Vitalograph Model 6600 Compact

• K Number: K142642
• Device Name: Vitalograph Model 6600 Compact
• Manufacturer: VITALOGRAPH(IRELAND) LTD.
• Date Cleared: 2015-06-30 ( 286 days)
• Product Code: BZG
• Regulation Number: 868.1840

Intended Use

The Vitalograph Model 6600 COMPACT is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on adults and paediatrics, 5 years and older. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC or connected to compatible Vitalograph or third party devices to acquire, view, store and print the device output.

Device Description

Vitalograph Model 6600 Compact, running Vitalograph Model 7000 Spirotrac software, ref 510(k) K141546, shall provide a mains-powered desktop spirometer for creating, adding and recalling subjects and performing Spirometry testing on those subjects to aid in the measuring the effect of lung disease on pulmonary function. Model 6600 Compact will also, via the Spirotrac software, connect to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject. All connected compatible third party devices are those cleared via Model 7000 510(k) K141546. The intended use of the Compact is in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry. Its primary functions are: 1. Interaction will be via the touch Screen interface. 2. Running the Spirotrac software, as cleared in K141546, The model 6600 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 3. Record subject demographic data. 4. Produce printed reports to external printers.

Predicate Devices

K141546, K100687

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard spirometer measuring respiratory parameters and connecting to other devices, with no mention of AI or ML.

Therapeutic

No
The device is a diagnostic tool, designed to measure respiratory parameters and assess lung function, not to treat or cure a condition.

Diagnostic

Yes

The device measures patient respiratory parameters and aids in "measuring the effect of lung disease on pulmonary function," which clearly falls under diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "mains-powered desktop spirometer" and performs measurements using a "fleisch Pneumotachograph," indicating it includes hardware components for data acquisition.

IVD (In Vitro Diagnostic)

Based on the provided information, the Vitalograph Model 6600 COMPACT is not an In Vitro Diagnostic (IVD) device.

Here's why:

• IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• Device Function: The Vitalograph Model 6600 COMPACT measures respiratory parameters directly from the patient's breath (a physical process), not from a biological specimen. It's a spirometer, which is a type of medical device used for pulmonary function testing.
• Intended Use: The intended use describes measuring patient respiratory parameters and aiding in the measuring the effect of lung disease on pulmonary function. This is a direct measurement of a physiological function, not an analysis of a biological sample.

Therefore, the Vitalograph Model 6600 COMPACT falls under the category of a medical device used for physiological measurement, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Vitalograph Model 6600 COMPACT is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on adults and paediatrics, 5 years and older. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC or connected to compatible Vitalograph or third party devices to acquire, view, store and print the device output.

Product codes (comma separated list FDA assigned to the subject device)

BZG

Device Description

Vitalograph Model 6600 Compact, running Vitalograph Model 7000 Spirotrac software, ref 510(k) K141546, shall provide a mains-powered desktop spirometer for creating, adding and recalling subjects and performing Spirometry testing on those subjects to aid in the measuring the effect of lung disease on pulmonary function.

Model 6600 Compact will also, via the Spirotrac software, connect to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject. All connected compatible third party devices are those cleared via Model 7000 510(k) K141546.

Compatible third party devices are:

• Nonin iPod
• A&D Blood Pressure
• Corscience BT12
• A&D weighing scales

The intended use of the Compact is in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry.

Its primary functions are:

• 1. Interaction will be via the touch Screen interface.
• 2. Running the Spirotrac software, as cleared in K141546, The model 6600 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
• 3. Record subject demographic data.
• 4. 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

lung

Indicated Patient Age Range

adults and paediatrics, 5 years and older.

Intended User / Care Setting

a physician in a hospital or clinic setting.

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 Vitalograph Model 6600 underwent validation 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.
• Random Vibration, sinusoidal Vibration, and Bump Tests.
• Storage conditions testing.
• Operating temperature limits testing.

All tests and validations demonstrated satisfactory results. As with the predicate device the Model 6600 Compact successfully passed the performance requirements of these tests.

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.

K141546, K100687

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

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized human figure with three faces, representing the department's focus on health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2015

Vitalograph Ireland Ltd. Tom J. Healy Regulatory Affairs/OA Manager Gort Road Business Park Ennis, Co Clare Ireland

Re: K142642

Trade/Device Name: Vitalograph Model 6600 Compact Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: May 25, 2015 Received: May 27, 2015

Dear Mr. 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.

1

Page 2 - Tom J. Healy

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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

Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142642

Device Name

Vitalograph Model 6600 Compact

Indications for Use (Describe)

The Vitalograph Model 6600 COMPACT is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on adults and paediatrics, 5 years and older. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC or connected to compatible Vitalograph or third party devices to acquire, view, store and print the device output.

