(4 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.
This document describes the Philips M2376A DeviceLink System, a device intended for electronic data collection and clinical information management from external medical devices. However, the provided text does not contain information typically associated with acceptance criteria and studies proving device performance in the context of diagnostic or therapeutic medical devices.
Instead, this is a 510(k) summary filed with the FDA, primarily focusing on proving substantial equivalence to previously marketed devices. The key elements of this filing are:
- Device Description: What the DeviceLink system is and what it does (receives digital data from external devices, converts it to HL7, and transmits it to a Clinical Information System).
- Intended Use: For electronic data collection and clinical information management. Critically, it explicitly states it is not for monitoring purposes and does not control attached source devices. This clarifies its role as a data intermediary, not a diagnostic or treatment device itself.
- Predicate Devices: The 510(k) process relies on demonstrating that a new device is "substantially equivalent" to legally marketed predicate devices. The document lists several types of externally connected devices (e.g., blood pressure computers, cardiac monitors, infusion pumps) that the DeviceLink system can interface with.
Given this context, the questions you've asked about acceptance criteria and performance studies (sample size, ground truth, expert opinions, MRMC studies, standalone performance, training sets) are generally applicable to devices that make a diagnostic claim, provide a therapy, or have a direct impact on patient outcomes based on their own internal performance. The DeviceLink System, as described, is a data integration tool. Its "performance" would likely be evaluated on:
- Data Integrity: Does it accurately transmit the data received from the external devices?
- Data Format Conversion: Does it correctly convert data to HL7?
- Interoperability: Does it successfully connect and communicate with specified external devices and Clinical Information Systems?
- Reliability/Availability: Does it operate consistently without significant downtime or data loss?
The 510(k) summary provided does not detail specific studies or acceptance criteria for these types of performance metrics. The FDA's letter primarily acknowledges the review of the submission and the determination of substantial equivalence, which is a regulatory classification, not an endorsement of detailed performance study results in the common sense of device efficacy or diagnostic accuracy.
Therefore, I cannot populate the table or answer most of your detailed questions because the provided text does not contain that information for this specific type of device (a data integration system).
If this were a diagnostic AI device, for example, the information would be structured very differently, with explicit sensitivity, specificity, accuracy, and ROC curve analyses. For a data integration device, the "acceptance criteria" and "study" would likely refer to internal validation tests for data accuracy, throughput, and interoperability, which are not typically detailed in a publicly available 510(k) summary in the way you've outlined.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a data integration device, not a performance study report for a diagnostic or therapeutic medical device.
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JUL 2 3 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 July 14, 2004.
- 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 | CLASSIFICATION NAME | PANEL | PROCODE |
|---|---|---|---|
| NUMBER | |||
| 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 |
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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.
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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.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2004
Phillips Medical Systems c/o Mr. Herbert van Dyk Quality and Regulatory Engineer Cardiac and Monitoring Systems Hewlett-Packard Str. 2 D710340 Böblingen GERMANY
Re: K041942
Trade Name: M23764A DeviceLink System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: MWI Dated: July 14, 2004 Received: July 19, 2004
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.
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Page 2 – Mr. Herbert van Dyk
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I toase be actived that I be mination that your device complies with other requirements of the Act that 1 Dr Accomment and regulations administered by other Federal agencies. You must or any 1 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 OF A rat 607); adoming (21 CFR Part 820); and if applicable, the electronic forth in the quand 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 promated nonineted 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 11 you dome specific an enoliance at (301) 594-4648. 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,
Neil R.P. Ogden
Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K04194:
Philips Medical Systems
Page
Indications for Use
510(k) Number (if known): K041942
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.
Neil R. Ogden
(Division Sign-Off)
Division of Cardiovascular Devices
frrBDZ
510(k) Number K041942
AND / OR
Prescription Use Yes (part 21 CFR 801 Subpart D)
Over-The-Counter Use No (part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
(Optional Format 3-10-98)
§ 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).