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 Description

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.

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.

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.

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

AI/ML Overview

This 510(k) submission describes modifications to the Siemens INFINITY SC 6002XL Series. The submission primarily focuses on functional and hardware changes rather than performance changes for existing functionalities, particularly with respect to a medical device's AI component. The NIBP algorithm changed from linear to stepped deflation, but no performance data is provided for this change against acceptance criteria. There's also support for new SpO2 sensors and a larger display option.

Due to the nature of the submission (modifications to an existing device, mainly addressing hardware and software architecture, with no specific AI component mentioned and no performance study explicitly cited for a new AI feature), much of the requested information regarding acceptance criteria and a study to prove device performance is not available in the provided text.

Here's an attempt to answer the questions based only on the provided text, indicating what information is missing:

1. Table of acceptance criteria and the reported device performance

The provided 510(k) summary does not contain a table of acceptance criteria or reported device performance for the modifications (NIBP algorithm change, SpO2 sensor support, display size increase, wireless security improvements). This submission focuses on describing the changes and asserting substantial equivalence, rather than providing detailed performance data against specific criteria for new or modified functions.

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

Not provided. The submission states "Assessment of non-clinical performance data for equivalence: Section L" but Section L is not included. It also states "Assessment of clinical performance data for equivalence: Not applicable," which further suggests no specific clinical test set was used for these modifications.

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

Not applicable/Not provided. Given that no clinical performance data is mentioned, there would be no ground truth established by experts for a test set.

4. Adjudication method for the test set

Not applicable/Not provided. As no test set with expert ground truth is mentioned, no adjudication method would have been used.

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

Not applicable. The provided text does not describe an AI or an AI-assisted feature. Therefore, no MRMC study or effect size related to AI assistance is mentioned.

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

Not applicable/Not provided. The submission describes modifications to a patient monitor. While it mentions an NIBP algorithm change, it does not describe a standalone performance study for this algorithm as a distinct AI component without human intervention. The "Assessment of non-clinical performance data for equivalence: Section L" might contain related information, but it is not provided.

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

Not applicable/Not provided. As no clinical performance study is described with a test set requiring ground truth, no type of ground truth is mentioned.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of a training set, which would typically be associated with machine learning or AI algorithm development.

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

Not applicable/Not provided. Since no training set is mentioned, the method for establishing its ground truth is also not.

Summary

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

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: (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 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 (withArrhythmia Detection or Alarms)	MHX	III	870.1025
Arrhythmia Detector & Alarm	74DSI	III	870.1025
System, Network and Communication,Physiological Monitors	MSX	II	870.2300

Legally Marketed Device:

Siemens INFINITY SC 6002XL K993974, K002105, K020144

Description of Device Modifications:

Non-Invasive Blood Pressure

SpO2 Masimo Sensor Support

1 of 2

Siemens Medical Solutions, USA

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

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

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

K030313
page 2 of 2

Display size

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

2/2

Siemens Medical Solutions, USA Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

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

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

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.

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

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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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

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

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 .

Page 1 of 1

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(Per 21 CFR 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
	(Division Sign-Off)Division of Cardiovascular Devices
510(k) Number	K030313

Regulation Number and Section

§ 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.