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Found 504 results
510(k) Data Aggregation
(60 days)
Trade/Device Name:** Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
Regulation Number: 21 CFR 870.1330
Trade/Device Name:** Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
Regulation Number: 21 CFR 870.1330
Product code:** DQX
Classification Name: Wire, Guide, Catheter
Regulation Number: 21 CFR 870.1330
Product code:** DQX
Classification Name: Wire, Guide, Catheter
Regulation Number: 21 CFR 870.1330
The Splashwire Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.
The Splashwire Hydrophilic guide wire consists of a nitinol core wire with a ground tapered distal section. A polyurethane jacket which contains tungsten for radiopacity is applied over the core wire and a hydrophilic coating is applied over the polyurethane jacket. The surface of the jacket is uniform with both the distal and proximal ends fully coated. The wire is placed inside a multiple loop flush dispenser, also referred to as a hoop. The dispenser has a flush port which facilitates solution flushing through the hoop to hydrate the guide wire. The wire is placed so that the distal end of the wire comes out of the outer portion of the hoop. A J-straightener is placed on the other end of the hoop to introduce the wire into the catheter. The wire is sold sterile and is a single use device. The subject Splashwire Hydrophilic Guide Wire Line Extensions and the predicate Splashwire Hydrophilic Guide Wire share the device characteristics described above, with the subject guide wire incorporating the following additional modifications:
J-Tip Guide Wires:
The J Tip devices incorporate a distal tip formed into a J shape. These guide wires are provided with a 3.0 mm J Tip.
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(261 days)
: K251385**
Trade/Device Name: InQwire Super Stiff Guide Wire
Regulation Number: 21 CFR 870.1330
Product code:** DQX
Classification Name: Wire, Guide, Catheter
Regulation Number: 21 CFR 870.1330
Product code:** DQX
Classification Name: Wire, Guide, Catheter
Regulation Number: 21 CFR 870.1330
The InQwire Super Stiff Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures. The InQwire Super Stiff Guide Wire is indicated for use in the peripheral vasculature and chambers of the heart, excluding the coronary arteries and cerebral vasculature.
The Merit InQwire Super Stiff guide wire consists of 0.032" and 0.035" outer diameter (OD) guidewire configurations with guidewire lengths of 80cm, 100cm, 150cm, 180cm and 260cm. The guidewire is provided in straight and J3mm with a range of flexible properties.
The Merit InQwire Super Stiff guide wire is composed of a stainless-steel core wire and a PTFE coated stainless steel coil. The guidewire is welded at the distal and proximal tip with each tip having a polished weld finish. The stainless-steel construction provides radiopacity. The guidewire is supplied sterile, non-pyrogenic and is intended for single patient use only.
The Merit InQwire Super Stiff guide wire is placed through a vascular access device and advanced under fluoroscopy to the desired location according to the planned procedure by the clinician. It is used to facilitate the placement of devices during diagnostic and interventional procedures within the peripheral vasculature and central circulatory system, excluding the coronary arteries and cerebral vasculature.
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(137 days)
K252674**
Trade/Device Name: Solo Pace Fusion System (SOLOFUSE1)
Regulation Number: 21 CFR 870.1330
K252674**
Trade/Device Name: Solo Pace Fusion System (SOLOFUSE1)
Regulation Number: 21 CFR 870.1330
System |
|---|---|
| Common / Usual Name | Catheter Guidewire |
| Classification Name | 21 CFR 870.1330
System |
|---|---|
| Common / Usual Name | Catheter Guidewire |
| Classification Name | 21 CFR 870.1330
Solo Pace Fusion is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures. Solo Pace Fusion can be used for temporary intracardiac pacing by transmitting an electrical signal from Solo Pace Control to the heart.
The Solo Pace Fusion System consists of the following components:
- Fusion Guidewire
- Fusion Ground Pad
- Fusion Connection Cable
- Solo Pace Control System, consisting of the following:
- Solo Pace Remote Control Module (RCM), packaged with the Fusion Guidewire, Fusion Ground Pad and Fusion Connection Cable
- Solo Pace External Pulse Generator (EPG) (sold separately)
The Fusion Guidewire is intended to deliver interventional devices into the heart and serve as the pacing conduit when used with the Solo Pace Control system. The Fusion Guidewire is made of stainless steel and includes a pre-shaped pigtail distal tip. The Fusion Guidewire has a diameter of 0.035" (0.89 mm) and a length of 275 cm. The Fusion Guidewire is supplied with a tip insertion tube to help advance the guidewire into a catheter. A PTFE coating covers the shaft for lubricity. The proximal 8mm is uncoated to allow connection of the Fusion Guidewire to the Fusion Connection Cable. The pigtail is coated with silicone for lubricity. The Fusion Guidewire is supplied sterile, non-pyrogenic and is intended for single use only.
