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The Nipro SafeTouch LOCKTAIL™ is intended for use as a blood access device for blood purification and for other treatments requiring extracorporeal circuit. The Nipro SafeTouch LOCKTAIL ™ aids in the prevention of accidental needle stick injuries. The compatibility of available configurations is the responsibility of the physician in charge.

The NIPRO SafeTouch LockTail™ Safety Fistula Needle is a sterile, single use, safety AVF needle. It consists of an arterial and venous adapter, flexible tube and needle with an active sharps safety feature (non-implanted blood access device) as described in 21 CFR 876.5540.

The NIPRO SafeTouch LockTail "" includes 2 basic types of designs; fixed wing type (stationary) and turnable wing type (rotating). These two designs are offered in 80 configurations with options that include needle gauge (14-18G), needle length (1" and 1 ¼"), type of needle (with or without backeye), clamp color (white, red/blue), and tubing length (150 and 300 mm).

The integrated sharps injury prevention feature requires physical action by the clinician to activate and is designed to cover the needle tip after treatment. Correct use of this anti-stick feature will eliminate accidental needlesticks.

These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.

I am sorry, but based on the provided text, there is no detailed information about specific acceptance criteria or the study that proves the device meets those criteria in the format you described.

The document is a 510(k) summary for a medical device (NIPRO SafeTouch LockTail™ Safety Fistula Needle), which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of performance against specific, quantifiable acceptance criteria.

Here's what the document does state regarding testing:

• Non-clinical tests submitted: "The results of biocompatibility data support the equivalence of the predicate device and include sterility, bacterial endotoxin, systemic injection, intracutaneous reactivity, hemolysis and implantation testing. Performance testing was also conducted and is included in this submission."
• Conclusions drawn from non-clinical and clinical tests: "The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the NIPRO SafeTouch LockTail™ Safety Fistula Needle performs equivalent to the predicate device and is safe and effective when used as intended."

However, it does not provide:

1. A table of specific acceptance criteria (e.g., "sharps injury rate < X%") and reported device performance.
2. Sample sizes used for test sets.
3. Data provenance (country of origin, retrospective/prospective).
4. Number of experts or their qualifications.
5. Adjudication method for a test set.
6. Information about MRMC comparative effectiveness studies.
7. Information about standalone algorithm performance (not applicable for this type of device).
8. The type of ground truth used (again, not applicable in the context of an AI/algorithm).
9. Sample size for the training set.
10. How ground truth for the training set was established.

This document is a regulatory submission summary, which typically focuses on stating that testing was done and met requirements for substantial equivalence, rather than detailing the methodology and results of those tests.

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This product is a safety intravascular administration set and is indicated for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. Secondly it incorporates a safety mechanism to help protect against exposure to blood borne pathogens caused by accidental needlestick injuries.

The Nipro SafeTouch Huber Infusion Set is a standard non-coring Huber type needle and administration set with an integrated safety mechanism to prevent in accidental needlesticks. This device is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling.

The NIPRO SafeTouch Huber Infusion Set is a safety intravascular administration set designed for fluid and drug administration or blood sampling through surgically implanted vascular ports. It also incorporates a safety mechanism to protect against accidental needlestick injuries and associated bloodborne pathogen exposure.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a distinct "test set" sample size in the context of a clinical study with human subjects. The evaluation primarily relies on non-clinical testing and comparison to a predicate device.
• Data Provenance: The document does not mention any human clinical data or its provenance (e.g., country of origin, retrospective/prospective). The study is described as non-clinical.

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

• This question is not applicable as the provided documentation describes a non-clinical study for substantial equivalence rather than a clinical study requiring expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

• This question is not applicable as the provided documentation describes a non-clinical study.

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

• No, an MRMC comparative effectiveness study was not conducted. The submission focuses on substantial equivalence based on non-clinical testing and comparison to a predicate device, not on comparing human reader performance with or without AI assistance.

