Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and mechanical performance of a vascular sheath, with no mention of AI/ML capabilities or data processing for diagnostic or analytical purposes.

Therapeutic

No.
The device is a non-active, surgically invasive device used for the introduction of other interventional devices, not for therapeutic purposes itself.

Diagnostic

No

The device is indicated for "introduction of interventional devices into the peripheral and neuro vasculature", which describes a therapeutic or interventional function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, single-use vascular catheter with specific dimensions, materials, and physical properties. It is described as a "non-active, surgically invasive device" and the performance studies focus on bench testing of physical characteristics and biocompatibility, not software validation.

IVD (In Vitro Diagnostic)

Based on the provided information, the 6F Wallaby Long Sheath is not an In Vitro Diagnostic (IVD) 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 tool used during a medical procedure to facilitate the delivery of other devices, not a device used to perform a diagnostic test on a sample taken from the body.
Device Description: The description focuses on the physical characteristics of a catheter designed for insertion into blood vessels. It describes its dimensions, materials, and features that aid in navigation within the vasculature.
Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
Performance Studies: The performance studies focus on the physical and functional properties of the device (e.g., strength, flexibility, lubricity, biocompatibility) and its ability to perform its intended function of delivering other devices. There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with IVDs.

In summary, the 6F Wallaby Long Sheath is a medical device used in interventional procedures, but it does not fit the definition of an In Vitro Diagnostic device, which is used to perform tests on samples taken from the human body to provide diagnostic information.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The 6F Wallaby Long Sheath is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Product codes

DQY, QJP

Device Description

The 6F Wallaby Long Sheath is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device has an inner diameter (ID) of 0.088 inch and outer diameter (OD) of 0.105 inch designed with three different working lengths (80 cm, 90 cm, and 100 cm) and two different tip configurations (straight and multipurpose curve). The distal tip of the 6F Wallaby Long Sheath is visible under fluoroscopy and the distal shaft of the catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of the catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. The 6F Wallaby Long Sheath has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.

The 6F Wallaby Long Sheath 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

Not Found

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

Non-clinical bench and biological compatibility testing was conducted.
Visual Inspection: The 6F Wallaby Long Sheath was evaluated to verify the visual inspection requirements were met. The device met all pre-defined acceptance criteria.
Dimensional Inspection: The 6F Wallaby Long Sheath was evaluated to verify the dimensional requirements for ID, OD, overall length, working length, and coating length were met. The subject device met all pre-defined acceptance criteria.
Simulated Use: The 6F Wallaby Long Sheath was evaluated under a simulated use in a representative tortuous anatomical model. Subject device compatibility with 6F and 8F catheters, the RHV, guidewire, and stent retriever were evaluated. The device performed as intended.
Physician Validation: The 6F Wallaby Long Sheath was evaluated under a simulated use in a representative tortuous anatomical model by physicians in comparison to the predicate device, including preparation and ease of assembly, 8F short sheath interaction, RHV Luer connection interaction, dilator interaction, compatibility with guidewire, guide and aspiration catheters, and kink resistance. The subject device performed as intended.
Delivery and Retrieval: The 6F Wallaby Long Sheath was evaluated under a simulated use in a representative tortuous anatomical model for delivery and retrieval forces in comparison to the predicate device. The forces required to deliver and retrieve the subject device with ancillary devices were compared to the predicate device, which demonstrated similar forces.
Tip Stiffness: The tip stiffness of the 6F Wallaby Long Sheath was evaluated and compared to the predicate device. The results demonstrated tip stiffness is similar to the predicate.
Tensile Strength and Elongation to Failure: The 6F Wallaby Long Sheath was evaluated to verify the tensile strength of the distal shaft and the proximal hub and met the minimum tensile requirement. The 6F Wallaby Long Sheath was evaluated to verify the shaft elongation to failure. The device met all predefined acceptance criteria.
Torque Strength: The 6F Wallaby Long Sheath was tested for torque to failure in a simulated use test model. Test results demonstrated the torque strength of the subject device is similar to the predicate device.
Coating Integrity: The 6F Wallaby Long Sheath coating integrity was inspected after the particulate testing and no visible defects or sign of irregularity were observed.
Coating Lubricity: The 6F Wallaby Long Sheath was evaluated for frictional forces in a simulated use test model and demonstrated similar results between the subject device and the predicate device.
Catheter Dynamic and Static Burst (Pressure) Leak (Liquid) Leak (Air): The 6F Wallaby Long Sheath was evaluated for leakage and burst and is compatible with accessories per ISO 10555-1.
Kink Resistance: The 6F Wallaby Long Sheath was evaluated for resistance to kinking around bends with clinically relevant radii at specific locations along the shaft and met the acceptance criteria.
Particulate: The 6F Wallaby Long Sheath was evaluated within a simulated use anatomical model to verify the amount of particulate generated. The number of particulates was comparable to the predicate. The device met the acceptance criteria.
Corrosion Resistance: The 6F Wallaby Long Sheath was evaluated for corrosion resistance per ISO 10555-1 and met the acceptance criteria.
Insertion and Retrieval Forces: The 6F Wallaby Long Sheath was evaluated for insertion and retrieval forces with a dilator. The results demonstrated similar forces for the subject device and the predicate device.
Radiopacity: The 6F Wallaby Long Sheath was evaluated for marker band visibility under fluoroscopy during the physician validation testing and demonstrated results similar to the predicate device.

