(181 days)
No
The summary describes a mechanical aspiration catheter and tubing set. There is no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device is intended for the revascularization of patients with acute ischemic stroke, which is a medical treatment.
No
The device is an aspiration catheter used for revascularization in acute ischemic stroke, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines a physical, single-use vascular catheter and associated tubing set, which are hardware components. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease." This is a therapeutic intervention performed directly on the patient's body to treat a medical condition.
- Device Description: The description details a physical catheter designed to be inserted into blood vessels. It describes its physical characteristics, materials, and how it's used in a surgical context.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are used to perform tests on these types of samples.
The device is a medical device used for a therapeutic procedure, not a diagnostic test performed on in vitro samples.
N/A
Intended Use / Indications for Use
The Esperance 3+ Aspiration Catheter with the Wallaby Aspiration Tubing set and a compatible aspiration pump is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Product codes
NRY
Device Description
The Esperance® 3+ Aspiration Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device has a tapered shaft with tapered inner diameter (ID) from 0.054'' (proximal) to 0.041'' (distal) and tapered outer diameter (OD) from 0.066'' (proximal) to 0.050'' (distal). It has five different working lengths: 120 cm, 133 cm, 145 cm, 153 cm, and 160 cm. The device is supplied as a kit with the Wallaby Aspiration Tubing Set provided with a single catheter. The distal tip of each catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each catheter incorporates a strain relief and a standard luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.
The Esperance 3+ Aspiration Catheter System is a non-active, surgically invasive device intended for short term use within the neurovasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial large vessel occlusive disease (within internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Environment of Use: The Esperance 3+ Aspiration Catheter System is solely intended for use by trained physicians in a healthcare facility/hospital.
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)
Biocompatibility:
- Study type: Biocompatibility testing based on ISO 10993-1:2018 and FDA guidance.
- Key results: Cytotoxicity (No cytotoxic effect), Skin Irritation (No sensitization indicated), Sensitization (No sensitization indicated), Systemic Toxicity (No acute systemic toxicity indicated; deemed non-pyrogenic), Hemocompatibility (No hemolysis indicated; deemed comparable to predicate for Complement Activation and Thromboresistance Evaluation). Accessory tests (Introducer Sheath, Wallaby Aspiration Tubing, Rotating Hemostasis Valve) also showed no cytotoxic effect, no sensitization, no irritation, no acute systemic toxicity, and no hemolysis, and RHV deemed non-pyrogenic.
Sterilization:
- Study type: Sterilization validation.
- Key results: Sterilized by Ethylene Oxide to ensure a sterility assurance level (SAL) of 10-6. Adopted into an existing validated cycle per EN ISO 11135:2014 and AAMI TIR28:2009.
Shelf Life:
- Study type: Accelerated aging (AA) studies.
- Key results: Testing after 1 year AA showed that devices met design and performance specification requirements. Packaging integrity, seal strength, and device functionality met all acceptance criteria for the 12-month shelf life.
Non-Clinical Performance Data (Bench Testing):
- Study type: Full suite of bench performance testing.
- Key results:
- Dimensional Verification (Working Length, Coating Length, ID, OD): All samples met the acceptance criteria.
- Navigability: All samples met the acceptance criteria.
- Clot Removal: All samples met the acceptance criteria.
- Kink Resistance: All samples met the acceptance criteria.
- Lubricity: All samples met the acceptance criteria.
- Coating Integrity: All samples met the acceptance criteria.
- Torque Strength: All samples met the acceptance criteria.
- Delivery and Retrieval Force: All samples met the acceptance criteria.
- Vacuum Resistance: All samples met the acceptance criteria.
- Aspiration Flow Rate: All samples met the acceptance criteria.
- Elongation to Failure: All samples met the acceptance criteria.
- Tip Stiffness: All samples met the acceptance criteria.
- Atraumatic Distal Tip: All samples met the acceptance criteria.
- Tip Shaping Ability: All samples met the acceptance criteria.
- Introducer Sheath Compatibility: All samples met the acceptance criteria.
