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510(k) Data Aggregation
(30 days)
The Morph DNA Steerable Introducer Sheath is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.
The Morph DNA Steerable Introducer Sheath is sterile, single-use bidirectional deflectable catheter with an ergonomic handle that has an integrated swiveling hemostasis valve. When the handle is fully actuated, the distal tip deflects to a nominal angle in either of two directions based on the diameter and the working length of the catheter. The catheter tip includes a fluoroscopic marker to help visualize the tip location and vent holes to facilitate aspiration and flushing of the lumen. The Morph DNA handle includes a brake to hold the deflection angle, an integrated hemostasis valve with a swiveling sideport, and 3-way stopcock. Devices are packaged with a compatible dilator on a plastic backing card within a sealed Tyvek pouch, all of which are contained in a product box.
The provided text describes the 510(k) premarket notification for the BioCardia Morph DNA Steerable Introducer Sheath (K242169). This document does not include information about acceptance criteria and a study proving the device meets these criteria in the context of an AI/ML-driven medical device, as the product is a physical medical instrument (a steerable introducer sheath), not an AI/ML software device.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), or ground truth establishment for a machine learning model, as this content is not present in the provided document.
The document details the device's technical specifications, comparison to predicate devices, and various benchtop and simulated use tests conducted to demonstrate that modifications did not affect product specification requirements. These tests are focused on the physical and functional performance of the catheter, not on an AI's diagnostic or predictive capabilities.
Here's a breakdown of what the document does provide in relation to performance testing, which is different from an AI/ML performance study:
Device Performance Testing (Not AI/ML Study)
The document lists performance tests conducted to confirm the device meets product specifications due to modifications from predicate/reference devices.
1. Acceptance Criteria and Reported Device Performance: This section is presented as a list of tests conducted, implying that successful completion of these tests (meeting internal product specifications for each test) is the "acceptance criteria" for this type of physical device. The specific quantitative acceptance criteria values or detailed reported performance values for each test are not explicitly stated in the provided text. Instead, it indicates that the tests were conducted "to confirm that the modifications... did not affect the ability to meet all product specification requirements."
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied as Met) |
|---|---|
| In-Vitro Bench Top Testing: | |
| Distal Tip Performance (angle, curve, residual curvature, angular deviation) | Passed internal specifications |
| Catheter Dimensional Verification (inner/outer diameter, working length) | Passed internal specifications |
| Catheter & Handle Functionality (leakage, connections, rigidity, kinks, column support, force, curve size, deflection, robustness, tensile strength, brake retention, push kink) | Passed internal specifications |
| Fatigue Resistance (deflection, torque) | Passed internal specifications |
| Dilator Verification (inner diameter, joint tensile strength, extension length) | Passed internal specifications |
| Packaging Integrity: | |
| Atmospheric Conditioning (ASTM D4332-14) | Leveraged from predicate and reference devices, implying compliance. |
| Shipping Simulation (ASTM D7386-16) | Leveraged from predicate and reference devices, implying compliance. |
| Gross Leak (ASTM F2096-11) | Leveraged from predicate and reference devices, implying compliance. |
| In-Vitro Simulated Use Testing: | |
| Catheter Navigation to all intended anatomy | Confirmed as functional |
| Deflection Mechanism | Confirmed as functional |
| Brake Mechanism | Confirmed as functional |
| Device Compatibility to guide therapeutic catheters | Confirmed as functional |
| Biocompatibility: | |
| Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, Thromboresistance, Complement Activation | Leveraged from predicate/reference devices, meeting ISO 10993-1 and FDA guidance. |
| Sterilization: | |
| Ethylene Oxide Sterilization | Adopted into existing validation per TIR 28:2009. |
2. Sample Size Used for the Test Set and Data Provenance: Not applicable for a physical device. Testing would involve a number of manufactured units, but this is not typically referred to as a "test set" in the context of data for AI. No information on data provenance (country, retrospective/prospective) is provided as there's no data being collected for an AI model.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not applicable. The "ground truth" for a physical device like this is its physical and functional performance according to engineering specifications and simulated use scenarios, not expert interpretation of medical images or data.
4. Adjudication Method for the Test Set: Not applicable for this type of device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done: No, an MRMC study is relevant for AI/ML diagnostic or prognostic tools that assist human readers. This is a physical medical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no AI algorithm.
7. The Type of Ground Truth Used: For this physical device, the "ground truth" is defined by established engineering and medical device standards (e.g., ISO 10993, ASTM standards) and internal product specifications for attributes like tip deflection, catheter diameter, material properties, and functional performance in simulated use models.
8. The Sample Size for the Training Set: Not applicable, as there is no training set for an AI model.
9. How the Ground Truth for the Training Set Was Established: Not applicable.
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