SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR

K993974 · Siemens Medical Solutions USA, Inc. · MHX · Feb 22, 2000 · Cardiovascular

Device Facts

• Record ID: K993974
• Device Name: SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Feb 22, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of the SC 6002XL is substantially equivalent to that of the predicate devices in that it monitors heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, central apnea, and end-tidal carbon dioxide. 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.

Device Story

The INFINITY SC 6002XL is a portable, configured patient monitor combining technologies from the SC 600X and SC 7000 series. It accepts physiological inputs including ECG (heart rate/arrhythmia), respiration, invasive/non-invasive blood pressure, temperature, SpO2, pulse rate, and end-tidal CO2. The device processes these signals to provide real-time monitoring, visual/audible alarms for limit violations, and data recording. It is designed for use in clinical environments by trained healthcare professionals. The device features a 6.7-inch color TFT display and a compact, portable form factor. Output is viewed directly on the monitor or via the INFINITY network/R50 recorders. By providing continuous physiological surveillance and alerting clinicians to parameter deviations, the device supports timely clinical decision-making and patient management.

Clinical Evidence

Bench testing and A/B clinical performance tests were conducted comparing the INFINITY SC 6002XL to the SC 7000 predicate. In-house verification and validation testing confirmed the device is as safe and effective as the predicate devices. No specific clinical trial data or statistical metrics (e.g., sensitivity/specificity) were provided in the summary.

Technological Characteristics

Compact, portable patient monitor with 6.7-inch color TFT display. Measures physiological parameters via standard sensors. Connectivity via INFINITY network or direct connection to R50 recorders. Powered by lead-acid or lithium-ion batteries. Software-based monitoring and alarm system. No sterilization required (non-invasive).

Indications for Use

Indicated for adult, pediatric, and neonatal patient populations requiring monitoring of heart rate, respiration rate, invasive/non-invasive pressure, temperature, arterial oxygen saturation, pulse rate, central apnea, and end-tidal CO2. Arrhythmia monitoring is indicated for adult and pediatric populations only, not neonates. 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

• SC 7000 / SC 9000XL INFINITY Modular Bedside Monitor (K980882)
• SC 7000 / SC 9000XL INFINITY Modular Bedside Monitor (K982730)
• SC 6000 / SC 6000P (K944350)
• SC 6000 / SC 6000P Neonatal (K962404)
• SC 6000 / SC 6000P w/Arrhythmia (K955743)

Reference Devices

• MVWS INFINITY Telemetry System Additional Arrhythmia Calls (K983980)
• SC3000 MULTIVIEW WorkStation and Remote Display (K955059)
• INFINITY etCO2 Pod (K992116)

Submission Summary (Full Text)

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

#### 510(k) Notification INFINITY SC 6002XL Portable Patient Monitor

K993974

#### 510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: [phone] Fax: [phone] Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: November 23, 1999

Trade Name, Common Name and Classification Name:

- A. Trade Name: Siemens INFINITY SC 6002XL Portable Patient Monitor
#### B. Common Name, Classification Name, Class and Regulation Number:

| Common Name | Classification<br>Number | Class | Regulation Number |
|--------------------------------------------------------------------------|--------------------------|-------|-------------------|
| Cardiac Monitor | 74DRT | II | 21 CFR 870.2300 |
| Pulse Rate Monitor | 74BWS | II | 21 CFR 870.2300 |
| Pulse Oximeter | 74DQA | II | 21 CFR 870.2700 |
| Breathing Frequency Monitor | 73BZQ | II | 21 CFR 868.2375 |
| Clinical Electronic Thermometer | 80BWX | II | 21 CFR 880.2910 |
| Indwelling Blood Pressure Monitor | 74CAA | II | 21 CFR 870.1110 |
| Noninvasive Blood Pressure Monitor | 74DXN | II | 21 CFR 870.1130 |
| Heart Rate Monitor, Neonatal | 74FLO | II | 21 CFR 870.2300 |
| Ventilatory Effort Monitor (Apnea Detector) | 73FLS | II | 21 CFR 868.2375 |
| Monitor Blood Pressure, Neonatal, Invasive | 74FLP | II | 21 CFR 870.1110 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 73CCK | II | 21 CFR 868.1400 |
| Arrhythmia Detector & Alarm System | 74DSI | III | 21 CFR 870.1025 |
| Monitor, Physiological, Patient (with arrhythmia<br>detection or alarms) | MHX | III | 21 CFR 870.1025 |

Predicate Device Identification:

| K980882 | SC 7000 / SC 9000XL INFINITY Modular Bedside Monitor |
|----------------------------|------------------------------------------------------------|
| K982730 | SC 7000 / SC 9000XL INFINITY Modular Bedside Monitor |
| K944350 | SC 6000 / SC 6000P |
| K962404 | SC 6000 / SC 6000P Neonatal |
| K955743 | SC 6000 / SC 6000P w/Arrhythmia |
| Other relevant submissions | |
| K983980 | MVWS INFINITY Telemetry System Additional Arrhythmia Calls |
| K955059 | SC3000 MULTIVIEW WorkStation and Remote Display |
| K992116 | INFINITY etCO2 Pod |

#### -

#### COMPANY CONFIDENTIAL

# Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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

