FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Super Distal Access (SDA) is a single lumen, variable stiffness catheter and has a shaft reinforced with a Stainless Steel/Nitinol coil. The SDA has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a maximum outer diameter of 0.084 inches. It has a tapered design that includes a nominal inner diameter of 0.062 inches in the distal end and 0.068 inches in the proximal end. There are three working lengths available: 115 cm, 125 cm, and 135 cm. The Super Distal Access has a PTFE-lined lumen in the distal end a Polyimide/PTFE-lined lumen in the proximal end. The catheter is flexible and has a hydrophilic coating. The SDA is inserted through a guide catheter or vascular sheath, provides access to the target site, and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a split sheath introducer. The SDA is supplied sterile, non-pyrogenic, and intended for single use only.

AI/ML Overview

The provided text describes the non-clinical performance testing for the Super Distal Access (SDA) device to demonstrate its substantial equivalence to a predicate device. It includes acceptance criteria and conclusions for various tests.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance (Conclusion)
Biocompatibility - Material Mediated Pyrogen	The test article extracts must not cause a febrile reaction greater than 0.5°C in any individual subject.	SDA test samples met the acceptance criteria for Material Mediated Pyrogen to demonstrate that the SDA is substantially equivalent to the predicate device.
Biocompatibility - Cytotoxicity MEM Elution	The cultures treated with the test article must not have a reactivity grade greater than 2.	SDA test samples met the acceptance criteria for Cytotoxicity MEM Elution to demonstrate that the SDA is substantially equivalent to the predicate device.
Biocompatibility - Hemolysis ASTM Method, extract human blood	The hemolytic index above the negative control article must be less than 5%.	SDA test samples met the acceptance criteria for Hemolysis ASTM Method, extract human blood to demonstrate that the SDA is substantially equivalent to the predicate device.
Biocompatibility - Hemolysis, ASTM method, direct contact (human blood)	The hemolytic index above the negative control article must be less than 5%.	SDA test samples met the acceptance criteria for Hemolysis, ASTM method, direct contact (human blood) to demonstrate that the SDA is substantially equivalent to the predicate device.
Biocompatibility - Unactivated Partial Thromboplastin Time	There must be no statistical decrease between the UPTT of plasma exposed to the test article and to the negative or untreated control.	SDA test samples met the acceptance criteria for Unactivated Partial Thromboplastin Time to demonstrate that the SDA is substantially equivalent to the predicate device.
Biocompatibility - Complement Activation	There must be no statistical increase between either the C3a or SC5b-9 concentrations in plasma exposed to the test article as compared to the negative and untreated controls.	SDA test samples met the acceptance criteria for Complement Activation to demonstrate that the SDA is substantially equivalent to the predicate device.
Biocompatibility - Dog Thromboresistance	The test articles must receive a thrombus formation score less than or equal to that of the control.	SDA test samples met the acceptance criteria for Dog Thromboresistance to demonstrate that the SDA is substantially equivalent to the predicate device.
Biocompatibility - Maximization Sensitization	The test article must elicit a positive response in less than 10% of the test animals.	SDA test samples met the acceptance criteria for Maximization Sensitization to demonstrate that the SDA is substantially equivalent to the predicate device.
Biocompatibility - Intracutaneous Toxicity/Reactivity	The test article extracts must not induce a significantly greater biological reaction than the control.	SDA test samples met the acceptance criteria for Intracutaneous Toxicity/Reactivity to demonstrate that the SDA is substantially equivalent to the predicate device.
Biocompatibility - Acute Systemic Toxicity Test	The test article extracts must not induce a significantly greater biological reaction than the control.	SDA test samples met the acceptance criteria for Acute Systemic Toxicity Test to demonstrate that the SDA is substantially equivalent to the predicate device.
Animal Testing - Angiographic Evaluation	No units tested can cause vessel injury.	SDA test samples met the acceptance criteria for Animal Testing - Angiographic Evaluation to demonstrate that the SDA is substantially equivalent to the predicate device.
Chemical Compatibility	Chemicals have no negative effect on the catheter or accessories.	SDA test samples met the acceptance criteria for Chemical Compatibility to demonstrate that the SDA is substantially equivalent to the predicate device.
Radiographic Detectability	Product shall be visible under fluoro imaging.	SDA test samples met the acceptance criteria for Radiographic Detectability to demonstrate that the SDA is substantially equivalent to the predicate device.
Visual Inspection	Catheter shall appear free from damage, including a rounded tip and smooth transition points.	SDA test samples met the acceptance criteria for Visual Inspection to demonstrate that the SDA is substantially equivalent to the predicate device.
Working Length	Test samples should be within existing working length specification.	SDA test samples met the acceptance criteria for Working Length to demonstrate that the SDA is substantially equivalent to the predicate device.
Hub compatibility	Hub shall meet existing Luer specifications.	SDA test samples met the acceptance criteria for Hub compatibility to demonstrate that the SDA is substantially equivalent to the predicate device.
Outside diameter	Test samples should be within existing outside diameter specification.	SDA test samples met the acceptance criteria for Outside diameter to demonstrate that the SDA is substantially equivalent to the predicate device.
Leak - Air	Test samples should be within existing Air - Leak specifications.	SDA test samples met the acceptance criteria for Leak - Air to demonstrate that the SDA is substantially equivalent to the predicate device.
Leak - Liquid	Test samples should be within existing Leak - Liquid specifications.	SDA test samples met the acceptance criteria for Leak – Liquid to demonstrate that the SDA is substantially equivalent to the predicate device.
Particulates	Test samples should be within existing Particulate specifications.	SDA test samples met the acceptance criteria for Particulates to demonstrate that the SDA is substantially equivalent to the predicate device.
Simulated Use - Bench	Test samples must meet predetermined user needs.	SDA test samples met the acceptance criteria for Simulated Use - Bench to demonstrate that the SDA is substantially equivalent to the predicate device.
Catheter Burst	Test sample burst pressures must meet or exceed existing minimum burst pressure specification.	SDA test samples met the acceptance criteria for Catheter Burst to demonstrate that the SDA is substantially equivalent to the predicate device.
Tensile	Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications.	SDA test samples met the acceptance criteria for Tensile to demonstrate that the SDA is substantially equivalent to the predicate device.
Corrosion	Test samples shall exhibit no evidence of corrosion.	Test results for the predicate device were leveraged for the SDA as the materials and manufacturing processes are equivalent.
Packaging - Dye Leak	Test sample shall not exhibit any visual leaks or channels.	Test results for the predicate device were leveraged for the SDA as the materials and manufacturing processes are equivalent.
Packaging - Peel	Test sample tensile strength must meet or exceed existing tensile strength specifications.	Test results for the predicate device were leveraged for the SDA as the materials and manufacturing processes are equivalent.
Kink Resistance	Test sample kink resistance must meet or exceed existing Kink Resistance specifications.	SDA test samples met the acceptance criteria for Kink Resistance to demonstrate that the SDA is substantially equivalent to the predicate device.
Torque	Test sample torque results must meet or exceed existing torque specifications.	SDA test samples met the acceptance criteria for Torque to demonstrate that the SDA is substantially equivalent to the predicate device.
PTFE Liner inspection	Test sample liner adhesion must meet or exceed existing PTFE Liner inspection specifications.	SDA test samples met the acceptance criteria for PTFE Liner inspection to demonstrate that the SDA is substantially equivalent to the predicate device.
Hydrophilic Coating Integrity	Test sample results must meet or exceed existing Hydrophilic Coating Integrity specifications.	SDA test samples met the acceptance criteria for Hydrophilic Coating Integrity to demonstrate that the SDA is substantially equivalent to the predicate device.
Labeling Legibility	Test samples shall demonstrate text legibility.	SDA test samples met the acceptance criteria for labeling legibility to demonstrate that the SDA is substantially equivalent to the predicate device.
Barcode	Test samples shall demonstrate readily readable barcodes.	SDA test samples met the acceptance criteria for barcode testing to demonstrate that the SDA is substantially equivalent to the predicate device.
Sterilization	Sterilization load shall pose an equal or lesser challenge to sterilize than existing sterile product loads.	SDA sterilization load met the acceptance criteria for sterilization to demonstrate that the SDA is substantially equivalent to the predicate device.
Shelf Life	Aged test samples must meet or exceed existing specifications.	SDA test samples met the acceptance criteria for shelf life to demonstrate that the SDA is substantially equivalent to the predicate device.

