Search Results

The Dimesol Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. This device is for inhospital or hemodialysis center use only.
The Dimesol Disposable A.V. Fistula Needle Sets (Safety Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Protective Shield aids in the prevention of accidental needlesticks. This device is for inhospital or hemodialysis center use only.
The Dimesol Disposable A.V. Fistula Needle Sets are intended for use as a nonimplantable (i.e., less than 30 days use) vascular/blood access device for temporary cannulation in procedures requiring an extracorporeal circuit, such as hemodialysis.
The Dimesol Disposable A.V. Fistula Needle Sets are intended for use as a nonimplantable (less than 30 days use) vascular access device for temporary cannulation in procedures requiring an extracorporeal circuit, such as hemodialysis.

The Dimesol Disposable A.V. Fistula Needle Sets are intended for use as a nonimplantable (i.e., less than 30 days use) vascular/blood access device for temporary cannulation in procedures requiring an extracorporeal circuit, such as hemodialysis. The cannula (needle) of the device is used to puncture the appropriate area of a patient and the opposite end of the device is attached to a blood tubing set. Typically, two needle sets are used for each treatment. The first set is used to access the patient's artery to transfer blood to the dialyzer and the second set is used to access the patient's vein to transfer filtered blood back to the patient's body. The AV fistula needle sets are available in two main variants: (i) needle sets that do not include a safety feature; and (ii) needle sets that do include a safety feature. The safety feature is a protective shield that covers the cannula after use and requires physical action by the clinician to activate. Both variants are sterile and intended for single use only. Both variants are provided in a fixed-wing design (stationary) and a rotatable wing design (rotatable). The major components of these AV fistula needle sets are manufactured from medical-grade polyvinyl chloride, polypropylene, fire-retardant polyethylene, and other medical-grade macromolecule materials and innocuous stainless steel. These AV fistula needle sets are latex-free and can be inserted into a patient's vein and then connected to a hemodialysis bloodline tubing set. The tubing is soft, transparent, smooth and non-kink. The wings of the needle set are suitably rigid, and the on/off clamps are simple and convenient with regard to use. The wing for 15G is Blue, 16G is Green, and 17G is Red. The tip of the cannula is sharpened to reduce the pain for the patient. The backeye is slender and close to the cannula tip and is slipresistant for smooth puncturing.
The Dimesol Disposable A.V. Fistula Needle Sets without safety shield includes the following structural components: (1) a protective cap for the cannula; (2) a cannula (arterial or venous); (3) a hub; (4) a color-coded fixed or rotatable gripping wing; (5) flexible tubing; (6) a small on/off hemostatic clamp; (7) a connective female luer lock; and (8) a cap for the female luer lock. These AV fistula needle sets are sterilized using gamma radiation. The patient and/or blood contacting components are the cannula, the tubing segment, and the luer lock.
The Dimesol Disposable A.V. Fistula Needle Sets with safety shield includes the following structural components: (1) a protective polypropylene cap for the cannula; (2) a cannula (arterial or venous); (3) a hub; (4) a color-coded fixed or rotatable gripping wing; (5) a safety shield for encapsulating the cannula after use; (6) flexible tubing; (7) a small on/off hemostatic clamp; (8) a connective female luer lock; and (9) a cap for the female leur lock. These AV fistula needle sets are sterilized using gamma radiation. The patient and/or blood contacting components are the cannula, the hub, the tubing segment, and the luer lock.
The protective shield component is generally tubular in shape and includes a locking mechanism that is adapted to secure the hub inside the protective shield when the hub is in its retracted position. The locking mechanism prevents the needle from inadvertently protruding out of the protective shield, thereby ensuring safe disposal of the cannula after use. The oppositely placed axial slots on the protective shield are adapted to receive the wings when the hub moves into the protective shield, thereby ensuring a correct rotational position of the protective shield relative to the hub. The axial length of the slots is long enough to receive both the hub and the cannula, particular the sharp tip of the cannula, thereby preventing accidental exposure to the tip of the needle. The locking mechanism includes two locking aspects. With regard to the first locking aspect, the tubular wall is spread apart when the hub moves into the protective shield. The lower portion of the tubular wall includes a curve that facilitates the insertion of the upper tubular wall includes a locking hoot that maintains the wings in a downward position when the hub moves into the slot. This aspect facilitates the continuous transition of the hub and wings from the minimum width regions of the slots toward the enlarged regions of the slots. With regard to the second locking aspect, two asymmetric locking hooks extend from the tubular walls. These hooks maintain the hub and winds in the enlarged slot. The cannula and hub are thus fully received and locked inside the protective shield and the device may be disposed of in a safe manner. An audible click indicates to the user that the device is in its final locked position.

The provided text is a 510(k) Summary for the Dimesol Disposable AV Fistula Needle Set. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving specific performance metrics against pre-defined acceptance criteria in the context of an AI/ML device.

Therefore, the requested information regarding acceptance criteria, study findings against those criteria, sample sizes, expert involvement, and ground truth establishment, typically associated with performance studies for AI/ML medical devices, is not present in this document.

The document primarily focuses on:

• Device Description: What the device is, its variants (safety and non-safety), and components.
• Indications for Use: What the device is intended for (vein puncture for hemodialysis).
• Substantial Equivalence: A comparison of the Dimesol device's materials, dimensions, intended use, indications for use, configuration, and other factors to legally marketed predicate devices (NIPRO SafeTouch Tulip Safety Fistula Needle, JMS A.V. Fistula Needle Set, EXEL A.V. Fistula Needle Set).
• Performance Testing: A statement that specific performance tests were conducted and found "substantially equivalent" to predicate devices, but without providing the specific acceptance criteria or the reported device performance values for these tests.