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

• This question is not applicable as the device is a physical medical device (Huber Infusion Set) and not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for this device's evaluation is primarily established through:
  • Predicate Device Equivalence: The performance and characteristics of the legally marketed EXEL SecureTouch Safety Huber Infusion Set serve as the benchmark for "ground truth" regarding safety and effectiveness for this device type.
  • Engineering Specifications and Standards: The "ground truth" for dimensional, mechanical, performance, and biocompatibility testing would be adherence to established engineering specifications and relevant industry standards for medical devices of this class.

8. The Sample Size for the Training Set

• This question is not applicable as the device is a physical medical device and not an AI/machine learning system that requires a "training set."

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

• This question is not applicable for the same reason as above (not an AI/machine learning system).

Summary of the Study and Device Performance:

The NIPRO SafeTouch Huber Infusion Set underwent a premarket notification (510(k)) process, which primarily focused on demonstrating substantial equivalence to a previously legally marketed predicate device, the EXEL SecureTouch Safety Huber Infusion Set.

The study presented in the 510(k) summary consisted of:

• Non-clinical tests: Dimensional, Mechanical, Performance, and Biocompatibility testing were performed. The specifics of these tests (e.g., sample sizes for each test, exact methodologies, quantitative results) are not detailed in the summary but are stated to have been included in the full submission.
• Comparison of technological characteristics: The NIPRO SafeTouch Huber Infusion Set was compared to the predicate device in terms of design, physical characteristics, basic scientific technology, and intended use.

The conclusion drawn from these tests and comparisons was that the NIPRO SafeTouch Huber Infusion Set performs equivalently to the predicate device and is safe and effective when used as intended. The FDA's issuance of the 510(k) clearance confirms this finding of substantial equivalence. The "acceptance criteria" were met by demonstrating that the device's characteristics and performance are comparable to a known safe and effective predicate device, as evidenced by the non-clinical testing.

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The Nipro® Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient's blood during Hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.

The Nipro® Blood Tubing Set with Transducer Protector and Priming Set includes arterial and venous dialysis blood tubing with transducer protectors and priming set (non-implanted blood access device) as described in 21 CFR 876.5820. The devices are packaged together for convenient use during hemodialysis procedures. There are 13 different configurations of the arterial line and 6 different configurations of the venous line. The various blood set models are being manufactured for application with various models of dialysis machines. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood and monitor pressure. The devices are packaged sterile and labeled for single use only. There is no ability to clean and reuse these devices. They are restricted for sale by or on the order of a physician.

The provided text describes a 510(k) summary for a medical device called "Nipro® Set - Blood Tubing Set with Transducer Protector and Priming Set." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study details, and data provenance for AI/ML performance is not explicitly available in this document.

However, based on the information provided, here's what can be extracted and what is not available:

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

The document does not provide a table of discrete acceptance criteria with numerical targets and corresponding device performance values as would be typical for a new AI/ML device. Instead, it states that "Performance testing was conducted to verify that the device is safe and effective for its intended use." The conclusions drawn are that the device "performs equivalent to the predicate device and is safe and effective when used as intended."

Specific tests mentioned (without acceptance criteria or quantitative results):

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

This information is not provided in the document. The document refers to "Performance testing" but does not detail the sample size (e.g., number of units tested), the nature of the test set (e.g., specific blood samples, simulated conditions), or the data provenance.

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

This information is not applicable and not provided. This device is a blood tubing set, not an AI/ML diagnostic or image analysis tool that would require expert consensus for ground truth.

4. Adjudication method for the test set

This information is not applicable and not provided. As above, adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies, which is not relevant to the testing described for a blood tubing set.

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 not provided. This document does not describe an AI/ML device, nor does it involve human readers or diagnostic interpretations.

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

This information is not applicable and not provided. This device is a physical medical tubing set, not an algorithm.

