(77 days)
The JMS Blunt AV Fistula Needle Set with Site Preparation Tool is intended for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment and for the removal of scabs that have developed over the constant site prior to cannulation. 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 A.V. Fistula Blunt Needle Set with Site Preparation Tool is a modification of the previously cleared JMS A.V. Fistula Blunt Needle Set (K082882). The modification is the replacement of the standard needle cover with a site preparation tool "scraper" feature that removes the scabs that have developed over the constant site prior to cannulation.
Here's an analysis of the provided 510(k) summary regarding the JMS Blunt A.V. Fistula Needle Set with Site Preparation Tool, focusing on acceptance criteria and supporting studies.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (JMS A.V. Fistula Blunt Needle Set, K082882) by showing that the new device shares similar technical and performance characteristics, with the key difference being the addition of a "site preparation tool" (scraper) on the needle cover.
The summary states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical/Performance Specification | Met established acceptance criteria |
| Biocompatibility | All patient contacting materials meet biocompatibility standards for ISO-10993 for non-implanted blood access contacting device less than 30 days |
| Sterilization | Validations performed in accordance with EN-550 and ISO 11135 |
| Ease of Use & Label Comprehension | Clinical usability study was performed to verify ease of use and label comprehension. |
Note: The document does not provide specific numerical or qualitative acceptance criteria (e.g., "tear strength must be X N", "cytotoxicity must be scale Y or less"). Instead, it states that established criteria were met, or refers to adherence to international standards. The 510(k) process often relies on demonstrating compliance with recognized standards or equivalency to a predicate for which such standards were previously deemed met.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions a "Clinical Usability Study" but does not specify the sample size for this study. It also does not explicitly state the data provenance (e.g., country of origin, retrospective/prospective). However, given that it's a medical device for use in dialysis, it's highly probable it would involve prospective data collection in a clinical setting relevant to dialysis treatment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not provide this information. For a "clinical usability study," the "ground truth" might be subjective user feedback or objective observations by trained personnel, but the number and qualifications of evaluators are not detailed.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the clinical usability study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This question is not applicable. The device described (JMS Blunt A.V. Fistula Needle Set with Site Preparation Tool) is a physical medical device (a needle set), not an AI-powered diagnostic or assistive tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study involving AI assistance would not be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable. As explained above, the device is a physical medical tool, not an algorithm.
7. The Type of Ground Truth Used
For the "Clinical Usability Study," the "ground truth" would likely be based on:
- User feedback: Direct qualitative and quantitative feedback from healthcare professionals (nurses, technicians) on the device's ease of use, functionality of the scraper, and overall performance in a real or simulated clinical setting.
- Observational data: Assessment by trained observers of how efficiently and effectively users performed tasks with the device, and whether the scraper feature successfully removed scabs as intended.
- Label Comprehension: Verification that users understood instructions and warnings on the device labeling.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical medical product and does not involve a "training set" in the context of machine learning or AI models. The design and testing are based on engineering principles, material science, and clinical evaluation.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
§ 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.