The Fusion Ground Pad is a transcutaneous pad placed on the patient to serve as the anode terminal for unipolar pacing via a unique connection to the Fusion Connection Cable. The Ground Pad acts as the return electrode for the pacing signal delivered to the patient's heart through the Fusion Guidewire. The Ground Pad cable is 60 inches (1.5 m) long and the skin contacting surface area is 350 cm².
The Fusion Connection Cable connects the Fusion Guidewire and the Fusion Ground Pad to the Solo Pace Control System (EPG component) in a manner that ensures proper polarity. The Fusion Connection Cable is approximately 60 inches (1.5 m) long.
The Solo Pace Control System RCM is a single use sterile device supplied with the Solo Pace Fusion System. The Solo Pace RCM connects wirelessly with the EPG to allow physician control of the EPG in the sterile field.
The Solo Pace Control System EPG is a reusable, external pulse generator described in detail in its Instructions for Use (IFU). The Solo Pace Control IFU should be reviewed, in its entirety, prior to the use of the Solo Pace Fusion System. Solo Pace Control was cleared for use under K241781.
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(61 days)
95131
Re: K253168
Trade/Device Name: 0.014" Willow Guidewire
Regulation Number: 21 CFR 870.1330
Guidewire
Common Name: Wire, Guide, Catheter
Classification Name: Wire, Guide, Catheter, 21 CFR 870.1330
Guidewire
Common Name: Wire, Guide, Catheter
Classification Name: Wire, Guide, Catheter, 21 CFR 870.1330
0.014" Willow Guidewire (K253168) |
|---|---|---|
| Classification Name | Wire, Guide, Catheter, 21 CFR 870.1330
The 0.014" Willow 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 neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Like the predicate device, the 0.014" Willow Guidewire is a single-use product with a shapeable tip available in straight and pre-shaped configurations, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The 0.014" Willow Guidewire comes in three stiffness profiles: Soft, Standard and Support.
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(166 days)
K251596**
Trade/Device Name: Lunderquist Extra Stiff Wire Guide
Regulation Number: 21 CFR 870.1330
Common Name: Guidewire
Classification Name: Catheter guide wire
Regulation: 21 CFR 870.1330
The Lunderquist Extra Stiff Wire Guides are intended to facilitate catheterization and/or placement of devices during vascular interventional procedures.
The Lunderquist Extra Stiff Wire Guides are intended for use in the aorta, including its access vessels and major adjacent vessels.
The Lunderquist Extra Stiff Wire Guides are auxiliary devices and hence not primary interventional devices themselves. Instead, they are intended to facilitate vascular access and/or delivery of over-the-wire medical devices during endovascular procedures, including TEVAR/EVAR procedures.
The Lunderquist Extra Stiff Wire Guides are both long and stiff; features that make them suitable for facilitating endovascular procedures that involve placement of large devices e.g., stent grafts in the aorta. The wire guides are not intended for coronary or neurovascular use.
The Lunderquist® Extra Stiff Wire Guides are 0.035 inch PTFE coated stainless steel wire guides consisting of a mandril and a 15 cm or 18 cm long coil. The mandril has a tapered end with a length of 11 cm and an additional 4 or 7 cm flexible tip. The Lunderquist wire guides are available in the following configurations:
Straight Lunderquist wire guides (TSMG-/-LES) are available in lengths of 90, 145, 180, 260, and 300 cm and either a 4 cm or 7 cm flexible tip. For the 260 cm and 300 cm lengths, the flexible tip includes an inner gold coil.
Curved Lunderquist wire guides (TSCMG-/-LES) are available in lengths of 90, 145, 180, 260, and 300 cm and either a 4 cm or 7 cm flexible tip. For the 260 cm and 300 cm lengths, the flexible tip includes an inner gold coil. The J-curve radius for the curved wire guides is either 3 mm or 7 mm.
