(193 days)
This device is intended to provide access to a patient's blood for Apheresis. This device is intended to single use only and is for temporary catheterization less than 30 days. Regarding to pre-attached Anti-stick Device, use for prevention of needlestick injury a the time of needle withdrawal after usage.
Apheresis Needle
The provided documents (FDA Premarket Notification K990510 for the JMS Apheresis Needle) contain very limited information about performance testing or acceptance criteria. Based on the content, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
No detailed acceptance criteria or specific performance data are provided in these documents. The submission is a 510(k) for an apheresis needle, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive de novo performance testing. The FDA letter implicitly confirms that substantial equivalence was demonstrated, which means general safety and effectiveness were considered adequate based on comparisons to existing devices, but specific performance metrics are not listed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided documents. Test sets, if used for performance evaluation (e.g., for needle integrity, flow rates, or anti-stick mechanism function), would typically be part of a more detailed submission and are not summarized here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable and not available from the provided documents. Apheresis needles are mechanical devices, and their performance is assessed through engineering and bench testing, not typically through expert-read clinical ground truth establishment as would be done for diagnostic imaging AI.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not available for the reasons stated above. Adjudication methods are relevant for subjective interpretations, like radiology reads, not for mechanical device performance.
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 information is not applicable and not available. This type of study is relevant for AI-assisted diagnostic tools, not for a medical device like an apheresis needle.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not available. This concept applies to AI algorithms, not a standalone medical device like an apheresis needle.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a mechanical device like an apheresis needle, "ground truth" would typically refer to objective measurements from engineering tests (e.g., material strength, fluid flow properties, sterilization efficacy, anti-stick mechanism functionality). The documents do not specify the exact types of ground truth or performance data collected for this device. The phrase "ground truth" as typically used in AI/diagnostic evaluation is not applicable here.
8. The sample size for the training set
This information is not applicable and not available. Training sets are used for machine learning models, which are not relevant to the approval of this apheresis needle.
9. How the ground truth for the training set was established
This information is not applicable and not available for the same reasons as above.
Summary of what is known from the provided documents:
- Device: JMS Apheresis Needle
- Intended Use: To provide access to a patient's blood for apheresis.
- Specifics: Intended for single use, temporary catheterization (less than 30 days), and includes a pre-attached anti-stick device for needlestick injury prevention.
- Regulatory Clearance: 510(k) clearance (K990510) based on substantial equivalence to a predicate device.
- Regulatory Class: Class II (21 CFR §876.5820/Procode: 78 FIE).
The FDA's 510(k) process primarily relies on demonstrating substantial equivalence to predicate devices, meaning the new device is as safe and effective as a legally marketed device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and does not raise different questions of safety and effectiveness, or if it has different technological characteristics, that those characteristics do not raise different questions of safety and effectiveness and that performance data demonstrate the device is as safe and effective as the predicate device. The provided letters do not include the detailed performance data or test reports that would have been part of the 510(k) submission.
§ 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.