(267 days)
Not Found
No
The summary describes a standard multi-parameter physiological monitoring module and does not mention any AI or ML capabilities.
No.
The device is a hemodynamic multiparameter monitor used for monitoring various physiological parameters, not for treating any condition.
Yes
The device monitors numerous hemodynamic parameters such as ECG, respiration, NIBP, temperature, SpO2, and invasive blood pressure, which are used to evaluate a patient's physiological state and identify potential health issues.
No
The device description explicitly states it is a "hemodynamic multiparameter module" and lists various physical measurements it performs (ECG, blood pressure, SpO2, temperature, respiration), indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use and Indications for Use: The device is intended for monitoring hemodynamic parameters of hospitalized patients. These parameters (ECG, respiration, NIBP, temperature, SpO2, invasive blood pressure) are measured directly from the patient's body, not from a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The description details a multiparameter module that measures physiological signals from the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or performing tests on these samples to provide diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device measures physiological signals directly from the patient, which falls under the category of patient monitoring equipment, not IVD.
N/A
Intended Use / Indications for Use
Intended use:
The Datex-Ohmeda PRESTN model family E-PRESTN is intended to be used with Datex-Ohmeda modular monitors for monitoring hemodynamic parameters of hospitalized patients.
Indications for use:
The Datex-Ohmeda E-PRESTN module family (including E-PRESTN, E-RESTN, E-PRETN, E-PP, E-PT,a nd E-P modules) and accessories is indicated for monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG (including ST-segment and arrhythmia), Impedance respiration, NIBP, Temperature, SpO2 (including monitoring during conditions of clinical patient motion), and invasive blood pressure. Impedance Respiration measurement is indicated for patient's ages 3 and up. The NIBP measurement is indicated for patients who weigh 5kg (11 lb.) and up.
The device is indicated for use by qualified medical personnel only.
Product codes (comma separated list FDA assigned to the subject device)
MHX, MLD, DQA, DPZ, DRT, DPS, DXN, FLL, DSK, DRQ
Device Description
The Datex-Ohmeda E-PRESTN module family and accessories is a hemodynamic multiparameter module which is able to measure ECG, two Invasive blood pressures, SpO2, two Temperatures, Non-invasive blood pressure and Impedance Respiration.
The Datex-Ohmeda E-PRESTN module can be used with the following Datex-Ohmeda modular monitors.
S/5 Anesthesia Monitor(AM) with main software L-ANE05(A)..00 or newer version
S/5 Compact Anesthesia Monitor (CAM), with main software L-CANE05(A) or newer version
S/5 Critical Care Monitor (CCM) with main software L-ICU05(A) or newer version
S/5 Compact Critical Care Monitor (CCCM), with main software L-CICU05(A) or newer version
There are 6 different model variants of the module:
E-PRESTN: (includes all possible parameters) NIBP, ECG, SpO2, 2T, 2inv. press.,Resp
E-RESTN: (does not include invasive pressures) NIBP, ECG, SpO2, 2*T, Resp
E-PRETN: (does not include SpO2) NIBP, ECG, 2T, 2inv. press.,Resp.
E-PP: Two invasive pressure measurement channels
E-PT: One invasive pressure measurement channel, dual temperature measurement channel One invasive pressure measurement channel E-P:
The letters in the module name stand for:
P= Invasive Pressure
R= Impedance Respiration
E= 12-Lead ECG
S= Pulse Oximetry
T= Temperature
N=NIBP, Non-Invasive Blood Pressure
In the remainder of this document," E-PRESTN module family" is used to denote all six modules, "E-PRESTN" is used as a collective name for the double-width E-PRESTN, E RESTN, and E-PRETN modules, and the respecitve module names "E-PP", "E-PT" or "E-P" (or "E-PT/E-P") are used for the single-width modules.
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
Impedance Respiration measurement is indicated for patient's ages 3 and up.
The NIBP measurement is indicated for patients who weigh 5kg (11 lb.) and up.
Intended User / Care Setting
Intended Use: hospitalized patients
Intended User: qualified medical personnel
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)
The device has been thoroughly tested through validation and verification of specifications against the following standards:
- FDA regulation 21 CFR 898.12
- IEC 60601-1:1988 + Amendments: A1:1991, ,A2:1995, .
- IEC 60601-1-2:2001 .
- IEC 60601-1-4:1996 + AI 1999 .
- ANSI/AAMI ES1 (1993) .
- CAN/CSA C22.2 No. 601-1-M90 + S1 (1994)+Amdt2:1998 .
- IEC 60601-2-27 (1994) .
- IEC 60601-2-30 (1999) .
- IEC 60601-2-34 (2000) .
- . IEC 60601-2-49:2001
- EN 12470-4:2000 .
