(116 days)
The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery.
The Entry Needle is an accessory device which is used to gain access to the vein or artery, for placement of the Mini Guide Wire.
The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery.
The Pinnacle Precision Access System consists of an introducer sheath and a dilator which are packaged together with a metallic entry needle, a mini guide wire and a guide wire inserter, prior to sterilization. The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery. The sheath and dilator contain bismuth, making these devices visible under fluoroscopy
The entry needle (cannula) is an accessory device which is used to gain access to the vein or artery for placement of the mini guide wire.
The mini guide wire is an accessory device which is used for placement of the sheath and dilator into the vein or artery. The mini guide wire is offered in two versions, a stainless steel (spring coil) model and a Palladium tipped Nitinol model.
A guide wire inserter is also provided to assist in insertion of the mini guide wire into the cannula.
The provided text describes the Terumo Medical Corporation's Pinnacle Precision Access System and its premarket notification (510(k) summary) to the FDA. This document is for a medical device (catheter introducer) and therefore does not involve AI or machine learning. As such, many of the requested categories related to AI model evaluation are not applicable.
Here's the information that can be extracted or deduced from the provided text, along with an explanation for categories that are not applicable:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally implied by the successful passing of the listed performance tests. The reported device performance is that it "successfully passed all of the following performance tests." Specific quantitative thresholds for "acceptance" are not explicitly detailed in the summary but are inherent in the "pass" result for each test.
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Needle | Needle surface free from defects | Free from defects | Passed |
| Needle OD | Within specified range | Passed | |
| Needle length | Within specified range | Passed | |
| Needle ID | Within specified range | Passed | |
| Needle hub conical entry angle | Within specified range | Passed | |
| Bevel indicator visibility | Visible | Passed | |
| Bevel indicator position | Correct position | Passed | |
| Needle to hub joint strength | Meets strength requirements | Passed | |
| Gauge luer taper | Conforms to standard | Passed | |
| Liquid leakage from fitting assembly under pressure | No liquid leakage | Passed | |
| Air leakage into the fitting assembly during aspiration | No air leakage | Passed | |
| Separation force of fitting assembly | Meets force requirements | Passed | |
| Unscrewing torque of fitting assembly | Meets torque requirements | Passed | |
| Ease of assembly | Easy to assemble | Passed | |
| Resistance to overriding | Resistant to overriding | Passed | |
| Stress cracking | No stress cracking | Passed | |
| Tip penetration through thin film | Effective penetration | Passed | |
| Corrosion resistance | Resistant to corrosion | Passed | |
| Guidewires | Guidewire surface free from defects | Free from defects | Passed |
| Tip buckling test | No buckling | Passed | |
| Test for resistance of guidewires to damage by flexing | Resistant to damage | Passed | |
| Test for fracture of guidewires | No fracture | Passed | |
| Test for distal tip retention and proximal end retention | Tip retention maintained | Passed | |
| Guidewire OD | Within specified range | Passed | |
| Guidewire length | Within specified range | Passed | |
| Corrosion resistance | Resistant to corrosion | Passed | |
| Radiopacity | Radiopaque | Passed | |
| Dilator | Dilator surface free from defects | Free from defects | Passed |
| Dilator tip ID | Within specified range | Passed | |
| Dilator to hub joint strength | Meets strength requirements | Passed | |
| Dilator length | Within specified range | Passed | |
| Dilator OD at sheath tip interface | Within specified range | Passed | |
| Dilator hub to sheath hub snap fit strength | Meets strength requirements | Passed | |
| Hypotube length | Within specified range | Passed | |
| Hypotube to hub joint strength | Meets strength requirements | Passed | |
| Hypotube fall-out | No fall-out | Passed | |
| Wire passage | Smooth wire passage | Passed | |
| Sheath | Corrosion resistance (hypotube) | Resistant to corrosion | Passed |
| Sheath surface free from defects | Free from defects | Passed | |
| Sheath tip ID | Within specified range | Passed | |
| Sheath length | Within specified range | Passed | |
| Sheath tip cracks | No cracks | Passed | |
| Radiopacity | Radiopaque | Passed | |
| Simulated Use | System use in anatomical model | Successful deployment and function in model | Passed |
| Dilator and sheath tip penetration | Effective tip penetration | Passed | |
| Biocompatibility | Physicochemical profile | Meets USP requirements | Meets requirements |
| Cytotoxicity | Not considered to have cytotoxic potential | Not considered cytotoxic | |
| Hemolysis | Non-hemolytic | Non-hemolytic | |
| In vitro Hemocompatibility Assay | Pass | Pass | |
| Thrombogenicity Study in Dogs | Thrombosis not significant | Not considered significant | |
| Complement Activation | Meets requirements | Meets requirements | |
| Unactivated Partial Thromboplastin time | Meets requirements | Meets requirements | |
| Prothrombin Time | No adverse effect on prothrombin time | No adverse effect | |
| Sensitization | Meets requirements | Meets requirements | |
| Intracutaneous Reactivity | Meets requirements | Meets requirements | |
| Acute Systemic Toxicity | Negative | Negative | |
| Pyrogenicity | Meets requirements | Meets requirements | |
| Genotoxicity | Not considered mutagenic | Not considered mutagenic | |
| Other Tests | Analysis of Metals in Extract by ICP-MS (Echogenic Taper Needle) | Meets ISO 7864 requirements | Meets requirements |
| Biocompatibility (Aged Devices) - Physicochemical profile | Meets USP requirements | Meets requirements | |
| Biocompatibility (Aged Devices) - Cytotoxicity | Not considered to have cytotoxic potential | Not considered cytotoxic | |
| Biocompatibility (Aged Devices) - Hemolysis | Non-hemolytic | Non-hemolytic | |
| Sterilization | Sterility Assurance Level (SAL) | 10^-6 | Achieved SAL of 10^-6 |
| Residual EO/ECH | EO |
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).