(207 days)
Not Found
No
The description focuses on standard spirometry measurements using a Fleisch Pneumotachograph and does not mention any AI or ML algorithms for data analysis, interpretation, or prediction.
No
The device is a diagnostic tool that measures lung function parameters to aid in assessing respiratory function and the effect of lung disease. It does not provide any treatment or therapy.
Yes
The device measures patient respiratory parameters to aid in measuring the effect of lung disease on pulmonary function, which is a diagnostic purpose.
No
The device description explicitly states it consists of a main body incorporating hardware components like an LCD, touch panel, pressure transducer, flow circuitry, and a detachable flow head. It also mentions a physical principle of operation involving a Fleisch Pneumotachograph and pressure transducer. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a spirometer. It measures respiratory parameters directly from the patient's breath (air exhaled or inhaled). It does not analyze a specimen taken from the body.
- Intended Use: The intended use is to measure lung function parameters to aid in measuring the effect of lung disease. While this information can be used in diagnosis and monitoring, the device itself is performing a direct physiological measurement, not an in vitro analysis of a specimen.
Therefore, while the data collected by the spirometer is used in a diagnostic context, the device itself does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Vitalograph micro is a handheld spirometer designed for lung function for use on adults and pediatrics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healthcare provider.
Product codes (comma separated list FDA assigned to the subject device)
BZG
Device Description
Vitalograph Model 6300 micro is a handheld portable spirometer for performing Spirometry testing to aid in measuring the effect of lung disease on pulmonary function. The device may be used in hospital, healthcare facilities and homes under the supervision of a healthcare provider.
The intended use of the 6300 micro is in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry.
The proposed device consists of a main body which incorporates an LCD, a touch panel, pressure transducer and flow circuitry as well as a detachable flow head. The device is used with a pulmonary function filter. Reports may be printed using the USB cable provided.
Principles of Operation: The Vitalograph micro measures a subject's lung ventilation by using a flowhead containing a Fleisch Pneumotachograph capable of giving linear signals throughout the entire physiological range. During testing, the airflow through the flowhead produces a pressure differential. Internally this pressure is applied to a pressure transducer, which produces an electric signal. This signal is converted into digital form so that the unit can perform calculations and display the results.
Primary functions are:
- Interaction will be via the touch screen interface.
- . The model 6300 Compact performs spirometric measurements using the established fleisch Pneumotachograph, using single breath and multiple-breath testing techniques, to display and record lung volumes and flow rates (including FVC, FEV1, FEV6, PEF, MVV and VC) and their sub-divisions to aid in the measuring the effect of lung disease on pulmonary function
- Record subject demographic data.
- Produce printed reports to external printers.
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
adults and pediatrics, 5 years and older
Intended User / Care Setting
hospital wards, health centers and private homes under the supervision of a healthcare provider.
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)
Clinical testing was not carried out on the 6300 micro. The Vitalograph Model 6300 underwent non-clinical testing to ensure performance according to its specifications against current standards. These tests included performance testing against international standards such as
- ISO 26782{ Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time forced expired volumes in humans}.
- ATS/ERS 2005 { ATS/ERS Task Force: Standardisation of Lung . Function Testing } and
- ISO 23747 { Anaesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans } .
Mechanical shock testing was also performed to evaluate the effects on the device during transport.
These tests included: - Drop test of the packaged device from a specified height onto all corners and edges.
- Storage conditions testing.
- Operating temperature limits testing.
- . Cleaning method validation was completed.
All tests and validations demonstrated satisfactory results. The Model 6300 Micro successfully passed the performance requirements of these tests and compliance to the requirements of the standards was achieved.
As such, the model 6300 performance is substantially equivalent to the legally marketed predicate devices.
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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2016
Vitalograph Ireland Ltd. Tom J. Healy Regulatory Affairs/QA Manager Gort Road Business Park Ennis. Co Clare IRELAND
Re: K160253
Trade/Device Name: Vitalograph Model 6300 micro Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic spirometer Regulatory Class: II Product Code: BZG Dated: July 25, 2016 Received: July 27, 2016
Dear Mr. Tom J. Healy:
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.
