(9 days)
Not Found
Not Found
No
The summary describes a data collection and conversion system (HL7 format) without mentioning any analytical or predictive capabilities typically associated with AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly "Not Found".
No.
The device is described as a data collection and management system that converts and transmits data, not as a device that provides therapy or directly affects patient health.
No
The device is described as a data collection and management system that converts clinical device data to HL7 format for transmission to information systems. It is explicitly stated that it is "not intended for monitoring purposes" and does not "control any of the clinical devices." Its function is data handling, not diagnosis based on that data.
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:
- Intended Use: The intended use is for data collection and clinical information management from independent bedside devices. This involves processing data generated by other medical devices, not analyzing biological samples (which is the core function of IVDs).
- Device Description: The device receives digital data, converts it to HL7 format, and transmits it. This is a data management function, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing any kind of diagnostic test on a sample outside of the body.
The M2376A DeviceLink System appears to be a medical device focused on data integration and management within a clinical setting.
N/A
Intended Use / Indications for Use
The M2376A DeviceLink System is indicated for use in data collection and clinical information management either correctly 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 (comma separated list FDA assigned to the subject device)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KO414-01
JUN - 4 2004
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 Current Classification is (74) Cardiovascular MWI, name is DeviceLink. 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'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 |
| Special 510(k) M2376A | Company confidential | oade | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|---|---|
| 1 | |||
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | of the first and them the a from the may be a firms of the | 1. C. C. S. A. A. A. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. |
1
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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.
|
1 540/レ) MO276A
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|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | more announce an announce the first and the common of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comm | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three horizontal lines above it, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN = 4 2004
Philips Medical Systems c/o Mr. Herbert van Dyk Quality and Regulatory Engineer Cardiac and Monitoring Systems 3000 Minuteman Road, Mail Stop 0490 Andover, MA 01810-1099
Re: K041401
Trade Name: M2376A DeviceLink System Regulation Number: 21 CFR 870.2300 Regulation Number: 21 CFN 870.2500
Regulation Name: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: II (two) Product Code: MWI Dated: May 24, 2004 Received: May 26, 2004
Dear Mr. Van Dyk:
We have reviewed your Section 510(k) premarket notification of intent to market the the indicati We have reviewed your Section 9 ro(x) premained is substantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate relerenced above and nave decembled the enclicate devices marketed in interstate for use stated in the encrosulty manation promotion Device Amendments, or to commerce prior to May 20, 1976, the enaothor with the provisions of the Federal Food, Drug, devices that have been recialsmod in acceraarse wear at also premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the and Cosment Act (Act) that do not require approvine as a controls provisions of the Act. The You may, therefore, market the devices, boyse to annual registration, listing of
general controls provisions of the Act include requirements for annual registration, listing general controls provisions of the fist here in a prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such adultional controls. Existing and be found in the Code of Featur regarning 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 Please be advised that FDA s issuated of a states complies with other requirements of the Act that FDA has made a determination and Journer Federal agencies. You must or any Pederal Statutes and regulations daminibers but not limited to: registration and listing (21 comply with an the Act stequirements, moraaling, and manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections over device as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your i his letter will anow you to begin manically your maneting of your device to a legally premarket nothleadon: "The PDA maing of baction 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 If you desire specific advice for Jour as (301) 594-4648. Also, please note the regulation entitled, Colliact the Office of Compullier at (SST) 31 (SFR Part 807.97). You may obtain Misoranuing of Icrerches to prenazionalibilities under the Act from the Division of Small other general informational 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,
Aefae Myp
Zuckerman, M.D. Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Philips Medical Systems
Page of ___________________________________________________________________________________________________________________________________________________________________________
Indications for Use
510(k) Number (if known):
Device Name: M2376A DeviceLink System
Indications for Use:
The M2376A DeviceLink System is indicated for use in data collection and clinical information management either correctly 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.
.
AND / OR
Over-The-Counter Use No (part 21 CFR 801 Subpart C)
Prescription Use Yes (part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Office of Device Evaluation (ODE)
Mera Maya for BD2
(Division/Sign-Off)
Division of Cardiovascular Devices
K041401
(Posted November 13, 2003)
(Optional Format 3-10-98)
| Special 510(k) M2376A | Company confidential | page 26 of 26 |
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||
| A 48, 40, 40, 40, 000 AM RESERVED THE RESEARCE OF THE CONSULTION OF CONSULTION OF | ||
| AND AND PROPERTY OF THE PERSONAL PROPERTY OF CHARACTER | ||
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