2. Sample size used for the test set and the data provenance:

Sample Size: The document repeatedly states "SDA test samples met the acceptance criteria". However, it does not specify the exact sample size (N) used for each test.
Data Provenance: The biocompatibility tests were "conducted pursuant to 21CFR58, Good Laboratory Practices." The animal testing occurred in a "porcine model". Other non-clinical tests mention "conditioned samples" or "test samples". The origin of the data (country) is not explicitly stated, but the submission is to the U.S. FDA. The tests are prospective as they were conducted for the purpose of this submission to demonstrate substantial equivalence of the new device.

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):

For the "Simulated Use - Bench" test, it states the product was evaluated "by a physician in a benchtop model." It does not specify the number or qualifications of this physician or any other experts involved in establishing ground truth for other tests. These appear to be laboratory and engineering tests rather than requiring expert clinical "ground truth" in the diagnostic sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

The document does not describe any adjudication method. The tests are primarily objective performance metrics against pre-defined acceptance criteria, not subjective interpretations requiring adjudication.

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, this document does not describe an MRMC comparative effectiveness study. This is a 510(k) submission for a medical catheter (Super Distal Access), not an AI-powered diagnostic device. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, this document does not describe any algorithm-only or human-in-the-loop performance studies. As mentioned, this is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device's performance is established by objective measurements and observations against engineering standards, biocompatibility guidelines (e.g., ISO 10993 series, ASTM standards, USP 788), and pre-defined specifications. For example, for "Biocompatibility - Material Mediated Pyrogen", the ground truth is the measured febrile reaction in test subjects. For "Radiographic Detectability", the ground truth is visibility under fluoro imaging. In some cases, such as "Animal Testing - Angiographic Evaluation", the "ground truth" is absence of vessel injury observed in a porcine model.

8. The sample size for the training set:

This concept is not applicable here. This is a physical medical device undergoing non-clinical performance testing, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

This concept is not applicable here, as there is no training set for a machine learning model.

Summary

Regulation Number and Section

§ 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).