This device is capable of monitoring heart rate, respiration rate, invasive blood pressure, non-invasive blood pressure, arrhythmia, cardiac output, temperature, arterial oxygen saturation, pulse rate, apnea, ST segment analysis.

Infinity Alpha will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings.

The device is intended to be used in an 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.

Device Description

The Infinity Alpha is a light-weight, handheld portable patient monitor that displays real-time vital signs and provides continuous trending. The Infinity Alpha is capable of measuring heart rate, respiration rate, invasive blood pressure, non-invasive blood pressure, arrhythmia, temperature, cardiac output, arterial oxygen saturation, pulse rate, apnea, ST segment analysis, and 12-lead ST segment analysis. The device produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced.

AI/ML Overview

The provided text does not include detailed information regarding specific acceptance criteria for performance metrics (such as sensitivity, specificity, or accuracy) of the Infinity Alpha patient monitor for each of its functionalities (e.g., heart rate, respiration rate, arrhythmia detection, etc.). It primarily focuses on regulatory approval and substantial equivalence to a predicate device.

Therefore, I cannot populate a table with acceptance criteria and reported device performance, nor can I provide information about sample sizes for test or training sets, expert qualifications, ground truth methods, or MRMC study details.

However, I can extract the information that is present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not specified in the provided document. The document states that the device was "determined to be as safe and effective for its intended use as the predicate device" in accordance with applicable standards and internal design control procedures.
Reported Device Performance: Not specified in terms of quantitative metrics. The document only states that "Clinical performance evaluations indicate that the Infinity Alpha Patient Monitor is substantially equivalent to the Infinity Delta series monitors."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not specified in the provided document.

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 specified in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified in the provided document.

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 specified in the provided document. The device is a patient 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

The device is a standalone physiological monitor. The "clinical performance evaluations" would have assessed its standalone performance compared to the predicate device. Specific details or metrics of this evaluation are not provided.

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

Not specified in the provided document. It states "Clinical performance evaluations," but the methodology for establishing ground truth within those evaluations is not detailed.

8. The sample size for the training set

Not specified in the provided document.

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

Not specified in the provided document.

Summary

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K 051658

NOV 1 6 2005

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 Alpha

Device Description:

Intended Use:

The Infinity Alpha is intended for multi-parameter patient monitoring. The device produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced.

Predicate Devices:
Infinity Modular Monitors	K043439

Page 1 of 2

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Substantial Equivalence:

Assessment of non-clinical performance data for equivalence:

The Infinity Alpha Patient Monitor was tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate device.

Assessment of clinical performance data for equivalence:

Clinical performance evaluations indicate that the Infinity Alpha Patient Monitor is substantially equivalent to the Infinity Delta series monitors.

Biocompatability: Not applicable

Sterilization: Not applicable

IEC 60601-1 and applicable and collateral standards Standards and Guidance: IEC 60601-1-2 Electromagnetic Compatibility CISPR11, Class B UL60601-1, CSA 22.2 No 60601-1

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol on the right side. To the left of the symbol, the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol.

NOV 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051658

Trade Name: Infiniti Alpha Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: October 14, 2005 Received: October 17, 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. 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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

Blumman for

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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510(k) Number (if known):

Device Name: InfinityAlpha

Indications for Use:

Infinity Alpha will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings.

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 Infinity Alpha is not compatible for use in a MRI magnetic field.

Prescription Use く (Per 21 CFR 801.109) OR

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)

Blamimina
Division Sign-Off

(División Sign-Off
Division of Cardiovascular Devices
510(k) Number Ko51458

Page 1 of 1

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.