(106 days)
To replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. Repairs Spire BioMedical Xpresso®, Decathlon™, & Alta LR™ catheters.
The Spire BioMedical repair kit is used to replace damaged female luer connectors, clamps, or repair extensions where there is a minimum of 2.5 cm viable extension tubing. This repair kit is to be used on the Spire BioMedical Xpresso®, Decathlon™, and Alta LR™ catheters.
The provided K062435 document describes a 510(k) premarket notification for a "Repair Kit for XpressO®, Decathion™, and Alta LR™ Catheters." This device is a repair kit for existing medical catheters, and the submission focuses on demonstrating substantial equivalence to a predicate device, the Pourchez Retro Repair Kit (K022644).
Given the nature of this submission (a repair kit for existing catheters, demonstrating equivalence to an existing repair kit), the "study" conducted is a series of bench tests rather than a clinical trial involving human or animal subjects that falls under a typical AI/ML performance study. The focus is on physical and material characteristics.
Therefore, many of the requested categories (such as sample size for test/training sets, ground truth establishment for AI, expert involvement, MRMC studies, standalone AI performance) are not applicable to this type of device and submission. The "acceptance criteria" and "device performance" in this context refer to the physical and mechanical properties tested during bench validation.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "A series of physical tests were conducted to demonstrate substantial equivalence to the Pourchez Retro Repair Kit (K022644). Refer to Section 18 'Bench Testing' for physical test data."
However, Section 18 "Bench Testing" is not included in the provided excerpts. Therefore, the specific acceptance criteria and the quantitative reported performance values are not available here. We can infer that the general acceptance criterion would be that the repair kit's performance in these physical tests is equivalent to or not worse than the predicate device.
| Acceptance Criteria (Inferred from "substantial equivalence") | Reported Device Performance (Not explicitly stated in provided document) |
|---|---|
| Must demonstrate equivalent physical characteristics to the Pourchez Retro Repair Kit (K022644) in a series of bench tests. | Passed all physical tests, demonstrating substantial equivalence to the predicate device. (Specific data, e.g., tensile strength, leak integrity, not provided in excerpt) |
| Must be biocompatible (for new materials). | Biocompatibility testing conducted only on new materials. (Specific results not provided in excerpt) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document. For physical bench testing, sample sizes vary depending on the specific test and statistical requirements.
- Data Provenance: The tests were conducted "in-house" by Spire Biomedical, Inc. (manufacturer), likely at their facility in Bedford, MA, USA. This is a retrospective evaluation based on laboratory testing of the device prototypes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For physical bench testing of a medical device repair kit, "ground truth" is typically established by engineering specifications, material standards, and benchmark performance of predicate devices, not by expert consensus on clinical data. The tests are objective measurements of physical properties.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1 or 3+1) are relevant for subjective assessments, such as image interpretation or clinical outcomes, typically involving multiple human readers. Bench testing involves objective measurements against established technical specifications.
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 not an AI/ML-driven diagnostic or assistive tool for human readers. It's a physical medical device repair kit.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done
- Not Applicable. This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used
- For physical tests: Engineering specifications, material standards, and benchmark performance data of the predicate device (Pourchez Retro Repair Kit K022644).
- For biocompatibility: Adherence to recognized biocompatibility standards (e.g., ISO 10993 series) for medical devices.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device, so there is no "training set." The repair kit itself is the "device," designed and manufactured according to specifications.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML model, this question does not apply.
§ 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.