Search Results

The Safety Auto-Disable Syringe with Needle (Auto-Lock) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.

It has a detachable needle with a dedicated fitting. The Safety Auto-Disable Syringe with Needle (Auto-Lock) contains an inner mechanism used to allow the needle to be retracted inside the plunger rod of the syringe after the operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

The proposed device is a single use, sterile syringe composed of barrel, plunger, plunger, push-button, spring, spring holder, rubber stopper, needle cap, and autodisable part.

The document provided is a 510(k) premarket notification for a "Safety Auto-Disable Syringe with Needle (Auto-Lock)". It describes the device, its intended use, and a comparison to predicate devices, along with summaries of performance testing.

Here's an analysis of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" for each individual test in the format usually expected for a medical device. Instead, it lists various bench tests and indicates that the device conforms to relevant ISO standards. For the simulated clinical study, a specific performance metric related to the failure rate is given.

Here's a table based on the information provided, focusing on the simulated clinical study's outcome as the most direct "performance" metric stated:

For other tests, the document generally states "Conforms to [ISO Standard]" or "Comply to [ISO Standard]" as the performance, implying that the standards themselves define the acceptance criteria. Examples include:

2. Sample size used for the test set and the data provenance

• Sample Size for Simulated Clinical Study: 512 devices.
• Data Provenance: The simulated clinical study and a "clinical investigation" were "performed in China per the requirements of China FDA." This indicates the data is prospective, acquired from China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of "experts" to establish ground truth in the context of the simulated clinical study or other performance tests. The tests performed are primarily bench tests and a simulated clinical study, which would rely on objective measurements and established protocols rather than expert consensus on a "ground truth" (e.g., as in image interpretation).

4. Adjudication method for the test set

Not applicable. The tests described are objective performance and safety evaluations, not subjective assessments requiring adjudication by multiple readers or experts.

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

Not applicable. This is a medical device (syringe), not an AI-powered diagnostic or assistive tool where MRMC studies would be relevant to evaluate AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical syringe, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, clinical outcomes) is not directly applicable to the performance testing of this physical medical device. The "ground truth" for the tests mentioned (e.g., sterility, fluid delivery accuracy, needle integrity) would be defined by the specifications and measurable parameters within the referenced ISO standards. For example, for "Sterile test," the ground truth is "sterile" as determined by microbiology methods conforming to standards. For "hub/needle bond strength," the ground truth is a specific force threshold defined in ISO 7864.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The Ritract Safety Syringe is a sterile, single-use, disposable, nonreusable, auto-retracting safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injury and the potential for syringe reuse.

The Ritract Safety Syringe is a sterile, single-use, disposable, nonreusable, 3mL, 5mL, 10ml, auto-retracting safety syringe with a standard luer lock needle connection.

The provided K060002 510(k) premarket notification for the Ritract Safety Syringe does not contain the specific details about acceptance criteria or a dedicated study that proves the device meets such criteria.

This document is a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a detailed performance study with explicit acceptance criteria. The equivalence is primarily based on:

• Mode of operation: The Ritract Safety Syringe and the predicate (BD Integra Spring Based Syringe K011103) both use the action of the plunger bottoming out to release a compressed spring, retracting the needle.
• Function: Both devices are auto-retracting safety syringes intended for injecting fluids while reducing sharps injury and preventing reuse.
• Materials used, packaging, and manufacturing processes: The document states these are also equivalent.

Therefore, I cannot populate the requested table or answer most of the questions using the provided text. The submission implies that by being substantially equivalent to a predicate device, it inherently meets the performance standards expected for such devices, rather than establishing new, explicit acceptance criteria and proving them through a dedicated study within this document.

Here's what can be inferred or explicitly stated from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative metrics (e.g., success rate percentage for needle retraction). The implicit acceptance criterion is that the device functions to auto-retract the needle upon full plunger depression, similar to the predicate.
• Reported Device Performance: The document states, "The Ritract Safety Syringe also uses the action of the plunger bottoming out to release the compressed spring. In the case of the Ritract Syringe the spring is held in compression by a collar system which as the plunger bottoms out the interaction of the plunger profile and the collar activates the release of the spring and draws the needle into the barrel of the syringe with no protrusion of the needle tip from the device." This describes the mechanism and successful retraction, but no quantitative performance data (e.g., 100% success rate across X number of trials) is provided in this summary.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned; no specific performance study data is included in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as no specific test set and ground truth establishment methodology are described in this regulatory submission.

4. Adjudication method for the test set:

• Not applicable.

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:

• Not applicable. This is not an AI/software device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is not an AI/software device.

7. The type of ground truth used:

• Not applicable, as no formal ground truth for a test set is described. The "truth" in this context is the successful demonstration of the device's mechanism of action (needle retraction) as described, which is considered equivalent to the predicate.

8. The sample size for the training set:

• Not applicable, as this is not an AI/software device with a distinct training set.

9. How the ground truth for the training set was established:

• Not applicable.

Summary of Device and Equivalence Statement:

The Ritract Safety Syringe is a sterile, single-use, disposable, non-reusable, 3mL, 5mL, 10mL auto-retracting safety syringe with a standard luer lock needle connection. It is indicated for the injection of fluids into the body, while reducing the risk of sharps injury and the potential for syringe reuse.

The submission claims substantial equivalence to the BD Integra Spring Based Syringe (K011103) based on:

• Similar mode of operation (plunger bottoming out activates a mechanism to retract the needle).
• Similar function (auto-retracting safety syringe).
• Similar materials, packaging, and manufacturing processes.

The 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive de novo clinical trials or detailed performance studies with explicit, quantitative acceptance criteria in the summary document. The FDA's issuance of the 510(k) clearance (JUN - 2 2006) indicates they agreed with the substantial equivalence claim.

Ask a specific question about this device