(355 days)
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No
The document describes a standard spirometer and pulse oximeter with data transmission capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is intended to test lung function and measure oximetry readings, which are diagnostic purposes for monitoring health, not for treating conditions.
Yes
The device is intended to test lung function and perform spirometry testing and oximetry readings, which are diagnostic procedures to assess a patient's health status.
No
The device description explicitly states it is made up of a "central unit," a "removable sensor for the measurement of respiratory air flow and volume," and a "removable pulse oximetry sensor," all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Spirodoc Spirometer and pulse oximeter measures lung function (spirometry) and blood oxygen saturation/pulse rate (oximetry). These measurements are taken directly from the patient's body (breathing into the device, placing a sensor on a finger), not from a sample taken from the body.
- Intended Use: The intended use describes testing lung function and taking oximetry readings, which are physiological measurements, not diagnostic tests performed on samples.
Therefore, the Spirodoc falls under the category of a medical device that performs physiological measurements, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spirodoc Spirometer and pulse oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician.
The device is intended to test lung function and can perform spirometry testing in adult and pediatric patients, excluding infants and neonates, and oximetry readings in patients of all ages.
Product codes (comma separated list FDA assigned to the subject device)
BZG, DQA
Device Description
Spirodoc is a pocket-size spirometer and oximeter.
The device is made up of:
- a central unit which measures and collects information related to the state of health of the patient, with wireless or cable transmission of the collected data using a microprocessor based system with a touch screen display, USB communication port and Bluetooth, .
- a removable sensor for the measurement of respiratory air flow and volume, ﮯ
- a removable pulse oximetry sensor -
Stored data can be then delivered through landline, broadband, wireless and cell-phone technology to be received by a web server and can then be accessed by medical staff.
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
lung
Indicated Patient Age Range
adult and pediatric patients, excluding infants and neonates, and oximetry readings in patients of all ages.
Intended User / Care Setting
used by a physician or by a patient under the prescribed use of a physician.
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
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.
The accuracy of SpO2 and pulse rate have been verified in-house using an optical simulator. The results obtained were within specification.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was done to ensure that the Spirodoc 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 Spirodoc 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.
The accuracy of SpO2 and pulse rate have been verified in-house using an optical simulator. The results obtained were within specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
NOV 2 1 2011
Image /page/0/Picture/1 description: The image shows the logo for Medical International Research (MIR). The logo consists of a stylized, interconnected "M" shape above the letters "MIR" in bold, sans-serif font. Below the letters, the full name "MEDICAL INTERNATIONAL RESEARCH" is written in a smaller, sans-serif font.
1
510(k) Summary
K 103530
1. Applicant Information
| Date Prepared: | November 09, 2011 |
|---|---|
| Submitter: | MIR Medical International Research |
| Address: | Via del Maggiolino, 125 |
| 00155 Roma -- Italy | |
| Contact Person: | Ed Kohere |
| Phone Number: | +39 06.22.754.777 |
| Mobile Number: | (719) 337-3947 |
2. Device Information
Trade Name: Spirodoc Classification Name: spirometer and oximeter
3. Identification of legally marketed device to which the submitter claims equivalence:
| Company Name: | MIR |
|---|---|
| Device Name: | Spirobank II |
| 510(k) number: | K061712 |
4. Description of the device:
Spirodoc is a pocket-size spirometer and oximeter.
The device is made up of:
- a central unit which measures and collects information related to the state of health of the patient, with wireless or cable transmission of the collected data using a microprocessor based system with a touch screen display, USB communication port and Bluetooth, .
- a removable sensor for the measurement of respiratory air flow and volume, ﮯ
- a removable pulse oximetry sensor -
Stored data can be then delivered through landline, broadband, wireless and cell-phone technology to be received by a web server and can then be accessed by medical staff.
5. Statement of Intended Use:
The Spirodoc Spirometer and pulse oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician.
1
The device is intended to test lung function and can perform spirometry testing in adult and pediatric patients, excluding infants and neonates, and oximetry readings in patients of all ages.
6. Summary of the technological characteristics of the new device in comparison to those of the predicate device:
Spirodoc uses the same measurement method and sensors, and calculates the same parameters as the predicate device.
It has a new enclosure, whose thickness is half that of the predicate device. The part accommodating the spirometry sensor (turbine) is now detachable. It uses a touch-screen display instead of a keyboard.
It uses a new microprocessor (and a new PCB), and the same oximetry board as the predicate device.
7. Brief discussion of the clinical and nonclinical tests relied on for a determination of SE.
Testing was done to ensure that the Spirodoc 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 Spirodoc 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.
The accuracy of SpO2 and pulse rate 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 device.
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Mr. Ed Kohere President Medical International Research USA, Incorporated 1900 Pewaukee Road, Suite O Waukesha, Wisconsin 53188
NOW 2 1- 2011
Re: K103530
Trade/Device Name: Spirodoc Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG, DQA Dated: November 9, 2011 Received: November 14, 2011
Dear Mr. Kohere:
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. Iisting 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 – Mr. Kohere
Please be advised that ITDA'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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. 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: K103530
Device Name: Spirodoc
Indications for Use: The Spirodoc Spirometer and pulse oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician.
The device is intended to test lung function and can perform spirometry testing in adult and pediatric patients, excluding infants and neonates, and oximetry readings in patients of all ages.
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)
L. Ashulthon
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K(03530
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