(198 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter and its accessories, with no mention of AI or ML capabilities.
No
The device is described as an access catheter for introducing other interventional devices, rather than directly treating a condition itself.
No
The device is described as a catheter for introducing other interventional devices, and the "Key Metrics" section explicitly states "Device is a catheter, not a diagnostic device."
No
The device description clearly details physical components like a hollow cylindrical tube, metal coils/braids, medical grade polymers, a hydrophilic coating, an angled distal tip, a radiopaque marker, and a luer fitting. It also includes physical accessories like a Rotating Hemostasis Valve and a Catheter Introducer. This indicates a hardware medical device, not a software-only one.
No, 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 vasculature. This is a procedural device used in vivo (within the body) to facilitate other medical procedures.
- Device Description: The description details a catheter designed for physical access and delivery of other devices within the body. It does not describe a device that analyzes biological samples in vitro (outside the body) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples. The device's function is mechanical and procedural.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the catheter (trackability, flexibility, compatibility, etc.) and its safety in an animal model in vivo. They do not involve evaluating the device's ability to detect or measure analytes in biological samples.
The EagleRay Long Sheath and EagleRay Access Catheter are interventional catheters, not IVDs.
N/A
Intended Use / Indications for Use
The EagleRay Long Sheath and EagleRay Access Catheter are 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 EagleRay Long Sheath and EagleRay Access Catheter, hereinafter referred to as EagleRay Catheters, are 0.014"-0.038" guidewire compatible single lumen catheters that provide access to peripheral, coronary and neuro vasculature which allows insertion of other interventional devices.
The catheters are comprised of a hollow cvlindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. Additionally, an angled distal tip facilitates smoother tracking past vessel branches. The distal tip also has a radiopaque marker to provide the user with clear visual confirmation of the distal tip location under fluoroscopy.
The EagleRay Catheters will be offered with various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1 below.
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)
Bench and Lab (in-vitro) testing were conducted in order to evaluate the similarities and differences between the largest diameter EagleRay Catheters and the predicate Neuron Max System. Comparative testing was also performed to evaluate the similarities and differences between the smallest EagleRay Catheters and the predicate Micro Therapeutics Intracranial Support Catheters.
The test results were reviewed and found to demonstrate that any differences between the proposed and predicate devices do not significantly impact any catheter performance parameters that would affect the safety or efficacy of the subject EagleRay Catheters.
A series of subacute and chronic animal studies were conducted to evaluate the safe use of the EagleRay Catheter design in a porcine model. 510(k) cleared neurovascular catheters, including the predicate Penumbra Neuron Max System, were used as control devices. The studies concluded that:
- There was no angiographic evidence of vessel injury in any of the treated vessel segments (test or control).
- No significant histological findings were found in relation to use of the test or control devices.
- Use of the test devices resulted in no significant vascular response during these studies and was found to be comparable to the control devices by the study pathologist and the study director.
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).
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August 8, 2018
Imperative Care Inc. Jake Wolenberg Ouality Assurance and Regulatory Affairs Manager 1221 Innsbruck Drive Sunnyvale, California 94089
Re: K180169
Trade/Device Name: EagleRay Long Sheath, EagleRay Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: Julv 3. 2018 Received: July 9, 2018
Dear Jake Wolenberg:
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.html; 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 medical devices and radiation-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.
