Search Results
Found 2 results
510(k) Data Aggregation
(37 days)
The HYBRID Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in the coronary arteries.
HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It is used in association with catheters to enable insertion and easier navigation into the intracranial vascular branches for diagnostic or therapeutic use. Guidewires constitute an important element that conditions the success of the operation. They can be pushed and torqued to move forward through patient's tortuous anatomy.
HYBRID Guidewire consists of a proximal coated stainless steel core wire and a distal coated nitinol core wire. The distal core wire is tapered at the distal tip and is contained within a 92/8 platinum/tungsten and stainless steel coil for maximum radiopacity. The distal tip comes in various tip designs; it can be straight or curved distal tip (forming a double angle).
The coil section of the HYBRID Guidewire and the distal stainless steel section is coated with hydrophilic coating, while the proximal stainless steel section is coated with Polytetrafluoroethylene (PTFE). The purpose of the surface coatings is to provide lubricity when HYBRID Guidewire is passed through compatible microcatheters. A torquer and an introducer are also provided with the device.
The HYBRID Guidewire is a Class II device intended for general intravascular use, including neuro and peripheral vasculature, to facilitate the selective placement of diagnostic or therapeutic catheters. It is not intended for use in coronary arteries.
Here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual and Dimensional Inspection | External surface free from process and surface defects; dimensions (overall length, radiopaque length, outer diameter, distal shape) per product specification. | All test samples passed testing. |
| Catheter Compatibility & Simulated Use | In vitro performance under simulated use conditions using a worst-case tortuous ICA vessel model. | All test samples passed testing. |
| Coating Integrity and Adherence | Coating quality (after dyeing and simulated use) inspected under a microscope. | All test samples passed testing. |
| Tensile Strength | Minimum force to break the guidewire meets ISO 11070. Tensile strength comparable to the predicate device. | All test samples passed testing. Tensile strength was comparable to predicate devices. |
| Corrosion Resistance | No visual evidence of corrosion after immersion in sodium chloride solution and boiling distilled/deionized water. | All test samples passed testing. |
| Torque Strength | Number of turns-to-failures comparable to the predicate device. | All test samples passed testing. The torque strength of the subject device is equivalent to the predicate device. |
| Torqueability | Rotational input to output ratio comparable to the predicate device. | All test samples passed testing. The torqueability value of the subject device is equivalent to the predicate device. |
| Fracture Resistance and Flexing Test | Resistance to damage by flexing and resistance to fracture per ISO 11070. | All test samples passed testing. |
| Tip Flexibility | Force required to deflect the distal tip (45° and 90°) comparable to the predicate device. | All test samples passed testing. The tip flexibility of the subject device is equivalent to the predicate device. |
| Particulate Matter Characterization | Particulate matter in injections quantified after simulated use comparable to the predicate device. | All test samples passed testing. Particulate matter characterization was comparable to predicate device. |
| Design Verification and Packaging Validation | Device design and packaging design meet product specification requirements at t=1 year time-point after exposure to 1x EtO sterilization. | All test samples passed testing. |
| Packaging Integrity (Visual Inspection) | Packaging free of damage; all seals free of incomplete seals, voids, channels, wrinkles, foreign material, and/or over-heated sections. Labels legible, intact, no damage or delamination. | All test samples met the acceptance criteria. |
| Packaging Integrity (Bubble Leak Test) | No leaks per ASTM F2096-11. | All test samples met the acceptance criteria. |
| Packaging Integrity (Seal Strength) | Meets seal strength per ASTM F88/F88M-15. | All test samples met the acceptance criteria. |
| Animal Testing (GLP) | In vivo performance in an acute porcine model: Trackability, handling, radiopacity, and microcatheter compatibility comparable to predicate devices. | All test samples passed testing. Trackability and handling of the guidewire, radiopacity, and compatibility with microcatheter were comparable to predicate device. |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic (percent viability of test article not less than 70% compared to cells exposed to control). | The percent viability of the test article was 110.6%. Non-cytotoxic. |
| Biocompatibility (Sensitization) | Did not induce delayed sensitization. | Did not elicit sensitization response. |
| Biocompatibility (Irritation) | Non-irritant. | Non-irritant. |
| Biocompatibility (Acute Systemic Toxicity) | No evidence of significant systemic toxicity or mortality. | Non-toxic. |
| Biocompatibility (Pyrogenicity) | Non-pyrogenic (rabbit temperature rise not exceeding 0.5°C). | Non-pyrogenic. |
| Biocompatibility (Hemolysis) | Non-hemolytic (mean hemolytic index for direct contact and extract not exceeding 2%). | Non-Hemolytic. (Mean hemolytic index for direct contact was 0.71%; for extract was 0.61%). |
| Biocompatibility (Thrombogenicity) | Minimal thrombus formation; similar thromboresistance characteristics as control devices. | Passed. Minimal thrombus formation associated with test devices; neither animal's clotting abilities were compromised. Similar thromboresistance characteristics to control devices. |
| Biocompatibility (Complement Activation) | Statistically similar to negative control data. | Passed. Statistically similar to the reference negative control data (p > 0.050). |
