DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES

K052976 · GE Healthcare · DQK · Jan 13, 2006 · Cardiovascular

Device Facts

• Record ID: K052976
• Device Name: DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES
• Applicant: GE Healthcare
• Product Code: DQK · Cardiovascular
• Decision Date: Jan 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Indications for Use

The Datex-Ohmeda S/5™ Cardiac Output module, E-COP and accessories are intended to be used for monitoring cardiac output (C.O.), right ventricular ejection fraction (REF), and invasive blood pressure of hospitalized patients.

Device Story

The Datex-Ohmeda S/5 E-COP is a plug-in parameter module for S/5 modular monitoring systems. It processes invasive signals to measure cardiac output, right ventricular ejection fraction, and invasive blood pressure. Used in hospital settings by qualified medical personnel, the module connects to S/5 anesthesia or critical care monitors. It transforms raw invasive signals into hemodynamic and oxygenation parameters, which are displayed on the monitor screen with adjustable waveform size, color, and sweep speed. Data is trended to assist clinicians in hemodynamic assessment and decision-making. The device benefits patients by providing continuous, real-time monitoring of critical cardiovascular parameters.

Clinical Evidence

Bench testing only. The device was verified and validated against safety and performance standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-34, IEC 60601-2-49, and ISO 14971. No clinical data was required for this 510(k) submission.

Technological Characteristics

Single-width plug-in module for S/5 modular monitors. Uses invasive sensing for cardiac output and blood pressure. Employs surface-mounted electronic components. Connectivity via proprietary module frame interface. Complies with IEC 60601-1, IEC 60601-1-2, and AAMI ES1-1993 standards. Software-based parameter calculation.

Indications for Use

Indicated for monitoring cardiac output (C.O.), right ventricular ejection fraction (REF), and invasive blood pressure in hospitalized patients. For use by qualified medical personnel only.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• Datex-Ohmeda M-COP Module (K922876)

Submission Summary (Full Text)

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# JAN I 3 2006

## Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5™ Cardiac Output module , E-COP 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:

October 19, 2005

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

#### TRADE NAME:

Datex-Ohmeda S/5TM Cardiac Output module , E-COP and accessories

### COMMON NAME:

Cardiac Output, Invasive Pressure Module

### CLASSIFICATION NAME:

The following Class II classifications appear applicable:

| Product Code | Classification Name | CFR Section |
|--------------|-----------------------------------|-------------|
| DQK | Diagnostic, programmable computer | 870.1425 |
| DSK | Blood pressure computer | 870.1110 |

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™ Cardiac Output module, E-COP is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-COP Module (K922876).

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

The Datex-Ohmeda S/5TM Cardiac Output module, E-COP is a single-width plug-in parameter module for a Datex-Ohmeda S/5 modular monitoring system. E-COP is used for monitoring cardiac output (C.O.) and right ventricular ejection fraction (REF) of hospitalized patients. Invasive pressure measurement is also available. All measurements are invasive. The Datex-Ohmeda Cardiac Output module, E-COP can be used with the following Datex-Ohmeda modular monitors with 510(k) clearances:

- S/5TM Anesthesia Monitor (AM) with main software S-STD96(A) or S ARK96(A) or newer ●
- S/5™ Compact Anesthesia Monitor (CAM) with main software S-STD96(A) or S-ARK96(A) . or newer
- S/5TM Critical Care Monitor (CCM) with main software S-ICU97(A) or newer. .

S/5TM Compact Critical Care Monitor (CCCM) with main software S-ICU97(A) or newer. . The E-COP module can be used both with the legacy S/5 8-module monitor frame F CU8 and with the new 5-module monitor frame F-CU5(P) (submitted separately). The Cardiac Output or invasive pressure signal can be displayed on the monitor screen. The waveform size, color and sweep speed can be adjusted. The E-COP module calculates a number of parameters related to oxygenation or hemodynamics. All the calculated parameters can be selected on the display, and trended. Accessories that are in contact with the patient are CE-marked by Baxter and distributed by GE Healthcare

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

#### Intended Use:

The Datex-Ohmeda S/5™ Cardiac Output module, E-COP and accessories are intended to be used for monitoring cardiac output (C.O.), right ventricular ejection (REF), and invasive blood pressure of hospitalized patients.

#### Indications for use:

The Datex-Ohmeda S/5TM Cardiac Output module , E-COP and accessories are indicated for monitoring cardiac output (C.O.), right ventricular ejection fraction (REF), and invasive blood pressure of hospitalized patients.

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 \$/5™ Cardiac Output module, E-COP is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-COP Module (K922876). The E-COP module has the following similarities compared to the predicate M-COP (K922876):

- . The same intended use and indications for use with the addition of the REF measurement
- Identical fundamental scientific technology ●
- Use the same operating principle .
- . Identical accessories for Cardiac Output measurement
- Have the same user interface at the monitor and alarms (can be used with the same . monitor software)
- The Customer and parameter specifications are the same .
- Have the same safety and effectiveness .
- Are manufactured using the same processes .