Xiaolin Zheng -S
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) K180169
Device Name
EagleRay Long Sheath, EagleRay Access Catheter
Indications for Use (Describe)
The EagleRay Long Sheath and EagleRay Access Catheter are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary EagleRay Long Sheath and EagleRay Access Catheter
A. Submitter Information
Submitter's Name: Address:
- Telephone: Email: Contact Person: Date of Preparation:
B. Subject Device
Proprietary Name: 510(k) #: Common/Usual Name: Classification Name: Product Code:
C. Primary Predicate Device
- Primary Proprietary Name: Manufacturer: 510(k) #'s: Common/Usual Name: Classification Name: Product Code:
D. Additional Predicate Devices
Proprietary Name: Manufacturer: 510(k) #: Common/Usual Name: Classification Name: Product Code:
Proprietary Name: Manufacturer: 510(k) #: Common/Usual Name: Classification Name: Product Code:
Imperative Care Inc. 1359 Dell Avenue Campbell, CA 95008 248-496-0198 JWolenberg@ImperativeCare.com Jake Wolenberg July 3, 2018
EagleRay Long Sheath, EagleRay Access Catheter K180169 Guide Sheath & Guide Catheter Catheter, Percutaneous DQY per 21 C.F.R. 870.1250
Neuron Max System Penumbra Inc. K111380 Guide Sheath Catheter, Percutaneous DQY per 21 C.F.R. 870.1250
Arc & Arc Mini Intracranial Support Catheter Micro Therapeutics, Inc. Dba Ev3 Neurovascular K150107 Guide Catheter Catheter, Percutaneous DQY per 21 C.F.R 870.1250
Navien Intracranial Support Catheter Micro Therapeutics, Inc. Dba Ev3 Neurovascular K161152 Guide Catheter Catheter, Percutaneous DQY per 21 C.F.R 870.1250
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Device Description: E.
The EagleRay Long Sheath and EagleRay Access Catheter, hereinafter referred to as EagleRay Catheters, are 0.014"-0.038" guidewire compatible single lumen catheters that provide access to peripheral, coronary and neuro vasculature which allows insertion of other interventional devices.
The catheters are comprised of a hollow cvlindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. Additionally, an angled distal tip facilitates smoother tracking past vessel branches. The distal tip also has a radiopaque marker to provide the user with clear visual confirmation of the distal tip location under fluoroscopy.
The EagleRay Catheters will be offered with various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1 below.
| Commercial | Model | Distal Diameter | Proximal Diameter | Nominal Usable | ||
|---|---|---|---|---|---|---|
| Name | Number | Inner | Outer | Inner | Outer | Catheter Length |
| EagleRay | ||||||
| Long Sheath | ICLS088080 | 0.088" | 0.106" | 0.088" | 0.108" | 80cm |
| ICLS088090 | 90cm | |||||
| ICLS088100 | 100 cm | |||||
| ICLS088110 | 110 cm | |||||
| EagleRay | ||||||
| Access | ||||||
| Catheter | ICAC071137 | 0.071" | 0.083" | 0.071" | 0.083" | 137cm |
| ICAC055137 | 0.055" | 0.069" | 0.067" | 0.080" | 137cm | |
| ICAC045144 | 0.045" | 0.060" | 0.064" | 0.080" | 144cm | |
| ICAC035158 | 0.035" | 0.051" | 0.047" | 0.060" | 158cm |
Table 1: EagleRay Catheter Device Sizes
All EagleRay Catheters are packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.
The 0.088" ID EagleRay Long Sheath is packaged with an additional accessory, a short, retractable Catheter Introducer. This accessory is intended to prevent damage to the EagleRay Long Sheath when advancing it through the hemostasis valve on the access site introducer sheath.
In addition to the supplied accessories discussed above, the adjunctive devices and supplies listed below are intended to be used with the EagleRay Catheters. All of these accessories are also commonly used with the predicate devices.
- Guidewires
- Support/Diagnostic Catheters ●
- Introducer Sheaths ●
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F. Indications for Use:
The EagleRay Long Sheath and EagleRay Access Catheter are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
G. Predicate Comparison:
The primary predicate device for the EagleRay Catheters is the Neuron Max System (Penumbra, Inc) cleared under K111380. The Neuron Max System was selected as the primary predicate for the EagleRay Catheters as the Neuron Max System has similar dimensions to the largest device sizes for the EagleRay Catheters and has the same intended use.
In addition to the primary predicate device, the devices in the Micro Therapeutics Intracranial Support Catheter product line, which include the Arc and Arc Mini catheters cleared under K150107 and the Navien catheters cleared under K161152, were used as predicate devices for the smaller EagleRay Catheter device sizes as they have similar dimensions and the same intended use.
Table 2 presented below provides a comparison of the similarities and differences between the proposed EagleRay Catheters, the predicate Neuron Max System, and the predicate Micro Therapeutics Intracranial Support Catheter product line. Bench and lab testing was conducted as appropriate to evaluate any differences that were identified.
