(239 days)
The AltaTrack equipment is an imaging device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected AltaTrack Catheter and/or AltaTrack Guidewire during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of an AltaTrack Catheter and/or AltaTrack Guidewire.
The AltaTrack Guidewire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter during navigation in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.
The AltaTrack Catheter is an angiographic catheter with Fiber Optic RealShape (FORS) technology, intended to deliver radiopaque media or lead a guidewire in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.
AltaTrack equipment: The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a 3D image in real time of an AltaTrack Guidewire and/or AltaTrack Catheter and overlay it on real-time or pre-recorded 2D fluoroscopy images and/or on pre-operative 3D CT images, if available. The AltaTrack equipment comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component.
AltaTrack Guidewire: The AltaTrack Guidewire is a single-use, sterile, hydrophilic guidewire with FORS technology. The primary function of the AltaTrack Guidewire is to direct an AltaTrack Catheter or other compatible catheter to a desired anatomical location. It can be visualized in 3D in real time by the AltaTrack equipment using FORS technology.
AltaTrack Catheter: The AltaTrack Catheter is a single-use, sterile, angiographic catheter with FORS technology. Its primary function is to deliver radiopaque media or lead an AltaTrack Guidewire or other compatible quidewire to a desired anatomical location. It can be visualized in 3D in real time by the AltaTrack equipment using FORS technology.
The provided text does not contain a table of acceptance criteria or a detailed study proving the device meets specific performance metrics in terms of accuracy or efficacy. The document focuses on establishing substantial equivalence to predicate devices through various performance tests, but it does not specify quantitative acceptance criteria for image quality, tracking accuracy, or diagnostic performance of the AltaTrack equipment like a typical AI/ML device submission would.
Instead, the document primarily describes compliance with recognized standards and verification tests for mechanical, electrical, and biological safety, as well as usability and basic functionality. It emphasizes that no clinical testing was required because substantial equivalence was demonstrated through non-clinical testing and comparison of intended use and technological characteristics.
Therefore, I cannot provide the detailed information requested in the format of a table of acceptance criteria and reported device performance directly from this document. The document confirms that "all norm-compliance, verification and validation tests have been used to support substantial equivalence of the subject devices and to demonstrate that the AltaTrack devices: comply with the aforementioned international and FDA recognized consensus standards and FDA guidance documents; and meet the acceptance criteria and are adequate for their intended use." However, it does not explicitly list these "acceptance criteria" in a quantitative, measurable format for device performance (e.g., specific accuracy percentages, resolution in mm, etc.).
Here's what can be extracted based on the provided text, addressing some of your points but highlighting the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria (General): The document states that the AltaTrack devices "meet the acceptance criteria and are adequate for their intended use." However, these specific criteria are not quantitatively defined in the provided text for metrics like imaging accuracy, tracking precision, etc. Instead, acceptance is predicated on passing various normative and verification tests related to safety, usability, and functionality. E.g., for norm-compliance, the acceptance criterion is simply "passed" the respective standard.
- Reported Device Performance: Similarly, specific quantitative performance data (e.g., 3D image resolution, tracking accuracy in mm, etc.) are not provided in this summary. The results are reported as "all executed verification tests have been passed," "all relevant tests... have been passed," and "Results demonstrated all study endpoints were met" for animal/phantom testing.
2. Sample Size for Test Set and Data Provenance
- Test Set (Non-clinical Validation):
- Animal and Phantom Testing: A "team of vascular surgeons and interventional radiologists" conducted tests with "live animal and phantom." No specific sample size (number of animals, number of phantom models) is provided.
- Human Factors Validation Testing: Performed by "teams of intended user groups." Each team comprised "a physician (interventional radiologist or vascular surgeon), and two OR staff members." No total number of teams or individual participants is specified.
- Data Provenance:
- Animal and Phantom Testing: No specific country of origin is mentioned beyond "a simulated clinical environment."
- Human Factors Validation Testing: Conducted "in a simulated clinical environment in the United States."
- Retrospective/Prospective: The testing described appears to be prospective validation for the purpose of regulatory submission.
3. Number of Experts and Qualifications for Ground Truth
- Animal and Phantom Testing: "A team of vascular surgeons and interventional radiologists." Specific number of individuals is not stated. Their qualifications are implied by their titles.
- Human Factors Validation Testing: "A physician (interventional radiologist or vascular surgeon), and two OR staff members" per team. Specific numbers for the overall study not provided.