- Device Compatibility: All samples met the acceptance criteria.
- Surface Defects: All samples met the acceptance criteria.
- Tensile Force: All samples met the acceptance criteria.
- Liquid Leakage: All samples met the acceptance criteria.
- Air Leak: All samples met the acceptance criteria.
- Static Burst: All samples met the acceptance criteria.
- Power Injection: All samples met the acceptance criteria.
- Corrosion: All samples met the acceptance criteria.
- Particulate Testing: Particulate generation was similar between the subject and reference device.
- Hub/Luer Fitting: All samples met the acceptance criteria.
Clinical Testing:
- Study type: Not performed.
- Key results: Clinical data were not deemed necessary to establish substantial equivalence.
Animal Testing:
- Study type: Not performed.
- Key results: Animal data were not deemed necessary as substantial equivalence was established based upon successful completion of non-clinical performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
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October 1, 2024
Wallaby Medical Rachel McDaid Senior Regulatory Affairs Specialist 22901 Mill Creek Drive Laguna Hills, California 92653
Re: K240917
Trade/Device Name: Esperance 3+ Aspiration Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: August 30, 2024 Received: August 30, 2024
Dear Rachel McDaid:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240917
Device Name Esperance 3+ Aspiration Catheter System
Indications for Use (Describe)
The Esperance 3+ Aspiration Catheter with the Wallaby Aspiration Tubing set and a compatible aspiration pump is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
| 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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Image /page/4/Picture/1 description: The image shows the logo for Wallaby Medical. The logo consists of a green and blue circle with a white design inside, followed by the text "沃比医疗" in Chinese characters, with "Wallaby Medical" written below in English. The text is also in green and blue, matching the colors of the circle.
K240917 510(k) Summary (21 CFR 807.92)
I. SUBMITTER
Wallaby Medical 22901 Mill Creek Drive Laguna Hills, California 92653
Contact Person: Rachel McDaid Phone: +353 (0)91 740128 Date Prepared: September 30, 2024
II. DEVICE
Device Trade Name: Esperance 3+ Aspiration Catheter System Common or Usual Name: Catheter, Thrombus Retriever Classification: Class II Regulation Number: 21 CFR 870.1250 Product Code: NRY
III. PREDICATE DEVICE
Name: Penumbra System MAX Manufacturer: Penumbra, Inc. 510(k) number: K113163
IV. DEVICE DESCRIPTION
Device Description:
The Esperance® 3+ Aspiration Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device has a tapered shaft with tapered inner diameter (ID) from 0.054'' (proximal) to 0.041'' (distal) and tapered outer diameter (OD) from 0.066'' (proximal) to 0.050'' (distal). It has five different working lengths: 120 cm, 133 cm, 145 cm, 153 cm, and 160 cm. The device is supplied as a kit with the Wallaby Aspiration Tubing Set provided with a single catheter. The distal tip of each catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each catheter incorporates a strain relief and a standard luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.
The Esperance 3+ Aspiration Catheter System is a non-active, surgically invasive device intended for short term use within the neurovasculature.
Environment of Use:
The Esperance 3+ Aspiration Catheter System is solely intended for use by trained physicians in a healthcare facility/hospital.
V. INDICATIONS FOR USE
The Esperance 3+ Aspiration Catheter with the Wallaby Aspiration Tubing set and a compatible aspiration pump is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
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Image /page/5/Picture/1 description: The image shows the logo for Wallaby Medical. The logo features a green and blue gradient circle with a white abstract design inside. To the right of the circle is the company name in both Chinese and English. The English name, "Wallaby Medical," is written in a green and blue gradient font.
The Indications for Use statement of the subject device is similar to the predicate device. The differences do not raise new or different questions of safety or effectiveness.
