(185 days)
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 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.
The provided text describes the non-clinical testing performed on the "6F Wallaby Long Sheath" to demonstrate substantial equivalence to a predicate device, the "Neuron MAX System." This document does not describe the evaluation of an AI/ML powered medical device. Therefore, the information requested in the prompt related to AI/ML device evaluations (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable or available in this document.
However, I can extract the acceptance criteria and reported device performance from the Design Verification Testing - Bench and Biocompatibility sections as they relate to a medical device in general.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document often states that the device "met all pre-defined acceptance criteria" or "demonstrated similar results to the predicate," rather than providing specific numerical acceptance thresholds. Where quantitative results are provided, they are included.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| Visual Inspection | Visual inspection requirements met. | The device met all pre-defined acceptance criteria. |
| Dimensional Inspection (ID, OD, overall length, working length, coating length) | Dimensional requirements met. | The subject device met all pre-defined acceptance criteria. |
| Simulated Use | Device performs as intended with compatibility with 6F and 8F catheters, RHV, guidewire, and stent retriever. | The device performed as intended. |
| Physician Validation | Device performs as intended and is comparable to predicate for preparation, 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 Forces | Similar forces to predicate required to deliver and retrieve with ancillary devices. | Demonstrated similar forces to the predicate device. |
| Tip Stiffness | Similar tip stiffness to predicate. | Tip stiffness is similar to the predicate. |
| Tensile Strength (distal shaft, proximal hub) | Met minimum tensile requirement. | Met the minimum tensile requirement. |
| Elongation to Failure (shaft) | Met pre-defined acceptance criteria. | Met all pre-defined acceptance criteria. |
| Torque Strength | Similar torque strength to predicate. | Torque strength is similar to the predicate device. |
| Coating Integrity | No visible defects or irregularity after particulate testing. | No visible defects or sign of irregularity were observed. |
| Coating Lubricity | Similar frictional forces to predicate. | Demonstrated similar results between the subject device and the predicate device. |
| Catheter Dynamic/Static Burst, Leak (Liquid/Air) | Compatible with accessories per ISO 10555-1. | Compatible with accessories per ISO 10555-1. |
| Kink Resistance | Met acceptance criteria for resistance to kinking around bends with clinically relevant radii at specific locations. | Met the acceptance criteria. |
| Particulate | Comparable number of particulates to predicate; met acceptance criteria. | The number of particulates was comparable to the predicate. The device met the acceptance criteria. |
| Corrosion Resistance | Met acceptance criteria per ISO 10555-1. | Met the acceptance criteria. |
| Insertion and Retrieval Forces (with dilator) | Similar forces to predicate. | Demonstrated similar forces for the subject device and the predicate device. |
| Radiopacity | Marker band visible under fluoroscopy; similar to predicate. | Demonstrated results similar to the predicate device. |
| Sterilization & Shelf Life | ||
| Sterility Assurance Level (SAL) | 10^-6 | SAL of 10^-6 achieved in accordance with ISO 11135:2014. |
| Shelf Life | Device and packaging functional for 12 months with packaging integrity, seal strength, and device functionality maintained. | Established that the device and its packaging remains functional for the 12-month shelf life, meeting acceptance criteria. |
| Biocompatibility (Sheath - 100 cm model) | ||
| MTT – L-929 Cytotoxicity Study | Viability ≥ 70%. | Viability ≥ 70%; 80-91%. (Non-cytotoxic) |
| ISO Intracutaneous Irritation | Difference between average scores of test article extract and vehicle control is 0. | Difference between average scores is 0. (Non-irritant) |
| ISO Guinea Pig Maximization Sensitization | Test and control animals' responses not greater than "0". | Test and control animals' responses are not greater than "0". (Non-sensitizing) |
| ISO Acute Systemic Toxicity | No abnormal clinical signs indicative of toxicity for 72 hours; all animals alive at 72 hours; body weight changes within acceptable parameters. | No abnormal clinical signs, all animals alive, body weight changes within acceptable parameters. (Non-toxic) |
| ISO Material Mediated Rabbit Pyrogen | No rabbit temperature rise ≥ 0.5°C. | No rabbit temperature rise ≥ 0.5°C. (Non-pyrogenic) |
| Complement Activation - SC5b-9 Assays | Results within acceptable range compared to comparator device. | Results within acceptable range as compared to the comparator device. (Similar complement activation to comparator) |
| ASTM Hemolysis - Direct Contact and Extract Method | Hemolytic index below threshold for non-hemolytic. | Blank corrected Hemolytic index: 0.4, 0.1. (Non-hemolytic) |
| Platelet and Leukocyte counts | Counts within acceptable ranges and comparable to Control Device. | Ranges/levels within acceptable range and comparable to Control Device. |
