(14 days)
· Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients.
Intended use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities.
EASI 12-lead ECG is only for use on adult and pediatric patients.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.
The name of this device is the Philips Medical Systems, M1275B Component Compact Monitor.
The modification is updated software and the ability to connect to the Philips M1026A Anesthesia Gas Module.
The provided text describes a 510(k) submission for the Philips Medical Systems, M1275B Component Compact Monitor. This submission is for an updated software and the ability to connect to the Philips M1026A Anesthesia Gas Module, and it aims to demonstrate substantial equivalence to previously cleared devices rather than providing a study for a novel device's acceptance criteria and performance.
Therefore, many of the requested sections about acceptance criteria, detailed study results, sample sizes, expert ground truth establishment, and comparative effectiveness are not available or directly applicable in this context. The document focuses on demonstrating that the updated device meets the specifications of its predicate, not on establishing new performance criteria.
Here's an analysis based on the provided text, indicating where information is present and where it is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." However, the specific quantitative acceptance criteria and the detailed reported performance values for each parameter (e.g., accuracy, precision) are not provided in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly detailed in the summary. The document states "Pass/Fail criteria were based on the specifications cleared for the predicate device." | Not explicitly detailed in the summary. The document states "test results showed substantial equivalence" and "The results demonstrate that Component Compact Monitor meets all reliability requirements and performance claims." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the summary. The text mentions "system level tests, performance tests, and safety testing from hazard analysis" but does not specify the sample size of any test sets or the provenance of any data used for these tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the summary. As the submission focuses on substantial equivalence to a predicate device and relies on engineering and performance testing based on existing specifications, the concept of "ground truth established by experts" in the context of clinical interpretation (like in imaging or diagnostic AI) is not directly applicable here.
4. Adjudication Method for the Test Set
This information is not provided in the summary. Adjudication methods (like 2+1 or 3+1) are typically used when human interpretation is involved in establishing a ground truth for diagnostic accuracy studies. For this type of device, which is a physiological monitor, the "ground truth" would likely be established through calibrated instruments and established engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted (or at least not mentioned in the summary). This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance, to measure an effect size. This device is a physiological monitor, and its evaluation focuses on technical performance and equivalence.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The evaluation described is inherently a standalone performance assessment of the device against established specifications. The text states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate." This implies testing the device's technical performance without a human-in-the-loop performance study, as would be typical for a physiological monitor. However, it's not explicitly framed as an "algorithm only" study as if it were an AI diagnostic tool.
7. Type of Ground Truth Used
The ground truth for evaluating this physiological monitor would have been based on:
- Established engineering specifications and standards: Performance parameters (e.g., accuracy of gas measurements, heart rate monitoring) would be verified against known, calibrated inputs or reference devices that serve as the "ground truth."
- Predicate device specifications: The summary explicitly states: "Pass/Fail criteria were based on the specifications cleared for the predicate device." The performance of the predicate device, already deemed safe and effective, serves as the benchmark.
8. Sample Size for the Training Set
This information is not provided in the summary. The device's "updated software" suggests firmware or operating system updates for controlling hardware, not necessarily a machine learning model that requires a "training set" in the typical sense of AI development. If any algorithms within the device were developed using data, the size and nature of such a training set are not mentioned.
9. How Ground Truth for the Training Set Was Established
As no "training set" in the context of AI development is explicitly mentioned or implied for this physiological monitor's updated software, the method for establishing its ground truth is not applicable/provided.
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510 (k) Summary 9.0
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 CFR §807.92.
