(17 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.
Here's an analysis of the provided text regarding acceptance criteria and study details:
The provided document (K033680) is a 510(k) summary for the Philips M2376A DeviceLink System, submitted to the FDA in 2003. This document focuses on establishing substantial equivalence to a predicate device for regulatory clearance, primarily by describing the device's function and intended use.
Critically, the provided text DOES NOT contain specific information about:
- Acceptance Criteria for Device Performance: The document describes the function of the device (receiving, converting, and transmitting data) and its intended use (data collection and clinical information management), but it doesn't define any quantitative or qualitative performance metrics (e.g., data accuracy, latency, error rates) that the device must meet.
- Studies Proving Device Meets Acceptance Criteria: Since no acceptance criteria are explicitly stated for device performance, there are no details of a study designed to prove the device meets such criteria. The 510(k) process primarily assesses substantial equivalence, which often involves comparing the new device's technological characteristics and intended use to a legally marketed predicate, rather than extensive performance studies against pre-defined acceptance criteria for a novel functionality.
- AI/ML Specifics: The device, as described, is a data integration system and does not appear to incorporate artificial intelligence or machine learning components. Therefore, questions related to AI-specific studies (e.g., MRMC, standalone AI performance) are not applicable.
However, based on the information available, we can extract the following:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Functionality | Receive digital data from external devices | "receives digital data produced by external devices" | This is a descriptive statement of the device's capability, not a performance metric with an acceptance threshold. |
| Convert data to HL7 format | "converts that data into the HL7 format" | Descriptive statement, not a performance metric. | |
| Transmit data to networked Clinical Information System | "transmits that information to any networked Clinical Information System" | Descriptive statement, not a performance metric. | |
| Intended Use | Electronic data collection | "intended for electronic data collection" | Descriptive of intended use. |
| Clinical information management | "intended for... clinical information management" | Descriptive of intended use. | |
| Safety Restrictions | Not patient connected | "neither patient connected" | A design constraint to ensure safety. |
| Does not remotely control attached source device | "nor does it remotely control the attached source device" | A design constraint to ensure safety. | |
| Not for monitoring purposes | "not intended for monitoring purposes" | Clarification of intended use, prevents misuse. | |
| Not intended to control clinical devices | "not intended to control any of the clinical devices" | Clarification of intended use, prevents misuse. |
Explanation: The document does not provide quantifiable "acceptance criteria" in the sense of performance thresholds (e.g., "data conversion must achieve 99% accuracy"). Instead, the "acceptance criteria" for K033680 are primarily related to:
- Functional capabilities: What the device does.
- Intended Use: How the device should be used and not used.
- Safety characteristics: Design elements that prevent potential hazards.
The "reported device performance" in the table above consists of descriptive statements from the document itself, outlining the device's capabilities and limitations as stated by the manufacturer for regulatory review. There are no results from specific performance tests against numerical targets.
Additional Information (as requested, but not explicitly present for this device's performance):
- Sample size used for the test set and the data provenance: Not applicable as no performance study with a test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a data integration system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a data integration system, not an algorithm with performance evaluated in isolation.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided K033680 document:
The K033680 document is a regulatory submission for a data integration device. Its primary purpose is to demonstrate substantial equivalence to a predicate device by describing its intended use, technological characteristics, and safety features. It doesn't include details of performance studies against specific, quantifiable acceptance criteria, as might be found for devices with diagnostic or therapeutic functions that require extensive clinical or technical performance validation. The "acceptance" in this context refers to FDA's determination of substantial equivalence, allowing the device to be marketed.
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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:
| REGULATIONNUMBER | 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 recirculationmonitoring | 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 |
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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.
-
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
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.
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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 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
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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
§ 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).