### 510(k) Notification INFINITY SC 6002XL Portable Patient Monitor

#### Device Description:

The INFINITY SC 6002XL is an addition to Siemens INFINITY patient monitoring series that has combined the technologies of two predicate devices: the INFINITY SC 600X and the INFINITY SC 7000. Like the SC 600X the INFINITY SC 6002XL is a compact, configured monitor whose small size allows for ease of portability. Modifications have been made to the SC 600X software to make it more analogous to the SC 7000 platform. The front panel display is similar in design to the SC 7000 for a more uniform look to the INFINITY product line. In addition to A/B clinical performance tests that compared the new INFINITY SC 6002XL to the SC 7000, in-house verification and validation tests were performed. All tests confirmed that the new INFINITY SC 6002XL is as safe and effective as the predicate devices.

#### Intended Use:

The intended use of the SC 6002XL is substantially equivalent to that of the predicate devices in that it monitors heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, central apnea, and end-tidal carbon dioxide. 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.

Assessment of non-clinical performance data for equivalence: Substantially equivalent (Section U)

Assessment of clinical performance data for equivalence: Substantially equivalent (Section V)

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidance: Section S

COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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

| Manufacturer | Legally Marketed Device<br>SC 600X<br>Siemens Medical Systems | Legally Marketed Device<br>SC 7000<br>Same | Modified Device<br>INFINITY SC 6002XL<br>Same | Explanation of Differences |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The intended use of this device is to<br>measure heart rate, respiration rate,<br>invasive pressure, non-invasive<br>pressure, arrhythmia (adult),<br>temperature, arterial oxygen<br>saturation, pulse rate, and (central)<br>apnea. This device will produce<br>visual and audible alarms if any of<br>these parameters vary beyond preset<br>limits and produce timed or alarm<br>recordings. This device will connect<br>to the Siemens SIRENET or Infinity<br>(Olympus) network | The intended use of this device is to<br>monitor heart rate, respiration rate,<br>invasive pressure, non-invasive<br>pressure, arrhythmia, temperature,<br>arterial oxygen saturation and pulse<br>rate, cardiac output, central apnea,<br>end-tidal carbon dioxide, ST<br>segment analysis, 12-Lead ST<br>segment analysis, and<br>transcutaneous oxygen &<br>transcutaneous carbon dioxide. This<br>device will produce visual and<br>audible alarms if any of these<br>parameters vary beyond preset limits<br>and produce timed or alarm<br>recordings. This device will connect<br>to Siemens R50 recorder, either<br>directly or via the INFINITY<br>network. | The intended use of this device is to<br>monitor heart rate, respiration rate,<br>invasive pressure, non-invasive<br>pressure, arrhythmia, temperature,<br>arterial oxygen saturation and pulse rate,<br>central apnea, end-tidal carbon dioxide.<br>This device will produce visual and<br>audible alarms if any of these<br>parameters vary beyond preset limits<br>and produce timed or alarm recordings.<br>This device will connect to Siemens<br>R50 recorders, either directly or via the<br>INFINITY network. | ST segment analysis, 12-lead ST<br>segment analysis, transctaneous<br>oxygen & transcutaneous carbon<br>dioxide, and cardiac output are not<br>available. |
| Intended<br>Population | Adult/Pediatric/Neonatal | Same | Same | |
| Intended<br>Environment | In a healthcare environment where<br>patient care is provided by<br>healthcare professionals. | Same | Same | |
| Display type | Color TFT, 6" diagonal | Color TFT, 10.4" diagonal | Color TFT, 6.7" diagonal | New mechanical design |
| Weight | 2.9 kg (6.63 lb) with battery | 7.2 kg (15.9 lbs) with battery | 3.42 kg (7.54 lb) with lead-acid battery<br>3.22 kg (7.10 lb) with lithium-ion<br>battery | New mechanical design |
| Dimensions (H x<br>W x D) | 189 x 225 x 131 mm<br>(7.4 x 8.9 x 5.2 in.) | 224 x 330 x 190 mm<br>(8.8 x 13.0 x 7.5 inches) | 196 x 223 x 134 mm<br>(7.7 x 9.8 x 5.3 inches) | New mechanical design |

# Table of Device Similarities and differences to legally marketed device

# COMPANY CONFIDENTIAL

# Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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

Image /page/3/Picture/1 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the edge of the logo. In the center of the logo is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 2 2 2000

Mr. David Simard Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923

Re: K993974 INFINITY SC 6002XL Portable Patient Monitor Regulatory Class: III (three) Product Code: 74 MHX, MSX Dated: November 23, 1999 November 24, 1999 Received:

Dear Mr. Simard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2 - Mr. David Simard

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Zita for
Written

Witten, Ph.D., M.D. Celia M. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

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

Siemens INFINITY SC 6002XL Portable Patient Monitor Device Name:

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 .

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 to be used on Adult. Pediatric and Neonatal populations, with the exception of Arrhythmia which is not intended for the neonatal population.

MRI Compatibility Statement:

The Siemens INFINITY SC 6002XL is 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 (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

2/22/00

(Division Sign-Off) Division of Cardiovascu = Respiratory, and Neurological Devices

510(k) Number.