INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE

K040188 · Draeger Medical Systems, Inc. · NHP · Apr 14, 2004 · Anesthesiology

Device Facts

• Record ID: K040188
• Device Name: INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE
• Applicant: Draeger Medical Systems, Inc.
• Product Code: NHP · Anesthesiology
• Decision Date: Apr 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1500
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The intended use of this device is to monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, central apnea is accomplished through impedance plethysmography and apnea through capnography, end-tidal carbon dioxide, and ST Segment Analysis. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders, either directly or via the INFINITY network. When connected to a SCIO module sampled breathing gases from adults and pediatrics can be displayed. The gas module continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors. The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition. The devices are intended for use in the Adult, Pediatric and Neonatal populations, with the exception of Arrhythmia and ST Segment Analysis which are not intended for the neonalal population.

Device Story

INFINITY GammaXL/SC 6802XL are modular patient monitors; input signals include ECG, pressure, temperature, SpO2, and respiratory gases via connected Scio gas module. Device processes physiological data to display real-time waveforms and numeric values; triggers visual/audible alarms for out-of-limit parameters. Used in clinical environments by trained physicians, nurses, and technicians. Output enables continuous patient status assessment; supports clinical decision-making regarding patient stability and intervention. Scio module provides continuous measurement of CO2, N2O, O2, and anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, Desflurane). System connects to R50 recorders directly or via INFINITY network. Not MRI compatible.

Clinical Evidence

No clinical data provided. Equivalence established via verification and validation testing demonstrating the device operates as intended with no adverse effects.

Technological Characteristics

Modular patient monitor; connects to Scio gas module via specific cable. Software version VF3 and above. Connectivity via INFINITY network. Not MRI compatible. No specific materials or sterilization methods listed as applicable.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring physiological monitoring of heart rate, respiration, invasive/non-invasive pressure, temperature, SpO2, pulse rate, apnea (via impedance/capnography), end-tidal CO2, and anesthetic gases. Arrhythmia and ST segment analysis are contraindicated for neonates.

Regulatory Classification

Identification

An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture.

Predicate Devices

• INFINITY GammaXL / SC 6802XL (K033600)
• INFINITY Modular Monitors with Scio (K030313)
• INFINITY Modular Monitors (K993974)
• Scio gas module (K031340)

Submission Summary (Full Text)

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INFINITY GAMMAXL / SC 6802XL WITH SCIO

#### 510(k) SUMMARY

as required per 807.92(c)

Submitters Name. Address:

(k) Notification

Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: [phone] Fax: [phone] Official Correspondent: Connie Hertel, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Regulatory Submissions Manager Date submission was prepared: January 23, 2004

Trade Name, Common Name and Classification Name: Trade Name: INFINITY GammaXL and SC 6802XL with Scio

# Common Name, Classification Name, Class and Regulation Number:

| Common Name | Product Code | Class | Regulation Number |
|--------------------------------------------------------------------------|--------------|-------|-------------------|
| Monitor, Physiological, Patient (with Arrhythmia<br>Detection or Alarms) | MHX | II | 870.1025 |
| Arrhythmia Detector & Alarm | 74DSI | II | 870.1025 |
| System, Network and Communication,<br>Physiological Monitors | MSX | II | 870.2300 |

Legally Marketed Device:

INFINITY GammaXL / SC 6802XL INFINITY Modular Monitors with Scio

K033600 / K030313 / K993974 K031340

### Description of Device Modifications:

The INFINITY GammaXL and SC 6802XL with software version VF3 and above are capable of displaying gas-monitoring data received from a Scio gas module (K031340). Anesthetic gas monitoring is available when a GammaXL or SC 6802XL is attacted via a specific cable to a Scio gas module. This is a password protected locked optical. The GammaXL and SC 6802XL with Scio are similar to the Infinity Modular Monitors with Scio (K031340) in that they display gas-monitoring parameters received from the Scio gas module. Testing of the INFINITY GammaXL and SC 6802XL with Scioindic bero new issues of safety and efficacy.

Page 1 of 2

#### COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc.

16 Electronics Avenue Danvers, MA . 01923

Tel: [phone] Fax: [phone]

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### Intended Use:

The intended use of this device is to monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, central apnea is accomplished through impedance plethysmography and apnea through capnography, end-tidal carbon dioxide, and ST Segment Analysis. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders, either directly or via the INFINITY network.

Assessment of non-clinical performance data for equivalence: Verification and validation testing of the Infinity GammaXL and SC 6802XL with SCIO, indicates no new issues relative to safety and efficacy.

Assessment of clinical performance data for equivalence: The review of clinical data indicates that the GammaXL/SC 6802XL with Scio operates as intended with no adverse affects.

Biocompatability: Not applicable

Sterilization: Not applicable

- Draft Reviewer Guidance for Premarket Notification 510(k) Standards: Submissions, November 1993 IEC 601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety
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Draeger Medical Systems, Inc.

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Penelope H. Greco Regulatory Submissions Manager Draeger Medical Systems, Incorporated 16 Electronics Avenue Danvers, Massachusetts 01923

Re: K040188

Trade/Device Name: Infinity Gammaxl and SC 6802XL with the Scio Gas Module Regulation Number: 868.1500 Regulation Name: Enflurane gas analyzer Regulatory Class: II Product Code: NHP. MHX Dated: April 8, 2004 Received: April 9, 2004

Dear Ms. Greco:

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.

APR 1 4 2004

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Page 2 - Ms. Greco

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 (OS) 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/dsma/dsmamain.html

Sincerely yours.

Qur

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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510(k) Number (if known):_ KO40 188

## Device Name: INFINITY GammaXL / SC 6802XL with Scio

Indications for Use:

This device is capable of monitoring:

- . Heart Rate
- Respiration Rate ●
- Invasive Pressure .
- . Non-Invasive Pressure
- Arrhythmia .
- . Temperature
- Arterial oxygen saturation .
- . Pulse rate

SAwhlm

logy. General Hospital

510(k) Number: KO 40188

- central apnea accomplished through impedance plethysmography ●
- apnea accomplished through capnograpy .
- � end-tidal CO2
- ST Segment Analysis ◆

This Infinity GammaXL and SC 6802XL will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders, either directly or via the INFINITY network.

When connected to a SCIO module sampled breathing gases from adults and pediatrics can be displayed. The gas module continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.

The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The devices are intended for use in the Adult, Pediatric and Neonatal populations, with the exception of Arrhythmia and ST Segment Analysis which are not intended for the neonalal population.

#### MRI Compatibility Statement:

The INFINITY GammaXL and SC 6802XL are not compatible for use in a MRI magnetic field.

Prescription Use _ ) OR Over-The-Counter Use_ (Per 21 CFR 801.109)

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Concurrence of CDRH, Office of Device Evaluation (ODE)