performance bench testing and animal testing (Table 2) indicate that ECLIPSE 2L (Subject Device) meets established performance requirements and is substantially equivalent for its intended use.
Biocompatibility: Results of the biocompatibility testing (Table 3) indicate that ECLIPSE 2L (Subject Device) is biocompatible and is substantially equivalent for its intended use.
Shelf life: The accelerated shelf life testing for ECLIPSE 2L has been conducted (T=1 years accelerated aging) with test results confirmed that all acceptance criteria were met. No new questions of safety or effectiveness are raised. Based on the results, we can conclude that ECLIPSE 2L will perform as intended to the Design Specification. ECLIPSE 2L will be labeled for 1-year shelf life.
Packaging: The packaging validation, T=1 year accelerated aging was performed on the ECLIPSE 2L. The results from packaging testing conducted on ECLIPSE 2L showed that the acceptance criteria were met. Therefore, we can conclude the ECLIPSE 2L packaging will provide the adequate and effective protection and sterile barrier requirements.
Sterilization: ECLIPSE 2L is sterilized using 100% Ethylene Oxide (EO) gas in the same manner as FDA cleared predicate device, Scepter C/XC Occlusion Balloon Catheter (K121785) and HyperGlide and HyperForm Occlusion Balloons (K101570). ECLIPSE 2L is sold sterile, for single use and single patient only. The sterilization was performed and documented. The sterilization validation results showed that the sterilization dose and routine sterilization process was validated to achieve a SAL of 10-6 for the ECLIPSE 2L.
Key results from performance bench testing include:
- Corrosion Resistance: All test samples met acceptance criteria.
- Particulate Matter Characterization: All test samples met acceptance criteria. Particulate matter characterization of the Subject Device was comparable to Predicate Device.
- Coating Integrity and Adherence: All test samples met acceptance criteria.
- Compatibility and Coil Remodeling: All test samples met acceptance criteria.
- Simulated Use/Coating Lubricity and Durability: All test samples met the acceptance criteria. The overall performance of the Subject Device is equivalent or better than the Predicate Device.
- Flow Rate: Testing was conducted for reference only.
- Dynamic Burst: All test samples met the acceptance criteria.
- Liquid Leak: All test samples met the acceptance criteria.
- Air Leak: All test samples met the acceptance criteria.
- Static Burst: All test samples met the acceptance criteria.
- Torque Strength: All test samples met the acceptance criteria. The torque strength of the Subject Device is equivalent or better to the Predicate Device.
- Physical Attributes: All test samples met the acceptance criteria.
- Dead Space Volume: Testing was conducted for reference only.
- Balloon Deflation Time: All test samples met the acceptance criteria.
- Balloon Compliance: All test samples met the acceptance criteria.
- Balloon Fatigue: All test samples met the acceptance criteria.
- Balloon Burst Volume: All test samples met the acceptance criteria.
- Kink Resistance: All test samples met the acceptance criteria. The kink resistance performance of the Subject Device is equivalent or better to the Predicate Device.
- Surface Contamination: All test samples met the acceptance criteria.
- Tensile Force: All test samples met the acceptance criteria.
- Gauge Test: All test samples met the acceptance criteria.
- Ease of Assembly: All test samples met the acceptance criteria.
- Unscrewing Torque: All test samples met the acceptance criteria.
- Resistance to Overriding: All test samples met the acceptance criteria.
- Separation Force: All test samples met the acceptance criteria.
- Stress Cracking: All test samples met the acceptance criteria.
- Catheter Flexural Fatigue: All test samples met the acceptance criteria.
- DMSO Compatibility: All test samples met the acceptance criteria.
Key results from performance animal testing (GLP) include:
- All test samples met the acceptance criteria.
- Trackability and handling of the catheter, radiopacity, and the balloon test occlusion were comparable to predicate device.
Key results from biocompatibility testing include:
- Cytotoxicity - Extraction ISO 10993-5: Non-cytotoxic.
