SIEMENS INFINITY SC 6002XL MODIFICATIONS

K030313 · Siemens Medical Solutions USA, Inc. · MHX · Feb 11, 2003 · Cardiovascular

Device Facts

• Record ID: K030313
• Device Name: SIEMENS INFINITY SC 6002XL MODIFICATIONS
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Feb 11, 2003
• 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, noninvasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, central apnea, end-tidal carbon dioxide, and ST Segment Analysis. This device wisual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to Siemens 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.

Device Story

Multi-parameter patient monitor; inputs include physiological signals (ECG, SpO2, NIBP, temperature, CO2, pressure); processes data via software (version VF2) to provide real-time monitoring, arrhythmia detection, and ST segment analysis; outputs visual/audible alarms and recordings; used in clinical settings by physicians, nurses, and technicians; connects to Siemens R50 recorders or INFINITY network; supports Masimo and Nellcor SpO2 sensors; features 802.11 wireless encryption; provides clinicians with continuous patient status updates to facilitate timely clinical intervention.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Patient monitor with 6.5 or 8-inch display; supports Nellcor and Masimo SpO2 sensors; NIBP uses oscillometric method with stepped deflation; 802.11 wireless encryption; software-based parameter monitoring and alarm generation; not MRI compatible.

Indications for Use

Indicated for monitoring heart rate, respiration, invasive/non-invasive pressure, arrhythmia, temperature, SpO2, pulse rate, central apnea, end-tidal CO2, and ST segment analysis in adult, pediatric, and neonatal patients. Arrhythmia and ST segment analysis are contraindicated for neonates.

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

• Siemens INFINITY SC 6002XL (K993974)
• Siemens INFINITY SC 6002XL (K002105)
• Siemens INFINITY SC 6002XL (K020144)

Submission Summary (Full Text)

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# 1. 510(k) SUMMARY

as required per 807.92(c)

FEB 1 1 2003

Submitters Name, Address:

Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS 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: January 29, 2003

Trade Name, Common Name and Classification Name:

Trade Name:

Siemens INFINITY SC 6002XL Series Modifications

Common Name, Classification Name, Class and Regulation Number:

| Common Name | Product Code | Class | Regulation Number |
|--------------------------------------------------------------------------|--------------|-------|-------------------|
| Monitor, Physiological, Patient (with<br>Arrhythmia Detection or Alarms) | MHX | III | 870.1025 |
| Arrhythmia Detector & Alarm | 74DSI | III | 870.1025 |
| System, Network and Communication,<br>Physiological Monitors | MSX | II | 870.2300 |

Legally Marketed Device:

Siemens INFINITY SC 6002XL K993974, K002105, K020144

Description of Device Modifications:

Non-Invasive Blood Pressure

The Infinity SC 6002XL / SC 6802XL utilize the oscillometric method to measure noninvasive blood pressure (NIBP). With the release of software version VF2, the NIBP algorithm has changed from a linear to a stepped deflation system.

SpO2 Masimo Sensor Support

The SC 6002XL VF2 release includes the support of Masimo sensors in addition to Nellcor sensors already available. Users now have the ability to choose locked options for use of either Nellcor or Masimo sensors.

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Siemens Medical Solutions, USA

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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K030313
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### Display size

Customers can now choose either the current 6.5 inch display or a new 8-inch display. The 8inch display has the same configuration and layout as the 6.5-inch display. Current SC 6002XL customers have the ability to upgrade from their present 6.5-inch screen to the new 8-inch display.

WEP Wireless Security

To support secure wireless network communication, wireless encryption that complies with 802.11 has been added

#### Intended Use:

The intended use of this device is to monitor heart rate, respiration rate, invasive pressure, noninvasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, central apnea, end-tidal carbon dioxide, and ST Segment Analysis. This device wisual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to Siemens R50 recorders, either directly or via the INFINITY network.

Assessment of non-clinical performance data for equivalence: Section L

Assessment of clinical performance data for equivalence: Not applicable

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidances: See Section J

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Siemens Medical Solutions, USA Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three lines forming its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circumference of the circle.

FEB 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Siemens Medical Solutions USA, Inc. c/o Ms. Penelope H. Greco Manager, Regulatory Submissions Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923

Re: K030313

Trade Name: Siemens INFINITY SC 6002XL/SC 6802XL Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: January 29, 2003 Received: January 30, 2003

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/dsma/dsmamain.html

Sincerely yours.

Dallas Tich

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: Siemens INFINITY SC 6002XL / SC 6802XL

Indications for Use:

This device is 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 preset limits and produce timed or alarm recordings. This device will connect to Siemens R50 recorders, either directly or via the INFINITY network.

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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 Siemens INFINITY SC 6002XL / SC 6802XL are not compatible for use in a MRI magnetic field.

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|------------------------------------------|-----------------------------------------------------------|--------------------------------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
| | (Division Sign-Off)<br>Division of Cardiovascular Devices | |
| 510(k) Number | K030313 | |