INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL

K033957 · Draeger Medical Systems, Inc. · MHX · May 14, 2004 · Cardiovascular

Device Facts

• Record ID: K033957
• Device Name: INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL
• Applicant: Draeger Medical Systems, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: May 14, 2004
• 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 an R50 Bedside recorder, either directly or via the INFINITY Network.

Device Story

INFINITY Modular Monitors are multi-parameter patient monitoring systems used by physicians, nurses, and technicians in clinical environments. The system collects physiological data including ECG (arrhythmia/ST segment), pressure, temperature, cardiac output, SpO2, EEG, and respiratory gases via the Scio module. The Scio module samples breathing gases (CO2, N2O, O2, anesthetic agents) from adult and pediatric patients, providing real-time and derived gas information. The VF4 software update specifically enables dual-anesthetic agent display. The device processes these inputs to provide continuous monitoring, visual/audible alarms for out-of-limit parameters, and data recording. It interfaces with bedside recorders and the INFINITY network. Healthcare providers use the displayed data to assess patient status and make clinical decisions. The device benefits patients by providing continuous surveillance of vital signs and respiratory status, facilitating timely intervention.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing of the VF4 software and hardware modifications confirmed safety and efficacy.

Technological Characteristics

Multi-parameter physiological monitor. Software-based (VF4 release). Connectivity via INFINITY Network and MIB protocol converter. Supports Scio gas module for continuous gas sampling (CO2, N2O, O2, anesthetic agents). Not MRI compatible.

Indications for Use

Indicated for multi-parameter monitoring of adult, pediatric, and neonatal patients. Parameters include heart rate, respiration, invasive/non-invasive pressure, arrhythmia, temperature, cardiac output, SpO2, pulse rate, apnea, ST segment analysis, 12-lead ST segment analysis, tcPO2/tcPCO2, EEG, FiO2, and respiratory gases (CO2, N2O, O2, anesthetic agents). ST segment and arrhythmia analysis are for adult use only; tcPO2/tcPCO2 is for neonatal use only (not under gas anesthesia). Used by healthcare professionals 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 Modular Monitors with Scio (K031340)
• INFINITY SC 8000 Monitor (K983632 / K990563)
• INFINITY SC 7000 / SC 9000XL Modular Monitors (K031340, K003243/K982730/ K980882)

Submission Summary (Full Text)

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K033957

#### Special 510(k) Notification INFINITY Modular Monitors VF4 Modifications with Scio

# MAY 1 4 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 Date submission was prepared: May 13, 2004

Trade Name, Common Name and Classification Name:

- A. Trade Name:
INFINITY Modular Monitors

- B. Common Name, Classification Name, Class and Regulation Number:

| Common Name | Product Code | Class | Regulation Number |
|-----------------------------------------------------------------------------|--------------|-------|-------------------|
| Monitor, Physiological, Patient<br>(with arrhythmia detection or<br>alarms) | MHX | II | 21 CFR 870.1025 |
| Arrhythmia detector & Alarm | 74DSI | II | 21 CFR 870.1025 |

Legally Marketed Device Identification:

INFINITY Modular Monitors with Scio K031340 INFINITY SC 8000 Monitor, K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, K031340, K003243/K982730/ K980882

Description of Modification:

The INFINITY Modular monitor VF4 software release includes a modification in support of the Scio gas module for dual-anesthetic agent display.

Testing in accordance with internal design control procedures has verified that the INFINITY Modular Monitors VF4 modifications with Scio are as safe and effective as the previous released versions of the monitors.

#### 1 of 2

Draeger Medical Systems, Inc.

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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### Special 510(k) Notification INFINITY Modular Monitors VF4 Modifications with Scio

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 an R50 Bedside recorder, either directly or via the INFINITY Network.

Assessment of non-clinical performance data for equivalence:

Verification and validation testing of VF4 software, as well as testing applicable to the hardware modifications for the new Draeger look indicate no new issues relative to safety and efficacy.

Assessment of clinical performance data for equivalence: Not applicable

Biocompatability: Not applicable

Sterilization: Not applicable

IEEE 802.11 Standards and Guidances: Reviewer Guidance for Premarket Notification 510(k) Submissions, November 1993

Draeger Medical Systems, Inc.

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three stylized human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2004

Ms. Penelope H. Greco Regulatory Submissions Manager Siemens Medical Solutions USA, Incorporated 16 Electronics Avenue Danvers, MA 01923

Re: K033957

Trade Name: INFINITY Modular Monitors VF4 Modifications with Scio Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor, (W/ Arrhythmia Detection or Alarms) Regulatory Class: II Product Code: MHX Dated: April 14, 2004 Received: April 15, 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 adultcration.

If your device is classified (sec 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 Please be advised that I DT 5 issualled on that your device complies with other requirements mean that ITDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal statues and regirements, including, but not limited to: registration You must comply with an the Fee o required (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Part 007), labeling (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality ison 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) This letter will anow you to begal mading of substantial equivalence of your device to a premarket notification. - The PD Printers 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), If you desire specific advice for your as 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 Inay obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Driston 01 01 01638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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## Indications for Use

510(k) Number (if known): Device Name:____ INFINITY Modular Monitors

Indications for Use:

The INFINITY Modular monitors are capable of monitoring:

- Heart rate .
- Respiration rate .
- Invasive pressure .
- Non-invasive pressure .
- Arrhythmia .
- Temperature .
- Cardiac output .
- Arterial oxygen saturation .
- Pulse rate .
- Apnea .
- ST Segment Analysis ●
- 12-Lead ST Segment Analysis �
- tcn02/tcp(02 .
- EEG signals .
- FiQ2 .

The SCIO and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas I he octo and ivalitious mancedo internet of CO2, NO, O2 and one of the anesthetic agents, halothane, inoduces continuously mousal rane 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 with etCO2 and instream 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 The devices are intended to ot Segment Analysis, and arrhythmia which are intended for use in the adult purameter Cardial Galph, and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.

#### MRI Compatibility Statement:

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

Prescription Use_Y (Per 21 CFR 801.109) OR

Over-The-Counter Use_

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Concurrence of CDRH, Office of Device Evaluation (ODE

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