(153 days)
Neuron MAX System (K111380)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guide catheter/long sheath, with no mention of AI or ML capabilities.
No.
The device facilitates the introduction of other interventional devices into the vasculature; it does not directly treat a condition itself.
No
The device is described as a guide catheter/long sheath for introducing interventional devices, not for diagnosing conditions.
No
The device description clearly outlines physical components made of materials like PTFE, stainless steel, and thermoplastics, indicating it is a hardware device, not software-only.
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 describes a device used within the body for a procedural purpose, not for testing samples outside the body.
- Device Description: The description details a physical catheter/sheath designed for insertion into blood vessels. This aligns with an in-vivo medical device, not an in-vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in-vitro diagnostics.
In-vitro diagnostics are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to facilitate procedures within the body.
N/A
Intended Use / Indications for Use
The Ballast 088 Long Sheath 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)
DQY
Device Description
The Ballast 088 Long Sheath is a sterile, single lumen, variable stiffness Guide Catheter / Long Sheath that is designed for facilitating the introduction of appropriately sized interventional devices into target blood vessels in the peripheral, coronary, and neuro vasculature.
The Ballast 088 Long Sheath consists of a lubricous inner liner made from Polytetrafluoroethylene (PTFE) reinforced by a stainless steel coil over the inner liner and stainless steel braid partially covering the inner coil layer. The outer jacket consists of thermoplastics ranging from thermoplastic polyurethane (TPU), polyether block amide (Pebax), and polyamide 12.
The distal section of the Ballast 088 Long Sheath is coated with hydrophilic coating to provide lubricity during use. A Platinum/Iridium marker band is placed at the distal end of the catheter for maximum radiopacity. An introducer sheath, 9F hemostasis valve, 8F hemostasis valve adapter and a dilator are also provided with the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Performance Bench Testing and Animal Testing: Results of the performance bench testing and animal testing (Table 2) indicate that Ballast 088 Long Sheath (Subject Device) meets established performance requirements and is substantially equivalent for its intended use.
Summary of Performance Bench Testing:
- Visual and Dimensional Inspection: All test samples passed testing.
- Surface Contamination: All test samples passed testing.
- Catheter Compatibility: All test samples passed testing.
- Simulated Use: All test samples passed testing.
- Coating Integrity and Adherence: All test samples passed testing.
- Lubricity/Durability of Hydrophilic Coating: All test samples passed testing.
- Dynamic Burst: All test samples passed testing.
- Liquid Leakage at 46 psi: All test samples passed testing.
- Air Leakage: All test samples passed testing.
- Catheter Static Burst Test: All test samples passed testing.
- Tensile Strength: All test samples passed testing.
- Corrosion Resistance: All test samples passed testing.
- Torque Strength: All test samples passed testing. The Torque Strength of the subject device is comparable to the predicate device.
- Kink Resistance Test: All test samples passed testing. The Kink Resistance of the subject device is comparable to the predicate device.
- Catheter Stiffness Testing: All test samples passed testing.
- Fracture Resistance and Flexing Test: All test samples passed testing.
- Particulate Matter Characterization: All test samples passed testing.
- Luer Dimensional Inspection: All test samples passed testing.
- Separation Force: All test samples passed testing.
- Unscrewing Torque: All test samples passed testing.
- Resistance to Overriding: All test samples passed testing.
- Stress Cracking: All test samples passed testing.
- Subatmospheric-pressure Air Leakage: All test samples passed testing.
- Packaging Integrity Test: All test samples passed testing.
- Seal strength: All test samples passed testing.
- Bubble Immersion: All test samples passed testing.
- Visual Inspection (Seal Integrity): All test samples passed testing.
Summary of Performance Animal Testing:
- Animal Testing (GLP): All test samples passed testing. Trackability and handling of the guide catheter, radiopacity, and catheter compatibility with microcatheter were comparable to predicate device.
