DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES

K051635 · GE Healthcare · KOI · Jul 15, 2005 · Anesthesiology

Device Facts

• Record ID: K051635
• Device Name: DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES
• Applicant: GE Healthcare
• Product Code: KOI · Anesthesiology
• Decision Date: Jul 15, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.2775
• Device Class: Class 2

Intended Use

The Datex-Ohmeda S/5™ E-NMT module is intended to be used to monitor the relaxation of the patient and regional block stimulation for nerve location.

Device Story

Module monitors neuromuscular transmission (NMT) in hospitalized patients; measures impulse transfer between nerve and muscle. Input: electrical stimulation of peripheral nerve (usually hand); piezoelectric sensor registers thumb motion, converting physical movement to electrical signal. Operation: stimulates nerve; evaluates muscle response to assess neuromuscular block level. Used in clinical settings by physicians/nurses. Output: NMT data displayed on monitor; assists clinicians in managing neuromuscular blocking agents/drugs causing paralysis. Benefits: ensures appropriate patient relaxation/paralysis levels during procedures.

Clinical Evidence

Bench testing only. Device verified against safety standards including IEC 60601-1, IEC 60601-2-10, and IEC 60601-2-40. No clinical data presented.

Technological Characteristics

Peripheral nerve stimulator; piezoelectric sensor for motion detection. Electronic measurement board identical to predicate. Connectivity: integrates with S/5 monitor system. Software: version 2.0, includes EEPROM data storage enhancement. Defibrillation protection circuitry. Complies with IEC 60601-1, IEC 60601-2-10, and IEC 60601-2-40.

Indications for Use

Indicated for monitoring patient relaxation and regional block stimulation for nerve location in hospitalized patients. For use by qualified medical personnel only.

Regulatory Classification

Identification

An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.

Predicate Devices

• Datex-Ohmeda M-NMT Module (K955026)

Submission Summary (Full Text)

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JUL 1 5 2005

K051635

## Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5 NeuroMuscular Transmission Module, E-NMT 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:

June 17, 2005

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

#### TRADE NAME:

Datex-Ohmeda S/5 NeuroMuscular Transmission Module, E-NMT and Accessories.

#### COMMON NAME:

Neuromuscular Transmission Measurement Module and Accessories

#### CLASSIFICATION NAME:

The following Class II classification appears applicable:

Product Code Classification Name KOI Electrical peripheral nerve stimulator

CFR Section 868.2775

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

The Datex-Ohnneda S/5TM Neuromuscular Transmission Module, E-NMT is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M NMT Module (K955026).

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

The Datex-Ohmeda S/5 NeuroMuscular Transmission Module, E NMT and accessories are used for monitoring neuromuscular transmission (NMT) of hospitalized patients. NeuroMuscular Transmission (NMT) is the transfer of an impulse between a nerve and a muscle in the neuromuscular junction. NMT can be blocked by neuromuscular blocking agents or drugs which cause transient muscle paralysis and prevent the patient from moving and breathing spontaneously. The level of neuromuscular block is measured with the E-NMT module by stimulating a peripheral nerve, usually in the hand, and by evaluating the muscle response. For example, with the Datex-Ohmeda MechanoSensor the motion of the thumb is registered by a piezoelectric sensor, converting the physical motion to a measurable electrical signal. The intended use for the modified device is the same as for the predicate, Datex-Ohmeda M-NMT module and accessories (K955026). There has been no change to the basic technology from the predicate.. The E-NMT module is a facelifted version of the predicate M-NMT module (K955026). The module cover and mechanics have changed, but electronic measurement board is identical to the predicate device (K955026). The module software has some minor modifications for manufacturing and an enhancement saving the supramaximal current and the reference value to the NMT board EEPROM after start-up. The module software version changed from 1.0 to 2.0. The E-NMT module input board connecting the module connector to the measurement board has a minor enhancement for better defibrillation protection.

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

#### Intended Use:

The Datex-Ohmeda S/5™ E-NMT module is intended to be used to monitor the relaxation of the patient and regional block stimulation for nerve location.

Indications for Use:

The Datex-Ohmeda S/5™ E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.

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

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### SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

The Datex-Ohmeda S/5™ Neuromuscular Transmission Module, E-NMT is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M NMT Module (K955026).

The E-NMT module has the following similarities compared to the predicate M-NMT (K955026):

- identical intended use and indications for use. .
- identical fundamental scientific technology .
- identical electronic measurement board .
- same module software with an enhancement to save NMT data to the NMT board EEPROM after . start-up.
- Can be used with the same NMT-specific monitor software. The function for storing NMT data to ◆ the EEPROM requires monitor software versions 97 or newer
- use the same operating principle .
- The same accessories, and additionally a pediatric version of the mechanosensor .
- have the same user interface at the monitor (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 .

