MODIFICATION TO MINISPIR, SPIROLAB III

K082766 · Mir Medical Intl. Research Srl · BZG · Dec 17, 2008 · Anesthesiology

Device Facts

• Record ID: K082766
• Device Name: MODIFICATION TO MINISPIR, SPIROLAB III
• Applicant: Mir Medical Intl. Research Srl
• Product Code: BZG · Anesthesiology
• Decision Date: Dec 17, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Minispir - Spirolab III spirometers and pulse oximeters are intended to be used by either a physician, respiratory therapist or technician. The devices are intended to test lung function and can make: spirometry testing in people of all ages, excluding infants and neonates. oximetry testing in people of all ages. They can be used in any setting.

Device Story

Minispir and Spirolab III are respiratory analysis instruments performing FVC, VC, and MVV spirometry tests; integrated oximetry option measures %SpO2 and pulse rate. Inputs include airflow via external turbine sensor and oximetry signals. Device calculates spirometric parameters, predicted values, and percentage deviations; interprets FVC tests per ATS/ERS standards; computes statistical parameters from SpO2/pulse data. Operated by physicians, respiratory therapists, or technicians in any setting. Spirolab III features integrated display/keyboard/printer; Minispir connects to PC for result visualization. Output provides clinicians with diagnostic respiratory data to support clinical decision-making and patient monitoring.

Clinical Evidence

Bench testing only. Safety/EMC testing per EN 60601-1 and EN 60601-1-2. Spirometry accuracy verified against American Thoracic Society (ATS) standards. SpO2 and pulse rate accuracy verified using optical simulator. No clinical trial data presented.

Technological Characteristics

Spirometry via external turbine flow sensor; oximetry via integrated board. Spirolab III includes keyboard, display, and printer. Minispir is PC-connected. Compliance with EN 60601-1 (safety) and EN 60601-1-2 (EMC). Algorithms for spirometry and oximetry parameters are identical to predicate devices.

Indications for Use

Indicated for lung function testing in patients of all ages (excluding infants/neonates for spirometry) and pulse oximetry testing in patients of all ages. Intended for use by physicians, respiratory therapists, or technicians 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

• MIR Spirolab (K052140)
• MIR Spirotel

Submission Summary (Full Text)

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MEDICAL INTERNATIONAL RESEARCH

DEC 1 7 2008

# 510 (k) Summary

#### 1. Applicant Information

| Date Prepared: | June 10, 2008 |
|-----------------|---------------------------------------------|
| Submitter: | MIR Medical International Research |
| Address: | Via del Maggiolino, 125 00155 Roma - Italy |
| Contact Person: | Simon Fowler |
| Phone Number: | +39 06.22.754.777 |

#### 2. Device Information

Minispir - Spirolab III Trade Name: Classification Name: spirometer

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

| Company Name: | MIR Medical |
|----------------|--------------|
| Device Name: | MIR Spirolab |
| 510(k) number: | K052140 |

International Research o II

As Spirometer : Regulation Number 868.1840

As oximeter:

Regulation Number 870.2700 ·

### 4. Description of the device:

MIR Minispir - Spirolab III are instruments for the analysis of respiratory function, which carries out three different spirometric tests, FVC, VC(insp/exp) and MVV, with a calculation of the main spirometric parameters, predicted values and percentage deviations compared to the measured values. Plus Flow/Volume and Volume/time curves and the interpretation of the FVC test following the international spirometry standards (ATS/ERS). What is more Minispir - Spirolab III with their integrated oximetry option, can calculate both Oxygen Saturation (expressed as %SpO2) and Pulse Rate (expressed as Beats Per Minutes- BPM). In additon Minispir - Spirolab III calculate several (up to 20) additional statistical parameters derived from the SpO2 and the pulse rate.

#### 5. Statement of Intended Use:

The Minispir - Spirolab III spirometers and pulse oximeters are intended to be used by either a physician, respiratory therapist or technician.

The devices are intended to test lung function and can make:

spirometry testing in people of all ages, excluding infants and neonates.

- oximetry testing in people of all ages. ♥

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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:

## Spirometry function (for both Minispir and Spirolab III) The MIR Spirolab III has the

- same intended use .
- same operating principle .
- same spirometry parameters .
- same algorithms for spirometry parameters calculation .
- same physical aspect (keyboard, display, size and weight) .
- same printer .

as the Spirolab II.

The main differences between Spirolab III and Spirolab II are shortly described as follow:

- Spirolab III has an integrated oximetric option, so it can calculate both Oxygen . Saturation (expressed as %SpO2) and Pulse Rate (expressed as Beats Per Minutes-BPM).
- Spirolab III has an additional function key to address directly the operator to the oximetric ● functions.
- The Software of both spirometers use the same algorithms for spirometric values � calculations, but the language is different.
- The flow sensor of both Spirolab III and Spirolab II is outside the device. The flow sensor . of Spirolab III is Minispir . However the Minispir's sensor and turbine are the same as those used in the cleared Spirolab II.

### MIR Minispir has the

- same intended use .
- same operating principle .
- same spirometry parameters .
- same algorithms for spirometry parameters calculation
- same turbine
- same sensor and mouthpiece holders

as the Spirolab II.

Minispir has different size, weight and physical aspect from the cleared Spirolab II. In fact Minispir doesn't have any keyboard and display and it is connected to a PC to show the calculated spirometric results.

### Oximetry function (for both Minispir and Spirolab III)

The MIR Minispir - Spirolab III have the same pulse oximetry function as the cleared MIR Spirotel.

### The MIR Minispir - Spirolab III have the

- same intended use
- same operating principle
- same sensors . . .
- same oximetry board
- same oximetry parameters (SpO2, pulse rate)
- same algorithms for oximetry parameters calculation

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### as the MIR Spirotel.

Minispir - Spirolab III calculates more oximetry parameters than Spirotel

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 Minispir - Spirolab III 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 MIR Minispir - Spirolab III are in compliance with the guidelines and standards referenced and that they performs within their specifications.

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 and the statistical parameters which the devices calculate, 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 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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Simon Fowler MIR Medical International Research SRL Via Del Maggiolino, 125 Roma ITALY 00155

# DEC 1 7 2008

Re: K082766

Trade/Device Name: Minispir - Spirolab III Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG, DQA Dated: November 4, 2008 Received: November 17, 2008

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 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. 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Syjite Y. Mohan MD

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 (if known):

バイ

Device Name: Minispir -Spirolab III

Indications for Use: The MIR Minispir - Spirolab III spirometers and pulse oximeters are intended to be used by either a physician, respiratory therapist or technician.

The devices are intended to test lung function and can make:

- spirometry testing in people of all ages, excluding infants and neonates.
- oximetry testing in people of all ages.

They can be used in any setting.

Prescription Use X (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)

Saute Michau Dus

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

510(k) Number: k082766