- Establishing Ground Truth: The document does not describe the establishment of a "ground truth" in the typical sense of a diagnostic AI/ML study (e.g., using expert consensus for disease presence). Instead, these experts participated in validation of the device's functionality and usability against its intended use requirements. For the FORS technology, the "ground truth" for the device's intended function (creating a 3D image in real time) would be inherent in the engineering verification of the optical properties and algorithms rather than expert consensus on medical images.
4. Adjudication Method for Test Set
- Not Applicable in the traditional sense. There is no mention of an adjudication method for conflicting interpretations, as the focus was on functional and usability validation rather than diagnostic performance where multiple readers might differ.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was performed or described. The document explicitly states: "No clinical testing was required as substantial equivalence was demonstrated by the attributes of intended use, technological characteristics, and non-clinical testing." Therefore, there is no information on how human readers might improve with AI assistance. The AltaTrack is an imaging/navigation aid, not an AI for diagnostic interpretation.
6. Standalone (Algorithm Only) Performance
- The AltaTrack equipment's primary function is to "create a 3D image in real time of an AltaTrack Catheter and/or AltaTrack Guidewire and overlay it on real-time or pre-recorded 2D fluoroscopy images and/or on pre-operative 3D CT images." This implies a human-in-the-loop system. The document does not provide standalone performance metrics for the algorithm in isolation from this system or human interaction (e.g., a "standalone accuracy" for tracking or shape reconstruction). The performance testing focuses on the system as a whole.
7. Type of Ground Truth Used
- The concept of "ground truth" in this submission pertains to the functional correctness, safety, and usability validation of the device, rather than a diagnostic label (e.g., disease presence).
- For norm-compliance and verification, the "ground truth" is that the device passes specific, predefined technical and safety standards (e.g., electrical safety, biocompatibility, sterilization efficacy).
- For animal and phantom testing, the "ground truth" is that the device enables the intended positioning and navigation in a simulated clinical environment as observed and assessed by the medical team, meeting "study endpoints" (which are not detailed but are likely related to successful navigation and visualization).
- For human factors validation, the "ground truth" is that the user interface is "safe and effective for the intended users, uses and use environments," determined through observation of task completion and interviews.
8. Sample Size for Training Set
- Not applicable/Not mentioned. This device is described as an "imaging device with Fiber Optic RealShape (FORS) technology" and a "Programmable diagnostic computer," but the text does not indicate that it uses machine learning/AI models that require a separate "training set" of data in the common sense for diagnostic image analysis. The technology is based on Fiber Optic RealShape, which is a sensing technology, not explicitly an AI/ML image interpretation algorithm requiring a training dataset derived from clinical cases. If there are internal models that were "trained," the nature and size of that training data are not disclosed in this regulatory summary.
9. How Ground Truth for Training Set was Established
- Not applicable/Not mentioned (see point 8).
In summary, this 510(k) submission focuses on demonstrating substantial equivalence through compliance with safety standards and functional/usability validation, rather than providing quantitative performance metrics for an AI/ML algorithm used for diagnostic interpretation.
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December 17, 2020
Philips Medical System Nederland B.V. Gert De Vries Senior Regulatory Affairs Manager Veenpluis 4-6 Best, Noord-Brabant 5684 PC Netherlands
Re: K201081
Trade/Device Name: AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQK, DQX, DQX, DQO Dated: November 10, 2020 Received: November 16, 2020
Dear Gert De Vries:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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
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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 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 (OS) 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 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,
Carmen Gacchina Johnson, Ph.D. Assistant Director DHT2B: Division of Circulatory Support, Structural & Vascular Devices Devices OHT2: Office of Cardiovascular 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) K201081
Device Name AltaTrack equipment; AltaTrack Guidewire: AltaTrack Catheter
Indications for Use (Describe)
The AltaTrack equipment is an imaging device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected AltaTrack Catheter and/or AltaTrack Guidewire during endovascular procedures of the peripheral, aortic side branch vasculature, by creating a 3D image in real time of an AltaTrack Catheter and/or AltaTrack Guidewire.
The AltaTrack Guidewire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter during navigation in endovascular procedures of the and aortic side branch vasculature.
