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

(2) Safety Blood Collection Needle for Single Use
The Safety Blood Collection Needle for Single Use 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.

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

(4) Safety Blood Collection Needle with Holder for Single Use
The Safety Blood Collection Needle with Holder for Single Use 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.

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

(6) Safety Blood Collection Set for Single Use
The Safety Blood Collection Set for Single Use 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.

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

(8) Safety Blood Collection Set with Holder for Single Use
The Safety Blood Collection Set with Holder for Single Use 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 subject devices are single use, EtO sterilized with a shelf-life of 5 years. Blood collection needles and holders are intended to be used with a 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.

(1) Blood Collection Needle for Single Use
This product use PP, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, needle tube and needle sleeve.

(2) Safety Blood Collection Needle for Single Use
This product use PP, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub with safety shield, needle tube, needle sleeve.

(3) Blood Collection Needle with Holder for Single Use
This product use PP, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, needle tube, needle sleeve, holder.

(4) Safety Blood Collection Needle with Holder for Single Use
This product use PP, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub with safety shield, needle tube, needle sleeve, holder.

(5) Blood Collection Set for Single Use
The products use PP, ABS, PVC, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, needle tube, tubing, butterfly wings, needle sleeve.

(6) Safety Blood Collection Set for Single Use
The products use PP, ABS, PVC, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, safety shield, needle tube, tube, tubing, butterfly wings, needle sleeve.

(7) Blood Collection Set with Holder for Single Use
The products use PP, ABS, PVC, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, needle tube, tubing, butterfly wings, needle sleeve, holder.

(8) Safety Blood Collection Set with Holder for Single Use
The products use PP, ABS, PVC, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, safety shield, needle tube, tubing, butterfly wings, needle sleeve, holder.

The provided text describes a 510(k) premarket notification for various blood collection devices and compares them to a predicate device. This document focuses on demonstrating substantial equivalence to an already legally marketed device rather than proving a novel device meets specific acceptance criteria through a clinical study or AI performance evaluation.

Therefore, many of the requested points related to AI performance, multi-reader multi-case studies, expert consensus, and training/test set ground truth establishment are not applicable to this type of regulatory submission and the information provided.

However, I can extract the relevant information regarding the non-clinical tests performed to demonstrate safety and effectiveness.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are derived from compliance with international standards for medical devices, particularly those related to sterile hypodermic needles and stainless steel needle tubing. The "reported device performance" is a statement of conformity to these standards.

Note on "No significant evidence of sterilization": This phrasing appears in the document's comparison table under biocompatibility, but it's likely a typo and should refer to "sensitization" (as in ISO 10993-10).

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

• Sample Size: The document does not specify the exact sample sizes for each non-clinical test (e.g., how many needles were tested for patency, or how many samples for biocompatibility). It states tests were performed "on the subjective device."
• Data Provenance: The tests were conducted as part of the submission process for the manufacturer, Jiangsu Micsafe Medical Technology Co., Ltd in China. The data would be prospective as it was generated specifically for this regulatory submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

• This information is not applicable. The ground truth for this device's performance is established by compliance with international standards and laboratory testing protocols, not by expert consensus in a clinical setting for diagnostic purposes.

4. Adjudication Method for the Test Set

• This information is not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical trial ground truth establishment, especially for image-based diagnostic AI, not for physical device performance testing against engineering 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 information is not applicable. This is a submission for physical blood collection devices, not an AI/diagnostic software. No MRMC study was done, nor would it be relevant.

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

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

7. The Type of Ground Truth Used

• The "ground truth" for this submission is compliance with established international standards for medical devices (ISO standards). This involves objective measurements, chemical analyses, and physical performance tests conducted in a laboratory setting. A "simulated clinical use study" was also performed for the safety mechanism, where the success of the safety feature would be the measured outcome against pre-established criteria.

8. The Sample Size for the Training Set

• This information is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• This information is not applicable. There is no training set.

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The Insulin Syringe is a sterile, single use and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.
The Insulin Syringe with Safety Retractable is a sterile, single use and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.

(1) Insulin Syringe
This product uses PP, Polyisoprene rubber and SUS304 as the main materials. It consists of barrel, plunger, plunger stopper, needle tube and needle cap.
The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years.
Product Contact Classification: Externally Communicating, Blood Path and Tissue Contact with prolonged contact duration (>24 h to 30 d).
(2) Insulin Syringe with Safety Retractable
This product uses PP, Polyisoprene rubber and SUS304 as the main materials. It consists of barrel, plunger, plunger stopper, needle tube, safety shield and needle cap.
The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years.
Product Contact Classification: Externally Communicating, Blood Path and Tissue Contact with prolonged contact duration (>24 h to 30 d).

