(30 days)
No
The document describes standard patient monitoring functions and network connectivity without mentioning AI or ML. The arrhythmia analysis is referred to as an "algorithm," which in this context likely refers to a deterministic rule-based system, not a machine learning model.
No
The device is described as capable of monitoring various physiological parameters and producing alarms. Its intended use is for patient monitoring and assisting healthcare professionals in assessing a patient's medical condition, not for treatment or therapy.
Yes
Explanation: The device monitors various physiological parameters such as heart rate, respiration rate, arrhythmia, and temperature, and produces alarms when these parameters vary beyond preset limits. This continuous monitoring and alerting for physiological changes are primary functions of a diagnostic device, aiding healthcare professionals in assessing a patient's medical condition. The "Intended Use" explicitly states that healthcare professionals will "make the final assessment of the patient's medical condition" based on the information provided by the device.
No
The device description explicitly mentions hardware components like a "wireless ethernet adapter installed in the PCMCIA port" and communication with "installed access points hardwired to the network." It also refers to patient monitors (SC 6002XL, SC 7000, SC 8000, SC 9000XL) which are hardware devices.
Based on the provided text, 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.
- Device Function: The description clearly states the device monitors physiological parameters directly from the patient (Heart Rate, Respiration Rate, Pressure, Temperature, Oxygen Saturation, etc.). It does not process samples taken from the body.
- Intended Use: The intended use is for monitoring patients in a healthcare setting and providing real-time data and alarms to healthcare professionals. This is consistent with a patient monitoring device, not an IVD.
The device is a patient monitoring system that gathers data in vivo (within the living body), not in vitro (in glass/outside the body).
N/A
Intended Use / Indications for 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 will produce visual and audible end tidal 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 .
- ST Segment Analysis .
This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed on always were waters Deyond preset mints and proof directly or via the INFINITY network.
Product codes (comma separated list FDA assigned to the subject device)
MHX, 74DSI, MSX
Device Description
SC 6002XL Wireless Option
A wireless ethernet adapter installed in the PCMCIA port communicates with the INFINITY Network (K955059) through installed access points hardwired to the network. All patient related and network data is transmitted to the pre-installed access points allowing the transmitted data from the monitor to be viewed at an assigned MultiView WorkStation (K955059). This configuration provides the network with the same functionality as a hardwired system.
The MultiView WorkStation supports wireless operation by providing information to the SC6002XL allowing the monitor to have a unique network address. Once the SC6002XL has established itself on the network, the MultiView WorkStation has no new functionality. MultiView WorkStation hazards identified with the MVWS support of the wireless functionality have been addressed in MVWS VF2 software.
SC 6002XL with Full Arrhythmia Option
The SC 6002XL VF1 release includes the Full Arrhythmia Option. With this option eight additional arrhythmia calls are enabled. The arrhythmia algorithm is the same algorithm found in Siemens MVWS INFINITY Telemetry (K003179), as well as Siemens patient monitors, including: SC 7000 / SC 9000XL (K980882) and SC 8000 (K983632). Previous releases of the SC 6002XL (K993974 DC 900012 (1196002) the same arrhythmia algorithm, however, in the first two releases of the SC and I would the Basic Arrhythmia functionality, with fewer arrhythmia calls was made available.
Fourth Channel Option
In addition, to provide customers with more readily available information, a fourth channel is being made available. The fourth channel is also a locked option.
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
The devices are intended to be used in the Adult, Pediatric and Neonatal populations, with the exception of the The devices are intended to be ascu in the Raan, I valuational for the neonatal population.
Intended User / Care Setting
The device is intended to be used in the environment where patient care is provided by The device is miended to be used in the environment, and technicans, trained on the use of the Healthcare Froressionals, F.C. pity Sichans, Indicated, based upon their devices, who willement of the patient's medical condition.
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)
Not Found
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.
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.
K955059, K003179, K980882, K983632
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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
FEB 1 5 2002
| 1. 510(k) SUMMARY |
|---|
| as required per 807.92(c) |
| Submitters Name, Address: |
| Siemens Medical Solutions, Inc. |
| Electromedical Systems Group, PCS |
| Danvers, MA 01923 |
| Tel: (978) 907-7500 |
| Fax: (978) 750-6879 |
| 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 14, 2002 |
2. Trade Name, Common Name and Classification Name:
- A. Trade Name:
Siemens INFINITY SC 6002XL Modifications
- Common Name, Classification Name, Class and Regulation Number: B.
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Monitor, Physiological, Patient (with | |||
| Arrhythmia Detection or Alarms) | MHX | III | 870.1025 |
| Arrhythmia Detector & Alarm | 74DSI | III | 870.1025 |
| System, Network and Communication, | |||
| Physiological Monitors | MSX |
SC 6002XL Wireless Option
A wireless ethernet adapter installed in the PCMCIA port communicates with the INFINITY Network (K955059) through installed access points hardwired to the network. All patient related and network data is transmitted to the pre-installed access points allowing the transmitted data from the monitor to be viewed at an assigned MultiView WorkStation (K955059). This configuration provides the network with the same functionality as a hardwired system.