Biocompatibility testing for the sheath: Non-cytotoxic, Non-irritant, Non-sensitizing, Non-toxic, Non-pyrogenic, complement activation was similar to the comparator device, Non-hemolytic, Counts from subject device are within acceptable ranges and are similar to the control, not considered an activator of the intrinsic coagulation pathway, Thrombogenic risk potential similar to the control device.
Biocompatibility testing for the dilator: Non-cytotoxic, Non-irritant, Non-sensitizing, Non-toxic, Non-pyrogenic, Non-activator of complement system, Non-hemolytic, Thrombogenic risk potential similar to the control device.
Biocompatibility testing for the RHV: Non-cytotoxic, Non-irritant, Non-sensitizing, Non-toxic, Non-pyrogenic, Non-hemolytic.

No animal or clinical testing was deemed necessary.

Key Metrics

Not Found

Predicate Device(s)

K111380

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

March 2, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Wallaby Medical David Ruiz Staff Quality Engineer 22901 Mill Creek Drive Laguna Hills, California 92653

Re: K222603

Trade/Device Name: 6F Wallaby Long Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: February 1, 2023 Received: February 1, 2023

Dear David Ruiz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 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 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-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

Enclosure

2

Indications for Use

510(k) Number (if known)

K22603

Device Name 6F Wallaby Long Sheath

Indications for Use (Describe)

The 6F Wallaby Long Sheath is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Type of Use (Select one or both, as applicable)

V Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K222603 510(k) Summary

As required by 21 CFR 807.92:

| Applicant: | Wallaby Medical
22901 Mill Creek Drive
Laguna Hills, CA 92653 |
|------------------------|-----------------------------------------------------------------------------------------------------|
| Contact: | David Ruiz |
| Phone Number: | (1)-951-818-7984 |
| Date Prepared: | 03/02/23 |
| Device Trade Name: | 6F Wallaby Long Sheath |
| Device Common Name: | Sheath, Access |
| Classification Name: | DQY (Catheter, Percutaneous) and QJP (Catheter, Percutaneous,
Neurovasculature), 21 CFR 870.1250 |
| Predicate Device Name: | Neuron MAX System (K111380) |

Device Description a.

The 6F Wallaby Long Sheath is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device has an inner diameter (ID) of 0.088 inch and outer diameter (OD) of 0.105 inch designed with three different working lengths (80 cm, 90 cm, and 100 cm) and two different tip configurations (straight and multipurpose curve). The distal tip of the 6F Wallaby Long Sheath is visible under fluoroscopy and the distal shaft of the catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of the catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. The 6F Wallaby Long Sheath has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.

The 6F Wallaby Long Sheath is a non-active, surgically invasive device intended for short term use within the vasculature.

b. Indications for Use

The 6F Wallaby Long Sheath is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

C. Predicate Comparison

The predicate device for the 6F Wallaby Long Sheath is the Neuron MAX System cleared under K111380. The table below describes the technological differences between the 6F Wallaby Long Sheath and the Neuron MAX System:

| Device Name | Predicate Device:
Neuron MAX System | Subject Device:
6F Wallaby Long Sheath | Rationale for Difference |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K111380 | K222603 | |
| Classification | Class II, DQY | Class II, DQY and QJP | QJP product code added |
| Device Name | Predicate Device:
Neuron MAX System | Subject Device:
6F Wallaby Long Sheath | Rationale for Difference |
| Indications for
Use | The Neuron MAX System is
indicated for the introduction of
interventional devices into the
peripheral, coronary, and neuro
vasculature. | The 6F Wallaby Long Sheath is
indicated for the introduction
of interventional devices into
the peripheral and neuro
vasculature. | The 6F Wallaby Long Sheath is
not indicated for use in the
coronary vasculature. |
| Materials
Shaft | | | |
| Extrusions | Outer layer:
Polyurethane, polyamide

