FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The SiteGuard needle securement device has the following features:
a. It allows the needle to be held at a consistent angle during treatment;
b. It secures wing/hub to the patient's skin and helps prevent movement and/or dislodgement of the needle during use; and,
c. It helps to immobilize the patient's vein or access during cannulation so that it is not necessary for caregivers to hold the vein or access with their fingers.

Device Description

The subject of this 510(k) is a removable, rigid plastic securement device that is attached to the AVF needle set by the care giver. The SiteGuard securement device will be included in the unit packaging pouch with the Medisystems AVF needle set and also will be available for purchase as an individually packaged accessory.

Because the tape, the AVF wing, and the patient's skin are flexible, the needle may dislodge or move within the patient's access during treatment due to this inherent flexibility. The securement device adds a rigid structure to increase the ability of the tape to prevent the needle from accidentally dislodging or moving within the patient's vascular access.

This accessory also will immobilize the patient's vein during insertion of the cannula so that it is not necessary for caregivers to hold the vein or access with their fingers. The channel along the bottom of the securement device is designed to immobilize the patient's vein during insertion. This feature is especially helpful for patients who have newly created fistulas or implanted grafts because new accesses tend to move during cannulation.

AI/ML Overview

This 510(k) summary does not contain the information requested regarding acceptance criteria and a study proving device performance against those criteria.

Instead, this document focuses on establishing substantial equivalence to legally marketed predicate devices rather than demonstrating performance against specific acceptance criteria through a comparative study.

Here's a breakdown of why the requested information is absent and what the document does provide:

Acceptance Criteria and Reported Device Performance: These are not mentioned. The document states that "all finished products are tested and must meet all required release specifications before distribution" and that "The required testing is defined by written and approved procedures that conform to the product design specifications." However, what these specifications or acceptance criteria are, or the quantitative results of such testing, are not provided in this 510(k) summary.
Study That Proves the Device Meets Acceptance Criteria: No such specific study is described. The document refers to "risk analysis, test and design considerations, and verification and validation testing processes" as part of product development, but it doesn't detail a study designed to demonstrate performance against acceptance criteria.

Let's address the specific points you asked for, indicating where the information is not present in this document:

A table of acceptance criteria and the reported device performance:
- Not present. The document mentions "required release specifications" and "product design specifications" but does not enumerate them or report specific performance metrics against them.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not present. No specific test set or data from a performance study is described.
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 present. There is no mention of ground truth establishment or experts for a test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not present. No test set or adjudication method is described.
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 present. This device is a physical securement device, not an AI or imaging device, so an MRMC study is not relevant and not discussed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not present. As this is a physical device, this concept does not apply.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not present. No ground truth type is mentioned as no performance study is detailed.
The sample size for the training set:
- Not present. There is no mention of a training set, as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not present. Not applicable, as there's no training set mentioned.

Summary of what the document does convey regarding "Safety and effectiveness":

The document states:

"To assure that the devices are safe and effective, all finished products are tested and must meet all required release specifications before distribution."
"The required testing is defined by written and approved procedures that conform to the product design specifications."
"The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and verification and validation testing processes."
The primary justification for safety and effectiveness is "substantial equivalence" to legally marketed predicate devices (TNT Moborg Intl., LTD, Immobile Non-sterile and Immobile A/C t non-sterile (K941850); and, TNT Immobile sterile and Immobile A/C sterile (K941940)). The document explicitly states, "There are no new issues of safety or effectiveness resulting from the inclusion of this accessory in the legally marketed needle set."

In essence, this 510(k) relies on the argument that the SiteGuard device is similar enough to already approved devices that it shares their established safety and effectiveness profile, without needing to conduct new, explicit performance studies detailed in this summary.

Summary

Regulation Number and Section

§ 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.