Search Results

The B. Braun Omnifix Syringe NRFit is intended for neuraxial use for aspiration/injection of fluids used by healthcare professionals in healthcare facilities.

B. Braun Medical Inc. Omnifix Syringe NRFit configurations are sterile, single use syringes with ISO 80369-6 NRFit compliant fittings. They are available in 1mL, 3mL, 10mL, and 20mL lock and slip configurations. The NRFit tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a barrel with a printed graduated scale in milliliters (mL), a stopper and a plunger rod. The plunger rod is yellow to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.

The provided text describes a 510(k) premarket notification for a medical device, the Omnifix Syringe NRFit. This document focuses on demonstrating the substantial equivalence of the new device to a predicate device (B. Braun Piston Syringes, K071459) rather than presenting a traditional clinical study with acceptance criteria for an AI/algorithm-driven device.

Therefore, the request for a table of acceptance criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for a device meeting acceptance criteria by an AI/algorithm is not applicable to this document.

This FDA clearance is for a physical medical device (a syringe) that has been modified to include a new type of connector (NRFit) for neuraxial use. The "performance" being described in the document relates to mechanical and material properties of the syringe, and its biocompatibility, according to established ISO and ASTM standards, not to the performance of an artificial intelligence algorithm.

Instead, the document details nonclinical performance tests conducted to demonstrate the modified syringe's safety and effectiveness. Here's a breakdown of what is provided and why it doesn't fit the requested AI/algorithm performance criteria:

Summary of Device Performance (as presented in the document):

The document states that the Omnifix Syringe NRFit configurations are "equivalent to that of the predicate B. Braun Medical Inc. Omnifix Syringe in intended use, materials and performance characteristics." The differences primarily relate to the connector type (NRFit vs. Luer) and the
resulting change in indicated use (neuraxial vs. general purpose).

The device's performance is demonstrated through compliance with various international standards, which serve as the "acceptance criteria" for a physical medical device. These are detailed under "Functional Testing Summary of ISO 80369-6 compliant nonclinical tests" and other sections.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a physical device and not an AI algorithm, the "acceptance criteria" are the successful demonstration of compliance with the listed ISO and ASTM standards. The document explicitly states "Bench testing performed on the proposed devices supports substantial equivalence." This implies that the device successfully met the requirements of these tests.

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

• The document implies that standard test methods prescribed by each ISO/ASTM standard were followed. Therefore, the "sample size" would be the number of devices required by these standards for each respective test (e.g., number of syringes for leakage tests, number of samples for biocompatibility, etc.). These specific numbers are not provided in this high-level summary but would be detailed in the underlying test reports.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is internal lab testing of the manufactured product.

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. Ground truth for a physical device's mechanical integrity and biocompatibility is established by adherence to reproducible, standardized test methods, not by expert consensus (like in imaging diagnosis). The "experts" would be qualified laboratory technicians and scientists performing and interpreting these standardized tests.

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

• Not applicable. This concept applies to human reader studies or algorithmic output interpretation, not to physical device testing against objective 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 is not an AI-assisted diagnostic device.

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

• Not applicable. This is not an AI algorithm.

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

• The "ground truth" for this device's performance is objective compliance with engineering and biocompatibility standards (e.g., specific dimensions, leakage rates, material reactions in biological assays). It is not expert consensus for diagnostic interpretation or patient outcomes data in the sense of a clinical trial for an AI.

8. The sample size for the training set:

• Not applicable. There is no AI algorithm being trained.

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

• Not applicable. There is no AI algorithm being trained.

In conclusion, the provided FDA 510(k) clearance letter and its summary are for a modified physical medical device. The "study" proving it meets acceptance criteria refers to a battery of nonclinical, laboratory-based functional and biocompatibility tests against established international standards (ISO, ASTM, USP), not an AI algorithm validation study. Therefore, most of the specific questions posed are not relevant to the content of this document.

Ask a specific question about this device

The Artiglass NRFit tip Glass Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard textbooks. These syringes are not intended for injection or aspiration.

