(113 days)
The JMS Blunt AV Fistula Needle Set is intended for temporary cannulation (nonımplantable, less than 30 days) to vascular access for extracorporeal blood treatment The device is intended for single use only The JMS AV Fistula Blunt Needle Set is for use on developed 'constant site' access sites
JMS AV Fistula Blunt Needle Set is intended as a non-implanted blood access device, which consists of a needle that is attached to wings, a flexible tube and a luer lock connector
Here's a breakdown of the acceptance criteria and study information based on the provided text, though it's important to note that the document is a 510(k) summary for a medical device (a blunt needle set), not a typical AI/software device. As such, many of the requested categories (like MRMC, training sets, ground truth for AI, etc.) are not applicable in their usual sense. This device relies on "substantial equivalence" to predicate devices rather than a standalone performance study as would be seen for an imaging AI.
Device Name: JMS A V Fistula Blunt Needle Set
1. Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" and "reported device performance" are primarily demonstrated through equivalence to legally marketed predicate devices, focusing on functional aspects, materials, and intended use. The document doesn't provide specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) typical of AI/software. Instead, the "acceptance" is that it performs as intended and is comparable to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Intended Use: Temporary cannulation for extracorporeal blood treatment on developed 'constant site' access sites. | Device is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. Intended for single use only, on developed 'constant site' access sites. This matches the predicate devices. |
| Functional Performance: Performs as a non-implanted blood access device with a needle, wings, flexible tube, and luer lock connector. | "Functional tests performance data are comparable to predicate device." "Bench testing was conducted to verify that the JMS AV Fistula Blunt Needle Set performs as intended to be a safe and effective medical device, data and reports are enclosed within this submission document." (Specific results of these bench tests are not detailed in this summary). |
| Materials: Material composition of blood-contact components. | "JMS A V Fistula Blunt Needle Set... adopts identical fundamental scientific technology as the predicate devices." "JMS AV Fistula Blunt Needle Set has the same intended usage, same materials used in the blood-contact components..." (Specific material types are not detailed in this summary, but they are stated to be the same as predicates). |
| Safety and Effectiveness: Demonstrated through equivalence. | "The information provided in this submission clearly demonstrates the substantial equivalence of JMS AV Fistula Blunt Needle Set to the predicate device..." |
2. Sample Size Used for the Test Set and Data Provenance
For this device, there isn't a "test set" in the sense of a clinical trial dataset for an AI algorithm. The performance is assessed through bench testing for functional performance and a comparison of specifications to predicate devices.
- Sample Size for Test Set: The document mentions "bench testing was conducted," but it does not specify the sample size of devices used in these tests.
- Data Provenance: The document doesn't specify data provenance (country of origin, retrospective/prospective) for any test data. The tests would have been performed by the manufacturer (JMS Singapore Pte Ltd or JMS North America Corporation). The nature of the tests (bench testing) implies a controlled laboratory environment rather than patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable to this type of device submission.
Ground truth, in the context of typical AI/imaging studies, refers to the verified correct diagnosis or finding. For a physical medical device like a needle set, performance is evaluated against engineering specifications and functional benchmarks, not by expert consensus on clinical findings from a "test set" of images or patient data.
4. Adjudication Method for the Test Set
This question is not applicable. There is no "test set" or adjudication method in the context of clinical interpretations for this device. Performance is based on bench testing and comparison to predicate devices.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging systems or AI tools where human readers interpret cases. The JMS AV Fistula Blunt Needle Set is a physical access device, not an imaging or interpretive technology.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is a physical medical device, not an algorithm, and therefore does not have a "standalone" algorithmic performance.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by engineering specifications, material science standards, and the demonstrated performance of the legally marketed predicate devices. The device's functional tests would verify these engineering specifications.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" for a physical medical device. Training sets are used to develop and refine AI algorithms or software.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. As there is no training set, there is no ground truth for it to be established.
§ 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.