(330 days)
No
The document describes a mechanical catheter and does not mention any AI or ML components or functionalities.
No
The device is described as an "introduction of interventional devices" catheter and is a "non-active, surgically invasive device." It facilitates the use of other devices rather than providing direct therapeutic action itself.
No
The described Esperance Distal Access Catheter is used for the introduction of interventional devices, which is a therapeutic function, not a diagnostic one. It facilitates treatment rather than providing information about a condition.
No
The device description clearly describes a physical catheter and associated hardware components (peelable introducer, shaping mandrel, Luer adapter). It is a tangible medical device, not software.
Based on the provided information, the Esperance Distal Access Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "introduction of interventional devices into the peripheral and neuro vasculature." This describes a device used within the body for a procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a catheter designed for insertion into blood vessels. It mentions features like a lumen, variable stiffness, hydrophilic coating, and a Luer adapter for attaching accessories. These are characteristics of a medical device used for access and delivery within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Esperance Distal Access Catheter does not fit this description.
N/A
Intended Use / Indications for Use
The Esperance Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QJP, DQY
Device Description
The Esperance® Distal Access Catheter is a single-use, single lumen, variable stiffness, composite catheter. The device includes 5F and 6F catheters with inner diameters of 0.055" and 0.071", respectively, designed with three different working lengths for both sizes: 115 cm, and 131 cm. The device is supplied with a peelable introducer and shaping mandrel. 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® Distal Access Catheter is a non-active, surgically invasive device intended for short term use within the vasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Peripheral 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 performance testing was conducted to support the subject Esperance® Distal Access Catheter submission. Because there are no changes in the design, materials, and manufacturing of the subject Esperance® Distal Access Catheter and accessories versus the respective components of the reference device, the Esperance Aspiration Catheter System (K211697), for tests marked with * in the table below performance data from the reference device were used in support of the subject device.
Tests conducted include:
- Visual Inspection*: The device met all pre-defined acceptance criteria.
- Dimensional Inspection* (ID, OD, Overall Length, Working Length, Coating Length, Distal Tip to Marker Band, Hub/Strain Relief Length): The device met all pre-defined acceptance criteria.
- Simulated Use: The device was evaluated in a simulated anatomy model (preparation/ease of assembly, introducer sheath interaction, introducer peel away, compatibility with guidewire/microcatheter, lubricity and durability of hydrophilic coating, and kink resistance). Testing of the reference device, Esperance Aspiration Catheter System (K211697), was used and supplemented with additional testing for the intended use of the subject device. Device performs as intended and met all pre-defined acceptance criteria.
- Physician Validation*: The device was evaluated in a simulated anatomy model by physicians and performed as intended.
- Delivery and Retrieval Forces: The device was subjected to delivery and retrieval forces testing in a vascular model under simulated use conditions and met all pre-defined acceptance criteria. Testing of the reference device, Esperance Aspiration Catheter System (K211697), was used and supplemented with additional testing.
- Tip Stiffness*: The device tip was deflected on a universal testing machine and met acceptance criteria.
- Tip Shaping*: The device tip was shaped with the shaping mandrel and steam and met the pre-defined acceptance criteria.
- System Tensile* (Hub, Shaft, Tip): The device met all predefined acceptance criteria.
- Elongation to Failure*: The device met all pre-defined acceptance criteria.
- Torque Strength*: The device torque response was assessed in a vascular model and met the predefined acceptance criteria.
- Coating Integrity (after particulate testing): Testing of the reference device, Esperance Aspiration Catheter System (K211697), was used and supplemented with additional testing. The device coating integrity was inspected pre- and post-insertion and retrieval through a vascular model and met all pre-defined acceptance criteria.
- Coating Lubricity*: The device was evaluated for frictional forces on a universal testing machine and met all pre-defined acceptance criteria.
- Catheter Burst, Leak (Liquid and Air): The device was evaluated and met acceptance criteria. Testing of the reference device, Esperance Aspiration Catheter System (K211697) was used and supplemented with additional testing.
- Kink Resistance*: The device met acceptance criteria.
- Particulate: The device was evaluated within a simulated anatomy model and met acceptance criteria. Testing of the reference device, Esperance Aspiration Catheter System (K211697) was used and supplemented with additional testing.
