(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.
§ 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.