(8 days)
Not Found
Not Found
No
The description focuses on data collection, conversion, and transmission, with no mention of AI/ML terms or functionalities like analysis, interpretation, or decision support based on the data.
No.
The device is described as a system for data collection and clinical information management, explicitly stating it is not for monitoring, controlling clinical devices, or providing medical diagnoses. Its function is to convert and transmit data, not to treat or diagnose patients.
No.
The document states that the device is for "data collection and clinical information management" and "is not intended for monitoring purposes" and "does not analyze data collected, nor does it remotely control the attached source device." This indicates it's a data management tool, not a diagnostic one.
No
The device description explicitly states it receives digital 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:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- M2376A function: The M2376A DeviceLink System is described as a system for data collection and clinical information management from independent bedside devices. It receives digital data, converts it, and transmits it to a clinical information system.
- No mention of biological samples: The description does not mention the device interacting with or analyzing any biological samples (blood, urine, tissue, etc.). Its function is purely data handling and communication.
Therefore, the M2376A DeviceLink System falls outside the scope of 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 (comma separated list FDA assigned to the subject device)
MWI
Device Description
The M2376A Device Link System receives digital data produced by external devices through device specific cables, converts that data into the HL7 External us noos through anformation 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
K020494
p 1/2
FEB 2 1 2002
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.
- The submitter of this premarket notification is:
Mike Hudon Regulatory Approvals Engineer Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099 Tel.: (978) 659-3173 Fax.: (978) 687-2651
This summary was prepared on November 9, 1998, and updated on February 12, 2002.
- The name of this device is the M2376A Device Link System. The common name is Device Link. 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'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 |
| 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 |
1
| 870.4360 | Cardiopulmonary Bypass Blood Pump | Cardiovascular | 74 KFM |
|---|---|---|---|
| ---------- | ----------------------------------- | ---------------- | -------- |
-
The M2376A Device Link System receives digital data produced by external devices through device specific cables, converts that data into the HL7 External us noos through anformation to any networked Clinical Information System.
-
When connected to a bedside device, the M2376A Device Link System is intended for electronic data collection and clinical information management. is intended for olocionis data collected, 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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized emblem that resembles an abstract caduceus, a symbol often associated with healthcare. The emblem features three curved lines that converge at the bottom, creating a sense of movement and flow.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2002
Mr. Mike Hudon Regulatory Approvals Engineer Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099
Re: K020494
Trade Name: M2376A 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: February 12, 2002 Received: February 13, 2002
Dear Mr. Hudon:
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. Mike Hudon
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualic of a subscribe with other requirements of the Act
that FDA has made a determination that your device Ederal agencies. You must that FDA has made a determination that your dones Federal agencies. You must
or any Federal statutes and regulations administed to: registration and listing or any Federal statures and regulations and unitied to: registration and listing (21)
comply with all the Act's requirements, including, but not its equirements as set comply with all the Act s requirements, including, onetice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807); labeling (21 CFR Pat 601); good manatestally production in electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and if applicable, 1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
This letter will allow you to begin marketing your device as described in your Section 510(k)
1978 (as a more and a more of aller of selection as wour device to a legal This letter will allow you to begin makemily your covice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales of this premarket notification. The FDA inding of substantial equively of the more of this, 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 If you desire specific advice for your do vites on one case contact the Office of
additionally 21 CFR Part 809.10 for in vites diagnostic devices, please contact on and adver additionally 21 CFR Part 809.10 100 100 100 100 100 100 100 100 100 100 1000 1000 1000 1000 Compliance at (301) 394-4040. Additionally, 18. quest (301) 594-4639. Also, please note the your device, please contact the Office of compinated in (11CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket not the obtained from the regulation entitled, "Misoranumy by responsibilities under the Act may be obtained from the Other general information on your responsional 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,
Dan Tillh
ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page
510(k) Number (if known): __ Ko20494
Device Name: M2376A Device Link 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)
OR
Division of Cardiovascular & Respiratory Devices
510(k) Number K020494
x Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)