- Sensitization - ISO Guinea Pig Maximization Sensitization Test-(2 Extracts) ISO 10993-10: Did not elicit sensitization response.
- Irritation or Intracutaneous - ISO Intracutaneous Study in Rabbits – Two Extracts ISO 10993-10: Non-irritant.
- Acute Systemic Toxicity – ISO Acute Systemic Toxicity Study in Mice – Two Extracts ISO 10993-11: Non-toxic.
- Systemic Toxicity – ISO Materials Mediated Rabbit Pyrogen ISO 10993-11: Non-pyrogenic.
- Hemocompatibility-Hemolysis (Direct) ISO 10993-4: Non-Hemolytic.
- Hemocompatibility - ASTM Hemolysis (Extract Method) ISO 10993-4: Non-Hemolytic.
- Hemocompatibility – Complement Activation – SC5b-9 ISO 10993-4: Passed.
- Hemocompatibility – Partial Thromboplastin Time (PTT) ISO 10993-4: Passed.
- Hemocompatibility – Platelet & Leukocyte Counts (PLC) 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.
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
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains 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.
April 30, 2019
Balt USA, LLC Nancy Xu Regulatory Affairs Manager 29 Parker Irvine, California 92618
Re: K183045
Device Name: ECLIPSE 2L Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN, DQY Dated: March 29, 2019 Received: April 1, 2019
Dear Nancy Xu:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183045
Device Name ECLIPSE 2L
Indications for Use (Describe)
The ECLIPSE 2L is indicated for use in the blood vessels of the periovasculature where temporary occlusion is desired. These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms.
ECLIPSE 2L is indicated for use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic devices, such as embolization coils.
ECLIPSE 2L is also indicated for neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic devices, such as DMSO based embolization materials, that have been approved for use in the neurovasculature and are compatible with the diameter of the ECLIPSE 2L.
| 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
ECLIPSE 2L 510(k) Summary
This 510(k) summary for ECLIPSE 2L is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendation outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)], dated 28 July, 2014.
SUBMITTER [807.92(a)(1)]
Balt USA, LLC 29 Parker Irvine CA 92618
| Contact Person: | Nancy Xu |
|---|---|
| Director of Regulatory Affairs | |
| Telephone: | 949-788-1443 |
| E-mail: | nancy.xu@balt-usa.com |
| Date prepared: | April 29, 2019 |
DEVICE [807.92(a)(2)]
| Name of Device: | ECLIPSE 2L |
|---|---|
| Common or Usual Name: | Occlusion Balloon Catheter |
| Classification Name: | Vascular Clamp |
| Percutaneous Catheter | |
| Product Code: | MJN |
| DQY | |
| Regulatory Class: | Class II |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | 21 C.F.R. 870.4450 |
| 21 C.F.R. 870.1250 | |
| Reviewing Product Branch: | Division of Neurological and Physical Medicine Devices (Office of |
| Device Evaluation, CDRH) |
PREDICATE DEVICE [807.92(a)(3)]
Scepter C/XC Occlusion Balloon Catheter (K121785)
REFERENCE DEVICE
HyperGlide and HyperForm Occlusion Balloons (K101570)
4
DEVICE DESCRIPTION [807.92(a)(4)]
ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in a parallel configuration. The guidewire lumen or the working lumen is DMSO compatible and can be used for infusion/delivery of diagnostic and therapeutic devices. The inflation lumen is used for the inflation and deflation of the balloon. The inflation of the balloon can be achieved independently of the presence of the guidewire. ECLIPSE 2L balloon catheter is equipped with a non-detachable low inflation pressure super compliant balloon welded to the distal end of the catheter.