Table 1: Comparison of Indications for Use of the Esperance 3+ Aspiration Catheter System with the predicate and reference devices
| Parameter | Reference Device
Esperance Aspiration
Catheter System (K211697) | Predicate Device
Penumbra System MAX
(K113163) | Subject Device
Esperance 3+ Aspiration
Catheter System
(K240917) | |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Indications for
Use | The Esperance Aspiration
Catheter with the Medela
Dominant Flex Surgical
Suction Pump and
Wallaby Aspiration Tubing
set is intended for use in
the
revascularization of
patients with acute
ischemic stroke secondary
to intracranial large vessel
occlusive disease (within
internal carotid, middle
cerebral – M1 and M2
segments, basilar, and
vertebral arteries) within 8
hours of symptom onset.
Patients who are ineligible for
intravenous tissue
plasminogen activator (IV-
tPA) or who fail IV t-PA
therapy are candidates for
treatment. | The Penumbra System
is intended for use in
the revascularization of
patients with acute
ischemic stroke
secondary to
intracranial large vessel
occlusive disease (in
the internal carotid,
middle cerebral – M1
and M2 segments,
basilar, and vertebral
arteries) within 8 hours
of symptom onset. | The Esperance 3+
Aspiration Catheter with
the Wallaby Aspiration
Tubing set and a
compatible aspiration
pump is intended for use
in the revascularization
of patients with acute
ischemic stroke
secondary to intracranial
large vessel occlusive
disease (within internal
carotid, middle cerebral
– M1 and M2 segments,
basilar, and vertebral
arteries) within 8 hours of
symptom onset. Patients
who are ineligible for
intravenous tissue
plasminogen activator (IV
t-PA) or who fail IV t-PA
therapy are candidates for
treatment. | |
| Parameter | Reference Device
(K211697) | Predicate Device
(K113163) | Subject Device
(K240917) | |
| Device Name | Esperance Aspiration
Catheter System | Penumbra System
MAX | Esperance 3+ Aspiration
Catheter System | |
| Model # | ASP6F131KIT
ASP6F125KIT
ASP6F115KIT
ASP6F131
ASP6F125
ASP6F115 | 6F
3MAXC | ASP3F160KIT
ASP3F153KIT
ASP3F145KIT
ASP3F133KIT
ASP3F120KIT | |
| | ASP5F131KIT
ASP5F125KIT
ASP5F115KIT
ASP5F131
ASP5F125
ASP5F115 | 5F | | |
| 510(k) Number | K211697 | K113163 | K240917 | |
| Classification | Class II | Class II | Class II | |
| Product Code | NRY | NRY | NRY | |
| Device
Design/Materials | Nitinol braided shaft,
nitinol coil, polymeric
exterior | Stainless steel and
Nitinol coiled shaft,
polymeric exterior | Inner shaft:
Stainless steel braided
shaft, Nitinol coil
Outer layer:
Polymeric exterior Tecoflex
(thermoplastic
polyurethane), Pellethane
(thermoplastic
polyurethane), Pebax
(polyether block amide),
Vestamid (polyamide)
Inner layer: PTFE
Hub: Polyamide | |
| Wire
Reinforcement | Nitinol coil and braid | Stainless steel and
Nitinol coiled shaft | Stainless steel
braided shaft,
Nitinol coil | |
| Strain Relief | Thermoplastic
vulcanizate,
polypropylene | Unknown | Silicone | |
| Colorant | Natural or Green or
Blue | Unknown | Green/Blue/White | |
| | Tip Configuration | | | |
| | Straight, steam shapeable by user | Straight, steam shapeable by user | Straight, steam shapeable by user | |
| Marker Band Material/ Radiopacity | Radiopaque C-cut Platinum/Iridium | Radiopaque | Radiopaque Platinum/Iridium | |
| Hub Material | Nylon | Unknown | Polyamide | |
| Coating and Length | Hydrophilic coating Length: 60 cm | Hydrophilic coating Length: 95 cm | Hydrophilic coating Length: 100 cm | |
| Working Length | 115 cm
125 cm
131 cm | 153 cm | 120 cm
133 cm
145 cm
153 cm
160 cm | |
| Outer Diameter | 6F 0.084" Distal
0.084" Proximal
5F 0.065" Distal
0.069" Proximal | 0.050" Distal
0.062" Proximal | 0.050" Distal
0.066" Proximal | |
| Inner Diameter | 6F 0.070"
5F 0.054" | 0.035" min | 0.041" Distal
0.054" Proximal | |
| Use | Single Use Device | Single Use Device | Single Use Device | |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | |
| Shelf Life | 12 months | Unknown | 12 months | |
| Accessory Devices | Aspiration Tubing
