(89 days)
Medisystems Transducer Protectors are single use, disposable prescription devices intended for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway.
Medisystems Transducer Protectors are designed to be used as protective devices for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 µm hydrophobic filter helps prevent cross-contamination by bacteria and particulate matter while preventing the flow of fluids to the machine pressure monitor at pressures less than 600 mmHg.
The provided 510(k) summary describes a medical device, the Medisystems Transducer Protectors, and its asserted equivalence to a predicate device. However, it does not include the kind of detailed study information (acceptance criteria, performance metrics, sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies) that would typically be found in a submission for a device involving AI or complex performance claims. This summary is for a relatively simple disposable component, and thus the "study" described is primarily quality control and manufacturing process validation rather than a clinical performance study.
Here's an analysis based only on the provided text, highlighting what's not present given the nature of the request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Functionality | Prevent cross-contamination by bacteria and particulate matter | "The 0.2 µm hydrophobic filter helps prevent cross-contamination by bacteria and particulate matter." |
| Prevent flow of fluids to machine pressure monitor at pressures less than 600 mmHg | "preventing the flow of fluids to the machine pressure monitor at pressures less than 600 mmHg." | |
| Prevent passage of bacteria and particulate contamination from machine pressure monitor to blood tubing set | "Due to the pore size of the filter, bacteria and particulate contamination are prevented from passing from the machine pressure monitor to the blood tubing set." | |
| Prevent flow of fluids, bacteria, and particulate matter into the pressure monitor at pressure lower than the rated pressure | "The combination of the pore size and hydrophobic nature of the filter also prevents the flow of fluids, bacteria, and particulate matter into the pressure monitor at pressure lower than the rated pressure of the device." | |
| Manufacturing/Quality Control | Sterility | All finished products are tested and must meet required release specifications before distribution. (Sterility is listed as one of these tests). |
| Pyrogenicity | All finished products are tested and must meet required release specifications before distribution. (Pyrogenicity is listed as one of these tests). | |
| Physical Testing | All finished products are tested and must meet required release specifications before distribution. (Physical testing is listed as one of these tests). | |
| Visual Examination | All finished products are tested and must meet required release specifications before distribution. (Visual examination of both in-process and finished product is listed as one of these tests). | |
| General Safety & Effectiveness | (Implied: Device is safe & effective) | "To assure that the device is safe and effective, all finished products are tested and must meet all required release specifications before distribution." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The submission refers to "all finished products" being tested as part of the release specifications. This implies a manufacturing quality control process rather than a discrete clinical/performance study with a defined sample size for a test set.
- Data Provenance: Not applicable in the context of clinical or AI-related data. The testing described is part of the manufacturing and quality assurance process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" for this device's performance comes from its physical properties (0.2 µm filter, hydrophobic nature) and manufacturing quality control tests (sterility, pyrogenicity, physical testing, visual examination) against defined specifications, not from expert interpretation of complex data.
4. Adjudication method for the test set
- Not applicable. There is no expert adjudication process described. The acceptance criteria are objective tests against specifications.
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
- No. This device is a passive mechanical filter. It does not involve AI or human readers, so an MRMC study is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a passive mechanical filter. There is no algorithm or AI component mentioned.
7. The type of ground truth used
- Objective physical and chemical properties, combined with manufacturing process control specifications. The device's function relies on its 0.2 µm pore size and hydrophobic material. "Ground truth" for its performance is established by demonstrating these properties and verifying manufacturing quality (sterility, pyrogenicity, physical integrity) according to internal procedures and specifications.
8. The sample size for the training set
- Not applicable. There is no training set mentioned, as this device does not involve machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. There is no training set mentioned.
§ 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.