(278 days)
The MedSafe ClickSafe™ syringe is a 3cc sterile, non-toxic, non-pyrogenic, disposable, manually activated, plunger type, anti-stick syringe with integral hypodermic needle. Its primary intended use and indication for use is to provide safe, accurate and reliable method of injecting medication into a patient, subcutaneous as well as intramuscular. Needle retraction is activated by the syringe user after removing the needle from the patient first. Its secondary intended use and indication for use is to retract and contain the contaminated needle after injection and render the syringe inoperable for further injections while not introducing any additional steps to the one-handed operation method, for the purpose of aiding in the prevention of accidental needle stick injuries that would be occurring between removing the needle from the patient and disposing it into the Sharps container.
The MedSafe ClickSafe™ Syringe is a 3cc, sterile, non-toxic, non-pyrogenic, disposable, manually activated, plunger type, Anti-Stick syringe with integral hypodermic needle, as detailed within this submission and in relevant patents. The primary intended use of the device is to give safe and accurate subcutaneous and intramuscular injections. Its secondary intended use is to retract and contain the contaminated needle after injection and render the syringe inoperable for further injections while not introducing any additional steps to the one-handed operating method, for the purpose of aiding in the prevention of accidental needle stick injuries. The MedSafe Safety Syringe operates in the same manner as standard hypodermic syringes, prior to the actuation of the safety mechanism. The plunger is retracted as the medication is drawn up to the desired amount. Next, the medication is administered to the patient in the usual way, by inserting the needle into the patient's tissue and depressing the plunger. Figure 1 shows the syringe in its configuration after the medication has been expelled and before the actuation of the safety mechanism. The various parts are identified therein, including the plunger, the boot, the body (barrel) and the needle, all of which are common to standard syringes. The difference is that the boot in the MedSafe syringe is rupturable and the plunger is hollow. The needle is held by the needle hub, which is in turn held in place by the base, which also serves to seal the medication in the syringe. The base is held in place at its plunger-end by an interior shelf in the body. There is a spring around the needle which is held in place by the nose and bears against the needle hub. Once the medication is expelled, the continued depression of the plunger causes the base (which contains the entire needle assembly) to slide, thereby compressing the spring. Continued depression of the plunger drives the needle hub against the nose and pushes the base over the needle hub. As the needle hub exits the base, it stretches the boot which subsequently ruptures. At this time, the compressed spring propels the needle and hub into the hollow plunger, where it is caught and secured by the needle catch (integral to the plunger). Thus, the "dirty" needle is securely held out of harm's way inside the plunger, as depicted in Figure 2. After use, the healthcare worker disposes of the syringe in a sharps container in accordance with OSHA regulations.
This document is a 510(k) Pre-market Notification for a medical device called the "MedSafe ClickSafe™ Safety Antistick Syringe with hypodermic needle". This type of submission is for demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving safety and efficacy through extensive clinical studies with specified acceptance criteria.
Therefore, the document does not contain the detailed information typically found in a study demonstrating a device meets specific acceptance criteria based on performance metrics that would be applicable to AI or software-as-a-medical-device.
However, based on the provided text, I can infer and extract some relevant information as it pertains to demonstrating equivalence for a traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the same way one might for a novel AI device with specific performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" for K032517 are implicitly tied to demonstrating substantial equivalence to its predicate device (VANISHPOINT SYRINGE, K946219). The performance, in this context, refers to the device being at least as safe and effective as the predicate.
The table provided shows a comparison of technological characteristics:
| FDA file reference number | K946219 (Predicate Device) | MedSafe ClickSafe™ Safety Antistick Syringe |
|---|---|---|
| Technological Characteristics | Comparison result | (Implied Acceptance Criteria) |
| Indications for use | Identical | Must be identical to predicate |
| Target population | Identical | Must be identical to predicate |
| Design | Similar | Can be similar, not necessarily identical |
| Materials | Similar | Can be similar, not necessarily identical |
| Performance | Identical | Must be identical to predicate |
| Sterility | Similar | Must meet similar sterility standards |
| Biocompatibility | Similar | Must meet similar biocompatibility standards |
| Mechanical safety | Identical | Must achieve identical mechanical safety |
| Chemical safety | Similar | Must achieve similar chemical safety |
| Anatomical sites | Identical | Must be identical to predicate |
| Human factors | Similar | Must have similar human factors |
| Energy used and/or delivered | Identical | Not applicable (identical) |
| Compatibility with environment and other devices | Identical | Must be identical to predicate |
| Where used | Identical | Must be identical to predicate |
| Standards met | Similar | Must meet similar standards |
| Electrical safety | Identical (not applicable) | Not applicable (identical) |
| Thermal safety | Identical (not applicable) | Not applicable (identical) |
| Radiation safety | Identical (not applicable) | Not applicable (identical) |
Reported Device Performance:
The document states "This device is safe and effective as the predicate device cited above." and the comparison table explicitly states "Comparison result" as "Identical" or "Similar" for all characteristics, implying that the MedSafe ClickSafe™ Syringe meets or exceeds the demonstrated performance of the predicate device across these characteristics. Specifically, for "Performance" and "Mechanical safety", it is stated as "Identical." The primary performance claim is its ability to retract and contain the contaminated needle and render the syringe inoperable, aiding in the prevention of accidental needle stick injuries, which is equivalent to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective). This is typical for a 510(k) submission for this type of device, which relies heavily on comparison to a predicate and performance testing (bench testing, biocompatibility, sterilization validation) rather than extensive clinical trials with human participant data. While there would have been performance tests (e.g., force to activate, needle retraction reliability), the document does not detail these studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this 510(k) submission. "Ground truth" established by experts is typically associated with studies involving diagnostic accuracy or interpretation of medical images/data, which is not the focus of this syringe submission.
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of a test set requiring adjudication in the context of expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed for this device. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with and without AI assistance, which is irrelevant for a manually operated safety syringe.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study for an algorithm was not performed. This term applies to AI/software, not a physical medical device like a syringe. The syringe's primary safety mechanism is physical and manually operated, not algorithmic.
7. Type of Ground Truth Used
The concept of "ground truth" as typically discussed in AI/diagnostic studies is not directly applicable here. For this device, "truth" would be established through:
- Bench testing: Verifying the mechanical function (e.g., needle retraction, rendering inoperable).
- Biocompatibility testing: Ensuring materials are safe for human contact.
- Sterilization validation: Confirming sterility.
- Comparison to predicate device's established performance.
These are functional and safety verifications, not "ground truth" derived from expert interpretation or outcomes data in a clinical trial context.
8. Sample Size for the Training Set
There is no mention of a "training set" sample size. The concept of a training set is relevant to machine learning algorithms, which are not part of this device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this information is not applicable.
§ 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).