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)

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510K Summary

as required by 21 CFR 807.92

• 1. Company Information: Name: Vitalograph (Ireland) Ltd Address: Gort Road Business Park, Ennis, Co Clare, Ireland.
     Tel: [phone] Fax: [phone].
• 2. Contact Person / Official Correspondent: Mr. Tom J Healy Regulatory Affairs / Quality Assurance Manager
• 3. Date prepared: 29th June 2015.
• 4. Device Trade Name: Vitalograph Model 6600 Compact
• 5. Common / Usual name: Diagnostic Spirometer, Vitalograph Compact Expert
• 6. Classification number:

Class 2 Diagnostic Spirometer as classified per 21 CFR 868.1840. Product Code BZG.

7. Predicate Device:

Manufacturer	: Vitalograph
Device Name	: Model 7000 Spirotrac
510(k) No	: K141546, Class 2, Product Code BZG.

8. Description of Device:

Vitalograph Model 6600 Compact, running Vitalograph Model 7000 Spirotrac software, ref 510(k) K141546, shall provide a mains-powered desktop spirometer for creating, adding and recalling subjects and performing Spirometry testing on those subjects to aid in the measuring the effect of lung disease on pulmonary function.

Model 6600 Compact will also, via the Spirotrac software, connect to compatible third party devices to read and display the output from these devices to allow the

5

information to be retained with the subject. All connected compatible third party devices are those cleared via Model 7000 510(k) K141546.

Compatible third party devices are:

• Nonin iPod
• . A&D Blood Pressure
• Corscience BT12 ●
• A&D weighing scales ●

The intended use of the Compact is in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry.

Its primary functions are:

• 1. Interaction will be via the touch Screen interface.
• 2. Running the Spirotrac software, as cleared in K141546, The model 6600 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
• 3. Record subject demographic data.
• 4. Produce printed reports to external printers.
• 9. Indications for Use:

The Vitalograph Model 6600 COMPACT is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on adults and paediatrics. 5 years and older. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC or connected to compatible Vitalograph or third party devices to acquire, view, store and print the device output.

• 10. Technological Characteristics
      The differences between the Model 6600 Compact and the predicate devices are the software which is being used as the primary interface with the user. This software was previously cleared, ref K141546. The profile and weight of the Model 6600 Compact also differs where the Model 6600 is larger.

These differences do not pose any risks to the intended use of the device. The Model 7000 Spirotrac software (K141546) to be used independently of a PC within a controlled environment with all of the functions of a PC still available.

For performance, the same flow measurement and operating principles are used on the predicate devices as are on the Vitalograph Model 6600 Compact device. The flow circuit will use the same exact circuit and transducer as used in the Vitalograph Model 2120 {ref K100687 }. While, a new industrial design has been created, this has the

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same touchscreen input mechanism, interface and functionality as was cleared for the Model 7000 Spirotrac, {ref K141546}.

The indications for use for the Vitalograph Pneumotrac now include pediatric population in line with the updated FDA guidance. The Model 6600 has the same indications for use, including pediatric population, as the Model 7000 as cleared under K141546. No new testing was required for this revised indication for use. No new risks have been introduced as a result of pediatric population inclusion. The device complies with the existing international performance standards to cater for all population groups.

Materials used continue to be those materials that have been previously used and do not introduce any new risks in relation to safety and effectiveness.

In relation to Patient interface accessories the Model 6600 will use the established Model 2820 and Model 2020 mouthpieces which have their own previous clearances and active device listings. See comparison table below.

The characteristics of the Model 6600 Compact are similar to those of the predicate devices listed in comparison table below. The similarities are

• Identical user interface, and software, as cleared via model 7000 Spirotrac, ref . 510(k) K141546.
• Same indications for use (Clarification of pediatric population and parameters ● measured)
• Some 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 ●

Risks have been evaluated and the performance has been validated. This validation is on file for all devices.

| | Compact Model
6600 | K141546
Spirotrac Model
7000 {predicate} | K100687 Model
2120 {predicate} |
|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------|
| Spirometry -
acquire, view,
store and print
measures and
waveforms of
pulmonary
function | Yes | Yes | Yes |
| ECG waveforms -
view, store, print | Yes | Yes | No |
| ECG waveforms -
acquire | Yes, From
compatible device. | Yes, From
compatible device. | No |
| ECG waveform-
view, store, print | Yes | Yes | No |
| ECG
Interpretation via
algorithms | Yes | Yes | No |
| Ambulatory Blood
Pressure -
retrieve, view,
store and print
patient
ambulatory blood
pressure history | Yes, from compatible
device. | Yes, from
compatible device. | No |
| Spot Oximetry
download, view. | Yes, From
compatible device. | Yes, From
compatible device. | No |
| Weight
(measurement) | Manual entry or
download via
connection to
compatible device | Manual entry or
download via
connection to
compatible device | No |
| Microsoft
windows
Operating
Systems
Supported: | Yes | Yes | No |
| Database: | MS SQL Server | MS SQL Server | MS SQL when
downloaded to
Spirotrac {K100687
& K141546} |
| Where used | Hospital, Health
centre, primary
care practices and clinics | Hospital, Health
centre, primary care
practices and clinics | Hospital wards,
health centres and
homes |
| Networked
operation | Yes | Yes | No |
| Subject
Management:
Demographic
Entry,
Maintenance and
Deletion | Yes | Yes | Yes |
| Report Printing | Yes | Yes | Yes |
| Spirometry
testing | Yes | Yes | Yes |
| Trending Graphs
for Spirometry
Results | Yes | Yes | Yes, when
downloaded to
Spirotrac {K100687
& K141546} |
| Spirometry
Predicted Value
Equations | Yes | Yes | Yes |

