(367 days)
The GlidePath™ Long-Term Hemodialysis Catheters are indicated for use in attaining short-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 40cm are intended for femoral vein insertion.
The HemoStar™ and HemoStar™ XK Long-Term Hemodialysis Catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein or femoral vein. Catheters greater than 40 cm are intended for femoral vein insertion.
The GlidePath™, HemoStar™, and HemoStar™ XK Long-Term Hemodialysis Catheters feature a dual-lumen shaft with 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. Both the staggered and symmetrical catheter tips contain holes that aid in the distribution of blood flow or aid in over-the-quidewire placement. The dialysis catheters are offered in various lengths in straight or Alphacurve™ configurations. Alphacurve™ configurations feature a pre-formed, ~225 ° curve. Long-term dialysis catheters are tunneled to provide greater distance between the skin and entry site into the vein and provide a physical barrier to the migration of skin organisms.
The HemoStar™ and HemoStar™ XK Long-Term Dialysis Catheters feature a fixed, staggered distal tip. This tip design is identical to that of the predicate devices, HemoGlide™ Star Series and HemoGlide™ Star Series XK Long-Term Dialysis Catheters, cleared August 12, 2005 under K051748.
The GlidePath™ Long-Term Dialysis Catheters, launched in February 2013, are a modification of the HemoStar™ Long-Term Dialysis Catheters. GlidePath™ catheters feature an optimized catheter shaft extrusion profile and a modified tip which is fixed and symmetrical, allowing for reduced luminal pressure during use. The GlidePath™ catheters also include a preloaded stylet for ease of placement. This accessory was previously cleared under K090101. The changes to the catheter were documented via internal note to file prior to launch in 2013.
The provided text describes the 510(k) summary for the Bard Access Systems' GlidePath, HemoStar, and HemoStar XK Long-Term Hemodialysis Catheters. It details performance testing conducted to demonstrate substantial equivalence to predicate devices, but does not provide specific acceptance criteria values or detailed reported device performance in a table format. It also does not include information on sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details as these are not relevant for a medical device clearance focused on physical and fluid dynamics performance instead of AI/software performance.
Therefore, I cannot populate all the requested sections. However, I can summarize the information related to device performance and the study that "proves" the device meets acceptance criteria, based on the provided text.
Acceptance Criteria and Device Performance for GlidePath, HemoStar, and HemoStar XK Long-Term Hemodialysis Catheters
The provided 510(k) summary indicates that the devices underwent a series of bench tests to demonstrate substantial equivalence to predicate devices. The "study" mentioned here refers to these non-clinical bench tests. The report states that the devices met all predetermined acceptance criteria, implying that the performance observed during these tests was within acceptable limits established for each test. However, the specific quantitative acceptance criteria values and the reported device performance measurements are not detailed in this summary document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (Specific Values NOT Provided in Document) | Reported Device Performance (Specific Measurements NOT Provided in Document) |
|---|---|---|
| HemoStar™ and HemoStar XK™ Alphacurve™: | ||
| Guidewire Removal | Defined criteria for ease and integrity of guidewire removal (e.g., no damage, smooth passage). | Met predetermined acceptance criteria (implies smooth removal without issues). |
| Priming Volume | Defined volumetric range for priming. | Met predetermined acceptance criteria (implies volume within range). |
| Shaft Bifurcation Tensile | Defined tensile strength thresholds for the bifurcation point (e.g., withstand specified force without failure). | Met predetermined acceptance criteria (implies sufficient tensile strength). |
| Flow Rate | Defined flow rate thresholds (e.g., maintain specified flow rate at given pressure). | Met predetermined acceptance criteria (implies flow rates within acceptable ranges). |
| Shaft Tensile | Defined tensile strength thresholds for the catheter shaft. | Met predetermined acceptance criteria (implies sufficient shaft tensile strength). |
| Burst Testing | Defined pressure thresholds for burst resistance (e.g., withstand specified pressure without bursting). | Met predetermined acceptance criteria (implies burst resistance meets thresholds). |
| Kink Testing | Defined criteria for resistance to kinking and recovery from kinking (e.g., no permanent occlusion after kinking, flow maintained). | Met predetermined acceptance criteria (implies good kink resistance and recovery). |
| GlidePath™ Modifications (including Alphacurve™): | ||
| Shaft Stiffness With and Without Stylet | Defined stiffness ranges for ease of insertion and patient comfort. | Met predetermined acceptance criteria (implies appropriate shaft stiffness). |
| Catheter-to-Tunneler Detachment | Defined force thresholds for securement and detachment characteristics. | Met predetermined acceptance criteria (implies secure attachment and controlled detachment). |