Double Curved Lunderquist wire guides (TSCMG-/-LESDC) are available in lengths of 260 and 300 cm with a 4 cm flexible tip that includes an inner gold coil. The Double Curved Lunderquist wire guides have a large curve/J-curve radius of 75/15 mm.
Extended Double Curved Lunderquist wire guides (TSCMG-/-E-LESDC) are available in lengths of 260 and 300 cm with a 4 cm flexible tip that includes an inner gold coil. The Extended Double Curved Lunderquist wire guides have an extended large curve/J-curve radius of 55/15 mm.
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(64 days)
LumiGuide Wire
Classification Name: Catheter guide wire
Classification Regulation: 21 CFR, Part 870.1330
Page 6
Classification Name: Catheter guide wire
Classification Regulation: 21 CFR, Part 870.1330
The LumiGuide Equipment is a visualization device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected LumiGuide Wire and, optionally, a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real-time of the connected LumiGuide Wire and, of an endovascular catheter, when combined with a LumiGuide 3D Hub.
The LumiGuide Wire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.
The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide Wire and the LumiGuide Equipment.
The LumiGuide system consists of the following primary devices:
The LumiGuide Equipment R2.1 is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a real time 3D image of a LumiGuide Wire and, optionally, an endovascular catheter when combined with LumiGuide 3D Hub, and overlay this on real time or pre-recorded X-ray images and/or on a pre-operative CT volume. The LumiGuide Equipment R2.1 comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component.
The LumiGuide Wire is a sterile, single use, angiographic guidewire with Fiber Optic RealShape (FORS) technology that is available in two configurations: LumiGuide Navigation Wire 3D Ultra and LumiGuide Navigation Wire 3D Plus. The primary function of the LumiGuide Wire is to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature. The LumiGuide Wire can be visualized in 3D in real time by the LumiGuide Equipment R2.1 using FORS technology.
The LumiGuide 3D Hub is a sterile, single use accessory to the LumiGuide Equipment R2.1 that connects to the luer connector of endovascular catheters. When the LumiGuide Hub is connected to an endovascular catheter and is used in combination with a LumiGuide Wire, the LumiGuide Equipment R2.1 enables real time 3D visualization of the connected endovascular catheter.
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(266 days)
27541
Re: K250203
Trade/Device Name: SureAx-Guide™ Guidewire
Regulation Number: 21 CFR 870.1330
Catheter guide wire
Regulatory Class: Class II
Product Code and Regulation: DQX, 21 CFR 870.1330
Approach Hydro ST Guidewire | N/A |
| Product Code | DQX | DQX | Same |
| Regulation Number | 21 CFR 870.1330
| 21 CFR 870.1330 | Same |
| Regulatory Class | II | II | Same |
| Nominal Wire Outer Diameter | 0.014
The SureAx-Guide guidewire is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature. The SureAx-Guide guidewire is not intended for use in the coronary or neuro vasculature.
The SureAx-Guide™ guidewire is comprised of a stainless-steel wire with a PTFE coating and distal coils and soldered tip. The distal end has a urethane sheath and PVP-based hydrophilic coating. The maximum outside diameter is 0.0142 inches and it will be available in 135cm and 190cm lengths. It will be supplied sterile and intended for single use.
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(269 days)
Re: K250031/S001
Trade/Device Name: Amplatzer Guidewire
Regulation Number: 21 CFR 870.1330
Re: K250031/S001
Trade/Device Name: Amplatzer Guidewire
Regulation Number: 21 CFR 870.1330
Catheter Guide Wire
Device Class: Class II
Product Code: DQX
Product Regulation: 21 CFR 870.1330
The Amplatzer™ Guidewire is intended to facilitate the introduction and exchange of a delivery system or catheter within the vasculature and chambers of the heart.
The Amplatzer™ Guidewire is 0.035-inch in diameter and made of a stainless steel core and a full length stainless steel spring coil coated with low-friction polytetrafluoroethylene (PTFE). The stainless steel core extends to the distal tip of the guidewire for one model (9-GW-001). Two models (9-GW-002 and 9-GW-003) have a stainless steel core that does not extend to the distal end of the wire. These models have an additional ribbon wire that runs parallel to the stainless steel core and extends to the distal end of the guidewire. The stainless steel core for all three models is tapered at the distal end of the guidewire to provide a smooth transition to the distal floppy segment.
