DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES

K062576 · GE Healthcare · MHX · Sep 29, 2006 · Cardiovascular

Device Facts

• Record ID: K062576
• Device Name: DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES
• Applicant: GE Healthcare
• Product Code: MHX · Cardiovascular
• Decision Date: Sep 29, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Datex-Ohmeda S/5 PSM module (consisting of E-PSM, E-PSMP and E-INTPSM Modules) and accessories is intended for monitoring hemodynamic parameters of hospitalized patients.

Device Story

Hemodynamic plug-in parameter module for modular monitoring systems; inputs include ECG leads, SpO2 sensors, NIBP cuffs, temperature probes, and invasive pressure transducers. Module processes physiological signals; transmits data to monitor for display, trending, and alarm management. Used in clinical settings (hospitals) by qualified medical personnel. E-INTPSM interface module enables compatibility with S/5 F-CU8 and Compact monitor frames; allows mounting on IV-poles or anesthesia machines. Output provides real-time waveforms and vital sign readings to assist clinicians in patient assessment and clinical decision-making.

Clinical Evidence

Bench testing only. Device underwent validation and verification of specifications against recognized standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27, IEC 60601-2-30, IEC 60601-2-34, ISO 9919, and EN 12470-4.

Technological Characteristics

Modular hemodynamic monitor; includes NIBP, 12-lead ECG, Impedance Respiration, SpO2, invasive pressure, and temperature measurement boards. Connectivity via module bus data communication. Software-based processing for ECG (heartbeat/arrhythmia detection) and NIBP. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-27, IEC 60601-2-30, IEC 60601-2-34, IEC 60601-2-49, ISO 9919, and EN 12470-4.

Indications for Use

Indicated for monitoring hemodynamic parameters of all hospital patients. Includes ECG (ST-segment/arrhythmia), Impedance respiration (ages 3+), NIBP (weight 5kg/11 lbs+), Temperature, SpO2 (including motion), and invasive blood pressure. For use by qualified medical personnel only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Datex-Ohmeda E-PSM Module (K043551)

Submission Summary (Full Text)

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# KOG2576

Page 1 of 4

SEP 2 9 2006

# Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5 E-PSM(P) Module (consisting of E-PSM, E-PSMP and E-INTPSM Modules) 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: [phone] Fax: [phone]

#### NAME OF CONTACT:

Mr. Joel Kent

DATE:

August 22, 2006

#### DEVICE NAME as required by 807.92(a)(2)

#### TRADE NAME:

Datex-Ohmeda S/5 E-PSM(P) Module (consisting of E-PSM, E-PSMP and E-INTPSM Modules) and accessories

### COMMON NAME:

Multi-parameter Hemodynamic Module

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## CLASSIFICATION NAME:

## The following Class II classifications appear applicable:

| Product Code | Classification Name | CFR Section |
|--------------|-------------------------------------------------------------|-------------|
| MHX | Arrhythmia detector & alarm | 870.1025 |
| MLD | Monitor ST-segment & 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 |
| DSK | Blood pressure computer | 870.1110 |
| DRQ | Transducer signal amplifier and conditioner | 870.2060 |
| FLL | Clinical Electronic Thermometer | 880.2910 |

## NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)

The Datex-Ohmeda E-PSM Module (consisting of E-PSM, E-PSMP and E-INTPSM modules) and accessories is substantially equivalent in safety and effectiveness to the legally marketed and decessories to adocument of the module (consisting E-PSM and E-PSMP Modules) and accessories (K043551).

## DEVICE DESCRIPTION as required by 807.92(a)(4)

E-PSMP is a hemodynamic plug-in parameter module including the NIBP measurement, 12-lead ECG with the Impedance Respiration measurement, SpO2 with the plethysmographic waveform, two invasive pressure measurements (P1 and P2) and two temperature measurements (T1 and T2). two firessere measurements ( module for a modular monitoring system. This module can E-t own is a nemouring. I modular monitor and in other monitors using the new F-CU5P frame. With the new mounting accessories for the PSM module, E-PSM(P) plug-in parameter module can be removed from the FM monitor frame or S/5 F-CU5P frame and used near the patient on an IV-pole or anesthesia machine. Via the new E-INTPSM module and the new paticin on an IV-poic of unebhe massis. (P) plug-in parameter module can be attached thounting accessories for the S/5 F-CU8 frame or with Compact Monitor frames or used near the uncenty to a monitor asuage as a machine. S/5 F-CU8 frames or Compact Monitor frames have patient on I v pole of anesticoln his software licer. The monitors display waveforms and measurement readings, and handle the trending and alarm management. The ECG (e.g. heart beat medium in readings, and hance money and expiration algorithms are in the monitor software. and arrifything detection) and send them to the monitor. The NIBP, SpO2, Temperature and I he modules measure organis are in the module. There are two available options of the module: E-Invasive Pressure agormes P1 and P2 and E-PSM without P1 and P2. There are three r Sivil Will Invasive pressures I v aE-PSMP module for processing the measurement signals. Each parameter creat boards made the 2 1 chith software. The new E-INTPSM module and the new processing board has a mechanical and electrical interfacing between the E-PSM(P) module and mounting accessories are neemanted. a -INTPSM module and the new mounting accessories include only connections for the power supply and module bus data communication. There are no microcontrollers or software in the module or mounting accessories.

