(204 days)
The UltraSafe® Model T200 Injector with Needle Guard is designed to hold a TUBEX® Sterlie Cartridge-Needle Unit 2.5 ml. 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 T200 Injector is used with a Tubex® Sterile Cartinge-Needle Unit 2.5 ml. 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 parenteral methods of administration.
The UltraSafe® Model T200 Injector with Needle Guard is a product which is intended to be used with a TUBEX® Sterile Cartridge-Needle Units 2.5 ml 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 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.
This device is a medical injector system and the documentation provided is a 510(k) premarket notification to the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone performance metrics.
Therefore, many of the requested specific details regarding acceptance criteria, study design, and performance metrics (like sensitivity, specificity, F1 score, effect size in MRMC studies, sample sizes for test and training sets with ground truth specifics) are not available in the provided text. The document is primarily a descriptive comparison and regulatory submission.
However, based on the input, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Protection from accidental needle stick injuries | Needle shield can be snapped into place after use, eliminating need to recap and minimizing accidental needle sticks. |
| Functionality: Deliver medication from cartridge | Intended to be used to deliver medication from a cartridge. |
| Ease of Assembly and Use | As easy to assemble and use as the Wyeth Injector (predicate device). |
| Material Biocompatibility | Materials have passed biocompatibility tests. |
| Strength (Mechanical) | Considerably greater strength than the predicate device. |
| Usable Needle Length (when ready-to-use) | Provides the same usable needle length as an unguarded needle. |
| Equivalent Hypodermic Procedures | User can perform typical hypodermic procedures equivalently to standard, unguarded needles. |
| Disposability | Totally disposable. |
| Compatibility with TUBEX® Sterile Cartridge-Needle Units | Designed to hold a TUBEX® Sterile Cartridge-Needle Unit 2.5 ml. |
| User Protection during Disposal | Guard is intended to protect the user from needle sticks after injection and during disposal. |
| Material Equivalence to Predicate Device | Made of K-Resin KR01, KR03, and ABS Resin, same as Safety Syringes predicate device. |
| Labeled Warning Statements | "Hands must remain behind the needle at all times during use and disposal." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "The Model T200 Injector with Needle Guard has been tested," but does not provide details on the number of devices or subjects tested.
- Data Provenance: Not specified. It's implied to be internal testing by Safety Syringes, Inc. The document does not mention country of origin explicitly or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Not specified. The document describes a statement of substantial equivalence rather than a detailed clinical or performance study with adjudication.
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
- No, an MRMC study was not done. This device is a mechanical injection system, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. The device is a physical injection system, not an algorithm. The "standalone performance" refers to the device's inherent mechanical safety and functionality, which is implicitly what the "testing" mentioned in the document aimed to assess.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance would be derived from specific measurable engineering and functional tests (e.g., force required to activate safety mechanism, needle exposure length, material strength tests) and perhaps user performance assessments (e.g., ease of use, ability to perform typical hypodermic procedures). The document states the device "has been tested" and "found to have considerably greater strength," indicating these types of tests were performed.
- For biocompatibility, the ground truth would be established through standardized biocompatibility tests as per medical device regulations.
8. The Sample Size for the Training Set
- Not applicable. This device is a mechanical medical device, not an AI/machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no training set for this type of device.
§ 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).