Introducer Sheath
Shaping Mandrel
Rotating Haemostasis Valve | Aspiration Tubing
Introducer Sheath
Shaping Mandrel
Rotating Haemostasis Valve | Aspiration Tubing
Introducer Sheath
Shaping Mandrel
Rotating Haemostasis Valve | |
| Aspiration Tubing Dimensions | 112 inch length
Tubing ID = 0.110 inch
Integrated valve for vacuum control | 112 inch length
Tubing ID = 0.110 inch | 112 inch length
Tubing ID = 0.110 inch
Integrated valve for vacuum control | |
| Aspiration Tubing Materials | Polyurethane & Nylon | Polyurethane & Nylon | Polyurethane & Nylon | |
| Packaging Components/ Configuration | Device is stored within a HDPE packaging hoop
Packaging hoop is contained within a sterile barrier Tyvek to nylon pouch
Packaged within a shipping carton | Supplied within a dispenser hoop
Dispenser hoop is contained within a sterile barrier pouch
Packaged within a shipping carton | Device is stored within a HDPE packaging hoop
Packaging hoop is contained within a sterile barrier Tyvek to nylon pouch
Packaged within a shipping carton | |
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Image /page/6/Picture/1 description: The image shows the logo for Wallaby Medical. The logo consists of a green and blue circle with a white design inside, followed by the text "Wallaby Medical" in green and blue. Above the text are Chinese characters in blue and green.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Table 2: Comparison of technological characteristics of the Esperance 3+ Aspiration Catheter System with predicate and reference devices
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Image /page/7/Picture/0 description: The image shows the logo for Wallaby Medical. The logo features a green and blue color scheme. To the left is a green circular graphic with a white design inside. To the right of the graphic is the company name, with the Chinese characters above the English name.
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Image /page/8/Picture/1 description: The image contains the logo for Wallaby Medical. The logo consists of a circular graphic on the left, with a stylized image inside. To the right of the graphic is the company name in both Chinese and English. The English name, "Wallaby Medical", is written in a smaller font size below the Chinese characters.
VII. PERFORMANCE DATA
Biocompatibility
Biocompatibility testing for the Esperance 3+ Aspiration Catheter System was conducted based on International Organization for Standardization (ISO) 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process," and the FDA guidance document "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process"" (2020).
Table 3 below summarizes biocompatibility testing performed on the Esperance 3+ Aspiration Catheter System and accessories to be marketed with the device.
| Test | Test Description | Conclusion |
|---|---|---|
| Esperance 3+ Aspiration Catheter Test Results | ||
| Cytotoxicity | ||
| ISO 10993-5 | MTT- L929 Cytotoxicity Study | No cytotoxic effect. |
| Skin Irritation | ||
| ISO 10993-10 | ISO Intracutaneous Irritation | No sensitization indicated. |
| Sensitization | ||
| ISO 10993-10 | ISO Guinea Pig Maximization | |
| Sensitization | No sensitization indicated. | |
| Systemic Toxicity | ||
| ISO 10993-11 | ISO Acute Systemic Toxicity | No acute systemic toxicity indicated. |
| ISO Material Mediated Rabbit | ||
| Pyrogen (GLP) | Esperance 3+ Aspiration Catheter is | |
| deemed non-pyrogenic. | ||
| Hemocompatibility | ||
| ISO 10993-4 | Hemolysis (ASTM method) Indirect | |
| Extract | No hemolysis indicated. | |
| ASTM Hemolysis - Direct Contact | ||
| and Extract Method (GLP) | No hemolysis indicated. | |
| Complement Activation | Esperance 3+ Aspiration | |
| Catheter is deemed comparable | ||
| to predicate. | ||
| Thromboresistance Evaluation | Esperance 3+ Aspiration Catheter is | |
| deemed comparable to predicate. | ||
| Partial Thromboplastin Time | Esperance 3+ Aspiration Catheter is | |
| deemed comparable to predicate. | ||
