(230 days)
SmartGUIDE guidewire is intended for general intravascular and peripheral vascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. SmartGUIDE is intended to be used only by physicians trained in percutaneous, intravascular techniques and procedures.
SmartGUIDE is a deflectable quidewire for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. The device is available with a nominal outer diameter of 0.014" (0.36 mm) and overall length of 200 cm. The device is available sterile and is for single use only.
The provided text describes the SmartGUIDE deflectable hydrophilic guidewire (K222690), a medical device, and its substantial equivalence to a predicate device. It details various tests conducted to demonstrate its safety and effectiveness, but it does not pertain to an Artificial Intelligence (AI) or machine learning device.
Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test sets and training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable to this document.
However, I can extract and present the acceptance criteria and performance data for the physical medical device as described in the provided text.
Here is the information based on the provided document:
1. A table of acceptance criteria and the reported device performance
For the SmartGUIDE deflectable hydrophilic guidewire, the acceptance criteria are generally implied by conformity to established standards and guidance documents (e.g., FDA Guidewire Guidance, ISO 11070) and comparative equivalence to a predicate device. The "reported device performance" is consistently "Pass" or "Pass / Equivalent," indicating that the device met these criteria.
| Acceptance Criteria (Implied by Test and Standard) | Reported Device Performance Statement |
|---|---|
| Bench Testing: | |
| Dimensional and Visual Verification (per FDA Guidewire Guidance & ISO 11070) | Pass |
| Simulated Use (per FDA Guidewire Guidance) | Pass |
| Tip Flexibility (per FDA Guidewire Guidance) | Pass |
| Torqueability (per FDA Guidewire Guidance) | Pass |
| Kink Resistance (per FDA Guidewire Guidance) | Pass |
| Fracture Test (per ISO 11070) | Pass |
| Flexing Test (per ISO 11070) | Pass |
| Tensile Strength and Tip Pull (per FDA Guidewire Guidance & ISO 11070) | Pass |
| Torque Strength (per FDA Guidewire Guidance) | Pass |
| Particulate Release (per FDA Guidewire Guidance) | Pass |
| Lubricity (per FDA Guidewire Guidance) | Pass |
| Coating Integrity (per FDA Guidewire Guidance) | Pass |
| Corrosion Resistance (per FDA Guidewire Guidance & ISO 11070) | Pass |
| Radiopacity (per FDA Guidewire Guidance) | Pass |
| Specific Bench Tests for In Situ Bending Mechanism: | |
| Tip actuation force (maximum tip deflection force within specified range) | Pass |
| Tip fatigue (durability of tip deflection mechanism to 30 full handle actuations) | Pass |
| Blood clot crossing (crossing of soft and hard clots) | Pass |
| Biocompatibility: | |
| Cytotoxicity (per ISO 10993) | All tests confirmed biocompatibility |
| Sensitization (per ISO 10993) | All tests confirmed biocompatibility |
| Intracutaneous reactivity (per ISO 10993) | All tests confirmed biocompatibility |
| Material mediated pyrogenicity (per ISO 10993) | All tests confirmed biocompatibility |
| Bacterial endotoxins (per ISO 10993) | All tests confirmed biocompatibility |
| Acute systemic toxicity (per ISO 10993) | All tests confirmed biocompatibility |
| Complement activation (per ISO 10993) | All tests confirmed biocompatibility |
| Hemolysis (per ISO 10993) | All tests confirmed biocompatibility |
| Thrombogenicity (per ISO 10993) | All tests confirmed biocompatibility |
| EtO sterilization residuals (per ISO 10993) | All tests confirmed biocompatibility |
| Sterilization and Shelf Life: | |
| Sterilization process validated (per EN ISO 11135) | Device is non-pyrogenic; process validated |
| Shelf-life (after 2 years accelerated aging) | All acceptance criteria met |
| Pre-Clinical Animal Testing (GLP study in domestic swine): | |
| Overall, in life health (Clinical health status of animals) | Pass / Equivalent (Subject device equivalent to predicate device) |
| Efficacy / functional evaluation (Maneuverability, navigability, etc.) | Pass / Equivalent (Subject device equivalent to predicate device) |
| Procedural, Subacute, and Chronic safety (Macro- and microscopic evaluation) | Pass / Equivalent (Subject device equivalent to predicate device) |
| Thrombogenicity (Thrombus formation, fibrin deposits, non-patent artery, etc.) | Pass / Equivalent (Subject device equivalent to predicate device) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This document describes a non-AI/ML medical device.
