(8 days)
Not Found
Not Found
No
The summary describes a data collection and conversion system, with no mention of AI/ML terms, image processing, or performance studies typically associated with AI/ML devices.
No.
The device's stated intended use is for data collection and clinical information management, not for treating or diagnosing medical conditions. It explicitly states it is "not intended for monitoring purposes" and "not intended to control any of the clinical devices."
No
This device is for data collection and management, converting data to HL7 format and transmitting it. It is explicitly stated that it is "not intended for monitoring purposes," which is a key characteristic of diagnostic devices.
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 Device Link 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 digital data from independent bedside devices. It does not interact with or analyze biological samples.
- The device's function is data collection and management. It acts as a data converter and transmitter, facilitating the flow of information from clinical devices to information systems. This is a data processing function, not a diagnostic test performed on a specimen.
Therefore, the M2376A falls outside the scope of what is considered an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The M2376A Device Link 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 Device Link System receives digital data produced by external devices through device specific cables, converts that data into the HL7 6xemat 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
MAY 0 7 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:
Denise Haley Quality and Regulatory Engineer Philips Medical Systems 3000 Minuteman Road MS 0490 Andover, MA 01810-1099 Tel.: (978) 659-2701 Fax .: (978) 685-5624
This summary was prepared on November 9, 1998, and updated on April 26, 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 |
| 870.4360 | Cardiopulmonary Bypass Blood Pump | Cardiovascular | 74 KFM |
K021347
page 1 of 2
1
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The M2376A Device Link System receives digital data produced by external devices through device specific cables, converts that data into the HL7 6xemat and transmits that information 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. Device Link is neither patient connected, nor does it remotely control the attached source device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 7 2002
Ms. Denise Haley Quality and Regulatory Engineer Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road, Mail Stop 0490 Andover, MA 01810-1099
Re: K021347
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: April 26, 2002 Received: April 29, 2002
Dear Ms. Haley:
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 - Ms. Denise Haley
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 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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Noel "Tell"
Donna-Bea Tillman, Ph.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): ____________________________________________________________________________________________________________________________________________________
Device Name: M2376A Device Link System
Indications for Use:
The M2376A Device Link 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 Cardiovascular & Respiratory Devices
510(k) Number K021347
OR
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)