The ECLIPSE 2L balloon catheter incorporates 3-4 radiopaque markers. The radiopaque marker bands are located at the distal end of the working lumen and at either end of the balloon to facilitate fluoroscopic visualization during procedure. The short nose (SN) variant has an additional proximal marker located 3 cm from the distal tip of the catheter to aid in positioning detachable coils. The ECLIPSE 2L also has distal purge air from the balloon prior to use. The catheter and the outer surface of the balloon is coated with hydrophilic coating to reduce friction and increase lubricity. An introducer sheath is provided with the device as an accessory.
INDICATIONS FOR USE [807.92(a)(5)]
The ECLIPSE 2L is indicated for use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired. These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms.
ECLIPSE 2L is indicated for use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic devices, such as embolization coils.
ECLIPSE 2L is also indicated for neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic devices, such as DMSO based embolization materials, that have been approved for use in the neurovasculature and are compatible with the diameter of the ECLIPSE 2L.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]
The technological characteristics of the ECLIPSE 2L is highly analogous to the technological characteristics of the Scepter C/XC Occlusion Balloon Catheter (K121785) and HyperGlide and HyperForm Occlusion Balloons (K101570). Substantial equivalence is determined based on the following similarities:
- similar intended use/indications for use
- Same principles of operation ●
5
- Same fundamental scientific technology .
- Incorporate similar basic balloon catheter design .
- Incorporate similar balloon catheter construction material .
Table 1 comprises the comparison between ECLIPSE 2L (Subject Device), Scepter C/XC Occlusion Balloon Catheter (Predicate Device, K121785) and HyperGlide and HyperForm Occlusion Balloons (Reference Device, K101570).
6
| Feature | Scepter C/XC Occlusion Balloon
Catheter | HyperGlide and HyperForm
Occlusion Balloons | ECLIPSE 2L |
|-------------------|--------------------------------------------|------------------------------------------------|--------------------------------------------------|
| | [PREDICATE DEVICE]
[K121785] | [REFERENCE DEVICE]
[K101570] | [SUBJECT DEVICE] |
| Product Code | MJN
DQY | MJN | Same as Predicate Device |
| Regulatory Class | Class II | Class II | Same as Predicate Device and
Reference Device |
| Regulation Number | 21 CFR 870.4450
21 CFR 870.1250 | 21 CFR 870.4450 | Same as Predicate Device |
| Regulation Name | Vascular Clamp
Percutaneous Catheter | Vascular Clamp | Same as Predicate Device |
| Generic Name | Occlusion Balloon Catheter | Occlusion Balloon Catheter | Same as Predicate Device and
Reference Device |
7
| Indications for Use
| Statement | |||
|---|---|---|---|
| For use in the blood vessels of the | |||
| peripheral and neurovasculature where | |||
| temporary occlusion is desired. These | |||
| catheters offer a vessel selective | |||
| technique of temporary vascular | |||
| occlusion which is useful in selectively | |||
| stopping or controlling blood flow and | |||
| for balloon assisted embolization of | |||
| intracranial aneurysms. | |||
| For use in the peripheral vasculature for | |||
| the infusion of diagnostic agents, suchas contrast media, and therapeutic | |||
| agents, such as embolization materials. | |||
| For neurovascular use for the infusion | |||
| of diagnostic agents, such as contrast | |||
| media, and therapeutic agents, such as | |||
| embolization materials, that have been | |||
| approved or cleared for use in the | |||
| neurovasculature and are compatible | |||
| with the diameter of the Scepter C/XC | |||
| Balloon Catheter. | The ev3 Occlusion Balloon | ||
| Catheters are indicated for use in | |||
