The Infinity Masimo SET® SpO2 Pod is intended for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Infinity Masimo SET® SpO2 Pod is intended for use with Adult, Pediatric, and Neonatal populations. The Infinity Masimo SET® SpO2 Pod is intended to be used by Healthcare Providers, i.e. Physicians, Nurses, and Technicians in hospital and hospital type facilities.

The Infinity Masimo SET® Pod is intended for use under the direct supervision of a licensed healthcare practioner (i.e. . Physicians, Nurses, and Technicians). It is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).

The Infinity Masimo SET® SpO2 Pod is indicated for use with adult, pediatric and neonatal patients.

The Infinity Masimo SET® SpO2 Pod and accessories are indicated for use during both motion and non-motion conditions, and for patients who are well or poorly perfused in hospitals and hospital type facilities.

Device Description

The Infinity Masimo SET® SpO2 Pod is an addition to Draeger Medical Systems' Infinity patient monitoring series that provides continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and neonatal patients. The Infinity Masimo SET® SpO2 Pod is manufactured by Draeger Medical Systems, Inc. and contains the Masimo SET OEM circuit board with Masimo's SpO2 measurement algorithm.

The pod works as a component of the Infinity patient monitoring series and does not function on its own. The Infinity Masimo SET® SpO2 Pod is connected externally via RS232 using only the X8 connector on the modular monitors Delta/Kappa (USB connector on Gamma series). The Masimo SET® SpO2 pod is powered by the patient monitor.

An oximetry sensor is attached to a patients finger and one end of a patient cable is connected to the sensor and the other end connected to the Masimo SET® SpO2 Pod. The monitor will begin continuously displaying the patient's pulse rate and SpO2 value. Hi and Low SpO2 and pulse rate alarm limits, alarms, trends and status messages are all controlled by the bedside monitor.

AI/ML Overview

The provided 510(k) summary for the Infinity Masimo SET® SpO2 Pod does not contain details about specific acceptance criteria, a study proving the device meets these criteria, or a detailed breakdown of performance metrics except for its intended purpose of continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.

The document primarily focuses on establishing substantial equivalence to predicate devices and adherence to general medical device regulations. It is a 510(k) summary, which often provides an overview rather than granular study details.

Here's what can be extracted and what is missing, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document	The device provides continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The 510(k) states it "was determined to be as safe and effective for its intended use as the predicate device" after testing in accordance with applicable standards and internal design control procedures. However, specific performance metrics (e.g., accuracy, precision) or numerical acceptance criteria are not presented.

Acceptance Criteria

Reported Device Performance

Not specified in the document

The device provides continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The 510(k) states it "was determined to be as safe and effective for its intended use as the predicate device" after testing in accordance with applicable standards and internal design control procedures. However, specific performance metrics (e.g., accuracy, precision) or numerical acceptance criteria are not presented.

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

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The document mentions "testing in accordance with applicable standards and internal design control procedures," implying internal data, but details like country of origin or whether it was retrospective or prospective are absent.

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

Not specified. The document does not describe the methodology for establishing ground truth for any testing.

4. Adjudication method for the test set

Not specified.

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

No MRMC comparative effectiveness study is mentioned. This device is an oximeter, which provides direct physiological measurements, not interpretations, so an MRMC study comparing human readers with and without AI assistance is not applicable in this context.

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

The device integrates the Masimo SET® OEM circuit board with Masimo's SpO2 measurement algorithm. The 510(k) process typically evaluates the device's performance as a standalone measurement system (algorithm + hardware) when establishing substantial equivalence. However, the document does not explicitly describe a "standalone" algorithmic performance study with specific metrics, but rather states the device (which includes the algorithm) was tested and deemed "as safe and effective."

7. The type of ground truth used

Not specified. For oximeters, the "ground truth" for SpO2 accuracy studies typically involves arterial blood gas (ABG) analysis as a reference. However, the document does not describe the methodology that would confirm the use of ABG or any other specific ground truth.

8. The sample size for the training set

Not applicable/Not specified. This filing is for a medical device that includes an algorithm (Masimo SET® SpO2 measurement algorithm), but it doesn't describe the development or "training" of this algorithm itself, nor does it imply a machine learning model that would have a distinct training set in the typical sense of AI/ML software. The algorithm is embedded within the device for physiological measurement.

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

Not applicable/Not specified, as no training set for a machine learning model is described.

Summary of what's provided for acceptance criteria and study information:

The document broadly states that "The Infinity Masimo SET® SpO2 Pod 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." This is the general statement of meeting acceptance, but it lacks specific numerical criteria, performance data, or details about the studies themselves (e.g., sample sizes, ground truth methods, expert involvement). The intent of a 510(k) summary is often to declare equivalence, not to detail the full scientific study. More detailed information would typically be in the full 510(k) submission, which is not publicly available in this summary format.

Summary

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A Dräger and Siemens Company

510(k) SUMMARY

K061329

as required per 807.92(c)

Submitter's Name and Address:

Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923

7 2006

Contact Person:

Thomas M. McIntosh Quality Assurance & Regulatory Affairs Tel: (978) 907-7500 Fax: (978) 907-7734

Date submission was prepared: May 10, 2006

Trade Name, Common Name and Classification Name:

A. Trade Name: Infinity Masimo SET® SpO2 Pod

B. Common Name, Classification Name, Class and Regulation Number:

Common Name	Classification Number	Class	Regulation Number
Oximeter	74DQA	II	870.2700

Predicate Device Identification:

Masimo SET® Intellivue Pulse Oximeter Module 510(k) Number - K040259 Masimo SET® Rad-5 Pulse Oximeter 510(k) Number - K033296

Device Description:

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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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5. Intended Use:

6. Comparison to Predicate Device:

Similar to Masimo SET® Intellivue Pulse Oximeter Module and Masimo SET® Rad-5 Pulse Oximeter, the Infinity Masimo SET® SpO2 Pod provides continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and neonatal patients.

7.Assessment of non-clinical performance data for equivelance:

The Infinity Masimo SET® SpO2 Pod 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.

Biocompatability: Not applicable

1. Sterilization: Not applicable

Standards and Guidances: 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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Public Health Service

JUL - 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas McIntosh Director, Quality Assurance & Regulatory Affairs Draeger Medical Systems, Incorporated 16 Electronics Avenue Danvers, Massachusetts 01923

Re: K061329

Trade/Device Name: Infinity Masimo SET® Sp()2 Pod Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 5, 2006 Received: June 7, 2006

Dear Mr. McIntosh:

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 – Mr. McIntosh

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) 276-0115. 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 vours.

Swette y Michael Oms

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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Indications for Use

510(k) Number (if known): K061329

Device Name: Infinity Masimo SET® SpO2 Pod

The Infinity Masimo SET® SpO2 Pod is indicated for use with adult, pediatric and neonatal patients.

MRI Compatibility Statement: The Infinity Masimo SET® SpO2 Pod is not compatible for use in a MRI magnetic field.

Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Sign-Off)
ion of Anesthesiology, General Hospital,
ion Control, Dental Devices

Number	K061329
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Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).