The AltaTrack Catheter is an angiographic catheter with Fiber Optic RealShape (FORS) technology, intended to deliver radiopaque media or lead a guidewire in endovascular procedures of the peripheral, aortic side branch 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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510(K) SUMMARY
This 510(k) summary has been prepared in accordance with 21 CFR 807.92.
510(k) Number: K201081
SUBMITTER INFORMATION
Submitted by: Philips Medical Systems Nederland B.V. Veenpluis 4-6, 5684 PC Best, The Netherlands
Contact Person: Gert de Vries, Senior Regulatory Affairs Manager
Telephone Number: +31 (0)6 182 06 281 Email: gert.de.vries@philips.com Date Prepared: April 16 2020
DEVICE NAME
| Device Trade Name: | AltaTrack equipment |
|---|---|
| Common Name: | Computer, diagnostic, programmable |
| Classification Name: | Programmable diagnostic computer, 21 CFR 870.1425: Class IIProduct code DQK |
| Device Trade Name: | AltaTrack Guidewire |
| Common Name: | Wire, guide, catheter |
| Classification Name: | Catheter guide wire, 21 CFR 870.1330: Class II Product code DQX |
| Device Trade Name: | AltaTrack Catheter |
| Common Name: | Catheter, intravascular, diagnostic |
| Classification Name: | Diagnostic intravascular catheter, 21 CFR 870.1200: Class IIProduct code DQO |
| PREDICATE DEVICES |
MediGuide™ Technology System Version 17.0 (K162643) AltaTrack equipment Radifocus Glidewire® (K152740) AltaTrack Guidewire
| AltaTrack Catheter | Radifocus® Optitorque™ Angiographic Catheter (K150232) |
|---|---|
| -------------------- | -------------------------------------------------------- |
DEVICE DESCRIPTION
| AltaTrack equipment | The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a 3D image in real time of an AltaTrack Guidewire and/or AltaTrack Catheter and overlay it on real-time or pre-recorded 2D fluoroscopy images and/or on pre-operative 3D CT images, if available.The AltaTrack equipment comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component. |
|---|---|
| --------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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- AltaTrack Guidewire The AltaTrack Guidewire is a single-use, sterile, hydrophilic guidewire with FORS technology. The primary function of the AltaTrack Guidewire is to direct an AltaTrack Catheter or other compatible catheter to a desired anatomical location. It can be visualized in 3D in real time by the AltaTrack equipment using FORS technology. AltaTrack Catheter The AltaTrack Catheter is a single-use, sterile, angiographic catheter with FORS technology. Its primary function is to deliver radiopaque media or lead an AltaTrack Guidewire or other compatible quidewire to a desired anatomical location. It can be visualized in 3D in real time by the AltaTrack
INDICATIONS FOR USE
AltaTrack equipment The AltaTrack equipment is an imaging device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected AltaTrack Catheter and/or AltaTrack Guidewire during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of an AltaTrack Catheter and/or AltaTrack Guidewire.
equipment using FORS technology.
- The AltaTrack Guidewire is an angiographic guidewire with Fiber Optic AltaTrack Guidewire RealShape (FORS) technology, intended to direct a catheter during navigation in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.
The AltaTrack Catheter is an angiographic catheter with Fiber Optic AltaTrack Catheter RealShape (FORS) technology, intended to deliver radiopaque media or lead a quidewire in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.
TECHNOLOGICAL CHARACTERISTICS
The proposed AltaTrack equipment and the predicate MediGuide™ Technology AltaTrack equipment System Version 17.0 (K162643) have fundamentally the same intended use. The AltaTrack equipment and the predicate MediGuide™ Technology System both enable real time positioning and navigation for (minimally) invasive device(s) in peripheral endovascular interventions. Both support their own technology equipped quidewire(s) and catheter(s). The tracking technology deployed with AltaTrack equipment is Fiber Optic RealShape (FORS) technology to visualize the shape of the invasive devices over their entire length. The predicate device deploys Electromagnetic (E/M) sensing technology, which is typically used to visualize the distal tip of the invasive devices. The technological difference does not raise any new questions regarding safety and effectiveness
Table below provides a device comparison between the subject AltaTrack equipment and the predicate MediGuide™ Technology System Version 17.0 (K162643).
