(18 days)
No
The summary does not mention AI, ML, or related terms, nor does it describe any features or performance metrics typically associated with AI/ML algorithms. The focus is on monitoring physiological parameters and software updates.
No.
The device is used for monitoring physiological parameters and alarming, which falls under diagnostic or monitoring functions, not therapeutic intervention.
No
The device is indicated for "monitoring, recording and alarming of multiple physiological parameters" of patients. While monitoring can inform diagnosis, the direct purpose of the device is not to diagnose conditions itself.
No
The device description explicitly states the device names are "Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors," which are hardware devices. The modification is the introduction of new software into these existing hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring the physiological parameters of patients." This involves measuring vital signs and other bodily functions directly from the patient.
- Device Description: The device is described as a "Patient Monitor," which is consistent with a device that measures physiological parameters from a living patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices specifically work with samples taken from the body, not by directly monitoring the body itself. This device falls under the category of a patient monitoring system, which is a different type of medical 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 of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare facilities. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within healthcare facilities.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.
Product codes
DSI, MLD, MHX, DSJ, DSK, DXN, DXG, KRB, DRQ, DRT, MSX, DPS, MLC, DRW, KRC, DXJ, DRJ, DQA, DSB, DSH, DSF, DRS, DSA, DRG, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, FLL, GWR, GWS
Device Description
Not Found
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.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.
Intended User / Care Setting
health care professionals / hospital environment and during transport within hospital environments
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 established the performance, functionality, and reliability of the modified device with respect to the characteristics of the modified predicate. Testing involved system level, sub-system level tests, performance tests, Pass/Fail tests, and safety testing from previous submissions cleared for the predicate device and other Philips medical devices. The results showed substantial equivalence. The results demonstrated that the Philips modified devices meet the requirements and reliability requirements and performance claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K014159, K021778, K030038, K032858, K040304, K040183, K040357, K041235, K41741, K042845, K050141, 050762, K040337, K041259, K1273522
Reference Device(s)
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
K060221
p1/3
FEB 1 7 2006
510 (k) Summary 8.0
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe
is submitted in accordance with the requirements of the Safe 13 Submitted In accordinate of 1990 and 21 C.F.R. $807.92.
- The submitter of this premarket notification is: Herbert van Dyk Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany - 71054 Bocking - 463-1734 - Fax: ++49 7031 463-2442 e-mail: herbert.van_dyk@philips.com
This summary was prepared on January 27, 2006.
-
- The names of the devices are the Philips MP20, MP30, MP40,
MP40, MP30, Lunco, Lunco, Intellilly, Pations Monitor The Mames Of the devices a 8990 IntelliVue Patient Monitors. Classification names are as follows:
- The names of the devices are the Philips MP20, MP30, MP40,
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Circulatory | |||
| System Devices | |||
| (12625) | $870.1025, II | DSI | Detector and alarm, arrhythmia |
| $870.1025, II | MLD | Monitor, ST Segment with Alarm | |
| $870.1025, II | 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) | |||
| $870.2300, II | MSX | System, Network and | |
| Communication, Physiological | |||
| Monitors | |||
| $870.2340, II | DPS | Electrocardiograph | |
| $870.2340, II | MLC | Monitor, ST Segment | |
| $870.2350, II | DRW | Electrocardiograph, Lead | |
| Switching Adapter | |||
| $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 | |
| $870.2850, II | DRS | Extravascular Blood Pressure | |
| Transducer |
COMPANY CONFIDENTIAL
1
| | $870.2900, I | DSA | Cable, Transducer and
Electrode, incl. Patient
Connector |
|------------------------------------------------------|-------------------------|----------------|------------------------------------------------------------------------------|
| | $870.2910, II | DRG | Transmitters and Receivers,
Physiological Signal,
Radiofrequency |
| Anesthesiology
and Respiratory
Therapy (12624) | $868.1400, II | CCK | Analyzer, Gas, Carbon Dioxide,
Gaseous-Phase |
| | $868.1500, II | CBQ | Analyzer, Gas, Enflurane,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1500, II | NHO | Analyzer, Gas, Desflurane,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1500, II | NHP | Analyzer, Gas, Sevoflurane,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1500, II | NHQ | Analyzer, Gas, Isoflurane,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1620, II | CBS | Analyzer, Gas, Halothane,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1700, II | CBR | Analyzer, Gas, Nitrous Oxide,
