Search Results

The Blood Collection Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Blood Collection Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Safety Blood Collection Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Safety Blood Collection Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Blood Collection Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Safety Blood Collection Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Safety Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood.

The proposed devices are blood collection devices form a channel between patient's vein and the evacuated blood collection tube intended for collection of blood.

The Blood Collection Set with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle handle, Flexible tube, Connector Luer adapter and Holder.

The Safety Blood Collection Set with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield to aid in the protection against accidental needle stick injury. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle handle, Safety sheath, Flexible tube, Connector, Luer adapter and Holder.

The Blood Collection Needle with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle hub, Luer adapter and Holder.

The Safety Blood Collection Needle with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cannula, Safety sheath, Needle hub, Luer adapter and Holder.

The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood. The Pre-attached Holder is designed to aid in protection against accidental non-patient needle injury and blood splatter. It is provided sterile and single use. The proposed devices are composed of Connect base (ABS), Non-patient end needle tube (Stainless Steel SUS304), Rubber sleeve (Gather Isoprene Rubber), Needle Holder (PP).

The provided document is a 510(k) Summary for a Blood Collection Set. It does not contain information typically found in an AI/ML device submission regarding acceptance criteria, study details, human reader performance, or specific ground truth methodologies for algorithmic performance.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on regulatory requirements for a traditional medical device (not an AI/ML device). The "acceptance criteria" here refer to conformity with established industry standards and regulations for blood collection devices, rather than performance metrics for an AI algorithm.

Therefore, many of the requested fields cannot be directly answered from the provided text.

Here's an attempt to extract relevant information and explain why other fields are not applicable:

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

The document does not present specific quantitative acceptance criteria or numerical performance results in a table format as would be expected for an AI/ML device validating diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC). Instead, "acceptance criteria" are implied by adherence to recognized standards and successful completion of various tests.

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 applicable and not provided. The "test set" in this context refers to physical samples of the device undergoing mechanical, chemical, and biological testing, not a dataset for an algorithm. The document does not specify the number of physical units subjected to each test. Data provenance (country, retrospective/prospective) is typically for clinical data or imaging datasets, which are not relevant here.

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 is not applicable as the device is not an AI/ML diagnostic or image analysis tool requiring human expert annotation for ground truth. The "ground truth" for this device is established through validated laboratory testing protocols and adherence to international standards.

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

This is not applicable. Adjudication methods like 2+1 are used for resolving disagreements among human annotators in AI/ML performance studies. This is a traditional medical device demonstrating substantial equivalence through bench testing.

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 is not applicable. No MRMC study was performed as this is not an AI-assisted diagnostic device. The document explicitly states: "No clinical study is included in this submission as the device does not require clinical studies to determine substantial equivalence with the predicate device."

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

This is not applicable. The device is a physical blood collection implement, not an algorithm.

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

The "ground truth" for this device's performance is established by objective measurements against recognized international standards and validated laboratory test methods. Examples include:

• Physical dimensions and material properties.
• Sterility validation (absence of microorganisms).
• Chemical purity (endotoxin limits, residuals).
• Biocompatibility (absence of toxic, irritating, or sensitizing effects on biological systems).
• Mechanical integrity (seal strength, needle sharpness, flexibility).

8. The sample size for the training set

This is not applicable. There is no AI/ML component, so there is no "training set."

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

This is not applicable as there is no AI/ML component and therefore no training set.

Ask a specific question about this device

The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose.

The Sterile Disposable Syringe is a sterile luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.

The Sterile Disposable Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.

The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only, which consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle size. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Disposable Syringe with Needle is intended for manual and single use only, which consists of a hypodermic needle and a luer slip or luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle size.

The Sterile Disposable Syringe is intended for manual and single use only, which consists of barrel, plunger and piston. The proposed device is available in a variety syringe volume. The syringe is available in luer slip and luer lock two connector types which are intended to be connected with a hypodermic needle.

The Sterile Disposable Safety Needle is intended for manual and single use only, which consists of a hypodermic needle with a safety sheath attached to the connector hub. The proposed device is available in variety combination of needle gauge and needle length. The proposed device is compatible for use with a luer slip or luer lock syringe. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Disposable Needle is intended for manual and single use only, which is compatible for use with a luer slip or luer lock syringe. The proposed device is available in variety combination of needle gauge and needle length.

The provided document describes the predicate devices and performance tests for Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, and Sterile Disposable Needle (K170651) manufactured by Yangzhou Medline Industry Co., Ltd.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document details performance against various international standards rather than explicit acceptance criteria with numerical targets. However, the implicit acceptance criterion is compliance with the specified standard. The reported device performance is that the device meets or complies with these standards.

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

The document does not explicitly state the specific sample sizes used for each individual non-clinical performance test. It only indicates that "Non clinical tests were conducted to verify that the proposed device met all design specifications."

• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of performance and biocompatibility testing for medical devices, these would typically be prospective laboratory studies conducted by the manufacturer or contracted labs.

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

This information is not applicable in this context. The "ground truth" for the performance criteria of a medical device like a syringe and needle is established by the specified international standards (ISO, ASTM, USP) and FDA guidance documents. These standards define the verifiable physical, chemical, and biological properties expected of the device. There isn't a "ground truth" established by human experts in the same way as, for example, image interpretation in a diagnostic AI study. The tests themselves are designed to objectively measure properties against defined limits.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used when expert opinion is required to establish a gold standard or "ground truth" for subjective assessments, typically in clinical studies or when interpreting complex medical data. For objective performance testing against engineering and biological standards, the results are typically quantitative measurements or pass/fail determinations based on defined thresholds in the standards, not subject to expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical study is included in this submission." This type of study is usually for evaluating diagnostic devices or complex interventional systems where human interaction and interpretation are key.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical medical instrument (syringe and needle), not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this submission.

7. The Type of Ground Truth Used

As mentioned in point 3, the "ground truth" for this device is based on international standards and regulations. Specifically:

• Engineering Standards: ISO 7886-1, ISO 7864, ISO 9626, ISO 594-1, ISO 594-2 for various physical and mechanical properties.
• Packaging Standards: ASTM F88, F1140, F1929 for sterile barrier integrity.
• Sterilization Residue Standards: ISO 10993-7 for Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residues.
• Biocompatibility Standards: ISO 10993-5, 10993-10, 10993-11, 10993-4 for various biological responses, and ASTM F756-13 for hemolysis.
• Pyrogenicity Standards: USP and Bacterial Endotoxin Limits (USP 38-NF 33 ).
• FDA Guidance: "Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005" for the simulated clinical study of the safety mechanism.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not Applicable. As explained above, no training set was used for this device.

Ask a specific question about this device