(119 days)
The Route 92 Medical Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.
The Route 92 Medical Access System is comprised of an Access Catheter and a Delivery Catheter. The distal portion of the Access Catheter is a single-lumen, variable stiffness catheter. Like the predicate device, the proximal portion is a stainless-steel control wire. The Delivery Catheter is a hubbed, singlelumen variable stiffness catheters are hydrophilically coated. The Route 92 Medical Access System is intended for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. The devices are provided sterile and non-pyrogenic and are intended for single use only.
The provided text describes the acceptance criteria and the studies conducted for the Route 92 Medical Access System.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for all tests was "PASS". The reported device performance for all tests was also "PASS". This is explicitly stated for each test category.
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Demonstrates non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic, minimal complement activation, non-activator of intrinsic coagulation, non-hemolytic, similar thromboresistance, non-mutagenic, and non-clastogenic. | All tests passed, concluding the device meets biocompatibility requirements. |
| Dimensional Verification | Conformance to specifications | PASS |
| Luer Integrity | Per ISO 80369-7:2016 | PASS |
| RHV Sealing | Sealing around catheter shafts | PASS |
| Tensile Strength | Strength of catheter sections and bonds | PASS |
| Kink Resistance | Resistance to kinking in a defined bend diameter | PASS |
| Torsion Resistance | Integrity after rotation | PASS |
| Tip Flexibility | Flexibility of the tip | PASS |
| Air Leakage | Per ISO 10555-1:2013 Annex D | PASS |
| Liquid Leakage / Static Burst | Per ISO 10555-1:2013 Annex C | PASS |
| Dynamic Burst | Mechanical integrity up to specified pressures | PASS |
| Flow | Contrast media flow rates equivalent to predicate devices | PASS |
| Hydrophilic Coating Integrity | Integrity after multiple insertion/withdrawal cycles | PASS |
| Particulate Recovery | Effluent water tested per USP after multiple cycles | PASS |
| Corrosion Resistance | Per ISO 10555-1:2013 Annex A | PASS |
| Simulated Use Testing | Deliverability and compatibility in a neurovascular model | PASS |
| Packaging Integrity | Per ISO 11607-1 Part 1 & ISO 11607-2 Part 2 | PASS |
| Radiopacity | Radiopacity in an animal model under fluoroscopy | PASS |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific "sample size" for each individual test within the performance and biocompatibility sections. Instead, it generally refers to "All samples" or "test animals" for biocompatibility.
- For Biocompatibility: The tests used "animals" (Guinea Pigs, Rabbits, Mice, potentially others for in-vitro tests). The number of animals per test is mentioned for some (e.g., "None of the animals", "rabbits administered").
- For Performance Testing: The results consistently state "All samples met the pre-determined acceptance criteria." without specifying the number of samples.
- Data Provenance: The studies are non-clinical, meaning they are laboratory or animal-based tests. The document does not specify the country of origin of the data, nor whether it is retrospective or prospective, though non-clinical tests are generally prospective laboratory studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The studies described are non-clinical in nature, focusing on the physical and biological characteristics of the device. There is no mention of "experts" establishing a "ground truth" for a test set in the context of human evaluation or diagnostic accuracy, as this device is a medical instrument, not a diagnostic algorithm.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable given the nature of the non-clinical testing performed. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies evaluating human interpretation (e.g., image reading) where disagreement among experts needs resolution.
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
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic AI systems or those involving human interpretation of data, which is not the function of the Route 92 Medical Access System.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a physical medical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic AI is not directly applicable here. For the non-clinical tests:
- Biocompatibility: Ground truth is established by standardized biological evaluation methods and safety endpoints (e.g., no signs of toxicity, irritation, sensitization).
- Performance Testing: Ground truth is established by engineering specifications, recognized industry standards (e.g., ISO standards), and functional requirements (e.g., flow rates, mechanical integrity).
8. The Sample Size for the Training Set
This information is not applicable. This document describes the testing of a physical medical device, not a machine learning model, so there is no "training set."
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 medical device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).