7. The type of ground truth used

For this device, "ground truth" would relate to the physical and chemical properties and performance of the tubing set. The document indicates that "Performance testing" and "Biocompatibility testing" were conducted. This implies that the ground truth would be established through:

• Engineering specifications and measurements (e.g., flow rates, pressure resistance, connection integrity).
• Chemical and biological assays according to established standards (e.g., for pyrogenicity, acute toxicity, hemolysis).
• Comparison to the performance characteristics of the predicate device.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML model, so there is no training set in the conventional sense.

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

This information is not applicable and not provided. As it is not an AI/ML model, there is no training set or ground truth established for one.

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The NIPRO BioHole™ Needle is intended for use as a blood access device for dialysis procedures using a constant-site cannulation technique of needle insertion with an established, mature constant-site also known as a buttonhole access site.

The NIPRO BioHole™ Needle is a sterile, single-use device that consists of a hollow, winged needle, a flexible tube, mini clamp and locking connector. This device is provided in four design types: fixed wing type A, turnable wing type A, fixed wing type B, turnable wing type B. Needles are available in two lengths, 1" and 1¼", as well as four gauges (14-17), with and without back eye. The flexible tubing comes in lengths of 150mm and 300mm. The NIPRO BioHole™ Needle is packaged individually in a plastic pouch with paper backing, which contains labeling that adequately defines indications for use and warnings. These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.

The provided text is a 510(k) Summary for the NIPRO BioHole™ Needle. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and standalone effectiveness results for the new device against a specified ground truth.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria in the context of diagnostic or screening performance.

However, based on the non-clinical tests section, we can infer the general acceptance criteria and the nature of the "study":

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document mentions "Performance testing was conducted" (Page 1, 807.92(b)(1)), but does not specify a sample size or data provenance (e.g., country of origin, retrospective/prospective). This likely refers to engineering and biocompatibility tests rather than a clinical efficacy study with a "test set" in the sense of a machine learning model.

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

• This information is not applicable/not provided. The "ground truth" for this type of device submission would be compliance with engineering standards, biocompatibility requirements, and material specifications, verified through laboratory testing. There isn't a "test set" requiring expert labeling as would be the case for an AI/ML diagnostic device.

4. Adjudication method for the test set:

• Not applicable/not provided.

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, an MRMC comparative effectiveness study was not done, as this is not an AI/ML diagnostic device.

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

• No, this is not an algorithm, but a physical medical device.

7. The type of ground truth used:

• For the non-clinical tests mentioned, the "ground truth" would be established through objective measurements and adherence to recognized standards (e.g., sterilization validation, material strength tests, biocompatibility testing, fluid flow characteristics). These are typically physical or chemical properties, not expert consensus on an image or clinical outcome for a "test set."

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

• Not applicable.

In summary: The NIPRO BioHole™ Needle submission is a conventional 510(k) for a physical medical device. It demonstrates substantial equivalence through a comparison of technological characteristics with predicate devices and non-clinical performance testing (likely engineering, material, and biocompatibility tests). It does not involve AI/ML, clinical efficacy studies with ground truth derived from expert consensus, or multi-reader studies as would be seen for diagnostic software.

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The NIPRO® Safetouch II Gamma is intended for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood. Secondly, it is designed with an active sharps safety feature requiring physical action by the clinician to aid in the prevention of accidental needlesticks. The compatibility of available configurations is the responsibility of the physician in charge.

The NIPRO® SafeTouch II Gamma is a sterile, single use, safety AVF needle. It includes 2 basic types of designs; fixed wing type (stationary) and turnable wing type (rotating). These two designs are offered in 64 configurations with options that include needle gauge, needle length, type of needle (with or without backeye), and tubing length. The NIPRO® SafeTouch II Gamma includes an arterial and venous fistula adapter consisting of flexible tube and needle with an active sharps safety feature (nonimplanted blood access device) as described in 21 CFR 876.5540. The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks into place. The only difference being the material used for the protector which has changed from a frosted to a transparent component, making it easier to confirm blood flash black. These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.