- Corrosion Resistance*: The catheter is corrosion resistant per ISO 10555-1.
- Radiopacity*: The device was evaluated for marker band visibility under fluoroscopy and met the pre-defined acceptance criteria.
- Luer Hub Testing*: The device was evaluated per ISO 80369-7 and ISO 80369-20 and met the pre-defined specifications.
- Animal data were not deemed necessary.
- A clinical study was not deemed necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 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
March 8, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Wallaby Medical Emily Dobosz Senior Manager Regulatory Affairs 22901 Mill Creek Drive Laguna Hills, California 92653
Re: K231056
Trade/Device Name: Esperance Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: February 2, 2024 Received: February 5, 2024
Dear Emily Dobosz:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (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).
1
2
Your device is also subject to, among other requirements, the Quality System (OS) 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
2
Indications for Use
510(k) Number (if known) K231056
Device Name Esperance Distal Access Catheter
Indications for Use (Describe)
The Esperance Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Wallaby Medical. The logo consists of a green and blue gradient circle with a white abstract design inside, followed by the words "Wallaby Medical" in a sans-serif font. The colors of the text also have a green and blue gradient, matching the circle.
510(k) Summary (21 CFR 807.92)
510(k) Number: K231056
Date Prepared: March 06, 2024
510(k) Submitter:
Wallaby Medical 22901 Mill Creek Drive Laguna Hills, CA 92653
| Contact: | Emily Dobosz |
|---|---|
| Title: | Senior Manager Regulatory Affairs |
| Phone: | +353 91 740 100 |
| Email: | emily.dobosz@wallabyphenox.com |
| Device Trade Name: | Esperance® Distal Access Catheter |
|---|---|
| Common or Usual Name: | Catheter, Percutaneous, Neurovasculatur |
| Regulation Number: | 21 CFR 870.1250 |
| Regulation Name: | Percutaneous Catheter |
| Review Panel: | Neurology, Cardiovascular |
| Device Class: | Class II |
| Product Codes: | QJP, DQY |
PREDICATE AND REFERENCE DEVICES
| Device Name | 510(k) Number |
|---|---|
| Predicate: React™71 Catheter | K182097 |
| Reference: Esperance Aspiration Catheter System | K211697 |
DEVICE DESCRIPTION
The Esperance® Distal Access Catheter is a single-use, single lumen, variable stiffness, composite catheter. The device includes 5F and 6F catheters with inner diameters of 0.055" and 0.071", respectively, designed with three different working lengths for both sizes: 115 cm, and 131 cm. The device is supplied with a peelable introducer and shaping mandrel. 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® Distal Access Catheter is a non-active, surgically invasive device intended for short term use within the vasculature.
4
Image /page/4/Picture/0 description: The image shows the logo for Wallaby Medical. The logo consists of a green and blue gradient circle with a white design inside, followed by the words "Wallaby Medical" in a green and blue gradient sans-serif font. The logo is simple and modern, and the colors are calming and professional.
