(262 days)
The DORA 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.
The DORA Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment.
The proposed device, DORA Disposable A.V. Fistula Needle Sets, is a non-implantable blood access device, which mainly consists of an adaptor, flexible tube and sharp needle. It is available in two types, 1) Needle sets with safety feature and 2) Needle sets without safety feature. Both the two types of proposed device are provided sterile and are for single use only.
The two types of proposed devices are offered in difference configurations with options that include needle gauge, needle length, wing types (fixed wing or rotatable wing).
The proposed device and its package are designed to be provided in Gamma sterilization. The package could maintain the sterility of the device for three years.
The Protective Shield for injury prevention requires physical action by the clinician to activate and is designed to cover the cannula after treatment. Correct use of this safety feature will eliminate accidental needlestick injuries.
The proposed device is used in conjunction with following hemodialysis blood tubing sets during clincial use.
The provided document, a 510(k) Summary for the DORA Disposable A.V. Fistula Needle Sets, details the premarket notification of intent to market the device and its substantial equivalence to a legally marketed predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as an already approved device, rather than proving novel effectiveness through extensive clinical trials.
As such, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of:
- A table of acceptance criteria and reported device performance for an AI/ML or diagnostic device. This document is for a physical medical device (AV fistula needle sets).
- Sample sizes for a test set (for AI/ML validation). The testing described is for physical characteristics and biocompatibility, not for a 'test set' in the AI/ML sense.
- Data provenance for a test set (for AI/ML validation). Not applicable to a physical medical device.
- Number of experts and their qualifications for establishing ground truth. Not applicable.
- Adjudication method for a test set. Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Not applicable.
- Standalone (algorithm only) performance. Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data). Not applicable.
- Sample size for training set. Not applicable.
- How ground truth for training set was established. Not applicable.
Instead, the document focuses on non-clinical testing and substantial equivalence to a predicate device.
Here's what the document does provide regarding acceptance criteria and performance:
1. Acceptance Criteria (via Standards Compliance and Performance Testing) and Reported Device Performance:
The acceptance criteria for this device are demonstrated through adherence to various international and national standards, as well as the successful completion of specific non-clinical performance tests. The reported performance is that the device "met all design specifications" and "is similar as that of the predicate device" or "acceptable."
| Acceptance Criteria Category | Specific Criterion/Standard | Reported Device Performance |
|---|---|---|
| Material/Component Standards | ISO/FDIS 9626:2016 (Stainless steel needle tubing) | Complies with ISO/FDIS 9626:2016 (Needle Performance) |
| Packaging Integrity | ASTM F88/F88M - 15 (Seal Strength) | Complies |
| ASTM F1929 – 15 (Seal Leaks by Dye Penetration) | Complies | |
| Biological Safety (Biocompatibility) | USP (Bacterial Endotoxin Limit) | Complies |
| ISO 10993-3:2014 (Genotoxicity, carcinogenicity, reproductive toxicity) | Complies with ISO 10993 series standards; tests performed (Cytotoxicity; | |
| Sensitization; Irritation sensitivity; Systemic toxicity; | ||
| Pyrogen; Hemolysis; Thromboresistance; Partial thromboplastin time; | ||
| Complement activation; Bacterial reverse mutation; | ||
| Mammalian chromosome aberration; Mouse bone marrow micronucleus; | ||
| Activated clotting time of whole blood; Platelet adhesion; | ||
| Muscle implantation; Subchronic systemic toxicity) | ||
| ISO 10993-4:2002 A1:2006 (Interactions with blood) | Complies | |
| ISO 10993-5:2009 (Vitro Cytotoxicity) | Complies | |
| ISO 10993-6:2007 (Local effects after implantation) | Complies | |
| ISO 10993-10:2010 (Irritation and skin sensitization) | Complies | |
| ISO 10993-11:2006 (Systemic toxicity) | Complies | |
| ASTM F756-13 (Hemolytic Properties) | Complies | |
| Functional/Mechanical Performance | ISO 594-1:1986 (Luer Taper - General) | Complies (Female Conical Fitting Testing) |
| ISO 594-2:1998 (Luer Taper - Lock Fittings) | Complies (Female Conical Fitting Testing) | |
| ISO 10555-1:2013 (Intravascular catheters – General requirements) | Complies | |
| Shipping/Packaging Performance | ASTM D4169-16 (Performance Testing Of Shipping Containers) | Complies |
| Specific Device Performance | Simulated Use Needlestick Prevention Testing | Test results demonstrated similarity to predicate device |
| Needle Performance Testing | Test results demonstrated similarity to predicate device | |
| Mechanical Testing (Wing torque, final lock, needle pushback, mechanical hemolysis) | Test results demonstrated similarity to predicate device | |
| Tensile Strength Testing (Tube to wing pull, tube to joint, needle to cover pull, cannula to hub) | Test results demonstrated similarity to predicate device | |
| Tubing Kinking Test | Test results demonstrated similarity to predicate device | |
| Leakage Testing (Liquid leakage, air leakage) | Test results demonstrated similarity to predicate device | |
| Clamp Stop Testing | Test results demonstrated similarity to predicate device | |
| Flow Rate Testing (Also listed as an AV Fistula Needle Set Performance Test) | Test results demonstrated similarity to predicate device | |
| Particulate Contamination Testing (Also listed as an AV Fistula Needle Set Performance Test) | Test results demonstrated similarity to predicate device | |
| Sterility Assurance | SAL: 10-6 (Sterility Assurance Level) via Gamma Sterilization | Achieved 10-6 SAL |
2. Sample sizes used for the test set and the data provenance:
- Sample Sizes: Not explicitly stated with specific numbers (e.g., "n=X needles were tested"). The document generally states "Non clinical tests were conducted" and "The test results demonstrated...". For a 510(k) submission for a physical device, detailed sample sizes for each specific test are typically found in the full technical documentation, not summarized in the 510(k) summary as it is here.
- Data Provenance: The tests were conducted internally by Bain Medical Equipment (Guangzhou) Co., Ltd. or by test labs they contracted. The document implicitly indicates the tests originate from China (Guangzhou) as that's the manufacturer's location. The tests are "non-clinical" and likely conducted in laboratory settings, not on patient data or retrospective/prospective human studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical medical device. "Ground truth" in this context refers to compliance with established engineering and biocompatibility standards, not expert human interpretation for a diagnostic or AI device.
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, a MRMC study was not done. This device is a physical medical instrument, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For physical devices, the "ground truth" is adherence to predefined engineering specifications, internationally recognized standards (ISO, ASTM, USP), and established safety and performance benchmarks (e.g., sterilization effectiveness, material strength, biocompatibility profiles). It's a truth based on physical and chemical properties and their interaction, rather than clinical outcomes or diagnostic interpretations.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that uses a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.