(206 days)
The UltraSafe® Model C200 Injector with Needle Guard is designed to hold a sterile medication cartridge with needle in place while administering an injection. The guard is intended to protect the user from needle sticks after injection and during disposal of the needle cartridge unit.
The UltraSafe® Model C200 Injector is used with a standard Sanofi-Winthrop Carpuject® 2.0ml medication cartridge to deliver medication from the cartridge to the tissue of a patient, and is equipped with a shield that covers the needle during disposal. This device is used for a wide range of patients from children to adults and for a wide range of clinical conditions.
The UltraSafe® Model C200 Injector with Needle Guard is a product which is intended to be used with a sterile medication cartridge with needle to deliver medication from the cartridge into the tissues of the patient. The device is totally disposable and is equipped with a needle shield which consists of a safety guard that can be snapped into place after use of a syringe, thus protecting the caregiver by eliminating the need to recap the needle, and minimizing accidental needle stick injuries during disposal of the syringe/needle. The guard requires a two-handed action in order to cover the needle point after use. The Model C200 Injector is made of K-Resin KR01, KR03, and ABS Resin.
The provided text describes the K972877 Premarket Notification for the UltraSafe® Injection System Model C200 Injector with Needle Guard. This document focuses on the substantial equivalence of the new device to existing predicate devices, rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics in the way a clinical trial for a novel drug or a complex AI diagnostic device would.
Here's an analysis based on the provided text, addressing your points as much as possible:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, there are no explicit quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as this is a 510(k) for a medical device seeking substantial equivalence, not a clinical effectiveness trial for a new therapeutic or diagnostic.
However, we can infer some implied criteria and reported performance based on the comparison to predicate devices:
| Acceptance Criterion (Implied) | Reported Device Performance (UltraSafe® Model C200 Injector with Needle Guard) |
|---|---|
| Ability to deliver medication from a cartridge | Intended to be used with a sterile medication cartridge with needle to deliver medication. |
| Protection against accidental needle stick injuries | Equipped with a needle shield that can be snapped into place after use, protecting the caregiver by eliminating the need to recap and minimizing accidental needle stick injuries. |
| Ease of assembly and use (compared to predicate) | "As easy to assemble and use as the Sanofi-Winthrop Injector." |
| Usable needle length (compared to unguarded needles) | "Provides the same useable needle length as an unquarded needle." |
| Ability to perform typical hypodermic procedures | User can perform typical hypodermic procedures equivalently to standard, unguarded needles. |
| Needle guard strength (compared to predicate) | "Found to have considerably greater strength than the predicate device." |
| Biocompatibility of materials | Uses the same materials as the Safety Syringes predicate device, which "have passed biocompatibility tests." |
| Requires two-handed action to cover needle | "Requires a two-handed action in order to cover the needle point after use." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a "test set" in the context of performance metrics or a study. The information presented is descriptive and comparative based on the device's design, materials, and intended function. There is no mention of a particular sample size for testing users or assessing effectiveness in a clinical setting in this document. The data provenance is primarily from the manufacturer's internal assessments and comparisons to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not available in the provided text. The document is a regulatory submission for substantial equivalence based on device design and comparison, not a study requiring a ground truth established by experts for performance evaluation.
4. Adjudication Method for the Test Set
This information is not available in the provided text. As there is no explicitly defined "test set" with performance metrics requiring adjudication, this concept does not apply to the provided document.
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
An MRMC study is not applicable to this device. This device is a manual medical instrument (injector with a needle guard) and does not involve AI or "human readers" in a diagnostic or interpretive sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a mechanical injector, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not available or applicable in the context of a "ground truth" for performance evaluation in the way it would be for a diagnostic or AI device. The "ground truth" for this device revolves around its physical properties (e.g., strength of the guard, ease of use with standard procedures) and safety features (prevention of needle sticks), which are presumably assessed through engineering tests, usability studies, and adherence to established biocompatibility standards.
8. The sample size for the training set
This information is not applicable as the device is a mechanical medical instrument, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is a mechanical medical instrument, not an AI model.
Summary of the Study (as described in the document):
The document describes a comparison study (or more accurately, a descriptive comparison for the purpose of a 510(k) submission) to demonstrate substantial equivalence of the UltraSafe® Injection System Model C200 Injector with Needle Guard to its predicate devices.
The "study" or justification for equivalence is based on the following:
- Design and Functionality Comparison: The C200 is intended for the same use (delivering medication from a cartridge) as the predicate Sanofi-Winthrop Injector. Its needle guard is designed to prevent needle stick injuries, similar to the concept of the UltraSafe Aspirating Syringe.
- Performance Comparison:
- The C200's needle guard reportedly has "considerably greater strength than the predicate device." However, the standard or test method for this strength comparison is not detailed.
- It's stated to be "as easy to assemble and use" as the Sanofi-Winthrop Injector. This is a qualitative assessment.
- It provides the "same useable needle length" as an unguarded needle, ensuring equivalent performance of hypodermic procedures.
- Material Equivalence and Biocompatibility: The C200 uses the "same materials" (K-Resin KR01, KR03, and ABS Resin) as the Safety Syringes predicate device, and these materials have "passed biocompatibility tests."
- Safety Features: The primary safety feature is the needle shield that can be snapped into place after use, eliminating recapping and minimizing accidental needle sticks. A key operational safety aspect highlighted is the "two-handed action" required to cover the needle.
In essence, the "study" presented here isn't a traditional scientific study with detailed experimental protocols, control groups, and statistical analysis of performance metrics. Instead, it's a submission for regulatory clearance asserting that the new device is fundamentally similar in design, materials, and intended use, and performs equivalently to legally marketed devices, with an improvement in needle guard strength.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).