INDICATIONS FOR USE
The Esperance Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Predicate Device | Subject Device | Reference Device | |
|---|---|---|---|
| Trade Name | React™ 71 Catheter | Esperance® Distal Access | |
| Catheter | Esperance® Aspiration Catheter | ||
| System | |||
| 510(k) number | K182097 | K231056 | K211697 |
| Product | |||
| Classification | Class II | Class II | Class II |
| Regulation | |||
| Number | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 |
| Regulation | |||
| Name | Percutaneous Catheter | Catheter, Percutaneous, | |
| Neurovasculature | Catheter, Thrombus Retriever | ||
| Product Code | DQY | QJP, DQY | NRY |
| Intended | |||
| Use/Indications | |||
| for Use | The React™ 71 Catheter is | ||
| indicated for the | |||
| introduction of | |||
| interventional devices into | |||
| the peripheral and neuro | |||
| vasculature. | The Esperance Distal Access | ||
| Catheter is indicated for the | |||
| introduction of interventional | |||
| devices into the peripheral | |||
| and neuro vasculature. | 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 t-PA) or who fail IV | |||
| t-PA therapy are candidates | |||
| for treatment. | |||
| Accessories | Peelable Sheath | Peelable Sheath, | |
| Shaping Mandrel | Peelable Sheath, | ||
| Shaping Mandrel | |||
| Dimensions | |||
| Working | |||
| Length | 132 cm | 115 cm | |
| 125 cm | |||
| 131 cm | 115 cm | ||
| 125 cm | |||
| 131 cm | |||
| Proximal Outer | |||
| Diameter (OD) | 0.0855 in (Max) | 5F: 0.069 in Max | |
| 6F: 0.084 in Max | 5F: 0.069 in Max | ||
| 6F: 0.084 in Max | |||
| Distal OD | 0.0855 in (Max) | 5F: 0.065 in Max | |
| 6F: 0.084 in Max | 5F: 0.065 in Max | ||
| 6F: 0.084 in Max | |||
| (ID) | 6F: 0.070 in Min | 6F: 0.070 in Min | |
| Materials | |||
| Hub | Trogamid | Nylon | Nylon |
| Strain Relief | DynaFlex | Thermoplastic vulcanizate, | |
| polypropylene | Thermoplastic vulcanizate, | ||
| polypropylene | |||
| Inner Layer | PTFE, Polyolefin | PTFE | PTFE |
| Reinforcement | Nitinol | Nitinol | Nitinol |
| Outer Jacket | Polyamide, | ||
| Polyolefin, | |||
| Polyurethane | Tecothane (polyurethane | ||
| elastomer), Pebax (polyether | |||
| block amide), Vestamid | |||
| (polyamide) | Tecothane (polyurethane | ||
| elastomer), Pebax (polyether | |||
| block amide), | |||
| Vestamid (polyamide) | |||
| Marker Band | Platinum/Iridium | Platinum/Iridium | Platinum/Iridium |
| Adhesive | Cyanoacrylate | Cyanoacrylate | Cyanoacrylate |
| Coating | Hydrophilic | Hydrophilic | Hydrophilic |
| Packaging | |||
| Configuration | Pouch, Packaging Card, | ||
| Packaging Hoop | Pouch, Packaging Card, | ||
| Packaging Hoop | Pouch, Packaging Card, | ||
| Packaging Hoop | |||
| Sterilization | |||
| Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| How | |||
| Supplied | Sterile, Single Use | Sterile, Single Use | Sterile, Single Use |
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Image /page/5/Picture/0 description: The image shows the logo for Wallaby Medical. The logo consists of a circular icon on the left and the text "Wallaby Medical" on the right. The icon is green and blue and appears to have a stylized image of a kangaroo. The text "Wallaby Medical" is also green and blue, with the color gradient changing from green to blue from left to right.
BIOCOMPATIBILITY
Biocompatibility of the subject Esperance® Distal Access Catheter is supported by the previously conducted biocompatibility evaluation of the reference device, the Esperance Aspiration Catheter System (K211697), because there are no changes in the design, materials, and manufacturing of the subject Esperance® Distal Access Catheter and accessories versus the respective components of the reference device system.
NON-CLINICAL PERFORMANCE DATA
Bench performance testing was conducted to support the subject Esperance® Distal Access Catheter submission. Because there are no changes in the design, materials, and manufacturing of the subject Esperance® Distal Access Catheter and accessories versus the respective components of the reference device, the Esperance Aspiration Catheter System (K211697), for tests marked with * in the table below performance data from the reference device were used in support of the subject device.