The Artiglass NRFit TM tip Glass Syringes provided not sterile with ISO 80369-6 (NRFit™) compliant fittings. They are available in 5mL and 10mL, lock and slip configurations and 5mL and 10mL lock configurations. The NRFit™ tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a borosilicate neutral with a graduated scale in milliliters (mL), a borosilicate neutral glass plunger and a nickel-plated brass tip. The plunger rod is amber colored to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles.

This document is a 510(k) premarket notification for a medical device, the Artiglass NRFit™ Tip L.O.R. Glass Syringes. It is typically submitted to the FDA to demonstrate that a device is substantially equivalent to a predicate device already on the market. Such submissions generally focus on demonstrating equivalence through comparison of technological characteristics and performance testing based on established standards, rather than clinical trials with human subjects or complex AI model evaluation.

Therefore, the sections of your request related to AI model evaluation, multi-reader multi-case studies, expert consensus on ground truth, and separate training/test sets for AI are not applicable to this document. The document describes a physical medical device, not an AI/ML diagnostic or prognostic tool.

Here's an analysis of the provided text based on the elements that are applicable:

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

The acceptance criteria are generally defined by the relevant ISO standards. The document states that the testing "demonstrates the proposed devices conform to the applicable requirements" of these standards. While a detailed table with specific numerical results vs. criteria isn't provided, it indicates compliance.

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

The document does not specify exact sample sizes for each non-clinical test (e.g., how many syringes were tested for leakage). It mentions that "Connector testing performed on the proposed device," implying that a sample was used, but the specific number is not provided.

• Data Provenance: The tests are non-clinical, meaning they are performed in a lab setting on the manufactured device, not using patient data. The country of origin of the data is implicitly the location where Artiglass Srl conducts its manufacturing and testing, which is Italy. The data is prospective in the sense that the testing is performed on the newly manufactured device to demonstrate its performance.

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 physical device, and the "ground truth" for performance is established by objective measurements against engineering standards (ISO norms), not by expert interpretation of data like in an AI/ML context.

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

Not applicable, as no human experts are adjudicating "ground truth" in the context of device performance testing against objective 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 is a physical medical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device, 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 defined by the requirements and specifications within established international standards (e.g., ISO 80369-6, ISO 80369-20, ISO 595-2, ISO 10993 series). The device's performance is measured against these objective, predefined engineering and biocompatibility criteria.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

Ask a specific question about this device

The NRFit® cap is a sterile, single-use device intended to provide positive closure to prevent fluid loss and contamination in Neuraxial devices CADD Cassettes or Syringes utilizing NRFit® connections. The NRFit® cap is intended to be used for less than 24 hours on any single application.

The NRFit® Caps (abbreviated as "NRFit") are ISO 80369-6 compliant caps designed to prevent fluid loss in Neuraxial devices. The NRFit cap is made from medical grade polypropylene with yellow colorant. The NRFit cap is available with either a male neuraxial lock connection or a female neuraxial lock connection. The NRFit cap is made of materials appropriate for a limited exposure duration, externally communicating, tissue/bone/dentin contacting medical device.

The provided document describes the NRFit® Caps, Male and Female Neuraxial Tip Caps, and its substantial equivalence to a predicate device. It specifies performance testing but does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML performance.

The document is purely about the 510(k) premarket notification for a physical medical device (caps for neuraxial devices) and its comparison to a similar predicate device. The performance data presented are for non-clinical, physical tests of the device (e.g., leakage, stress cracking, axial separation), not for AI/ML performance metrics.

Therefore, I cannot provide the requested information regarding AI/ML device performance, as the provided text does not pertain to an AI/ML powered medical device.

If you have a document describing an AI/ML medical device and its performance studies, please provide that.

Ask a specific question about this device

The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are intended for neuraxial use by healthcare professionals for aspiration/injection of fluids.

The BD® Syringe NRFit™ Lok and BD® Syringe NRFit™ Slip are sterile, single use syringes with ISO 80369-6 (NRFit™) compliant fittings. They are available in 3mL, 5mL and 10mL, lock and slip configurations and 20mL and 50mL lock configurations. The NRFit™ tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale in milliliters (mL), a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is yellow to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.

