(23 days)
Use for temporary cannulation (non-implantable, less than 30 days) to vascular access for extracorporeal blood treatment. The device is intended for single use only and has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries.
SysLoo® MINI (V3) is intended as non-implanted blood access device, which consists of flexible tube and needle with integrated sharps safety features as described in 21 CFR 876.5540.
SysLoc® MINI (V3) comes with a rotational feature and the needle is retracted with the wing sheath after deliberate release of secured external lock, and final locking is assured by an audible 'click' sound when the hub/tube is pulled rearwards.
The modifications stated for SysLoc® MINI (V3) included in this 510(k) are to have an additional packaging configuration and an alternative Polycarbonate Grade to component (lupilon EB30001R). The modification of the packaging is done accordingly to the device packing, and the modification of polycarbonate grade is evaluated accordingly with the Safety Hub and other components such as wing in order to realize the intended device. The review of modifications is documented within this submission document.
The provided document describes a 510(k) premarket notification for a medical device, the JMS SysLoc® MINI A.V. Fistula Needle Set / Apheresis Needle Set (V3). This submission aims to demonstrate substantial equivalence to a predicate device, the SysLoc® MINI (V2), for two modifications: a new packaging configuration and an alternative polycarbonate grade for a component.
The document does not describe a study involving device performance, clinical outcomes, or human interaction that would typically involve acceptance criteria and a detailed study report. Instead, it focuses on bench testing to verify that the modified device performs as intended and is safe and effective. The acceptance criteria mentioned are primarily related to compliance with various ISO standards and USP requirements, which are typical for medical device manufacturing and material safety.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth for test set, training set details) are not applicable or cannot be extracted from this type of regulatory submission, as it does not detail a clinical or performance study of that nature.
Here's a summary of the available information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ISO 14971:2007 (Risk Management) | Device complies, modifications reviewed. |
| USP 32:2009 (Sterility Tests) | Device complies. |
| ISO 594-2:1998 (6% Luer Taper) | Device complies. |
| ISO 594-1:1986 (6% Luer Taper) | Device complies. |
| ISO 11137-1 (Radiation Sterilization) | Device complies. |
| ISO 11135-1:2007 (Ethylene Oxide Sterilization) | Device complies. |
| ISO 10993-5:2009 (In Vitro Cytotoxicity) | Device complies. |
| ISO 10993-4:2002 (Interactions with Blood) | Device complies. |
| ISO 10993-10 (Irritation & Hypersensitivity) | Device complies. |
| ISO 10993-11 (Systemic Toxicity) | Device complies. |
| Bench testing (Performance) | Performed to verify performance; data and reports enclosed (details not provided in summary). |
| Intended Use (functionality with modifications) | Performs as intended; safe and effective for temporary cannulation for extracorporeal blood treatment, with anti-stick feature. |
2. Sample size used for the test set and the data provenance
The document only states that "Bench testing was conducted" and "data and reports are enclosed within this submission document." It does not specify the sample size for any test set in the context of a performance study on a specific population or data set. The testing described is primarily laboratory-based (bench testing) and compliance-based (ISO standards). Data provenance is internal to the manufacturer (JMS Singapore Pte Ltd).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This type of information is not relevant for the bench and compliance testing described for a 510(k) submission regarding material and packaging changes.
4. Adjudication method for the test set
Not applicable. No expert review or adjudication method for a test set is described.
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. This device is a physical medical needle set, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to an AI algorithm performance, which is not relevant to this device. However, the bench testing conducted can be considered "standalone" in the sense that the device's functional performance was evaluated independent of human use context, but within a laboratory setting.
7. The type of ground truth used
For the bench testing and compliance, the "ground truth" is defined by the requirements and specifications of the referenced international standards (ISO, USP) and the device's own design specifications for its intended function (e.g., proper Luer taper fit, successful sterilization, lack of cytotoxicity, safe sharps retraction).
8. The sample size for the training set
Not applicable. This refers to an AI training set, which is not relevant to this device.
9. How the ground truth for the training set was established
Not applicable. This refers to an AI training set, which is not relevant to this device.
§ 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.