(64 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware modifications (new display unit and modified rack).
No.
The device is indicated for monitoring, recording, and alarming of physiological parameters, not for treating conditions.
No
The device is indicated for monitoring, recording, and alarming of physiological parameters, which are functions of a patient monitor, not a diagnostic device.
No
The device description explicitly states it is a "Component Compact Monitor" and mentions a "new display unit and a modified rack," indicating it is a hardware device with physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities." This describes a device that measures physiological signals directly from the patient's body (e.g., ECG, transcutaneous gas).
- Device Description: The description mentions a "Component Compact Monitor" and a "new display unit and a modified rack." This aligns with a patient monitoring system.
- Lack of IVD Characteristics: There is no mention of analyzing samples taken from the body (like blood, urine, tissue). IVD devices are specifically designed to perform tests on these types of samples to provide diagnostic information.
- Physiological Parameters: The parameters mentioned (ECG, ST Segment monitoring, transcutaneous gas measurement) are all measured directly from the patient's body surface or through the skin, not from in vitro samples.
Therefore, this device is a patient monitoring system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
CCK, BZQ, LKD, KLK, DSI, MLD, MHX, DSJ, DSK, DXN, DXG, KRB, DRQ, DRT, DPS, MLC, KRC, DXJ, DRJ, DQA, DSB, DSH, DSF, MSX, FLL
Device Description
The modification is a new display unit and a modified rack.
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
adults, pediatrics, and neonates
Intended User / Care Setting
health care professionals / health care facilities
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)
Verification, validation, and testing activities establish the verformance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved che new device me, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K971910, K990972, K991773, K992273, K993383, K000822, R981370, K903621, K001057, K001333, K003621, K001037, K0015337, K00088, K923682, K925910, K941811, K990125, K990476, K992595, K001722
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
NOV 2 8 2001
Image /page/0/Picture/1 description: The image shows the text "K013199 p.1/a" in black font. The text appears to be handwritten. The text is likely a document identifier or page number.
9.0 510 (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 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 21 September, 2001
-
- The name of this device is the Philips Medical Systems, M1275B Classification names are as follows: Component Compact Monitor.
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Panel 73 | |||
| Anesthesiology | 868.1400, II | CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| 868.2375, II | BZQ | Monitor, Breathing Frequency | |
| 868.2480, II | LKD | Monitor, Carbon-Dioxide, Cutaneous | |
| 868.2500, II | KLK | Monitor, Oxygen, Cutaneous, for Infant not under Gas Anesthesia | |
| Panel 74 | |||
| Cardiovascular | 870.1025, III | DSI | Detector and Alarm, Arrhythmia |
| 870.1025, III | MLD | Monitor, ST Segment with Alarm | |
| 870.1025, III | MHX | Monitor, Physiological, Patient (with arrhythmia Detection or alarms) | |
| 870.1100, II | DSJ | Alarm, Blood-Pressure | |
| 870.1110, II | DSK | Computer, Blood-Pressure | |
| 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 Signal Conditioner, Transducer Signal | |
| 870.2300, II | DRT | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) | |
| 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 |
1
| Device Panel | Classification | Product Code | Description |
|---|---|---|---|
| 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 and | |
| Communication, | |||
| Physiological Monitors | |||
| Panel 80 | |||
| General | |||
| Hospital | 880.2910, II | FLL | Thermometer, electronic, |
| clinical |
-
- The new device is substantially equivalent to the previously cleared M3/M4 (M3046/3000A) device marketed pursuant to K971910, creared , and K990972, K991773, K992273, K993383, K000822, R981370 , und K903621, as well as M1175/76A pursuant to
K001057, K001333, and K003621, as well 2011, x000135 R001037, K0015337, Kra K088, K923682, K925910, K941811, K990125, к990476, к992595, к001722.
- The new device is substantially equivalent to the previously cleared M3/M4 (M3046/3000A) device marketed pursuant to K971910, creared , and K990972, K991773, K992273, K993383, K000822, R981370 , und K903621, as well as M1175/76A pursuant to
- The modification is a new display unit and a modified rack. 4 .
বা - 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 legally marketed predicate device.
-
- Verification, validation, and testing activities establish the verformance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved che new device me, 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.
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 features a stylized image of an eagle with three horizontal lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2001
Mr. Dave Osborn Phillips Medical Systems, Inc. Cardiac and Monitoring Systems 3000 Minuteman Rd. Andover, MA 01810-1099
K013199 Re:
Trade Name: M1275B Component Compact Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: MHX Dated: November 12, 2001 Received: November 13, 2001
Dear Mr. Osborn:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed 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. 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 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 (QS) 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,
Denta Tille
James E. Dilla Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
_ of _________________________________________________________________________________________________________________________________________________________________________ Page _
Over-The-Counter
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Philips Medical Systems, M1275B Component Compact Monitor, Release A.01.
Indicated for use by health care professionals Indications for Use: 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
Prescription Use Usc (Per 21 CFR 801.109) (Optional Format 1-2-96)
Telh
Division of Cardiovascular & Respiratory Devices
510(k) Number K013199