SPIROTEL

K130784 · Mir Medical Intl. Research Srl · BZG · Oct 30, 2013 · Anesthesiology

Device Facts

• Record ID: K130784
• Device Name: SPIROTEL
• Applicant: Mir Medical Intl. Research Srl
• Product Code: BZG · Anesthesiology
• Decision Date: Oct 30, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1840
• Device Class: Class 2

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 pocket-sized diagnostic spirometer with optional pulse oximetry. Spirometry uses a bi-directional turbine with infra-red light interruption to measure airflow and volume (FVC, FEV1, PEF, etc.). Oximetry uses red and infra-red LEDs to measure SpO2 and pulse rate via finger absorption. Device operates autonomously or connects to PC via USB, Bluetooth, or GSM/GPRS/EDGE. Used by physicians, paramedics, or patients in homes, clinics, or hospitals. Data is transmitted to PCs or via email/SMS for clinical review. Provides objective respiratory and oxygenation metrics to assist in patient monitoring and clinical decision-making.

Clinical Evidence

Bench testing only. Spirometry accuracy verified against American Thoracic Society (ATS) standards. Oximetry accuracy (SpO2 and pulse rate) verified using optical simulators per FDA guidelines and ISO 9919:2005. Data transmission integrity (USB, Bluetooth, GSM) verified in-house. Battery performance and safety verified for the new rechargeable Li-ion power system.

Technological Characteristics

Bi-directional turbine (infra-red interruption) for spirometry; dual-LED (red/IR) sensor for oximetry. Enclosure: PC and ABS+PC. Power: 3.7V 1100mAh Li-ion battery. Connectivity: USB 2.0, Bluetooth (2402-2480 MHz), GSM (Quad-Band). Processor: ATMEL UC3A0512. Memory: Flash AT49BV320D. Standards: EN 60601-1, EN 60601-1-2, ISO 9919:2005, ATS spirometry standards.

Indications for Use

Indicated for lung function testing in patients of all ages. Intended for use by physicians, paramedics, or patients under professional instruction 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 (K043528)
• Spirodoc (K082766)
• Minispir (K122384)

Submission Summary (Full Text)

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**OCT** 30 2013

# 510 (k) Summary

# 1. Applicant Information

| Date Prepared: | Oct 30, 2013 |
|-----------------|-----------------------------------------------|
| Submitter: | MIR Medical International Research |
| Address: | Via del Maggiolino, 125<br>00155 Roma - Italy |
| Contact Person: | Gerda Van Houts |
| Phone Number: | +39 06.22.754.777 |

## 2. Device Information

| Trade Name: | Spirotel |
|----------------------|------------------------|
| <i>As spirometer</i> | |
| Classification Name: | Spirometer, diagnostic |
| Regulation Number | 868.1840 |
| Product code | BZG |
| <i>As oximeter</i> | |
| Classification Name | Oximeter |
| Regulation Number | 870.2700 |
| Product code | DQA |

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

| Company Name: | MIR Medical International Research |
|----------------|------------------------------------|
| Device Name: | Spirotel |
| 510(k) number: | K043528 |

### 4. Description of the device:

Spirotel is a pocket spirometer that can also feature a pulse oximeter function (optional). It measures a range of functional respiratory parameters, and the oxygen saturation and pulse rate.

The device can operate completely autonomously or can be connected to a personal computer by means of various types of connections: USB, Bluetooth, GSM.

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| Option | BT | GSM | SpO2 | Ref. Code |
|-----------------|-----|-----|------|-----------|
| - | No | No | No | 9107000 |
| SpO2 | No | No | Yes | 9107001 |
| GSM | No | Yes | No | 9107010 |
| GSM + SpO2 | No | Yes | Yes | 9107011 |
| BT | Yes | No | No | 9107100 |
| BT + SpO2 | Yes | No | Yes | 9107101 |
| BT + GSM | Yes | Yes | No | 9107110 |
| BT + GSM + SpO2 | Yes | Yes | Yes | 9107111 |

The device is identified as follows, according with the presence/absence of the options Bluetooth, GSM, SpO2:

#### Spirometry function

A turbine inside the device that uses the interruption of infra-red light as its operating principle, measures volume and flow rate.

