SIEMENS MICRO2+ WITH VAI SOFTWARE

K030640 · Siemens Medical Solutions USA, Inc. · DQA · Jun 3, 2003 · Cardiovascular

Device Facts

• Record ID: K030640
• Device Name: SIEMENS MICRO2+ WITH VAI SOFTWARE
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 3, 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

Siemens 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. Modification (software version VA1) enables recognition of Nellcor OxiMax sensors and updates device labeling. Used in clinical settings for patients with varying perfusion levels; operated by healthcare professionals. Output assists clinicians in patient status assessment and monitoring. Benefits include reliable monitoring during motion and low perfusion states.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing of software version VA1.

Technological Characteristics

Pulse oximeter; software-controlled signal processing. Compatible with Nellcor OxiMax sensors. Not MRI compatible. Software version VA1.

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 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+ (K012770)

Submission Summary (Full Text)

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K030640

# Special 510(k) Notification SIEMENS MicrO2+ VA1 Modifications

#### 510(k) SUMMARY

as required per 807.92(c)

### Submitters Name, Address:

Siemens Medical Solutions USA, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: [phone] Fax: [phone] Official Correspondent: Connie Hertel, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: February 26, 2003

Trade Name, Common Name and Classification Name:

- A. Trade Name: Siemens MicrO2+ Nellcor N-45
- 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) K012770

### Description of Modification:

The release of software version VA1 includes a re-labeling of the MicrO2+ and the recognition of Nellcor OxiMax sensors. The modifications implemented with the release of software version VA1 have not altered the basic fundamental technology of the MicrO2+. Testing with VA1 software indicates no new issues relative to safety and efficacy.

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

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 & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 2003

Ms. Penelope H. Greco Siemens Medical Solutions USA, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923

Re: K030640

Trade/Device Name: Siemens MicrO2+ with VA1 Software Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 23, 2003 Received: May 27, 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, 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 vour 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 [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 Rumm

Susan Runner, DDS, MA Interim 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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Page 1 of 1 --

510(k) Number (if known): KC 306 YO

Device Name: Siemens 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 Siemens 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 (Per 21 CFR 801.109)

______________________________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use____________

(Optional Format 1-2-96)

Susan Pearson

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

510(k) Number: 4/3k3