Biocompatibility: Results of the biocompatibility testing (Table 3) indicate that the Ballast 088 Long Sheath (Subject Device) is biocompatible and is substantially equivalent for its intended use.
Summary of Biocompatibility Tests:
- Cytotoxicity – MEM Elution Test – 48 hours ISO 10993-5: Non-cytotoxic
- Sensitization - ISO Guinea Pig Kligman Maximization Test 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
- Genotoxicity: Ames Test (Solids), 2 extracts, 4 strains of Salmonella typhimurium and one strain of Escherichia coli ISO 10993-3: Non-mutagenic
- Genotoxicity: Chromosomal Aberration Assay in Chinese Hamster Ovary (CHO) cells, 2 extracts, OECD 473 ISO 10993: Non-genotoxic
- Hemocompatibility-Hemolysis, ASTM Method (Indirect) ISO 10993-4: Non-Hemolytic
- Hemocompatibility-Hemolysis, ASTM Method (Direct) 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 and Leukocyte Count (PLC) ISO 10993-4: Passed
- Hemocompatibility - 40x Digital Optical Microscopy - comparative analysis of surface morphology: Passed
Shelf life: The accelerated shelf life testing for Ballast 088 Long Sheath has been conducted (T=1 year 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 Ballast 088 Long Sheath will perform as intended to the Design Specification. Ballast 088 Long Sheath will be labeled for 1-year shelf life.
Packaging: The packaging validation, T=1 year accelerated aging was performed on the Ballast 088 Long Sheath. The results from packaging testing conducted on Ballast 088 Long Sheath showed that the acceptance criteria were met. Therefore, we can conclude the Ballast 088 Long Sheath packaging will provide the adequate and effective protection and sterile barrier requirements.
Sterilization: Ballast 088 Long Sheath is sterilized using 100% Ethylene Oxide (EtO) gas in the same manner as FDA cleared predicate device, Neuron MAXIM System (K111380). Ballast 088 Long Sheath is sold sterile, for single use and single patient only. The sterilization was performed and is 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 Ballast 088 Long Sheath.
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.
Neuron MAX System (K111380)
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
Image /page/0/Picture/0 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
March 21, 2019
Balt USA, LLC Charles Yang Senior Vice President, Quality Assurance and Regulatory Affairs 29 Parker Irvine, California 92618
Re: K182918
Device Name: Ballast 088 Long Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 15, 2019 Received: February 19, 2019
Dear Charles Yang:
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
1
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 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 (OS) 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.
Lin Zheng
Digitally signed by
Xiaolin Zheng -S
Date: 2019.03.21
10:11:36 -04'00'
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) K182918
Device Name Ballast 088 Long Sheath
Indications for Use (Describe)
The Ballast 088 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Ballast 088 Long Sheath 510(k) Summary
This 510(k) summary for Ballast 088 Long Sheath 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: | Charles Yang |
|---|---|
| Senior Vice President, Quality Assurance and Regulatory Affairs | |
| Telephone: | 949-788-1443 |
| E-mail: | charles.yang@balt-usa.com |
| Date prepared: | March 13, 2019 |
DEVICE [807.92(a)(2)]
| Name of Device: | Ballast 088 Long Sheath |
|---|---|
| Common or Usual Name: | Guide Catheter / Long Sheath |
| Classification Name: | Catheter, Percutaneous |
| Product Code: | DQY |
| Regulatory Class: | Class II |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | 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)]
Neuron MAX System (K111380)
4
DEVICE DESCRIPTION [807.92(a)(4)]
The Ballast 088 Long Sheath is a sterile, single lumen, variable stiffness Guide Catheter / Long Sheath that is designed for facilitating the introduction of appropriately sized interventional devices into target blood vessels in the peripheral, coronary, and neuro vasculature.
The Ballast 088 Long Sheath consists of a lubricous inner liner made from Polytetrafluoroethylene (PTFE) reinforced by a stainless steel coil over the inner liner and stainless steel braid partially covering the inner coil layer. The outer jacket consists of thermoplastics ranging from thermoplastic polyurethane (TPU), polyether block amide (Pebax), and polyamide 12.
