(27 days)
- Device Functionality: Spirometry .
- Primary Spirometric Parameters: FVC, MVV, SVC and FEF .
- Patient Population: Male/Female, Pediatric to Adult .
- Environment of Use: Hospital, Clinic and Home Use under trained professional supervision (Prescription Use)
The QRS Diagnostic Orbit Spirometer is intended for the acquisition, analysis, display and print of measurements and waveforms of pulmonary function for the purposes of assily any clinicians in the diagnosis of various pulmonary function diseases and/or treatment regimens.
The QRS Orbit product model Z-7000-0101 consisting of a spirometer, pressure tube, disposable pneumotachometer, Office Medic Software and a host computer is a compact and versatile personal computer (PC) based pulmonary function analyzer (spirometer). The product measures a patient's expiratory and inspiratory airflow, analyzes the data with print options that includes the measured and predicted values and flow vs. volume or volume vs. time graphs.
The Orbit spirometer includes the following components:
- . Spirometer
- Spirometer Pressure Tube .
- Disposable pneumotachometer (mouthpiece)
- Office Medic Software .
- Host PC (User Provided) .
Here's an analysis of the provided text regarding the QRS Diagnostic Orbit Spirometer, specifically addressing the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The submission indicates that the QRS Diagnostic Orbit Spirometer's performance is demonstrated by its compliance with established standards. The table below summarizes these standards and the reported compliance.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| American Thoracic Society (ATS/ERS) 2005 Standard | Complies |
| Safety IEC/EN 60601-1 3rd Ed. (Medical electrical equipment Part 1: General requirements for basic safety and essential performance) | Complies |
| Electromagnetic Compatibility (EMC) IEC/EN 60601-1-2 3rd Ed. (Medical Electrical Equipment - Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Test) | Complies |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The QRS Diagnostic Orbit Spirometer has been tested or found otherwise to comply with applicable sections of the following standards." However, it does not provide details on the sample size used for performance testing (if human subjects were involved), nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature of the study). The testing primarily focused on compliance with technical standards for spirometers rather than direct clinical performance data from a patient cohort.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since the "study" primarily revolved around testing compliance with technical standards (ATS/ERS, IEC/EN), rather than a clinical trial with patient data and diagnosed outcomes, there's no mention of experts establishing ground truth for a test set in the traditional sense of clinical diagnosis. Compliance with standards would typically be assessed by engineers or technicians with expertise in medical device testing and regulatory standards.
4. Adjudication Method for the Test Set
As there's no mention of a clinical test set requiring diagnostic interpretation, there's no information provided on an adjudication method (like 2+1 or 3+1). The "adjudication" in this context would be the determination of whether the device's measurements meet the specifications outlined in the technical standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported in this document. The submission focuses on demonstrating substantial equivalence to a predicate device (SpiroCard) based on technical specifications and compliance with standards, not on comparing reader performance with and without AI assistance. The device itself is a spirometer, which measures physiological parameters, and not an AI-driven diagnostic imaging interpretation tool that would typically involve a MRMC study.
6. Standalone Performance Study
The "Summary of Performance Testing" refers to testing of the device itself to verify compliance with the listed standards. This implies a standalone performance evaluation (algorithm only performance, in the sense of the device's measurement and calculation capabilities) was conducted against the criteria set by these standards. The device's primary function is to acquire and analyze pulmonary function data, and its performance is judged on the accuracy and reliability of these measurements as per the standards.
7. Type of Ground Truth Used
The ground truth used for this device involves the specifications and requirements outlined in the American Thoracic Society (ATS/ERS) 2005 Standard for spirometry. This standard sets forth the acceptable ranges and accuracy for various spirometric parameters (e.g., volume, flow, timing). The device's measurements were compared against these established technical and physiological benchmarks, which serve as the "ground truth" for its accuracy and functionality.
8. Sample Size for the Training Set
This document describes a medical device (spirometer) that measures physiological parameters. It does not suggest the use of machine learning or AI models that require a "training set" of data in the typical sense. Therefore, there is no information provided about a training set size. The device's functionality is based on established physics and engineering principles, and its "training" would be its design, calibration, and manufacturing processes to meet the defined standards.