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| Attribute | Proposed device | Predicate device | |||
|---|---|---|---|---|---|
| Name | AltaTrack equipment | MediGuide™ TechnologySystem Version 17.0(K162643) | |||
| Manufacturer | Philips Medical Systems | St. Jude Medical | |||
| Product code | DQK | DQK | |||
| Classification | II | II | |||
| Indications for use | The AltaTrack equipment isan imaging device withFiber Optic RealShape(FORS) technologyintended to aid thepositioning and navigationof a connected AltaTrackCatheter and/or AltaTrackGuidewire duringendovascular procedures ofthe peripheral, aortic andaortic side branchvasculature, by creating a3D image in real time of anAltaTrack Catheter and/orAltaTrack Guidewire. | The MediGuide™Technology system isintended for the evaluationof vascular and cardiacanatomy. It is intended toenable real time tippositioning and navigationof a MediGuide Enabled™/ Sensor Enabled ™(equipped with a magneticsensor) invasive deviceused in vascular or cardiacinterventions in the CathLab environment, on bothlive fluoroscopy orrecorded background. TheSystem is indicated for useas an adjunct tofluoroscopy. | |||
| Patientpopulation | Patients eligible forendovascular procedures. | Patients eligible forvascular or cardiacinterventional procedures. | |||
| Applicationarea | Peripheral, aortic and aorticside branch | Vascular or cardiacinterventions | |||
| Clinicalenvironment | In the control room and inthe exam room of aninterventional suite orhybrid operating room. | In the control room and inthe exam room of aninterventional suite orhybrid operating room. | |||
| Adjunctdevices | Used in conjunction withfluoroscopy | Used in conjunction withfluoroscopy | |||
| Summary ofdevicedescription | AltaTrack equipmentconsists of hardware andsoftware elements, whichare installed in conjunctionwith an interventional X-raysystem. The interventionalsystem continues toperform safely andeffectively per its intendeduse, while enablingenhanced anatomicalcontext visualization andinvasive devicevisualization. | MediGuide™ TechnologySystem consists ofhardware and softwareelements, which areinstalled in conjunctionwith the existingfluoroscopy ImagingSystem in a Cath Lab. Theconventional fluoroscopyImaging System, equippedwith MediGuide TMTechnology elements,continues to performsafely and effectively perits intended use asfluoroscopic imagingdevice, while enablingdevice tracking andenhanced visualizationtools supplied byMediGuide™ Technologycapabilities. | |||
| Technologyfor invasivedevice | visualization | Fiber-Optic RealShape(FORS) technology. | Electro-magnetic (E/M)sensing technology. | ||
| Trackedinvasive | AltaTrack CatheterAltaTrack Guidewire | Variety of MediGuideEnabled™ /Sensor |
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| device | Enabled™ catheters, guidewires |
|---|---|
| -------- | -------------------------------- |
AltaTrack Guidewire The AltaTrack Guidewire and the predicate Radiofocus Glidewire (K152740) have the same intended use. The AltaTrack Guidewire and the predicate device are both designed for use in peripheral endovascular procedures, with similarities including mechanical handling properties, radiopacity, sterilization method and packaging design. Contrary to the predicate device, the AltaTrack Guidewire contains a fiberoptic sensor, which enables it to be visualized using FORS technology. The technological difference does not raise any new questions regarding safety and effectiveness.
The table below provides a device comparison between the subject AltaTrack Guidewire and the predicate Radifocus Glidewire (K152740).