The comparison between the subject and predicate devices found that the EagleRay Catheters are substantially equivalent to the predicate Neuron Max System and Micro Therapeutics Intracranial Support Catheters, and that there are no new safety or efficacy concerns. This conclusion is based on all devices sharing the same intended use, basic technology characteristics, and performance characteristics, as demonstrated through well-designed bench and lab testing.
| Device Attribute | EagleRay Catheters
(subject device) | Penumbra
Neuron Max System | Micro Therapeutics
Intracranial Support
Catheters |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| FDA Product
Classification | Class II, DQY, 21 CFR
870.1250 | Same | Same |
| Intended Use | Intended for use in
supporting the introduction
of interventional devices into
the vasculature. | Same | Same |
| Condition
Supplied | Sterile and Single Use | Same | Same |
| Sterilization
Method | Ethylene Oxide (EtO), SAL
10-6 | Same | Same |
| Device Attribute | EagleRay Catheters
(subject device) | Penumbra
Neuron Max System | Micro Therapeutics
Intracranial Support
Catheters |
| Inner Diameter
(Distal) | 0.035" – 0.088" | 0.088" | 0.035" – 0.072" |
| Outer Diameter
(Distal) | 0.051" – 0.106" | 0.105" | 0.044" – 0.084" |
| Inner Diameter
(Proximal) | 0.047" – 0.088" | 0.088" | 0.044" – 0.072" |
| Outer Diameter
(Proximal) | 0.060" – 0.110" | 0.110" | 0.060" – 0.084" |
| Effective Length | 80 – 158cm | 80 – 90cm | 90 – 163cm |
| Tip Design | Beveled edge, soft, flexible, and atraumatic | Square edge, soft, flexible, and atraumatic | Square edge, soft, flexible, and atraumatic |
| Coating | Surmodics Hydrophilic coating | Surmodics Hydrophilic coating | Hydrophilic coating |
| Materials | Commonly used medical grade plastics & metals with hydrophilic coating. | Commonly used medical grade plastics & metals with hydrophilic coating. | PTFE lined polymeric catheter shaft with hydrophilic coating, nitinol support wire, and platinum marker bands. |
| Packaged
Accessories | Catheter Introducer
Rotating Hemostasis Valve
(RHV) | Dilator
Rotating Hemostasis
Valve (RHV)
Hemostasis Valve | Catheter Introducer |
| Packaging
Configuration | The catheters are placed in a protective polyethylene tube and then mounted, along with the accessories, onto a polyethylene packaging card.
The packaging card is inserted into a Tyvek® pouch which is then sealed.
The sealed pouch and IFU | Same | Same |
Table 2: EagleRav Catheters, Neuron Max System, and Micro Therapeutics Intracranial Support Catheter Comparison
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Performance Data Supporting Substantial Equivalence: H.
Bench and Lab (in-vitro) testing were conducted in order to evaluate the similarities and differences between the largest diameter EagleRay Catheters and the predicate Neuron Max System. Comparative testing was also performed to evaluate the similarities and differences between the smallest EagleRay Catheters and the predicate Micro Therapeutics Intracranial Support Catheters.
The test results were reviewed and found to demonstrate that any differences between the proposed and predicate devices do not significantly impact any catheter performance parameters that would affect the safety or efficacy of the subject EagleRay Catheters.
A summary of the tests and performance specifications that were evaluated is presented in Table 3. These tests were performed per company approved protocols and test methods based primarily on catheter performance standard ISO 10555-1.