9. How the Ground Truth for the Training Set Was Established
Given that there is no indication of a training set for machine learning, this question is not applicable to the information provided. The "ground truth" for the device's operation is inherently built into the design and calibration to comply with the ATS/ERS standards, which are developed by expert consensus in respiratory medicine.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for QRS Music Technologies. The logo consists of the letters "QRS" in a bold, sans-serif font. The letters are connected to each other, forming a single, unified shape. There is a trademark symbol to the right of the letter "S".
Technology in Practice™
Date: 3/15/12
... ...
.
APR 1 9 2012
Submitter: National Biomedical LLC, dba QRS Diagnostic Street Address: 6901 E. Fish Lake Road #188 City: Maple Grove State: MN Zip Code: 55369 Telephone: 763-559-8492 Facsimile: 763-559-2961
Contact: Mary Kay Jensen Phone: 763-515-5323 Facsimile: 763-559-2961 e-mail: mkjensen@grsdiagnostic.com
Device Name:
Trade Name: Orbit Spirometer Common Name: Spirometer Classification Name: Spirometer, Diagnostic Classification: Listed as Class II Panel Code: BZG Regulation Number: 868.1840
Identification of Legally Marketed (Unmodified) Device (Predicate Device):
| Name ofPredicate | Manufacturer | Use | 510K) | DateCleared |
|---|---|---|---|---|
| SpiroCard | QRS Diagnostic | Spirometer | K973138 | 10/8/1998 |
Device Description:
The QRS Orbit product model Z-7000-0101 consisting of a spirometer, pressure tube, disposable pneumotachometer, Office Medic Software and a host computer is a compact and versatile personal computer (PC) based pulmonary function analyzer (spirometer). The product measures a patient's expiratory and inspiratory airflow, analyzes the data with print options that includes the measured and predicted values and flow vs. volume or volume vs. time graphs.
The Orbit spirometer includes the following components:
- . Spirometer
- Spirometer Pressure Tube .
- Disposable pneumotachometer (mouthpiece) �
- Office Medic Software .
{1}------------------------------------------------
- Host PC (User Provided) .
Indications for Use
- Device Functionality: Spirometry .
- Primary Spirometric Parameters: FVC, MVV, SVC and FEF .
- Patient Population: Male/Female, Pediatric to Adult .
- Environment of Use: Hospital, Clinic and Home Use under trained professional . supervision (Prescription Use)
The QRS Diagnostic Orbit Spirometer is intended for the acquisition, analysis, display and print of measurements and waveforms of pulmonary function for the purposes of assily any clinicians in the diagnosis of various pulmonary function diseases and/or treatment regimens.
Technological Comparison to (Unmodified) Predicate Device:
The following summary table of comparisons compares the Modified Orbit Device to the Previously Cleared SpiroCard Device:
| # | Area | Modified Device(Orbit) | Previously ClearedDevice(SpiroCard) | Same | Different |
|---|---|---|---|---|---|
| Indications for Use | |||||
| 1 | Patient Population | Male/FemalePediatric to Adult | Male/FemalePediatric to Adult | X | |
| 2 | Environment of Use | Hospital, Clinic,Home Use | Hospital, Clinic,Home Use | X | |
| Fundamental Scientific Technology | |||||
| 3 | Interpretation Algorithm | InterpretationAlgorithm functionsper specification | InterpretationAlgorithm functionsper specification | X | |
| 4 | Device Components | • Spirometer (PCB,PressureTransducer andEnclosure)• Plastic Mouthpiece• Pressure Tube• Computer withWindows OS• Software | • Spirometer (PCB,PressureTransducer andEnclosure)• Plastic Mouthpiece• Pressure Tube• Computer withWindows OS• Software | X | |
| Contraindications | |||||
| 5 | Contraindications | No contraindications | No contraindications | X | |
| Sterility/Expiration Dating | |||||
| 6 | N/A | N/A | N/A | X | |
| Energy Type | |||||
| # | Area | Modified Device(Orbit) | Previously ClearedDevice(SpiroCard) | Same | Different |
| 7 | Energy Type | AC or Battery Basedupon computerutilized | AC or BatteryBased uponcomputer utilized | X | |
| Environmental Specifications | |||||
| 8 | Temperature | -15 to 50° C | -15 to 50° C | X | |
| 9 | Relative Humidity | 90% Maximum (non-condensing) | 90% Maximum (non-condensing) | X | |
| 10 | Atmospheric Pressure | 700 to 1060 hPa | 700 to 1060 hPa | X | |
