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DeRoyal Angiography Kits are intended for use by licensed physicians. The intended use of individual medical products assembled in these kits will not be changed from the manufacturer's original intended use. These kits are assembled of devices used during cardiac catheterization laboratory procedures such as cardiac catheterization, angiography, arteriogram, etc.

Device Description

DeRoyal Angiography Kits (sometimes referred to as Challenge Kit or Standard Heart and Vascular Kit in this submission) are kits assembled of legally marketed medical devices- either exempt, marketed according to a 510(k), or pre-amendment devices-intended for prescription use during procedures occurring in the cardiac catheterization laboratory. The kits are assembled using DeRoyal and other manufacturer's medical devices. DeRoyal purchases the medical device components assembled in these kits bulk, non-sterile. DeRoyal assembles the kits, packages, and sterilizes the kits.

The DeRoyal Angiography Kit components intended use are unchanged from that of the original manufacturers intended use. These kits are assembled according to customer specifications who specify the contents, quantity of devices and placement of the devices in the kit. DeRoyal customers may request that certain components be bonded prior to placement in the kit for convenience purposes in reducing set up time prior to a procedure. The devices used in the DeRoyal Angiography Kits are standard items used in catheterization laboratory procedures. These kits are assembled in a controlled manufacturing environment and are sterilized by Ethylene Oxide.

AI/ML Overview

The provided text describes a 510(k) submission for DeRoyal Angiography Kits and focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI or diagnostic device. As such, the typical structure for AI/diagnostic device studies (sample size, expert ground truth, MRMC, etc.) does not directly apply.

However, I can extract the relevant information regarding the testing performed to demonstrate the device meets its stated safety and effectiveness for a 510(k) submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a medical kit (an assembly of existing devices), the "acceptance criteria" are primarily related to the manufacturing, sterilization, and material safety of the kit as a whole, focusing on demonstrating these aspects are equivalent to predicate devices and do not raise new safety or effectiveness concerns.

Feature/Test	Acceptance Criteria (Implied by 510(k) Process & Predicate Comparison)	Reported Device Performance
Intended Use	Must be the same as predicate devices (Navilyst Medical Angiography Syringe Kits - K933846, Merit Medical Systems, Inc. - Merit Custom Kits - K913682); individual components' intended uses must remain unchanged.	"Same as predicate" - "intended for use by licensed physicians... during cardiac catheterization laboratory procedures." Individual component intended uses are unchanged.
Contents	Must utilize legally marketed devices.	"Same as predicate" - "Various legally marketed devices." Kits are "assembled of legally marketed medical devices- either exempt, marketed according to a 510(k), or pre-amendment devices."
Assembly (Bonding)	Bonded components must maintain integrity; bonding process must not negatively affect the kit.	"Same as predicate" - "Bonded and non-bonded components." Bench testing performed: visual, pull test, and air leak test. Validation "insure there is not a negative effect on the kit." Specific results (e.g., bond strength values) are not reported in this summary, but the implication is that they met internal criteria.
Design	Customizability using currently marketed devices.	"Same as predicate" - "Custom contents using currently marketed devices and assembled at customer request."
Bonding Agents	Use of agents similar to or established as safe in predicate devices.	"Same as predicate" - "Methylene Chloride or Cyclohexanone or Methylene Chloride 50% and Cyclohexanone 50%."
Sterility	Achieve sterility via Ethylene Oxide (EO) equivalent to predicate devices.	"Same as predicate" - "Ethylene Oxide."
Packaging	Packaging methods equivalent to predicate devices.	"Same as predicate" - "Sterile Pouch."
Biocompatibility (of Kit Materials/Fluidic Path)	Materials must meet ISO 10993-1 for appropriate contact level; fluidic path of bonded components must be biocompatible. Limited patient-contacting materials' biocompatibility established through history of use of original components.	Biocompatibility testing conducted through the fluidic path of bonded components: ISO 10993-1, -5 (Cytotoxicity), -10 (Skin Irritation/Sensitization), -11 (Systemic Toxicity), and ASTM F756 (Hemolytic Properties). Implied successful completion.
Impact on Safety & Effectiveness	The proposed device/kits must not raise any new issues of safety and effectiveness compared to predicate devices.	"The proposed device/kits do not raise any new issues of safety and effectiveness." This is the ultimate conclusion derived from the substantial equivalence argument and testing.

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

Sample Size: The document mentions "The validation was conducted on the DeRoyal Angiography Kit 77-400980". This implies at least one specific kit configuration was tested for bench testing (visual, pull, air leak). Specific numbers of individual samples (e.g., how many bonds were pulled, how many kits were tested for air leaks) are not specified in this summary.
Data Provenance: This is internal company bench testing. No country of origin for external data is mentioned, as it's not a clinical study involving patients. It is retrospective in the sense that it's performed on manufactured kits to validate the manufacturing process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert ground truth in the context of diagnostic accuracy. The "ground truth" for manufacturing and material safety is established by compliance with recognized standards (ISO, ASTM) and successful completion of bench tests.

4. Adjudication method for the test set

Not applicable for this type of submission. Bench tests typically involve direct measurement against a predefined specification.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation of clinical data, which is not the nature of an angiography kit 510(k) submission.

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

No, a standalone performance study (algorithm only) was not done. This is not an AI or algorithm-based device. The "device" is a physical medical kit.

7. The type of ground truth used

The "ground truth" for this submission revolves around:

Compliance with recognized standards: ISO 10993 series and ASTM F756 for biocompatibility.
Successful completion of bench tests: Visual inspection, pull tests for bonded components, and air leak tests. These tests would have internal specifications representing acceptable manufacturing quality and safety.
Substantial equivalence: The primary ground truth is demonstrating that the kit's characteristics (intended use, contents, assembly, sterilization, etc.) are fundamentally the same as legally marketed predicate devices and thus do not raise new questions of safety and effectiveness.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device.

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

Not applicable, for the same reason as above.

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