INFINITY ALPHA

K051658 · Draeger Medical Systems, Inc. · MHX · Nov 16, 2005 · Cardiovascular

Device Facts

• Record ID: K051658
• Device Name: INFINITY ALPHA
• Applicant: Draeger Medical Systems, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Infinity Alpha is intended for multi-parameter patient monitoring. The device produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced.

Device Story

Infinity Alpha is a lightweight, handheld portable patient monitor; measures heart rate, respiration, invasive/non-invasive blood pressure, arrhythmia, temperature, cardiac output, SpO2, pulse rate, apnea, and ST segment analysis. Device processes physiological signals to display real-time vital signs and continuous trends; triggers visual and audible alarms when parameters exceed preset limits; generates timed or alarm-based recordings. Used in clinical settings by physicians, nurses, and technicians. Healthcare providers use output to assess patient status and make clinical decisions. Benefits include continuous patient surveillance and timely notification of physiological changes.

Clinical Evidence

Clinical performance evaluations indicate the Infinity Alpha is substantially equivalent to the Infinity Delta series monitors. No specific study metrics (e.g., sensitivity, specificity) provided. Bench testing conducted in accordance with IEC 60601-1, IEC 60601-1-2, CISPR11, UL60601-1, and CSA 22.2 No 60601-1.

Technological Characteristics

Handheld portable patient monitor. Parameters: HR, RR, IBP, NIBP, arrhythmia, temp, cardiac output, SpO2, pulse rate, apnea, ST segment analysis. Standards: IEC 60601-1, IEC 60601-1-2 (EMC), CISPR11 Class B, UL60601-1, CSA 22.2 No 60601-1. Not MRI compatible.

Indications for Use

Indicated for multi-parameter monitoring of adult, pediatric, and neonatal patients. Parameters include heart rate, respiration rate, invasive/non-invasive blood pressure, cardiac output, temperature, arterial oxygen saturation, pulse rate, apnea, arrhythmia, and ST segment analysis. Arrhythmia and ST segment analysis are contraindicated for the neonatal population. Intended for use by trained healthcare professionals (physicians, nurses, technicians) in clinical environments. Not MRI compatible.

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 Modular Monitors (K043439)

Reference Devices

• Infinity Delta series monitors

Submission Summary (Full Text)

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K 051658

NOV 1 6 2005

#### 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: | Penelope H. Greco<br>Regulatory Affairs Manager<br>Tel: [phone]<br>Fax: [phone] |
| Date submission was prepared: | June 17, 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 Alpha

# Device Description:

The Infinity Alpha is a light-weight, handheld portable patient monitor that displays real-time vital signs and provides continuous trending. The Infinity Alpha is capable of measuring heart rate, respiration rate, invasive blood pressure, non-invasive blood pressure, arrhythmia, temperature, cardiac output, arterial oxygen saturation, pulse rate, apnea, ST segment analysis, and 12-lead ST segment analysis. The device produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced.

## Intended Use:

The Infinity Alpha is intended for multi-parameter patient monitoring. The device produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced.

| Predicate Devices: | |
|---------------------------|---------|
| Infinity Modular Monitors | K043439 |

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# Substantial Equivalence:

Assessment of non-clinical performance data for equivalence:

The Infinity Alpha Patient Monitor was tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate device.

Assessment of clinical performance data for equivalence:

Clinical performance evaluations indicate that the Infinity Alpha Patient Monitor is substantially equivalent to the Infinity Delta series monitors.

Biocompatability: Not applicable

Sterilization: Not applicable

IEC 60601-1 and applicable and collateral standards Standards and Guidance: IEC 60601-1-2 Electromagnetic Compatibility CISPR11, Class B UL60601-1, CSA 22.2 No 60601-1

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol on the right side. To the left of the symbol, the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol.

NOV 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Draeger Medical Systems, Inc. c/o Ms. Penelope H. Greco Regulatory Affairs Manager 16 Electronics Avenue Danvers, MA 01923

#### Re: K051658

Trade Name: Infiniti Alpha Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: October 14, 2005 Received: October 17, 2005

### 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.

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## Page 2 - Ms. Penelope H. 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 (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,

Blumman 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):

Device Name: InfinityAlpha

Indications for Use:

This device is capable of monitoring heart rate, respiration rate, invasive blood pressure, non-invasive blood pressure, arrhythmia, cardiac output, temperature, arterial oxygen saturation, pulse rate, apnea, ST segment analysis.

Infinity Alpha will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings.

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.

MRI Compatibility Statement: The Infinity Alpha is not compatible for use in a MRI magnetic field.

Prescription Use く (Per 21 CFR 801.109) OR

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)

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Blamimina
Division Sign-Off

(División Sign-Off
Division of Cardiovascular Devices
510(k) Number Ko51458

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