(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).
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4/30/99
5.0 510(k) Summary
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safety and onestical 1990 and 21 C.F.R. §.807.92.
The name of this device is the Hewlett Packard M2376A DeviceLink System. The common name is the HP DeviceLink. Classification names are as follows:
| REGULATION | CLASSIFICATION NAME | PANEL | PROCODE |
|---|---|---|---|
| NUMBER | |||
| 868.5895 | Continuous ventilator | Anesthesiology | 73 CBK |
| 876.5820 | System, hemodialysis, accessrecirculation monitoring | Gastro-urology | 78 MQS |
| 880.5725 | Pump, infusion | Gnr'l Hospital | 80 FRN |
The above device is substantially equivalent to the HP M1032A VueLink Interface Plug-in Module marketed pursuant to K923682.
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 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.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 1999
Mr. Mike Hudon Requlatory Affairs Engineer Medical Products Group Hewlett-Packard GmbH Herrenberger Strasse 110-140 71034 Boeblingen GERMANY
Re: K984194 Hewlett-Packard Model M2376A Device Link System Regulatory Class: II (two) Product Code: MQS Dated: March 11, 1999 Received: March 12, 1999
Dear Mr. Hudon:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices : General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements
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concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, 2Misbranding by reference to premarket notification² (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahson
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page ______________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Hewlett-Packard M2376A Devicel .ink System Ocvice Name:
Indications for Use:
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;
-
- IMED 1310 (PC-1) channel IV Pump
-
- In-line Diagnostic HR Crit-Line Monitor
-
- Newport Wave Ventilator
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDIED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Q. K. Stillwell
510(k) Number K192444
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use ----------
(Optional Format 1-2-96)
§ 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.