(104 days)
The GlidePath™ 10F long-term hemodialysis catheter is indicated for use in attaining short-term vascular access in pediatric, adolescent and adult patients for hemodialysis, hemoperfusion or apheresis as determined by the prescribing physician. Access is attained via the internal jugular vein, or femoral vein, Catheters longer than 22 cm are intended for femoral vein insertion, depending on patient anatomy and size.
The Glidepath™ 10F Long-Term Hemodialysis Catheter features a dual-lumen shaft with optimized double-D cross-sectional designs providing separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector connects to the blood intake on the dialysis machine and the venous (blue) luer connector connects to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. Long-term dialysis catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in overthe-guidewire placement. The dialysis catheters are offered in various lengths. This line extension of GlidePath™ has been designed with smaller patients in mind and for physicians that may prefer a smaller diameter catheter, so product offerings include the smaller lumen diameter, 10 F, and shorter lengths, 10 cm to 23 cm. Additionally, Glidepath™ 10F Long-Term Hemodialysis Catheter has been designed to reach adequate flow rate requirements for pediatric patients or smaller adult patients for whom a physician desires a smaller catheter size.
The provided text describes the regulatory clearance of a medical device, the GlidePath 10F Long-Term Hemodialysis Catheter, and its substantial equivalence to predicate devices. However, the document does not contain the specific details required to answer all parts of your request regarding acceptance criteria and the study that proves the device meets those criteria, especially in the context of an AI/ML device.
This document is a 510(k) summary for a physical medical catheter, not an AI/ML device. Therefore, questions relating to AI/ML device performance (e.g., test sets, ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to the information provided.
The document discusses performance data for the physical catheter, but these tests are related to mechanical and physical properties of the device, not diagnostic accuracy or AI performance.
Here's a breakdown of what can be extracted from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document lists various in vitro tests performed to demonstrate substantial equivalence, and states that the "subject device... meets all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not provide a table detailing the specific acceptance criteria (e.g., numerical thresholds for flow rates, tensile strength) or the reported numerical performance data for the GlidePath 10F Long-Term Hemodialysis Catheter against those criteria. It only lists the types of tests performed.
| Acceptance Criteria (Category) | Reported Device Performance |
|---|---|
| Catheter Tip (Damage After Flexure) | Met predetermined acceptance criteria |
| Tip Tensile | Met predetermined acceptance criteria |
| Tunneler (Shaft to Tunneler Tensile) | Met predetermined acceptance criteria |
| Catheter Tip Stiffness | Met predetermined acceptance criteria |
| Surface Inspection | Met predetermined acceptance criteria |
| Catheter Insertion Over Split Sheath Introducer | Met predetermined acceptance criteria |
| Assembly Leak Resistance | Met predetermined acceptance criteria |
| Flow Rates | Met predetermined acceptance criteria (comparable to pediatric reference device) |
| Catheter Collapse | Met predetermined acceptance criteria |
| Catheter Tensile (Shaft to Bifurcation) | Met predetermined acceptance criteria |
| Catheter Tensile (Extension Leg to Bifurcation) | Met predetermined acceptance criteria |
| Catheter Tensile (Extension Leg to Connector) | Met predetermined acceptance criteria |
| Cuff Securement | Met predetermined acceptance criteria |
| Burst | Met predetermined acceptance criteria |
| Recirculation | Met predetermined acceptance criteria (comparable to pediatric reference device) |
| Mechanical Hemolysis | Met predetermined acceptance criteria (comparable to pediatric reference device) |
| Catheter Shaft Stiffness | Met predetermined acceptance criteria |
| Catheter Radiopacity | Met predetermined acceptance criteria |
| Thumb Clamps | Met predetermined acceptance criteria |
| Extension Legs (Knitting, Flow) | Met predetermined acceptance criteria |
Note: The phrase "Met predetermined acceptance criteria" is inferred from the statement "The subject device... meets all predetermined acceptance criteria of design verification and validation." Specific numerical values for the criteria or the device's performance are not provided.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify sample sizes for the "test set" in the context of diagnostic performance, nor does it describe data provenance for patient data. The "performance data" refers to in vitro mechanical/physical tests on the device itself, not a clinical study on patient data.
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):
Not applicable, as this is not an AI/ML device or a diagnostic device relying on expert interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the physical device performance tests, the "ground truth" or reference is established by the specifications in applicable standards, guidance documents, and internal test protocols. For example, a "burst" test would have a specified pressure it must withstand, and the device either passes or fails that engineering specification.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML 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.