(330 days)
The Esperance Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
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.
The provided document is a 510(k) Substantial Equivalence Determination letter from the FDA for a medical device called the "Esperance Distal Access Catheter." It details non-clinical performance testing but does not include information about a study proving device performance against acceptance criteria in the context of an AI/ML-driven device or human-in-the-loop performance.
Specifically, the document states:
- "Animal data were not deemed necessary as substantial equivalence was established based upon successful completion of non-clinical bench testing."
- "A clinical study was not deemed necessary as substantial equivalence was established based upon successful completion of non-clinical bench testing."
Therefore, I cannot extract the requested information points related to a study proving the device meets acceptance criteria for an AI/ML device, as such a study was not performed or detailed in this submission. The tests listed are primarily engineering bench tests for a physical catheter, not AI model validation.
However, I can extract the acceptance criteria for the physical device's performance from the "NON-CLINICAL PERFORMANCE DATA" section.
Here's what I can provide based on the document:
1. A table of acceptance criteria and the reported device performance (for non-clinical bench tests):
| Test | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| 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) | Requirements were met. | The device met all pre-defined acceptance criteria. |
| Simulated Use | Performs as intended, meets pre-defined acceptance criteria for: preparation/ease of assembly, introducer sheath interaction, introducer peel away, compatibility with guidewire/microcatheter, lubricity and durability of hydrophilic coating, and kink resistance. | Device performs as intended and met all pre-defined acceptance criteria under simulated use conditions. (Supplemented by additional testing beyond reference device, K211697) |
| Physician Validation* | Performs as intended under simulated use conditions. | Device performs as intended under simulated use conditions. |
| Delivery and Retrieval Forces | Meets pre-defined acceptance criteria in a vascular model under simulated use conditions. | Met all pre-defined acceptance criteria. (Supplemented by additional testing beyond reference device, K211697) |
| Tip Stiffness* | Meets acceptance criteria when deflected on a universal testing machine. | Met acceptance criteria. |
| Tip Shaping* | Meets pre-defined acceptance criteria when shaped with shaping mandrel and steam. | Met the pre-defined acceptance criteria. |
| System Tensile* (Hub, Shaft, Tip) | Meets the minimum tensile requirement. | The device met all predefined acceptance criteria. |
| Elongation to Failure* | Met all pre-defined acceptance criteria, obtained from shaft tensile testing data. | The device met all pre-defined acceptance criteria. |
| Torque Strength* | Meets the predefined acceptance criteria in a vascular model. | Met the predefined acceptance criteria. |
| Coating Integrity (after particulate testing) | Meets all pre-defined acceptance criteria (inspected pre- and post-insertion and retrieval through a vascular model). | The device coating integrity was inspected pre- and post-insertion and retrieval through a vascular model and met all pre-defined acceptance criteria. (Supplemented by additional testing beyond reference device, K211697) |
| Coating Lubricity* | Meets all pre-defined acceptance criteria from frictional forces on a universal testing machine. | Met all pre-defined acceptance criteria. |
| Catheter Burst, Leak (Liquid and Air) | Does not leak, burst, and is compatible with accessories per ISO 10555-1 and meets acceptance criteria. | Met acceptance criteria. (Supplemented by additional testing beyond reference device, K211697) |
| Kink Resistance* | Meets acceptance criteria for resistance to kinking around bends with clinically relevant radii. | Met acceptance criteria. |
| Particulate | Any particulate generated is comparable to cleared comparator devices and meets acceptance criteria. | The device met acceptance criteria. (Supplemented by additional testing beyond reference device, K211697) |
| Corrosion Resistance* | Is corrosion resistant per ISO 10555-1. | The catheter is corrosion resistant per ISO 10555-1. |
| Radiopacity* | Meets the pre-defined acceptance criteria for marker band visibility under fluoroscopy. | Met the pre-defined acceptance criteria. |
| Luer Hub Testing* | Meets the pre-defined specifications per ISO 80369-7 and ISO 80369-20. | Met the pre-defined specifications. |
For the remaining points, the document explicitly states that clinical or animal studies were not deemed necessary beyond the non-clinical bench testing for this specific device (a physical catheter). Therefore, the following information cannot be provided from the given text:
- Sample sized used for the test set and the data provenance: Not applicable for an AI/ML context, as no such test set was described. Bench tests were performed on physical units, but specific sample sizes for each test are not listed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML system is not relevant to this physical device's non-clinical bench testing. "Physician Validation" was mentioned, but no details on the number or qualifications of physicians, nor their role in establishing a ground truth for an AI system.
- 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, as this is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for an AI/ML system. Ground truth in this context would refer to the reference standards for the physical tests (e.g., precise measurements, material specifications, functional performance during simulated use).
- The sample size for the training set: Not applicable, as there is no AI/ML training set.
- How the ground truth for the training set was established: Not applicable, as there is no AI/ML training set.
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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).
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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
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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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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.
