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This device is used when viscous liquid needs to be hand-force injected into a manifold or tubing set. The polycarbonate housing enables pressure to be exerted without fear of breakage. nowsing charice problams of so so catheterization procedure.

Control Syringe Models 10200, 10201, 10202, 10203, 10204 and 10205

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria. The documents are a regulatory approval letter (K972655) for "Control Syringe Models 10200, 10201, 10202, 10203, 10204 and 10205" and an "Indications For Use" statement.

Specifically, the text is missing:

1. A table of acceptance criteria and reported device performance: This information is not present. The letter only states that the device is "substantially equivalent" to predicate devices.
2. Sample size used for the test set and data provenance: No details about a test set or its characteristics are provided.
3. Number of experts and their qualifications for ground truth: No mention of experts or ground truth establishment for a test set.
4. Adjudication method: Not discussed in the provided documents.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No information on such a study.
6. Standalone performance study: No details about an algorithm-only performance study.
7. Type of ground truth used: Not specified, as no study details are given.
8. Sample size for the training set: Not mentioned.
9. How ground truth for the training set was established: Not mentioned.

The documents focus solely on the regulatory approval process based on "substantial equivalence" to a predicate device, as opposed to a detailed performance study with specific acceptance criteria.

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Output:
This device is intended for hand injection of contrast media during angiography.

The SDM Control Syringes consist of visibly clear high strength polycarbonate barrels, an elastomeric piston, and a high strength polymeric plunger terminating in a palm plate. The device is modeled in the European style in regard to the finger grips and palm plate. Each barrel is marked to 10cc's of volume in increments of 0.2cc and is very lightly coated with a medical grade silicone oil to enhance smootheness of operation. Two models will be available, one having a 0.5cc reservoir of internal volume remaining in the fully inserted position. The other model will leave no reservoir following full travel of plunger to the bottom of the barrel. These devices will be supplied single packaged and sterile. Packaging will consist of standard Tyvek/Poly pouches.

This document provides a Summary of Safety and Effectiveness for SDM Control Syringes, which are high-pressure syringes intended for hand injection of contrast media during angiography. However, the document does not describe any specific acceptance criteria or a study proving the device meets acceptance criteria.

Instead, it focuses on establishing substantial equivalence to currently marketed devices based on intended use, materials, and design.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies from this document. The document primarily makes the following claims:

• Classification: Class II device; no performance standards established yet.
• Product Description: Visibly clear high-strength polycarbonate barrels, elastomeric piston, polymeric plunger with palm plate. Two models with different internal volume reservoirs. Supplied single-packaged and sterile.
• Intended Use: Hand injection of contrast media during angiography.
• Rationale for Substantial Equivalence: Similar to predicate devices (Medex, Namic, Becton Dickinson, Merit) in intended use, materials, and design. No significant changes or modifications from predicates.
• Biocompatibility: Materials are same type and grade as substantially equivalent devices. Testing performed per ISO Standard 10993, Part I, shows the device to be biocompatible for an externally communicating device (blood path indirect).

The document concludes that, based on these factors, the SDM Control Syringes are substantially equivalent in safety and effectiveness to other high-pressure syringes currently approved for use. None of the detailed study information you requested (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, training set details) is present in this regulatory submission summary.

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Ask a specific question about this device