| blood vessels of the peripheral and | |||
| neuro vasculature where temporary | |||
| occlusion is desired. These catheters | |||
| offer a vessel selective technique of | |||
| temporary vascular occlusion, which | |||
| is useful in selectively stopping or | |||
| controlling blood flow; the | |||
| Occlusion Balloon Catheters may | |||
| also be used in balloon-assisted | |||
| embolization of intracranial | |||
| aneurysms. | The ECLIPSE 2L is indicated for | ||
| use in the blood vessels of the | |||
| peripheral and neurovasculature | |||
| where temporary occlusion is | |||
| desired. These catheters offer a | |||
| vessel selective technique of | |||
| temporary vascular occlusion which | |||
| is useful in selectively stopping or | |||
| controlling blood flow and for | |||
| balloon assisted embolization of | |||
| intracranial aneurysms. | |||
| ECLIPSE 2L is indicated for use in | |||
| the peripheral vasculature for the | |||
| infusion of diagnostic agents, such | |||
| as contrast media, and therapeutic | |||
| devices, such as embolization coils. | |||
| ECLIPSE 2L is also indicated for | |||
| neurovascular use for the infusion | |||
| of diagnostic agents, such as | |||
| contrast media, and therapeutic | |||
| devices, such as DMSO based | |||
| embolization materials, that have | |||
| been approved for use in the | |||
| neurovasculature and are | |||
| compatible with the diameter of the | |||
| ECLIPSE 2L. | |||
| Feature | Scepter C/XC Occlusion Balloon | ||
| Catheter | HyperGlide and HyperForm | ||
| Occlusion Balloons | ECLIPSE 2L | ||
| [PREDICATE DEVICE] | |||
| [K121785] | [REFERENCE DEVICE] | ||
| [K101570] | [SUBJECT DEVICE] | ||
| Intended Use | For use in the blood vessels of the | ||
| peripheral and neurovasculature where | |||
| temporary occlusion is desired. These | |||
| catheters offer a vessel selective | |||
| technique of temporary vascular | |||
| occlusion which is useful in selectively | |||
| stopping or controlling blood flow and | |||
| also offers balloon assisted | |||
| embolization of intracranial aneurysms. | |||
| For general intravascular use, including | |||
| the peripheral and neurovasculature, for | |||
| the infusion of diagnostic agents, such | |||
| as contrast media, and therapeutic | |||
| agents, such as embolization materials. | The ev3 Occlusion Balloon | ||
| Catheters are intended for use in the | |||
| peripheral and neuro vasculature | |||
| wherever temporary occlusion is | |||
| desired as well as for balloon- | |||
| assisted embolization of intracranial | |||
| aneurysms. | Same as Predicate Device. |
8
9
| Lumen Configuration | Dual coaxial lumen | Single lumen | Dual Lumen (parallel) |
|---|---|---|---|
| Guidewire Lumen | |||
| Inner Diameter | 0.0165" | Not Listed | 0.0161" (guidewire lumen inner |
| diameter) | |||
| Outer Diameter | 2.6-2.8F | Not Listed | Major OD: 3.3 F (1.1mm) |
| Minor OD: 2.7 F (0.9mm) | |||
| Balloon Diameter | 4 mm | 3-7 mm | 6 mm |
| Balloon Length | 10-20 mm | 7-30 mm | 7-20 mm |
| Material | Polyether block amide, polyolefin, | ||
| stainless steel, PTFE, polyurethane | |||
| elastomeric alloy, Pt alloy, | |||
| polypropylene | Not Listed | Polyamide, Polyether Block | |
| Amide, Estane, PTFE, TPE, Gold | |||
| Introducer Sheath | Yes | Not Listed | Same as Predicate Device |
| Shaping Mandrel | Yes | Not Listed | No |
| Distal Tip Shaping | Yes | Not Listed | No |
| Guidewire | |||
| Compatibility | 0.014" wire or smaller | 0.010" wire | 0.014" max |
| Method of Supply | Sterile and single use | Sterile and single use | Same as Predicate Device and |
| Reference Device |
10
PERFORMANCE DATA [807.92(b)]
Performance Bench Testing and Animal Testing: Results of the performance bench testing and animal testing (Table 2) indicate that ECLIPSE 2L (Subject Device) meets established performance requirements and is substantially equivalent for its intended use.