The guidewires are available in two working lengths, 260 cm (9-GW-001 and 9‑GW‑002) and 300 cm (9-GW-003). The distal tip of the guidewire is available in two designs: a Modified J-Tip (9-GW-001) and a J-Tip (9-GW-002 and 9-GW-003). The J-straightener can be used to straighten the distal tip for all models. Model 9-GW-003 can also be manually straightened. The guidewire is sterile and for single use only.
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(135 days)
Re: K251181
Trade/Device Name: Splashwire Hydrophilic Guide Wire
Regulation Number: 21 CFR 870.1330
code:** | DQX |
| Classification Name: | Wire, Guide, Catheter |
| Regulation Number: | 21 CFR 870.1330
code:** | DQX |
| Classification Name: | Wire, Guide, Catheter |
| Regulation Number: | 21 CFR 870.1330
The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures. These guide wires are not intended for Percutaneous Transluminal Coronary Angioplasty use or for use in the neurovasculature.
The Splashwire Hydrophilic guide wire consists of a nitinol core wire with a ground tapered distal section. A polyurethane jacket which contains tungsten for radiopacity is applied over the core wire and a hydrophilic coating is applied over the polyurethane jacket. The surface of the jacket is uniform with both the distal and proximal ends fully coated. The wire is placed inside a multiple loop flush dispenser, also referred to as a hoop. The dispenser has a flush port which facilitates solution flushing through the hoop to hydrate the guide wire. The wire is placed so that the distal end of the wire comes out of the outer portion of the hoop. A J-straightener is placed on the other end of the hoop to introduce the wire into the catheter. The wire is sold sterile and is a single use device. The subject Splashwire Hydrophilic Guide Wire Line Extensions and the predicate Splashwire Hydrophilic Guide Wire share the device characteristics described above, with the subject guide wire incorporating the following additional modifications:
J-Tip Guide Wires:
The J Tip devices incorporate a distal tip formed into a J shape. These guide wires are provided with a 1.5 mm J Tip.
Long Taper Guide Wires:
The Long Taper Guide Wires incorporate an extended core wire taper length providing enhanced flexibility.
The provided FDA 510(k) clearance letter and summary for the Splashwire Hydrophilic Guide Wire (K251181) outlines the regulatory approval process and demonstrates substantial equivalence to a predicate device (K201595). However, it does not contain the specific information required to address your request regarding acceptance criteria and the detailed study that proves the device meets those criteria, particularly for an AI-enabled medical device.
The document describes a traditional medical device (a guide wire) and the non-clinical bench testing performed to ensure its safety and performance. This typically involves physical and mechanical property tests. It does not refer to AI/ML software, algorithms, or any studies involving human readers or ground truth expert consensus in the way you've outlined.
Therefore, I cannot provide a table of acceptance criteria and reported device performance for an AI-enabled device, nor details on sample sizes, expert ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.
Based on the provided document, the device is a physical medical device (a guide wire), not an AI-enabled one. The acceptance criteria and "study" described are standard bench tests for physical properties, not performance metrics for an AI algorithm.
Here's a breakdown of what can be inferred from the document regarding the device's performance, but it does not align with the parameters of an AI/ML study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Testing was conducted on the subject Splashwire Hydrophilic Guide Wire in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." And "All test results were comparable to the predicate Splashwire Hydrophilic Guide Wire and the subject Splashwire Hydrophilic Guide Wire met the predetermined acceptance criteria."
