K Number
K072979
Device Name
SPIROBANK G
Date Cleared
2007-12-26

(65 days)

Product Code
Regulation Number
868.1840
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
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.
More Information

K983909, KK061712

Not Found

No
The document does not mention AI, ML, or any related concepts like training or test sets for algorithms. The focus is on standard spirometry measurements and connectivity.

No.
The device is used to test lung function and calculate spirometric parameters, which is a diagnostic function, not a therapeutic one.

Yes
The device is intended to "test lung function" and "can make spirometry testing," which are diagnostic activities. It also "calculates more than 30 spirometric parameters" for the "total valuation of lung function," indicating its use in diagnosing or evaluating conditions.

No

The device description explicitly states "Spirobank G is a spirometer designed to facilitate the total valuation of lung function," indicating it is a physical device that measures lung function, not solely software. The performance studies also mention testing related to electrical, mechanical durability, and temperature/humidity, which are characteristic of hardware testing.

Based on the provided information, the Spirobank G spirometer is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
  • Spirobank G Function: The Spirobank G measures lung function by having the patient breathe into the device. This is a direct measurement of a physiological process occurring within the body, not an examination of a specimen derived from the body.
  • Intended Use: The intended use describes testing lung function in people, which is a physiological measurement.

Therefore, the Spirobank G is a medical device used for physiological measurement, not an IVD.

N/A

Intended Use / 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.

Product codes

BZG

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lung function

Indicated Patient Age Range

people of all ages, excluding infants and neonates.

Intended User / Care Setting

used by a physician or by a patient under the instruction of a physician or paramedic. It can be used in any setting.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K983909, KK061712

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 868.1840 Diagnostic spirometer.

(a)
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.(b)
Classification. Class II (performance standards).

0

Image /page/0/Picture/0 description: The image shows the logo for MIR Medical International Research. The logo consists of a stylized, interconnected "M" shape on the left, followed by the letters "MIR" in bold, sans-serif font. Below the logo, the words "MEDICAL INTERNATIONAL RESEARCH" are printed in a smaller, sans-serif font, completing the company's name.

Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string is "K072979". The characters are written in a dark ink on a white background. The handwriting is somewhat stylized.

Summary of Safety and Effectiveness

1. Applicant Information

Date Prepared:October 03, 2007
Submitter:MIR Medical International Research
Address:Via del Maggiolino, 125
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.

1

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.

2

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.

3

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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

4

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

Page 1 of 1

510(k) Number: K072979