#### Parameters measured

| Symbol | Description | Units |
|----------|-----------------------------------------|-------|
| FVC | Forced Vital Capacity | L |
| FEV1 | Volume exhaled in 1st second of test | L |
| FEV1% | $FEV1/FVC x 100$ | % |
| PEF | Peak expiratory flow | L/m |
| FEF-2575 | Average flow between 25% and 75% of FVC | L/s |

### Oximetry function

The oximetry sensor features two light emitting diodes (LED), one emits visible red light and the other infra-red. Both bands of light pass through the finger to reach a light detector. During the passage through the finger, some of the light is absorbed by the blood and soft tissue depending on the concentration of haemoglobin. The amount of each light frequency absorbed depends on how oxygenated the blood is inside the tissue.

#### Technical specifications

| Spirometry function | |
|------------------------------|------------------------|
| Flow/volume sensor | Bi-directional turbine |
| Temperature sensor | semiconductor (0-45°C) |
| Method of detection | Infra-red interruption |
| Maximum volume measured | 10 L |
| Volume accuracy | $\pm$ 3% or 50 mL |
| Flow rate measurement range | $\pm$ 16 L/s |
| Flow rate accuracy | $\pm$ 5% or 200 mL/s |
| Dynamic resistance at 12 L/s | <0.5 cmH2O/L/s |

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| Oximetry function | |
|------------------------------|------------------------------------|
| Method of detection | Red and infra-red light absorption |
| SpO2 measurement range | 0 - 99% (with 1% increments) |
| SpO2 resolution | 1% |
| SpO2 accuracy | ± 2% (between 70-100% SpO2) |
| Pulse rate measurement range | 30 – 300 BPM |
| Pulse rate resolution | 1 BPM |
| Pulse rate accuracy | ± 2 BPM or 2% whichever is greater |

Bluetooth function

| Operating frequency range | 2402 - 2480 MHz |
|---------------------------|---------------------------------|
| Number of antennas | 1 |
| Antenna type | Integrated ceramic chip antenna |
| Output power | 0.1 mW |

GSM function

| Band | Quad-Band 850/900/1800/1900 MHz |
|------------------------|-----------------------------------|
| Communication standard | EDGE (E-GPRS) multi-slot class 10 |
| Antenna type | Internal |
| Antenna gain | gain 2.42 dBi |

Other specifications

| Power supply | Li-ion 3.7 V 1100mAh battery |
|--------------|--------------------------------|
| Dimensions | 88x74x38 mm; |
| Weight | 151 g (including battery pack) |

# 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 devices:

The new device has the following characteristics:

- light restyling of the enclosure to adapt to the new larger graphic display with touchscreen. Enclosure material is the same as the material used in Spirodoc (K082766)
- recheargeable battery
- same oximetry board and oximetry sensors as used in Minispir (K122384)
- data transmission based on new technologies as USB 2.0, Bluetooth (optional) and GSM/GPRS/EDGE (optional)
- new Main Board

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# Detailed description of the modification