Inner layer:
PTFE | Outer layer:
Neusoft (polyurethane),
PEBAX, polyamide, PET

Table 1: 6F Wallaby Long Sheath Technological Comparison to Neuron MAX System

4

5

d. Non-Clinical Performance Tests

To establish the substantial equivalence of the 6F Wallaby Long Sheath to the predicate Neuron MAX System and to meet the requirements of the risk analysis , non-clinical bench and biological compatibility testing was conducted and driven by the risk analysis. The testing and results are summarized below:

Design Verification Testing - Bench

Performance testing was conducted. The results of the design verification and validation testing confirm that the 6F Wallaby Long Sheath conforms to the pre-defined acceptance criteria. Testing included:

Test	Methods and Results
Visual Inspection	The 6F Wallaby Long Sheath was evaluated to verify the visual inspection requirements were met. The device met all pre-defined acceptance criteria.
Dimensional Inspection	The 6F Wallaby Long Sheath was evaluated to verify the dimensional requirements for ID, OD, overall length, working length, and coating length were met. The subject device met all pre-defined acceptance criteria.
Simulated Use	The 6F Wallaby Long Sheath was evaluated under a simulated use in a representative tortuous anatomical model. Subject device compatibility with 6F and 8F catheters, the RHV, guidewire, and stent retriever were evaluated. The device performed as intended.
Physician Validation	The 6F Wallaby Long Sheath was evaluated under a simulated use in a representative tortuous anatomical model by physicians in comparison to the predicate device, including preparation and ease of assembly, 8F short sheath interaction, RHV Luer connection interaction, dilator interaction, compatibility with guidewire, guide and aspiration catheters, and kink resistance. The subject device performed as intended.
Delivery and Retrieval	The 6F Wallaby Long Sheath was evaluated under a simulated use in a representative tortuous anatomical model for delivery and retrieval forces in comparison to the predicate device. The forces required to deliver and retrieve the subject device with ancillary devices were compared to the predicate device, which demonstrated similar forces.

6

Test	Methods and Results
Tip Stiffness	The tip stiffness of the 6F Wallaby Long Sheath was evaluated and compared to the predicate device. The results demonstrated tip stiffness is similar to the predicate.
Tensile Strength and Elongation to Failure	The 6F Wallaby Long Sheath was evaluated to verify the tensile strength of the distal shaft and the proximal hub and met the minimum tensile requirement. The 6F Wallaby Long Sheath was evaluated to verify the shaft elongation to failure. The device met all predefined acceptance criteria.
Torque Strength	The 6F Wallaby Long Sheath was tested for torque to failure in a simulated use test model. Test results demonstrated the torque strength of the subject device is similar to the predicate device.
Coating Integrity	The 6F Wallaby Long Sheath coating integrity was inspected after the particulate testing and no visible defects or sign of irregularity were observed.
Coating Lubricity	The 6F Wallaby Long Sheath was evaluated for frictional forces in a simulated use test model and demonstrated similar results between the subject device and the predicate device.
Catheter Dynamic and Static
Burst (Pressure)
Leak (Liquid)
Leak (Air)	The 6F Wallaby Long Sheath was evaluated for leakage and burst and is compatible with accessories per ISO 10555-1.
Kink Resistance	The 6F Wallaby Long Sheath was evaluated for resistance to kinking around bends with clinically relevant radii at specific locations along the shaft and met the acceptance criteria.
Particulate	The 6F Wallaby Long Sheath was evaluated within a simulated use anatomical model to verify the amount of particulate generated. The number of particulates was comparable to the predicate. The device met the acceptance criteria.
Corrosion Resistance	The 6F Wallaby Long Sheath was evaluated for corrosion resistance per ISO 10555-1 and met the acceptance criteria.
Insertion and Retrieval Forces	The 6F Wallaby Long Sheath was evaluated for insertion and retrieval forces with a dilator. The results demonstrated similar forces for the subject device and the predicate device.
Radiopacity	The 6F Wallaby Long Sheath was evaluated for marker band visibility under fluoroscopy during the physician validation testing and demonstrated results similar to the predicate device

Design Verification Testing – Animal

No animal testing was deemed necessary to support the substantial equivalence of the 6F Wallaby Long Sheath.

Sterilization and Shelf Life

The 6F Wallaby Long Sheath is sterilized using an Ethylene Oxide (EO) sterilization cycle. The sterilization cycle was verified to ensure a sterility assurance level (SAL) of 10 * in accordance with 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.

Aging studies for the 6F Wallaby Long Sheath have established the device and its packaging remains functional for the 12-month shelf life. Aging studies for packaging integrity, seal strength, and device functionality were performed and met the acceptance criteria.

