Search Results

Shina Safety Needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of skin. Shina Safety Needle is compatible for use with standard syringes.

Shina Safety Needle has safety shield that covers the needle after using the product to prevent reuse and accidental needle sticks.

Shina Safety Needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of skin. Shina Safety Needle is compatible for use with standard syringes.

Shina Safety Needle has safety shield that covers the needle after using the product to prevent reuse and accidental needle sticks.

This document is a 510(k) clearance letter for the Shina Safety Needle, a hypodermic single lumen needle. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about the acceptance criteria or a study that proves the device meets those criteria, nor does it include details about AI/ML performance, ground truth, or study methodologies that are typically found in a clinical study report or a more detailed section of a 510(k) submission.

The document focuses solely on:

• The FDA's decision regarding substantial equivalence.
• General regulatory requirements for the device.
• Indications for Use for the Shina Safety Needle.

Therefore, I cannot provide the requested information based on the input text. The information requested typically comes from performance testing reports, clinical studies, or AI/ML validation studies, none of which are detailed in this regulatory clearance letter.

Ask a specific question about this device

ShinaPen® is intended for use with pen injector devices for the subcutaneous injection of insulin.

The ShinaPen® are designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility the of the needle because primary container covers the hub and needle cap with blister paper sealed on the opening hole of primary container. The needle hub can be connected screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube. The ShinaPen® are offered various gauges sizes (29G, 30G, 31G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (Eo gas sterilization), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.

The provided text describes a 510(k) premarket notification for the ShinaPen®, an insulin pen needle. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with detailed performance metrics. Therefore, many of the requested elements (e.g., acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, training set details) are not applicable or cannot be extracted from this document.

Here's an analysis based on the information available:

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

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

• Sample sizes: Not explicitly stated for any of the performance tests. The document only mentions "performance testing" and "biocompatibility testing" without providing the number of units tested.
• Data provenance: Not explicitly stated. However, the manufacturer is SHINA CORPORATION from Korea. The testing would presumably have been conducted by or for the manufacturer. It is non-clinical safety and performance testing, not data derived from human subjects.

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

• Not applicable. This document describes non-clinical engineering and laboratory tests (e.g., meeting ISO standards, material biocompatibility, sterilization validation). These types of tests do not typically involve human experts establishing "ground truth" in the way clinical studies or diagnostic algorithm validations do. The "truth" is defined by the passing criteria of the standards themselves (e.g., a certain force to remove a needle shield, a concentration limit for residues).

4. Adjudication method for the test set

• Not applicable. See point 3.

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 an insulin pen needle, a physical medical device. It is not an AI-powered diagnostic or assistive tool, and therefore, MRMC studies or AI assistance are not relevant.

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

• Not applicable. See point 5.

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

• Standard-defined criteria/specifications: For the performance tests (ISO standards, internal standards, biocompatibility, sterilization, shelf-life), the "ground truth" or acceptance criteria are defined by the specific requirements and limits set forth in the referenced international standards (e.g., ISO7864, ISO9626, ISO11608-2, ISO10993-1, ISO11135, ISO10993-7) and the manufacturer's own internal specifications for needle shield assembly force and sharpness.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. See point 8.

Ask a specific question about this device

This device is a hypodermic insulin syringe for subcutaneous injection of insulin.

Shina Insulin Syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange. The Syringes are available in the following sizes:

1/2cc and 1cc 28 gauge x 1/2"
3/10cc, 1/2cc, and 1cc 29 gauge x ½"
3/10cc, 1/2cc, and 1cc 30 gauge x 1/2"
3/10cc, 1/2cc, and 1cc 30 gauge x 5/16"
3/10cc, 1/2cc, and 1cc 31 gauge x 5/16"

These devices operate on the principles of a piston syringe. The syringe fluid path is sterile (EO Gas sterilization), non-toxic, non-pyrogenic, and single use disposable.

The provided text describes a 510(k) summary for Shina Insulin Syringes, which is a submission to the FDA to demonstrate substantial equivalence to a predicate device. This document does not contain an "acceptance criteria and study" in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity, specificity, or accuracy compared to a ground truth established by experts.

Instead, the "performance" section refers to bench tests conducted to demonstrate equivalence to a predicate device for the purpose of regulatory clearance.

Here's the information extracted from the document, organized to address your questions as much as possible within the given context:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The results demonstrate that Shina Insulin Syringes perform equivalent to the predicate devices and are safe and effective when used as intended." This implies that the acceptance criteria for each test were met if the performance was equivalent to the predicate devices (BD Insulin Syringe: K941657, K955235, K024112).

2. Sample Size and Data Provenance

• Sample Size for Test Set: The document does not specify the sample size used for the bench tests.
• Data Provenance: The tests were conducted internally by Shina Corporation, whose factory is located in Kongju-City, Choong Nam, Korea. The study is retrospective in the sense that it's a submission for regulatory clearance based on testing of the manufactured product, not a prospective clinical trial.