| Attribute | Proposed deviceAltaTrack Guidewire | Predicate deviceRadifocus Glidewire(K152740) |
|---|---|---|
| Name | AltaTrack Guidewire | Radifocus Glidewire(K152740) |
| Manufacturer | Philips Medical Systems | Terumo Corporation |
| Product code | DQX | DQX |
| Classification | II | II |
| Indications forUse | The AltaTrack Guidewire isan angiographic guidewirewith Fiber OpticRealShape (FORS)technology, intended todirect a catheter duringnavigation in endovascularprocedures of theperipheral, aortic andaortic side branchvasculature. | The Glidewire isdesigned to direct acatheter to the desiredanatomical location inthe peripheralvasculature duringdiagnostic orinterventionalprocedures.This device is notintended forneurovascular orcoronary interventions. |
| Site in thebody | Peripheral, aortic andaortic side branchvasculature | Peripheral vasculature |
| Operationprinciple | Manual | Manual |
| Specifications | Wire diameter: 0.035"Device length (in-bodysection): 120 cm | Wire diameter: 0.035"Device length: 260, 300,350, 400, and 450 cm.Note that K152740extends the workinglength of its predicate(K863138), which haslengths from 30-300cm.Lengths of the flexiblepart of the distal tip: 3and 5 cm.Distal tip shape: straightand angledShaft configurations:standard and stiff |
| Length of the flexible partof the distal tip: 3 cmDistal tip shape: angledShaft configuration:standard | ||
| PackagingConfiguration | Individual package, unitbox, shipping carton. | Individual package, unitbox, shipping carton. |
| SterilizationMethod | Ethylene Oxide (EO) | EO |
| Attribute | Proposed device | Predicate device |
| Name | AltaTrack Catheter | Radifocus® Optitorque™ |
| Angiographic Catheter | ||
| Manufacturer | Philips Medical Systems | Terumo Corporation |
| Product code | DQO | DQO |
| Classification | II | II |
| Indications for | The AltaTrack Catheter is | The Radifocus Optitorque |
| use | an angiographic catheter | Angiographic Catheter is |
| with Fiber Optic RealShape | indicated for use in cardiac | |
| (FORS) technology, | and vascular procedures. It | |
| intended to deliver | is designed to deliver | |
| radiopaque media or lead a | radiopaque media, guide | |
| guidewire in endovascular | wires, catheters, and | |
| procedures of the | therapeutic agents to | |
| peripheral, aortic and aortic | selected sites in the vascular | |
| side branch vasculature. | system. The different shapes | |
| are designed to selectively | ||
| engage arteries from access | ||
| sites such as the femoral, | ||
| radial, and brachial artery. | ||
| Application | Peripheral, aortic and aortic | Selected sites in the vascular |
| area | side branch | system. |
| Operation | Manual | Manual |
| principle | ||
| Specifications | Outer / Inner Diameter: | Outer / Inner Diameter: |
| 5.5 Fr / 0.99mm | • 4 Fr / 1.05mm | |
| • 5 Fr / 1.22mm | ||
| • 6 Fr / 1.32mm | ||
| Length: 80 cm | Lengths: 65-120 cm | |
| Guidewire compatibility: | Guidewire compatibility: | |
| 0.035" | ≤0.038 " | |
| Maximum Labeled Injection | Maximum Labeled Injection | |
| Pressure: | Pressure: | |
| Not applicable for manual | • 4 Fr: 750 psi | |
| injection | • 5 Fr and 6 Fr: 1000 psi | |
| Packaging | Plastic tray | Paperboard mount |
| Individual package | Individual package | |
| Unit box | Unit box | |
| Shipping carton | Shipping carton | |
| Pouch | Pouch | |
| Sterilization | Ethylene Oxide (EO) | EO |
AltaTrack Catheter
The AltaTrack Catheter and the predicate Radifocus® Optitorque™ Angiographic Catheter (K150232) have fundamentally the same intended use. Both the AltaTrack
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Catheter and the predicate device are designed for use in peripheral endovascular procedures with similarities including mechanical handling properties, radiopacity, sterilization method and packaging design.
Contrary to the predicate device, the AltaTrack Catheter contains a fiber-optic sensor, which enables it to be visualized using FORS technology. The technological difference does not raise any new questions regarding safety and effectiveness.
The table below provides a device comparison between the subject AltaTrack Catheter and the predicate Radifocus® Optitorque™ Angiographic Catheter (K150232).
PERFORMANCE TESTING
The performance testing for AltaTrack equipment, AltaTrack Guidewire and AltaTrack Catheter consists of norm-compliance testing, design verification and validation testing. For norm-compliance and design verification, the testing was performed per subject device, while the validation, such as non-clinical validation and usability validation, were performed at system level representing a logical clinical workflow following the intended use.
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Performance testing data of the proposed devices demonstrate that the subject devices are substantially equivalent to their predicate devices, and that the design input requirements.
