(264 days)
The Gambro Cartridge® Blood Set Low Weight-Low Volume is intended for single use in a hemodialysis treatment using the Phoenix® Dialysis Delivery System.
The Low-Weight - Low Volume model is used when a low extra-corporeal blood volume is recommended. The Low Weight - Low Volume model with a priming volume of 40 ml is indicated for patients with a body weight greater than 15 kg and lower or equal to 20 Kg.
The Gambro Cartridge® Blood Set Low Weight – Low Volume is single use sterile tubing set employed in the Gambro hemodialysis equipments extracorporeal circulation. It conveys the patient's blood from the arterial-venous access fistula to the dialyzing filter (arterial line) and back after purification (venous line) and it is commonly referred to as bloodline. A Gambro Cartridge® Blood Set Low Weight - Low Volume can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.
The provided document describes a 510(k) submission for the Gambro Cartridge® Blood Set Low Weight - Low Volume. This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, rather than clinical performance data or AI/ML model performance.
Therefore, many of the requested criteria related to AI/ML device testing (such as ground truth establishment, expert adjudication, MRMC studies, training set details) are not applicable to this submission.
Here's the information that can be extracted or deduced from the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the format of a table with specific numerical thresholds for each test. Instead, it describes a series of non-clinical performance tests designed to establish the safety and effectiveness of the device as performing "as well as or better than the legally marketed predicate device." The "acceptance" for these tests would be successful completion, indicating the device performs as intended and is comparable to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Integrity of strength between connections (Pressure leak testing) | Successfully demonstrated. |
| Flow rate (Endurance testing of the pump segment) | Successfully demonstrated. |
| Endurance testing of injection ports (Access sites) | Successfully demonstrated. |
| Priming volume assessment | Successfully demonstrated (specific priming volume of 40 ml indicated for patients with body weight > 15 kg and ≤ 20 Kg). |
| Tensile testing of joints and materials of all tubing segments | Successfully demonstrated. |
| Pressure transducers testing | Successfully demonstrated. |
| Tubing clamps testing | Successfully demonstrated. |
| Hemocompatibility testing | Successfully demonstrated. |
| Kinking resistance testing | Successfully demonstrated. |
| Hemodialysis delivery system compatibility | Successfully demonstrated (intended for use with Phoenix® Dialysis Delivery System). |
| Expiration date testing (Materials biocompatibility, performance, packaging integrity testing) | Successfully demonstrated. |
| Overall Safety and Effectiveness (Compared to predicate) | The successful testing demonstrates the safety and effectiveness of the Gambro Cartridge® Blood Set Low Weight – Low Volume when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device. |
Study Information
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Sample size used for the test set and the data provenance:
- The document describes non-clinical performance testing (bench testing). It does not refer to "test sets" in the context of patient data for a clinical or AI/ML study.
- No information about specific sample sizes (e.g., number of devices tested for each bench test) or data provenance (country of origin, retrospective/prospective) is provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a non-clinical bench testing study, not a study requiring expert ground truth for clinical outcomes or diagnostic accuracy.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for a non-clinical bench testing study. The results of the bench tests (e.g., pressure leak, flow rate, tensile strength) would be objectively measured against engineering specifications, not adjudicated by experts.
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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 MRMC study was done. This document describes a traditional medical device (blood set) and its non-clinical testing, not an AI-powered device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" would be established by engineering specifications, material properties, and accepted industry standards for medical device performance and safety (e.g., ISO standards for blood contacting devices, internal Gambro specifications).
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The sample size for the training set:
- Not applicable. There is no AI/ML model for which a training set would be required.
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How the ground truth for the training set was established:
- Not applicable as there is no AI/ML model or training set.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.