The distal section of the Ballast 088 Long Sheath is coated with hydrophilic coating to provide lubricity during use. A Platinum/Iridium marker band is placed at the distal end of the catheter for maximum radiopacity. An introducer sheath, 9F hemostasis valve, 8F hemostasis valve adapter and a dilator are also provided with the device.
INDICATIONS FOR USE [807.92(a)(5)]
The Ballast 088 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]
The technological characteristics of the Ballast 088 Long Sheath are highly analogous to the technological characteristics of the Neuron MAX™ System previously cleared (K111380). Substantial equivalence is determined based on the following similarities:
- Same intended use/indications for use
- Same principles of operation ●
- Same fundamental scientific technology ●
- Incorporate similar basic Guide Catheter / Long Sheath design .
- . Incorporate similar Guide Catheter / Long Sheath construction material
Table 1 comprises the comparison between Ballast 088 Long Sheath (Subject Device) and Neuron MAXTM System (Predicate Device, K111380).
5
| Feature | Neuron MAX™ System | Ballast 088 Long Sheath |
|---|---|---|
| [PREDICATE DEVICE | ||
| K111380] | [SUBJECT DEVICE] | |
| Product Code | DQY | Same |
| Regulatory Class | Class II | Same |
| Regulation Number | 21 CFR 870.1250 | Same |
| Regulation Name | Catheter, Percutaneous | Same |
| Generic Name | Guide Catheter / Long Sheath | Same |
| Indications for Use | ||
| Statement | The Neuron MAX™ System is | |
| indicated for the introduction of | ||
| interventional devices into the | ||
| peripheral, coronary, and neuro | ||
| vasculature. | Same | |
| Function | Guide Catheter / Long Sheath for | |
| facilitating the introduction of | ||
| appropriately sized interventional | ||
| devices into target blood vessels in | ||
| the peripheral, coronary, and neuro | ||
| vasculature | Same | |
| Principle of Operation | The steerable Guide Catheter / Long | |
| Sheath is used to facilitate the | ||
| selective placement of interventional | ||
| devices | Same | |
| Anatomical Location | Peripheral, coronary, and neuro | |
| vasculature. | Same | |
| Visualization | Visible under radiographic imaging | Same |
| Feature | Neuron MAX™ System | Ballast 088 Long Sheath |
| [PREDICATE DEVICE | ||
| K111380] | [SUBJECT DEVICE] | |
| Configurations | PNML6F088804 | |
| (Usable Length 80, Straight Tip | ||
| Shape) | ||
| PNML6F088804M | ||
| (Usable Length 80, Multipurpose | ||
| Tip Shape) | ||
| PNML6F088904 | ||
| (Usable Length 90, Straight Tip | ||
| Shape) | ||
| PNML6F088904M | ||
| (Usable Length 90, Multipurpose | ||
| Tip Shape) | Ballast80 | |
| (Usable Length 80 cm) | ||
| Ballast90 | ||
| (Usable Length 90 cm) | ||
| Ballast100 | ||
| (Usable Length 100 cm) | ||
| Ballast105 | ||
| (Usable Length 105 cm) | ||
| Tip Shape | Straight, | |
| Multipurpose | Straight | |
| Overall Length | 80 cm - 90 cm | 80 cm - 105cm |
| Proximal Outer | ||
| Diameter | 8F | Same |
| Distal Outer Diameter | 8F | Same |
| Internal Diameter | 0.088" | Same |
| Coil Length | Not Listed | 77 cm - 102 cm |
| Length from | ||
| Radiopaque marker | ||
| band to distal tip | Not Listed | 0.025" |
| Braided Shaft Length | Not Listed | 9 cm from distal tip |
| Feature | Neuron MAX™ System | Ballast 088 Long Sheath |
| [PREDICATE DEVICE | ||
| K111380] | [SUBJECT DEVICE] | |
| Coil | Not Listed | Stainless Steel |
| Inner Liner | Not Listed | PTFE |
| Braid | Stainless Steel | Same |
| Radiopaque Marker | Not Listed | Platinum/Iridium |
| Coating | Hydrophilic Coating | Same |
| Hydrophilic Coating | ||
| Length | Not Listed | 20 cm |
