INFINITY MICRO2+

K012770 · Siemens Medical Solutions USA, Inc. · DQA · Jul 23, 2002 · Cardiovascular

Device Facts

• Record ID: K012770
• Device Name: INFINITY MICRO2+
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jul 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

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

INFINITY MICRO2+ is a compact, battery-operated, hand-held ambulatory pulse oximeter. It utilizes an external oxygen transducer (sensor) to input arterial hemoglobin signals; processes these signals to calculate SpO2 and pulse rate; and outputs visual and aural alarms when parameters exceed preset limits. Used in clinical environments by licensed healthcare professionals for continuous monitoring. Device connects to Siemens INFINITY Telemetry transmitters or personal computers for trend display/printing. Enhancements over predicate include improved tolerance for motion, artifact, and low perfusion. Benefits include reliable monitoring across diverse patient populations and perfusion states.

Clinical Evidence

Clinical and bench testing performed to demonstrate safety and effectiveness. No specific study metrics (e.g., sensitivity, specificity) provided in the summary document.

Technological Characteristics

Hand-held, battery-operated ambulatory pulse oximeter. Uses external oxygen transducers (sensors). Connectivity via Siemens INFINITY Telemetry or PC interface. Software-based SpO2 and pulse rate algorithm with enhanced motion and low perfusion tolerance.

Indications for Use

Indicated for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate in neonatal, pediatric, and adult patients, including those with motion or poor perfusion, in clinical environments.

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 (K913489)
• SC 7000/9000XL (K980882)

Reference Devices

• SC 9000 (K946306)
• SC 9000 Neonatal (K962291)
• SC3000 WorkStation & Remote Display (K955059)
• MVWS INFINITY Telemetry System (K972714)

Submission Summary (Full Text)

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510(k) Notification INFINITY MICRO2+ Pulse Oximeter JUL 2 3 2002

KC12))0

## 510(k) SUMMARY

as required per 807.92(c)

- 1. Submitters Name, Address:
Siemens Medical Systems, 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: August 15, 2001

- 2. Trade Name, Common Name and Classification Name: A. Trade Name:
INFINITY MICRO2+

#### Common Name, Classification Name, Class and Regulation Number; B.

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

- Predicate Device Identification: 3. MICRO2 510(k) K913489 SC 7000/9000XL K980882

| Other Relevant Submissions | |
|--------------------------------------------------------------------------|---------|
| SC 9000 | K946306 |
| SC 9000 Neonatal | K962291 |
| SC3000 WorkStation & Remote Display<br>(MultiView WorkStation & Network) | K955059 |
| MVWS INFINITY Telemetry System | K972714 |

1

### Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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# 4. Device Description:

The INFINITY MICRO2+ is a small, compact battery operated ambulatory pulse oximeter.

The hand-held INFINITY MICRO2+ is a redesign of the MICRO2 (K913489) used for the noninvasive measurement of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate with the use of an oxygen transducer (sensor),

The SpO2 algorithm is essentially the same as that of the predicate (K980882), but enhanced for greater artifact, motion and low perfusion tolerance. A range of compatible sensors is available for use with the INFINITY MICRO2+.

The INFINITY MICRO2+ can be connected to a Siemens INFINITY Telemetry transmitter (K972714) or to a customer's personal computer for the display and printing of SpO2 trend information. The device is intended to provide continuous. non-invasive SpO2 monitoring for neonatal, pediatric and adult patient populations in health care environments where patient care is provided by licensed health care professionals.

# 5. 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

2

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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# Table of Device Similarities and differences to predicate devi 9

| Manufacturer | Predicate Device<br>Siemens Medical Systems<br>MICRO2 | Predicate Device<br>Siemens Medical Systems<br>SC 7000/ SC 9000XL | Applicant<br>Siemens Medical Systems<br>INFINITY MICRO2+ | Explanation of Differences |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K913489 | K980882 | To be determined | |
| Intended Use | To non-invasively measure<br>functional oxygen saturation of<br>arterial hemoglobin and pulse rate<br>using a range of compatible sensors<br>and to produce visual and aural<br>alarms if these parameters vary<br>beyond preset limits. | The intended use of the SC 7000 and<br>SC 9000XL INFINITY Modular<br>Bedside Monitoring Series is to<br>measure heart rate, respiration rate,<br>invasive pressure, non-invasive<br>pressure, arrhythmia, temperature,<br>arterial oxygen saturation and pulse<br>rate, cardiac output, central apnea, ST<br>segment analysis, and 12-Lead ST<br>Segment Analysis. This device will<br>produce visual and audible alarms if<br>any of these parameters vary beyond<br>preset limits and produce timed or<br>alarm recordings. This device will<br>connect to a Siemens R50 Bedside<br>Recorder, either directly or via the<br>Infinity network. | The MICRO2+ is intended for the<br>continuous, non-invasive monitoring<br>of functional oxygen saturation of<br>arterial hemoglobin and pulse rate<br>during both no motion and motion<br>conditions, and for patients who are<br>well or poorly perfused, using a range<br>of compatible sensors. The device will<br>produce visual and aural alarms if<br>these parameters vary beyond preset<br>limits. | Same SpO2 and<br>Pulse Rate algorithm<br>as K980882 with<br>modifications,<br>including motion<br>detection |
| Intended<br>Population | Adult/pediatric | Adult/pediatric/neonatal | Same as K980882 | |
| Intended<br>Environment | Clinical environment | For use in an environment where<br>patient care is provided by Healthcare<br>Professionals | Same as K980882 | |
| Clinical and non-<br>clinical testing | | | Clinical and bench testing performed<br>demonstrate that the INFINITY<br>MICRO2+ is as safe and effective as | |

క

Siemens Medical Systems, Inc.
Electromedical Systems Group, PCS

6 Electronics Avenue
Danvers, MA 01923

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# 510(k) Notification INFINITY MICRO2+ Pulse Oximeter

Assessment of non-clinical performance data for equivalence: Section S 7.

Assessment of clinical performance data for equivalence: Section T 8.

- 9. Biocompatability: Not applicable
- 10. Sterilization: Not applicable
- 11. Standards and Guidances: Section U

4

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract image of an eagle with its head facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2002

Ms. Penelope H. Greco Siemens Medical Solutions USA, Incorproated Division of EM-PCS 16 Electronics Avenue Danvers, Massachusetts 01923

Re: K012770

Trade/Device Name: Infinity Micro2+ Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 25, 2002 Received: April 29, 2002

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.

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.

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Page 2 - Ms. Greco

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runoe

Timothy A. Ulatowski 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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KO12770 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.

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

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)

SA Winterhesn

ntal, Infect