| Modification | Description of modification<br>Spirotel (subject device) | | predicate device<br>name and 510(k)<br>number |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------|
| Enclosure | Light restyling of the enclosure to<br>adapt to the new larger graphic<br>display with touchscreen. | | |
| | Color is white with an orange stripe<br>which goes all around the device. | Same color as | Spirodoc (K082766) |
| | Material has changed to PC (orange<br>part of the enclosure) and ABS + PC<br>(white part of the enclosure). | Same material as | Spirodoc (K082766) |
| Dimensions | 74 x 88 x 38 mm | 70 x 80 x 30 mm | Spirotel (K043528) |
| Weight | 151 g | 100 g | Spirotel (K043528) |
| Display | LCD backlit touch screen display,<br>resolution 160 x 80 | STN LCD, 2 lines x 16<br>alphanumeric characters | Spirotel (K043528) |
| Keyboard | None | Membrane, 5 keys | Spirotel (K043528) |
| Power supply | 3.7V, 1100mA rechargeable lithium-<br>ion battery | 3V Lithium battery CR123A | Spirotel (K043528) |
| Oximetry board | MIR 046 | Same board as | Minispir (K122384) |
| Oximetry sensors | BCI 1300<br>BCI 3026<br>BCI 3043<br>BCI 3078<br>BCI 3178<br>BCI 3444<br>BCI 3044 | Same sensors as | Minispir (K122384) |
| Oximetry sensor connector | Mini HDMI | Same connector as | Minispir (K122384) |
| Spirometry Board | MIR 043<br>Processor: ATMEL UC3A0512<br>Memory: Flash AT49BV320D (4M)<br>RTC: embedded in the ferro-<br>magnetic RAM FM33256 | MIR 007<br>Processor: Motorola 68HC11F1<br>Memory: SRAM TC551001 (1M)<br>RTC: DS2417 | Spirotel (K043528) |
| Data transmission | USB 2.0<br>Bluetooth (optional)<br>GSM, GPRS, EDGE (optional) | RS 232<br>Acoustic coupling via telephone | Spirotel (K043528) |

# 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 is substantially equivalent to the predicate device within the environments for which it is to be marketed.

Safety and environmental testing was conducted in accordance with EN 60601-1:2006 and EN 60601-1-2:2007. Electromagnetic compatibility (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing have been completed. The results demonstrates that the MIR Spirotel is in compliance with the guideline and standards referenced and that it performs within its specifications.

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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 oximetry parameters SpO2 and pulse rate has been verified in-house using an optical simulator. The results obtained were within the range of accuracy required by FDA guideline on Pulse Oximeters and ISO 9919:2005.

A battery testing was performed on the rechargeable battery (3.7V, 1100mA lithium-ion battery) which replaces the primary cell battery (3V CR123A Lithium battery) of the predicate Spirotel, in order to verify charging performance in normal condition and safety in short-circuits condition. Test showed that duration of the battery is approximately the same as the predicate Spirotel.

USB 2.0 transmission replaces RS232 transmission of the predicate Spirotel. A verification of integrity of data transmitted via USB 2.0 to a Personal Computer has been carried out inhouse and the results have shown that data were received without corruption.

Bluetooth transmission is performed using the proprietary module MIR 045 which has been FCC certified by a third party laboratory (FCCID: TUK-MIR045).

A verification of integrity of data transmitted via Bluetooth to a Personal Computer has been carried out in-house and the results have shown that data were received without corruption.

# GSM/GPRS/EDGE transmission is performed using an FCC approved module.

A verification of the integration of the module into Spirotel has been carried out by the manufacturer of the module.

A verification of integrity of data transmitted (e-mail message with attached archive sent to a specific email address, or SMS message sent to a specific mobile phone) has been carried out in-house and the results have shown that data were received without corruption.

#### 8. Conclusions

Based on these results, it is our determination that the device is substantially equivalent to the legally marketed device.

This summary on 510(k) substantial equivalence information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 30, 2013

M.I.R. Medical International Research Ms. Gerda Van Houts Export Area Manager Via Del Maggiolino, 125 Roma - Italy 00155

Re: K130784

Trade/Device Name: Spirotel Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG, DQA Dated: September 12, 2013 Received: September 27, 2013

Dear Ms. Van Houts:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 -- Ms. Van Houts

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

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Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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): ¥1307 8 Y

Device Name: Spirotel

Indications for 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 singlepatient device and can be used in any setting - home, factory, pharmacy, hospital or physician's office.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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