(30 days)
The Medcomp Safety Slide Clamp is intended to provide a secondary extension tube clamp on the Medicomp Ash Split-Cath, Duo-Flow 400XL and Duo-Split Catheters to prevent leakage during connection or disconnection of the bloodlines.
Medcomp selected a standard "off the shelf" slide clamp designed to pinch or occlude a variety of medical tubing. This slide clamp is widely used throughout the medical device industry to prevent air or fluid communication.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medcomp Safety Slide Clamp:
Unfortunately, the provided text does not contain a detailed table of acceptance criteria or specific performance data with numerical metrics. It focuses more on the problem the device addresses (faulty original clamps) and the fact that a "simulated use testing" was performed, which is referred to as "Performance Data (Simulated Use Testing V-1026)". There are no explicit performance metrics, target values, or reported device performance against those targets.
However, based on the information provided, we can infer some aspects:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Problem Statement) | Reported Device Performance (Inferred from Study Conclusion) |
|---|---|
| Clamp must effectively occlude the extension tube. | The retrofit of the safety slide clamp proves to be a safe and effective correction for implanted catheters. It successfully prevents blood loss. |
| Clamp must prevent blood loss between dialysis treatments. | The retrofit of the safety slide clamp proves to be a safe and effective correction for implanted catheters. |
| Clamp must not damage the extension tube with repeated application. | "This failure mode [extension tube damage] did not occur during the 52-week simulated use testing." |
| Device must be safe for use. | The retrofit of the safety slide clamp proves to be a safe and effective correction. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document mentions "52-week simulated use testing." While the specific number of devices or tests performed is not explicitly stated as a sample size, the duration (52 weeks) indicates a prolonged test. It also refers to "performance data (Simulated Use Testing V-1026)", which implies a specific test protocol.
- Data Provenance: The study was conducted by Medcomp ("Medcomp confirmed the complaints and determined the root cause... Medcomp has determined that to prevent possible leakage..."). It is a retrospective analysis in the sense that the need for the device arose from existing complaints. The testing itself (simulated use) would be considered prospective for the new clamp design. The country of origin for the data is not explicitly stated, but Medcomp is a US-based company (Harleysville, PA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not mention the use of external experts to establish ground truth for the simulated use testing. The "ground truth" for the effectiveness of the clamp seems to be based on the direct observation during the simulated use testing and the conclusion of Medcomp's internal assessment that the clamp prevented the target failure mode.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method involving multiple reviewers for establishing ground truth within the simulated use testing. The evaluation appears to be a direct assessment of the clamp's function during the simulated use.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not conducted or mentioned. This approval is for a device modification (a clamp), and the "study" described is a simulated use test, not a comparative human reader study. Therefore, there's no discussion of human reader improvement with or without AI assistance.
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 (a clamp), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
- The ground truth for the simulated use testing was direct observation of physical performance and absence of failure modes (e.g., no leakage, no damage to the extension tube). It is performance-based ground truth derived from a physical test.
8. The Sample Size for the Training Set
- This question is not applicable as the device is a physical medical device (a clamp), not an AI algorithm. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as the device is a physical medical device and does not involve a training set.
§ 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.