(158 days)
The HP M2376A Device Link System is indicated for use in data collection and clinical information management, either connected directly or through networks, with the independent bedside devices that are listed below;
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- IMED 1310 (PC-1) channel IV Pump
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- In-line Diagnostic HR Crit-Line Monitor
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- Newport Wave Ventilator
The Hewlett Packard M2376A DeviceLink System receives digital data frontuced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System.
When connected to a bedside device, the HP M2376A DeviceLink System is intended for electronic data collection and clinical Information management. DeviceLink is neither patient connected, nor does it remotely control the attached source device.
The provided document is a 510(k) summary for the Hewlett Packard M2376A DeviceLink System. It primarily focuses on demonstrating substantial equivalence to a predicate device and obtaining marketing clearance from the FDA. It does not describe or contain a study proving the device meets acceptance criteria in the way typically expected for a medical device performance study (e.g., clinical trial data, analytical performance data with specific metrics like sensitivity, specificity, accuracy).
Therefore, based on the provided text, a table of acceptance criteria and reported device performance, information about sample sizes, ground truth, expert involvement, MRMC studies, or standalone performance studies cannot be extracted.
The document states:
- Device Function: The Hewlett Packard M2376A DeviceLink System receives digital data from external devices, converts that data into the HL7 format, and transmits that information to any networked Clinical Information System.
- Intended Use: When connected to a bedside device, the HP M2376A DeviceLink System is intended for electronic data collection and clinical information management. DeviceLink is neither patient connected, nor does it remotely control the attached source device.
- Predicate Device: The HP M1032A VueLink Interface Plug-in Module (K923682).
- Technological Characteristics: "The technological characteristics are the same or similar to those found with the predicate device, with the exception that neither waveforms, alarms, nor image data are transmitted in the DeviceLink System."
Conclusion based on the provided text:
This submission is a regulatory clearance document rather than a scientific study report. It focuses on the device's intended use, its functional similarity to a previously cleared device, and its regulatory classification. It does not provide the kind of detailed performance data and study design (acceptance criteria, sample size, ground truth, expert review, standalone performance, etc.) that would typically be associated with proving a device meets specific performance criteria through a dedicated study.
Therefore, the requested information cannot be filled out from the provided text.
If this were a different type of medical device (e.g., an AI-powered diagnostic tool), the 510(k) summary would typically include a section detailing analytical and/or clinical performance studies with the requested metrics. However, for a data communication system like the DeviceLink, the primary focus for regulatory clearance is often on functional equivalence and safety (e.g., no adverse control of connected devices, proper data transmission format).
§ 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.