(91 days)
The Universal Adjustable T-Rail Table Bracket is intended to be used as an accessory for supporting Medrad Mark IV, Mark V, and Mark V Plus Angiographic injectors and other Medrad injectors of similar weight and post size.
The Universal Adjustable T-Rail Table Bracket, catalog number KMA-350, is substantially equivalent to Medrad's Universal T-Rail Table Bracket, catalog number KMA-339, a pre-amendment device. Both products have the same intended use to support Medrad Mark IV, Mark V, and Mark V Plus Angiographic Injectors and other Medrad injectors of similar weight (22 lbs. for the Mark IV, 19 lbs. for the Mark V Plus) and post size. Both fit on table rails from ¼ to ½ inches thick and 7/8 to 1-1/8 inches high. The primary differences are that the design of the proposed KMA-350 Table Bracket is modified to allow the bracket height to be adjusted; and that the KMA:350 Table Bracket can be secured to a table rail without needing to be disassembled.
This document describes a 510(k) submission for the Medrad Universal Adjustable T-Rail Table Bracket (KMA-350), seeking substantial equivalence to the predicate device, Medrad Universal T-Rail Table Bracket (KMA-339). The submission focuses on comparing the new device's characteristics to the predicate and highlighting its modified design for adjustability and ease of attachment.
Here's an analysis of the provided information, framed by your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly defined by the characteristics of the predicate device, as the submission aims for substantial equivalence. The "device performance" refers to the new device's characteristics.
| Criterion (Feature) | Acceptance (Predicate Device KMA-339) | Reported Device Performance (Proposed Device KMA-350) |
|---|---|---|
| Intended Use | Accessory for supporting Medrad Angiographic Injectors. | Accessory for supporting Medrad Mark IV, Mark V, and Mark V Plus Angiographic injectors and other Medrad injectors of similar weight and post size. |
| Dimensions (Height) | 17-3/8 inches | 12 to 17 inches |
| Height Adjustable | No | Yes (5 inches) |
| Table Rail Size Compatibility | From 1/8 to ½ inches thick and 7/8 to 1-1/4 inches wide | From ¼ to ½ inches thick and 7/8 to 1-1/8 inches high |
| Electrical Isolation | Same (isolated from injector head via plastic bushing) | Yes (The bracket is isolated from the injector head via a plastic bushing at the injector head collar.) |
Study Proving Device Meets Acceptance Criteria:
The document describes a substantial equivalence determination study. This type of study does not involve traditional clinical trials or performance testing against acceptance criteria in the same way a new, novel device might. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
The study presented here is a design comparison and functional assessment against a predicate device.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not applicable in the traditional sense of a human subject or data-driven 'test set'. The "test set" here comprises the design specifications and physical characteristics of the proposed KMA-350 device, which are then compared to the predicate KMA-339. There are no patient data or image sets involved.
- Data Provenance: The data provenance is from Medrad Inc.'s internal design and manufacturing specifications for both the proposed KMA-350 and the predicate KMA-339. This is retrospective in the sense that the predicate device is already on the market, and its specifications are established. The new device's specifications are part of its development process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. "Ground truth" in this context would be the established specifications and performance of the predicate device, and the design intent/specifications of the proposed device. This is determined by the manufacturer's engineering and design teams, not by independent experts establishing a "ground truth" for a test set in the clinical or AI sense.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method in the sense of resolving discrepancies in expert opinions, as no such opinions are being solicited for a clinical or image-based test set. The comparison is objective, based on physical and functional specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a mechanical bracket for supporting an injector. MRMC studies are typically used for diagnostic devices (e.g., imaging software) where human readers interpret medical cases.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This device is a mechanical accessory, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this substantial equivalence submission is essentially the established specifications, intended use, and performance of the predicate device (KMA-339), as well as the design and engineering specifications of the new device (KMA-350). These are objective engineering parameters and manufacturer-defined intended uses.
8. Sample Size for the Training Set
Not applicable. There is no "training set" as this is a mechanical device, not an AI or machine learning application.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reasons as point 8.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.