| Partial Thromboplastin Time (PTT) | Similar performance to predicate devices. | Test and predicate devices have similar performance. (Not an activator of intrinsic coagulation) |
| Thromboresistance Evaluation | No adverse effects or clinical signs; no thrombus score > 3 for test or control device. | No adverse effects/clinical signs, no thrombus score > 3. (Thrombogenic risk similar to control) |
| Biocompatibility (Dilator) | ||
| MTT – L-929 Cytotoxicity Study | Viability ≥ 70%. | Viability ≥ 70%; 79.8%. (Non-cytotoxic) |
| ISO Intracutaneous Irritation | Difference between average scores of test article extract and vehicle control is 0. | Difference between average scores is 0. (Non-irritant) |
| ISO Guinea Pig Maximization Sensitization | Test and control animals' responses not greater than "0". | Test and control animals' responses not greater than "0". (Non-sensitizing) |
| ISO Acute Systemic Toxicity | No abnormal clinical signs indicative of toxicity for 72 hours; all animals alive at 72 hours; body weight changes within acceptable parameters. | No abnormal clinical signs, all animals alive, body weight changes within acceptable parameters. (Non-toxic) |
| ISO Material Mediated Rabbit Pyrogen | No rabbit temperature rise ≥ 0.5°C. | No rabbit temperature rise ≥ 0.5°C. (Non-pyrogenic) |
| Complement Activation - SC5b-9 Assays | Results within acceptable range compared to negative reference material. | Results within acceptable range as compared to the negative reference material. (Non-activator of complement system) |
| ASTM Hemolysis - Direct Contact and Extract Method | Hemolytic index below threshold for non-hemolytic. | Blank corrected Hemolytic index: 0.3, 0.5. (Non-hemolytic) |
| Thromboresistance Evaluation | No adverse effects or clinical signs during test period; no thrombus score > 3 for test or control device. | No adverse effects/clinical signs, no thrombus score > 3. (Thrombogenic risk similar to control device) |
| Biocompatibility (RHV) | ||
| Cytotoxicity MEM Elution | Cytotoxic Score: 0; 0% Cell Lysis. | Percent Cell Lysis: 0%; Cytotoxic Score: 0. (Non-cytotoxic) |
| ISO Intracutaneous Irritation | Difference between average scores of test article extract and vehicle control is 0. | Difference between average scores is 0. (Non-irritant) |
| ISO Guinea Pig Maximization Sensitization | Test and control animals' response not greater than "0". | Test and control animals' response not greater than "0". (Non-sensitizing) |
| ISO Acute Systemic Toxicity | No abnormal clinical signs indicative of toxicity for 72 hours; all animals alive at 72 hours; body weight changes within acceptable parameters. | No abnormal clinical signs, all animals alive, body weight changes within acceptable parameters. (Non-toxic) |
| ISO Material Mediated Rabbit Pyrogen | No rabbit temperature rise ≥ 0.5°C. | No rabbit temperature rise ≥ 0.5°C. (Non-pyrogenic) |
| ASTM Hemolysis - Direct Contact and Extract Method | Hemolytic index below threshold for non-hemolytic. | Blank corrected Hemolytic index: 0.0, 0.1. (Non-hemolytic) |
For the following points, the information is not applicable to this document as it details the clearance of a non-active, surgically invasive device (a vascular catheter), not an AI/ML powered device.
- Sample size used for the test set and the data provenance: Not applicable. Data provenance is not relevant for bench and biological testing of this type of device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Physician Validation" involved physicians but their exact number or role in "ground truth" establishment (which is an AI/ML concept) is not detailed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth as typically defined for AI/ML evaluations is not relevant here. The ground truth for device performance is based on established engineering principles, ISO standards, and comparison to a legally marketed predicate device.
- The sample size for the training set: Not applicable. There is no AI/ML training set.
- How the ground truth for the training set was established: Not applicable. There is no AI/ML training set.
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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
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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
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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 Medical22901 Mill Creek DriveLaguna 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 forUse | The Neuron MAX System isindicated for the introduction ofinterventional devices into theperipheral, coronary, and neurovasculature. | The 6F Wallaby Long Sheath isindicated for the introductionof interventional devices intothe peripheral and neurovasculature. | The 6F Wallaby Long Sheath isnot indicated for use in thecoronary vasculature. |
| MaterialsShaft | |||
| Extrusions | Outer layer:Polyurethane, polyamideInner layer:PTFE | Outer layer:Neusoft (polyurethane),PEBAX, polyamide, PETInner layer:PTFE | Both device materials arebiocompatible, designed to beused in the vasculature. |
| WireReinforcement | Stainless Steel | Stainless Steel and Nitinol | |
| Components | |||
| Hub | Polyamide | Polyamide | SAME |
| Coating | Hydrophilic Coating | Hydrophilic Coating | The subject device materials arebiocompatible and designed tobe used in vasculature. |
| Strain Relief | Stainless Steel | Pebax | biocompatible and designed tobe used in vasculature. |
| Colorant | Clear/Natural or Blue | Clear/Natural or Purple | The subject device colorantsare biocompatible. |