The main differences between the new E-NMT and the predicate M-NMT (K955026) is primarily due to fact that the new E-NMT module has the following changes:

- new color, shape, and size and thus differing mechanics .
- The front panel and labeling have changed .
- Slightly modifited module software (software version changed from 1.0 to 2.0) includes . enhancement for manufacturing and saving of NMT data to the NMT board EEPROM after startup.
- . A pediatric version of the mechanosensor has been designed.
- The input board connecting the module connector to the measurement board has a minor . enhancement for better defibrillation protection

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/5TM Neuromuscular Transmission Module, E-NMT are substantially equivalent to the predicate Datex-Ohmeda M- NMT Module (K955026).

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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/5TM Neuromuscular Transmission Module, E-NMT have 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)
- ·EC 60601-2-10:1987 + A1: 2001 Medical electrical equipment Part 2: Particular requirements for . the safety or nerve and muscle stimulators
- IEC 60601-2-40:1998 Medical electrical equipment Part 2: Particular requirements for the safety of . electromyographs and evoked response equipment.
- FDA Performance standard, 21 CFR Part 898.12 PERFORMANCE STANDARD FOR . ELECTRODE LEAD WIRES AND PATIENT CABLES

#### CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/S™ Neuromuscular Transmission Module, E-NMT is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M NMT Module (K955026) as compared to the predicate device.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 5 2005

GE Healthcare Mr. Joel C. Kent Mir. Joer C. Regulatory and Regulatory Affairs 86 Pilgrim Road Needham, Massachusetts 02492

Re: K051635

K051635
Trade/Device Name: Datex-Ohmeda S/5 Neuromuscular Transmission Module, E-NMT
Trade/Device Name: Date: 10 0775 Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical peripheral nerve stimulator Regulatory Class: II Product Code: KOI Dated: June 17, 2005 Received: June 20, 2005

Dear Mr. Kent:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) prematice is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and nave delemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate device. Davice Amendments for use stated in the enclosure) to tegally manced produce dedical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food Drug. commerce prior to May 28, 1976, the enactinence with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approvate or a pel. controls provisions of the Act. The You may, therefore, market the device, subject to the group registration, listing of
general controls provisions of the Act include requirements michranding and general controls provisions of the Act mondes requirement of the management 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) mits - Titler on are pour device can be reader can
may be subject to such additional controls. Title - 000 a 800 and in addition FDA may be subject to such additions. Lastig may or ogalato 898 In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 In addition, F be found in the Code of I cueral Regarations, For device in the Federal Register.

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Page 2 - Mr. Kent

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substanted other requirements of the Act
that FDA has made a determination that your device compliss with requirements of the Act that FDA has made a determination inal your devices by other Federal agencies. You must
or any Federal statutes and regulations administered by other Federation and listin or any Federal statutes and regulations and limited to: registration and listing (21 l
comply with all the Act's requirements, including, but not ice registration and listing comply with all the Act's requirements; including, but increative requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing pri if annlicable, the ele CFR Part 807); labeling (21 CFR Parl 801); good manufactury platf.com
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applicable, 1050. forth in the quality systems (QS) regulancin (21 CFR 1000-1050, 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Sections 31 -342 or closection in your Section 510(k)
This letter will allow you to begin marketing your device as described in your dev This letter will allow you to begin market of substantial equivalence of your device to a legally
premarket notification. The FDA innding of substantial equir device and thi premarket notification. The FDA inding of substantal equive 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
r (1) (1) (1) (1) (1) (1) (1) (11) (112) - Also, please note the regulati If you desire specific advice for your device on our laoining negaments (ne regulation entitled,
contact the Office of Compliance at [phone]. Also, please note of the contact the Office of Compliance at (240) 2 iFe's Pat 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain "Misbranding by reference to prematici internet (1) on of the Act from the Division of Small
other general information on your responsibilities under the Act from the 1800 63 other general information on your responsibilities under (80) 2007 - 12-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number (800) by a Manufacturers, International and Consulter Assistance as no 100 e series and consectiondex.html.

Sincerely yours,

Sujette y. Michael Ornd

Chiu Lin Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

-

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Datex-Ohmeda S/5 NeuroMuscular Transmission Module, E-NMT and Accessories.

Indications for Use:

The Datex-Ohmeda S/5™ E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.

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)

Page ੀ ਨੀ

C. W. Moore

sion of Anesthestology, General Hospital, Infection Control. Denta

510(k) Number