However, I can extract the general "performance" aspects that the manufacturer claims are substantially equivalent:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, while specific numerical acceptance criteria and reported performance values are not detailed, the document states that the Dimesol Disposable AV Fistula Needle Sets underwent various performance tests and were found to be "substantially equivalent" to the predicate device (K071145). The table below reflects the types of performance criteria assessed, as indicated in Table 7 of the document. The "Acceptance Criteria" here are implicitly "demonstrates substantial equivalence to K071145 for this test," and the "Reported Device Performance" is consistently stated as "substantially equivalent."

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

• The document does not specify the sample sizes used for any of the performance tests.
• The data provenance is for a physical medical device (AV fistula needle set) and the testing would have been conducted by the manufacturer (Bain Medical Equipment (Guangzhou) Co., Ltd.) or a contracted lab. The document does not specify the country of origin of the test data. The product manufacturing is in Guangzhou, China. The application is submitted from the US.
• The document describes premarket testing of a physical device, not an AI/ML model. Therefore, the concepts of "retrospective or prospective" data sets in the context of AI models (which refer to how data was collected for the AI model's training/testing) do not directly apply here in the usual sense. These are engineering performance tests on manufactured product samples.

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

• This document is for a physical medical device. The concept of "ground truth" established by experts (e.g., radiologists for imaging) is not applicable here. The performance tests are engineering and biological validations (e.g., tensile strength, flow rate, biocompatibility) against established standards (e.g., ISO 10993) and comparison to predicate devices, not subjective expert interpretations of data.

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

• As this is a physical device being tested against engineering and biological standards, adjudication methods (common in expert consensus for AI/ML ground truth) are not applicable. The results would be quantitative measurements.

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 question is not applicable. The device is an AV fistula needle set, a physical medical instrument, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies and "human readers improving with AI assistance" are irrelevant.

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

• This question is not applicable. The device is a physical medical instrument.

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

• For physical devices like this, "ground truth" typically refers to adherence to pre-defined engineering specifications, international standards (e.g., ISO 10993 for biocompatibility), and physical performance measurements rather than a subjective or pathological "truth." The document states conformance to ISO 10993 for biocompatibility.

8. The sample size for the training set:

• This question is not applicable. There is no "training set" as this is not an AI/ML device.

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

• This question is not applicable. There is no "training set."

In summary: The provided text is a regulatory submission for a physical medical device (AV fistula needle set) under the 510(k) pathway, which focuses on demonstrating substantial equivalence to existing devices. It does not contain the specific information typically found in performance studies for AI/ML medical devices, which would detail precise acceptance criteria and quantitative performance results, or involve concepts like ground truth establishment by experts, human-in-the-loop studies, or training/test sets for algorithms. The "acceptance criteria" here are implicitly linked to demonstrating equivalence and meeting relevant device standards.

Ask a specific question about this device

The Dimesol Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician / clinician in charge.

The Dimesol blood tubing sets for hemodialysis are single use arterial and venous blood line (tubing) sets for use with polyethersulfone hollow-fiber hemodialyzers or other dialyzers that are indicated for hemodialysis treatment of acute and chronic renal failure. These tubing sets are intended for use as the extracorporeal blood circuit during hemodialysis and to connect a dialysis patient to a hemodialyzer. These tubing sets are intended for single use only. The major device components of these tubing sets are manufactured from medical-grade polyvinyl chloride (PVC), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), and fire-retardant polyethylene (PE).

The document provided is a 510(k) summary for the Dimesol Tubing Sets for Hemodialysis. It establishes substantial equivalence to predicate devices rather than proving the device meets explicit acceptance criteria through a standalone study. Therefore, some information typically found in a study demonstrating such criteria (like sample sizes for test/training sets, expert qualifications, or adjudication methods) is not applicable or not provided in the context of this 510(k) submission.

Here is a summary based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of explicit quantitative acceptance criteria with reported numerical performance values in a distinct table, the document refers to compliance with established international standards for various performance characteristics and biocompatibility. The "acceptance criteria" are implied by adherence to these standards and by demonstrating equivalence to predicate devices.

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

The document does not specify the sample sizes used for the tests conducted to demonstrate compliance with ISO standards. It states that tests were performed but does not detail the number of units tested.

The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. The manufacturing entity is Bain Medical Equipment (Guangzhou) Co., Ltd. in Guangzhou, China. The testing was conducted to international standards (ISO), which are globally recognized.

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

This information is not applicable to a 510(k) submission for a hemodialysis tubing set, as it is a medical device and not an AI/software device that typically requires expert consensus for ground truth establishment. The "ground truth" for demonstrating the safety and effectiveness of this device comes from compliance with recognized performance and biocompatibility standards.

4. Adjudication Method for the Test Set

Not applicable for this type of medical device submission. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessment, often seen in diagnostic imaging or AI performance evaluations.

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. The Dimesol Tubing Sets for Hemodialysis are physical medical devices, not an AI or software product. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was conducted or would be relevant for this submission.

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

Not applicable, as this is a physical medical device and not an algorithm or AI product.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established by compliance with recognized international standards (ISO 10993 for biocompatibility, ISO 8638 and ISO 594-2 for performance) and by demonstrating substantial equivalence to legally marketed predicate devices that have already met these standards.

8. The Sample Size for the Training Set

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

Not applicable, as there is no "training set" for this physical medical device.

Ask a specific question about this device