SPIROTEL

K043528 · Mir Medical Intl. Research Srl · BZG · Jul 19, 2005 · Anesthesiology

Device Facts

• Record ID: K043528
• Device Name: SPIROTEL
• Applicant: Mir Medical Intl. Research Srl
• Product Code: BZG · Anesthesiology
• Decision Date: Jul 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Spirotel spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a single-patient device and can be used in any setting – home, factory, pharmacy, hospital or physician's office.

Device Story

Spirotel is a 100g pocket-sized device combining spirometry and pulse oximetry. It measures functional respiratory parameters, oxygen saturation, and pulse rate. The device integrates an OEM oximeter board using technology from the BCI 3420 Digit Pulse Oximeter. It is intended for use by physicians or patients (under instruction) in various settings including homes, hospitals, and clinics. The device provides quantitative data to healthcare providers to assist in assessing lung function and monitoring patient vitals. It benefits patients by enabling portable, accessible respiratory and pulse monitoring.

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 accuracy requirements. Pulse oximetry performance validated via a desaturation trial; results were within specification.

Technological Characteristics

Pocket-sized (100g) spirometer and pulse oximeter. Integrates an OEM oximeter board. Complies with EN 60601-1:1990 for safety, EMC, and electrical/mechanical durability. Designed for single-patient use.

Indications for Use

Indicated for lung function testing and monitoring of oxygen saturation and pulse rate in patients of all ages. Intended for use by physicians or patients under the instruction of a physician or paramedic. Single-patient use in home, clinical, or occupational settings.

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

• Spirotel, Model 29-1020 (K031643)
• BCI, Inc. 3420 "Digit" Pulse Oximeter (K013171)

Submission Summary (Full Text)

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

JUL 19 2005

K043528

Image /page/0/Picture/2 description: The image shows the logo for MIR Medical International Research. The logo consists of a stylized graphic element resembling three interconnected arches, followed by the letters "MIR" in bold, sans-serif font. Below the graphic and letters, the words "MEDICAL INTERNATIONAL RESEARCH" are printed in a smaller, sans-serif font.

# Summary of Safety and Effectiveness

## 1. Applicant Information

| Date Prepared: | July 8, 2004 |
|-----------------|-----------------------------------------------|
| 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

Spirotel Trade Name: Classification Name: spirometer and oximeter

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

| Company Name: | SDI Diagnostics, Inc. |
|----------------|--------------------------|
| Device Name: | Spirotel, Model 29-1020. |
| 510(k) number: | K031643 |

BCI, Inc. Company Name: 3420 "Digit" Pulse Oximeter. Device Name: K013171 510(k) number:

## 4. Description of the device:

MIR Spirotel is a simple to operate precise pocket spirometer and pulse oximeter (weight only 100g). It measures the most important functional respiratory parameters and monitors the oxygen saturation and pulse rate.

## 5. Statement of Intended Use:

The Spirotel spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a single-patient device and can be used in any setting home, factory, pharmacy, hospital or physician's office.

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

MIR Spirotel combines in a single device the functions of a spirometer and a pulse oximeter. It is derived from the SDI Diagnostics Spirotel, to which the pulse oximetry function has been

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

added, through an OEM Oximeter Board, which uses the same technology found in the legally marketed BCI 3420 "Digit" Pulse Oximeter.

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

Testing was done to ensure that the MIR Spirotel 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 Saley and Cirillonmental teoling was ormatibility (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing have been completed. The salery (oporator and the MIR Spirotel 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.

For oximetry testing a desaturation trial was conducted. 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.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three heads, representing the department's focus on health, well-being, and human services. The figure is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2005

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

Re: K043528

Trade/Device Name: SPIROTEL Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG, DQA Dated: June 30, 2005 Received: July 5, 2005

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 for association 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 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 or any I oderal butther and st requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IC Fat 6077; laboring (21 CFR Part 820); and if applicable, the electronic form in the quand, 25wd provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of to begin marketing your device as described in your Section 510(k) I this loter with acation. The FDA finding of substantial equivalence of your device to a legally promatication "The 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 If you desire 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 other general micronianter 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,

Suite y. Michie M-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 (if known):

Device Name: Spirotel

Indications for Use: The Spirotel spirometer and pulse oximeter is intended to be Indications for Use. The Spiroter Spirometer and paraction of a physician or paramedic
used by a physician or by a patient under the instruction of a physician or paramedic used by a physician of by a patient ander the measured to be used as a singleto test lung function in people of all ages. It is also intended to be used as a singleto test lung function in people of all agos: it is also incometer
patient device and can be used in any setting – home, factory, pharmacy, hospital or physician's office.

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)

MLLY

(Division Sign-Off) Division of Anesthesiotogy, General Hospital Infection Control, Dental Device

510(k) Number: