(191 days)
The Vas-Cath Soft-Cell dual lumen hemodialysis cutheter is indicated for use in attaining short term or long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein.
Soft-Cell Dual Lumen Catheters as currently distributed by BAS are available in straight and precurved configurations, in multiple insertion lengths. Catheters are made of polyurethane containing barium sulfate to provide radiopacity. Colored luer connectors identify the arterial (red) and venous (blue) lumens. Each extension has an atraumatic occlusion clamp, which closes the catheter. A fixed suture wing is located at the bifurcation.
The provided document (K030277) describes a 510(k) submission for a change in the luer connectors of the Soft-Cell Dual Lumen Catheter. This is an Abbreviated 510(k) based on conformance to recognized standards, as the modification is related to the material and design of the luer connectors only, not involving the complete device redesign or new indications for use.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from recognized standards and guidance documents. The reported device performance indicates that all tests met the requirements.
| Acceptance Criteria (Standard/Guidance) | Reported Device Performance |
|---|---|
| ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General Requirements | "All test results confirm the modified device to be substantially equivalent to the predicate device." "The test results met the requirements." |
| ISO 594-2:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings | "All test results confirm the modified device to be substantially equivalent to the predicate device." "The test results met the requirements." |
| FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95 | "All test results confirm the modified device to be substantially equivalent to the predicate device." "The test results met the requirements." |
| ISO 10555-1:1997, Sterile, single-use intravascular catheters, Part 1. General requirements | "All test results confirm the modified device to be substantially equivalent to the predicate device." |
| ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central venous catheters | "All test results confirm the modified device to be substantially equivalent to the predicate device." |
| AAMI/ANSI/ISO-10993-1: 1997, Biological evaluation of medical devices - Part 1: Evaluation and testing, and the FDA Modified ISO 10993 Test Profile | "Biocompatibility testing results met the requirements of ISO-10993... and the FDA Modified ISO 10993 Test Profile." |
| AAMI/ANSI/ISO 11135:1994, Medical devices - Validation and routine control of ethylene oxide sterilization | Not explicitly stated as a separate test, but referenced for evaluation. Implied "All test results confirm the modified device to be substantially equivalent." |
| Specific performance tests for luer connection (Dimensions, Tensile strength of catheter body to hub attachment, Leakage at hub, Catheter burst pressure) | "All test results confirm the modified device to be substantially equivalent to the predicate device." "The test results met the requirements." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices) used for each performance test. It only states that "Bench testing was performed according to the above referenced standards and guidance document recommendations." and "All aspects of the modified devices are identical to the predicate devices except for the luer connector hub material and design. All performance testing conducted focused on the qualification of the new connector only."
The data provenance is prospective bench testing conducted in-house by Bard Access Systems, Inc. (the submitter). The country of origin of the data is implicitly the USA, where the submitter is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and therefore not provided in the document. The study involves bench testing of a medical device's physical properties and biocompatibility, not clinical trials or diagnostic accuracy evaluations where expert consensus for ground truth would be required. The "ground truth" for these tests is defined by the objective pass/fail criteria outlined in the referenced international standards (e.g., ISO for Luer fittings, catheter general requirements, and biocompatibility).
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for establishing ground truth in human-reader studies or clinical trials where there's subjectivity. In this bench testing context, results are objectively measured against established scientific and engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic imaging devices or other devices where human interpretation is involved. The submission concerns a physical modification to a catheter's luer connector, which is evaluated through bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical medical device (catheter connector) and not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The ground truth used for this study is objective measurement against recognized international and FDA standards and guidance documents. For instance:
- Dimensional accuracy: Ground truth is defined by the dimensional specifications within ISO 594 standards for Luer fittings.
- Tensile strength, leakage, burst pressure: Ground truth is defined by the minimum performance requirements specified in relevant ISO 10555 standards and FDA guidance for intravascular catheters.
- Biocompatibility: Ground truth is defined by meeting the requirements of ISO 10993-1 and the FDA Modified ISO 10993 Test Profile.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of bench testing for a physical medical device. Training sets are used in machine learning for AI/algorithm development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
§ 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.