HP M2376A DEVICE LINK SYSTEM

K993587 · Hewlett-Packard Co. · MQS · Jan 20, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K993587
• Device Name: HP M2376A DEVICE LINK SYSTEM
• Applicant: Hewlett-Packard Co.
• Product Code: MQS · Gastroenterology, Urology
• Decision Date: Jan 20, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Indications for Use

The M2376A Device Link System is indicated for use in data collection and clinical information management either connected directly or through networks with independent bedside devices. The M2376A is not intended for monitoring purpose, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

Device Story

HP M2376A Device Link System acts as a data gateway; receives digital data from external bedside medical devices via device-specific cables; converts data into HL7 format; transmits data to networked Clinical Information Systems. Device is not patient-connected; does not perform monitoring; does not control source devices. Used in clinical environments to facilitate integration of bedside device data into hospital information systems; assists clinicians by centralizing data management; improves workflow efficiency by automating data transfer.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Data interface system; converts proprietary digital signals from bedside devices to HL7 format for network transmission. Standalone hardware unit; connects via device-specific cables. No patient-contacting materials. Software-based data conversion.

Indications for Use

Indicated for electronic data collection and clinical information management in clinical settings where bedside devices are used. Not intended for patient monitoring or remote control of connected devices.

Regulatory Classification

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.

Submission Summary (Full Text)

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K993587

510(k) Summary.

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §.807.92.

1. The submitter of this premarket notification is:

Mike Hudon Requlatory Approvals Engineer Hewlett-Packard Company Patient Monitoring Division Healthcare Solutions Group 3000 Minuteman Road Andover, MA 01810-1099 Tel.: [phone] Fax.: [phone]

This summary was prepared on November 9, 1998.

2. The name of this device is the Hewlett Packard M2376A Device Link System. The common name is the HP Device Link. Classification is Cardiovascular (74) MSX, classification names for the externally connected devices are as follows:

| REGULATION<br>NUMBER | CLASSIFICATION NAME | PANEL | PROCODE |
|----------------------|----------------------------------------------------------|----------------|---------|
| 870.1100 | Alarm, blood pressure | Cardiovascular | 74 DSJ |
| 870.1110 | Computer, blood pressure | Cardiovascular | 74 DSK |
| 870.1100 | Alarm, blood pressure | Cardiovascular | 74 DSJ |
| 870.1130 | System, measurement, blood pressure,<br>noninvasive | Cardiovascular | 74 DXN |
| 870.2300 | Monitor, cardiac | Cardiovascular | 74 DRT |
| 876.1800 | Urinometer | Gastro-urology | 78 EXS |
| 876.5820 | System, hemodialysis, access<br>recirculation monitoring | Gastro-urology | 78 MQS |
| 880.5725 | Pump, infusion | Gnr'l Hospital | 80 FRN |

3. The Hewlett Packard M2376A Device Link System receives digital data produced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System.

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4. When connected to a bedside device, the HP M2376A Device Link System is intended for electronic data collection and clinical information management. Device Link is neither patient connected, nor does it remotely control the attached source device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 0 2000

Mr. Mike Hudon Senior Requlatory Affairs Engineer Agilent Technologies, Inc. Healthcare Solutions Group 3000 Minuteman Road Andover, Massachusetts 01810-1099

Re: K993587 Trade Name: Agilent Technologies Device Link System Model M2376A Regulatory Class: II Product Codes: MQS October 22, 1999 Dated: Received: October 22, 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 requlations affecting your device can be found in the Code of Federal Regulations, 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 concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Mike Hudon

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Alejandro Magnehen

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

K993587 510(k) Number (if known):

Hewlett-Packard M2376A Device Link System Device Name:

Indications for Use:

The M2376A Device Link System is indicated for use in data collection and clinical information management either connected directly or through networks with independent bedside devices.

The M2376A is not intended for monitoring purpose, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

Alvar Robles for DBT 1/18/20

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR Over-The-Counter Use _

(Optional Format 1-2-96)

Sames Chen Fu DBT 1/21/00