| Test | Description / Results |
|---|---|
| Visual Inspection* | The device was evaluated to verify the visual inspection |
| requirements were met. The device met all pre-defined acceptance | |
| criteria. | |
| Dimensional Inspection* (ID, OD, | |
| Overall Length, Working Length, | |
| Coating Length, Distal Tip to | |
| Marker Band, Hub/Strain Relief | |
| Length) | The device was evaluated to verify the dimensional requirements |
| were met. The device met all pre-defined acceptance criteria. | |
| Simulated Use | The device was evaluated in a simulated anatomy model for: |
| preparation/ease of assembly, introducer sheath interaction, | |
| introducer peel away, compatibility with guidewire/microcatheter, | |
| lubricity and durability of hydrophilic coating, and kink resistance. | |
| Testing of the reference device, Esperance Aspiration Catheter | |
| System (K211697), was used and supplemented with additional | |
| testing conducted to support the intended use of the subject | |
| Esperance Distal Access Catheter. Device performs as intended and | |
| met all pre-defined acceptance criteria under simulated use | |
| conditions. | |
| Physician Validation* | The device was evaluated in a simulated anatomy model by |
| physicians. Device performs as intended under simulated use | |
| conditions. | |
| Delivery and Retrieval Forces | The device was subjected to delivery and retrieval forces testing in a |
| vascular model under simulated use conditions and met all pre- | |
| defined acceptance criteria. Testing of the reference device, | |
| Esperance Aspiration Catheter System (K211697), was used and | |
| supplemented with additional testing conducted to support the | |
| intended use of the subject Esperance Distal Access Catheter. | |
| Tip Stiffness* | The device tip was deflected on a universal testing machine and met |
| acceptance criteria. | |
| Tip Shaping* | The device tip was shaped with the shaping mandrel and steam |
| and met the pre-defined acceptance criteria. | |
| System Tensile* (Hub, Shaft, Tip) | The device was evaluated to verify the tensile strength of the full |
| system meets the minimum tensile requirement. The device met all | |
| predefined acceptance criteria. | |
| Elongation to Failure* | The device elongation was obtained from the shaft tensile testing |
| data. The device met all pre-defined acceptance criteria. | |
| Torque Strength* | The device torque response was assessed in a vascular model and |
| met the predefined acceptance criteria. | |
| Coating Integrity (after particulate | |
| testing) | Testing of the reference device, Esperance Aspiration Catheter |
| System (K211697), was used and supplemented with additional | |
| testing conducted to support the intended use of the subject | |
| Esperance Distal Access Catheter. The device coating integrity was | |
| inspected pre- and post-insertion and retrieval through a vascular | |
| model and met all pre-defined acceptance criteria. | |
| Coating Lubricity* | The device was evaluated for frictional forces on a universal testing |
| machine and met all pre-defined acceptance criteria. | |
| Catheter Burst, Leak (Liquid and Air) | The device was evaluated to verify the device does not leak, burst, |
| and is compatible with accessories per ISO 10555-1 and met | |
| acceptance criteria. Testing of the reference device, Esperance | |
| Aspiration Catheter System (K211697) was used and supplemented | |
| with additional testing conducted to support the intended use of | |
| the subject Esperance Distal Access Catheter. | |
| Kink Resistance* | The device was evaluated for resistance to kinking around bends |
| with clinically relevant radii and met acceptance criteria. | |
| Particulate | The device was evaluated within a simulated anatomy model to |
| verify that any particulate generated is comparable to cleared | |
| comparator devices. The device met acceptance criteria. | |
| Testing of the reference device, Esperance Aspiration Catheter | |
| System (K211697) was used and supplemented with additional | |
| testing conducted to support the intended use of the subject | |
| Esperance Distal Access Catheter. | |
| Corrosion Resistance* | The catheter is corrosion resistant per ISO 10555-1. |
| Radiopacity* | The device was evaluated for marker band visibility under |
| fluoroscopy and met the pre-defined acceptance criteria. | |
| Luer Hub Testing* | The device was evaluated per ISO 80369-7 and ISO 80369-20 and |
| met the pre-defined specifications. |
6
@ Wallaby Medical
7
Image /page/7/Picture/0 description: The image shows the logo for Wallaby Medical. The logo consists of a green circle with a white design inside, followed by the words "Wallaby Medical" in a gradient from green to blue. The text is in a sans-serif font and is slightly curved.
PERFORMANCE DATA - ANIMAL
Animal data were not deemed necessary as substantial equivalence was established based upon successful completion of non-clinical bench testing.
PERFORMANCE DATA - CLINICAL
A clinical study was not deemed necessary as substantial equivalence was established based upon successful completion of non-clinical bench testing.
CONCLUSION
The Esperance® Distal Access Catheter is substantially equivalent to the React™ 71 Catheter (K182097). The differences in technological characteristics do not raise new questions of safety or effectiveness.
Non-clinical testing supports a determination that the Esperance® Distal Access Catheter is substantially equivalent to the predicate device.