(5 days)
The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.
The Entry Needle is an accessory device which is used to gain access to the vein or artery including but not limited to the radial 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 including but not limited to the radial artery.
The Glidesheath is comprised of an introducer sheath and a dilator. The Glidesheath is coated with a hydrophilic coating to reduce the frictional resistance of the sheath when inserting or removing the sheath from the patient's blood vessel. The Sheath and Dilator contain bismuth, making these devices visible under fluoroscopy. The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.
The Entry Needle is an accessory device which is used to gain access to the vein or artery including but not limited to the radial 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 including but not limited to the radial artery. The Guide Inserter which is attached to the Mini Guide Wire holder is used to straighten out the wire.
Accessories to the Glidesheath are the metal entry needle and the mini guide wire. Both the metal entry needle and the mini guide wire are packaged with the Glidesheath in a pouch prior to sterilization.
The provided text describes the 510(k) summary for the Glidesheath introducer sheath, comparing it to a predicate device (K082644) to demonstrate substantial equivalence. The information focuses on the device's design, materials, specifications, and performance testing, which is largely bench testing and biocompatibility studies.
Here's an analysis of the requested information based on the provided document:
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail threshold manner for each performance test. Instead, it lists the performance tests that were successfully passed. The implication is that passing these tests constitutes meeting the acceptance criteria for a medical device of this type.
Table of Acceptance Criteria and Reported Device Performance:
| Performance Test Category | Specific Test | Reported Device Performance |
|---|---|---|
| Needle | Needle surface free from defects | Successfully passed (implied: surface was free from defects) |
| Needle OD | Successfully passed (implied: met specified OD) | |
| Needle length | Successfully passed (implied: met specified length) | |
| Needle ID | Successfully passed (implied: met specified ID) | |
| Needle hub conical entry angle | Successfully passed (implied: met specified angle) | |
| Bevel indicator visibility | Successfully passed (implied: indicator was visible) | |
| Bevel indicator position | Successfully passed (implied: met specified position) | |
| Needle to hub joint strength | Successfully passed (implied: met strength requirements) | |
| Gauge Luer taper | Successfully passed (implied: conformed to Luer taper standards) | |
| Liquid leakage from fitting assembly under pressure | Successfully passed (implied: no liquid leakage) | |
| Air leakage into the fitting assembly during aspiration | Successfully passed (implied: no air leakage) | |
| Separation force of fitting assembly | Successfully passed (implied: met separation force requirements) | |
| Unscrewing torque of fitting assembly | Successfully passed (implied: met unscrewing torque requirements) | |
| Ease of assembly | Successfully passed (implied: easy to assemble) | |
| Resistance to overriding | Successfully passed (implied: resisted overriding) | |
| Stress cracking | Successfully passed (implied: no stress cracking) | |
| Corrosion resistance | Successfully passed (implied: resistant to corrosion) | |
| Guide Wire | Guidewire surface free from defects | Successfully passed (implied: surface was free from defects) |
| Tip buckling test | Successfully passed (implied: tip resisted buckling) | |
| Test for resistance of guidewires to damage by flexing | Successfully passed (implied: guidewire resisted damage from flexing) | |
| Test for fracture of guidewires | Successfully passed (implied: no fracture) | |
| Test for distal tip retention | Successfully passed (implied: distal tip was retained) | |
| Guidewire OD | Successfully passed (implied: met specified OD) | |
| Guidewire length | Successfully passed (implied: met specified length) | |
| Test for corrosion resistance | Successfully passed (implied: resistant to corrosion) | |
| Dilator | Dilator surface free from defects | Successfully passed (implied: surface was free from defects) |
| Dilator tip ID | Successfully passed (implied: met specified tip ID) | |
| Dilator to hub joint strength | Successfully passed (implied: met strength requirements) | |
| Sheath | Sheath surface free from defects | Successfully passed (implied: surface was free from defects) |
| Sheath tip ID | Successfully passed (implied: met specified tip ID) | |
| Sheath to housing joint strength | Successfully passed (implied: met strength requirements) | |
| Housing to cap joint strength | Successfully passed (implied: met strength requirements) | |
| Inserter | Guidewire inserter surface free from defects | Successfully passed (implied: surface was free from defects) |
| System | System use in model | Successfully passed (implied: system functioned correctly in a model) |
| Biocompatibility | Physicochemical Profile | Successfully passed (implied: met profile requirements) |
| Cytotoxicity | Successfully passed (implied: no cytotoxic effects) | |
| Sensitization | Successfully passed (implied: no sensitization) | |
| Acute Intracutaneous Reactivity | Successfully passed (implied: no intracutaneous reactivity) | |
| Acute Systemic Toxicity | Successfully passed (implied: no systemic toxicity) | |
| Hemolysis | Successfully passed (implied: no hemolysis) | |
| Thromobogenicity | Successfully passed (implied: not thrombogenic) | |
| Complement Activation Assay | Successfully passed (implied: no complement activation) | |
| Unactivated Partial Thromboplastin Time Assay | Successfully passed (implied: appropriate coagulation response) | |
| In Vitro Hemolysis | Successfully passed (implied: no in vitro hemolysis) | |
| Genotoxicity | Successfully passed (implied: no genotoxic effects) | |
| Pyrogen Study | Successfully passed (implied: non-pyrogenic) | |
| Extractable Metals and Acidity/Alkalinity | Successfully passed (implied: met requirements for extractables) | |
| Sterilization | ANSI / AAMI / ISO 11135 validation | Successfully validated to SAL of 10^-6 |
Study Details for Acceptance Criteria Proof:
-
Sample size used for the test set and data provenance:
- The document does not specify sample sizes for individual performance tests (e.g., how many needles were tested for joint strength).
- It also does not indicate the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of bench testing, it's typically performed in a laboratory setting by the manufacturer.
-
Number of experts used to establish the ground truth for the test set and their qualifications:
- This information is not provided. For mechanical and biocompatibility testing, ground truth is typically established by adhering to recognized international standards and internal quality control specifications, rather than relying on expert consensus in the way clinical studies do. The "experts" would be the engineers and scientists performing and interpreting the standardized tests.
-
Adjudication method for the test set:
- This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving subjective interpretations (e.g., image reading). The listed performance tests are primarily objective, quantitative, or qualitative assessments against defined standards.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging devices or devices where human interpretation is a key component, often comparing human performance with and without AI assistance. This document describes a physical medical device (introducer sheath) that does not involve diagnostic interpretation or AI.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical mechanical instrument and does not incorporate an AI algorithm.
-
The type of ground truth used:
- The ground truth for most performance tests (Needle, Guide Wire, Dilator, Sheath, Inserter, System) would be based on engineering specifications, material science standards, and functional requirements for similar medical devices.
- For Biocompatibility, the ground truth is established by international biological evaluation standards (ISO 10993), which define acceptable thresholds for biological responses (e.g., absence of cytotoxicity, genotoxicity, etc.).
- For Sterilization, the ground truth is based on sterilization validation standards (ANSI/AAMI/ISO 11135) to achieve a defined Sterility Assurance Level (SAL) of 10^-6.
-
The sample size for the training set:
- This is not applicable. The Glidesheath is a physical medical device, not an AI or machine learning model that requires a "training set."
-
How the ground truth for the training set was established:
- This is not applicable for the same reason as point 7.
§ 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).