(17 days)
Not Found
Not Found
No
The summary describes a data collection and conversion system, with no mention of AI or ML terms or functionalities.
No
The device is described as a system for data collection and clinical information management, converting data into HL7 format and transmitting it to a Clinical Information System. It is explicitly stated that it is "not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices," which means it does not directly manage or treat a patient's condition.
No
The device is described as a data collection and management system that converts data from bedside devices into a standard format (HL7) and transmits it to an information system. It is explicitly stated that it is "not intended for monitoring purposes" and not for controlling clinical devices. There is no indication that it performs any analysis or interpretation of data to aid in diagnosis.
No
The device description explicitly states it receives data through "device specific cables," indicating a hardware component is involved in the data acquisition process.
Based on the provided information, the M2376A DeviceLink System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The M2376A's intended use and description clearly state that it collects and manages data from independent bedside devices and transmits it to a Clinical Information System. It does not interact with or analyze biological samples.
- The device's function is data management and conversion. It receives digital data, converts it to HL7 format, and transmits it. This is a data processing function, not a diagnostic test performed on a specimen.
Therefore, the M2376A DeviceLink System falls outside the scope of what is considered an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
MWI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
DEC 1 1 2003
K033680
p.1/2
Philips Medical Systems
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 Regulatory 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 November 19, 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:
| REGULATION
| NUMBER | 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 recirculation | ||
| monitoring | Gastro-urology | 78 MQS | |
| 880.5725 | Pump, infusion | Gnr'i 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
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 2003
Philips Medical Systems c/o Mr. Herbert van Dyk Quality and Regulatory Engineer Cardiac and Monitoring Systems Hewlett-Packard Str. 2 Boblingen D71034 Germany
Re: K033680
Trade Name: M2376A Philips Device Link System Regulation Number: 21 CFR 870. 2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: November 19, 2003 Received: November 24, 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.
3
Page 2 – Mr. Herbert van Dyk
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toast of Identifical that I Drive issuation over device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I ederal battatoo the requirements, including, but not limited to: registration and listing Comply with an the Act 5 requirements, as 801); good manufacturing practice requirements as set (21 CFR Part 807), accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in also quant) by econo (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation comi of provisions (Steting your device as described in your Section 510(k) I mis lower will and in your he FDA finding of substantial equivalence of your device to a legally premarket noticated 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 n you desire 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 may be obtained from the Outer general mioniation turers, 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 vours.
Oleandlthy
Bram D. Zuckerman, I 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): ____ K 0 3 368 O
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)
Division of Cardin ascular & Respiratory Devices 510(K) Numi
K033650
Q0476650
for boz 12/11/13
OR
Per 21 CFR 801.109)
Prescription Use _ × (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Special 510(k) M2376A
Company confidential