SPIRODOC

K103530 · Medical International Research USA, Inc. · BZG · Nov 21, 2011 · Anesthesiology

Device Facts

• Record ID: K103530
• Device Name: SPIRODOC
• Applicant: Medical International Research USA, Inc.
• Product Code: BZG · Anesthesiology
• Decision Date: Nov 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Spirodoc Spirometer and pulse oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician. The device is intended to test lung function and can perform spirometry testing in adult and pediatric patients, excluding infants and neonates, and oximetry readings in patients of all ages.

Device Story

Spirodoc is a pocket-sized, microprocessor-based spirometer and pulse oximeter. It utilizes a removable turbine sensor for respiratory airflow/volume and a removable pulse oximetry sensor. The central unit features a touch-screen display, USB port, and Bluetooth connectivity. Operated by physicians or patients under prescription, the device collects health data, which can be transmitted via landline, broadband, wireless, or cellular technology to a web server for medical staff access. The device provides real-time lung function and oximetry measurements, enabling clinicians to monitor respiratory health and make informed diagnostic or therapeutic decisions. It benefits patients by facilitating remote monitoring and point-of-care testing.

Clinical Evidence

Clinical testing performed for both spirometry and pulse oximetry functions. Spirometry testing conducted in accordance with American Thoracic Society (ATS) standards; results met required accuracy ranges. Pulse oximetry (SpO2 and pulse rate) accuracy verified in-house using an optical simulator; results within specifications. Safety and environmental testing completed per EN 60601-1:1990 and EN 60601-1-2:1993.

Technological Characteristics

Pocket-sized spirometer/oximeter; microprocessor-based system. Features detachable turbine flow sensor and pulse oximetry sensor. Connectivity: USB, Bluetooth, and wireless/cellular data transmission. Interface: Touch-screen display. Power: Internal battery. Standards: EN 60601-1 (safety), EN 60601-1-2 (EMC).

Indications for Use

Indicated for lung function testing in adult and pediatric patients (excluding infants/neonates) and pulse oximetry readings in patients of all ages. Prescription use only.

Regulatory Classification

Identification

A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

Predicate Devices

• Spirobank II (K061712)

Submission Summary (Full Text)

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NOV 2 1 2011

Image /page/0/Picture/1 description: The image shows the logo for Medical International Research (MIR). The logo consists of a stylized, interconnected "M" shape above the letters "MIR" in bold, sans-serif font. Below the letters, the full name "MEDICAL INTERNATIONAL RESEARCH" is written in a smaller, sans-serif font.

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## 510(k) Summary

K 103530

## 1. Applicant Information

| Date Prepared: | November 09, 2011 |
|-----------------|------------------------------------|
| Submitter: | MIR Medical International Research |
| Address: | Via del Maggiolino, 125 |
| | 00155 Roma -- Italy |
| Contact Person: | Ed Kohere |
| Phone Number: | +39 06.22.754.777 |
| Mobile Number: | [phone] |

## 2. Device Information

Trade Name: Spirodoc Classification Name: spirometer and oximeter

#### 3. Identification of legally marketed device to which the submitter claims equivalence:

| Company Name: | MIR |
|----------------|--------------|
| Device Name: | Spirobank II |
| 510(k) number: | K061712 |

#### 4. Description of the device:

Spirodoc is a pocket-size spirometer and oximeter.

The device is made up of:

- a central unit which measures and collects information related to the state of health of the patient, with wireless or cable transmission of the collected data using a microprocessor based system with a touch screen display, USB communication port and Bluetooth, .
- a removable sensor for the measurement of respiratory air flow and volume, ﮯ
- a removable pulse oximetry sensor -

Stored data can be then delivered through landline, broadband, wireless and cell-phone technology to be received by a web server and can then be accessed by medical staff.

#### 5. Statement of Intended Use:

The Spirodoc Spirometer and pulse oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician.

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The device is intended to test lung function and can perform spirometry testing in adult and pediatric patients, excluding infants and neonates, and oximetry readings in patients of all ages.

## 6. Summary of the technological characteristics of the new device in comparison to those of the predicate device:

Spirodoc uses the same measurement method and sensors, and calculates the same parameters as the predicate device.

It has a new enclosure, whose thickness is half that of the predicate device. The part accommodating the spirometry sensor (turbine) is now detachable. It uses a touch-screen display instead of a keyboard.

It uses a new microprocessor (and a new PCB), and the same oximetry board as the predicate device.

## 7. Brief discussion of the clinical and nonclinical tests relied on for a determination of SE.

Testing was done to ensure that the Spirodoc would perform safely and accurately within the environments for which it is to be marketed.

Safety and environmental testing was conducted in accordance with EN 60601-1:1990 and EN 60601-1-2:1993. Electromagnetic compatibility (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing have been completed. The results demonstrates that the Spirodoc is in compliance with the guideline and standards referenced and that it performs within its specifications.

Testing of device performance included clinical testing of both spirometry and pulse oximetry functions.

Spirometry testing was performed according with American Thoracic Society (ATS) Standards. The results obtained were within the range of accuracy required by ATS.

The accuracy of SpO2 and pulse rate have been verified in-house using an optical simulator. The results obtained were within specification.

#### 8. Conclusions

Based on these results, it is our determination that the device is safe, effective, and performs as well as the legally marketed device.

This summary on 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Mr. Ed Kohere President Medical International Research USA, Incorporated 1900 Pewaukee Road, Suite O Waukesha, Wisconsin 53188

NOW 2 1- 2011

Re: K103530

Trade/Device Name: Spirodoc Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG, DQA Dated: November 9, 2011 Received: November 14, 2011

Dear Mr. Kohere:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Kohere

Please be advised that ITDA'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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety /ReportaProblem /default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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: K103530

Device Name: Spirodoc

Indications for Use: The Spirodoc Spirometer and pulse oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician.

The device is intended to test lung function and can perform spirometry testing in adult and pediatric patients, excluding infants and neonates, and oximetry readings in patients of all ages.

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

Over-The-Counter Use_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Ashulthon

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

510(k) Number: K(03530

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