(359 days)
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."
| Performance Test Type | Acceptance Criteria (Implicit) | Reported Device Performance (as stated) |
|---|---|---|
| Needle Performance Testing | Substantially equivalent to K071145 | substantially equivalent |
| Female Conical Fitting Testing | Substantially equivalent to K071145 | substantially equivalent |
| Mechanical Testing (wing torque, final lock, needle pushback, mechanical hemolysis) | Substantially equivalent to K071145 | substantially equivalent |
| Tensile Strength Testing (tube to wing pull, tube to joint, needle to cover pull, cannula to hub) | Substantially equivalent to K071145 | substantially equivalent |
| Tubing Kinking Test | Substantially equivalent to K071145 | substantially equivalent |
| Leakage Testing (liquid, air) | Substantially equivalent to K071145 | substantially equivalent |
| Clamp Stop Testing | Substantially equivalent to K071145 | substantially equivalent |
| Flow Rate Testing | Substantially equivalent to K071145 | 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.
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.