1. Acceptance Criteria and Reported Device Performance:

The document outlines the acceptance criteria by stating that the device "conforms with the requirements of ISO 7864 and ISO 8537" for performance, safety, and effectiveness, and "conforms to the requirement of ISO 10993 series Standards" for biocompatibility.

For the "Insulin Syringe with Safety Retractable," additional performance criteria specifically related to the safety feature are provided:

For the general Insulin Syringe and Insulin Syringe with Safety Retractable, the following criteria are implicitly met by conformance to the cited ISO standards. The "Reported Device Performance" column indicates that the device did conform to these standards.

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

The document does not explicitly state the sample sizes used for the non-clinical tests. It refers to standards like ISO 7864, ISO 8537, ISO 10993, ISO 9626, USP , ASTM D4169, ASTM F1929, ASTM F88, and ISO 23908. These standards likely define the minimum sample sizes for relevant tests. The data provenance is implied to be from testing conducted by Jiangsu Micsafe Medical Technology Co., Ltd in China, as it is the submitting company. The studies are prospective in nature, as they involve testing the device to ensure it meets established standards.

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

The document does not mention the use of experts to establish a "ground truth" in the context of clinical or diagnostic studies. The evaluation is focused on demonstrating conformance to established international and national standards for medical devices. Therefore, the "ground truth" is defined by the technical specifications and performance requirements outlined in these standards. The experts involved would be the engineers, scientists, and technicians conducting the tests and interpreting the results in accordance with these standards. Their qualifications would align with the specific tests performed (e.g., biocompatibility specialists, mechanical testing engineers).

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are objective measurements against predefined criteria in recognized standards, not subjective interpretations requiring adjudication.

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 (insulin syringe) that does not involve "readers" or Artificial Intelligence (AI) for diagnostic or interpretive tasks. The studies are related to the physical performance, safety, and biocompatibility of the syringe itself.

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

Not applicable. This device is not an algorithm or AI system. It is a physical medical device.

7. The Type of Ground Truth Used:

The ground truth used for these studies is defined by the established technical specifications and performance requirements detailed in the referenced international (ISO) and national (ANSI AAMI, ASTM, USP) standards. These standards set the benchmarks for characteristics like biocompatibility, sterility, physical dimensions, material properties, and safety features.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of a physical medical device undergoing performance and safety testing. This document describes the testing of a finished product against established standards, not the training of a machine learning model.

9. How the Ground Truth for the Training Set was Established:

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

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The Surgical Face Mask is intended to be worn to protect both the patient and healthcare persomel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided nonsterile.

The Surgical Face Mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Surgical Face Mask around the nose. The Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, only the outer layers' color is blue (colorant: 29H,31H- phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8), and the middle layer is made of Melt blown polypropylene filter. Ear loops, which is held to cover the users' mouth and nose by two Spandex elastic cord and chinlon ultrasonic welded to the Surgical Face Mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the Surgical Face Mask is in the middle layer of Surgical Face Mask to allow the user to fit the Surgical Face Mask around their noses, which is made of steel wire and polypropylene. The Surgical Face Mask is sold non-sterile and is intended to be single use, disposable device. The dimensions of each Surgical Face Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 115±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm.

The provided text describes the regulatory clearance of a Surgical Face Mask (Model: METH-03) through a 510(k) premarket notification. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing.

Here's an analysis of the acceptance criteria and study information, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

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Safety Needles: The safety needles are 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.

Sterile Syringe: The sterile 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.

Sterile Syringe with Safety Needle: 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.

Sterile Syringe with Needle: The sterile syringe with needle is intended for use the aspiration of fluids for medical purpose.

Hypodermic Needles for Single Use: The hypodermic needle is intended to be used with a luer slip or luer lock syringe for aspiration of fluids for medical purpose.

(1)Safety Needles: The Safety Needles are intended for manual and single use only. They consist of a needle cap, needle tube and hub with protector. 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.

(2)Sterile Syringe: The Sterile Syringe is intended for manual and single use only. It consists of a Barrel, Plunger, and Piston. The syringes are available with luer slip and luer lock connector types and are available in different sizes. They are intended to be connected to a safety/hypodermic needle.