- ISO 9919 (1994) / EN 865:1997
- UL 2601-1 : 1997
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
2006 FEB 3
Page 1 of 4
217
Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda PRESTN Module (Model family E-PRESTN, including E-PRESTN, E-RESTN,E-PRETN, E-PP,and E-PT/E-P) and accessories
GENERAL COMPANY INFORMATION as required by 807.92(a)(1)
COMPANY NAME/ADDRESS/PHONE/FAX:
GE Healthcare 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344
NAME OF CONTACT:
Mr. Joel Kent
DATE:
May 1, 2005
DEVICE NAME as required by 807.92(a)(2)
TRADE NAME:
Datex-Ohmeda PRESTN Module (Model family E-PRESTN, including E-PRESTN, E-RESTN, E-PRETN, E-PP and E-PT/E-P) and accessories.
COMMON NAME:
Multiparameter Hemodynamic Module (E-PRESTN, E-RESTN,E-PRETN) Invasive Pressure Measurement Module (E-PP, E-P) Invasive Pressure Temp Hemodynamic Module (E-PT)
1
CLASSIFICATION NAME:
The following Class II classifications appear applicable:
| Product Code | Classification Name | CFR Section |
|---|---|---|
| MHX | Monitor, Physiological, Patient (With Arrhythmia Detection or Alarm) | 870.1025 |
| MLD | Monitor, ST segment with Alarm | 870.1025 |
| DQA | Oximeter | 870.2700 |
| DPZ | Ear Oximeter | 870.2710 |
| DRT | Cardiac Monitor (including cardiotachometer and rate alarm) | 870.2300 |
| DPS | Electrocardiograph | 870.2340 |
| DXN | Non-invasive blood pressure measurement system | 870.1130 |
| FLL | Clinical Electronic Thermometer | 880.2910 |
| DSK | Blood pressure computer | 870.1110 |
| DRQ | Transducer signal amplifier and conditioner | 870.2060 |
NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)
The Datex-Ohmeda S/5™ E-PRESTN Module family is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-PRESTN..01 Module (K041772).).
DEVICE DESCRIPTION as required by 807.92(a)(4)
The Datex-Ohmeda E-PRESTN module family and accessories is a hemodynamic multiparameter module which is able to measure ECG, two Invasive blood pressures, SpO2, two Temperatures, Non-invasive blood pressure and Impedance Respiration.
The Datex-Ohmeda E-PRESTN module can be used with the following Datex-Ohmeda modular monitors.
S/5 Anesthesia Monitor(AM) with main software L-ANE05(A)..00 or newer version
S/5 Compact Anesthesia Monitor (CAM), with main software L-CANE05(A) or newer version
S/5 Critical Care Monitor (CCM) with main software L-ICU05(A) or newer version
S/5 Compact Critical Care Monitor (CCCM), with main software L-CICU05(A) or newer version
There are 6 different model variants of the module:
E-PRESTN: (includes all possible parameters) NIBP, ECG, SpO2, 2T, 2inv. press.,Resp
E-RESTN: (does not include invasive pressures) NIBP, ECG, SpO2, 2*T, Resp
E-PRETN: (does not include SpO2) NIBP, ECG, 2T, 2inv. press.,Resp.
E-PP: Two invasive pressure measurement channels
E-PT: One invasive pressure measurement channel, dual temperature measurement channel One invasive pressure measurement channel E-P:
The letters in the module name stand for:
P= Invasive Pressure
R= Impedance Respiration
E= 12-Lead ECG
S= Pulse Oximetry
T= Temperature
N=NIBP, Non-Invasive Blood Pressure
In the remainder of this document," E-PRESTN module family" is used to denote all six modules, "E-PRESTN" is used as a collective name for the double-width E-PRESTN, E RESTN, and E-PRETN modules, and the respecitve module names "E-PP", "E-PT" or "E-P" (or "E-PT/E-P") are used for the single-width modules.
2
INTENDED USE as required by 807.92(a)(5)
Intended use:
The Datex-Ohmeda PRESTN model family E-PRESTN is intended to be used with Datex-Ohmeda modular monitors for monitoring hemodynamic parameters of hospitalized patients.
Indications for use:
The Datex-Ohmeda E-PRESTN module family (including E-PRESTN, E-RESTN, E-PRETN, E-PP, E-PT,a nd E-P modules) and accessories is indicated for monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG (including ST-segment and arrhythmia), Impedance respiration, NIBP, Temperature, SpO2 (including monitoring during conditions of clinical patient motion), and invasive blood pressure. Impedance Respiration measurement is indicated for patient's ages 3 and up. The NIBP measurement is indicated for patients who weigh 5kg (11 lb.) and up.
The device is indicated for use by qualified medical personnel only.
SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)
The Datex-Ohmeda S/5™ E-PRESTN Module family is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-PRESTN..01 Module (K041772).).
