INFINITY GAMMA

K041087 · Draeger Medical Systems, Inc. · MHX · May 12, 2004 · Cardiovascular

Device Facts

• Record ID: K041087
• Device Name: INFINITY GAMMA
• Applicant: Draeger Medical Systems, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: May 12, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• 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.

Device Story

The INFINITY Gamma is a physiological patient monitor designed for clinical environments. It acquires patient data including heart rate, respiration rate, invasive/non-invasive pressure, temperature, SpO2, pulse rate, end-tidal CO2, and ECG signals for arrhythmia and ST segment analysis. Impedance plethysmography is used for central apnea detection; capnography for apnea detection. The device processes these inputs to provide real-time monitoring, visual/audible alarms for parameter limit violations, and timed/alarm recordings. It supports connectivity to R50 recorders directly or via the INFINITY network. Operated by trained healthcare professionals, the device assists in clinical decision-making by providing continuous patient status updates. It is a smaller form-factor version of the predicate INFINITY GammaXL, maintaining the same user interface, menu structure, and core monitoring capabilities.

Clinical Evidence

No clinical data. Bench testing performed in accordance with internal design control procedures verified equivalence to the predicate device.

Technological Characteristics

Physiological monitor; dimensions reduced compared to predicate. Connectivity via INFINITY network or direct to R50 recorders. Complies with IEC 60601-1. Features visual/audible alarm system (red/yellow indicators).

Indications for Use

Indicated for adult, pediatric, and neonatal patient populations for monitoring of physiological parameters. Arrhythmia and ST Segment Analysis are contraindicated for the neonatal population. 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 GAMMAXL (K033600)

Submission Summary (Full Text)

{0}------------------------------------------------

MAY 1 2 2004

#### 510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

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: April 23, 2004

Trade Name, Common Name and Classification Name:

Trade Name: INFINITY Gamma

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

| Common Name | Product Code | Class | Regulation<br>Number |
|--------------------------------------------------------------------------|--------------|-------|----------------------|
| Monitor, Physiological, Patient (with<br>Arrhythmia 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:

K033600 INFINITY GAMMAXL

### Description of Device Modifications:

The INFINITY Gamma, like the INFINITY GammaXL, supports the "look and feel" of the Draeger Medical product line, including the Draeger logo, colors, menu structure, and physical form. The Infinity Gamma also has an alarm at the top center that illuminates in red or yellow for the purpose of displaying both life threatening and serious alarms respectively. The primary difference between the INFINITY GammaXL and the new INFINITY Gamma is the smaller size.

Page 1 of 2

Draeger Medical Systems, Inc.

r

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

{1}------------------------------------------------

# Special 510(k): Device Modification INFINITY Gamma

#### 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:

Testing in accordance with internal design control procedures has verified that the INFINITY Gamma is as safe and effective as the INFINITY GammaXL as submitted in 510(k) K033600.

Assessment of clinical performance data for equivalence: Not applicable

Biocompatability: Not applicable

Sterilization: Not applicable

Standards: IEC 60601-1

Draeger Medical Systems, Inc.

द

er

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

{2}------------------------------------------------

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 depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 2004

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

Re: K041087

Trade Name: INFINITY Gamma Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: II (two) Product Code: MHX Dated: April 23, 2004 Received: April 26, 2004

Dear Ms. Greco :

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became i re(i) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the citilosure) to regars and in the Medical Device Amendments, or to commerce phor to May 20, 1977, are accordance with the provisions of the Federal Food, DNIg, de necs that have been require approval of a premarket approval application (PMA). alla Cosmetic Act (71ct) that do not required to the general controls provisions of the Act. The r ou may, therefore, mainer the we let include requirements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is clussinod (itso at controls. Existing major regulations affecting your device can inay be subject to suell additions, Title 21, Parts 800 to 898. In addition, FDA may ou lound in the Overning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean r lease of a rised that i ermination that your device complies with other requirements of the Act

{3}------------------------------------------------

# Page 2 – Ms. Penelope Greco

or any Federal statutes and regulations administered by other Federal agencies. You must of ally it catal statutes and regaranents, including, but not limited to: registration and listing (21 Compry with an the Her STequirements, n.i., good manufacturing practice requirements as set CFR in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by techno (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control provisions (Seeting your device as described in your Section 510(k) This letter with anow you to begin mailiers of substantial equivalence of your device to a legally premits that in the 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 If you desire specific advice for your act [phone]. Also, please note the regulation entitled, Contiact the Ories of Company of Company (21CFR Part 807.97). You may obtain Misoranums by reference to premainonsibilities under the Act from the Division of Small other general mionmation on your response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dara R. Vachner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# 510(k) Number (if known):_K041087

#### Device Name: INFINITY Gamma

This device is capable of monitoring:

- Heart Rate .
- . Respiration Rate
- Invasive Pressure .
- Non-Invasive Pressure .
- Arrhythmia .
- Temperature .
- Arterial oxygen saturation .
- . Pulse rate
- central apnea (accomplished through impedance plethysmography) .
- apnea (accomplished through capnograpy) .
- end-tidal CO2 .
- ST Segment Analysis .

This Infinity Gamma 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.

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 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 Gamma is not compatible for use in a MRI magnetic field.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Page 1 of 1

D. Vochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K041087