| Accessory Test Results - Introducer Sheath | ||
| Cytotoxicity | ||
| ISO 10993-5 | ISO MEM elution- L929 | No cytotoxic effect. |
| Sensitization | ||
| ISO 10993-10 | ISO Guinea Pig Maximization | |
| Sensitization | No sensitization indicated. | |
| Skin Irritation | ||
| ISO 10993-10 | ISO Intracutaneous Irritation | No sensitization indicated. |
| Systemic Toxicity | ||
| ISO 10993-11 | Systemic Toxicity - Acute | |
| Systemic Injection | No acute systemic toxicity indicated. |
Table 3: Biocompatibility Testing Results for the Esperance 3+ Aspiration Catheter System
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| | Material Mediated Pyrogenicity
Test | Test articles are deemed non-
pyrogenic. |
|----------------------------------------------------|-----------------------------------------------|---------------------------------------------|
| Hemocompatibility
ISO 10993-4 | ASTM Hemolysis -Extract Method | No hemolysis indicated. |
| Accessory Test Results - Wallaby Aspiration Tubing | | |
| Cytotoxicity
ISO 10993-5 | MTT- L929 Cytotoxicity Study | No cytotoxic effect. |
| Skin Irritation
ISO 10993-10 | ISO Intracutaneous Irritation | No sensitization indicated. |
| Sensitization
ISO 10993-10 | ISO Guinea Pig Maximization
Sensitization | No sensitization indicated. |
| Accessory Test Results - Rotating Hemostasis Valve | | |
| Cytotoxicity
ISO 10993-5 | ISO MEM elution- L929 | No cytotoxic effect. |
| Skin Irritation
ISO 10993-10 | ISO Intracutaneous Irritation | No sensitization indicated. |
| Sensitization
ISO 10993-10 | ISO Guinea Pig Maximization
Sensitization | No sensitization indicated. |
| Systemic Toxicity
ISO 10993-11 | ISO Acute Systemic Toxicity | No acute systemic toxicity indicated. |
| | ISO Material Mediated Rabbit
Pyrogen (GLP) | RHV is deemed non- pyrogenic. |
| Hemocompatibility
ISO 10993-4 | ASTM Hemolysis -Extract Method | No hemolysis indicated. |
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Image /page/10/Picture/0 description: The image contains the logo for Wallaby Medical. The logo consists of a green and blue gradient circle with a white abstract design inside. To the right of the circle is the company name in both Chinese characters and English. The English name "Wallaby Medical" is written in a smaller font size below the Chinese characters.
Sterilization
The Esperance 3+ Aspiration Catheter System is sterilized by Ethylene Oxide. Sterilization takes place in Steris Sterilization Technologies (Suzhou) Ltd., Jiangsu, China. The sterilization cycle was verified to ensure a sterility assurance level (SAL) of 10-6.
The Esperance 3+ Aspiration Catheter System has been adopted into an existing validated cycle per EN ISO 11135:2014 and AAMI TIR28:2009.
Standards utilized in regards to sterilization:
ISO 11135:2014 "Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices."
FDA guidance documents utilized in regards to sterilization:
"Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labelled as Sterile" (2016).
The sterilization cycle has been validated via the half cycle method.
Shelf Life
Shelf life conditioning has been completed and testing has been performed on devices subjected to an accelerated aging (AA) process to represent 1 year of aged units. Devices subjected to 1 year AA were tested to ensure design and performance specification requirements were met after the one year shelf life that the Esperance 3+ Aspiration Catheter System will have at commercialization. Aging studies for the Esperance 3+ Aspiration Catheter System have established that the catheters and packaging remain functional for the labeled use by date. Aging studies for packaging integrity, seal strength, and device functionality were performed and met all acceptance criteria.
FDA guidance documents utilized in regards to shelf life:
"Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019).
Non-Clinical Performance Data
The following non-clinical performance tests were performed to support the substantial equivalence determination as summarized below.