- Sample Size (Pre-Clinical Animal Study): Not explicitly stated, but it was a "controlled good laboratory practice (GLP) study in domestic swine." The number of animals used is not specified.
- Data Provenance: The pre-clinical animal study was conducted as a "controlled good laboratory practice (GLP) study in domestic swine." No country of origin is listed for the study data. It is a prospective study in animals.
- For bench and biocompatibility testing, sample sizes are also not explicitly stated, but these are standard laboratory tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is not an AI/ML device study requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the device's performance comes from validated laboratory tests and the observation of physical and physiological responses in animal studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not an AI/ML device study involving human interpretation with adjudication. The assessment of device performance in bench and animal studies relies on established measurement protocols and scientific observation.
5. 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/ML device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For bench testing: Established physical and mechanical measurement standards and validated laboratory protocols (e.g., measuring forces, observing fractures, checking coating integrity).
- For biocompatibility: Standardized in vitro and in vivo toxicology tests (e.g., cytotoxicity, sensitization, hemolysis) with predefined acceptance criteria as per ISO 10993.
- For pre-clinical animal testing: Direct physiological observation, macroscopic and microscopic evaluation of tissues and organs (pathology), and assessment of device functionality and complications in vivo.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/ML device.
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April 24, 2023
Image /page/0/Picture/1 description: The image shows 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Artiria Medical SA Robin Stephens Acting Head of Regulatory Campus Biotech B3 N06 Chemin des Mines 9 Geneva, CH-1202 Switzerland
Re: K222690
Trade/Device Name: SmartGUIDE deflectable hydrophilic guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: March 22, 2023 Received: March 24, 2023
Dear Robin Stephens:
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
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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,
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) K222690
Device Name SmartGUIDE deflectable hydrophilic guidewire
Indications for Use (Describe)
SmartGUIDE guidewire is intended for general intravascular and peripheral vascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. SmartGUIDE is intended to be used only by physicians trained in percutaneous, intravascular techniques and procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| \u2612 Prescription Use (Part 21 CFR 801 Subpart D) | \u2610 Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary SmartGUIDE deflectable hydrophilic guidewire K222690
| Submission Sponsor: | Artiria Medical SACampus Biotech B3 N06, Chemin des Mines 9,Geneva CH-1202, Switzerland |
|---|---|
| Company Phone No.: | +41 78 649 0401 |
| Applicant Contact:Email: | Mr. Guillaume Petit-Pierreguillaume@artiria-medical.com |
| Correspondent Contact:Email: | Mr. Robin Stephensrstephens@psephos.com |
| Date Prepared: | April 20, 2023 |
| Device Identification | |
| Trade/Proprietary Name: | SmartGUIDE deflectable hydrophilic guidewire |
| Common/Usual Name: | Catheter Guide Wire |
| Classification Name: | Guide, Wire, Catheter |
| Regulation Number: | 21 CFR 870.1330 |
| Product Code: | MOF, DQX |
| Device Class: | II |
Predicate Device(s):
| Primary predicate: Synchro² Support Guidewire (K190843, product code MOF, DQX) | |
|---|---|
| Predicate: | PV 2000 Synchro2 Guidewire (K053268, product code DQX) |
| Reference: | Columbus Guidewire (K200374, product code MOF, DQX) |
Indications for Use Statement
The Indications for Use for the SmartGUIDE deflectable hydrophilic guidewire are the same as the primary predicate Synchro2 Support Guidewire and are as follows:
SmartGUIDE guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. SmartGUIDE is intended to be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Device Description
SmartGUIDE is a deflectable quidewire for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. The device is available with a nominal outer diameter of 0.014" (0.36 mm) and overall length of 200 cm. The device is available sterile and is for single use only.
