Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard spirometer measuring respiratory parameters and does not mention AI or ML in its description, intended use, or performance studies.

Therapeutic

No

The device is a diagnostic tool that measures lung function to aid in the detection, diagnosis, and monitoring of chest diseases. It does not provide treatment.

Diagnostic

Yes

The device description explicitly states that the measurements obtained from the lung function test "form part of the various findings of a physician in the detection, diagnosis and monitoring of chest diseases." This indicates its role in aiding the diagnostic process.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "desktop spirometer" and describes it as a "USB-powered desktop spirometer". This indicates it is a hardware device that connects to software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Function: The Vitalograph Pneumotrac is a spirometer that measures respiratory parameters directly from the patient's breath. It does not analyze specimens taken from the body.
Intended Use: The intended use is to measure lung function parameters to aid in the measuring the effect of lung disease on pulmonary function. This is a direct measurement of a physiological process, not an analysis of a biological specimen.

Therefore, while it is a medical device used in diagnosis and monitoring, it falls under the category of a physiological measurement device rather than an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, MVV and VC. The Vitalograph Pneumotrac is a desktop spirometer designed for luse on adults and pediatics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healtheare provider.

Product codes

BZG

Device Description

The intended use of the Vitalograph Pneumotrac desktop spirometer, which connects to Vitalograph Model 7000 Spirotrac software, ref 510(k) K141546, shall provide a USB-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.

Spirometry is in the simple assessment of respiratory function through the measurement of dynamic lung volumes.
Its primary functions are;

1. Standalone spirometric measures using single breath or multiple-breath testing techniques, display and record lung volumes and flow rates (including FVC, MVV, VC) and it's subdivisions,
Display a single subject's demographic data entered by the user. 2.
ന്ന് Produce reports
In a clinical setting, the measurements obtained from a lung function test form part of the various findings of a physician in the detection, diagnosis and monitoring of chest diseases.

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 pediatics, 5 years and older

Intended User / Care Setting

healthcare provider / hospital wards, health centers and private homes

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 6800 Spirotrac underwent validation bench testing to ensure performance according to its specifications against current standards. These tests included performance testing against international standards such as

ISO 26782{Anesthetic and respiratory equipment -- Spirometers intended ● for the measurement of time forced expired volumes in humans},
ATS/ERS 2005 {ATS/ERS Task Force: Standardization of Lung Function Testing} and
. ISO 23747 {Anesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans}.
IEC 60601-1 ●
Biocompatibility was reviewed during the risk management process. Separate biocompatibility testing was not carried out as all materials we previously cleared in earlier submissions including K100687 and K925085.
Validation of the interfaces with model 7000 Spirotrac {K141546} was performed to ensure that the integrity of the information is maintained and that the information may be successfully downloaded and stored within the Spirotrac database.
All tests and validations demonstrated satisfactory results. Evidence of successful completion of tests and validations has been provided with this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy FEV1: +/- 3%
Accuracy FEV6: +/- 3%
Accuracy PEF: +/-5%

Predicate Device(s)

K100687

Reference Device(s)

K141546, K942779, K925085

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 seal for the Department of Health and Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

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

June 29, 2015

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

Re: K142812

Trade/Device Name: Vitalograph Model 6800 Pneumotrac Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic spirometer Regulatory Class: II Product Code: BZG Dated: May 27, 2015 Received: May 29, 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.

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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 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 vours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

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) K142812

Device Name

Vitalograph Model 6800 Pneumotrac

Indications for Use (Describe)

The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, MVV and VC. The Vitalograph Pneumotrac is a desktop spirometer designed for luse on adults and pediatics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healtheare 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)

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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."

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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: +353656864100 Fax: +353656829289.
1. Contact Person / Official Correspondent: Mr. Tom J Healy Regulatory Affairs / Quality Assurance Manager
1. Date prepared: 19th June 2015.
1. Device Trade Name: Vitalograph Model 6800 Pneumotrac
1. Common / Usual name: Vitalograph Pneumotrac,
1. Classification number:

Classified per 21 CFR 868.1840. Part 868 - Anesthesiology Devices, Subpart B--Diagnostic Devices Class 2 Diagnostic Spirometer Product Code BZG.

1. Predicate Device:

Manufacturer	:	Vitalograph
Device Name	:	Model 2120
510(k) No	:	K100687, Class 2, Product Code BZG.

8. Description of Device:

The intended use of the Vitalograph Pneumotrac desktop spirometer, which connects to Vitalograph Model 7000 Spirotrac software, ref 510(k) K141546, shall provide a USB-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.

Spirometry is in the simple assessment of respiratory function through the measurement of dynamic lung volumes.

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Its primary functions are;

1. Standalone spirometric measures using single breath or multiple-breath testing techniques, display and record lung volumes and flow rates (including FVC, MVV, VC) and it's subdivisions,
Display a single subject's demographic data entered by the user. 2.
ന്ന് Produce reports

In a clinical setting, the measurements obtained from a lung function test form part of the various findings of a physician in the detection, diagnosis and monitoring of chest diseases.

9. Indications for Use:

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 private homes under the supervision of a healthcare provider.

10. Technological Characteristics

The characteristics of the Pneumotrac are similar to those of the predicate device listed in comparison table below. The similarities are:

· Identical operating principle
Identical spirometry parameters measured
Both the subject and predicate devices comply with international performance standards including electrical safety {IEC 60601-1}, EMC {IEC 60601-1-2} and performance bench tests {ISO 23747, ISO 26782, ATS/ERS}
Sharing of Identical patient interface accessories

The primary differences between the Vitalograph Model 6800 and the predicate devices is that the predicate operates as a portable spirometer and the Model 6800 is a desktop spirometer.

