(107 days)
Medcomp's Hemo-Cath® silicone double lumen catheter can be utilitized for long term implantation as well as temporary access for hemodialysis, hemoperfusion, or apheresis therapy.
It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
Alternative insertion sites include subclavian vein as required.
- 12.5French double lumen design with cuff for long-term implant.
- Variety of lumen lengths: 15cm, 18cm, 24cm, 32cm, 32cm and 40cm.
- 12.5F with a pre-curved lumen in a 28cm and 32cm length.
- Radiopaque silicone material
- Lumen is connected to the extension via a soft pliable hub with a suture winq .
- Red and blue clamps and red and blue luers are provided on the extension tube to prevent air/fluid communications.
- The hub contains the device name and French size, clamp I.D. Rings are printed with the priming volume.
This document describes the Hemo-Cath® catheter, a medical device. The provided text is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of filing does not typically include detailed clinical studies with acceptance criteria in the same way a new drug or novel high-risk device might.
Therefore, many of the requested categories for acceptance criteria and study data are not applicable or not explicitly detailed in this type of regulatory submission. The focus here is on demonstrating equivalence through non-clinical performance testing and comparison to existing devices.
Here's a breakdown based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) summary for a medical device (hemodialysis catheter) demonstrating substantial equivalence, the "acceptance criteria" are primarily defined by the international standards listed and the successful outcome of the performance tests. The specific numerical targets for each test are not explicitly stated in this summary document, nor are precise performance metrics beyond a statement of "acceptable safety and performance outcomes."
| Acceptance Criteria (Implied by Standards) | Reported Device Performance (as stated) |
|---|---|
| Biocompatibility requirements of ISO 10993-1 for externally communicating, blood contacting, long-term devices. | "Biocompatibility requirements... were met. All materials used... were previously cleared for similar applications by Medcomp, Inc." |
| Sterile Single Use-Intravascular Catheters, General Requirements (ISO 10555-1:1997) | "Subject product testing has yielded acceptable safety and performance outcomes." |
| Sterile Single Use-Intravascular Catheters, Central Venous Catheters (ISO 10555-3:1997) | "Subject product testing has yielded acceptable safety and performance outcomes." |
| Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment - Part 2: Lock Fittings (ISO 594-2) | "Subject product testing has yielded acceptable safety and performance outcomes." |
| Specific Performance Tests: Air Leakage, Liquid Leakage, Priming Volume, Flow verse Pressure, Force at Break, Recirculation, Chemical Exposure, Accelerated Aging, Mechanical Hemolysis | "The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that the Split Cath® III [mistake, should be Hemo-Cath] is substantially equivalent to the cited predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for the performance tests conducted. These are typically benchtop or in-vitro tests, not human clinical trials.
- Data Provenance: The data provenance is internal to MEDCOMP, derived from controlled laboratory testing as described by the listed international standards. It is not patient data (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For a medical device like a catheter, "ground truth" is established through engineering specifications, international testing standards (e.g., ISO, ASTM), and design validation, rather than an expert consensus based on clinical observations or images. The "experts" involved would be engineers, materials scientists, and quality assurance personnel responsible for conducting and validating the tests according to established protocols.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1 or 3+1) are typically used for medical image interpretation or clinical outcomes in human studies where there's subjectivity or disagreement among experts. For device performance testing against engineering standards, the results are typically quantitative and assessed against predefined specifications, often following a pass/fail criterion.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with/without AI Assistance
- Not Applicable. This device is a hemodialysis catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study or evaluation of human readers with/without AI assistance is irrelevant to this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This is a hardware medical device, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- The "ground truth" for this device's performance is based on engineering specifications and established international standards (ISO). Performance is measured against these objective, quantifiable benchmarks. These are not human-centric ground truths like pathology or clinical outcomes in the context of this 510(k) summary. Clinical outcomes are typically assessed during post-market surveillance or more extensive clinical trials, which are not usually required for 510(k) submissions of substantially equivalent devices.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for a physical device, this question is not relevant.
§ 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.