(323 days)
The Arstasis ITG Vascular Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The ITG Vascular Access System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
The ITG Vascular Access System is a sterile, single use system that consists of the following components: ITG Vascular Access Device, ITG Guide Wire (0.016'' x 80 cm) and ITG Introducer Needle (21 gauge). The ITG Vascular Access System is designed to be used with the Merit Medical Prelude 5F or 6F Sheath Introducer (Merit Catalog Number PSI-6F-11-018 and PSI-5F-11-018; 510(k) K050962, K070159 and K073035; CE Mark CE023). The ITG Vascular Access Device with integrated needle is designed to traverse the femoral attery wall at a shallow, oblique angle as it enters the arterial lumen. The ITG Vascular Access System is used at the beginning of the procedure and creates a shallow vasular access pathway that, in conjunction with manual compression, helps reduce hemostasis time as compared to manual compression alone after removal of the procedural introducer sheath.
The ITG Vascular Access Device is a sterile, single use device and is comprised of four primary components: (1) guide cannula, (2) anchor mechanism, (3) shaft, and (4) handle with control features.
The guide cannula consists of a polymeric, single concentric lumen catheter that extends from the distal tip of the guide cannula to the anchor mechanism and has an access port that is compatible with a 0.016" Guide Wire. An anchor mechanism is located between the guide cannula and the catheter shaft. The anchor mechanism is used to position the device relative to the vessel wall prior to advancement of the integrated needle, and is also used during guide wire placement. The catheter shaft extends from the anchor mechanism proximally to the distal end of the device handle. At the distal end of the shaft there is a flexible, deflectable section that is controlled by a lever on the device handle. The integrated needle is housed at the distal end of the deflectable section and is attached to the plunger on the handle.
The handle contains controls that operate the different features of the ITG Vascular Access Device. The plunger at the proximal end of the handle controls deployment of the heel and integrated needle. The handle lever articulates the flexible, deflectable section of the shaft from a "path formation position" to a "deflected position" in order to control the path of the integrated needle. The lever is pressed against the handle to deflect the flexible section of the device in order to redirect the needle into the vessel lumen. Pressing the lever also releases the internal stop mechanism to allow full deployment of the integrated needle. Full deployment of the integrated needle into the vessel lumen is accomplished by completely depressing the plunger.
The 0.016" Guide Wire is inserted into the plunger port and advanced through the ITG Vascular Access Device into the arterial lumen. Plunger retraction automatically releases the anchor heel and retracts the integrated needle for device removal. The 0.016" Guide Wire remains in the arterial lumen as the ITG Vascular Access Device is removed. An introducer sheath is advanced over the 0.016" Guide Wire and the user proceeds with the percutaneous procedure.
The provided text describes the Arstasis ITG Vascular Access System and its regulatory submission (K091006). However, it does not include specific acceptance criteria or a detailed study proving the device meets said criteria. The document focuses on demonstrating substantial equivalence to predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that "Bench performance testing of the ITG Vascular Access System demonstrates that the ITG System meets or exceeds the performance requirements for the intended clinical use of the system." However, it does not list specific acceptance criteria (e.g., success rates, hemostasis times, complication rates) or provide a table comparing them to reported device performance. It only makes a general statement of compliance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions "Multiple clinical evaluations of the ITG Vascular Access System were conducted." It also states that "The long term safety, as well as the ability to access and re-access, was retrospectively studied in a smaller cohort of patients." However, specific sample sizes for these clinical evaluations are not provided.
- Data Provenance: The document does not specify the country of origin for the clinical data. It clearly states that the long-term safety and re-access study was retrospective. The "short term safety and clinical performance" studies are implied to be prospective, but this is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The filing focuses on the device itself and its equivalence to predicates, not on detailed expert-driven evaluations of a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
The Arstasis ITG Vascular Access System is a medical device for vascular access and hemostasis, not an AI or imaging diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study is not applicable in this context, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical evaluations, the "ground truth" would likely be based on clinical outcomes data related to successful vascular access, hemostasis time, and complication rates directly observed during the procedures. However, the document does not explicitly define how this "ground truth" was established or what specific metrics were used beyond general statements about "safety and clinical performance."
8. The sample size for the training set
The document does not refer to a "training set" in the context of device development or clinical evaluation. For a physical medical device, development often involves engineering testing, bench testing, and animal/cadaver studies, rather than a "training set" in the machine learning sense. The clinical studies mentioned are for verification and validation, not model training.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the machine learning context, this information is not applicable. For the preliminary animal and cadaver studies, the "ground truth" would be direct observation of the device's performance in these non-human models.
§ 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).