This document describes the NIPRO® SafeTouch II Gamma, a sterile, single-use safety AVF needle, and compares it to a legally marketed substantial equivalent device, the NIPRO® SafeTouch Safety AVF Needle (K032777).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with numerical targets in this document. Instead, the performance is demonstrated through a comparison of technological characteristics and non-clinical tests, concluding substantial equivalence to the predicate device.

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

The document does not explicitly state the sample size used for the test set of the NIPRO® SafeTouch II Gamma. It refers generally to "performance testing" and "biocompatibility data." The data provenance is not specified beyond indicating that "Those reports along with associated data are included in this submission." It is implied that these are prospective tests performed on the NIPRO® SafeTouch II Gamma, as part of its premarket notification.

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

This information is not provided in the document. As this is a medical device submission focused on substantial equivalence based on non-clinical testing and comparison to a predicate, the "ground truth" for the test set largely comes from established scientific and engineering principles for material safety and device functionality, rather than human expert interpretation of clinical data on the device itself.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or expert consensus on observations (e.g., image interpretation). This document focuses on the results of non-clinical testing and material property comparisons.

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

An MRMC comparative effectiveness study was not done and is not applicable to this device. This is a medical device for blood access, not an AI-driven diagnostic or interpretative tool. Therefore, there is no "human readers improve with AI vs without AI assistance" effect size to report.

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

A standalone performance study, as typically understood for an algorithm without human intervention, was not done and is not applicable. This is a physical medical device, not a software algorithm. Its performance is intrinsic to its design and materials.

7. The Type of Ground Truth Used

The ground truth for this device is based on:

• Established scientific and engineering standards: For biocompatibility (e.g., ISO standards for cytotoxicity, sensitization, etc.).
• Performance specifications: For the mechanical functionality of the safety feature and the needle itself (e.g., strength, sharpness, ease of activation).
• Predicate device characteristics: The NIPRO® SafeTouch Safety AVF Needle (K032777) serves as the primary reference for "ground truth" regarding acceptable performance and characteristics for this type of device.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The NIPRO® SafeTouch II Gamma is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable and therefore not provided. As there is no AI model or training set, there is no ground truth for a training set to be established.

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The Nipro Hypodermic Needle is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.

The subject devices can be classified as single use hypodermic needles as described in 21 CFR 880.5570. Needle sizes include 16-30 Gauge, lengths of ½ to 1 ½ inches, and regular or short bevels.

I'm sorry, but this document does not contain the information requested. The document is a 510(k) premarket notification for Nipro Disposable Needles, and it primarily focuses on establishing substantial equivalence to a predicate device. It does not include details on formal acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, or multi-reader multi-case studies as described in your request.

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The Disposable Hypodermic Syringes with or without Needle are intended for use to inject fluids into or withdraw fluids from the body.

The subject devices can be classified as piston syringes as described in 21 CFR 880.5860. Among the syringe types described are: luer lock, slip-tip, eccentric, and catheter tip. Syringes will be packaged with and without needles. Various sizes are described including: 1, 3, 5, 10, 20, 30, and 60 milliliters.

The provided text describes a 510(k) premarket notification for "NIPRO Disposable Syringe with or without needle." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a formal study design for a novel device. Therefore, much of the requested information (sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this type of regulatory submission and is not present in the provided text.

The core of this submission is a comparison of technical characteristics and performance to legally marketed predicate devices, with the goal of showing they are "substantially equivalent."

Here's the information that can be extracted or derived from the provided text, with explanations where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Not Applicable. The document describes performance tests to demonstrate substantial equivalence to voluntary standards, but it does not detail a specific "test set" or study in the manner requested (e.g., a clinical trial or a performance study with a distinct sample size of patients/cases). The "performance tests" are likely internal engineering and quality testing to ensure the device meets specified manufacturing and product standards rather than a clinical performance study.
• Data Provenance: Not specified, but likely refers to internal testing data generated by Nipro Medical Corporation.

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

• Not Applicable. This type of information is relevant for studies where expert consensus or interpretation is used to establish "ground truth" (e.g., in diagnostic devices). For a disposable medical device like a syringe, "ground truth" typically relates to its physical and functional performance meeting established engineering and safety standards, rather than expert interpretation of data.