| Method of supply | Sterile and single use | Same |
| Sterilization method | Ethylene oxide gas | Same |
| Accessories | Rotating Hemostasis Valve (RHV) | Introducer sheath |
| Hemostasis valve adapter (HVA) | 9F rotating hemostasis valve | |
| Dilator | 8F hemostasis valve adapter | |
| Dilator | ||
| Package configuration | Placed into a packaging card, | |
| Tyvek pouch and Carton box. | Same |
Table 1: Predicate Device vs. Subject Device Comparison Table
6
7
8
PERFORMANCE DATA [807.92(b)]
Performance Bench Testing and Animal Testing: Results of the performance bench testing and animal testing (Table 2) indicate that Ballast 088 Long Sheath (Subject Device) meets established performance requirements and is substantially equivalent for its intended use.
| Performance Bench Testing | ||
|---|---|---|
| Tests | Test Method Summary | Results |
| Visual and Dimensional | ||
| Inspection | Inspected dimensions for overall length, | |
| total length of proximal hub and strain | ||
| relief, inner diameter, outer diameter (distal | ||
| and proximal). | All test samples passed testing. | |
| Surface Contamination | A microscope was used to inspect the | |
| catheter surface for the presence of | ||
| particulates. | All test samples passed testing | |
| Catheter Compatibility | Verify the compatibility of the Ballast 088 | |
| Long Sheath with the following: |
- Accessory devices
- Guidewire
- 6F dilator and guidewire
- Inner guide catheter and guidewire
- Inner diagnostic catheter and
guidewire | All test samples passed testing. |
| Simulated Use | Verify the in vitro performance of the test
article under simulated use conditions
using Type III, Bovine Aortic Arch vessel
model. | All test samples passed testing. |
| Coating Integrity and
Adherence | Test samples were dyed and gone through
simulated use testing. The coating quality | All test samples passed testing |
| | of the dyed test articles were inspected
under a microscope. | |
| Lubricity/Durability of
Hydrophilic Coating | Test samples underwent 25 friction cycles
with a maximum friction force of 75 grams
to determine the lubricity and durability of
the catheter coating. | All test samples passed testing. |
| Dynamic Burst | A MEDRAD Mark V Plus Injection
System was used to measure catheter
dynamic burst test of the test samples. | All test samples passed testing. |
| Liquid Leakage at 46 psi | Determined whether liquid leaks from the
catheter under a pressure of 46 psi per ISO
10555-1 and ISO 594-2. | All test samples passed testing. |
| Air Leakage | Determined whether air leaks into the hub
assembly during aspiration per EN ISO
10555-1 and ISO 594-2. | All test samples passed testing. |
| Catheter Static Burst Test | A hydraulic Burst/Leak tester was used to
test the static burst resistance of the test
samples per ISO 10555-1. | All test samples passed testing. |
| Tensile Strength | Measured the catheter shaft peak tensile
force and the hub to shaft peak tensile
force using an Intron tensile tester per the
guidelines in ISO 10555-1. | All test samples passed testing. |
| 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 passed testing. |
| 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 passed testing.
The Torque Strength of the
subject device is comparable to
the predicate device. |
| Kink Resistance Test | The kink resistance of the test samples was
tested against the predicate device in
simulated use. In addition, kink resistance
of the test samples was tested against the
predicate device by wrapping the device
around a pin and examining the device for
kinks by using a microscope. | All test samples passed testing.