Biocompatibility

Biocompatibility testing for the 6F Wallaby Long Sheath and accessories was performed in accordance with ISO 10993- 1:2018, Biological evaluation of medical devices – Evaluation and testing within a risk management process.

7

Table 3: Biocompatibility Testing

Test	Results	Conclusion
Sheath (100 cm model)
MTT – L-929 Cytotoxicity Study	1X MEM test extract showed no cytotoxic potential to
L-929 mouse fibroblast cells undiluted or at any
dilution; viability ≥ 70%; 80-91%.	Non-cytotoxic
ISO Intracutaneous Irritation	The difference between the average scores of the test
article extract and the vehicle control are: 0; 0.	Non-irritant
ISO Guinea Pig Maximization Sensitization	Test and control animals' responses are not greater
than "0".	Non-sensitizing
ISO Acute Systemic Toxicity	No abnormal clinical signs indicative of toxicity were
observed for 72 hours. All animals were alive at the
end of 72 hours and body weight changes were within
acceptable parameters.	Non-toxic
ISO Material Mediated Rabbit Pyrogen	No rabbit temperature rise ≥ 0.5°C.	Non-pyrogenic
Complement Activation - SC5b-9 Assays
with Sponsor-Supplied Comparison	Results within acceptable range as compared to the
comparator device.	The test article
complement activation
was similar to the
comparator device
ASTM Hemolysis - Direct Contact and
Extract Method	Blank corrected Hemolytic index: 0.4, 0.1.	Non-hemolytic
Platelet and Leukocyte counts	No ranges or levels outside an acceptable range and
comparable to Control Device.	Counts from subject
device are within
acceptable ranges and are
similar to the control
Partial Thromboplastin Time (PTT)	Test and predicate devices have similar performance.	The test article is not
considered an activator of
the intrinsic
coagulation pathway
Thromboresistance Evaluation	No adverse effects or clinical signs during test period
and no thrombus score > 3 for either test or control
device.	Thrombogenic risk
potential similar to
the control device
Dilator
MTT – L-929 Cytotoxicity Study	1XMEM test extract showed no cytotoxic potential to
L-929 mouse fibroblast cells undiluted or at any
dilution; viability ≥70%; 79.8%.	Non-cytotoxic
ISO Intracutaneous Irritation	The difference between the average scores of the test
article extract and the vehicle control are: 0; 0.	Non-irritant
ISO Guinea Pig Maximization Sensitization	Test and control animals' responses are not greater
than "0".	Non-sensitizing
ISO Acute Systemic Toxicity	No abnormal clinical signs indicative of toxicity were
observed for 72 hours. All animals were alive at the
end of 72 hours and body weight changes were
within acceptable parameters.	Non-toxic
ISO Material Mediated Rabbit Pyrogen	No rabbit temperature rise ≥ 0.5°C.	Non-pyrogenic
Complement Activation - SC5b-9 Assays
with Sponsor-Supplied Comparison	Results within acceptable range as compared to the
negative reference material.	Non-activator of
complement system
ASTM Hemolysis - Direct Contact and
Extract Method	Blank corrected Hemolytic index: 0.3, 0.5.	Non-hemolytic
Thromboresistance Evaluation	No adverse effects or clinical signs during test period
and no thrombus score > 3 for either test or control device.	Thrombogenic risk potential similar to the control device
RHV
Cytotoxicity MEM Elution	Percent Cell Lysis: 0%
Cytotoxic Score: 0	Non-cytotoxic
ISO Intracutaneous Irritation	The difference between the average scores of the test article extract and the vehicle control are: 0; 0.	Non-irritant
ISO Guinea Pig Maximization Sensitization	Test and control animals' response not greater than "0".	Non-sensitizing
ISO Acute Systemic Toxicity	No abnormal clinical signs indicative of toxicity were observed for 72 hours. All animals were alive at the end of 72 hours and body weight changes were within acceptable parameters.	Non-toxic
ISO Material Mediated Rabbit Pyrogen	No rabbit temperature rise ≥ 0.5°C.	Non-pyrogenic
ASTM Hemolysis - Direct Contact and
Extract Method	Blank corrected Hemolytic index: 0.0, 0.1.	Non-hemolytic

8

Clinical

No clinical testing was deemed necessary to support the substantial equivalence of the 6F Wallaby Long Sheath.

Conclusion

The 6F Wallaby Long Sheath is substantially equivalent to the predicate Neuron MAX System based on the non-clinical testing results, as well as similar principles of operation, materials of construction, packaging, usability, and the indications for use. Any differences between the subject device and the predicate device do not raise different questions of safety and effectiveness.