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
1
Page 2 - Tom J. Healy
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K160253
Device Name Vitalograph Model 6300 micro
Indications for Use (Describe)
The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Vitalograph micro is a handheld spirometer designed for lung function for use on adults and pediatrics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healthcare provider.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510K Summary
as required by 21 CFR 807.92
-
- Company Information: Contact Person / Official Correspondent: Mr. Tom J Healy Regulatory Affairs / Quality Assurance Manager
Name: Vitalograph (Ireland) Ltd Address: Gort Road Business Park, Ennis, Co Clare, Ireland.
- Company Information: Contact Person / Official Correspondent: Mr. Tom J Healy Regulatory Affairs / Quality Assurance Manager
Tel: +353656864100 Fax: +353656829289.
Date prepared: 15th January 2016.
-
- Common / Usual name (s):
Vitalograph Model 6300 micro
- Common / Usual name (s):
Panel: Anesthesiology Class 2 Diagnostic Spirometer as classified per 21 CFR 868.1840. Product Code BZG.
-
- Predicate Device:
Manufacturer : Vitalograph Device Name : Model 2120 : K100687, Class 2, Product Code BZG. 510(k) No Classified per 21 CFR 868.1840
- Predicate Device:
| Manufacturer | Vitalograph |
|---|---|
| Device Name | Model 6800 Pneumotrac |
| 510(k) No | K142812, Class 2, Product Code BZG. |
| Classified per 21 CFR 868.1840 |
-
- Description of Device:
Vitalograph Model 6300 micro is a handheld portable spirometer for performing Spirometry testing to aid in measuring the effect of lung disease on pulmonary function. The device may be used in hospital, healthcare facilities and homes under the supervision of a healthcare provider.
- Description of Device:
The intended use of the 6300 micro is in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry.
The proposed device consists of a main body which incorporates an LCD, a touch panel, pressure transducer and flow circuitry as well as a detachable flow head. The device is used with a pulmonary function filter. Reports may be printed using the USB cable provided.
5
Principles of Operation: The Vitalograph micro measures a subject's lung ventilation by using a flowhead containing a Fleisch Pneumotachograph capable of giving linear signals throughout the entire physiological range. During testing, the airflow through the flowhead produces a pressure differential. Internally this pressure is applied to a pressure transducer, which produces an electric signal. This signal is converted into digital form so that the unit can perform calculations and display the results.
Primary functions are:
- Interaction will be via the touch screen interface. .
- . The model 6300 Compact performs spirometric measurements using the established fleisch Pneumotachograph, using single breath and multiple-breath testing techniques, to display and record lung volumes and flow rates (including FVC, FEV1, FEV6, PEF, MVV and VC) and their sub-divisions to aid in the measuring the effect of lung disease on pulmonary function
- Record subject demographic data.
- Produce printed reports to external printers. ●
-
- Indications for Use:
The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Vitalograph micro is a handheld spirometer designed for lung function testing for use on adults and pediatrics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healthcare provider.
-
- Technological Characteristics
Differences:
The differences between the Model 6300 device and the predicate Model 2120, K100687 revolve around the Model 6300 has a touchscreen for navigation only while the predicate device Model 2120 is used with touchscreen or button navigation. The profile and weight of the devices are also similar as outlined below where the model 6300 is lighter and dimensionally smaller. The model 6300 employs a colour display and has USB and Bluetooth options where the model 2120 allowed USB and SD card. For power the model 6300 uses USB power or replaceable batteries where the predicates, model 2120 is rechargeable and the model 6800 uses USB power only.
Similarities:
The proposed device uses scientific concepts, operating principles and materials already cleared in the predicate devices submissions. As such the differences outlined are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and do not affect the safety and effectiveness of the device when used as labelled.
6
For performance, the same flow measurement and operating principles are used on the predicate devices and the Vitalograph Model 6300 device.
The flow circuit in the model 6300 is identical to the circuit and transducer as the Vitalograph Model 2120 {ref K100687} and has the same touchscreen input mechanism, interface and functionality as cleared model 2120.
The indications for use for the Vitalograph 6300 micro now include pediatric population in line with the updated FDA guidance. The Model 6300 has the same indications for use, including pediatric population, as the Model 6800 as cleared under K142812. No new testing was required for this revised indication for use. The proposed device complies with the existing international performance standards to cater for all population groups. The micro device includes new parameters in the indications for use.
