(30 days)
The 10 Fr Tandem-Cath Chronic Hemodialysis Catheter is intended for hemodialysis, The 1011 Tandem Outh Online Homeans on each either percutaneously or by cutdown.
The Kendall TANDEM-CATH 10 Fr. Catheter System consists of two 10 Fr. Single lumen catheters. Each catheter is 50 cm long, however, the implant length measured from the cuff to the distal tip differs in arterial and venous catheters. The arterial catheter has an implant length 3 cm shorter than its paired venous catheter. The catheter lumens are distinguished by color-coded printing on the catheter shaft (redarterial / blue-venous). The catheters are offered with and without side holes. One configuration has 6 side holes oriented in a spiral pattern at the tip of both the arterial and venous catheters. The second configuration has no side holes on ether the arterial or venous catheter. The TANDEM-CATH is available in three different implant lengths. These variations are 19 cm / 22 cm (arterial / venous), 23 cm / 26 cm, and 28 cm / 31 cm. The Kendall TANDEM-CATH 10 Fr. Catheter System is supplied in kits that include other accessory devices to be used during the catheter implant process.
A Kendall TANDEM-CATH 10 Fr. Catheter repair kit to replace damaged extensions and / or extension adapters is currently marketed, however as there are no changes made to the repair kit, it is not intended to be within the scope of this special 510k.
The provided text describes a Special 510(k) Summary for a modified medical device, the Kendall Tandem-Cath 10Fr Catheter System, seeking substantial equivalence to a previously cleared device. Due to the nature of a 510(k) submission, especially a "Special 510(k)", the focus is on demonstrating that the modified device's performance is equivalent to an existing, legally marketed predicate device rather than establishing entirely new performance criteria or conducting a comprehensive study to prove novel "acceptance criteria" as one might find for a de novo device or a Class III device requiring PMA.
Therefore, the requested information elements related to a "study proving the device meets acceptance criteria" in the context of AI/software performance metrics (like sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable to this specific submission. This document pertains to physical device modifications and their performance characteristics against a predicate device.
Here's how the available information relates to your request:
1. A table of acceptance criteria and the reported device performance:
The document states: "Performance data for the modified 10Fr Tandem-Cath is compared to that of the predicate device identified in this 510(k) summary. Results of verification / validation demonstrate that the modified device is substantially equivalent to the legally marketed device."
This implies that the "acceptance criteria" are the performance characteristics of the predicate device. The "reported device performance" is that the modified device meets or is substantially equivalent to these predicate device characteristics. However, specific numerical acceptance criteria or performance metrics are not explicitly detailed in this summary. The assessment is qualitative, focusing on substantial equivalence.
Table (reconstructed based on the document's intent):
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Performance | Performance characteristics of the legally marketed predicate device (K002902) in hemodialysis, apheresis, and infusion. | "Results of verification / validation demonstrate that the modified device is substantially equivalent to the legally marketed device." |
| Materials | Materials used in the predicate device. | Substantially equivalent. |
| Physical Characteristics | Physical dimensions and features of the predicate device. | Substantially equivalent. |
| Intended Use | Hemodialysis, apheresis, and infusion for adult patients, with percutaneous or cutdown insertion. | Identical to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This document describes a physical medical device modification (catheter), not an AI/software product requiring a "test set" of data in the sense of AI model evaluation. The "performance data" refers to engineering verification and validation tests, not clinical data sets for AI.
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. Ground truth establishment by experts is relevant for AI models, not a physical device modification as described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method for a "test set" is mentioned as it's not relevant to this type of submission.
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 submission is about a physical catheter, not an AI system. MRMC studies are for evaluating diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" in this context would be the established performance and safety profile of the predicate device, against which the modified device's performance (e.g., tensile strength, flow rates, biocompatibility, etc. – although not detailed in this summary) would be compared through engineering tests.
8. The sample size for the training set:
- Not applicable. No AI training set is involved.
9. How the ground truth for the training set was established:
- Not applicable. No AI training set is involved.
In summary: The provided document is a regulatory submission for a physical medical device (catheter) modification, demonstrating substantial equivalence to a predicate device. The information requested, particularly points 2-9, is pertinent to AI/software device evaluation, which is not the subject of this 510(k) summary. The "study" mentioned is the internal "verification / validation" that ensured the modified device performed equivalently to the predicate, but specific details of these engineering tests (like exact benchmarks or test protocols) are not included in this high-level summary.
§ 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.