| Performance Bench Testing | |||
|---|---|---|---|
| Tests | Test Method Summary | Results | |
| Corrosion Resistance | The test article is immersed in sodium | ||
| chloride solution before being placed in | |||
| boiling distilled or deionized water. | |||
| Subsequently, the test article is examined | |||
| visually for evidence of corrosion. | All test samples met acceptance | ||
| criteria. | |||
| Particulate Matter | |||
| Characterization | Particulate matter in injections of the | ||
| sterilized device were quantified after pre- | |||
| conditioning per IFU and simulated use. | |||
| Particulate matter characterization of the | |||
| Subject Device was compared to the | |||
| Predicate Device. | All test samples met acceptance | ||
| criteria. Particulate matter | |||
| characterization of the Subject | |||
| Device was comparable to | |||
| Predicate Device. | |||
| Coating Integrity and | |||
| Adherence | Test samples were dyed and gone through | ||
| simulated use testing. Inspect the coating | |||
| quality of the dyed catheter under a | |||
| microscope. | All test samples met acceptance | ||
| criteria. | |||
| Compatibility and Coil | |||
| Remodeling | The compatibility of 6F Guide catheter | ||
| with microcatheter, balloon coiling and the | |||
| use of stent was evaluated and rated. No | |||
| coating particulate shall be observed during | |||
| and post simulated use. | All test samples met acceptance | ||
| criteria. | |||
| Simulated Use/Coating | |||
| Lubricity and Durability | The clinical use of the device in vitro using | ||
| a cerebrovascular benchtop model and the | |||
| lubricity/durability of the coating was | |||
| evaluated and rated. No coating particulate | |||
| shall be observed during and post | All test samples met the | ||
| acceptance criteria. The overall | |||
| performance of the Subject | |||
| Device is equivalent or better | |||
| than the Predicate Device. | |||
| simulated use. The overall performance | |||
| was compared to the competitor devices. | |||
| Flow Rate | The injection flow rate of saline and | ||
| contrast media of the device is measured. | |||
| The flow rate is measured for reference. | Testing was conducted for | ||
| reference only. | |||
| Dynamic Burst | Catheter hub and shaft junctions shall not | ||
| burst when injected with saline and | |||
| contrast media under hydrostatic pressure | |||
| by using an injection system. | All test samples met the | ||
| acceptance criteria. | |||
| Liquid Leak | Devices were tested for liquid leakage. No | ||
| liquid shall be leaking from hub and | |||
| catheter shaft under pressure. | All test samples met the | ||
| acceptance criteria. | |||
| Air Leak | Devices were tested for air leakage. Air | ||
| bubbles shall not leak into the hub | |||
| assembly during aspiration via syringe. | All test samples met the | ||
| acceptance criteria. | |||
| Static Burst | Perform static burst testing per ISO 10555- |
- The guidewire lumen shall not burst per
specification. | All test samples met the
acceptance criteria. | |
| Torque Strength | Torque strength was determined by number
of turns-to-failures. Torque strength of the
Subject Device was compared to the
Predicate Device. | All test samples met the
acceptance criteria. The torque
strength of the Subject Device
is equivalent or better to the
Predicate Device. | |
| Physical Attributes | Inspect and measure dimensions for both
the catheter and the balloon per product
specification. | All test samples met the
acceptance criteria. | |
| Dead Space Volume | Determine the dead space volume for both
the guidewire lumen and inflation lumen
by using syringe and syringe pump. | Testing was conducted for
reference only. | |
| Balloon Deflation Time | Perform balloon deflation time testing by
determining the time required to deflate the
balloon from the rated burst volume. | All test samples met the
acceptance criteria. | |
| Balloon Compliance | Perform balloon compliance testing by
measuring the balloon OD while inflating
incrementally to the max rated inflation
volume. | All test samples met the
acceptance criteria. | |
| Balloon Fatigue | Perform balloon fatigue testing by
evaluating the integrity of the test sample
after repeated inflation cycles. No leakage
or rupture shall be observed after 20 cycles
(inflation/deflation) to rated burst volume. | All test samples met the
acceptance criteria. | |
| Balloon Burst Volume | Determine the burst volume of the test
samples by incrementally inflating the
balloon with solution until burst failure. | All test samples met the
acceptance criteria. | |
| Kink Resistance | Perform kink resistance testing by
wrapping the test point with an appropriate
pin gauge to achieve a full 180° turn.