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#### INTENDED USE as required by 807.92(a)(5)

Intended Use:

The Datex-Ohmeda S/5 PSM module (consisting of E-PSM, E-PSMP and E-INTPSM Modules) and accessories is intended for monitoring hemodynamic parameters of hospitalized patients.

Indications for use:

The Datex-Ohmeda S/5 PSM module (consisting of E-PSM, E-PSMP and E-INTPSM Modules) and accessories are 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 lbs.) 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 E-PSM Module (consisting of E-PSM, E-PSMP and E-INTPSM modules) and accessories is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda E-PSM module (consisting E-PSM and E-PSMP Modules) and accessories (K043551).

The E-PSMP module (consisting E-PSM, E-PSMP and E-INTPSM Modules) and accessories have the following similarities compared to the predicate E-PSMP (K043551):

- same intended use and indications for use (only difference is to add E-INTPSM to the . name)
- identical fundamental scientific technology .
- . use the same operating principle
- the Customer and parameter specifications are the same except the Venous stasis values ◆ of the NIBP measurement
- have the same safety and effectiveness .
- have the same user interface at the monitor and alarms .
- are manufactured using the same processes .

The main differences between the new E-PSMP and the predicate E-PSMP (K043551) is primarily due to fact that the new E-PSM module has the following changes:

- added a new interface module, E-INTPSM, on the intended use and indications for use .
- with E-INTPSM the E-PSM(P) module can now used with S/5 F-CU8 monitor frame . and Compact monitor
- added new mounting accessories on the accessory list of the PSM module .
- added three reusable temperature probes and twelve disposable temperature probes .
- added an invasive pressure sensor on the accessory list of the PSM module .
- added new temperature and invasive pressure Care cables in the E-PSM(P) module . accessory list
- changed core material of the NIBP choke that is used in the power supply circuit of the . NIBP measurement board
- modified the software of the NIBP board to improve the Venous Stasis pressure used .

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# SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)

The Datex-Ohmeda S/5 PSM module (consisting of E-PSM, E-PSMP and E-INTPSM Modules) and I IN Dates Onlined OF I DN I assist 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 + A1 1999 .
- ANSI/AAMI ES1 (1993) .
- CAN/CSA C22.2 No. 601-1-M90 + SI (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 The Datex-Ohmeda S/5 PSM module (consisting of E-PSM, E-PSMP and E-INTPSM Modules) and accessories compared to the legally marketed (predicate) Datex-Ohmeda F-PSM module (consisting E-PSM and E-PSMP Modules) and accessories (K043551).

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Image /page/4/Picture/1 description: The image shows a stylized logo of the United States Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol of medicine, with a bird-like figure in the center. The bird-like figure is composed of three curved lines that resemble wings. The text "HHS" is located below the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

525 11 8 2006

GE Healthcare c/o Mr. Joel C. Kent Manager, Quality and Regulatory Affairs 86 Pilgrim Road Needham, MA 02492

Re: K062576

Trade Name: Datex-Ohmeda S/5 E-PSM(P) Module and accessories Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (With Arrhythmia Detection or Alarm) Regulatory Class: Class II (two) Product Code: MHX, MLD, DSK, DRQ, DQA, DPZ, DRT, DPS, DXN, FLL Dated: August 28, 2006 Received: August 31, 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 for ass stated in 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 r ou may, arorely initions 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 rr your de rice is existing (tional controls. Existing major regulations affecting your device can may oe subject to back as baseral 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. Joel C. Kent

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), please contact the Office of Compliance at [phone]. 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bermuda for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): __KCG ೭১76

# Device Name: Datex-Ohmeda S/5 PSM Module, (consisting of E-PSM, E-PSMP and E-INTPSM Modules) and accessories

Indications for Use:

The Datex-Ohmeda S/5 PSM module (consisting of E-PSM, E-PSMP and E-INTPSM Modules) and accessories are 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 patients ages 3 and up.

The NIBP measurement is indicated for patients who weigh 5kg (11 lbs.) and up.

The device is indicated for use by qualified medical personnel only.

Over-The-Counter Use _ Prescription 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)

Ahumma
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