The Kink Resistance of the
subject device is comparable to
the predicate device. |
| Catheter Stiffness Testing | An Instron tensile tester was used to
characterize the stiffness profile of the
device. | All test samples passed testing. |
| Fracture Resistance and
Flexing Test | Testing was conducted to determine the
Guide Catheter's resistance to damage by
flexing and resistance to fracture per ISO
-
| All test samples passed testing. |
| Particulate Matter
Characterization | Particulate matter in injections of the
device were quantified after simulated use. | All test samples passed testing. |
| Luer Dimensional
Inspection | Inspected the luer dimensions per ISO
80369-7. | All test samples passed testing. |
| Separation Force | Verified mating parts separation force per
ISO 594-1 and ISO 594-2. | All test samples passed testing. |
| Unscrewing Torque | Verified that the catheter luer remained
attached after applying an unscrewing
torque, per ISO 594-1 and ISO 594-2. | All test samples passed testing. |
| Resistance to Overriding | Verified that the catheter luer did not
override reference fitting threads, per ISO
594-1 and ISO 594-2. | All test samples passed testing. |
| Stress Cracking | Verified that there were no stress cracks on
microcatheter hub, per ISO 594-1 and ISO
594-2. | All test samples passed testing. |
| Subatmospheric-pressure
Air Leakage | ISO 80369-7 | All test samples passed testing. |
| | The fittings were assembled by applying an
axial force while rotating the test
connector.
The test connector and reference connector
assembly were secured to the test port on
the pressure decay leak tester and the
pressure decay rates were recorded. | |
| Separation Force | ISO 80369-7
The fittings were assembled by applying an
axial force while rotating the test
connector. An axial force is applied in the
direction away from the test connection. | All test samples passed testing. |
| Stress Cracking | ISO 80369-7
The fittings were assembled by applying an
axial force while rotating the test
connector. The test connector is
disconnected from the reference connector
and is reassembled again.
With the axis of the lock fitting horizontal,
the assembly outlet is sealed and the
internal water pressure is brought to an
effective pressure and maintained for a | All test samples passed testing. |
| Unscrewing Torque | specific time.
ISO 80369-7
The fittings were assembled by applying an
axial force while rotating the test
connector. A screwing torque was applied
for a certain hold period. | All test samples passed testing. |
| Resistance to Overriding | ISO 80369-7
The fittings were assembled by applying an
axial force while rotating the test
connector. Using a torque watch with no
axial load, a torque is applied for a specific
hold period. | All test samples passed testing. |
| Packaging Integrity Test | | |
| Visual Inspection
(Product carton) | Visually inspected packaging for any signs
of damage. | All test samples passed testing. |
| Seal strength | Perform seal strength test per ASTM
F88/F88M. | All test samples passed testing. |
| Bubble Immersion | Perform Bubble Immersion test per ASTM
F2096-11. No bubbles observed
attributable to leaks and no test fluid
attributable to leaks inside the device
packaging. | All test samples passed testing. |
| Visual Inspection
(Seal Integrity) | Visual inspection testing was performed
per ASTM F1886/F1886M-16 to visually
detect channel defects in package seals. | All test samples passed testing. |
| Performance Animal Testing | | |
| Animal Testing (GLP) | Animal testing is to evaluate the in vivo
performance of the device in an acute
porcine model. Trackability and handling
of the guide catheter, radiopacity, and
catheter compatibility were assessed.
Subject device was compared to predicate
device. | All test samples passed testing.