| Operating Specifications | |||||
| 11 | Temperature | 15 to 40° C | 15 to 40° C | X | |
| 12 | Relative Humidity | 10 to 90% (non-condensing) | 10 to 90% (non-condensing) | X | |
| 13 | Atmospheric Pressure | 700 to 1060 hPa | 700 to 1060 hPa | X | |
| Performance Standards | |||||
| 14 | American ThoracicSociety (ATS/ERS)2005 Standard | Complies | Complies | X | |
| 15 | British Thoracic Society(BTS) Standard | Complies | Complies | X | |
| 16 | National Institute forHealth and ClinicalExcellence (NICE)Guidelines | Complies | Complies | X | |
| 17 | Safety - IEC/EN 60601-1 | Complies | Complies | X | |
| 18 | ElectromagneticCompatibility (EMC) -IEC/EN 60601-1-2 | Complies | Complies | X | |
| Hardware | |||||
| 19 | Enclosure Dimensions | 127mm (L) x 102mm(W) x 51mm (H) | 140(L) mm x 53 mm(W) x 16 mm (H) | X | |
| 20 | Enclosure Material | Metalized LCP | ABS andPolycarbonate | X | |
| 21 | Pressure Transducer | New-ImprovedPerformance-+/- 10 inches of water | +/- 10 inches ofwater | X | |
| 22 | Analog front-end | A more preciseinstrumentationamplifier was usedwith active filtering.Pressure: +/- 6.2 | Pressure: +/- 6.2inches of waterGain=127 v/v | X | |
| inches of waterGain=96 v/vBandwidth= 16 Hz | Bandwidth=16 Hz | ||||
| # | Area | Modified Device(Orbit) | Previously ClearedDevice(SpiroCard) | Same | Different |
| 23 | A/D Converter | 16-bitresolution Samplingrate = 125 Hz | 16-bit resolutionSampling Rate= 100Hz | × | |
| 24 | Power Supply | New-Designed forUSB provided power | Designed forPCMCIA power | × | |
| 25 | Interface ConnectionType | USB | PCMCIA | × | |
| Software/Firmware | |||||
| 26 | Micro Processor | Updated | Existing | × | |
| 27 | Sample Rate | 125 samples/second | 100 samples/second | × | |
| 28 | Software Drivers | USB ConnectionDriver | PCMCIA/SerialConnection Driver | × | |
| 29 | Spirometry CalculationDLL | Add interface forUSB Spirometer | No interface for USBSpirometer | × |
{2}------------------------------------------------
전
a
,
来 ,对于
{3}------------------------------------------------
Summary of Performance Testing:
The QRS Diagnostic Orbit Spirometer has been tested or found otherwise to comply with applicable sections of the following standards:
- American Thoracic Society (ATS/ERS) 2005 Standard .
- Safety IEC/EN 60601-1 30 Ed., Medical electrical equipment Part 1: . General requirements for basic safety and essential performance
- Electromagnetic Compatibility (EMC) IEC/EN 60601-1-2 30 Ed., Medical . Electrical Equipment - Part 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Test.
Conclusions:
The results of the tests discussed above, indicate that the modified QRS Diagnostic Orbit device is as safe, as effective, and performs as well as or better than the non-modified device.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002.
Ms. Mary Kay Jensen
Ouality Assurance/Regulatory Affairs Consultant National Biomedical LLC, dba QRS Diagnostic 6901 E. Fish Lake Road #188 Maple Grove, Minnesota 55369
Re: K120880
Trade/Device Name: Orbit Spirometer Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: March 19, 2012 Received: March 23, 2012
Dear Ms. Jensen:
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.
APR 1 9 2012
{5}------------------------------------------------
Page 2 - Ms. Jensen
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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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
{6}------------------------------------------------
Indications for Use
510(k) Number (if known): To be determined
Device Name: Orbit Spirometer
Indications for Use:
- Device Functionality: Spirometry .
- Primary Spirometric Parameters: FVC, MVV, SVC and FEF .
- Patient Population: Male/Female, Pediatric to Adult .
- Environment of Use: Hospital, Clinic and Home Use under trained professional supervision (Prescription Use)
The QRS Diagnostic Orbit Spirometer is intended for the acquisition, analysis, display and print of measurements and waveforms of pulmonary function for the purpose of assisting clinicians in the diagnosis of various pulmonary function diseases and/or treatment regimens.
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)
L. Schutter
. Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
§ 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).