SPIROBANK G

K072979 · Mir Medical Intl. Research Srl · BZG · Dec 26, 2007 · Anesthesiology

Device Facts

• Record ID: K072979
• Device Name: SPIROBANK G
• Applicant: Mir Medical Intl. Research Srl
• Product Code: BZG · Anesthesiology
• Decision Date: Dec 26, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Spirobank G spirometer is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test lung function and can make spirometry testing in people of all ages, excluding infants and neonates. It can be used in any setting.

Device Story

Spirobank G is a portable, compact spirometer for lung function assessment; calculates >30 spirometric parameters. Used by physicians or patients (under instruction) in any setting. Features USB and Bluetooth connectivity for telemedicine. Device utilizes turbines (reusable or disposable) to measure airflow; internal microcontroller and ICs process signals to generate spirometric data. Healthcare providers review output to evaluate lung function and inform clinical decisions. Benefits include portable, accessible diagnostic testing.

Clinical Evidence

Bench testing only. Safety and environmental testing conducted per EN 60601-1:1990 and EN 60601-1-2:1993, covering EMC, electrical, mechanical durability, and environmental factors. Spirometry performance validated against American Thoracic Society (ATS) standards; results confirmed to be within required accuracy ranges.

Technological Characteristics

Portable spirometer with graphic display. Connectivity: USB, Bluetooth. Components: Microcontroller, ICs, memory, and reusable/disposable turbines. Standards: EN 60601-1:1990 (safety), EN 60601-1-2:1993 (EMC), and ATS standards for spirometry accuracy.

Indications for Use

Indicated for lung function testing in patients of all ages, excluding infants and neonates. Intended for use by physicians or patients under the instruction of a physician or paramedic in any setting.

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 (K983909)
• Spirobank II (KK061712)

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

#### 1. Applicant Information

| Date Prepared: | October 03, 2007 |
|-----------------|-----------------------------------------------|
| Submitter: | MIR Medical International Research |
| Address: | Via del Maggiolino, 125<br>00155 Roma - Italy |
| Contact Person: | Simon Fowler |
| Phone Number: | +39.0622754777 |

DEC 2 6 2007

### 2. Device Information

Trade Name: Spirobank G Classification Name: spirometer

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

| Company Name: | MIR. |
|----------------|-----------|
| Device Name: | Spirobank |
| 510(k) number: | K983909 |

| Company Name: | MIR. |
|----------------|--------------|
| Device Name: | Spirobank II |
| 510(k) number: | KK061712 |

#### 4. Description of the device:

Spirobank G is a spirometer designed to facilitate the total valuation of lung function. It is designed for use by specialist who require a simple, portable and compact device, yet at the same time being capable of calculating more than 30 spirometric parameters.

Its connectivity capability (USB, Bluetooth) makes it suitable also for telemedicine applications.

#### 5. Statement of Intended Use:

The Spirobank G spirometer is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test lung function and can make spirometry testing in people of all ages, excluding infants and neonates. It can be used in any setting.

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

Spirobank G has the same functions (graphic display, USB, Bluetooth), the same hardware (ICs, memory end microcontroller) and the same turbines (reusable and disposable) as Spirobank II though maintaining the design of the enclosure of the original Spirobank.

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

Testing was done to ensure that Spirobank G 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 Spirobank G is in compliance with the guideline and standards referenced and that it performs within its specifications.

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

### 8. Conclusions

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

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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

DEC 2 6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Simon Fowler Sales Manager M.I.R. Medical International Research Via del Maggiolino, 125 Roma, Italy 00155

Re: K072979

Trade/Device Name: Spirobank G Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: November 20, 2007 Received: November 26, 2007

Dear Mr. Fowler:

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 - Mr. Fowler

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 vou 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 yours,

Robert S. Betz for

Chin-Lin, Ph.D.

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: K072979

Device Name: Spirobank G

Indications for Use: The Spirobank G spirometer is intended to be used by a physician or by a patient under the instruction of a physician or paramedic.

The device is intended to test lung function and can make spirometry testing in people of all ages, excluding infants and neonates.

It can be used in any setting.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Min Whold

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

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510(k) Number: K072979