(11 days)
The M2376A DeviceLink System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices.
The M2376A is not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.
The M2376A DeviceLink 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.
The provided text is a 510(k) summary for the Philips M2376A DeviceLink System. It primarily focuses on the device's function, classification, and substantial equivalence to predicate devices. Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary describes the device as one that "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." Its intended use is "for electronic data collection and clinical information management." It explicitly states that "DeviceLink is neither patient connected, nor does it remotely control the attached source device."
Because the device's function is data conversion and transmission within a medical information system, and not diagnostics or treatment, the regulatory approval process for such a device typically focuses on aspects like:
- Software Validation: Ensuring the software correctly performs its data conversion and transmission functions.
- Interoperability: Verifying it can correctly interface with various medical devices and clinical information systems.
- Data Integrity and Security: Ensuring data is accurately and securely transferred, without loss or corruption.
- Risk Management: Assessing and mitigating any potential risks associated with data handling.
However, the provided document does not detail any specific performance acceptance criteria or a study that evaluates these criteria. Therefore, I cannot extract the requested information.
If this were a diagnostic or AI-driven device, the information you requested would be critical. However, for a data integration device like this, the nature of "performance" and its "study" would be different and is not described in this 510(k) summary.
{0}------------------------------------------------
K030731
page 1 of 2
Philips Medical Systems
MAR 21 2003
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.
- The submitter of this premarket notification is:
Herbert van Dyk Quality and Requlatory Engineer Philips Medical Systems Hewlett-Packard Str. 2 D71034 Böblingen, Germany Tel .: +49 (7031) 463-1734 Fax .: +49 (7031) 463-2442
This summary was prepared on November 9, 1998, and updated on March 5, 2003.
- The name of this device is the M2376A DeviceLink System. The common name is DeviceLink. Current Classification is (74) Cardiovascular MWI, classification names for the externally connected devices are as follows:
| REGULATIONNUMBER | CLASSIFICATION NAME | PANEL | PROCODE |
|---|---|---|---|
| 870.1110 | Computer, blood pressure | Cardiovascular | 74 DSK |
| 870.1100 | Alarm, blood pressure | Cardiovascular | 74 DSJ |
| 870.1130 | System, measurement, blood pressure,noninvasive | Cardiovascular | 74 DXN |
| 870.2300 | Monitor, cardiac | Cardiovascular | 74 DRT |
| 876.1800 | Urinometer | Gastro-urology | 78 EXS |
| 876.5820 | System, hemodialysis, access recirculationmonitoring | Gastro-urology | 78 MQS |
| 880.5725 | Pump, infusion | Gnr'l Hospital | 80 FRN |
| 870.3535 | System, balloon, intra-aortic and control | Cardiovascular | 74 DSP |
| 868.5895 | Continuous ventilator | Anesthesiology | 73 CBK |
| 868.1730 | Computer, oxygen uptake | Anesthesiology | 73 BZL |
| 876.5860 | Dialyzer | Gastroenterology | 78 KDI |
| 870.2700 | Oximeter | Cardiovascular | 74 DQA |
| 868.1400 | Carbon Dioxide Gas Analyzer | Anesthesiology | 73 CCK |
| 870.1915 | Thermodilution probe | Cardiovascular | 74QGL |
| 882.1400 | Electroencephalograph | Neurological | 84GWQ |
| 868.2375 | Breathing Frequency Monitor | Anesthesiology | 73 BZQ |
| 880.5400 | Neonatal incubator | General Hospital | 80 FMZ |
| 870.4360 | Cardiopulmonary Bypass Blood Pump | Cardiovascular | 74 KFM |
{1}------------------------------------------------
K030731
page 2 of 2
Philips Medical Systems
-
The M2376A DeviceLink 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.
-
When connected to a bedside device, the 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.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right. The profiles are connected by flowing lines, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the central image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2003
Philips Medical Systems c/o Mr Herbert van Dyk Quality and Regulatory Engineer 300 Minuteman Road, Mail Stop 0490 Andover, MA 01810-1099
Re: K030731
Trade Name: M2376A DeviceLink System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: 74 MWI Dated: March 5, 2003 Received: March 10, 2003
Dear Mr. van Dyk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
{3}------------------------------------------------
Page 2 - Mr Herbert van Dyk
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Rath tich
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Philips Medical Systems
Page of
510(k) Number (if known): K030731/
Device Name:
/
M2376A DeviceLink System
Indications for Use:
The M2376A DeviceLink System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices.
The M2376A is not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
V. Deletu
510(k) Number K03073
OR
Prescription Use x (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).