(223 days)
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No
The summary describes a device for measuring respiratory parameters and oxygen saturation, focusing on hardware features, connectivity, and performance testing against standards. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is intended for testing lung function and measuring oxygen saturation and pulse rate, which are diagnostic and monitoring functions, not therapeutic.
Yes.
Explanation: The device is intended "to test lung function" and "measures a range of functional respiratory parameters, and the oxygen saturation and pulse rate," which are all diagnostic activities.
No
The device description explicitly states it is a "pocket spirometer" and can feature a "pulse oximeter function (optional)". It also mentions measuring "functional respiratory parameters, and the oxygen saturation and pulse rate". Furthermore, the performance studies detail testing related to electrical, mechanical durability, and a rechargeable battery, all indicative of a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as testing lung function and measuring oxygen saturation and pulse rate. These are physiological measurements taken directly from the patient's body.
- Device Description: The description confirms it's a spirometer and pulse oximeter, which are devices that measure physical parameters of the respiratory and circulatory systems.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze such specimens.
The device is a medical device used for physiological measurements, not an in vitro diagnostic device.
N/A
Intended Use / 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 single-patient device and can be used in any setting home, factory, pharmacy, hospital or physician's office.
Product codes
BZG, DQA
Device Description
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.
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.
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Finger (for oximetry function)
Indicated Patient Age Range
all ages
Intended User / Care Setting
Physician or patient under the instruction of a physician or paramedic.
Settings: home, factory, pharmacy, hospital or physician's office.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety and environmental testing: Conducted in accordance with EN 60601-1:2006 and EN 60601-1-2:2007. Results demonstrate compliance with guidelines and standards and performance within specifications.
Spirometry testing: Performed according to American Thoracic Society (ATS) Standards. Results obtained were within the range of accuracy required by ATS.
Oximetry accuracy: Verified in-house using an optical simulator. Results obtained were within the range of accuracy required by FDA guideline on Pulse Oximeters and ISO 9919:2005.
Battery testing: Performed on the rechargeable battery (3.7V, 1100mA lithium-ion battery) to verify charging performance and safety. Test showed duration is approximately the same as the predicate.
USB 2.0 transmission: Verification of integrity of data transmitted via USB 2.0 to a Personal Computer carried out in-house. Results shown data received without corruption.
Bluetooth transmission: Verification of integrity of data transmitted via Bluetooth to a Personal Computer carried out in-house. Results shown data received without corruption.
GSM/GPRS/EDGE transmission: Verification of the integration of the module into Spirotel carried out by the manufacturer of the module. 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) carried out in-house. Results shown data received without corruption.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/1 description: The image shows the logo for Medical International Research (MIR). The logo consists of a stylized, three-peaked mountain range above the letters "MIR" in bold, sans-serif font. Below the logo is the full name of the company, "MEDICAL INTERNATIONAL RESEARCH," in a smaller, sans-serif font.
OCT 30 2013
510 (k) Summary
1. Applicant Information
| Date Prepared: | Oct 30, 2013 |
|---|---|
| Submitter: | MIR Medical International Research |
| Address: | Via del Maggiolino, 125 |
| 00155 Roma - Italy | |
| Contact Person: | Gerda Van Houts |
| Phone Number: | +39 06.22.754.777 |
2. Device Information
| Trade Name: | Spirotel |
|---|---|
| As spirometer | |
| Classification Name: | Spirometer, diagnostic |
| Regulation Number | 868.1840 |
| Product code | BZG |
| As oximeter | |
| 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.
1
| 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 |