Materials used have been previously cleared in the predicate. No new biocompatibility testing was required to use these materials.
In relation to Patient interface accessories the Model 6300 will use the previously cleared Model 2820 mouthpieces and Nose clips which have their active device listings.
The characteristics of the Model 6300 are similar to those of the predicate devices listed in comparison table below. The similarities are
- Non-sterile device, components and accessories. ●
- Touchscreen user interface, ●
- Same indications for use ●
- Same operating principle and flow measurement principles. ●
- Same parameters calculation. ●
- Same method of use.
- Same performance when bench tested against performance standards.
- Same patient interface accessories.
- . Same cleaning method.
Risks have been evaluated and the performance has been validated. This validation is on file for all devices.
Clinical testing was not carried out on the 6300 micro. The Vitalograph Model 6300 underwent non-clinical testing to ensure performance according to its specifications against current standards. These tests included performance testing against international standards such as
- ISO 26782{ Anaesthetic and respiratory equipment -- Spirometers ● intended for the measurement of time forced expired volumes in humans}.
- ATS/ERS 2005 { ATS/ERS Task Force: Standardisation of Lung . Function Testing } and
7
- ISO 23747 { Anaesthetic and respiratory equipment -- Peak expiratory ● flow meters for the assessment of pulmonary function in spontaneously breathing humans } .
Mechanical shock testing was also performed to evaluate the effects on the device during transport.
These tests included:
- Drop test of the packaged device from a specified height onto all ● corners and edges.
- Storage conditions testing.
- Operating temperature limits testing. ●
- . Cleaning method validation was completed.
All tests and validations demonstrated satisfactory results. The Model 6300 Micro successfully passed the performance requirements of these tests and compliance to the requirements of the standards was achieved.
As such, the model 6300 performance is substantially equivalent to the legally marketed predicate devices.
Evidence of successful completion of tests and validations has been provided with this submission.
| | Micro 6300 | K100687 Model
2120 {predicate} | Vitalograph model
6800 Pneumotrac
K142812. |
|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Spirometry -
acquire, view,
store and print
measurements
and waveforms of
pulmonary
function | Yes | Yes | Yes |
| Environment of
Care | Hospital wards,
health centres and
homes | Hospital wards,
health centres and
homes | Hospital wards,
health centres and
homes |
| Volume Range: | 0-10 Litres | 0-10 Litres | 0-10 Litres |
| Report Printing
(via Vitalograph
Reports) | Yes | Yes | Yes, via Spirotrac
{K141546} |
| Spirometry
testing | Yes | Yes | Yes |
| Colour Display | Yes | Yes | Yes, via Spirotrac
{K141546} |
| Interface | Touchpanel (plus
On/Off button) | Touchpanel &
Buttons | On/Off switch.
Power button.
Navigation via
Spirotrac (K141546) |
| Target Population | Adult & Pediatric
(5yrs and over) | Adult, Pediatric | Adult & Pediatric
(5yrs and over) |
| Communication | USB, Bluetooth | USB, Micro SD card | USB |
| Storage | Non-volatile data
storage | Non-volatile data
storage | via Spirotrac
{K141546} |
| Sterile device or
components | No | No | No |
| Regulatory (USA): | FDA - 510(k) Class 2 | FDA - 510(k) Class 2
K100687 | FDA - 510(k) Class 2
K142812 |
| Device weight | 0.250Kg | 0.230Kg | 0.450Kg |
| Dimensions | 83 x 91x 32 mm | 160x100x45mm | 183x105x70mm |
| Power | 5V USB /6V AAA
Alkaline Batteries | 3V AAA Alkaline
Batteries | 5V USB |
| Operating Temp: | 10-40°C.
{At least 17-37°C
required per ATS
2005} | 10 to 40°C
{At least 17-37°C
required per ATS
2005} | 10 to 40°C
{At least 17-37°C
required per ATS
2005} |
| Storage Temp: | 0 - 50 °C | 0 - 50 °C | 0 - 50°C |
| Humidity: | 10 - 95% relative
humidity | 10 - 95% relative
humidity | 10 - 95% relative
humidity |
| Non-Clinical
Testing to
Performance
Standards
{incl bench tests}: | ATS ERS 2005, ISO
23747:2009 for PEF.