4. Adjudication Method

• Not Applicable. As no expert review or "ground truth" adjudication process in the requested sense is described.

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

• No. This type of study is typically done for diagnostic imaging devices or algorithms where human readers are making interpretations. It is not relevant for a disposable hypodermic syringe.

6. Standalone (Algorithm Only) Performance Study

• No. Syringes are mechanical devices; there is no embedded algorithm. "Standalone performance" here refers to the device's physical function. The document states that "Performance tests demonstrated that the devices are substantially equivalent and meet voluntary standards for syringes," which implies standalone testing of the device's physical properties and function. However, no specific metrics or study details are provided beyond this general statement.

7. Type of Ground Truth Used

• For the performance tests mentioned, the "ground truth" would be established by engineering specifications, recognized voluntary standards (e.g., ISO standards for syringes), and relevant regulatory requirements for physical and mechanical performance (e.g., plunger force, leak-tightness, sterility, material compatibility). The document states the device "meet voluntary standards for syringes," implying these standards serve as the "ground truth" for performance.

8. Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which are not part of a disposable syringe. Device validation for manufacturing would involve process validation and testing of production lots, rather than a "training set."

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

• Not Applicable. See point 8.

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The Nipro Disposable Stopcocks are intended for use to change the direction of flow of fluids through a tubing set.

The subject devices can be classified as stopcocks as described in 21 CFR 880.5440. Among the types described here are: click - stop; 3W-R; 3W-L; and, NCN. Both slip tip and luer lock are included.

This document is a 510(k) premarket notification for a Class II medical device (Nipro Disposable Stopcocks) and does not contain the details of a study with acceptance criteria and reported device performance in the manner typically associated with clinical or standalone performance studies for more complex devices.

The approval is based on a determination of substantial equivalence to a previously marketed predicate device, not on a new performance study demonstrating the device meets specific numerical acceptance criteria.

Therefore, many of the requested fields cannot be directly extracted from this document as the information simply isn't present for a device of this type and regulatory pathway.

Here's a breakdown based on the provided text, indicating where information is present and where it is not:

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

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

• Sample size for test set: Not mentioned.
• Data provenance: Not mentioned. Given the nature of a 510(k) for this type of device, performance tests would likely be in-vitro engineering tests (e.g., flow rate, pressure resistance, leak testing), not human clinical 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 device does not involve expert interpretation or ground truth establishment in the way an AI diagnostic device would.

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

• No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant or described.

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

• No. This is a physical medical device (stopcock), not an algorithm.

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

• Not applicable. The "ground truth" for a device like a stopcock is its adherence to engineering specifications and performance within safe parameters, typically verified through physical and mechanical testing rather than clinical "ground truth" as defined for diagnostic systems.

8. The sample size for the training set

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

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

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

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The Nipro® SafeTouch Safety Fistula Needle is intended for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit or larger volumes of blood. Secondly, it is designed with an active sharp safety feature requiring physical action by the clinician to aid in the prevention of accidental needle stick injuries.

The Nipro® SafeTouch Safety Fistula Needle includes arterial and venous fistula adapter consisting of flexible tube and needle with an active sharps safety feature (non-implanted blood access device) as described in 21 CFR 876.5540. The fistula needle included in this 510(k) is modified to include a change in material of the Safety AVF hub from ABS to PMMA compounds consisting of Methyl Methacrylate Polymer and Butadiene Polymer and a change in the shape of the Safety AVF stopper to enhance the activation of the safety mechanism. The sharps injury prevention system is connected between winged needle and polyvinyl chloride tubing and consists of three parts, the Safety Hub, Safety Stopper and Safety Protector. The needle is attached to the Safety Hub and is connected to the Safety Stopper. The Safety Protector then covers the Safety Hub. The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover latches into place. The Nipro® SafeTouch Safety Fistula Needle includes 2 basic types of design with clamps which remain the same: fixed wing type (stationary) and turnable wing type (rotating) which is offered in 96 configurations with options within it to include needle gauge, needle length, type of needle, and tubing length availability. The devices are packaged sterile and are labeled for single use only.