- The submitter of this premarket notification is: Dave Osborn Quality Program Manager Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1085
978 659 3178 Tel: 978 685 5624 Fax: Email: dosborn@hsgmed.com
This summary was prepared on 23 April, 2002
-
- The name of this device is the Philips Medical Systems, M1275B Component Compact Monitor. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Panel 73Anesthesiology | 868.1400, II | CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| 868.1500, II | CBQ | Analyzer, Gas, Enflurane,Gaseous-Phase (AnestheticConcentration) | |
| 868.1500, II | NHO | Analyzer, Gas, Desflurane,Gaseous-Phase (AnestheticConcentration) | |
| 868.1500, II | NHP | Analyzer, Gas,Sevoflurane, Gaseous-Phase(Anesthetic Concentration) | |
| 868.1500, II | NHQ | Analyzer, Gas, Isoflurane,Gaseous-Phase (AnestheticConcentration) | |
| 868.1620, II | CBS | Analyzer, Gas, Halothane,Gaseous-Phase (AnestheticConcentration) | |
| 868.1700, II | CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase(Anesthetic Concentration) | |
| 868.1720, II | CCL | Analyzer, Gas, Oxygen,Gaseous-Phase | |
| 868.2375, II | BZQ | Monitor, BreathingFrequency | |
| 868.2480, II | LKD | Monitor, Carbon-Dioxide,Cutaneous | |
| 868.2500, II | KLK | Monitor, Oxygen,Cutaneous, for Infant notunder Gas Anesthesia | |
| Panel 74Cardiovascular | 870.1025, III | DSI | Detector and Alarm,Arrhythmia |
| 870.1025, III | MLD | Monitor, ST Segment withAlarm | |
| 870.1025, III | MHX | Monitor, Physiological,Patient (with arrhythmiaDetection or alarms) | |
| 870.1100, II | DSJ | Alarm, Blood-Pressure | |
| 870.1110, II | DSK | Computer, Blood-Pressure |
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| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| 870.1130, II | DXN | System, Measurement,Blood-Pressure, Non-Invasive | |
| 870.1435, II | DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | |
| 870.1915, II | KRB | Probe, Thermodilution | |
| 870.2060, II | DRQ | Amplifier and SignalConditioner, TransducerSignal | |
| 870.2300, II | DRT | Monitor, Cardiac (incl.Cardiotachometer & RateAlarm) | |
| 870.2340, II | DPS | Electrocardiograph | |
| 870.2340, II | MLC | Monitor, ST Segment | |
| 870.2370, II | KRC | Tester, Electrode,Surface,Electrocardiograph | |
| 870.2450, II | DXJ | Display, Cathode-Ray Tube,Medical | |
| 870.2600, I | DRJ | System, Signal Isolation | |
| 870.2700, II | DQA | Oximeter | |
| 870.2770, II | DSB | Plethysmograph, Impedance | |
| 870.2800, II | DSH | Recorder, Magnetic Tape,Medical | |
| 870.2810, I | DSF | Recorder, Paper Chart | |
| - | MSX | System,Network andCommunication,Physiological Monitors | |
| Panel 80GeneralHospital | 880.2910, II | FLL | Thermometer, electronic,clinical |
-
- The new device is substantially equivalent to the previously cleared Philips Component Compact Monitor (M1275B) device marketed pursuant to K013199, the Philips Component Monitoring System marketed pursuant to K990125 with the Philips M1026A Anesthesia Gas Module marketed pursuant to K951127, K982619, & K994188, and the Philips M3 marketed pursuant to K971910.
- The modification is updated software and the ability to connect 4. to the Philips M1026A Anesthesia Gas Module.
- The new device has the same Indications for Use, for use by 5. health care professionals whenever there is a need for monitoring the physiological parameters patients, as the legally marketed predicate device.
- The new device has the same technological characteristics as the 6. legally marketed predicate device.
-
- Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of
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the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that Component Compact Monitor meets all reliability requirements and performance claims.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dave Osborn Quality Program Manager Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099
Re: K021300
Trade Name: Philips Medical Systems, M1275B Component Compact Monitor (CCM), Release A.03, with M1026A Anesthetic Gas Module Regulation Name: Arrhythmia Detector and Alarm Regulation Number: 21 CFR 870.1025 Regulatory Class: Class III (three) Product Code: DSI Dated: April 23, 2002 Received: April 24, 2002
Dear Mr. Osborn:
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. Dave Osborn
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 or any I vith 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 orth in the quality systems (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,
Robert Till
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ K02 (300_
Device Name: Philips Medical Systems, M1275B Component Compact Monitor, Release A.03, with M1026A Anesthetic Gas Module.
Indications for Use: · Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients.
Intended use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities.
EASI 12-lead ECG is only for use on adult and pediatric patients.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
ﺮ Prescription Use Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021300
11
Over-The-Counter
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.