INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS

K060039 · Draeger Medical Systems, Inc. · MHX · Apr 12, 2006 · Cardiovascular

Device Facts

• Record ID: K060039
• Device Name: INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS
• Applicant: Draeger Medical Systems, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Apr 12, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Infinity Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices will connect to R50 recorders, either directly or via the Infinity Network.

Device Story

Infinity Delta and Kappa series monitors provide multi-parameter physiological monitoring; inputs include ECG, respiratory gases (CO2, N2O, O2, anesthetic agents), and other physiological signals via pods/modules. System processes inputs to provide real-time data, derived gas information, and alarm triggers. Modifications include Pacer Fusion mode, Age-Based MAC, and support for BisX, tpO2, and FiO2 in Kappa XLT. Used in clinical environments by physicians, nurses, and technicians. Output displayed on monitor; used for clinical decision-making regarding patient status. Benefits include continuous monitoring and automated alarm notification for patient safety.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation testing performed to confirm safety and effectiveness of VF6 modifications.

Technological Characteristics

Modular patient monitoring system. Supports gas modules (Scio/MultiGas) for CO2, N2O, O2, and anesthetic agents. Connectivity via Infinity Network and MIB protocol converter. Features include Pacer Fusion mode, Age-Based MAC, and support for BisX and tpO2 pods. Not MRI compatible.

Indications for Use

Indicated for multi-parameter monitoring of adult, pediatric, and neonatal patients by healthcare professionals. Cardiac output, ST segment analysis, and arrhythmia detection are indicated for adult and pediatric patients only. tcpO2 monitoring is indicated for neonatal patients not under gas anesthesia. Gas modules (Scio/MultiGas) are indicated for adult and pediatric patients.

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 Kappa XLT (K053484)

Reference Devices

• Infinity Delta and Kappa Series Monitors (K043439)
• Infinity MIB (K042904)
• Infinity Gamma/Gamma XL (K050974)

Submission Summary (Full Text)

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**A Dräger and Siemens Company**

APR 1 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: | Thomas M. McIntosh<br>Regulatory Submissons Manager<br>Tel: [phone]<br>Fax: [phone] | |
| Date submission was prepared: | January 2, 2006 | |
| 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 Delta and Kappa<br>Series Monitors | |

### Device Description:

The intent of this 510(k) is to describe modifications for the Infinity Delta and Kappa series monitors (Delta, Delta XL, Kappa,, Vista XL, Gamma X XL, and Kappa XLT), including Pacer Fusion mode and Age-Based MAC. Kappa XLT now supports the BisX and tpO2 pods, and FiO2.

# Intended Use:

The Infinity Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices will connect to R50 recorders, either directly or via the Infinity Network.

### Predicate Devices:

Infinity Modular Monitors Infinity Kappa XLT Infinity MIB Infinity Gamma/Gamma XL

K043439 (Prior cleared submission K042904 (Prior cleared submission) K050974 (Prior cleared submission) K053484 - Predicate device

# Substantial Equivalence:

Verification and validation testing performed indicates that the VF6 modifications described are as safe and effective as previous versions and have not altered the fundamental technology of the device(s).

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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

APR 1 2 2006

Draeger Medical Systems, Inc. c/o Mr. Thomas M. McIntosh Regulatory Submission Manager 16 Electronics Avenue Danvers, MA 01923

Re: K060039

Trade Name: Infinity Delta and Kappa Series Monitors Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: March 17, 2006 Received: March 20, 2006

Dear Mr. McIntosh:

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. Iisting 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.

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Page 2 - Mr. Thomas M. McIntosh

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,

B/fimmuma 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): K060039

# Device Name: Infinity Delta / Kappa / Delta XL / Gamma X XL / Vista XL and Kappa XLT

Indications For Use:

The Scio and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.

With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored. The monitors can interface with specific third party devices via an MIB protocol converter.

The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, 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 to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.

### MR! Compatibility Statement:

The INFINITY Modular Monitors are not compatible for use in a MRI magnetic field.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blumuma
Division Sign-Off

5100kl Number

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