Norm-compliance and verification
| AltaTrackequipment | Norm-compliance performance testing has been performed on the AltaTrack equipment according to the following FDA recognized consensus standards, and were all passed: |
|---|---|
| [Rec. Number: 13-79], IEC 62304 Edition 1.1 2015 Medical device software - Software life cycle processes (Consolidated version) [Rec. Number: 5-114], IEC 62366-1:2015 Medical devices – Application of usability engineering to medical devices [Rec. Number: 5-117], ISO 15223-Thid Edition 2016, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied IEC 60601-1:2005 + A1:2012, Medical electrical equipment edition 3.1 - Part 1: General requirements for basic safety and essential performance1 [Rec. Number: 19-8], IEC 60601-1-2, Edition 4.0, 2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -- Requirements and tests [Rec. Number: 12-273], IEC 60825-1:2007 Safety of laser products - Part 1: Equipment classification and requirements [Rec. Number: 2-220], ISO 10993-1, Fourth Edition, 2009/A1:2010, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)] [Rec. Number: 2-245], ISO 10993-5 Third edition 2009, Biological evaluation of medical devices. Part 5: tests for in vitro cytotoxicity. [Rec. Number: 14-408], ANSI AAMI ISO 10993-7:2008(R) 2012, Biological evaluation of medical devices. Part 7: Ethylene oxide sterilization residuals [Rec. Number: 2-174], ANSI AAMI ISO 10993-10:2010/(R)2014, Biological evaluation of medical devices. Part 10: Tests for irritation and skin sensitization [Rec. Number: 14-529], ANSI AAMI ISO 11135:2014, Sterilization of health care products - Ethylene oxide -Requirements for development, validation and routing control of a sterilization process for medical devices [Rec. Number: 14-454], ANSI AAMI ISO 11607-1:2006/(R)2010, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barriers systems and packaging systems [Including: Amendment 1 (2014)] [Rec. Number: 14-455], ANSI AAMI ISO 11607-2:2006/(R)2010, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including: Amendment 1 (2014)] [Rec. Number:14-314], AAMI ANSI ST67:2011/(R)2017, Sterilization of healthcare products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile" | |
| Non-clinical performance testing has been performed to verify the implementation of requirements according to the system requirement specifications, as well as the implementation of identified risk control measures from risk management. The requirements categories include: "Functional Requirements", "Integration &Interoperability Requirements", "Configurations, Components and Options", "User Interface Requirements", "Service Requirements", "Manufacturing Requirements" and "Security Requirements". |
Test results demonstrated all executed verification tests have been passed.
1 Note!: the test report reflects the compliance with [Rec. Number: 19-4], AAMI ANSI 60601-1:2005/R2012 and A1:2012, c1:2009/(r) and A2:2010/(r)2012 Medical electrical equipment edition 3.1 – Part 1: General requirements for basic safety and essential performance.
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AltaTrack Guidewire and AltaTrack Catheter
Both AltaTrack Guidewire and AltaTrack Catheter are sterile, single-use devices to be used in peripheral vascular applications. There are commonalities in the list of FDA recognized consensus standards. The following standards for norm-compliance testing are applicable for both AltaTrack Guidewire and AltaTrack Catheter, and all relevant tests for both AltaTrack Guidewire and AltaTrack Catheter have been passed:
- [Rec. Number: 5-114], IEC 62366-1:2015, Medical devices Application ● of usability engineering to medical devices
- . [Rec. Number: 5-117], ISO 15223-Thid Edition 2016, Medical devices -Symbols to be used with medical device labels, labelling and information to be supplied
- [Rec. Number: 2-220], ISO 10993-1, Fourth Edition, 2009/A1:2010, ● Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]
- [Rec. Number: 2-248]. ISO 10993-4 Third edition 2017. Biological ● evaluation of medical devices. Part 4: Selection of tests for interactions with blood
- . [Rec. Number: 2-245], ISO 10993-5 Third edition 2009, Biological evaluation of medical devices. Part 5: tests for in vitro cytotoxicity.
- [Rec. Number: 2-250]. ASTM F756-17. Standard Practice for Assessment . of Hemolytic Properties of Materials
- . [Rec. Number: 14-408], ANSI AAMI ISO 10993-7:2008(R) 2012, Biological evaluation of medical devices. Part 7: Ethylene oxide sterilization residuals
- [Rec. Number:2-174], ANSI AAMI ISO 10993-10:2010/(R)2014, Biological ● evaluation of medical devices. Part 10: Tests for irritation and skin sensitization
- [Rec. Number: 2-255], ISO 10993-11 Third edition 2017, Biological evaluation of medical devices. Part 11: tests for systemic toxicity.