(3)Sterile Syringe with Safety Needle: This product is intended for manual and single use only. The Sterile Syringe with Safety Needle 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 of syringe and needle sizes. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

(4)Sterile Syringe with Needle: The Sterile Syringe with Needle is intended for manual and single use only. It consists of a hypodermic needle and a luer slip or luer lock syringe. The proposed device is available in a variety of syringe and needle sizes.

(5)Hypodermic Needles for Single Use: The Hypodermic Needle is intended for manual and single use only. It consists of a hub, needle tube, needle cap. The proposed device is compatible for use with a luer slip or luer lock syringe.

The provided document is a 510(k) Premarket Notification from Jiangsu Micsafe Medical Technology Co., Ltd. for various sterile syringe and needle products. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its "safety and effectiveness" through clinical trials as is typically done for novel devices.

Therefore, the document does not contain the kind of acceptance criteria, study details, and performance metrics typically associated with AI/ML-enabled medical devices that would involve a "test set," "ground truth," "expert adjudication," or "MRMC comparative effectiveness studies." The acceptance criteria and "study" described in this document relate to demonstrating substantial equivalence through non-clinical bench testing to established international standards for medical devices like needles and syringes, and biocompatibility.

Here's an analysis based on the information provided in the document, framed to address the prompt's categories where applicable, and noting where the information is not present or not relevant to the prompt's context (which often implies AI/ML or diagnostic performance studies):

Acceptance Criteria and Device Performance (based on provided document):

The document defines acceptance criteria by adhering to established ISO and ASTM standards for medical devices. The "performance" is the successful demonstration of conformity to these standards.

• No Cytotoxicity
• No Irritation to Skin
• No significant evidence of sensitization
• No systemic toxicity
• No Hemolysis
• Non pyrogenic | Conforms to the requirement of ISO 10993 series Standards:
• No Cytotoxicity
• No Irritation to Skin
• No significant evidence of sensitization
• No systemic toxicity
• No Hemolysis
• Non pyrogenic |
  | Safety Needles Performance (per ISO 7864 & ISO 9626, and ISO 23908:2011 for safety feature):
• Force to activate safety mode: NMT 10N
• Force to disengage safety mode: NLT 20N
• Force to separate safety feature from needle hub: NLT 50N | Conforms with the requirements of ISO 7864 and ISO 9626.
  Needle Safety Feature: Testing conducted per ISO 23908:2011.
• Force to activate safety mode: NMT 10N
• Force to disengage safety mode: NLT 20N
• Force to separate safety feature from needle hub: NLT 50N |
  | Sterile Syringe Performance (per ISO 7886 & ISO 80369-7):
• Cleanliness
• Limits for acidity or alkalinity
• Lubricant
• Tolerance on graduated capacity
• Scale, etc. | Conforms with the requirements of ISO 7886 and ISO 80369-7. (Specific values not provided in summary table, but implied by conformity statement) |
  | Sterile Syringe with Safety Needle Performance (per ISO 7864, ISO 9626, ISO 7886, ISO 80369-7, and ISO 23908:2011 for safety feature):
• Same as individual components. | Conforms with the requirements of ISO 7864, ISO 9626, ISO 7886, and ISO 80369-7.
  Needle Safety Feature: Testing conducted per ISO 23908:2011.
• Force to activate safety mode: NMT 10N
• Force to disengage safety mode: NLT 20N
• Force to separate safety feature from needle hub: NLT 50N |
  | Sterile Syringe with Needle Performance (per ISO 7864, ISO 9626, ISO 7886, ISO 80369-7):
• Same as individual components. | Conforms with the requirements of ISO 7864, ISO 9626, ISO 7886, and ISO 80369-7. (Specific values not provided in summary table, but implied by conformity statement) |
  | Hypodermic Needles for Single Use (per ISO 7864 & ISO 9626):
• Cleanliness
• Limits for acidity or alkalinity
• Limits for extractable metals
• Color coding
• Conical fitting, etc. | Conforms with the requirements of ISO 7864 and ISO 9626. (Specific values not provided in summary table, but implied by conformity statement) |
  | Particulate Testing (per USP ): | Performed (Result of conformity implied by overall conclusion of substantial equivalence). |

Regarding the prompt's specific questions:

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

   • See table above. The "performance" is reported as conformance to the specified ISO/ASTM standards and the specific thresholds for the safety features.