EN ISO 26782:2009
IEC / EN 60601 {EN
60601-1-1 and EN
60601-1-2} | ATS ERS 2005, ISO
23747:2009 for PEF.
EN ISO 26782:2009
IEC / EN 60601 {EN
60601-1-1 and EN
60601-1-2} | ATS ERS 2005, ISO
23747:2009 for PEF.
EN ISO 26782:2009
IEC / EN 60601 {EN
60601-1-1 and EN
60601-1-2} |
| | Drop tests.
Storage conditions.
Operating
temperature
Cleaning validation | Drop tests.
Storage conditions.
Operating
temperature | Drop tests.
Storage conditions.
Operating
temperature.
Cleaning validation |
| Device materials | ABS plastic Body,
Silicone Rubber,
Stainless Steel,
Aluminium, | ABS plastic Body,
Silicone Rubber,
Stainless Steel,
Aluminium, | ABS plastic Body,
Silicone Rubber,
Stainless Steel,
Aluminium, TPX
plastic |
| Biocompatibility | No new testing
required. All
materials previously
cleared in K100687
(same duration of
exposure and usage) | No new testing
required. No new
testing required. All
materials previously
cleared in K073155
(same duration of
exposure and usage) | No new testing
required. All
materials previously
cleared in K100687 &
K925085. |
| Patient interface
accessories | Model 2820 BVF
Mouthpiece,
Single; patient use. | Model 2820 BVF
Mouthpiece,
Single; patient use. | Model 2820 BVF
Mouthpiece
(K942779) {Class 2 |
| | 510(k) K942779.
Product Code BZG | 510(k) K942779.
Product Code BZG | with an active device
listing}. |
| Patient interface
accessories
contacting the gas
pathway | Vitalograph Nose
Clip, Single; patient
use {Class 1, 510(k)
exempt, with an
active device listing.
Device listing
D130170. Product
Code BXJ. Previously
cleared in K100687, | Model 2020
SafeTway
Mouthpiece.
Single; patient use
{Class 1, 510(k)
exempt, with an
active device listing.
Device listing:
D141382. Product
Code BYP,
Vitalograph Nose
Clip, Single; patient
use {Class 1, 510(k)
exempt, with an
active device listing.
Device listing
D130170. Product
Code BXJ | Model 2820 BVF
Mouthpiece,
Single; patient use.
510(k) K942779.
Product Code BZG |
| FDA Product
Code,
Device Class,
21 CFR section | BZG,
Class 2,
868.1840 | BZG,
Class 2,
868.1840 | BZG,
Class 2,
868.1840 |
| Indications for
Use | The device is a
spirometer which
measures patient
respiratory
parameters including
FVC, FEV1, FEV6,
PEF, MVV and VC.
The Vitalograph
micro is a handheld
spirometer designed
for lung function
testing for use on
adults and
pediatrics, 5 years
and older, in a
variety of
environments such
as hospital wards,
health centers and
private homes under | The device is a
battery operated
spirometer which
measures patient
respiratory
parameters. The
model 2120 is a hand
held spirometer
designed for lung
function
testing in a variety of
environments such
as hospital wards,
health centres and
private homes. The
model 2120 can be
configured as a
stand-alone
spirometer or | The device is a
spirometer which
measures patient
respiratory
parameters including
FVC, FEV1, FEV6,
PEF, MVV and VC.
The
Vitalograph
Pneumotrac is a
desktop spirometer
designed for lung
function testing for
use on adults and
pediatrics, 5 years
and older,
in a variety of
environments such
as hospital wards,
health centers and |
| | the supervision of a
healthcare provider. | connected to a
printer. | private homes under
the supervision of a
healthcare provider. |
8
9
10
11. Conclusion:
The characteristics of the Model 6300 Micro are similar to those of the predicate devices listed.
Based on the above, including the successful completion of all device testing Vitalograph conclude that this device is substantially equivalent to the predicate devices.
No new issues of safety or effectiveness have been introduced as a result.