Gaseous-Phase (Anesthetic
Concentration) |
| | $868.1720, II | CCL | Analyzer, Gas, Oxygen, Gaseous-
Phase |
| | $868.1880, II | BZC | Data calculator Pulmonary-
function |
| | $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 |
| General Hospital
and Personal Use
(12520) | $880.2910, II | FLL | Thermometer, Electronic,
Clinical |
| | Neurological
(12513) | $882.1400, II | GWR |
| | | $882.1420, I | GWS |
- The modified devices are substantially equivalent to 3. me modified dored Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and K040337, K041259, K1273522, and to Respironics Novametrix Rostion, Ro32001 , Rossister and Accessories "PN 3468-3475" (K053174)
- The modification is the introduction of Release D.02 software 4 . The MOGILLEACION ID che Internitor devices, MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90
- The modified devices have the same intended use as the 5. legally marketed predicate devices. They are intended for the regarry marketa ding, and alarming of multiple physiological Monicoring, recording, and trics, and neonates in hospital
COMPANY CONFIDENTIAL
2
environment and during transport within hospital environments .
- The modified devices have the same technological 6. The modified devices have the band elected predicate devices.
-
- Verification, validation, and testing activities establish verformance, functionality, and reliability the performance, functionally, mevice with respect to the characteristics of the modified as a level tests, performance
predicate. Testing involved system levely - Rang (Fail predicate. Testing involved bybeard analysis. Pass/Fail tests, and safety testing from hassisions cleared for the criteria were babed on storesults showed substantial predicate device and other demonstrate that the Philips equivalence. The rebuild acments and reliability requirements and performance claims.
- Verification, validation, and testing activities establish verformance, functionality, and reliability the performance, functionally, mevice with respect to the characteristics of the modified as a level tests, performance
COMPANY CONFIDENTIAL
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2006
Philips Medizinsysteme Boeblingen GmbH c/o Mr. Herbert van Dyk Sr. Regulatory Affairs Engineer Philips Medical Services 3000 Minuteman Road Andover, MA 01810
Re: K060221
文
K 060221
Trade Name: The Philips MP20, MP30, MP30, MP60, MP70, MP80 and MP90
Trade Name: The Philips MP30, Dalam Dalam D 02 Intellivue Patient Monitors, Release D.02 Regulation Number: 21 CFR 870.1025 Regulation Name: 21 CFR 870.1023
Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: January 27, 2006 Received: January 30, 2006
Dear Mr. Van Dyk:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) prematics in the manufated (for the indications referenced and nave decimined the device are devices marketed in interstate for use stated in the encrosule) to regally manced provice Americal Device Ameralments, or to commerce prior to May 20, 1970, the chaouthore with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance what approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applic and Cosmetic Act (Act) that do not require approvince approvisions of the Act. The Act. The You may, merelore, market the device, saloject to the greateration, listing of
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Are, Inc. Increase some in misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) me existing major regulations affecting your device can may be subject to such additional controlis. Entroling the 300 to 898. In addition, I'DA may be found in the Ood of Peachartergerning your device in the Federal Register.
4
Page 2 – Mr. Herbert van Dyk
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat FDA has made a determination that your device complies with other requirements of the Act that i Drederal statutes and regulations administered by other Federal agencies. You must or uny I 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 CI K Part 607), laoomig (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro begin marketing your device as described in your Section 510(k) This letter will and w yourse FDA finding of substantial equivalence of your device to a legally marketed predicated. " caresults 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 If you desire specific as not any at (240) 276-0120. 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 other general 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/industry/support/index.html.
Sincerely yours,
Bhimmar fa
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Release D.02
Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarmine of multiple physiological parameters of adults, pediatrics and memates in healthcare facilities. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within healthcare facilities.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.
Prescription Use yes___________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ No (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummenstor
n Sign-