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

   • The document does not specify exact sample sizes for each non-clinical bench test. The testing is described as complying with the requirements of the listed ISO/ASTM standards, which typically prescribe sample sizes for such tests.
   • Data Provenance: The tests were conducted by the manufacturer, Jiangsu Micsafe Medical Technology Co., Ltd. (China). The data would be specific to their manufactured devices, and these are non-clinical, bench-top tests, not human subject 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):

   • Not applicable. This submission is for physical medical devices (needles, syringes), not AI/ML software or diagnostic devices that require expert review of ground truth in the context of images or clinical data. The "ground truth" for these devices is defined by the performance specifications of the international standards themselves (e.g., a needle must meet certain force requirements, be free from defects, etc.). The experts involved are likely engineers or quality control specialists who conduct and verify the bench tests.

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

   • None. This concept is not relevant to non-clinical bench testing of physical medical devices. Adjudication methods are typically used in clinical studies, especially those involving subjective interpretations (e.g., by radiologists) to establish a consensus ground truth.

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:

   • No. This type of study is specifically for evaluating the impact of AI/ML algorithms on human reader performance, typically in diagnostic imaging. It is not relevant to the evaluation of sterile syringes and needles.

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

   • Not applicable. This concept pertains to the performance of an AI/ML algorithm by itself. The devices described (needles and syringes) are physical instruments for manual use, not software algorithms.

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

   • Ground Truth: For these devices, "ground truth" is established by adherence to globally recognized technical standards (ISO 7864, ISO 9626, ISO 7886, ISO 80369-7, ISO 23908, ISO 10993 series, USP , ASTM F756-17). These standards specify the physical, chemical, and biological properties and performance requirements for the devices. The "ground truth" is objective measurement and verification against these specified parameters, not subjective expert consensus on complex clinical cases or pathology.

8. The sample size for the training set:

   • Not applicable. This document describes the testing of a medical device, not the development or validation of an AI/ML model that would use training data.

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

   • Not applicable. As there is no AI/ML model or "training set," this question is not relevant.

Summary with respect to the 510(k) submission's purpose:

The document focuses on demonstrating substantial equivalence to an existing predicate device (K170651) by showing that the new devices meet the same safety and performance standards through non-clinical bench testing and biocompatibility assessments. The differences between the subject device and the predicate device (e.g., differences in available sizes, slight variations in luer connections, and specific safety feature force values) were addressed by demonstrating compliance with the relevant international standards. The FDA's clearance (K183665) indicates that the agency agreed that this non-clinical data was sufficient to establish substantial equivalence for these types of medical devices.

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The subject device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) are basically enteral syringes that can also be used for oral uses. There are two different types of models of the syringes, which are Type A and Type B. The Type A syringes of a polypropylene barrel and plunger rod and a synthetic rubber gasket stopper manufactured from polyisoprene. The Type B syringes consist of a polypropylene barrel and plunger rod and a silicone O-ring. The 10 to 60 mL syringes come with the standard female ENFit connector and the 1 to 5 mL syringes come with a female ENFit connector incorporating a low dose tip design.

The provided text focuses on establishing substantial equivalence for an Oral/Enteral Syringe, primarily through comparison to a predicate device and adherence to recognized standards. It does not contain information about an AI/ML powered medical device, or the kind of acceptance criteria and study designs that would be typical for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including specifics like sample size for test and training sets, expert ground truth establishment, MRMC studies, or standalone performance, as this information is not present in the provided document for this particular medical device.

The document discusses non-clinical tests performed to ensure the device's effectiveness and safety, primarily focusing on:

• Biocompatibility: Adherence to ISO 10993 series standards (in vitro cytotoxicity, irritation, skin sensitization, systemic toxicity).
• Performance safety and effectiveness (according to ISO 7886-1): Cleanliness, lubricant, limits of extractable metals, limits for acidity/alkalinity, tolerance on graduated capacity, graduated scale, dead space, barrel configuration, nozzle design verification, piston/plunger assembly, freedom from air and liquid leakage, force to operate the piston.
• Performance safety and effectiveness (according to ISO 80369-3 for connectors): Fluid leakage, stress cracking, resistance to separation from axial load, resistance to unscrewing, resistance to overriding, disconnection by unscrewing.
• Additional Performance tests: Dimensional verification (to ISO 80369-3, low dose tips, syringes), risk management report, dosing accuracy testing (for low dose tips and oral administration).

The conclusion states that the "subject device will be as safe and effective for usage as the listed predicate device," based on these non-clinical tests and the comparison of technological characteristics. No clinical tests were performed for this submission.

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