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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 AccessCatheter | Esperance® Aspiration CatheterSystem |
| 510(k) number | K182097 | K231056 | K211697 |
| ProductClassification | Class II | Class II | Class II |
| RegulationNumber | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 |
| RegulationName | Percutaneous Catheter | Catheter, Percutaneous,Neurovasculature | Catheter, Thrombus Retriever |
| Product Code | DQY | QJP, DQY | NRY |
| IntendedUse/Indicationsfor Use | The React™ 71 Catheter isindicated for theintroduction ofinterventional devices intothe peripheral and neurovasculature. | The Esperance Distal AccessCatheter is indicated for theintroduction of interventionaldevices into the peripheraland neuro vasculature. | The Esperance AspirationCatheter with the MedelaDominant Flex Surgical SuctionPump and Wallaby AspirationTubing set is intended for use inthe revascularization ofpatients with acute ischemicstroke secondary to intracraniallarge vessel occlusive disease(within internal carotid, middlecerebral - M1 and M2segments, basilar, andvertebral arteries) within 8hours of symptom onset.Patients who are ineligible forintravenous tissue plasminogenactivator (IV t-PA) or who fail IVt-PA therapy are candidatesfor treatment. |
| Accessories | Peelable Sheath | Peelable Sheath,Shaping Mandrel | Peelable Sheath,Shaping Mandrel |
| Dimensions | |||
| WorkingLength | 132 cm | 115 cm125 cm131 cm | 115 cm125 cm131 cm |
| Proximal OuterDiameter (OD) | 0.0855 in (Max) | 5F: 0.069 in Max6F: 0.084 in Max | 5F: 0.069 in Max6F: 0.084 in Max |
| Distal OD | 0.0855 in (Max) | 5F: 0.065 in Max6F: 0.084 in Max | 5F: 0.065 in Max6F: 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 (polyurethaneelastomer), Pebax (polyetherblock amide), Vestamid(polyamide) | Tecothane (polyurethaneelastomer), Pebax (polyetherblock amide),Vestamid (polyamide) |
| Marker Band | Platinum/Iridium | Platinum/Iridium | Platinum/Iridium |
| Adhesive | Cyanoacrylate | Cyanoacrylate | Cyanoacrylate |
| Coating | Hydrophilic | Hydrophilic | Hydrophilic |
| PackagingConfiguration | Pouch, Packaging Card,Packaging Hoop | Pouch, Packaging Card,Packaging Hoop | Pouch, Packaging Card,Packaging Hoop |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| HowSupplied | 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 inspectionrequirements were met. The device met all pre-defined acceptancecriteria. |
| Dimensional Inspection* (ID, OD,Overall Length, Working Length,Coating Length, Distal Tip toMarker Band, Hub/Strain ReliefLength) | The device was evaluated to verify the dimensional requirementswere 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 CatheterSystem (K211697), was used and supplemented with additionaltesting conducted to support the intended use of the subjectEsperance Distal Access Catheter. Device performs as intended andmet all pre-defined acceptance criteria under simulated useconditions. | |
| Physician Validation* | The device was evaluated in a simulated anatomy model byphysicians. Device performs as intended under simulated useconditions. |
| Delivery and Retrieval Forces | The device was subjected to delivery and retrieval forces testing in avascular model under simulated use conditions and met all pre-defined acceptance criteria. Testing of the reference device,Esperance Aspiration Catheter System (K211697), was used andsupplemented with additional testing conducted to support theintended use of the subject Esperance Distal Access Catheter. |
| Tip Stiffness* | The device tip was deflected on a universal testing machine and metacceptance criteria. |
| Tip Shaping* | The device tip was shaped with the shaping mandrel and steamand met the pre-defined acceptance criteria. |
| System Tensile* (Hub, Shaft, Tip) | The device was evaluated to verify the tensile strength of the fullsystem meets the minimum tensile requirement. The device met allpredefined acceptance criteria. |
| Elongation to Failure* | The device elongation was obtained from the shaft tensile testingdata. The device met all pre-defined acceptance criteria. |
| Torque Strength* | The device torque response was assessed in a vascular model andmet the predefined acceptance criteria. |
| Coating Integrity (after particulatetesting) | Testing of the reference device, Esperance Aspiration CatheterSystem (K211697), was used and supplemented with additionaltesting conducted to support the intended use of the subjectEsperance Distal Access Catheter. The device coating integrity wasinspected pre- and post-insertion and retrieval through a vascularmodel and met all pre-defined acceptance criteria. |
| Coating Lubricity* | The device was evaluated for frictional forces on a universal testingmachine 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 metacceptance criteria. Testing of the reference device, EsperanceAspiration Catheter System (K211697) was used and supplementedwith additional testing conducted to support the intended use ofthe subject Esperance Distal Access Catheter. |
| Kink Resistance* | The device was evaluated for resistance to kinking around bendswith clinically relevant radii and met acceptance criteria. |
| Particulate | The device was evaluated within a simulated anatomy model toverify that any particulate generated is comparable to clearedcomparator devices. The device met acceptance criteria.Testing of the reference device, Esperance Aspiration CatheterSystem (K211697) was used and supplemented with additionaltesting conducted to support the intended use of the subjectEsperance Distal Access Catheter. |
| Corrosion Resistance* | The catheter is corrosion resistant per ISO 10555-1. |
| Radiopacity* | The device was evaluated for marker band visibility underfluoroscopy and met the pre-defined acceptance criteria. |
| Luer Hub Testing* | The device was evaluated per ISO 80369-7 and ISO 80369-20 andmet the pre-defined specifications. |
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@ Wallaby Medical
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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.
§ 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).