(30 days)
To replace: Cracked or broken female luer lock connectors or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Soft-Cell* Long-Term Dual Lumen Catheter, Opti-Flow* Long-Term Dual Lumen Catheter, Slim-Cath* Short-Term Dual Lumen Catheter, Vaccess* Short-Term Single Lumen Catheter, HemoStar* Long-Term Dual Lumen Catheter, Flexxicon* Short-Term Dual Lumen Catheter, Niagara* Short-Term Dual Lumen Catheter, Flexxicon* II Short-Term Dual Lumen Catheter, HemoGlide* Long-Term Dual Lumen Catheter, and HemoSplit* Long-Term Hemodialysis Catheter.
The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.
Here's an analysis of the provided text regarding the Catheter Repair Kit with Replacement Connector:
The provided document is a 510(k) summary for a medical device called the "Catheter Repair Kit with Replacement Connector." This type of submission aims to demonstrate that a new device is substantially equivalent to a previously cleared device (predicate device), rather than proving stand-alone safety and effectiveness through extensive clinical trials. Therefore, the information typically found in studies designed to "prove the device meets acceptance criteria" in the way one might expect for novel, high-risk devices or AI algorithms is not present here.
Instead, the "study" demonstrating that the device meets acceptance criteria primarily consists of non-clinical performance testing to show equivalence to the predicate device, especially in light of a minor material formulation change.
Here's a breakdown of the requested information based on the provided text:
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Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical format of sensitivities, specificities, or other statistical measures for a decision-making algorithm. Instead, the acceptance criteria implicitly relate to the device functioning in a manner equivalent to the predicate device after a material change. The "performance" is demonstrated through non-clinical testing.
Acceptance Criterion (Implicit) Reported Device Performance (Summary) Safety and Effectiveness not adversely affected by minor material change. FMEA conducted, no new safety/effectiveness questions raised. Performance data demonstrate equivalence. Maintain intended use and functional characteristics of predicate device. Testing based on FDA guidance and standards to evaluate performance. Performance data demonstrate equivalence. Compatibility with listed catheters for repair (cracked/broken luer lock, damaged extension). Assumed to be met through equivalence to predicate device and non-clinical testing. -
Sample Size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document refers to "testing" and "performance data" without detailing the number of units or test iterations.
- Data Provenance: Not applicable in the context of human data. The testing would be laboratory-based (in-vitro) on device components.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the study described is for a physical medical device (catheter repair kit) and not an AI/diagnostic algorithm where expert ground truth is typically established. The "ground truth" would be the engineering specifications and intended function of the device.
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Adjudication method for the test set (e.g., 2+1, 3+1, none):
- Not applicable as this is not a study involving human readers or diagnostic interpretation. The "adjudication" of test results would be based on engineering and quality control standards.
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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:
- No. This is not an AI device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this type of device, the "ground truth" for performance testing (e.g., tensile strength, leak resistance, biocompatibility) would be defined by engineering specifications, recognized industry standards (e.g., ISO), and FDA guidance documents. The device must meet these predetermined physical and functional criteria.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this type of device.
Summary of the "Study" from the document:
The "study" referenced in the 510(k) process for the Catheter Repair Kit with Replacement Connector is a non-clinical performance testing program. This program was undertaken because of a minor material formulation change in the new device compared to its predicate.
- Objective: To determine if the material change affects the safety or effectiveness of the device and to demonstrate substantial equivalence to the predicate device (K030442).
- Methodology:
- A Failure Modes and Effects Analysis (FMEA) was conducted in accordance with ISO 14971:2000 to identify potential risks.
- Performance testing was conducted based on FDA guidance documents and standards.
- Results/Conclusion:
- The FMEA did not raise any new types of safety or effectiveness questions.
- The performance data generated from the testing demonstrated equivalence to the predicate device.
This approach is standard for 510(k) submissions where changes to an existing device are minor and do not introduce new scientific or technological challenges. The "acceptance criteria" are intrinsically linked to demonstrating that the new device performs identically (or equivalently) to the already cleared predicate device, ensuring no new risks or diminished effectiveness due to the material change.
§ 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.