| Biocompatibility (Partial Thromboplastin Time) | Within the same thrombogenicity category (minimal activator); responses considered similar to predicate. | Passed. Test article and predicate percent plasma control values fell within the same thrombogenicity category (minimal activator). Responses considered similar. |
| Biocompatibility (Platelet and Leukocyte Counts) | Test article comparable to reference control and comparison article (not statistically significant, p > 0.05). | Passed. Test article results for leukocyte and platelet counts showed 100.6-105.6% of negative control. Not statistically significant (p > 0.05) when compared to reference material or comparison article. Comparable to both. |
| Shelf Life (Accelerated Aging) | All acceptance criteria met at T=1 year accelerated aging, no new questions of safety or effectiveness raised. Performs as intended to Design Specification. | All acceptance criteria were met. Concluded that the HYBRID Guidewire will perform as intended to the Design Specification. Labeled for 1-year shelf life. |
| Sterilization Validation | Achieves a minimum Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11135:2007. | The validation study demonstrated that the sterilization process and equipment are capable of reliably and consistently sterilizing the devices to a minimum SAL of 10-6. Fractional cycles, half cycles, and full cycles met the acceptance criteria. |
| EO and ECH Residuals | Residual traces of Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) below limits specified in ISO 10993-7:2008. | The residual traces of EO and ECH for the worst-case device were well below the limits specified in ISO 10993-7. |
| Bacterial Endotoxin Levels | Below 2.15 EU/device, in accordance with FDA guidance, USP , and European Pharmacopeia BET 2.6.14. |
Ask a specific question about this device
(62 days)
The Novus 3000 Laser System is intended for use in the treatment of ocular pathology. The Novus 3000 Laser System is indicated for use in photocoagulation of both anterior and posterior segments including:
- Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy;
- choroidal neovascularization;
- branch retinal vein occlusion;
- age-related macular degeneration;
- retinal tears, detachments;
- retinopathy of prematurity.
- Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.
Laser Indirect Ophthalmoscope
The Laser Indirect Ophthalmoscope is indicated for the delivery of laser energy in eyes with retinal pathology. The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments and conditions: diabetic retinopathy (panretinal photocoagulation); peripheral neovascularization, retinal breaks, detachments, and tears, lattice degeneration, pneumatic retinopexy reattachment procedures, segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous cavities; pediatric retinal repairs (under general anesthesia), delivery of laser energy through small pupils or to eyes with focal lens opacities.
Endophotocoagulation
When used with a Novus 3000 Laser System, the Acculite EndoOcular Probes (Acculite EndoOcular Probe, Acculite Aspirating EndoOcular Probe, and Acculite Illuminating EndoOcular Probe) are intended for use in the following ophthalmic applications: photocoagulation of the anterior and posterior segment, including: anterior segment treatment in the surgical management of glaucoma; endophotocoagulation in vitreoretinal surgery, including panretinal photocoagulation, retinopexy, and treatment of neovascularization.
The laser delivery function of the Acculite Acculite EndoOcular Probes (Acculite EndoOcular Probe, Acculite Aspirating EndoOcular Probe and Acculite Illuminating EndoOcular Probe) is indicated for use in ocular surgery to deliver laser energy to the treatment area selected by the surgeon.
The aspiration function of the Acculite Aspirating EndoOcular Probe is indicated for use when unwanted fluid is present in the eye during ocular surgery, causing refraction or scattering of the laser beam from the intended treatment site.
The illumination function of the Acculite Illuminating EndoOcular Probe is indicated for use during ocular surgery to illuminate the interior of the eye.
Lumenis, Inc.'s Novus® 3000 Laser System with the Delivery Devices is an air cooled, diode-pumped, solid state, Nd: YAG Laser System, which produces a wavelength of 532 um of laser light with a treatment beam output ranging from 50 mw to 3.0 W. The main parts of the Novus® 3000 system include the laser console, a footswitch, a remote control and assorted laser accessories.
This 510(k) summary for the Lumenis Novus® 3000 Laser System and Delivery Devices does not include any performance data or a study to demonstrate that the device meets specific acceptance criteria.
The document explicitly states:
"No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). No data was submitted for section 807.92 6[(b)(1)(2)(3c)]."
Therefore, I cannot provide the requested information. The submission relies on demonstrating substantial equivalence to predicate devices based on similarities in intended use, indications for use, and technological characteristics, rather than on new performance data for this specific device.
If this were a submission that included a performance study, the requested information would typically be provided as follows:
Hypothetical Example if performance data were submitted:
Here's how the information would be presented if a study was conducted and acceptance criteria were defined, based on a typical medical device submission structure:
1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical Example)
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Laser Output Power Accuracy | Within ±10% of set value | ±5% (e.g., for 50 mW to 3.0 W range) |
| Beam Spot Size Accuracy | Within ±15% of nominal size | ±10% (e.g., for various delivery devices) |
| Pulse Duration Accuracy | Within ±5% of set value | ±2% (e.g., for 10 ms to 1000 ms range) |
| Aiming Beam Co-axiality | Within 0.5 mm relative to treatment beam |
Ask a specific question about this device
Page 1 of 1