INFINITY MASIMO SET SP02 POD

K061329 · Draeger Medical Systems, Inc. · DQA · Jul 7, 2006 · Cardiovascular

Device Facts

• Record ID: K061329
• Device Name: INFINITY MASIMO SET SP02 POD
• Applicant: Draeger Medical Systems, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jul 7, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

Infinity Masimo SET® SpO2 Pod is an external component for Draeger Infinity patient monitoring series; provides continuous non-invasive SpO2 and pulse rate monitoring. Input: signals from SpO2 sensor attached to patient finger. Processing: utilizes integrated Masimo SET OEM circuit board and proprietary Masimo SpO2 measurement algorithm. Output: SpO2 and pulse rate values displayed on bedside monitor. Operation: connected via RS232 (X8 connector) or USB; powered by host monitor. Usage: hospital/clinical settings by physicians, nurses, technicians. Clinical impact: enables continuous monitoring of oxygenation status; facilitates alarm management and trend analysis via host monitor; supports clinical decision-making regarding patient respiratory status.

Clinical Evidence

Bench testing only. Device tested in accordance with applicable standards (IEC 60601-1) and internal design control procedures to confirm safety and effectiveness equivalent to predicate devices.

Technological Characteristics

External pod component; connects via RS232 or USB to Draeger Infinity series monitors. Powered by host monitor. Incorporates Masimo SET OEM circuit board for SpO2 signal processing. Standards: IEC 60601-1. Not MRI compatible.

Indications for Use

Indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in adult, pediatric, and neonatal patients. Suitable for use during motion and non-motion conditions, and for patients with good or poor perfusion in hospital settings. Not MRI compatible.

Regulatory Classification

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.

Predicate Devices

• Masimo SET® Intellivue Pulse Oximeter Module (K040259)
• Masimo SET® Rad-5 Pulse Oximeter (K033296)

Submission Summary (Full Text)

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A Dräger and Siemens Company

# 510(k) SUMMARY

K061329

as required per 807.92(c)

1. 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: [phone] Fax: [phone]

Date submission was prepared: May 10, 2006

2. 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 |

3. Predicate Device Identification:

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

4. 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.

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## COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: [phone] Fax: [phone]

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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.

### 5. Intended Use:

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.

### 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.

8. Biocompatability: Not applicable

- 9. Sterilization: Not applicable
10. Standards and Guidances: IEC 60601-1

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### COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: [phone] Fax: [phone]

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by four curved lines that suggest a head and torso.

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 [phone]. 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 [phone] or [phone] 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® 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.

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)
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(Sign-Off)
ion of Anesthesiology, General Hospital,
ion Control, Dental Devices

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