INFINITY GAMMA / GAMMAXL, INFINITY VISTA

K053484 · Draeger Medical Systems, Inc. · MHX · Feb 22, 2006 · Cardiovascular

Device Facts

• Record ID: K053484
• Device Name: INFINITY GAMMA / GAMMAXL, INFINITY VISTA
• Applicant: Draeger Medical Systems, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Feb 22, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

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, 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 cither directly or via the Infinity network. * not available with the Infinity Vista monitor

Device Story

Infinity Gamma/GammaXL and Vista monitors are physiological patient monitors. Inputs include ECG, invasive/non-invasive pressure, temperature, SpO2, pulse, respiration, and gas concentrations (via Scio module). Device processes signals to provide real-time monitoring, arrhythmia detection, ST segment analysis, and gas measurement (CO2, N2O, O2, anesthetic agents). Outputs are visual/audible alarms, waveform displays, and recordings. Used in clinical environments by trained healthcare professionals to assess patient status and guide clinical decisions. Modifications include Pacer Fusion mode, new Scio gas module versions, and integration of Masimo SET pod. Device connects to R50 recorders directly or via Infinity network. Benefits include continuous patient surveillance and timely notification of parameter deviations.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Physiological patient monitor. Components include Scio gas module and Masimo SET pod. Connectivity via Infinity network or direct to R50 recorders. Software-based monitoring of vital signs and arrhythmia. Not MRI compatible.

Indications for Use

Indicated for monitoring heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, SpO2, pulse rate, central apnea, end-tidal CO2, and ST segment analysis in adult, pediatric, and neonatal populations. Arrhythmia and ST segment analysis are contraindicated for neonates. Intended for use by trained healthcare professionals (physicians, nurses, technicians) in clinical settings.

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

• Infinity Gamma Series & Vista with VF5 (K042656)
• Infinity GammaXL & SC 6802XL with Scio (K033600)
• Infinity Gamma (K040188)
• Infinity Gamma (K041087)

Submission Summary (Full Text)

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KO5348(

## Special 510(k) Infinity Gamma Series VF6 Modifications

FEB 2 2 2006

### 510(k) SUMMARY

as required per 807.92(c)

| | Submitter's Name and Address: | Draeger Medical Systems, Inc.<br>16 Electronics Avenue<br>Danvers, MA 01923 | |
|-------------------------------|-------------------------------|--------------------------------------------------------------------------------|----------|
| Contact Person: | | Karen A. Iorio<br>Director QA/RA<br>Tel: [phone]<br>Fax: [phone] | |
| Date submission was prepared: | | December 2, 2005 | |
| Device Name: | Common Name: | Monitor, Physiological, Patient<br>(with arrhythmia detection or alarms) | |
| | Classification Name: | MHX | |
| | Regulation Number: | 21 CFR 870.1025 | Class: 2 |

Legally Marketed Device Identification: - Infinity Gamma Series Monitors

#### Device Description:

The intent of this 510(k) is to describe modifications for the Infinity Gamma/GammaXL and Vista monitors, including Pacer Fusion mode, three new versions of the Scio gas module, and Draeger's Masimo SET pod.

#### 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, 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 cither directly or via the Infinity network.

* not available with the Infinity Vista monitor

#### Predicate Devices:

Infinity Gamma Series & Vista with VF5 Infinity GammaXL & SC 6802XL with Scio Infinity Gamma

K042656 K033600, K040188 K041087

#### Substantial Equivalence:

Verification and validation testing performed indicates that the modifications implemented in the VF6 release of the Gamma series monitors are as safe and effective as previous versions and have not altered the fundamental technology of the device(s).

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## COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: [phone] Fax: [phone]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2006

Draeger Medical Systems, Inc. c/o Ms. Karen A. Iorio Director, QA/RA 16 Electronics Ave. Danvers, MA 01923

Re: K053484

.

K055464
Trade Name: Infinity Gamma / GammaXL, Infinity Vista Regulation Number: 21 CFR 870.1025 Regulation Number: 21 CFN 876.1025
Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: January 25, 2006 Received: January 26, 2006

Dear Ms. Iorio:

We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section JTV(x) premainted is substantially equivalent (for the indications
referenced above and have determined the device is substantially interestate referenced above and nave determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices Mexico. Amendments for use stated in the enclosure) to regally manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment at the Federal Food. Drug commerce prior to May 28, 1970, the chacinene and othe provisions of the Federal Food. Drug, devices that have been reclassified in accordance what as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provinces of the Act . The and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The Act. The Act. The
You may, therefore, market the device, subject to the generation, l You may, therefore, market the device, subject to tirements for annual registration, listing of the general controls provisions of the 7tet merade requires 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 classified (see above) inlove in the major regulations affecting your device can
may be subject to such additional controls. Existing major regal In addi may be subject to such additional controls. Linking may be found in the Code of Federal Tregations, as a seeming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA S Issualice of a subscription with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA nas made a decemmation that your as rest works. The federal agencies. You must

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Page 2 -- Ms. Karen A. Iorio

comply with all the Act's requirements, including, but not limited to: registration and listing (21 Confory with an the 11et 31equirements)01); good manufacturing practice requirements as set CI K Fat 6077; adoling (2 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualis) by world provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

- production of to begin marketing your device as described in your Section 510(k) This letter with and in yourse of substantial equivalence of your device to a legally prematicated predicated. The 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 If you desire specific as not any and [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 other general miormational 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,

B Zimmerman 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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# 510(k) Number (if known): __Ko53484

Device Name: INFINITY Gamma/GammaXL and Vista

Indications for Use:

This devices are capable of monitoring:

- Heart Rate .
- Respiration Rate .
- Invasive Pressure .
- Non-Invasive Pressure .
- Arrhythmia .
- Temperature ◆
- Arterial oxygen saturation .
- Pulse rate �
- central apnea .
- end-tidal CO2* .
- ST Segment Analysis .

This device will produce visual and audible alarms if any of these parameters vary beyond presel linits and I mo do roo alarin recordings. The devices will connect to R50 recorders either directly or via the Infinity network.

When a GammaXL is 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 anestheic agents, Halothane, Isoflurane, Enflurane, Sevoflurane in any mixture and communicates real time and derived gas information to the GammaXL.

The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of 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 neonatal population.

* not available with Infinity Vista

#### MRI Compatibility Statement:

The devices are not compatible for use in an MRI magnetic field.

) Prescription Use __ (Per 21 CFR 801.109) ાર

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bummunma
Sign-On

Division of Cardiovascular Devices
510(k) Number K053484

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