The E-PRESTN module has the following similarities compared to the predicate M-PRESTN..01 (K041772):
- identical intended use and indications for use ●
- identical fundamental scientific technology .
- . use the same operating principle
- identical ECG connector .
- have the same safety and effectiveness .
- the Customer and parameter specifications are basically the same (four minor . modifications)
- . have the same user interface at the monitor and alarms
- are manufactured using the same processes .
The main differences between the new E-PRESTN and the predicate M-PRESTN..01 (K041772) is primarily due to the fact that the new E-PRESTN module has the following changes:
- . New color, shape, and size and thus differing mechanics
- . The front panel and labeling have changed
- . New GE-type NIBP, invBP, Temperature and SpO2 module connectors
- Dynamic module addressing in the module-to-monitor communication .
- . Minor enhancements to module software
- Minor modifications to the electronic measurement boards .
- The arrhythmia and ST detection and analysis algorithm in the monitor software . supporting the E-PRESTN modules have changed. The functionality is identical, the same arrhythmias are detected and alarms are initiated for them in a identical manner.
- . The single-width hemodynamic pressure and temperature modules E-PP, E-PT, and E-P have been added to the E-PRESTN Module family.
Based on the analysis and other documentation included in this 510(k) notification and attachments it is evident that the main features and indications for use of Datex-Ohmeda E-
3
PRESTN Module family are substantially equivalent to the predicate Datex-Ohmeda M-PRESTN..01 Module (K041772).
SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)
Datex-Ohmeda PRESTN Module (Model family E-PRESTN, including E-PRESTN, E-RESTN, E-PRETN, E-PP and E-PT/E-P) and accessories have been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.
- FDA regulation 21 CFR 898.12 .
- IEC 60601-1:1988 + Amendments: A1:1991, ,A2:1995, .
- IEC 60601-1-2:2001 .
- IEC 60601-1-4:1996 + AI 1999 .
- ANSI/AAMI ES1 (1993) .
- CAN/CSA C22.2 No. 601-1-M90 + S1 (1994)+Amdt2:1998 .
- IEC 60601-2-27 (1994) .
- IEC 60601-2-30 (1999) .
- IEC 60601-2-34 (2000) .
- . IEC 60601-2-49:2001
- EN 12470-4:2000 .
- ISO 9919 (1994) / EN 865:1997 ●
- · UL 2601-1 : 1997
CONCLUSION:
The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda PRESTN Module (Model family E-PRESTN, including E-PRESTN, E-RESTN, E-PRETN, E-PP and E-PT/E-P) and accessories as compared to the predicate device.
4
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3 2006
GE Healthcare c/o Mr. Joel C. Kent Manager, Quality and Regulatory Affairs 86 Pilgrim Road Needham, MA 02492
Re: K051217
Trade Name: Datex-Ohmeda S/5 E-PRESTN Module Family, including E-PRESTN, E-RESTN, E-PRETN, E-PP, and E-PT/E modules Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: January 06, 2006 Received: January 06, 2006
Dear Mr. Kent,
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.
5
Page 2 - Mr. Joel C. Kent
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a bucosains with other requirements of the Act
that FDA has made a determination that your device complies with other may that FDA has made a decemmation that your as read by other Federal agencies. You music or any Federal Statutes and regulations adminitives but not limited to: registration and listing comply with all the Act STequirements, morading proctice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing proctice description (21 CFR Part 807), laoching (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regardatin (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections on r device as described in your becise to 10(k) I his letter will anow you to ocgin marketing your antial equivalence of your device to a legally premarket notification. The PDA inding of substance of a lovice 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 spectific advice for your active of our and one one one one the regulation entitled,
contact the Office of Compliance at (240) 276-0210. Also, please note of Colliact the Office of Compilance an (21 the Part 807.97). You may obtain Misolanding by reference to premainters withing the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Oolisan http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blymmmofor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Datex-Ohmeda PRESTN Module (Model family E-PRESTN, including E-PRESTN, E-RESTN,E-PRETN, E-PP and E-PT/E-P) and accessories.
Indications for Use:
The Datex-Ohmeda E-PRESTN module family (including E-PRESTN, E-RESTN, E-PRETN, E-PP, E-PT, and E-P modules) and accessories is indicated for monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG (including STsegment and arrhythmia), Impedance respiration, NIBP, Temperature, SpO2 (including monitoring during conditions of clinical patient motion), and invasive blood pressure.
Impedance Respiration measurement is indicated for patients ages 3 and up.
The NIBP measurement is indicated for patients who weigh 5kg (11 lb.) and up.
The device is indicated for use by qualified medical personnel only.
Prescription Use _ × Over-The-Counter Use AND/OR -(Part 21 CFR 801 Subpart D) (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)
Bettmann
Division Sign-Off)
■ivision of Cardiovascular Devices
10(k) Number K05017
Page __ of _