| Test Attribute | Specification |
|---|---|
| Delivery, Compatibility, | |
| and Retraction | |
| (Trackability) | The catheter shall be able to be delivered, deployed, and retracted |
| per the IFU within a simulated neurological model without | |
| incurring any damage to the catheter. | |
| Flexibility and Kink | |
| Resistance | There shall be no kinking of shaft (permanent deformation) after |
| simulated use. | |
| Compatibility with other | |
| devices (external) | The catheters shall be able to be delivered through the minimum |
| introducer sheath or guide catheter size indicated in the product | |
| labeling. | |
| Guidewire compatibility | The catheters shall be able to be delivered over the maximum size |
| guidewire indicated in the product labeling. | |
| Interventional device | |
| compatibility (internal) | The catheters shall be able to accommodate other interventional |
| devices (e.g., support catheter, diagnostic catheter) up to the | |
| maximum size indicated in the product labeling. | |
| Luer compatibility | Devices and accessories shall be compatible with standard syringe |
| luer fittings per ISO 80369-7. | |
| Accessory compatibility | Devices shall be compatible with catheter introducer and RHV. |
| Catheter Bond Strength | The catheter shall have sufficient bond strengths to remain intact |
| throughout a procedure. |
| Table 3: Tests and Performance Specifications | ||
|---|---|---|
| Test Attribute | Specification | |
| Flowrate - positive | ||
| (forward) pressure | The catheter lumen shall allow for a minimum flowrate | |
| comparable to competitive products. | ||
| Freedom from Leakage | ||
| – positive pressure | No liquid leakage from the hub or catheter shaft at 46psi for 30 | |
| seconds. | ||
| Freedom from Leakage | ||
| – negative pressure | No air leakage into a 20cc syringe when vacuum pulled for 15 | |
| seconds. | ||
| Burst Pressure | Catheter does not burst under pressures that could be seen when | |
| performing contrast injections with a standard 10cc syringe. | ||
| Catheter Torque | ||
| Strength | No separation of any portion of the catheter when rotated at least | |
| two (2) full rotations (360 degrees). | ||
| Kink Resistance | There shall be no kinking of the catheter shaft (permanent | |
| deformation) after wrapping around anatomically relevant bend | ||
| radii. | ||
| Flexibility | The flexibility of the catheter tip shall be comparable to | |
| competitive products and allow for easily tracking the device to | ||
| the desired target anatomy. | ||
| Pushability | The proximal shaft of the catheters shall have sufficient stiffness | |
| that the user can easily push the catheter to the target anatomy | ||
| without buckling. | ||
| Coating - Particulate | The amount of particulate matter that comes off the hydrophilic- | |
| coated shaft during simulated use testing shall be determined and | ||
| compared to competitive products and techniques. | ||
| Coating - lubricity | Coating must be lubricious and maintain a minimum lubricity over | |
| 15 test cycles. | ||
| Corrosion Resistance | No visible corrosion present on devices after saline immersion | |
| followed by 30 minutes in boiling water followed by 48 hours in | ||
| 37°C water bath. | ||
| Radiopacity | The radiopaque marker on the catheter can be seen under | |
| fluoroscopy during use. |
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Image /page/9/Picture/0 description: The image shows the logo for Imperative Care. The logo features a stylized human head made up of orange triangles on the left side. To the right of the head is the word "Imperative" in a bold, sans-serif font, with the word "CARE" in a smaller font underneath.
I. Biocompatibility Testing:
Biocompatibility testing was performed on all direct patient contacting components of the EagleRay Catheters. This testing was conducted to ensure that the components and raw materials used in the proposed EagleRay Catheters, as well as the manufacturing processes and sterilization processes result in a biocompatible product. All biocompatibility tests were conducted pursuant to 21 CFR Part 58, Good Laboratory Practices, ISO 10993-1, and per the recommendations in FDA guidance document titled: Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
As the EagleRay Catheters are in direct contact with circulating blood and the average length of an endovascular procedure is typically less than 2 hours, the devices were evaluated for the tests recommended for the patient contact category: External communicating device, blood path direct, limited contact duration.
A summary of the selected biocompatibility tests performed for the EagleRay Catheters is presented for reference below and on the following pages in Table 4. All test results passed, indicating that the EagleRay Catheters are biocompatible for their intended use.
| Test | Test Method | Extraction
Methods/Conditions | Acceptance Criteria | Results |
|---------------------------------------------------------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity: ISO
MEM* Elution | ISO 10993-5 | Test device extracted in
MEM with 5% serum at 37 ±
1°C for 24 ± 2 hours | Sample extracts must
yield cell lysis grade 2 or
lower. | Pass, Non-
cytotoxic |
| Cytotoxicity: ISO
MTT* Assay | ISO 10993-5 | Test device extracted in
MTT* Assay Media at 37 ±
1°C for 24 ± 2 hours | The percentage of cells
exhibiting lysis should be
similar for all test devices. | Pass, No
Significant
Differences |
| Sensitization:
Magnusson-
Kligman Method, 2
extracts | ISO 10993-10 | Guinea pigs exposed to test
device extracts. Challenged
sites observed for skin
sensitization 24 ± 2 and 48 ±
2 hours after removal of
extracts.