The provided text describes a 510(k) summary for the Nipro® SafeTouch Safety Fistula Needle, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy or performance against specific, quantifiable acceptance criteria through detailed clinical studies.

Therefore, the input document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria.

Specifically:

• No acceptance criteria or reported device performance table: The document does not list any specific performance metrics or thresholds for the device.
• No sample size or data provenance for a test set: The document refers to the device being a modified version of a previously cleared one (K002813) and mentions "biocompatibility data support the equivalence," but provides no details of a test set, its size, or origin.
• No information on experts for ground truth or adjudication methods: Since no details of a performance study are provided, this information is not present.
• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This type of study is not mentioned or implied.
• No standalone (algorithm only) performance study: This device is a physical medical instrument, not a software algorithm, so this type of study is irrelevant and not included.
• No information on the type of ground truth used: As details of a performance study are missing, information about the ground truth is also absent.
• No sample size for the training set or how ground truth was established for it: The concept of "training set" and associated ground truth establishment is typically relevant to machine learning/AI devices, which this is not. The document focuses on demonstrating equivalence through design and material changes rather than a new performance evaluation with a training set.

The document primarily focuses on:

• Device Classification and Intended Use: Defining what the device is and what it's used for.
• Device Description and Characteristics: Highlighting changes from the predicate device (e.g., material change from ABS to PMMA for the Safety AVF hub, and a change in the shape of the Safety AVF stopper).
• Substantial Equivalence Argument: Stating that the modified device is substantially equivalent to the predicate in terms of intended use, materials, biocompatibility, and overall performance. Biocompatibility data is mentioned as supporting this equivalence, but no detailed study results or acceptance criteria are presented.

In summary, the provided filing is a 510(k) summary, which aims to demonstrate substantial equivalence to an existing device rather than presenting a de novo performance study against defined acceptance criteria. Therefore, the detailed information requested about acceptance criteria and associated study specifics is not available in this document.

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The Nipro Disposable Syringes are intended for use to inject fluids into or withdraw fluids from the body.

The subject devices can be classified as piston syringes as described in 21 CFR 880.5860. Among the syringe types described here are: flat-head; circular irrigation syringes; and, screw nozzle syringes. Various sizes are described including: 1, 2, 2.5, 3, 5, 10, 20, 30, 50, and 100 milliliters.

The provided text describes a 510(k) premarket notification for Nipro Disposable Syringes (K030683). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics of the new device itself.

Therefore, the information required to populate the table and answer the study-related questions is not present in the provided text. The document states that "Performance tests demonstrated that the devices are substantially equivalent," but it does not elaborate on these tests, their acceptance criteria, or the specific results.

Here's why the information is missing based on the nature of the document:

• 510(k) Summary: A 510(k) summary (or statement, as this appears to be part of) primarily aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technical characteristics and showing that any differences do not raise new questions of safety or effectiveness.
• Performance Tests Mentioned but Not Detailed: While "Performance tests demonstrated that the devices are substantially equivalent" is stated, the summary does not include the specifics of these tests, such as the actual criteria, methodologies, or outcomes. These details would typically be in a more comprehensive testing report submitted to the FDA, but not necessarily in the publicly available summary.
• Device Type: The device is a "Piston Syringe, Hypodermic, Single Lumen Syringe" and is classified as Class II. For such straightforward, well-understood devices, the "performance tests" likely refer to standard engineering and biocompatibility tests (e.g., sterilization validation, material strength, leakage, plunger force) that confirm it performs as expected for its intended use, rather than complex clinical studies involving human readers or AI algorithms.

Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or AI-related metrics because this information is not included in the 510(k) summary.

If this were a submission for a sophisticated AI/ML-based device, the content would be vastly different and would include detailed clinical validation studies addressing these points.

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