Trackability and handling of
the guide catheter, radiopacity,
and catheter compatibility with
microcatheter were comparable
to predicate device. |
| Test | Results | Conclusion |
| Cytotoxicity – MEM Elution Test
– 48 hours
ISO 10993-5 | Test Article extract showed no evidence of
lysed cells or cytotoxicity to L-929 cells,
with an average grade of 0 (no reactivity). | Non-cytotoxic |
| Sensitization - ISO Guinea Pig
Kligman Maximization Test
ISO 10993-10 | The 0.9% Sodium Chloride for injection
(NaCl) and Cottonseed Oil (CSO) extracts
did not induce delayed sensitization in the
guinea pig (0% Sensitization). | Did not elicit sensitization
response |
| Irritation or Intracutaneous - ISO
Intracutaneous Study in Rabbits -
Two Extracts
ISO 10993-10 | The difference between the test and the
control mean score was 0.0. | Non-irritant |
| Acute Systemic Toxicity - ISO
Acute Systemic Toxicity Study in
Mice – Two Extracts
ISO 10993-11 | There was no evidence of significant
systemic toxicity or mortality after test
article extracts injection. | Non-toxic |
| Systemic Toxicity -
ISO Materials Mediated Rabbit
Pyrogen
ISO 10993-11 | During the 3-hour observation period, none
of the rabbits administered with the test
article extract had a temperature rise >0.5℃
at the required observation time points. This
response did not exceed the USP limit and
meets the requirements for this test.
Therefore, these results indicate that the test
article was determined to be non-pyrogenic. | Non-pyrogenic |
| Genotoxicity: Ames Test (Solids),
2 extracts, 4 strains of Salmonella
typhimurium and one strain of
Escherichia coli
ISO 10993-3 | The test article extracts did not produce a
two-fold or a three-fold increase in the
number of revertants in any of the 5 tester
strains. The spot tests showed no zone of
increased reversion or of toxicity.
Therefore, the test article is considered non-
mutagenic. | Non-mutagenic |
| Genotoxicity: Chromosomal
Aberration Assay in Chinese
Hamster Ovary (CHO) cells, 2
extracts, OECD 473
ISO 10993 | The cytotoxicity data showed no reactivity
to the test article solutions when placed on
CHO cells. The polyploid,
endoreduplication rate, and the mitotic
index of the test article solutions showed no
significant difference from the controls.
Therefore, the test article is not considered
to be genotoxic when exposed to CHO cells. | Non-genotoxic |
| Hemocompatibility-Hemolysis,
ASTM Method (Indirect)
ISO 10993-4 | The difference between the hemolytic
indexes of the test article and the negative
control equals 0.15%, placing the test article
in the non-hemolytic range according to the
Hemolytic Grade scale | Non-Hemolytic |
| Hemocompatibility-Hemolysis,
ASTM Method (Direct)
ISO 10993-4 | The difference between the hemolytic
indexes of the test article and the negative
control equals 0.00%, placing the test article
in the non-hemolytic range according to the
Hemolytic Grade scale | Non-Hemolytic |
| Hemocompatibility -
Complement Activation, SC5b-9
ISO 10993-4 | The results of the complement activation
testing performed on the test article indicate
that it has a complement activation
comparable to the predicate device. | Passed |
| Hemocompatibility - Partial
Thromboplastin Time (PTT)
ISO 10993-4 | The clotting times exhibited by the test
article were lengthened when compared to
the clotting times exhibited by the predicate
device. | Passed |
| Hemocompatibility - Platelet and
Leukocyte Count (PLC)
ISO 10993-4 | The triplicate test article replicates were
within 25% of their average. The test article
results for the leukocyte and platelet counts
were 86.9% and 117.7%, respectively, of
the negative control. The platelet counts of
the test article were not statistically
significant (p>0.05) when compared to the
reference material. | Passed |
| Hemocompatibility -
40x Digital Optical Microscopy -
comparative analysis of surface
morphology | 40x images were taken from multiple
locations along the entire length of the
subject device and the predicate control
device to assess differences in surface
characteristics and/or geometry. | Passed |
| | Although the catheters differed in color and
transparency, there were no significant
differences in geometry, surface
morphology, or particulate contamination. | |
| 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 two (2) full
cycles. | 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. The
BI results confirm the
acceptable lethality of the
sterilization cycle to achieve
the required 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. |
| EO and ECH Residuals | EO and ECH residuals were
measured per ISO 10993-7:
2008. | 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 |