(355 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Spirodoc device:
Acceptance Criteria and Device Performance for Spirodoc
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Spirometry Function | Accuracy within American Thoracic Society (ATS) Standards | "The results obtained were within the range of accuracy required by ATS." |
| Pulse Oximetry (SpO2) Accuracy | Within predefined specifications | "The results obtained were within specification." |
| Pulse Oximetry (Pulse Rate) Accuracy | Within predefined specifications | "The results obtained were within specification." |
| Safety | Compliance with EN 60601-1:1990 | "The results demonstrates that the Spirodoc is in compliance with the guideline and standards referenced..." |
| Electromagnetic Compatibility (EMC) | Compliance with EN 60601-1-2:1993 | "...and that it performs within its specifications." |
| Electrical Safety | Compliance with relevant standards | "The results demonstrates that the Spirodoc is in compliance with the guideline and standards referenced..." |
| Mechanical Durability | Compliance with relevant standards | "The results demonstrates that the Spirodoc is in compliance with the guideline and standards referenced..." |
| Temperature/Humidity | Compliance with relevant standards | "The results demonstrates that the Spirodoc is in compliance with the guideline and standards referenced..." |
| Overall Performance | Safe, effective, and performs as well as the legally marketed predicate device (Spirobank II) | "Based on these results, it is our determination that the device is safe, effective, and performs as well as the legally marketed device." |
2. Sample Size Used for the Test Set and Data Provenance
- Spirometry: "Clinical testing of both spirometry and pulse oximetry functions" was performed. The specific sample size (number of patients) used for spirometry testing is not explicitly stated in the provided document. The data provenance is clinical testing, implying prospective data collection during the study. The country of origin for the data is not specified.
- Pulse Oximetry: "Accuracy of SpO2 and pulse rate have been verified in-house using an optical simulator." The specific sample size (number of data points or tests) for the optical simulator is not explicitly stated. This suggests the data was generated in a lab setting rather than from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Spirometry: For the clinical spirometry testing, the document states "Spirometry testing was performed according with American Thoracic Society (ATS) Standards." While ATS standards involve expert interpretation and quality control, the document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the test set of patients. It implies that the test results were compared against ATS accuracy requirements, which are derived from a consensus of experts in the field.
- Pulse Oximetry: Ground truth was established using an "optical simulator." This is an artificial standard, not based on human expert review. No human experts were involved in establishing this ground truth.
4. Adjudication Method for the Test Set
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for either the spirometry or pulse oximetry test sets. For spirometry, it simply states results were compared against ATS standards. For oximetry, an optical simulator was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported. The study focused on the device's standalone performance against established standards and an optical simulator. There is no mention of human readers or AI assistance.
6. Standalone Performance Study
- Yes, a standalone study was done. The entire clinical and nonclinical testing described is focused on the device's inherent performance (algorithm only, in a sense, as it refers to the device's computational outputs) without a human-in-the-loop component being evaluated for its impact on human performance. The device's spirometry measurements were compared against ATS standards, and its oximetry readings against an optical simulator, both representing standalone performance evaluations.
7. Type of Ground Truth Used
- Spirometry: The ground truth used was adherence to American Thoracic Society (ATS) Standards. While ATS standards are developed by experts and based on clinical evidence, the document doesn't detail how "ground truth" was established for individual patient cases in the test set. It suggests that the device's output itself was evaluated for accuracy against these established norms.
- Pulse Oximetry: The ground truth for SpO2 and pulse rate was established using an optical simulator, which provides a known, precise input for testing.
8. Sample Size for the Training Set
- The document does not provide any information regarding the sample size for a training set. As this is a medical device approval that primarily focuses on equivalence and performance against established standards, and not an AI/machine learning algorithm that typically requires a large training set, the concept of a "training set" in the context of this 510(k) summary is not applicable or discussed. The device uses known measurement methods and sensors.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As no training set is mentioned or implied for an AI/machine learning model, the method for establishing its ground truth is not discussed.
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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.
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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.
:
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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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§ 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).