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.

The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, e.g., Physicians, Nurses, and technicians, trained on the use of the devices, who will make the final assessment of the patient's medical condition.

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.

AI/ML Overview

The provided document is a 510(k) summary for the Siemens INFINITY SC 6002XL Modifications. It details the device, its intended use, and indicates the basis for its substantial equivalence determination to previously marketed predicate devices. However, it does not include detailed information about specific acceptance criteria, a study proving performance against those criteria, or the methodology (like ground truth establishment, sample sizes for training/testing, or expert qualifications) that would typically be found in a clinical or performance study report.

Here's a breakdown of the information that can be extracted and, crucially, what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the given document. The document states "Assessment of non-clinical performance data for equivalence: Section L" but does not elaborate on the specific criteria or the results of this assessment. For clinical performance, it explicitly states "Assessment of clinical performance data for equivalence: Not applicable."

2. Sample size used for the test set and the data provenance:

This information is not provided. Since no clinical performance study is described, there's no mention of a test set, its sample size, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. As no clinical performance study is described with a test set, there is no mention of experts or their qualifications for establishing ground truth.

4. Adjudication method for the test set:

This information is not provided. Since no test set is described, there is no adjudication method mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided. The document makes no mention of an MRMC study or any AI assistance. The device is a physiological monitor, not an AI-driven image interpretation or diagnostic aid that would typically involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not explicitly stated as a standalone performance study in the document. The document refers to the arrhythmia algorithm being "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)." This implies that the algorithm's performance was evaluated in the context of those previous submissions, but documentation for that specific evaluation is not part of this 510(k) summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided for any specific study in this document.

8. The sample size for the training set:

This information is not provided. The document does not describe a training set as it pertains to an AI/ML algorithm being developed or refined.

9. How the ground truth for the training set was established:

This information is not provided.

Summary of what the document does provide regarding the device's basis for market clearance:

The document focuses on demonstrating substantial equivalence to previously cleared devices (predicates) rather than providing a detailed de novo clinical performance study report.

Predicate Device: Siemens INFINITY SC 6002XL (K993974, K002105) and the arrhythmia algorithm from Siemens MVWS INFINITY Telemetry (K003179) and other Siemens patient monitors (SC 7000/SC 9000XL K980882, SC 8000 K983632).
Modifications: The 510(k) submission addresses modifications to the existing INFINITY SC 6002XL, specifically:
- Wireless Option: Adding a wireless ethernet adapter for network connectivity. The functionality is stated to be "the same functionality as a hardwired system."
- Full Arrhythmia Option: Enabling eight additional arrhythmia calls using an existing, previously cleared arrhythmia algorithm found in other Siemens devices.
- Fourth Channel Option: Providing a fourth channel of information.
Assessment of Equivalence:
- Non-clinical performance data: Referenced as "Section L," but details are not provided in this summary.
- Clinical performance data: Stated as "Not applicable," indicating that for these specific modifications, new clinical data was not deemed necessary by the submitter to demonstrate substantial equivalence, likely due to the use of a previously cleared algorithm and the nature of the wireless and fourth-channel additions.
Standards: IEEE 802.11 Standard for Wireless Medium Access Method (MAC) and Physical Layer (PHY) is listed, suggesting that the wireless component's performance would be evaluated against this standard.

In essence, the document asserts that the modified device is substantially equivalent to existing, legally marketed devices based on the inclusion of proven components (like the arrhythmia algorithm) and standard compliant technologies (like wireless networking), without presenting new, detailed performance study outcomes for these specific modifications.

Summary

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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 (withArrhythmia Detection or Alarms)	MHX	III	870.1025
Arrhythmia Detector & Alarm	74DSI	III	870.1025
System, Network and Communication,Physiological Monitors	MSX

1. Legally Marketed Device: Siemens INFINITY SC 6002XL K993974, K002105
1. Device Description:

SC 6002XL Wireless Option

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COMPANY CONFIDENTIAL

Siemens Medical Solutions, USA

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: (978) 907-7500 Fax: (978) 750-6879

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K020144
p. 2/2

SC 6002XL with Full Arrhythmia Option

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

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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.

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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
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,

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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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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Regulation Number and Section

§ 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).