Extracts were prepared at 50
± 2°C for 72 ± 2 hours. | Test Group shall yield
Grade 10% weight loss in 3
or more test animals
• Mortality of 2 or more
test animals
• Toxic signs such as
convulsions and
prostration in 2 or more
test animals | Pass, Non-Toxic |
| Hemocompatibility:
Complement
Activation | ISO 10993-4
ASTM F756 | Preformed in vitro using a
prepared Enzyme
Immunoassay (EIA) kit.
This kit will detect the presence of
specific complement
enzymes.
Test device incubated in
serum at 37± 2°C and tested
for C3a and SC5b at 0.5, 1,
and 1.5 hours. | The concentrations of C3a
and SC5b-9 in the test
devices are statistically
similar to the predicate
device (Penumbra Neuron
Max 6F Catheter) and
statistically lower than the
positive control for all
exposure times. | Pass, No
Significant
Differences
The test device had
statistically similar
or lower
concentrations than
the predicate and
negative controls. |
| Test | Test Method | Extraction
Methods/Conditions | Acceptance Criteria | Results |
| Hemocompatibility:
Hemolysis (Direct
Contact Method) | ASTM F 756
ISO 10993-4 | Test device extracted in
PBS* and diluted blood at 37
$\pm$ 2°C for 3 $\pm$ 5 minutes.
Test device exposed to blood
cell suspension.
% hemolysis is measured. | Sample extracts must be
nonhemolytic ( $\leq$ 2%
hemolytic index). | Pass, Non-
hemolytic |
| Hemocompatibility:
Hemolysis (Extract
Method) | ASTM F 756
ISO 10993-4 | Test device extracted in PBS
at 50 $\pm$ 2°C for 72 $\pm$ 2 hours.
Extract exposed to blood cell
suspension. % hemolysis is
measured. | Sample extracts must be
nonhemolytic ( $\leq$ 2%
hemolytic index). | Pass, Non-
hemolytic |
| Standard In vivo
Thrombogenicity,
Ovine Jugular
NAVI (ISO) | ISO 10993-
4:2002 | Performed in duplicate. Test
and control device are placed
in alternate sides of the
juggler vein. The devices are
implanted and remains in
place for 4 $\pm$ 0.5 hours. | The device must have
similar or lesser
thrombogenic potential
after 4 hours in vivo when
compared to a control
device (Penumbra Neuron
Max 6F Catheter). | Pass, Minimal
Thrombogenic
Potential
The test device had
less thrombogenic
potential than the
control device. |
Table 4: Biocompatibility Test Summary
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EagleRay Long Sheath and
EagleRay Access Catheter
Traditional 510(k) K180169
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*MEM=Minimal Essential Media,
MTT Assay = (3-(4,5-Dimethylthiazol-2-yl)-2,5-Diphenyltetrazolium Bromide)
NS = Normal Saline
PBS=Phosphate Buffered Saline
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Image /page/12/Picture/0 description: The image contains the logo for Imperative Care. On the left side of the logo is an orange geometric design that resembles a human head. To the right of the head is the text "Imperative" in a bold, dark gray font. Below "Imperative" is the word "CARE" in a smaller, orange font.
J. Sterilization:
The EagleRay Catheters are sterilized using a validated EtO process with a sterility assurance level of 1x10-6. The sterilization process was validated per the overkill method described recognized consensus standard ISO 11135, "Sterilization Of Health-Care Products - Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices." A summary of the completed testing is presented below in Table 5.
