SPIROLAB, SPIROLAB II

K052140 · Mir Medical Intl. Research Srl · BZG · Mar 16, 2006 · Anesthesiology

Device Facts

• Record ID: K052140
• Device Name: SPIROLAB, SPIROLAB II
• Applicant: Mir Medical Intl. Research Srl
• Product Code: BZG · Anesthesiology
• Decision Date: Mar 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Spirolab and Spirolab II spirometers are intended to be used by either a physician, respiratory therapist or technician to test lung function in people of all ages excluding infants and neonates. They can be used in any setting.

Device Story

Spirolab and Spirolab II are diagnostic spirometers used to measure lung function. The device performs FVC, VC (insp/exp), and MVV tests; calculates predicted values and percentage deviations; and generates Flow/Volume and Volume/time curves. It provides clinical interpretation of results based on ATS/ERS standards. Operated by physicians, respiratory therapists, or technicians in any setting, the device assists in assessing pulmonary health. The system includes a keyboard and display for user interaction and data visualization. Clinical decision-making is supported by the device's automated calculations and standardized interpretation, aiding in the diagnosis and monitoring of respiratory conditions.

Clinical Evidence

Bench testing only. Testing confirmed device performance, safety, and accuracy within specified environments. Compliance with EN 60601-1 (electrical/mechanical safety) and EN 60601-1-2 (EMC) was demonstrated. Spirometry performance was validated against American Thoracic Society (ATS) standards.

Technological Characteristics

Diagnostic spirometer; performs FVC, VC, and MVV tests. Features integrated keyboard and display. Operates on established spirometry algorithms for parameter calculation and curve generation. Complies with ATS/ERS standards. Safety testing per EN 60601-1:1990 and EN 60601-1-2:1993.

Indications for Use

Indicated for testing lung function in patients of all ages, excluding infants and neonates. Intended for use by physicians, respiratory therapists, or technicians in any clinical 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

• SDI Spirolab II (K012812)

Submission Summary (Full Text)

{0}------------------------------------------------

Kos2140

12 16 0003

Image /page/0/Picture/2 description: The image contains the words "MEDICAL INTERNATIONAL RESEARCH" in a simple, sans-serif font. The text is arranged in a single line, with each word clearly separated. The overall impression is clean and professional, suggesting a focus on medical research with an international scope.

## Summary of Safety and Effectiveness

#### 1. Applicant Information

| Date Prepared: | August 2, 2005 |
|-----------------|-----------------------------------------------|
| Submitter: | MIR Medical International Research |
| Address: | Via del Maggiolino, 125<br>00155 Roma - Italy |
| Contact Person: | Simon Fowler |
| Phone Number: | +39 06.22.754.777 |

#### 2. Device Information

| Trade Name: | Spirolab, Spirolab II |
|----------------------|-----------------------|
| Classification Name: | spirometer |

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

SDI Diagnostics, Inc. Company Name: SDI Spirolab II Device Name: K012812 510(k) number: Regulation Number 868.1840

#### 4. Description of the device:

4. Description of the device. which carries out three different spirometric tests, FVC, VC(insp/exp) and MVV, with a winch carres out three direrent spirometers, predicted values and percentage deviations calculation of the main ophomons plus Flow/Volume and Volume/time curves and the interpretation of the Incasured "raileswing the international spirometry standards (ATS/ERS).

#### 5. Statement of Intended Use:

The Spirolab and Spirolab II spirometers are intended to be used by either a physician, The Spirolab and Operatur in to test lung function in people of all ages excluding infants and neonates. They can be used in any setting.

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

MIR Spirolab and Spirolab II have the

- same intended use .
- same operating principle .
- same algorithms for spirometry parameters calculation .

{1}------------------------------------------------

- same physical aspect (keyboard, display, size and weight) .
# 7. Brief discussion of the clinical and non clinical tests relied on for a determination of

SE.
Testing was done to ensure that the MIR Spirolab/Spirolab/Spirolab/I 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 Safety and environmental testing was concursebundity (EMC), electrical, mechanical
EN 60601-1-2:1993(sMi). Electromagnetic compatibility, testing have been EN 60601-1-2:1993(sM). Electroniagnetic and temperature/humidty testing have been
durability, safety (operator and patient), and temperature/humidity testing have in durability, safety (operator and patient), and Spirolab and Spirolab and Spirolab Within it completed. The results demonstrates mar the MIX Spread in specifications.

Spirometry testing was performed according with American Thoracic Society (ATS) Spirometry testing was performed according was

#### 8. Conclusions

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 the I his summaly on "STO(K) Saree) - Saree) - SMDA 1990 and 21 CFR 807.92.
accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract design of an eagle or bird-like figure with three curved lines representing its wings or feathers. The logo is surrounded by the words "HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 16 2008

Mr. Simon Fowler Sales Manager M.I.R. Medical International Research (MIR) Via Del Maggiolino, 125 00155 Roma-Italy

Re: K052140

Trade/Device Name: Spirolab, Spirolab II Regulation Number: 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: March 2, 2006 Received: March 6, 2006

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 cquivalent (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.

{3}------------------------------------------------

Page 2 - Mr. Fowler

Please be advised that FDA's issuance of a substantial equivalence determination does not r read 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. or the Fet of any - east is requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instile to as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirely, 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), 11 you dontact 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,

Susan Rums
Chiu 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

{4}------------------------------------------------

# Indications for Use

510(k) Number: K052140

Device Name: Spirolab, Spirolab II

Device Name: Spirolab and Spirolab II spirometers are intended to be used by
Indications for Use: The Spirolab and Spirolab to test lung function in people of all Indications for Use: The Spirolab and Spirolab II spirohelels and Spirolabor in Spiraly
either a physician, respiratory therapist or technician to test inn function in people either a physician, respiratory merapist of techniqui-for any and in any setting.

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

Over-The-Counter Use ___ (21 CFR 801 Subpart C)

(Fall 21 Of NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suser Punor

-av General Hospital

KG 52140

Page 1 of 1