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Population Group Management
Data Import/Export	Yes	Yes	Yes
Subject and Spirometry Data Export	Yes	Yes	Yes
Manual data entry of results	Yes	Yes	Yes
Data export via Email	Yes	Yes	Yes, when downloaded to Spirotrac {K100687 & K141546}
Database Management	Yes	Yes	Yes, when downloaded to Spirotrac {K100687 & K141546}
Colour Display	Yes	Yes	No
Target Population	Adult & Paediatric	Adult & Paediatric	Adult, Paediatric
Communication	Bluetooth, USB,	Bluetooth, USB,	USB, Micro SD card
Storage	Dependent on storage media	Dependent on storage media	Non-volatile data storage
Sterile	No	No	No
Regulatory (USA):	FDA - 510(k) Class 2	FDA - 510(k) Class 2. K141546	FDA - 510(k) Class 2 K100687
Performance standards	ATS/ERS 2005
ISO 26782,
ISO 23747,	ATS/ERS 2005
ISO 26782,
ISO 23747,	ATS/ERS 2005
ISO 26782,
ISO 23747,
Safety Standards IEC / EN 60601 {EN 60601-1-1 and EN 60601-1-2}	Yes	Yes, for connected compatible devices	Yes
Performance Standards {incl bench tests}:	ATS ERS 2005, ISO 23747:2009 for PEF {formerly EN13826:2003}. EN ISO 26782:2009	ATS ERS 2005, ISO 23747:2009 for PEF {formerly EN13826:2003}. EN ISO 26782:2009	ATS ERS 2005, ISO 23747:2009 for PEF {formerly EN13826:2003}. EN ISO 26782:2009
	Drop test.
Vibration testing
Bump Tests.		Drop test.

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| | Operating
temperature | | Operating
temperature |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device materials | ABS plastic Body,
Silicone Rubber,
Stainless Steel,
Aluminium, TPX
plastic | N/A. Software | ABS plastic Body,
Silicone Rubber,
Stainless Steel,
Aluminium, TPX
plastic |
| Device weight | 2.5KG | N/A. Software | 0.230Kg |
| Dimensions | 375235110mm | N/A. Software | 160x100x45mm |
| Patient interface
accessories | Model 2820 BVF
Mouthpiece,
Singe; patient use.
510(k) K942779.
Product Code BZG | Dependent on
connecting
compatible third
party device. | Model 2820 BVF
Mouthpiece,
Singe; patient use.
510(k) K942779.
Product Code BZG

Model 2020
SafeTway
Mouthpiece.
Singe; patient use
{Class 1, 510(k)
exempt, with an
active device listing.
Device listing:
D141382. Product
Code BYP,

Vitalograph Nose
Clip, Singe; patient
use {Class 1, 510(k)
exempt, with an
active device listing.
Device listing
D130170. Product
Code BXJ |
| Product Code,
Class, CFR | BZG, Class 2,
868.1840 | BZG, Class 2,
868.1840 | BZG, Class 2,
868.1840 |
| Indications for
Use | The Vitalograph
Model 6600
COMPACT is
intended for use by
or on the order of a
physician in a
hospital or clinic
setting. The product
is designed for use
on adults and
paediatrics, 5 years
and older. The
device is intended to
be used as a | The Vitalograph
Model 7000
Spirotrac is
intended for use
by or on the order
of a physician in a
hospital or clinic
setting. The
product is
designed for use
on both adult and
pediatric patients.
The device is a PC
based software | The device is a
battery operated
spirometer which
measures three
basic patient
respiratory
parameters {FVC,
MVV and VC}. The
model 2120 is a
hand held
spirometer
designed for lung
function testing in a
variety of |

10

| | spirometer which
measures patient
respiratory
parameters including
FVC, FEV1, FEV6,
PEF, MVV and VC or
connected to
compatible
Vitalograph or third
party devices to
acquire, view, store
and print the device
output. | application which
is intended to be
used as a
spirometer or
connect to
compatible
Vitalograph or
third party devices
to acquire, view,
store and print the
device output. | environments such
as hospital wards,
health centres and
private homes. The
model 2120 can be
configured as a
stand-alone
spirometer or
connected to a
printer. |

--	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The Vitalograph Model 6600 underwent validation 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.
• Random Vibration, sinusoidal Vibration, and Bump Tests. ●
• Storage conditions testing. ●
• Operating temperature limits testing. ●

All tests and validations demonstrated satisfactory results.

As with the predicate device the Model 6600 Compact successfully passed the performance requirements of these tests. Evidence of successful completion of tests and validations has been provided with this submission.

11. Conclusion:

The characteristics of the Model 6600 Compact 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 as safe and as effective as the predicate devices.

No new issues of safety or effectiveness have been introduced as a result.