The SCIO module samples breathing gases from adults and pediatrics. The gas modules continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, halothane, isoffurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.

With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored. The monitors can interface with specific third party devices via an MIB protocol converter.

Device Description

The intent of this 510(k) is to submit a modification specific to Scio, a gas module used exclusively with Draeger Medical Systems' Infinity monitors. The modification is the addition of a sample gas return kit identifical to that of Draeger Medical's Vamos, 510(k) K040847. The modification allows the user the option of returning the sample gas from the Scio gas module to the breathing circuit.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Infinity Monitors with Scio Modifications:

The provided documents do not contain detailed acceptance criteria or a comprehensive study report as typically expected for demonstrating device performance. This submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full performance study with specific acceptance criteria and detailed results.

The key statement regarding performance is:

"Scio with sample gas return was tested in accordance with internal design control procedures and was determined to be as safe and effective for its intended use as the predicate device."

This statement is very general and lacks the specific details requested in the prompt. Therefore, much of the requested information cannot be extracted from these documents.

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, no specific acceptance criteria or quantitative performance metrics are provided in the document. The general statement is that the device was determined to be "as safe and effective for its intended use as the predicate device."

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Summary)
Safe for intended use	"Determined to be as safe... for its intended use as the predicate device."
Effective for intended use	"Determined to be as effective... for its intended use as the predicate device."
Sample gas return functions as intended	Implied by the modification being the "addition of a sample gas return kit" and the overall substantial equivalence claim.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified.
Data Provenance: Not specified. It's implied that "internal design control procedures" were followed, but whether this involved human or animal testing, or purely bench testing without biological samples, is not detailed. The origin (e.g., country, retrospective/prospective) is also not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. The term "ground truth" implies a reference standard, which is not described.

4. Adjudication Method for the Test Set

Not applicable/Not provided. There is no mention of expert review or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study is not mentioned. The device is a physiological monitor, not typically evaluated with MRMC studies as a diagnostic imaging device would be. The focus is on the accuracy and reliability of the physiological measurements and alarms.

6. Standalone (Algorithm Only) Performance Study

The document implies testing of the "Scio with sample gas return" module itself, which would be a standalone component of the monitoring system. However, the details of what "standalone performance" means in this context (e.g., accuracy of gas measurements in a lab setting) are not provided beyond the general statement of being "safe and effective."

7. Type of Ground Truth Used

Not specified. Given the nature of a physiological monitor, ground truth would typically involve:
- Reference gas standards: For accuracy of gas measurements (CO2, N2O, O2, anesthetic agents).
- Simulated physiological signals: For monitoring heart rate, respiration, pressures, etc., against known inputs.
- Clinical observation/comparison to established devices: For alarm functionality and overall patient monitoring effectiveness.
- However, the document does not specify which, if any, of these were used.

8. Sample Size for the Training Set

Not applicable/Not provided. This device is a hardware modification to a physiological monitor, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided, as there is no training set mentioned for this type of device.

Summary of Limitations:

The provided 510(k) summary is extremely high-level. It serves its purpose of demonstrating substantial equivalence to a predicate device by stating that "internal design control procedures" were followed and the device was determined to be "as safe and effective." However, it lacks the granular detail about specific performance metrics, test methodologies, sample sizes, and ground truth establishment that would be present in a detailed study report. This is typical for 510(k) summaries where the focus is on equivalence rather than novel performance claims.

Summary

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Special 510(k) Infinity Monitors with Scio Modifications

JUL 2 0 2005

germedical

A Dräger and Siemens Company

K051628

510(k) SUMMARY as required per 807.92(c)

Submitter's Name and Address:	Draeger Medical Systems, Inc.16 Electronics AvenueDanvers, MA 01923
Contact Person:	Penelope H. GrecoRegulatory Affairs ManagerTel: (978) 907-7503Fax: (978) 750-6879
Date submission was prepared:	June 17, 2005
Device Name:
Common Name:	Monitor, Physiological, Patient(with arrhythmia detection or alarms)
Classification Name:	MHX
Regulation Number:	21 CFR 870.1025
Class:	2

Legally Marketed Device Identification: Infinity Modular Monitors

Device Description:

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.

Predicate Devices:

Infinity Monitors with Scio: 510(k) K031340, K033957, K040188 Vamos: K040847

Substantial Equivalence:

Scio with sample gas return was tested in accordance with internal design control procedures and was determined to be as safe and effective for its intended use as the predicate device.

Page 1 of 1

COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird-like figure.

JUL 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Penelope H. Greco Regulatory Affairs Manager DRAEGER Medical Systems, Incorporated 16 Electronics Ave. Danvers, Massachusetts 01923

Re: K051628

Trade/Device Name: Infinity Monitors with SCIO Modifications Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: II Product Code: MHX Dated: June 17, 2005 Received: June 20, 2005

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.

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Page 2 - Ms. Greco

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Ficase oe advised that I Dris issuation sevice complies with other requirements of the Act that I Dri has made a astatutes and regulations administered by other Federal agencies. You must of ally I coleral statutes and registents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the qualisy by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Section ) vice as described in your Section 510(k) This letter will anow you to ough finding of substantial equivalence of your device to a legally prematics notineation. The 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 acrioliary at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misoranding by reference to presenters willities under the Act from the Division of Small other general mionnational 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/industry/support/index.html.

Sincerely yours,

Senette y. Michael Ond.

Chiu Lin, PH.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_

Device Name: Infinity Modular Monitors with Scio Modifications

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_ (Per 21 CFR 801.109)

Over-The-Counter Use_

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sukite Y. Michael Om.d

(Division Sign-Off) Division of Anesthesiology, General Ho Infection Control, Dental

510(k) Number: K051628

Page 1 of 2

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Indications for Use

The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, 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 the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.

MRI Compatibility Statement:

ﻌﺘﻤ ﺴ

The INFINITY Modular Monitors are not compatible for use in a MRI magnetic field.

Page 2 of 2 .

Auy Sulleron

(Division Sign-Off (Division Sign-Off)
Division of Anesthestelogy General Hospital, Infection Control, Dental D

510(k) Number:

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.