(242 days)
The Gambro Cartridge® Blood Set is intended for single use in a hemodialysis treatment using the Phoenix and Centrysystem 3 Dialysis Delivery Systems. The Low Weight model is used when a low extra-corporeal blood volume is recommended. The Low Weight model with a priming volume of 75 ml is indicated for patients with body weight greater than 20 Kg and lower or equal to 40 Kg. The standard models with a priming volume ranging from 103 ml to 162 ml are indicated for patients with body weight greater than 40 Kg.
The Gambro Cartridge® Blood Sets are single use sterile tubing sets employed in the Gambro hemodialysis equipments extracorporeal circulation. They convey the patient's blood from the arterial-venous access fistula to the dialyzing filter (arterial line) and back after purification (venous line) and they are commonly referred to as bloodlines. A Gambro Cartridge® Blood Set can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.
The acceptance criteria and study details for the Gambro Cartridge® Blood Set are outlined below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Performance Testing | Flow Rate | Not explicitly stated as a numerical criterion, but implied to "perform as well as or better than the legally marketed predicate device." | Successful non-clinical testing demonstrating capability. The device's priming volumes are comparable to or slightly different from the predicate, but within expected ranges for hemodialysis blood sets. |
| Validation of System Injection Ports (Access Sites) | Not explicitly stated as a numerical criterion, but implied to "perform as well as or better than the legally marketed predicate device." | Successful non-clinical testing demonstrating validation. | |
| Hemodialysis Machine Compatibility | Compatibility with Phoenix® and Centrysystem® 3 Dialysis Delivery Systems. | Predicate: The Cobe Cartridge Blood Tubing Set may be used with Gambro Dasco Phoenix, Gambro Model Cx, and Cobe Centrysystem 3 (and 3+) Systems. | |
| Modified Device: The Gambro Cartridge® Blood Set is intended for single use in a hemodialysis treatment using the Phoenix® and Centrysystem® 3 Dialysis Delivery Systems. (Matches predicate compatibility) | |||
| Mechanical Hemolysis | Not explicitly stated as a numerical criterion, but implied to "perform as well as or better than the legally marketed predicate device." | Successful non-clinical testing demonstrated acceptable levels. | |
| Integrity of Strength Between Connections | Not explicitly stated as a numerical criterion, but implied to "perform as well as or better than the legally marketed predicate device." | Successful non-clinical testing demonstrating integrity. | |
| Kink Resistance | Not explicitly stated as a numerical criterion, but implied to "perform as well as or better than the legally marketed predicate device." | Successful non-clinical testing demonstrating resistance. | |
| Clamping of Tubing | Not explicitly stated as a numerical criterion, but implied to "perform as well as or better than the legally marketed predicate device." | Successful non-clinical testing demonstrating proper clamping. | |
| Compliance with International Standards | Compliance with international standards applicable to extracorporeal blood circuits for hemodialyzers. | Successful non-clinical testing ensuring compliance. | |
| Biocompatibility | General Biocompatibility | Not explicitly stated as a numerical criterion, but implied that it should be safe for patient use. | Successful non-clinical testing demonstrating biocompatibility. |
| Predicate: Soft PVC material. | |||
| Modified Device: Soft PVC material with DEHP-free plasticizer (an improvement by being DEHP-free, which addresses a potential biocompatibility concern). | |||
| Injection Plug Material: Latex-free (matches predicate, addressing allergen concerns). | |||
| Sterilization & Shelf Life | Expiration Dating | 3 years | Predicate: 3 years |
| Modified Device: 3 years (Matches predicate). | |||
| Sterilization Method | Radiation | Predicate: Radiation | |
| Modified Device: Radiation (Matches predicate). | |||
| Physical Attributes | Priming Volumes | Acceptable priming volumes based on intended patient weight categories (e.g., 75ml for patients 20-40 Kg, 103-162ml for patients >40 Kg). | Predicate: SN: 145 ml, DN: 103-120 ml, SNK: 45 ml, P: 75 ml. |
