Search Results

Sterile Syringe with Safety needle for Single Use is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

Sterile Syringe with needle for Single Use is intended for use in the aspiration of fluids for medical purpose.

Sterile Syringe for Single Use 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.

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

Sterile Needle for Single Use is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose.

Not Found

I'm sorry, but this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is an FDA 510(k) clearance letter for various types of syringes and needles. It confirms that the devices are substantially equivalent to legally marketed predicate devices and mentions the indications for use.

It does not include any details about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their provenance.
• The number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) study or effect sizes of AI assistance.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set sample size or how its ground truth was established.

This type of information would typically be found in the 510(k) submission itself (which is not provided here) or a more detailed performance study report, not in the clearance letter summarizing the FDA's decision.

Ask a specific question about this device

The Sterile 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 Safety Needle is intended for manual and single use only. It consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The subject device is available in a variety of syringe volumes and needle sizes. The safety sheath is manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The provided FDA 510(k) summary (K211753) is for a Sterile Syringe with Safety Needle. This document outlines the premarket notification for a Class II medical device, comparing it to a predicate device (K193526) to demonstrate substantial equivalence.

It's important to note that this document does not describe AI/ML device performance or studies proving such performance. This is a traditional medical device submission, focusing on compliance with established engineering and safety standards for the physical product.

Therefore, many of the requested elements pertaining to AI/ML device performance, such as sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models, are not applicable to this document.

The document primarily focuses on:

• Indications for Use: The device is for aspiration and injection of fluids, with a safety shield to prevent needle sticks.
• Technological Characteristics: Comparison of physical attributes like syringe volume, needle gauge, length, and material.
• Performance Standards: Compliance with international standards for syringes, needles, luer connectors, and sterilization.
• Biocompatibility: Leveraged from a previously cleared device (K163161) due to identical patient contact materials.

However, I can extract information related to the physical device's "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in the context of this traditional medical device submission.

Here's the breakdown based on the provided text, focusing on the physical device performance and safety, not AI/ML:

Acceptance Criteria and Study for Sterile Syringe with Safety Needle (K211753)

The acceptance criteria for this device are primarily defined by compliance with recognized international and national standards for medical devices, particularly those related to syringes, needles, luer connectors, biocompatibility, and sterility. The studies proving the device meets these criteria are non-clinical bench tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes used for each individual non-clinical bench test. These are typically defined by the testing standards (e.g., ISO, ASTM).
• Data Provenance: The tests were conducted to demonstrate compliance with international standards (ISO, ASTM, USP). The manufacturing entity is Jiangxi Hongda Medical Equipment Group Ltd. in China. The testing would have been conducted by the manufacturer or a certified testing laboratory. The data is retrospective in the sense that the testing was completed prior to submission for clearance.

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

• Not Applicable. This is a traditional medical device (syringe with safety needle), not an AI/ML device relying on expert consensus for ground truth. Compliance is determined by objective physical and chemical testing against established engineering and biological standards.

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

• Not Applicable. As above, this is a traditional medical device; "adjudication" in the context of clinical reads or expert consensus for AI models is not relevant here. Test results are compared directly against the quantitative and qualitative requirements of the referenced 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

• Not Applicable. This document refers to a physical medical device (syringe), not an AI/ML diagnostic or assistive tool. MRMC studies are irrelevant for this type of submission.

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

• Not Applicable. There is no algorithm or software component described in this submission that would require standalone performance testing.

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

• Bench Testing Standards and Specifications: The "ground truth" for this device is its adherence to the performance requirements stipulated in the referenced international and national standards (e.g., ISO 7886-1 for syringe performance, ISO 9626 for needle tubing, ISO 80369-7 for luer connectors, ISO 10993 for biocompatibility, etc.). These standards define the acceptable mechanical, physical, chemical, and biological properties of the device.

8. The sample size for the training set

• Not Applicable. This is a hardware medical device, not an AI/ML model that requires a training set.

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

• Not Applicable. As above, there is no AI/ML training set.

Ask a specific question about this device

Sterile Syringe with Safety needle for Single Use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

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

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

Sterile Syringe with Safety needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of syringe (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.

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

Sterile Safety Needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, retractable cartridge, jointing medium and needle hub. The proposed device is available in variety of needle gauge and needle length. According to the needle length, the safety mechanism is available in 2-part cartridge (outer retractable cartridge and inner retractable cartridge) and 3-part cartridge (outer retractable cartridge, middle retractable cartridge and inner retractable cartridge). The proposed device is compatible for use with a luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.

The provided text describes a submission for K192679 (Sterile Syringe with Safety Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use) to the FDA, asserting substantial equivalence to predicate device K170651.

The document discusses acceptance criteria for various tests and confirms that the proposed device met these criteria through non-clinical testing and a simulated clinical study.

Here's a breakdown of the requested information based on the provided text:

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

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

The document does not explicitly state the numerical sample sizes for each test set. It mentions tests were performed on the "proposed device" and "aging samples" for shelf-life. In the Safety Feature Test, tests were performed on "both proposed device and predicate device".

The data provenance is from non-clinical tests conducted by Gemtier Medical (Shanghai) Inc. in China (manufacturer location). The nature of these tests (bench testing, simulated clinical study) implies they are prospective in execution, meaning they were designed and performed for the purpose of this submission.

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 section is not applicable as the document describes non-clinical and simulated clinical studies for a medical device (syringes and needles), not studies involving human subjects or expert assessment of medical images/data for ground truth. The acceptance criteria are based on compliance with international standards and internal design specifications, not expert consensus on medical conditions.

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

This section is not applicable. Adjudication methods are typically used in clinical studies or studies where subjective interpretations need to be resolved. The tests described here are objective performance measurements against established 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 is not applicable. The device is a sterile syringe and needle system, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

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 medical instrument, not an algorithm.

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

The "ground truth" for the device's performance is established by the international standards (e.g., ISO 7886-1, ISO 7864, ISO 9626, ISO 10993-7, ISO 23908, ISO 80369-7) and internal design specifications against which the device was tested. For biocompatibility, the lack of "negative impacts" is the ground truth. For the safety mechanism, meeting "pre-established criteria" of relevant guidance documents serves as the ground truth.

8. The sample size for the training set

This is not applicable. The document describes the testing and comparison of a physical medical device. There is no training set mentioned, as this is not an AI/ML device.

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

This is not applicable as there is no training set for this device.

Ask a specific question about this device