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Sure-fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

Sure-fine Insulin syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel(U-100), a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with expoxy.

The provided document describes a 510(k) premarket notification for "Sure-Fine Insulin Syringes." The submission is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical effectiveness study. Therefore, some of the requested information (such as effect size of human readers with/without AI assistance, standalone algorithm performance, number of experts for ground truth, and training set details) is not applicable to this type of medical device submission.

Here's the information that can be extracted from the document:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are implicitly tied to various testing standards to demonstrate biocompatibility and performance. The reported performance is that the device complies with these standards, supporting its substantial equivalence.

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

The document does not explicitly state the sample sizes for each specific test. These are typically determined by the requirements of the individual ISO and ASTM standards cited for each test. Data provenance is not specified, but these are laboratory tests performed on the device components or final product itself, not clinical data from countries of origin. The study described is a series of laboratory and biocompatibility tests, not a clinical study involving patients or data sets.

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

Not applicable. This is not a study requiring expert readers to establish ground truth. The "ground truth" for these tests comes from established scientific and engineering principles within each standard.

4. Adjudication method for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations. The results are typically quantitative measurements or qualitative assessments (e.g., presence/absence of cytotoxicity) as defined by the standard.

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 device is not an AI-assisted diagnostic tool, but a medical syringe.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used:

The ground truth is based on recognized industry standards and scientific testing procedures (ISO 10993 series, ASTM F756-17, ASTM F1980, ISO 8537, ISO 7864, USP ) for biocompatibility and performance of syringes.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-driven device requiring a training set.

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

Not applicable. This is not a machine learning or AI-driven device.

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Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

Sure-fine Insulin syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy. The syringes are available in the following sizes and cap color. The modified Sure-Fine Insulin syringe is substantially equivalent to the predicate device (Sure-Fine Insulin Syringes, K152879). The biggest difference between the modified device and predicate device is the addition of needle gauge (27G) and the addition of needle length (1/4"). The devices operate in the principles of a piston syringe fluid path is sterile (EO gas sterilization), Non-toxic, Non-pyrogenic and single use disposable.

This document is a 510(k) Pre-market Notification for "Sure-Fine Insulin Syringes." It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K152879) rather than presenting a standalone study with acceptance criteria and device performance metrics in the typical sense of AI/software device evaluation.

The changes in the current device (K191531) compared to the predicate device (K152879) are primarily the addition of a new needle gauge (27G) and a new needle length (1/4").

Therefore, the "acceptance criteria" and "study" described in the document are about demonstrating that these new configurations and the overall modified device continue to meet established standards for insulin syringes.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a typical "acceptance criteria" table with specific quantitative thresholds. Instead, it refers to compliance with recognized international standards for medical devices, which inherently contain the acceptance criteria for various tests. The "reported device performance" is essentially the finding that the device complies with these standards.

Note: The document states "appropriate testing was completed to demonstrate that the syringes comply with the following FDA recognized standards". It does not provide the raw data or specific test results for each of these standards in this summary. The "reported performance" is the claim of compliance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the sample sizes used for the testing conducted against the ISO standards. This information would typically be found in the full test reports, not in the 510(k) summary.
• Data Provenance: The document doesn't explicitly state the country of origin for the testing data itself, but the manufacturer is SHINA MED CORPORATION in South Korea (Rep. of Korea). The testing would presumably be conducted by or for the manufacturer, either in Korea or by a certified testing lab. The study is prospective in the sense that the testing was performed to support this specific submission for the modified device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This question is not applicable to this type of device submission. Insulin syringes are physical medical devices, and their performance is evaluated through engineering and biological testing against established international standards (like ISO standards), not by human expert interpretation or ground truth labeling in the way an AI/software device would be.

4. Adjudication Method for the Test Set

• This question is not applicable. There is no "test set" that requires adjudication by human experts. Device performance is determined by objective measurements against specified physical and chemical properties and functional requirements outlined in the ISO standards.