3. Number of Experts and Qualifications for Ground Truth

• This question is not applicable to this type of regulatory submission. Bench tests for medical devices like syringes do not typically involve human experts establishing a "ground truth" for diagnostic or predictive purposes. The "ground truth" for these tests is based on objective, measurable physical properties and engineering standards (e.g., force measurements, dimensional accuracy).

4. Adjudication Method for Test Set

• Not applicable. Bench tests measure physical properties against defined engineering specifications or in comparison to a predicate device, which does not require adjudication by human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is a physical medical device (syringe), not an AI or diagnostic imaging device that would typically involve an MRMC study.

6. Standalone Performance Study

• Yes, in the context of bench testing. The "Performance" section describes bench tests (needle pull-out, hub pull-off, needle angularity, needle break-off testing, and dose accuracy) that evaluate the device itself. These are considered standalone performance tests for the physical properties of the syringe.

7. Type of Ground Truth Used

• For this type of device, the "ground truth" refers to established engineering specifications, physical measurement standards, and performance characteristics of legally marketed predicate devices. The aim is to demonstrate that the Shina Insulin Syringes meet these specifications and perform equivalently to the predicate.

8. Sample Size for Training Set

• Not applicable. This document is about a physical medical device and its bench testing, not an algorithm or AI model that requires a "training set."

9. How Ground Truth for Training Set Was Established

• Not applicable. As above, no training set is relevant in this context.

Ask a specific question about this device

VACU-MED® Blood Collection Needles are designed for use in venous blood collection.

VACU-MED® Blood Collection Needles are manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber sleeve and a hard plastic needle cap. The opposite end of the needle is 1" or 1½" for withdrawing blood and is fitted with a color coded hard plastic needle cap. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that simplifies identification and acts as a seal of integrity. VACU-MED® Blood Collection Needles are a sterile single-use disposable product. The needles are non-toxic and non-pyrogenic, and are available in a variety of combinations of needle sizes (20 to 22 gauge) and needle lengths (1" and 1½").

This document is a 510(k) Premarket Notification for the SHINA CORPORATION VACU-MED® Blood Collection Needles. It does not contain the level of detail typically found in a clinical study report for evaluating AI/ML-based medical devices.

The information provided focuses on demonstrating substantial equivalence to a predicate device based on descriptive data and compliance with standards, rather than a detailed performance study with acceptance criteria in the way you've outlined for AI/ML devices.

Therefore, many of your requested items cannot be directly extracted from this document, as they are not applicable to a 510(k) submission for a non-AI/ML medical device like blood collection needles.

Here's an analysis based on the provided text, addressing what can be inferred and explicitly stating when information is not present:

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

This document does not present acceptance criteria or reported device performance in the format of a clinical study with numerical metrics like sensitivity, specificity, or accuracy.

Instead, the "acceptance criteria" are implied by compliance with established international standards for medical devices of this type, and the device's technological characteristics being similar to the predicate device.

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

This information is not provided in the document. The submission relies on descriptive data and compliance with standards, not on a specific clinical "test set" or patient data.

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)

This information is not applicable and therefore not provided. This is a submission for a physical medical device (blood collection needles), not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from images or other patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided. This is for a physical medical device, not an AI/ML system requiring adjudication of interpretations.

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 information is not applicable and therefore not provided. This is for a physical medical device, not an AI/ML system involving human readers.

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

This information is not applicable and therefore not provided. This is for a physical medical device, not an AI/ML algorithm.

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

The "ground truth" for this device's performance is compliance with established international performance standards (ISO) for hypodermic needles and the demonstrable equivalence of its physical and material properties to a legally marketed predicate device. There is no biological or diagnostic "ground truth" derived from patient data involved in this type of submission.

8. The sample size for the training set

This information is not applicable and therefore not provided. This is for a physical medical device, not an AI/ML system that uses a training set.

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

This information is not applicable and therefore not provided. This is for a physical medical device, not an AI/ML system that uses a training set.

Summary of the Study Proving Acceptance Criteria:

The "study" in this context is the comparison against the predicate device (Greiner VACUETTE®) and compliance with relevant international standards.

• Methodology: The manufacturer (SHINA CORPORATION) submitted descriptive data comparing their VACU-MED® Blood Collection Needles to the predicate device. They asserted that their device has "similar technological characteristics" and is "made from the same materials" (stainless steel needle tubing, polypropylene hub and needle caps, rubber needle sleeve) as the predicate.
• Standards Compliance: The submission explicitly states that the VACU-MED® Blood Collection Needles meet the following device-specific standards:
  • ISO 7864 (Sterile Hypodermic Needles for Single Use)
  • ISO 7886-1 (Sterile Hypodermic Syringes for Single Use)
  • ISO 9626 (Stainless Steel Needle Tubing for Manufacture of Medical Devices)
  • ISO 6009 (Hypodermic Needles for Single Use - Colour Coding for Identification)
• Conclusion: Based on this descriptive data and compliance with standards, the manufacturer concluded that the VACU-MED® Blood Collection Needles are "substantially equivalent" to the predicate devices. The FDA concurred with this finding, indicating that the device meets the regulatory requirements for market clearance without requiring a full-scale clinical trial typical for more novel or higher-risk devices.

Ask a specific question about this device