The provided text does not describe an AI/ML powered medical device, but rather a Becton, Dickinson and Company's (BD) Syringe NRFit Lok and BD Syringe NRFit Slip, which are medical devices that are substantially equivalent to a predicate device. Therefore, the specific details regarding acceptance criteria and studies for AI/ML performance (such as sample size for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or present in this document.

However, based on the provided text, the acceptance criteria and the studies performed to demonstrate equivalence of the BD Syringe NRFit™ Lok and BD Syringe NRFit™ Slip to a predicate device (BD Single Use, Hypodermic Syringe, K980987) are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The document details numerous functional, packaging, and biocompatibility tests performed according to specific ISO and ASTM standards. The reported device performance consistently states that the subject device "met all predetermined acceptance criteria for the above-listed performance tests" or comparable phrases indicating successful adherence to the standards. Since the exact numerical criteria and results are not always explicitly stated (e.g., for stress cracking, it doesn't give a specific force value), this table will summarize the type of test and the general outcome.

For the following points, as the device is a syringe and not an AI/ML powered device, these sections are generally not applicable and the provided text does not contain this information.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for this type of medical device assessment. The tests involve physical samples of the syringe rather than data sets.

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. Ground truth for physical device performance is established through adherence to national and international standards, rather than expert consensus on interpretive tasks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the evaluation is based on objective measurements against specified standard limits, not interpretive judgment.

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 not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by international and national consensus standards (ISO, ASTM, USP) that define safety and functional attributes for syringes and medical device materials, along with BD internal requirements for specific characteristics not fully covered by external standards.

8. The sample size for the training set
Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.

Ask a specific question about this device

The device is indicated for local administration, and regional administration, specifically, wound infiltrations, peripheral nerve block, and epidural block. The device is not indicated for subarachnoid/spinal blocks.

The proposed device is a disposable neuraxial syringe consist of three components: piston, plunger and barrel; and provided in a variety of volumes: 1ml, 3ml, 6ml, 10ml, 30ml, 35ml, 50ml, 30ml and 60 ml. The barrel of the syringe is printed with graduated markings indicating the volume of liquid inside the barrel.

The proposed device is used to inject anesthesia medicine with the cooperation of the spinal anesthesia needles and epidural anesthesia needles which has an NRFit connectors in compliance with ISO 80369-6. The NRFit tip could help to reduce the residual risk of misconnections.

The proposed device is provided in two statuses: sterile. The non-sterile NRFit syringe is intended to be sterilized prior to use to repackagers/medical device manufacturers, and the sterile NRFit syringe is supplied to the end user. The sterilized product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

The acceptance criteria and device performance for the NRFit Syringe are detailed in Section 8 of the provided 510(k) summary (pages 5 and 6 of the document). The study demonstrating the device meets these criteria is referred to as "Non-Clinical Test Conclusion."

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is reported as conformity to the specified standards and their respective clauses/annexes.

Additionally, the device was tested against and found to comply with the following standards:

• ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
• ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
• ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
• ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
• ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
• USP 39-NF34 Bacterial Endotoxins Test
• ISO 80369-20:2015 Small bore connectors for liquids and gases in healthcare applications- Part 20: Common test methods
• USP Particulate Matter in Injections (Method 1)

2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each individual test. It indicates that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" and that the "test results demonstrated that the proposed device complies with the following standards." The provenance of the data (country of origin, retrospective or prospective) is not specified, but the submission is from Jiangsu Caina Medical Co., Ltd in China, suggesting the tests were likely conducted by or for them.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for these non-clinical tests is established by the specifications of the referenced ISO and ASTM standards, not by expert consensus from medical professionals.

4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against established standard requirements, not subjective assessments 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 (syringe) and not an AI or diagnostic imaging device. Therefore, MRMC studies are not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device (syringe) and not an AI algorithm.

7. The Type of Ground Truth Used
The ground truth used for the non-clinical tests is based on engineering and performance specifications defined within internationally recognized standards (ISO, ASTM, USP). This includes measurable physical properties and biological safety limits.

8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned as this is not a machine learning or AI-based device.

9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.

Ask a specific question about this device