(27 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard spirometry measurements and analysis.
Yes
The device is used to assist clinicians in the diagnosis of various pulmonary function diseases and/or treatment regimens, which falls under the definition of a therapeutic device.
Yes
The intended use explicitly states its purpose is to "assily any clinicians in the diagnosis of various pulmonary function diseases."
No
The device description explicitly lists hardware components such as a spirometer, pressure tube, and disposable pneumotachometer, in addition to the software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. The description clearly states the device measures a patient's expiratory and inspiratory airflow directly from the patient. It does not analyze blood, urine, tissue, or any other sample taken from the body.
- The intended use is for measuring pulmonary function. This is a physiological measurement taken directly from the patient, not an analysis of a biological sample.
- The device components are consistent with a spirometer. The components listed (spirometer, pressure tube, pneumotachometer, software) are all typical for a device that measures airflow and volume directly from a patient's breathing.
Therefore, the QRS Diagnostic Orbit Spirometer is a medical device used for physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZG
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 .
- Host PC (User Provided) .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Pediatric to Adult
Intended User / Care Setting
Hospital, Clinic and Home Use under trained professional supervision (Prescription Use)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 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/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 of
Predicate | Manufacturer | Use | 510K) | Date
Cleared |
|----------------------|----------------|------------|---------|-----------------|
| 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 Cleared
Device
(SpiroCard) | Same | Different |
|-----------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------|-----------|
| Indications for Use | | | | | |
| 1 | Patient Population | Male/Female
Pediatric to Adult | Male/Female
Pediatric to Adult | X | |
| 2 | Environment of Use | Hospital, Clinic,
Home Use | Hospital, Clinic,
Home Use | X | |
| Fundamental Scientific Technology | | | | | |
| 3 | Interpretation Algorithm | Interpretation
Algorithm functions
per specification | Interpretation
Algorithm functions
per specification | X | |
| 4 | Device Components | • Spirometer (PCB,
Pressure
Transducer and
Enclosure)
• Plastic Mouthpiece
• Pressure Tube
• Computer with
Windows OS
• Software | • Spirometer (PCB,
Pressure
Transducer and
Enclosure)
• Plastic Mouthpiece
• Pressure Tube
• Computer with
Windows 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 Cleared
Device
(SpiroCard) | Same | Different |
| 7 | Energy Type | AC or Battery Based
upon computer
utilized | AC or Battery
Based upon
computer 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 Thoracic
Society (ATS/ERS)
2005 Standard | Complies | Complies | X | |
| 15 | British Thoracic Society
(BTS) Standard | Complies | Complies | X | |
| 16 | National Institute for
Health and Clinical
Excellence (NICE)
Guidelines | Complies | Complies | X | |
| 17 | Safety - IEC/EN 60601-
1 | Complies | Complies | X | |
| 18 | Electromagnetic
Compatibility (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 and
Polycarbonate | | X |
| 21 | Pressure Transducer | New-Improved
Performance-
+/- 10 inches of water | +/- 10 inches of
water | | X |
| 22 | Analog front-end | A more precise
instrumentation
amplifier was used
with active filtering.
Pressure: +/- 6.2 | Pressure: +/- 6.2
inches of water
Gain=127 v/v | | X |
| | | inches of water
Gain=96 v/v
Bandwidth= 16 Hz | Bandwidth=16 Hz | | |
| # | Area | Modified Device
(Orbit) | Previously Cleared
Device
(SpiroCard) | Same | Different |
| 23 | A/D Converter | 16-bit
resolution Sampling
rate = 125 Hz | 16-bit resolution
Sampling Rate= 100
Hz | | × |
| 24 | Power Supply | New-Designed for
USB provided power | Designed for
PCMCIA power | | × |
| 25 | Interface Connection
Type | USB | PCMCIA | | × |
| | Software/Firmware | | | | |
| 26 | Micro Processor | Updated | Existing | | × |
| 27 | Sample Rate | 125 samples/second | 100 samples/second | | × |
| 28 | Software Drivers | USB Connection
Driver | PCMCIA/Serial
Connection Driver | | × |
| 29 | Spirometry Calculation
DLL | Add interface for
USB Spirometer | No interface for USB
Spirometer | | × |
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: _______________________________________________________________________________________________________________________________________________________________