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

• This question is not applicable. This submission is for an insulin syringe, which is a physical medical device, not an AI/software device that involves human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is defined by the requirements and test methods specified in the referenced international standards (ISO 7864, ISO 9626, ISO 8537, ISO 10993-1). Compliance with these standards serves as the "ground truth" that the device is safe and effective for its intended use. For example, a needle's sharpness or a syringe's dose accuracy would be measured against specific, quantifiable criteria in these standards.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable. As there is no training set for a physical device.

In summary: The acceptance criteria and "study" for this device are based on demonstrating compliance with recognized international standards for medical devices, particularly those related to sterile hypodermic needles and insulin syringes. The document asserts that "appropriate testing was completed" to show this compliance, thereby proving the device meets the acceptance criteria for substantial equivalence to its predicate for its intended use, including the newly added specifications.

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Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

Sure-Fine Insulin Syringes are designed for the subcutaneous injection of a dose of U-100 insulin. The syringe has a graduated barrel, a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy. The syringes are available in the following sizes and cap color.
Category: U-100
Insulin syringe: 1/2cc and 1cc, 3/10cc, 1/2cc and 1cc
Needle Gauge: 28Gauge, 29Gauge, 30Gauge, 31Gauge
Needle Length: 1/2", 5/16"
Cap color: Needle cap: Orange, Plunger Cap: Orange or white
This device operates in the principles of a piston syringe fluid path is sterile (EO gas sterilization), single use disposable.

This document is a 510(k) Summary for the Sure-Fine Insulin Syringes, which is a regulatory submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not describe an acceptance criteria or a study designed to establish clinical performance of a novel device in the same way one might describe for a diagnostic AI algorithm.

Instead, the document details non-clinical testing to demonstrate that the Sure-Fine Insulin Syringes meet established performance and safety standards, proving substantial equivalence to a predicate device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with specific numerical thresholds for accuracy, sensitivity, or specificity as one would expect for an AI/diagnostic device. Instead, it lists the voluntary standards and clauses from those standards that the device was designed and tested to meet. The "reported device performance" is the conclusion that the device successfully met these requirements, thus demonstrating substantial equivalence.

| Standard/Test | Acceptance Criteria (implied by standard) | Reported Device Performance |
| :----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------- |
| Performance Testing (per ISO 8537:2007) | Compliance with physical and functional requirements for sterile single-use hypodermic syringes for insulin. (e.g., freedom from extraneous matter, extraction, lubrication, range of sizes, graduated scale, barrel, piston/plunger, nozzle, needles, assembled syringe performance). | Successfully met the applicable requirements. |
| Biocompatibility Testing (per ISO 10993 Series) | Compliance with biological safety requirements for devices in contact with patients (e.g., in vitro cytotoxicity, irritation, sensitization, acute systemic toxicity, interaction with blood, pyrogenicity). | Successfully passed testing as outlined. |
| Sterilization & Shelf-life Testing (per ISO 11135, ISO 10993-7) | Sterility Assurance Level (SAL) of 10-6; maximum levels of ethylene oxide and ethylene chlorohydrins within limits; a 5-year shelf-life. | Validated sterilization with SAL = 10-6; EO/ECH levels did not exceed limits; 5-year shelf-life supported. |

Important Note: This is a traditional medical device (insulin syringe), not an AI/software device. Therefore, the questions related to AI-specific metrics, ground truth, expert consensus, and MRMC studies are not applicable. The device's performance is assessed through engineering and biological safety tests against established standards for its mechanical function and material safety.

The following questions are not applicable to this specific submission as it pertains to a physical medical device (insulin syringe) and not an AI or diagnostic software. Therefore, there are no details on test sets, ground truth establishment by experts, or MRMC studies.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This is a physical medical device. Testing involved physical samples of the syringe, not a "data test set." The document does not specify the number of samples tested for each engineering or biological test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. There is no "ground truth" to be established by experts in the context of an insulin syringe's physical and functional properties.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 a physical medical device, not an AI or diagnostic software. No human readers or AI assistance are involved in its primary function or evaluation for substantial equivalence.

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

• Not Applicable. This is a physical medical device; no algorithm is present.

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

• Not Applicable.

8. The sample size for the training set

• Not Applicable. This is a physical medical device; there is no "training set" in the context of an AI or machine learning model.

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

• Not Applicable.

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