(90 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on combining existing technologies and software modifications.
No.
The device's stated purpose is to monitor various physiological parameters, not to provide therapy or treatment.
Yes
The device is capable of monitoring several physiological parameters (e.g., Heart Rate, Respiration Rate, Arrhythmia, Temperature), and its intended use section states that healthcare professionals will determine when the use of the device is indicated based on their professional assessment of the patient's medical condition, implying that the data gathered by the device aids in diagnosis or patient management.
No
The device description explicitly states it is a "compact, configured monitor" and mentions "front panel display," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: The description clearly states that this device is a patient monitor capable of monitoring various physiological parameters directly from the patient. These include heart rate, respiration rate, blood pressure (invasive and non-invasive), temperature, oxygen saturation, pulse rate, apnea, and end-tidal CO2. These are all measurements taken in vivo (within the living body).
- Intended Use: The intended use describes monitoring patients in a healthcare setting by healthcare professionals. This aligns with the function of a patient monitor, not an IVD.
Therefore, the INFINITY SC 6002XL is a patient monitoring device, not an in vitro diagnostic device.
No
This letter does not mention any elements of a Predetermined Change Control Plan (PCCP). A PCCP would typically be explicitly stated and outline planned modifications, their impact, and control measures for future changes to the device (often related to AI/ML software). This document describes a traditional device clearance for a new model based on predicate devices.
Intended Use / Indications for 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.
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 .
Product codes (comma separated list FDA assigned to the subject device)
74DRT, 74BWS, 74DQA, 73BZQ, 80BWX, 74CAA, 74DXN, 74FLO, 73FLS, 74FLP, 73CCK, 74DSI, MHX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, Pediatric, Neonatal (with the exception of Arrhythmia which is not intended for the neonatal population)
Intended User / Care Setting
In a healthcare environment where patient care is provided by healthcare professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K980882, K982730, K944350, K962404, K955743
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
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.(b)
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.
0
510(k) Notification INFINITY SC 6002XL Portable Patient Monitor
510(k) SUMMARY
as required per 807.92(c)
Submitters Name, Address:
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 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
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
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: (978) 907-7500 Fax: (978) 750-6879
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: (978) 907-7500 Fax: (978) 750-6879
2
| Manufacturer | Legally Marketed Device
SC 600X
Siemens Medical Systems | Legally Marketed Device
SC 7000
Same | Modified Device
INFINITY SC 6002XL
Same | Explanation of Differences |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The intended use of this device is to
measure heart rate, respiration rate,
invasive pressure, non-invasive
pressure, arrhythmia (adult),
temperature, arterial oxygen
saturation, pulse rate, and (central)
apnea. 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 the Siemens SIRENET or Infinity
(Olympus) network | 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, cardiac output, central apnea,
end-tidal carbon dioxide, ST
segment analysis, 12-Lead ST
segment analysis, and
transcutaneous oxygen &
transcutaneous 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 recorder, either
directly or via the INFINITY
network. | 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, 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. | ST segment analysis, 12-lead ST
segment analysis, transctaneous
oxygen & transcutaneous carbon
dioxide, and cardiac output are not
available. |
| Intended
Population | Adult/Pediatric/Neonatal | Same | Same | |
| Intended
Environment | In a healthcare environment where
patient care is provided by
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
3.22 kg (7.10 lb) with lithium-ion
battery | New mechanical design |
| Dimensions (H x
W x D) | 189 x 225 x 131 mm
(7.4 x 8.9 x 5.2 in.) | 224 x 330 x 190 mm
(8.8 x 13.0 x 7.5 inches) | 196 x 223 x 134 mm
(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: (978) 907-7500 Fax: (978) 750-6879
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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.