Table 5: Sterilization Validation Summary
| Requirement/Acceptance Criteria | Results | Summary |
|---|---|---|
| Positive BI controls must be positive in | ||
| fractional, half and full cycles. | PASS | All positive controls in each cycle read |
| positive. | ||
| Fractional cycle requirements: |
- IPCDs must be equal or less difficult to
sterilize than the EPCDs - The IPCDs and EPCDs may show growth
after 7 days with the EPCD required to be
equal or more EtO resistant. - Product Sterility testing must show no
growth in all samples. - Bacteriostasis/Fungistasis testing must
show that the product is not inhibitory for
growth. | PASS | 1) IPCDs showed growth after 7 days. - EPCDs were equal or more EtO
resistant than the IPCDs. - The devices did not show any
growth when tested per the methods
in ISO 11737-2. - Bacteriostasis/Fungistasis Testing
showed product is not inhibitory to
growth when tested per the methods
in ISO 11737-2. |
| Half cycle requirements: - The IPCDs must show no growth after 7
days - EPCD are expected to show no growth
after 7 days. A few positives are allowed
by ISO 11135. | PASS | 1) IPCDs showed no growth after 7
days. - EPCDs showed no growth after 7
days. |
| Full cycle requirements: - The IPCDs must show no growth after 7
days - Selected EPCD must show no growth after
7 days. - Samples exposed to 2X sterilization cycle
must pass EtO residual testing. | PASS | 1) IPCDs showed no growth after 7
days. - EPCDs showed no growth after 7
days. - Samples passed EtO residual testing
at 0 hour aeration time point. |
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Image /page/13/Picture/0 description: The image contains the logo for Imperative Care. On the left side of the logo is a graphic of a head made up of orange triangles. To the right of the graphic is the text "Imperative" in a bold, dark gray font. Below the word "Imperative" is the word "CARE" in a smaller, light orange font.
K. Shelf Life and Packaging:
Accelerated aging testing based on ASTM F1980 was conducted to verify device, accessory, and packaging performance. A real time aging equivalent of 13 months was used for this testing and will allow for labeling of product with a 1-year shelf life.
Device and accessory performance was verified by repeating the functional tests previously presented in Section H of this 510(k) summary.
Packaging and sterile barrier integrity through transportation has been verified for both the packaging configurations used for the EagleRay Catheters, a straight packaging configuration and a circular packaging configuration. Aging testing has also been performed that supports the sterile barrier integrity following 13 months of accelerated aging. A summary of the completed packaging test is presented below in Table 6.
| Test | Test Method | Straight Packaging
Results
(Pass/Fail) | Circular Packaging
Results
(Pass/Fail) |
|------------------------------------------------|------------------------------------------|----------------------------------------------|----------------------------------------------|
| Packaging Visual
Inspection | ASTM F1886
Imperative Care
TM00071 | Pass | Pass |
| Pouch Integrity Test -
Gross Leak Detection | ASTM F2096 | Pass | Pass |
| Pouch Seal Strength
– Peel Strength | ASTM F88 | Pass | Pass |
| Label Integrity | Imperative Care
TM00071 | Pass | Pass |
Table 6: Packaging Validation Summary
L. Animal Studies
A series of subacute and chronic animal studies were conducted to evaluate the safe use of the EagleRay Catheter design in a porcine model. 510(k) cleared neurovascular catheters, including the predicate Penumbra Neuron Max System, were used as control devices. The studies concluded that:
- . There was no angiographic evidence of vessel injury in any of the treated vessel segments (test or control).
- . No significant histological findings were found in relation to use of the test or control devices.
- Use of the test devices resulted in no significant vascular response during these studies and was found to be comparable to the control devices by the study pathologist and the study director.
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Image /page/14/Picture/0 description: The image contains the logo for Imperative Care. On the left side of the logo is a geometric design of a human head, with the face made up of many small triangles in shades of orange and yellow. To the right of the head is the word "Imperative" in a bold, sans-serif font, with the word "CARE" in a smaller font underneath.
EagleRay Long Sheath and EagleRay Access Catheter Traditional 510(k) K180169
M. Conclusions:
Where differences were identified between the subject EagleRay Catheters, the predicate Neuron Max System, and the predicate Micro Therapeutics Intracranial Support Catheters, a risk assessment was completed to determine if the difference would result in new safety or efficacy concerns regarding the use of the device. As appropriate, bench, lab, and animal testing was conducted to support this assessment.
Based on the results of the conducted risk assessments and associated bench, lab, and animal testing, it is concluded that EagleRay Catheters are substantially equivalent to the predicate Neuron Max System and predicate Micro Therapeutics Intracranial Support Catheters and that there are no new safety or efficacy concerns associated with the identified differences. This conclusion was determined based on the fact that the subject device and multiple predicate devices share the same intended use, basic technology characteristics, and performance characteristics, as confirmed through well-designed bench, lab, and animal testing.