The MultiView WorkStation supports wireless operation by providing information to the SC6002XL allowing the monitor to have a unique network address. Once the SC6002XL has established itself on the network, the MultiView WorkStation has no new functionality. MultiView WorkStation hazards identified with the MVWS support of the wireless functionality have been addressed in MVWS VF2 software.
1/2
COMPANY CONFIDENTIAL
Siemens Medical Solutions, USA
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
1
K020144
p. 2/2
SC 6002XL with Full Arrhythmia Option
The SC 6002XL VF1 release includes the Full Arrhythmia Option. With this option eight additional arrhythmia calls are enabled. The arrhythmia algorithm is the same algorithm found in Siemens MVWS INFINITY Telemetry (K003179), as well as Siemens patient monitors, including: SC 7000 / SC 9000XL (K980882) and SC 8000 (K983632). Previous releases of the SC 6002XL (K993974 DC 900012 (1196002) the same arrhythmia algorithm, however, in the first two releases of the SC and I would the Basic Arrhythmia functionality, with fewer arrhythmia calls was made available.
Fourth Channel Option
I ourth Chamer Option
In addition, to provide customers with more readily available information, a fourth channel is being made available. The fourth channel is also a locked option.
5. 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 will produce visual and audible end tidal 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: IEEE 802.11
Standard for Wireless Medium Access Method (MAC) and Physical Layer (PHY)
2/2
COMPANY CONFIDENTIAL
Siemens Medical Solutions, USA Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three parallel, curved lines representing the bird's body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2002
Ms. Penelope H. Greco Manager, Regulatory Submissions Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923
Re: K020144
Trade Name: Siemens Medical INFINITY SC 6002XL (VF1) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector & Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: January 14, 2002 Received: January 16, 2002
Dear Ms. Greco:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamined the device is substantially equivalent (for the indications ferenced above und nave acterimes ally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Americans, or to connicted proc to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, de necs that have been recassion at require approval of a premarket approval application (PMA). and Cosmeter roc (110) that as nov co, subject to the general controls provisions of the Act. The Tou may, dicrorere, mains of the Act include requirements for annual registration, listing of general controls provisions wastice, 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 If your device is elassified (soc as words. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of the may be subject to back address soulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Penelope H. Greco
Please be advised that FDA's issuance of a substantial equivalence determination does not mean
ts of the Active in the start the see device complies with other requirements o Please be advised that FDA's issuance of a substantial equires with other requirements of the Act
that FDA has made a determination that your device complies with other requi that FDA has made a determination inal your divres on other Federal agencies. You must
or any Federal statutes and regulations administered by other Federal on and listin or any Federal statutes and regulations and limited to: registration and listing (21
comply with all the Act's requirements, including, but not tice requirements as set comply with all the Act's requirements, including, out morning practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirement CFR Part 807); labeling (21 CFK Part 801); good manufacture policable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the e forth in the quality systems (QS) regulation (21 CFR Part obs) and 11 TT
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)
The are and the many on the time of rubstantial equivalence of your device to a This letter will allow you to begin marketing your ucvice of your device of your device to a legally
premarket notification. The FDA in a los if section for senits your devi premarket notification. The FDA finding of substantal equivalence by -------------------------------------------------------------------------------------------------------to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your devices on on ademing copy.es contact the Office of
additionally 21 CFR Part 809.10 for in vites diagnostic devices on the promotion an additionally 21 CFR Part 809. ID for m Wird unserved by promotion and advertising of
Compliance at (301) 594-464. Additionally, for questions on the promotion and advertisin Compliance at (301) 594-4646. Additionally, 10. questions of G44-4639. Also, please note the your device, please contact the Office of Complanse are a potification" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket not may be obtained f regulation entitled, "Misbranding of responsibilities under the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at its t Division of Sman Manazassassa or at its Internet address (600) 030x . fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): ٻک کان کا
Device Name: Siemens INFINITY SC 6002XL Modifications
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 This device will produce visual and adding arm recordings. This device will connect to
beyond preset limits and produce timed on always were waters Deyond preset mints and proof directly or via the INFINITY network.
The device is intended to be used in the environment where patient care is provided by The device is miended to be used in the environment, and technicans, trained on the use of the Healthcare Froressionals, F.C. pity Sichans, Indicated, based upon their devices, who willement of the patient's medical condition.
The devices are intended to be used in the Adult, Pediatric and Neonatal populations, with the exception of the The devices are intended to be ascu in the Raan, I valuational for the neonatal population.
MRI Compatibility Statement:
MRI Compatibunty 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 | OR | Over-The-Counter Use ______ | |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | ||
| Division of Cardiovascular & Respiratory Devices | |||
| 510(k) Number | K200444 |
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