(91 days)
The PRISMAFLO II is for warming dialysis fluid and returning blood flow.
The PRISMAFLO II is a modified version of the PRISMAFLO covered by K020103. The PRISMAFLO uses water in the heat transfer process. PRISMAFLO II is the same as PRISMAFLO except it is water free.
The PRISMAFLO II dialysis fluid and blood warmer is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Barkey Prismacomfort 510(K) Number K071909. The PRISMAFLO II blood warmer is used to warm the return blood flow line in order to replace heat lost to the atmosphere and effluent flow during a Prismaflex or PRISMA treatment. The PRISMAFLO II blood warmer consists of one control unit and one sleeve warmer. The control unit (Stihler PRISMAFLO II) controls the sleeve warmer and displays alarm and status messages.
The PRISMAFLO II blood warmer warns the returning blood flow line by means of a silicon tube heat exchanger which covers the blood return flow line of the Gambro Prismaflex or Prisma system completely. The heat is transferred by the contact of the resistance heating system to the inscried blood return line. The complete enclosure of the returning blood flow line to be warmed ensures that there are no temperature losses to the surroundings. The warmth produced by the sleeve warmer is therefore transferred to the return blood flow at maximum efficiency.
The sleeve warmer is powered with 22 VDC which is derived from 115 VAC (or where required 230 VAC). 50/60 Hz power supply and is controlled by an on-off switch on the front panel of the control unit Stihler PRISMAFLO II. Above the on-off switch is a display temperature monitor showing actual and set temperature. The temperature of the sleeve warmer and other performance characteristics of the sleeve warmer are controlled electronically, visual and audible alarms as well as cut-offs are hardware realized. Like the blood warmer Barkey Prismacomfort, the sleeve warmer PRISMAFLO II is constructed as a slotted enclosed silicon tube, which can completely enclose inserted blood return flow lines of up to 7.00 mm diameter. The PRISMAFLO II woighs approx 3.9 kg and is equipped with a holder at the rear side of the control unit, which allows mounting on hemodialysis system Gambro Prismatlex and Prisma system. Both products, the PRISMAFLO II and the Barkev Prismacomfort use sleeve warmers made of silicon. The flexibility of this material ensures a nearly complete enclosure of the blood return flow line on Gambro Prismallex and Prisma system.
Only the water free operation of the PRISMAFLO II differs to the PRISMAFLO.
This document describes the PRISMAFLO II blood warmer, a medical device. The information provided heavily emphasizes that the device is a modified version of an existing device (PRISMAFLO) and is substantially equivalent to a predicate device (Barkey Prismacomfort). The "study" described is a nonclinical performance verification.
Here's an analysis of the provided text in relation to your requested categories:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated Purpose of Tests) | Reported Device Performance |
|---|---|
| Verify the ability of the system to prevent cooling down of blood return lines on Gambro Prismaflex CRRT system. | "The following tests were carried out successfully: Verify the ability of the system to prevent cooling down of blood return lines on Gambro Prismaflex CRRT system." (Implies successful heating to prevent cooling, meeting the criterion) |
| Verify the ability of the system to protect the patient and to detect and alarm at unsafe operating conditions. | "The following tests were carried out successfully: Verify the ability of the system to protect the patient and to detect and alarm at unsafe operating conditions." (Implies successful safety mechanisms and alarm functionality, meeting the criterion) |
| Compliance with safety standards: | "The PRISMAFLO II blood warmer complies with the safety standards below and is therefore safe for the intended use. The device has been thoroughly tested through validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made: DIN EN 60601-1, DIN EN60601-1-2 , UL 2601-1/10.97 , CAN/CSA-C22.2 No. 601.1-M90, ASTM F 2172-02 (USA Standard for Blood and Fluid Warmers)." (Implies successful adherence to all listed standards) |
2. Sample size used for the test set and the data provenance
- Sample size used for the test set: Not explicitly stated. The document refers to "the following tests were carried out successfully" but does not give specific numbers of units tested or duration of tests. This is a non-clinical device so "samples" would refer to devices tested, not patient data.
- Data provenance: The tests were "carried out" by the manufacturer (Stihler Electronic GmbH), presumably in Germany given their address. The data is retrospective in the sense that the tests were completed before submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical device safety and performance verification. "Ground truth" in this context would refer to engineering specifications and regulatory standards, not expert medical opinion on patient data. The tests verify compliance with these objective standards.
4. Adjudication method for the test set
Not applicable. There is no mention of adjudication, as there are no human readers or subjective interpretations of results described. The tests are presented as objective measurements against predefined standards.
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
Not applicable. This is a medical device (blood warmer), not an AI-powered diagnostic or interpretive tool. There are no human readers involved in its direct operation that would be improved or assisted by AI within the scope of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device. The "standalone" performance refers to the device's ability to perform its function (warming blood) independently, which is what the non-clinical tests would have assessed. However, the term "algorithm only" is not relevant here as it's not a software-only device.
7. The type of ground truth used
The "ground truth" for the non-clinical tests was adherence to:
- Engineering specifications and design requirements for preventing blood cooling and ensuring safe operation (e.g., set temperature, alarm triggers, cut-off mechanisms).
- Mandatory and voluntary consensus standards for medical device safety and performance (e.g., DIN EN 60601-1, ASTM F 2172-02).
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical 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.