While specific numerical acceptance criteria and performance data are not provided in this summary, the document indicates that the following categories of non-clinical bench tests were successfully completed and met their predetermined acceptance criteria:
| Acceptance Criteria Category (Test Type) | Reported Device Performance (Implied) |
|---|---|
| Dimensional Verification | Met predetermined specifications (comparable to predicate) |
| Finished Wire Surface | Met predetermined specifications (comparable to predicate) |
| Tip Tensile Strength | Met predetermined specifications (comparable to predicate) |
| Tip Stiffness | Met predetermined specifications (comparable to predicate) |
| Tip Flexibility | Met predetermined specifications (comparable to predicate) |
| Prolapse Test | Met predetermined specifications (comparable to predicate) |
| Torque Strength | Met predetermined specifications (comparable to predicate) |
| Torqueability | Met predetermined specifications (comparable to predicate) |
| Coating Integrity | Met predetermined specifications (comparable to predicate) |
| Catheter Compatibility | Met predetermined specifications (comparable to predicate) |
| Fracture Test | Met predetermined specifications (comparable to predicate) |
| Flexing Test | Met predetermined specifications (comparable to predicate) |
| Simulated Use Testing | Met predetermined specifications (comparable to predicate) |
| Kink Resistance | Met predetermined specifications (comparable to predicate) |
| Ancillary Device Compatibility | Met predetermined specifications (comparable to predicate) |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not available in the provided document. For a physical medical device, "test set" would refer to the number of units tested for each characteristic. The provenance of the data is not applicable in the context of clinical images or patient data; it would refer to the samples of the manufactured guide wire used for the bench tests. These are likely internal lab tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to this type of device and study. "Ground truth" in this context would be derived from the physical properties of the device measured by laboratory instruments, not expert human interpretation of data.
4. Adjudication Method for the Test Set:
This information is not applicable as there are no human interpretations or adjudications involved in the physical bench tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
This information is not applicable. MRMC studies are relevant for software that aids human interpretation (e.g., AI for radiology). This device is a physical guide wire.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This describes the performance of a physical device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device is based on measurements of its physical and mechanical properties according to established industry standards and FDA guidance for guide wires (e.g., ISO standards, FDA guidance on guidewire performance). It's not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
This information is not applicable. This device is not an AI/ML algorithm that requires a training set. The "design controls" mentioned refer to the engineering and manufacturing process, not data training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for a physical device.
In summary, the provided document details the 510(k) clearance for a physical medical device (Premarket Notification: K251181) and its substantial equivalence based on standard bench testing. It does not provide information relevant to the assessment of an AI-enabled medical device.
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(238 days)
California 95008
Re: K244061
Trade/Device Name: X-Wire Guidewire
Regulation Number: 21 CFR 870.1330
Classification Name: Catheter guide wire
Product Codes: MOF, DQX
Regulation: 21 CFR 870.1330
Classification Name:* Catheter guide wire
Product Codes: MOF, DQX
Regulation: 21 CFR. 870.1330
Subject Device X-Wire Guidewire (K244061) |
|---|---|---|---|
| Regulation Number | 21 CFR 870.1330
The X-Wire Guidewire is indicated for general intravascular use within the peripheral and neuro vasculature to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
The Imperative Care's X-Wire Guidewires are guidewires with shapeable tips to aid in accessing the peripheral and neuro vasculature. The guidewires are available in 200cm - 300cm lengths, standard (S) and support (T) stiffness profiles, and 0.014", 0.018" and 0.024" diameters. The distal portion of the guidewire tip includes a radiopaque marker to facilitate fluoroscopic visualization. A hydrophilic coating on the distal segment and PTFE coating on the proximal segment serve to reduce friction during manipulation in vessels. The X-Wire Guidewire is supplied with a shaping mandrel, introducer, and torque device.
This document is a 510(k) clearance letter for a medical device and therefore does not contain acceptance criteria and study data in the format typically found in clinical efficacy studies for AI/software devices. The acceptance criteria and "study" described herein relate to the safety and performance of the physical guidewire device (X-Wire Guidewire) based on bench testing, biocompatibility testing, sterilization validation, and shelf-life testing, rather than a clinical study evaluating the performance of an AI algorithm.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document summarizes the performance testing done in Table 2: Summary of Bench Tests and Performance Specifications and Table 3: Biocompatibility Test Summary – X-Wire Guidewire.