| Modified Device: SN: 162 ml, DN: 103-119 ml, SNK: 45 ml, LW: 75 ml. (These appear to be within acceptable ranges for the specified patient populations, with slight variations from the predicate's ranges for some models, but the overall performance deemed equivalent). | |||
| Blood Tubing Length (Patient, Dialyzer venous, arterial) | Comparable to predicate lengths. | Predicate Patient Length: SN: 198 cm, DN: 183-244 cm, P: 183 cm. | |
| Modified Device Patient Length: SN: 198 cm, DN: 183-244 cm, LW: 183 cm. (Matches predicate) | |||
| Predicate Dialyzer Length (venous): SN: 46 cm, DN: 46-53 cm, SNK: 46 cm, P: 46 cm. | |||
| Modified Device Dialyzer Length (venous): SN: 46 cm, DN: 46-53 cm, SNK: 46 cm, LW: 46 cm. (Matches predicate) | |||
| Predicate Dialyzer Length (arterial): SN: 46 cm, DN: 30-46 cm, SNK: 50 cm, P: 30 cm. | |||
| Modified Device Dialyzer Length (arterial): SN: 46 cm, DN: 30-51 cm, SNK: 51 cm, LW: 30 cm. (Minor variations, but within general equivalence). | |||
| Blood Tubing Thickness | Comparable to predicate thickness for blood pathway and blood pump segment. | Predicate Blood Pathway: SN-DN: 1.16 mm, P: 1.62 cm. | |
| Modified Device Blood Pathway: SN-DN: 1.16 mm, SN-DN Connections to dialyzer lines: 1.32 mm, LW: 1.63 mm. (Minor variations, but within general equivalence). | |||
| Predicate Blood Pump Segment: SN-DN: 1.59 mm, P: 1.59 mm. | |||
| Modified Device Blood Pump Segment: SN-DN: 1.59 mm, LW: 1.59 mm. (Matches predicate). | |||
| General Safety & Effectiveness Statement | (Overall Conclusion) | The device is safe and effective for its defined indications for use and performs as well as or better than the legally marketed predicate device. | "The successful non-clinical testing demonstrates the safety and effectiveness of the Gambro Cartridge® Blood Set 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." |
2. Sample size used for the test set and the data provenance
The document mentions "non-clinical testing" and "performance testing (bench)" but does not specify numerical sample sizes for these tests.
The data provenance is from bench testing (laboratory studies), rather than clinical data from human patients. The country of origin of the data is not explicitly stated, but the submission is from Gambro Renal Products in Lakewood, CO, USA. The testing is prospective in nature, as it was conducted to support the 510(k) submission for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described is non-clinical (bench testing) and does not inherently involve human expert consensus for "ground truth" in the way a clinical study or image interpretation study would. Performance criteria are likely established by engineering standards and regulatory requirements.
4. Adjudication method for the test set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., imaging studies) to resolve discrepancies among experts. The described testing is non-clinical performance and engineering testing.
5. 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
There was no MRMC comparative effectiveness study done. This submission is for a medical device (blood set), not an AI algorithm, and therefore such a study is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A "standalone" study (in the context of an algorithm) was not done because the device is not an algorithm. The testing performed was standalone for the device itself (bench testing) to assess its physical and functional properties against established engineering and safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's non-clinical testing would be based on engineering specifications, established performance standards (e.g., ISO standards for medical devices), regulatory requirements, and comparison to the predicate device's known performance characteristics. For example, the "truth" for flow rate would be a measured flow rate compared against a specified acceptable range, or the "truth" for biocompatibility would be determined by whether the materials passed standard biocompatibility tests.
8. The sample size for the training set
This information is not applicable/not provided as this is not an AI/machine learning device. The term "training set" is not relevant here.
9. How the ground truth for the training set was established
This information is not applicable/not provided as this is not an AI/machine learning device.
§ 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.