(302 days)
Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site or "buttonhole" method of needle insertion.
The Medisystems Buttonhole Needle Set consists of a hollow, rigid needle/cannula, a flexible tube, and locking connector to provide access through the skin at a constant or "buttonhole" site. Different degrees of point sharpness are offered to accommodate creation of the buttonhole site and cannulation through an established buttonhole site.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility | Met |
| Pyrogenicity | Met |
| Physical Testing | Met |
| Visual Examination (in-process and finished product) | Met |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample size used for the test set of the Medisystems Buttonhole Needle Sets. It mentions that "all finished products are tested," implying a 100% inspection for release testing, but does not detail the size of any specific sample for formal effectiveness or safety studies.
The data provenance is from Medisystems Corporation, with the testing described as part of their Device Master Records which define "required testing." This suggests that the testing was conducted internally by the manufacturer. The document does not specify the country of origin of the data, but the submitter is based in Washington, DC, USA. The nature of the testing (manufacturing release testing) indicates it is prospective for each batch produced.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not describe the use of external experts or the establishment of a "ground truth" in the context of clinical or performance evaluation for the test set. The acceptance criteria are related to manufacturing release specifications (sterility, pyrogenicity, physical testing, visual examination) rather than clinical efficacy or diagnostic accuracy. Therefore, this section is not applicable based on the provided information.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the criteria are manufacturing release specifications, not clinical outcomes requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not completed for the Medisystems Buttonhole Needle Sets. The document focuses on the substantial equivalence of the device to predicate devices based on design, materials, and indicated use, and manufacturing release testing. It does not describe any studies involving human readers or comparative effectiveness in a clinical setting. Therefore, there is no information on the effect size of human readers with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. The device is a physical medical needle set, not an algorithm or AI-driven system. Therefore, a standalone (algorithm only) performance study against human-in-the-loop performance is not relevant.
7. Type of Ground Truth Used
The "ground truth" in this context refers to established manufacturing and product quality standards. The types of "ground truth" used are:
- Sterility: Absence of viable microorganisms, confirmed by validated methods.
- Pyrogenicity: Absence of fever-inducing substances (endotoxins), confirmed by validated tests.
- Physical Testing: Conformance to specified physical properties (e.g., tensile strength, dimensional accuracy, needle sharpness, cannula integrity), confirmed by engineering measurements and tests.
- Visual Examination: Absence of defects, verified by inspection against defined visual standards.
These are objective, measurable criteria directly related to the product's design specifications and defined by "written and approved procedures."
8. Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not a machine learning model. Therefore, there is no concept of a "training set" for an algorithm. The manufacturing process and quality control procedures are based on established engineering principles and standards, not data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable due to the device not being an AI/ML algorithm.
§ 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.