Table: Acceptance Criteria and Reported Device Performance (Synthesized from document)
| Test Attribute | Acceptance Criteria (Specification) | Reported Device Performance (Results) |
|---|---|---|
| Dimensional Verification | All defined guidewire dimensions are within the specified tolerances. | Pass |
| Visual Inspection | The guidewire shall be free of visual defects when removed from packaging. | Pass |
| Torqueability | The guidewire shall transmit rotation from the proximal end to the distal tip to allow users to select branches of the vasculature and reach the target location. | Pass |
| Torque Strength | Device shall not fail under expected torsional input when distal end is unable to move/rotate. | Pass |
| Tip Flexibility | Tip of guidewire shall not cause vessel damage; defined by ability to buckle to reduce contact pressure and prevent perforation. | Pass |
| Tensile Strength and Tip Pull | Guidewire shall withstand tensile forces expected in clinical use without breaking. | Pass |
| Kink Resistance | Guidewire shall be able to traverse through clinically relevant bends without kinking. | Pass |
| Coating Integrity | Coating shall remain intact during clinical use. | Pass |
| Coating Lubricity | Coating shall be lubricious to reduce frictional forces for navigation. | Pass |
| Particulate Evaluation | Guidewire shall not generate particles at a level greater than the range generated by the predicate. | Pass |
| Corrosion Resistance | Guidewire shall not corrode from time of manufacture through its shelf life. | Pass |
| Radiopacity | Opacity to x-ray shall allow physicians to visualize guidewire under fluoroscopy. | Pass |
| Simulated Use | Guidewire must be able to reach anatomical locations and deliver catheters and other interventional devices used in common neurovascular procedures. | Pass |
| Cytotoxicity | Test article extracts must yield grade 2 or lower. | Pass, Noncytotoxic |
| Sensitization | Overall pattern, intensity, duration, character of reactions compared to control conditions. | Pass, Nonsensitizer |
| Irritation or Intracutaneous Reactivity | Difference between test extract mean score and corresponding control mean score ≤1. | Pass, Nonirritating |
| Acute Systemic Toxicity | None of the animals treated with test article extracts must show significantly greater biological reactivity than control-treated animals. | Pass, Non-toxic (acute systemic) |
| Material Mediated Pyrogenicity | Test article extract must yield <0.5°C rise of individual animal baseline temperature. | Pass, Nonpyrogenic |
| Hemocompatibility – Hemolysis | Test article extract must result in hemolytic index of <2%. | Pass, Nonhemolytic for both Direct and Extract Methods |
| Hemocompatibility - SC5b-9 Complement Activation | SC5b-9 concentration of the test article is similar to both the activated NHS and negative controls. | Pass, Hemocompatible |
| Hemocompatibility – In vivo thromboresistance | Test article performs similarly to the predicate. | Pass, Hemocompatible |
| Sterilization Assurance Level | 1 x 10^-6 (implicit) | Achieved (via validated EO process) |
| Shelf Life (Accelerated Aging) | Device, accessory, and packaging performance maintained for stated shelf life. | Supports 8-month shelf life. |
Important Note: This document describes a physical medical device (guidewire), not a software/AI device. Therefore, many of the subsequent questions related to AI studies (test sets, ground truth, experts, MRMC studies, standalone performance, training sets) are not applicable to this 510(k) submission.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" in the typical sense of a clinical study. The testing here refers to physical guidewire samples subjected to bench tests and biological evaluations. The specific number of devices tested for each attribute (e.g., number of guidewires for torqueability, number of animal subjects for biocompatibility) is not detailed in this summary, but would be found in the full test reports.
- Data Provenance: N/A for clinical data. The data is generated from laboratory (bench and biocompatibility) testing of the physical device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth for the physical device performance (e.g., whether a guidewire kinks or corrodes) is established by objective measurements and standardized test protocols, not by expert consensus in a clinical diagnostic sense. However, for the biocompatibility testing, an "expert evaluation" is mentioned as confirming that the device met biological safety requirements. The number and qualifications of this expert(s) are not specified.
4. Adjudication Method (for the test set)
- Adjudication Method: Not applicable in the context of an AI study. For the bench and biocompatibility tests, "adjudication" would refer to the interpretation of raw test data against predefined acceptance criteria by qualified laboratory personnel, which is inherent in the "Pass" results reported.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No. This is a physical guidewire device, not an AI or software device that would typically involve human reader performance evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Not applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used
- Ground Truth Type:
- Bench Testing: Objective physical measurements, engineering specifications, and performance defined by established standards (e.g., ability to transmit torque, resistance to kinking, coating integrity). Performance is compared against similar predicate devices and general industry standards.
- Biocompatibility Testing: Established by standardized biological assays (e.g., ISO 10993 series) that measure cellular response, material-mediated effects, and systemic reactions in vitro/in vivo, compared to predefined safety thresholds.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is a physical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Training Set Ground Truth Establishment: Not applicable, as there is no training set for an AI model.
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