PERFORMANCE TESTING - BENCH
A full suite of bench performance testing was carried out on the Esperance 3+ Aspiration Catheter System. The results of this testing demonstrated compliance to all the design attributes and that the device performs as intended. Table 4 below summarizes the bench performance tests and results.
| Test | Test Method Summary | Results |
|---|---|---|
| Dimensional | ||
| Verification (Working | ||
| Length, Coating | ||
| Length, ID, OD) | The dimensions of the catheter and the | |
| introducer sheath are measured. | All samples met the | |
| acceptance criteria. | ||
| Test | Test Method Summary | Results |
| Navigability | The device is tested for its ability to reach target | |
| site in an anatomical model in comparison to the | ||
| predicate. | All samples met the | |
| acceptance criteria. | ||
| Clot Removal | The subject device is tested for its ability to | |
| aspirate clots in an anatomical model in | ||
| comparison to the predicate. | All samples met the | |
| acceptance criteria. | ||
| Kink Resistance | The catheter is tested at different locations | |
| for its ability to bend to clinically relevant | ||
| radii without kinking in comparison to | ||
| predicate. | All samples met the | |
| acceptance criteria. | ||
| Lubricity | The catheter's hydrophilic coating lubricity is | |
| tested by applying force to the coated | ||
| section of the catheter and measuring the | ||
| frictional force in comparison to the | ||
| predicate. | All samples met the | |
| acceptance criteria. | ||
| Coating Integrity | The coated length of the catheter is | |
| inspected for defects post simulated use in | ||
| comparison to the predicate. | All samples met the | |
| acceptance criteria. | ||
| Torque Strength | The catheter and predicate were evaluated | |
| for torque strength by rotating the test | ||
| sample within an anatomical model until | ||
| failure while the distal tip was not free to | ||
| rotate. | All samples met the | |
| acceptance criteria. | ||
| Delivery and Retrieval | ||
| Force | The subject device is tested for its ability to | |
| reach and be retracted from a target site in | ||
| an anatomical model with application of | ||
| force below a specified value. Delivery and | ||
| retrieval forces were also compared to the | ||
| predicate device. | All samples met the | |
| acceptance criteria. | ||
| Vacuum Resistance | The device is tested for its ability to | |
| withstand a specified vacuum pressure for a | ||
| specified time without damage, lumen | ||
| collapse, or kink. | All samples met the | |
| acceptance criteria. | ||
| Aspiration Flow Rate | The aspiration flow rate of the subject device | |
| at a specified vacuum pressure was | ||
| measured in comparison to the predicate. | All samples met the | |
| acceptance criteria. | ||
| Elongation | ||
| to | ||
| Failure | The catheter elongation at break was | |
| obtained from the shaft tensile testing data. | All samples met the | |
| acceptance criteria. | ||
| Test | Test Method Summary | Results |
| Tip Stiffness | The catheter tip is tested by bending in a test | |
| fixture and measuring the maximum load | ||
| that caused deflection. Tip stiffness was also | ||
| compared to the predicate. | All samples met the | |
| acceptance criteria. | ||
| Atraumatic Distal Tip | The catheter tip is inspected for smoothness. | All samples met the |
| acceptance criteria. | ||
| Tip Shaping Ability | The distal tip of the catheter is shaped using | |
| the shaping mandrel supplied with the | ||
| Esperance 3+ Aspiration Catheter System and | ||
| the distal tip is assessed for damage and the | ||
| ability to hold the tip shape. | All samples met the | |
| acceptance criteria. | ||
| Introducer Sheath | ||
| Compatibility | The supplied introducer sheath is tested for | |
| compatibility with the Esperance 3+ | ||
| Aspiration Catheter System. | All samples met the | |
| acceptance criteria. | ||
| Device Compatibility | An appropriately sized guidewire is delivered | |
| and retrieved through the catheter. The | ||
| catheter is delivered and retrieved through | ||
| an appropriately sized sheath. | All samples met the | |
| acceptance criteria. | ||
| Surface Defects | The catheter and introducer sheath are | |
| examined under magnification for | ||
| extraneous matter. | All samples met the | |
| acceptance criteria. | ||
| Tensile Force | The peak tensile force of the subject catheter | |
| is measured at different locations in | ||