| Tunneler Tip Bend | Defined criteria for flexibility and integrity of the tunneler tip (e.g., bend without breaking, return to original shape). | Met predetermined acceptance criteria (implies appropriate tunneler tip properties). |
| Stylet Removal | Defined criteria for ease and integrity of stylet removal. | Met predetermined acceptance criteria (implies smooth stylet removal without issues). |
| Guidewire removal and Visual Inspection | Defined criteria for ease of guidewire removal and absence of visual defects after removal. | Met predetermined acceptance criteria (implies smooth guidewire removal and no visual defects). |
| Kink Testing | Defined criteria for resistance to kinking and recovery from kinking. | Met predetermined acceptance criteria (implies good kink resistance and recovery). |
| Catheter Tip Tensile | Defined tensile strength thresholds for the catheter tip. | Met predetermined acceptance criteria (implies sufficient tip tensile strength). |
| Occlusion Simulation against vessel wall Initial Placement | Defined criteria for resistance to occlusion during initial placement (e.g., maintain flow, no collapse against vessel wall). | Met predetermined acceptance criteria (implies minimal occlusion risk during initial placement). |
| Occlusion Simulation against vessel wall Flow Method | Defined criteria for resistance to occlusion during use against a vessel wall (e.g., maintain flow, no collapse during pumping). | Met predetermined acceptance criteria (implies maintained flow and resistance to collapse). |
| Tip Stiffness | Defined stiffness ranges for the catheter tip (e.g., for atraumatic insertion and positioning). | Met predetermined acceptance criteria (implies appropriate tip stiffness). |
| Flow and Collapse | Defined criteria for maintained adequate flow rates and resistance to catheter collapse under negative pressure. | Met predetermined acceptance criteria (implies good flow characteristics and collapse resistance). |
| Recirculation Glass Heart Model | Defined acceptable levels of recirculation (e.g., less than a specified percentage). | Met predetermined acceptance criteria (implies low levels of recirculation). |
| Radiopacity | Defined criteria for visibility under fluoroscopy (e.g., clearly visible radiopaque markers, good overall visibility). | Met predetermined acceptance criteria (implies adequate radiopacity). |
| Assembly Tensile | Defined tensile strength thresholds for assembled components. | Met predetermined acceptance criteria (implies sufficient assembly tensile strength). |
| Assembly Leak Resistance | Defined pressure thresholds for leak resistance of assembled components. | Met predetermined acceptance criteria (implies leak-free assembly at specified pressures). |
| Burst | Defined pressure thresholds for burst resistance. | Met predetermined acceptance criteria (implies burst resistance meets thresholds). |
| Cuff Tensile | Defined tensile strength thresholds for the ingrowth cuff. | Met predetermined acceptance criteria (implies sufficient cuff tensile strength). |
| Priming Volume | Defined volumetric range for priming. | Met predetermined acceptance criteria (implies volume within range). |
| Introducer Sheath Passage | Defined criteria for smooth and damage-free passage through an introducer sheath. | Met predetermined acceptance criteria (implies smooth passage without damage). |
Summary of Device Performance:
The document concludes that the subject devices "met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." This statement indicates that all tests listed above were successfully passed according to their respective acceptance criteria.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary.
- Data Provenance: The tests were "bench tests" performed by Bard Access Systems, Inc. The data is non-clinical. No country of origin is specified, but the company is located in Utah, USA. The data is non-clinical and would be considered prospective in the context of device development and testing, meaning the tests were designed and executed to evaluate the new/modified devices.
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 is not applicable as the study involves bench testing of physical device characteristics, not interpretation of medical images or patient outcomes. The "ground truth" for these tests is established by engineering specifications, recognized standards, and established test protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable for bench testing. Test results are typically objective measurements against predefined 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:
- This is not applicable. The devices are physical hemodialysis catheters, not AI software or diagnostic imaging aids.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. The devices are physical hemodialysis catheters.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For bench testing, the "ground truth" is defined by engineering specifications, recognized industry standards (e.g., ISO, ASTM relevant to medical devices), and internal test protocols that establish the functional and safety requirements for the catheter's physical properties, fluid dynamics, and material integrity.
8. The sample size for the training set:
- This is not applicable. There is no machine learning or AI component to this device.
9. How the ground truth for the training set was established:
- This is not applicable. There is no machine learning or AI component 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.