The indications for use for the Vitalograph Pneumotrac now include pediatric population in line with the updated FDA guidance. The Model 6800 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.

All of the device materials were previously cleared in the predicate (K100687) and create no new risk profiles. The Model 7000 Spirotrac which connects to the Pneumotrac device was previously cleared. Materials used in the Vitalograph 6800 Pneumotrac are identical to those used in previously cleared devices. Thus separate biocompatibility testing was not performed for the subject device.

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Risks have been evaluated and the connectivity / communication by model 6800 Pneumotrac has been validated with the Vitalograph Model 7000 Spirotrac software. This validation is on file.

The operating principle, measuring range, application and use are unchanged. Packaging and labelling has been updated to conform to current regulatory requirements but otherwise remains substantially unchanged. Precautions, warnings, contra-indications and software functionality remain unchanged.

| Parameter | Vitalograph model 6800
Pneumotrac | Predicate Device – Vitalograph
Model 2120 (K100687) |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Volume Range | 0-10 Liters | 0-10Litres |
| Max Flow Range | 0-16 Liters / second | 0-16 Liters / second |
| Back Pressure | Less than 0.1kPa/L/s | 0.1kPa/L/s |
| Accuracy FEV1 | +/- 3% | +/- 3% |
| Accuracy FEV6 | +/- 3% | +/- 3% |
| Accuracy PEF | +/-5% | +/-5% |
| Calibration | Using calibration syringe | Using calibration syringe |
| Technology | Fleisch
Pneumotachograph | Fleisch Pneumotachograph |
| Set Predicted /
reference values | Yes | Yes |
| Memory Type /
Storage: | Uses Spirotrac database.
{K141546} | On-board or connection to
Spirotrac database {K141546} |
| Sounds | Audible beeps emitted
whilst performing a test,
for incentives. | Audible beeps emitted whilst
performing a test, for incentives. |
| Communication | USB | USB |
| Download to P.C | Yes. Downloads to
Spirotrac {K141546} | Yes. Downloads to Spirotrac
{K141546} |
| To be serviced | Yes, Has Service Manual. | Yes. Has Service Manual. |
| Connection to
external printer | Yes, via Spirotrac
{K141546} | Yes. Direct or via Spirotrac
{{K141546}} |
| Internal printer | No | No |
| Battery Type | USB Power | USB Power and 3.7V Li-ion |
| power | | Battery. |
| Dimensions | 183x105x70mm | 160x100x45mm |
| Weight | 0.45Kg | 0.23Kg |
| Material Type | ABS plastic Body, Silicone
Rubber, Stainless Steel,
Aluminum, TPX plastic | ABS plastic Body (identical),
Silicone Rubber(identical),
Stainless Steel(identical), |
| Biocompatibility | No new testing required.
All materials previously
cleared in K100687 &
K925085. | |
| 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} |
| Storage Temp | 0 - 50 °C | 0 - 50°C |
| Humidity | 10 - 95% relative
humidity | 10 - 95% relative humidity |
| Performance
Standards
{bench tests} | ATS ERS 2005, ISO
23747:2009 for PEF
{formerly EN13826:2003}.
EN ISO 26782:2009
ISO 10993-1 Fourth
Edition | ATS ERS 2005, ISO 23747:2009
for PEF {formerly
EN13826:2003}. EN ISO
26782:2009
ISO 10993-1 Fourth Edition |
| Compliance: | IEC / EN 60601 {EN
60601-1-1 and EN 60601-
1-2} | IEC / EN 60601 {EN 60601-1-1
and EN 60601-1-2} |
| Interface with
user | Spirotrac {K141546} | On-board Button Keypad /
touchscreen display or via
Spirotrac {{K141546}} |
| Regulatory | FDA - 510(k)
CE {0086} Class 2a | FDA - 510(k)
CE {0086} Class 2a |
| Product Code,
Class, CFR | BZG, Class 2, 868.1840 | BZG, Class 2, 868.1840 |
| Warranty | 1 Year | 1 Year |
| Patient interface
accessories | Model 2820 BVF
Mouthpiece (K942779)
{Class 2 with an active
device listing}. | Model 2820 BVF Mouthpiece
(K942779) {Class 2 with an active
device listing}.
Model 2020 SafeTway
Mouthpiece {Class 1 with an
active device listing}. |
| Indications for
Use | 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 private
homes under the
supervision of a
healthcare provider. | 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
environments such as hospital
wards, health centers and
private homes. The model 2120
can be configured as a stand-
alone spirometer or connected
to a printer. |

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The Vitalograph Model 6800 Spirotrac underwent validation bench testing to ensure performance according to its specifications against current standards. These tests included performance testing against international standards such as

ISO 26782{Anesthetic and respiratory equipment -- Spirometers intended ● for the measurement of time forced expired volumes in humans},
ATS/ERS 2005 {ATS/ERS Task Force: Standardization of Lung Function Testing} and
. ISO 23747 {Anesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans}.
IEC 60601-1 ●

Biocompatibility was reviewed during the risk management process. Separate biocompatibility testing was not carried out as all materials we previously cleared in earlier submissions including K100687 and K925085.

Validation of the interfaces with model 7000 Spirotrac {K141546} was performed to ensure that the integrity of the information is maintained and that the information may be successfully downloaded and stored within the Spirotrac database.

All tests and validations demonstrated satisfactory results. Evidence of successful completion of tests and validations has been provided with this submission.

11. Conclusion:

Based on the above, including the successful completion of all device testing Vitalograph conclude that Vitalograph model 6800 Pneumotrac is as safe and as effective as the predicate devices. No new issues of safety or effectiveness have been introduced as a result.