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The main differences between the new E-COP and the predicate M-COP (K922876) is primarily due to fact that the new E-COP module has the following changes:

- New color, shape, and size and thus differing mechanics .
- The front panel and labeling have changed (new GE-type connector for invasive . blood pressure)
- There is no Cardiac Output test connector in the front panel .
- New layout of electronic input board between module connector and measurement . board
- . Electronic measurement board uses surface mounted instead of through-hole components
- Minor modifications and corrections to the module software, and the addition of . the REF measurement.
- New invasive blood pressure accessories for the new GE-type connector .

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 the Datex-Ohmeda S/51M Cardiac Output Module, E-COP are substantially equivalent to the predicate Datex-Ohmeda M-COP Module (K922876).

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

The Datex-Ohmeda S/5TM Cardiac Output Module, E-COP and accessories has been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.

- . COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices
- FDA/DCRND Reviewer Guidance for Premarket Notification Submissions, November ◆ 1993
- IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (Part 1: General requirements for . safety)
- EN 60601-1:1990+ A1:1993 + A13:1996 + A2:1995 (identical to IEC60601-1:1988 + . Amdt. 1:1991 + Amdt. 2:1995)
- CAN/CSA C22.2 No. 601.1-M90 + S1:1994 (Canadian deviations to IEC 60601-1:1988 . + Amdt. 1:1991) + S2:1998 (=IEC Amdt 2:1995)
- UL 2601-1, October 24, 1997 (U.S. deviations to IEC 60601-1:1988 + Amdt. 1:1991+ . Amdt. 2:1995)
- . IEC 60601-1-2:2001 (Electromagnetic compatibility - Requirements and tests)
- AAMI ES1-1993 (Safe current limits for electromedical apparatus) .
- FDA/ODE Guidance for Content of Premarket Submission for Software Contained in . Medical Devices. (May 11, 2005)
- . ISO 14971:2000, Application of risk management to medical devices
- . IEC60601-2-34 Medical electrical equipment. Part 2: Particular requirements for the safety of Direct Blood Pressure Monitoring Equipment, 2000.
- . IEC 60601-2-49 Medical electrical equipment. Part 2: Particular requirements for the safety of MultifunctionPatient Monitoring Equipment: 2001.

#### CONCLUSION:

.

The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5TM Cardiac Output module, E-COP compared to the legally marketed (predicate) Datex-Ohmeda M-COP Module (K922876).

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Image /page/3/Picture/2 description: The image is a circular seal for the Department of Health and Human Services (USA). The seal features the department's logo, which is a stylized depiction of an eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2006

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

K052976 Re:

KU32976
Trade Name: Datex-Ohmeda S/5™ Cardiac Output Module, E-COP and Accessories Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: December 15, 2005 Received: December 16, 2005

### Dear Mr. Kent:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 310(x) premier is substantially equivalent (for the indications ferenced above and nave decembers and and marketed predicate devices marketed in interstate for use stated in the enclosure) to regars actiment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Lead Ford Ford. Day commerce prior to May 20, 1978, the enaouther with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the Unit devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM alle Cosmetic Act (71ct) that to her require apperal controls provisions of the Act. The Tou may, therefore, market the device, economics for annual registration, listing of general controls provisions of use tice, 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 If your device is olassimod (600 world). 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. Joel C. Kent

Please be advised that FDA's issuance of a substantial equivalence determination are not mean Please be advised that FDA s issualled of a substained on the other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decernmation and your contrastered by other Federal agencies. You must or any rederal statutes and regulations aannadines but not limited to: registration and listing (21 comply with an the Act s requirements, mortaling practice requirements as set CFR Part 807), labeling (21 CFRT art 800), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control pro risens (ovetice as described in your Section 510(k) This letter will anow you to begin maneting your and equivalence of your device to a legally premarket notification. The PDA midning of Succession 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 advice for Jour act [phone]. Also, please note the regulation entitled, p Contact the Office of Compullion at (216) 216-678 Part 807.97). You may obtain Misolallung by icrerchee to premainteriorities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Oolisanhibi/Www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blymmma 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): _ _ 0 5 - 2 97 6

Device Name: Datex-Ohmeda S/5™ Cardiac Output module , E-COP and accessories.

Indications for use:

The Datex-Ohmeda S/5™ Cardiac Output module , E-COP and accessories are indicated for monitoring cardiac output (C.O.), right ventricular ejection fraction (REF), and invasive blood pressure of hospitalized patients.

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

Over-The-Counter Use _ Prescription Use __ × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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