| Marker Band | C-cut Pt/Ir Band | C-cut Pt/Ir Band | SAME |
| TipConfiguration | Straight and multipurpose | Straight and multipurpose | SAME |
| Accessories | |||
| Dilator | HDPE | HDPE | SAME |
| RotatingHemostasisValve (RHV) | Not included | Polycarbonate, Silicone,Silicone Lubricant | The RHV materials arebiocompatible. |
| Dimensions | |||
| Shaft | |||
| Proximal OD | 0.110 in | 0.105 in | Both devices are evaluated toachieve proper placementduring advancement. |
| Distal OD | 0.105 in | 0.105 in | achieve proper placementduring advancement. |
| Proximal ID | 0.088 in | 0.088 in | SAME |
| Distal ID | 0.088 in | 0.088 in | SAME |
| EffectiveLength | 80-100 cm | 80-100 cm | SAME |
| Coating Length | 12 cm | 14 cm | Both devices are evaluated toachieve proper placementduring advancement. |
| Accessories | |||
| Dilator ID | 0.039 in Min | 0.039 in Min | SAME |
| Dilator OD | 0.085 in Max | 0.087 in Max | Both devices are evaluated forthe insertion and removal ofthe dilator from the sheath. |
| Device Name | Predicate Device:Neuron MAX System | Subject Device:6F Wallaby Long Sheath | Rationale for Difference |
| Packaging Material | |||
| Pouch | PET/PE/Tyvek Pouch | PA/Tyvek pouch | Packaging materials are similarand common for medicaldevices. Both packagingconfigurations maintainsterility of the devicethroughout the shelf life. |
| Tubing | HDPE | HDPE | SAME |
| Packaging Card | Polyethylene | Polyethylene | SAME |
| Display Carton | SBS Paperboard | SBS Paperboard | SAME |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | SAME |
| How Supplied | Sterile, Single Use | Sterile, Single Use | SAME |
| Shelf Life | 36 Months | 12 months | A 12-month shelf life wasvalidated for the subjectdevice. |
Table 1: 6F Wallaby Long Sheath Technological Comparison to Neuron MAX System
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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. |
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| 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 StaticBurst (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.
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Table 3: Biocompatibility Testing
| Test | Results | Conclusion |
|---|---|---|
| Sheath (100 cm model) | ||
| MTT – L-929 Cytotoxicity Study | 1X MEM test extract showed no cytotoxic potential toL-929 mouse fibroblast cells undiluted or at anydilution; viability ≥ 70%; 80-91%. | Non-cytotoxic |
| ISO Intracutaneous Irritation | The difference between the average scores of the testarticle extract and the vehicle control are: 0; 0. | Non-irritant |
| ISO Guinea Pig Maximization Sensitization | Test and control animals' responses are not greaterthan "0". | Non-sensitizing |
| ISO Acute Systemic Toxicity | No abnormal clinical signs indicative of toxicity wereobserved for 72 hours. All animals were alive at theend of 72 hours and body weight changes were withinacceptable parameters. | Non-toxic |
| ISO Material Mediated Rabbit Pyrogen | No rabbit temperature rise ≥ 0.5°C. | Non-pyrogenic |
| Complement Activation - SC5b-9 Assayswith Sponsor-Supplied Comparison | Results within acceptable range as compared to thecomparator device. | The test articlecomplement activationwas similar to thecomparator device |
| ASTM Hemolysis - Direct Contact andExtract Method | Blank corrected Hemolytic index: 0.4, 0.1. | Non-hemolytic |
| Platelet and Leukocyte counts | No ranges or levels outside an acceptable range andcomparable to Control Device. | Counts from subjectdevice are withinacceptable ranges and aresimilar to the control |
| Partial Thromboplastin Time (PTT) | Test and predicate devices have similar performance. | The test article is notconsidered an activator ofthe intrinsiccoagulation pathway |
| Thromboresistance Evaluation | No adverse effects or clinical signs during test periodand no thrombus score > 3 for either test or controldevice. | Thrombogenic riskpotential similar tothe control device |
| Dilator | ||
| MTT – L-929 Cytotoxicity Study | 1XMEM test extract showed no cytotoxic potential toL-929 mouse fibroblast cells undiluted or at anydilution; viability ≥70%; 79.8%. | Non-cytotoxic |
| ISO Intracutaneous Irritation | The difference between the average scores of the testarticle extract and the vehicle control are: 0; 0. | Non-irritant |
| ISO Guinea Pig Maximization Sensitization | Test and control animals' responses are not greaterthan "0". | Non-sensitizing |
| ISO Acute Systemic Toxicity | No abnormal clinical signs indicative of toxicity wereobserved for 72 hours. All animals were alive at theend of 72 hours and body weight changes werewithin acceptable parameters. | Non-toxic |
| ISO Material Mediated Rabbit Pyrogen | No rabbit temperature rise ≥ 0.5°C. | Non-pyrogenic |
| Complement Activation - SC5b-9 Assayswith Sponsor-Supplied Comparison | Results within acceptable range as compared to thenegative reference material. | Non-activator ofcomplement system |
| ASTM Hemolysis - Direct Contact andExtract Method | Blank corrected Hemolytic index: 0.3, 0.5. | Non-hemolytic |
| Thromboresistance Evaluation | No adverse effects or clinical signs during test periodand 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 andExtract Method | Blank corrected Hemolytic index: 0.0, 0.1. | Non-hemolytic |
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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.
§ 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).