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Technological Characteristics and Product Feature Comparison
The subject device, SmartGUIDE deflectable hydrophilic guidewire is substantially equivalent to the primary predicate device in terms of:
- . indications for use;
- . materials;
- technological characteristics;
- . packaging and sterilization of devices.
The differences in technological characteristics do not raise new questions of safety and effectiveness compared to the predicate device as outlined in the comparison table below.
| Feature | Synchro² Support GuidewirePrimary Predicate (K190843) | SmartGUIDESubject Device (K222690) |
|---|---|---|
| Regulation Number | 21 CFR 870.1330 | Same |
| Regulation Name | Catheter Guide Wire | Same |
| Regulatory Class | II | Same |
| Product Code | MOF, DQX | Same |
| Indications for Use | The Synchro² Guidewire series isintended for general intravascularuse, including neurovascular andperipheral vasculatures. It can beused to selectively introduce andposition catheters and otherinterventional devices within theperipheral and neurovasculature.This device should be used onlyby physicians trained inpercutaneous, intravasculartechniques and procedures. | SmartGUIDE guidewire isintended for general intravascularuse, including neurovascular andperipheral vasculatures. It can beused to selectively introduce andposition catheters and otherinterventional devices within theperipheral and neurovasculature.SmartGUIDE is intended to beused only by physicians trained inpercutaneous, intravasculartechniques and procedures. |
| Target Population | The device will be used inpatients undergoingendovascular treatment includingneurovascular and peripheralvasculatures. | Same |
| Anatomical Sites | Peripheral and neuro vasculature | Same |
| Guidewire Diameter | 0.014" | Same |
| Core Wire | 304 Stainless Steel | 304 Stainless Steel and Nickel-Titanium |
| Feature | Synchro² Support GuidewirePrimary Predicate (K190843) | SmartGUIDESubject Device (K222690) |
| Core Wire Length | 215 cm Access Length300 cm Exchange Length | 200 cm Access Length(Same as K053268) |
| Guidewire Tip | Nickel-Titanium,Micro-Machined Nitinol | Same |
| Radiopaque Coil | Platinum, 7 cm | Platinum/Iridium, 2 cm(Same as K200374) |
| Adhesive | UV Curable Adhesive | Thermal Curable Adhesive |
| Primer | Parylene Dimer | No primer |
| Hydrophilic Coating(Top) | Proprietary Hydrophilic Top Coat | Proprietary Hydrophilic Top Coat |
| Hydrophilic Coating(Base) | Proprietary Hydrophilic Base Coat | Proprietary Hydrophilic Base Coat |
| Torque Device | Available commercially perK936032 | Proprietary torque device /manipulator handle supplied |
| Tip Shaping | Manual shaping of the tip prior todevice delivery | In situ tip deflection mechanism,controlled by the user via theproximal end of the device(Same as K200374) |
| Dispenser Hoop | High Density Polyethylene | Same |
| Sterile Pouch | Tyvek® - Polyethylene | Same |
| Shipping Carton | Solid Bleached Sulphate (SBS) | Same |
| Sterilization Method | Ethylene Oxide | Same |
| How Supplied | Sterile/Single Use | Same |
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Testing Summary
The device passed all performance bench testing in accordance with internal requirements, referenced guidance and international standards as shown in the table below to support substantial equivalence of the device.
