The provided text is a 510(k) summary for modifications to Draeger Medical Systems' Infinity Modular Monitors. It states that the device modifications do not alter the fundamental technology and that "Verification and validation testing performed indicates that the modifications implemented with software version VF5 are as safe and effective as previous versions". It explicitly states "Assessment of clinical performance data for equivalence: Not applicable".

Therefore, the submission does not contain a study demonstrating the device meets acceptance criteria as typically understood for a new product, but rather asserts equivalence to a previously cleared device for software modifications.

Given this, I cannot extract the requested information as the document explains that no new study demonstrating acceptance criteria was performed. The acceptance criteria and performance are implicitly those of the predicate device (Infinity Modular Monitors, K033694 and Infinity MIB, K033807), as the modifications are deemed not to have changed the fundamental technology or safety/effectiveness.

To directly answer your points based on the provided text:

1. A table of acceptance criteria and the reported device performance
Not applicable. The submission states "Verification and validation testing performed indicates that the modifications implemented with software version VF5 are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)." This indicates a determination of equivalence rather than performing a new study against specific, newly defined acceptance criteria for the modified device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No new ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set adjudication is described.

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. This device is a physiological monitor, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The modifications are to software for a physiological monitor, not a standalone diagnostic algorithm. The phrase "Verification and validation testing performed" refers to internal design control procedures, not necessarily a performance study in the sense of demonstrating a new algorithm's accuracy from scratch.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new ground truth is described.

8. The sample size for the training set
Not applicable. No new training set is described for an algorithm in this submission.

9. How the ground truth for the training set was established
Not applicable. No new training set or ground truth establishment is described.

Summary

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510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Contact person for this submission: Penelope H. Greco Regulatory Submissions Manager Date submission was prepared: December 6, 2004

Trade Name, Common Name and Classification Name:

INFINITY Modular Monitors with VF5 Modifications Trade Name: (Delta/Kappa/Delta XL/Vista XL/Gamma X XL and SC 7000/8000/9000XL)

Common Name, Classification Name, Class and Regulation Number:

Common Name	Product Code	Class	Regulation Number
Monitor, Physiological, Patient (with ArrhythmiaDetection or Alarms)	MHX	II	8*0.1025
Arrhythmia Detector & Alarm	74DSI	II	8*0.1025
System, Network and Communication,Physiological Monitors	MSX	II	8*0.2300

Legally Marketed Device

Infinity Modular Monitors	K033694
Infinity MIB	K033807

Description of Device Modifications:

Software version VF5 is the latest release of the Infinity Modular Monitors, including the Infinity Vista XL and Gamma X XL (variants of the SC 7000 and Delta monitors) that supports direct connection to the Scio gas module, display of data received from the Infinity BisX and Infinity Trident NMT pods, as well as other minor software modifications. In addition, new devices have been tested for use with the Infinity MIB Protocol converter. Testing in accordance with internal design control procedures has verified that the Infinity Modular Monitors and the Infinity MIB Protocol Converter with VF5 modifications are as safe and effective as submitted in 510(k) K033807 and K033694.

Intended Use:

The Infinity Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices will connect to an R50 Bedside recorder, either directly or via the Infinity Network.

Page 1 of 2

COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc.

16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879

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Assessment of non-clinical performance data for equivalence: Verification and validation testing performed indicates that the modifications implemented with software version VF5 are as safe and effective as previous versions and have not altered the fundamental technology of the device(s).

Assessment of clinical performance data for equivalence: Not applicable

Biocompatability: Not applicable

Sterilization: Not applicable

and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen

Standards: IEC 60601-1

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COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc.

16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a stylized human figure. The logo is black and white.

FEB 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Draeger Medical Systems, Inc. c/o Ms. Penelope H. Greco Regulatory Submissions Manager 16 Electronics Ave. Danvers, MA 01923

Re: K043439

KU43439
Trade Name: Infinity Delta / Kappa / Delta XL / Gamma X XL / Vista XL with VF5 Software Regulation Number: 21 CFR 870.1025 Regulation Name: 21 CFR 876.1025
Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: December 10, 2004 Received: December 14, 2004

Dear Ms. Greco:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bection 910(s) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule for legally while in the Medical Device Amendments, or to commerce prior to May 20, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Costlience Act (Act) that to not require the general controls provisions of the Act. The r ou may, mercere, manel the device, equirements for annual registration, listing of general controls provisions of tactice, 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 crassified (see aboro) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Coursements 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 I loase oc advised that I Dris brounders a your device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must of any it call 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 CI It Far 6077, laceming (21 CFR Part 820); and if applicable, the electronic forul in the quarty bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (1) (1) = 1) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = I his letter will anow you to ough finding of substantial equivalence of your device to a legally premaired 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 If you desire specific advice for your as (240) 276-0120. Also, please note the regulation entitled, Contact the Ories of Company of Set notification" (21CFR Part 807.97) you may obtain. IMISolanding of reference to premation on your responsibilities under the Act may be obtained from the Oiler general information on Jour respectional 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,

Bhimmafor

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

Enclosure

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KD4343939 510(k) Number (if known):__

Device Name: Infinity Delta / Kappa / Delta XL / Gamma X XL / Vista XL

Indications for Use:

The INFINITY Modular monitors are capable of monitoring:

. Heart rate
Respiration rate .
. Invasive pressure
. Non-invasive pressure
. Arrhythmia
. Temperature
Cardiac output .
Arterial oxygen saturation .
Pulse rate .
Apnea .
. ST Segment Analysis
12-Lead ST Segment Analysis .
tcp02/tcpC02 .
EEG signals .
FiO2 .

Prescription Use_ く (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhimmer

(Division/Sign-Off) Division of Cardiovascular Dev 510(k) Number

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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.