DRAEGER MICRO2+ AND MASIMO MINISAT

K032537 · Draeger Medical Systems, Inc. · DQA · Nov 25, 2003 · Cardiovascular

Device Facts

• Record ID: K032537
• Device Name: DRAEGER MICRO2+ AND MASIMO MINISAT
• Applicant: Draeger Medical Systems, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 25, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The MICRO2+ is intended for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused, using a range of compatible sensors. The device will produce visual and aural alarms if these parameters vary beyond preset limits

Device Story

Draeger MicrO2+ is a pulse oximeter for continuous, non-invasive monitoring of arterial hemoglobin oxygen saturation and pulse rate. Device processes signals from compatible sensors to calculate physiological parameters; provides visual and aural alarms when values exceed preset limits. Used in clinical settings by healthcare professionals. Modification (software version VA2) enables recognition of Masimo LNOP sensors and re-labeling. Device operates under prescription use; provides real-time monitoring to assist clinicians in patient assessment and management; benefits include continuous oversight of oxygenation status in diverse perfusion and motion conditions.

Clinical Evidence

Bench testing only. No clinical data presented. Testing confirmed that software version VA2 modifications did not alter fundamental technology or impact safety and efficacy.

Technological Characteristics

Pulse oximeter; non-invasive sensor interface. Software version VA2. Compatible with Masimo LNOP sensors. Provides continuous monitoring of SpO2 and pulse rate. No changes to fundamental sensing technology.

Indications for Use

Indicated for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate in patients who are well or poorly perfused, under both motion and no-motion conditions. Not intended for use in MRI magnetic fields.

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

• MICRO2+ (K030640)
• Masimo SET Radical Pulse Oximeter and LNOP Series Sensors (K013792)

Reference Devices

• MICRO2+ (K012770)

Submission Summary (Full Text)

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NOV 2 5 2003

K032537

Special 510(k) Notification MicrO2+ VA2 Modifications

## 510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

Draeger Medical Systems, Inc. Danvers, MA 01923 Tel: [phone] Fax: [phone] Connie Hertel, Director Official Correspondent: Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco November 24, 2003 Date submission was prepared:

Trade Name, Common Name and Classification Name:

- A. Trade Name:
Draeger MicrO2+

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

| Common Name | Product Code | Class | Regulation Number |
|--------------|--------------|-------|-------------------|
| Oximeter | 74 DQA | II | 870.2700 |
| Ear Oximeter | 74 DPZ | II | 870.2710 |

Legally Marketed Device Identification:

MICRO2+, 510(k) K030640, K012770 Masimo SET Radical Pulse Oximeter and LNOP Series Sensors, K013792

Description of Modification:

The release of software version VA2 includes a re-labeling of the MicrO2+ and the recognition of Masimo LNOP sensors. The modifications implemented with the release of software version VA2 have not altered the basic fundamental technology of the MicrO2+. Testing with VA2 software indicates no new issues relative to safety and efficacy.

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COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc.

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax [phone]

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Intended Use:

The MICRO2+ is intended for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused, using a range of compatible sensors. The device will produce visual and aural alarms if these parameters vary beyond preset limits

Assessment of non-clinical performance data for equivalence: _ See Section J

Assessment of clinical performance data for equivalence: See Section J

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidances: See Section J

Page 2 of 2

## COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc.

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax [phone]

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Public Health Service

NOV 25 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Penelope H. Greco Draeger Medical System, Incorporated 16 Electronics Avenue Danvers, MA 01923

Re: K032537

Trade/Device Name: Draeger Infinity MicrO2+ Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ Dated: November 14, 2003 Received: November 17, 2003

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. Iisting 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.

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

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Page 2 - Ms. Penelope H. Greco

forth in the quality systems (OS) 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/dsma/dsmamain.html.

Sincerely yours,

Susan Purnell

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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): KO32537

Device Name: INFINITY MICRO2+

Indications for Use:

The MICRO2+ is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused.

MRI Compatibility Statement: The INFINITY MICRO2+ is not intended for use in a MRI magnetic field.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ V (Per 21 CFR 801.109)

______________________________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

S.A. Wutcher

neral Hospital.

510(k) Number