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| Test | Standards and guidance | Results |
|---|---|---|
| Dimensional and VisualVerification | FDA Guidance for Industry and Food and DrugAdministration Staff: Coronary, Peripheral, andNeurovascular Guidewires - Performance Testsand Recommended Labeling, October 2019(thereinafter, "FDA Guidewire Guidance") and ISO11070 | Pass |
| Simulated Use | FDA Guidewire Guidance | Pass |
| Tip Flexibility | FDA Guidewire Guidance | Pass |
| Torqueability | FDA Guidewire Guidance | Pass |
| Kink Resistance | FDA Guidewire Guidance | Pass |
| Fracture Test | ISO 11070 | Pass |
| Flexing Test | ISO 11070 | Pass |
| Tensile Strength and Tip Pull | FDA Guidewire Guidance and ISO 11070 | Pass |
| Torque Strength | FDA Guidewire Guidance | Pass |
| Particulate Release | FDA Guidewire Guidance | Pass |
| Lubricity | FDA Guidewire Guidance | Pass |
| Coating Integrity | FDA Guidewire Guidance | Pass |
| Corrosion Resistance | FDA Guidewire Guidance and ISO 11070 | Pass |
| Radiopacity | FDA Guidewire Guidance | Pass |
In addition, specific bench tests were designed to support the subject device in situ bending mechanism. These are listed below.
| Test | Description | Results |
|---|---|---|
| Tip actuation force | The maximum tip deflection force wasmeasured during complete deflection in asimulated vessel to verify it is within thespecified range. | Pass |
| Tip fatigue | Testing was conducted to demonstrate the tipdeflection mechanism durability to 30 fullhandle actuations. | Pass |
| Blood clot crossing | Testing was conducted to demonstratecrossing of soft and hard clots. | Pass |
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Biocompatibility
The materials used in the manufacture of the subject device SmartGUIDE deflectable hydrophilic quidewire are of well characterized medical grade.
Biocompatibility testing was completed in accordance with ISO 10993 and consisted of the following tests:
- Cytotoxicity ●
- Sensitization
- Intracutaneous reactivity ●
- Material mediated pyrogenicity ●
- . Bacterial endotoxins
- . Acute systemic toxicity
- Complement activation
- Hemolysis ●
- Thrombogenicity
- EtO sterilization residuals ●
All tests confirmed biocompatibility.
Sterilization and Shelf life
The device is sterilized using Ethylene Oxide. The sterilization process has been validated in accordance with EN ISO 11135. The device is non-pyrogenic.
Testing of the device after accelerated aging (T = 2 years accelerated aging) confirmed that all acceptance criteria were met supporting the shelf-life of the device.
Pre-Clinical Animal Testing Data
As part of demonstrating the substantial equivalence to the predicate device. Artiria Medical completed a controlled good laboratory practice (GLP) study in domestic swine with the subject device and the predicate device. Usability, performance, subacute (3-day) and chronic (30day) vascular safety, and thrombogenicity were assessed in this study. The following table presents an overview of the results of this study.
| Endpoint | Assessed parameters | Results(Subject deviceequivalent topredicate device) |
|---|---|---|
| Overall, in life health | Clinical health status of animals. | Pass / Equivalent |
| Efficacy / functionalevaluation | Manoeuvrability, navigability, pushability,trackability, compatibility with ancillary devices. | Pass / Equivalent |
| Procedural, Subacute,and Chronic safety | Macro- and microscopic evaluation of the treatedvessels, downstream tissues, and major organs. | Pass / Equivalent |
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| Thrombogenicity | Thrombus formation at the surface of the test and control articles. | Pass / Equivalent |
|---|---|---|
| Fibrin deposits or thrombosis in treated arteries. | ||
| Presence of non-patent artery. | ||
| Thrombus in distal organs. |
Statement of Substantial Equivalence
The SmartGUIDE deflectable hydrophilic guidewire has the same intended use and indications for use, and similar technological characteristics compared to the Synchro² Support Guidewire predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness compared to the predicate, and the nonclinical testing discussed above demonstrates that the subject device performs as intended. Therefore, the device is substantially equivalent to the predicate device.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.