- [Rec. Number: 14-529], ANSI AAMI ISO 11135:2014, Sterilization of . health care products - Ethylene oxide -Requirements for development, validation and routing control of a sterilization process for medical devices
- [Rec. Number: 14-454], ANSI AAMI ISO 11607-1:2006/(R)2010, . Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barriers systems and packaging systems [Including: Amendment 1 (2014)]
- [Rec. Number: 14-455], ANSI AAMI ISO 11607-2:2006/(R)2010, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including: Amendment 1 (2014)]
- [Rec. Number: 14-314], AAMI ANSI ST67:2011/(R)2017, Sterilization of . healthcare products - Requirements and quidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
The following standards for norm-compliance testing are applicable for AltaTrack Catheter, and all the applicable tests were passed:
- [Rec. Number: 6-408], ISO 10555-1 Second Edition 2013, Sterile, single-. use intravascular catheters -- Part 1: General requirements
- [Rec. Number: 6-11], ISO 594-1:1986, Conical fittings with 6% (luer) taper ● for syringes, needles and certain other medical equipment - Part 1: General requirements
- [Rec. Number: 6-129], ISO 594-2:1998, Conical fittings with 6% (luer) . taper for syringes, needles and certain other medical equipment – Part 2: lock fittings
The following FDA guidance was also considered for AltaTrack Guidewire:
- Guidance for Industry and Food and Drug Administration Staff: Coronary, . Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, October 10, 2019
- Guidance for Industry and Food and Drug Administration Staff: ● Intravascular Catheters, Wires, and Delivery Systems with Lubricious
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Non-clinical performance testing has been performed to verify the requirements for AltaTrack Guidewire and AltaTrack Catheter, respectively. The requirements include dimensional, mechanical, packaqinq and other safety and/or performance related requirement specifications.
Biocompatibility testing in accordance with ISO 10993
- . Cytoxicity
- Sensitization ●
- . Irritation/Intracutaneous reactivity
- Acute Systemic Toxicity ●
- Material mediated Pyrogenicity .
- Hemocompatibility ●
- Endotoxin ●
Results demonstrated all verification tests for AltaTrack Guidewire and AltaTrack Catheter have been passed.
Validation testing
Validation testing was performed at system level (AltaTrack system), representing a logical clinical workflow of using AltaTrack equipment, AltaTrack Guidewire and AltaTrack Catheter in combination, to validate that AltaTrack devices conform to their intended use and user needs. The validation was performed with the following testing:
- Animal and phantom testing was executed by a team of vascular surgeons and interventional . radiologists with live animal and phantom in a simulated clinical environment. The participants have executed a representative clinical workflow according to a protocol, to validate the intended use, user needs, and effectiveness of the safety related measure. Results demonstrated all study endpoints were met.
- Human factors validation testing: .
- Human factors (HF) engineering process was followed in accordance with the following:
- IEC 62366-1:2015, Medical devices Application of usability engineering to medical devices o
- FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices o Guidance for Industry and Food and Drug Administration Staff, Feb 2016
- Human factors (HF) engineering process was followed in accordance with the following:
The human factors validation test (summative usability evaluation) was performed by teams of intended user groups in a simulated clinical environment in the United States. Each team comprised a physician (interventional radiologist or vascular surgeon), and two OR staff members. Production-equivalent production-equivalent packaging and labels were used in the study. All safety-related-functions (including critical tasks), and all the Frequently Used Functions have been evaluated in the usability study. Results of the summative usability evaluation for critical and non-critical tasks (including all Frequently Used Functions) and interviews with the participants demonstrated that the user interface of the AltaTrack system is safe and effective for the intended users, uses and use environments.
- . Customer service validation has been executed to validate the service user needs.
Conclusion on performance testing
All norm-compliance, verification and validation tests have been used to support substantial equivalence of the subject devices and to demonstrate that the AltaTrack devices:
- comply with the aforementioned international and FDA recognized consensus standards and FDA . guidance documents; and
- meet the acceptance criteria and are adequate for their intended use.
Based on the information provided above, the AltaTrack devices are considered substantially equivalent to their predicate devices.
No clinical testing was required as substantial equivalence was demonstrated by the attributes of intended use, technological characteristics, and non-clinical testing.
OVERALL CONCLUSION
The proposed devices, AltaTrack equipment, AltaTrack Guidewire and AltaTrack Catheter, are substantially equivalent to the above-mentioned predicate devices, in terms of intended use and technological characteristics.
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Substantial equivalence was demonstrated by non-clinical performance tests provided in this 510(k) premarket notification. These tests demonstrate that the proposed devices comply with the user needs specifications and product requirements, as well as the requirements specified in the international and FDArecognized consensus standards.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).