| comparison to the predicate. | All samples met the | |
| acceptance criteria. | ||
| Liquid Leakage | The subject catheter is tested for leakage per | |
| ISO 10555-1 and compared to the reference | ||
| device. | All samples met the | |
| acceptance criteria. | ||
| Air Leak | The subject catheter is tested for air leakage | |
| per ISO 10555-1 and compared to the | ||
| reference device. | All samples met the | |
| acceptance criteria. | ||
| Static Burst | The subject catheter is tested to withstand a | |
| specified static pressure. | All samples met the | |
| acceptance criteria. | ||
| Test | Test Method Summary | Results |
| Power Injection | The distal tip of the catheter was blocked, | |
| and fluid was injected into the lumen using a | ||
| power injector until the catheter burst. | All samples met the | |
| acceptance criteria. | ||
| Corrosion | The subject device is visually inspected for | |
| signs of corrosion post exposure to required | ||
| conditions per ISO 10555-1. | All samples met the | |
| acceptance criteria. | ||
| Particulate Testing | The size and number of particulates | |
| generated during simulated use of the device | ||
| in a neurovascular model were measured and | ||
| calculated. Particulate generation was | ||
| compared to the reference device. | Particulate generation was | |
| similar between the subject | ||
| and reference device. | ||
| Hub/Luer Fitting | The catheter hub is tested as per ISO 80369- |
-
| All samples met the
acceptance criteria. |
Table 4: Summary of Non-Clinical Bench Testing
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Image /page/11/Picture/1 description: The image contains a logo for Wallaby Medical. The logo features a green and blue color scheme. The text "Wallaby Medical" is written in English below the Chinese characters.
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Image /page/12/Picture/1 description: The image is a logo for Wallaby Medical. The logo features a green and blue gradient circle with a white kangaroo-like figure inside. To the right of the circle is the text "沃比医疗" in Chinese characters, followed by "Wallaby Medical" in English.
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Image /page/13/Picture/1 description: The image is a logo for Wallaby Medical. The logo features a green and blue gradient circle with a white abstract design inside. To the right of the circle is the text "沃天比医疗" in blue and green, followed by "Wallaby Medical" in a smaller font size.
Standards utilized in regards to bench testing:
ISO 10555-1:2013/A1:2017 "Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements."
ISO 80369-20 "Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods."
ISO 80369-7:2016 "Small-bore connectors for liquids and gases in healthcare application - Part 7: Connectors for intravascular or hypodermic applications.
ISO 62366-1: 2015 + AC:2015 & A1 2020 "Medical Devices- Part 1: Application of Usability Engineering to Medical Devices."
FDA quidance documents utilized in regards to bench testing:
"Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019).
"Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters - Class II Special Controls Guidance for Industry and FDA" (2010).
"Applying Human Factors and Usability Engineering to Medical Devices" (2016).
Clinical Testing
Clinical testing was not performed on the Esperance 3+ Aspiration Catheter System as clinical data were not deemed necessary to establish substantial equivalence.
Animal Testing
Animal data were not deemed necessary as substantial equivalence was established based upon successful completion of non-clinical performance testing presented above.
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Image /page/14/Picture/1 description: The image contains a logo for Wallaby Medical. The logo features a green and blue gradient circle with a white kangaroo-like figure inside. To the right of the circle, the text "沃比医疗" is written in blue and green, followed by "Wallaby Medical" in a smaller font size.
VIII. CONCLUSIONS
Wallaby Medical has demonstrated that the Esperance 3+ Aspiration Catheter System is substantially equivalent to the predicate device Penumbra System MAX (K113163). The subject device has the same intended use, similar technological characteristics, similar materials, and the same operating principle as the predicate device. The differences do not raise new questions of safety or effectiveness. The subject device has been demonstrated to perform as intended through successful non-clinical performance testing.