Verify the OD has not changed and the
catheter is not kinked using a microscope.
Kink resistance of the Subject Device was
compared to the Predicate Device. | All test samples met the
acceptance criteria. The kink
resistance performance of the
Subject Device is equivalent or
better to the Predicate Device. | |
| Surface Contamination | Test samples were visually inspected for
surface contamination under 2.5x
magnification. The entire catheter surface
should be free of presence of particulate. | All test samples met the
acceptance criteria. | |
| Tensile Force | Perform tensile force testing per ISO
10555-1.
Peak tensile strength of distal tip
should be ≥ 3N (OD ≥.55mm 0.05) when
compared to the comparison article.
Therefore, the statistical analysis indicates
that the test article is comparable to the
comparison article. | Passed |
Table 3: Biocompatibility Test Summary
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Shelf life: The accelerated shelf life testing for ECLIPSE 2L has been conducted (T=1 years accelerated aging) with test results confirmed that all acceptance criteria were met. No new questions of safety or effectiveness are raised. Based on the results, we can conclude that ECLIPSE 2L will perform as intended to the Design Specification. ECLIPSE 2L will be labeled for 1-year shelf life.
Packaging: The packaging validation, T=1 year accelerated aging was performed on the ECLIPSE 2L. The results from packaging testing conducted on ECLIPSE 2L showed that the acceptance criteria were met. Therefore, we can conclude the ECLIPSE 2L packaging will provide the adequate and effective protection and sterile barrier requirements.
Sterilization: ECLIPSE 2L is sterilized using 100% Ethylene Oxide (EO) gas in the same manner as FDA cleared predicate device, Scepter C/XC Occlusion Balloon Catheter (K121785) and HyperGlide and HyperForm Occlusion Balloons (K101570). ECLIPSE 2L is sold sterile, for single use and single patient only. The sterilization was performed and documented. The sterilization validation results showed that the sterilization dose and routine sterilization process was validated to achieve a SAL of 106 for the ECLIPSE 2L.
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| Test Description | Test Summary | Results |
|---|---|---|
| Original Sterilization | ||
| Validation and adoption | 100% EO is used to sterilize | |
| the device to achieve a | ||
| minimum SAL of 10-6. The | ||
| validation was conducted in | ||
| accordance with ISO 11135. | ||
| The original validation of the | ||
| EO sterilization cycle of a | ||
| worst-case device family was | ||
| performed using one (1) | ||
| fractional exposure cycle, | ||
| three (3) half exposure cycles | ||
| and one (1) full exposure | ||
| cycle, overkill approach | ||
| described in ISO 11135. The | ||
| subject device was adopted to | ||
| the original validated | ||
| sterilization cycle by | ||
| performing one (1) full cycle. | The validation study | |
| demonstrated that the | ||
| sterilization process and | ||
| equipment are capable of | ||
| reliably and consistently | ||
| sterilizing the devices to a | ||
| minimum SAL of 10-6. | ||
| Fractional cycles, half cycles, | ||
| and full cycles met the | ||
| acceptance criteria. The | ||
| subject device was | ||
| successfully adopted to the | ||
| original sterilization | ||
| validation by performing one | ||
| (1) full cycle. | ||
| EO and ECH Residuals | EO and ECH residuals were | |
| measured per ISO 10993-7: |
-
| The residual traces of EO and
ECH for the subject device
are below the limits specified
in ISO 10993-7. |
| Bacterial Endotoxin Levels | LAL testing was conducted in
accordance with FDA
guidance document (June
2012), USP, and
European Pharmacopeia BET
2.6.14 |