The Vitalograph Model 2120 In2itive eDiary device is a battery-operated spirometer which measures three basic patient respiratory parameters (FVC, MVV and VC). The Vitalograph Model 2120 In2itive eDiary is a handheld spirometer designed for lung function testing in a variety of environments such as hospital wards, health centres and private homes. It is intended for Adults and pediatrics, 5 years and older.

The Vitalograph Model 2120 In2itive eDiary can be configured as a stand-alone spirometer or connected to a printer.

Device Description

The Vitalograph Model 2120 In2itive eDiary is a hand-held, battery-operated spirometer which measures the following lung function parameters FVC, MVV and VC in hospital, clinical and home settings.

It can be configured as a standalone spirometer or connected to a printer. Its primary functions and technology are:

. Spirometry measurements using single breath and multiple-breath testing techniques, the
display and recording of measured lung volumes and flow rates (including FVC, VC, ● MVV) and other parameters which are subsets of these measured parameters.
. Record subject data. Storage of data and test results on unit for later printing or export to Spirotrac software
The Flowhead utilizes a Fleisch Pneumotachograph.
User Interface navigation via five buttons (Up, Down, Enter/Select, Cancel/Esc and . Power On/Off) or an optional touch screen.

AI/ML Overview

The Vitalograph Model 2120 In2itive eDiary is a diagnostic spirometer. The device's acceptance criteria and the study proving it meets these criteria are outlined below.

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria are established by various international standards for spirometry and medical device safety. The reported device performance is compared to these standards and the predicate device (Vitalograph Model 2120).

Feature	Acceptance Criteria (Predicate / Standard)	Reported Device Performance (Subject Device)	Outcome
Indications for Use	Measures FVC, MVV, VC for adults and pediatrics (5+ years) in various environments (hospital, health centers, private homes). Stand-alone or connected to printer.	Measures FVC, MVV, VC for adults and pediatrics (5+ years) in various environments (hospital, health centers, private homes). Stand-alone or connected to printer.	Identical
Fundamental Technology	Fleisch Pneumotachograph type Flowhead connected to transducer, with signal-processing circuitry.	Fleisch Pneumotachograph type Flowhead connected to transducer, with signal-processing circuitry.	Same
Parameters Measured	FVC, MVV, VC	FVC, MVV, VC	Same
Hand-held	Yes	Yes	Same
Patient Interface	Flowhead cone	Flowhead cone	Same
Cleaning	Unit surface cleaning and 70% alcohol	Unit surface cleaning and 70% alcohol	Same
Patient Use	Single Patient, multi-use	Single Patient, multi-use (implied, as cleaning is for multi-use)	Same
Back pressure	Less than 0.1kPa/L/second @ 14L/s	Less than 0.1kPa/L/second @ 14L/s	Identical
Volume detection	Flow integration sampling @ 100Hz	Flow integration sampling @ 100Hz	Identical
Maximum displayed volume	10L	10L	Identical
Volume accuracy	+3% or 0.05L (ATS/ERS, ISO 23747, ISO 26782 standards)	Yes (met standard)	Identical
Min. Volume	0.01L	0.01L	Identical
Flow Accuracy	Flow ±10% or 0.3 L/s, Max. flow rate ±16 L/s, Min. flow rate ±0.02 L/s (ATS/ERS, ISO 23747, ISO 26782 standards)	Flow ±10% or 0.3 L/s, Max. flow rate ±16 L/s, Min. flow rate ±0.02 L/s	Identical
Linearity	Better than ±3%	Better than ±3%	Identical
Operating temperature	10-40°C	10-40°C	Identical
Performance standards	ATS/ERS (2005), ISO 23747, ISO 26782	ATS/ERS (2005), ISO 23747, ISO 26782	Identical
Electrical Safety & EMC	ES 60601-1, IEC 60601-1-2	ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 (for home use)	Similar (Added new standard for home use)
Storage Temperature	0-50°C	0-50°C	Identical
Storage Relative Humidity	10%-95%	10%-95%	Identical
Communications	USB x 1 for connection to Spirotrac	USB x 1 for connection to Spirotrac	Identical
Biocompatibility	Surface Contact, Skin / Mucosa, Limited Duration (predicate's materials)	Surface Contact, Skin / Mucosa, Limited Duration (new material tested to ISO 10993-1, 5, 10, found non-cytotoxic, non-irritating, non-sensitizing)	Identical patient contact, new material tested.
Software Level of Concern	-	Moderate	N/A

2. Sample size used for the test set and the data provenance:

The document does not explicitly state a 'sample size' in terms of patient data for the performance testing of the spirometer itself. The performance testing was primarily bench testing against established standards.

The provenance is implied to be laboratory/bench testing data, not patient data in the context of clinical trials. There is no mention of country of origin for any data or whether it was retrospective or prospective, as it appears to be primarily device performance verification against standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth for this device's performance is established by international technical standards (e.g., ATS/ERS, ISO 23747, ISO 26782) for spirometry, and electrical safety standards (e.g., IEC 60601 series). These are objective measurements performed on the device.

4. Adjudication method for the test set:

Not applicable. The performance testing involves objective measurements against predefined technical standards, not subjective interpretations requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a diagnostic spirometer, not an AI-assisted diagnostic imaging or interpretation tool that would involve "human readers" or AI assistance in that context. The device directly measures respiratory parameters.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The performance evaluation described is for the device as a standalone measuring instrument. This is implicitly how the "Bench Testing" for performance (peak flow, timed forced expired volume) was conducted against ISO standards. The product is a diagnostic spirometer that provides direct measurements, so its standalone performance is its primary function.

7. The type of ground truth used:

The ground truth used for performance validation is based on established international technical standards for spirometry (e.g., ATS/ERS, ISO 23747, ISO 26782) for parameters like volume accuracy, flow accuracy, and linearity, and electrical safety and EMC standards (e.g., IEC 60601 series). For biocompatibility, the ground truth is defined by ISO 10993 standards.

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI that would require a "training set" in the traditional sense. Its core functionality relies on physical measurement principles (Fleisch Pneumotachograph) and established algorithms for calculating spirometry parameters.

9. How the ground truth for the training set was established:

Not applicable, as no training set for machine learning was used.

Summary

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July 27, 2020

Vitalograph Ireland Ltd. % Paul Dryden Consultant ProMedic. LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704

Re: K200550

Trade/Device Name: Vitalograph Model 2120 In2itive eDiary Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: June 27, 2020 Received: June 30, 2020

Dear Paul Dryden:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K200550

Device Name

Vitalograph Model 2120 In2itive eDiary

Indications for Use (Describe)

The Vitalograph Model 2120 In2itive eDiary can be configured as a stand-alone spirometer or connected to a printer.

Type of Use (Select one or both, as applicable)

| XX Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Date Prepared:	27-July-2020
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I. Submitter Vitalograph Ireland Ltd. Gort Road Business Park Ennis Co Clare V95 HFT4 Ireland Tel - +353-65-6864100

Submitter Contact:	Tony O'HanlonRegulatory Affairs / Quality Assurance Manager
Submission Correspondent:	Paul Dryden ProMedic, LLC
II.Device
Proprietary or Trade Name:	Vitalograph Model 2120 In2itive eDiary
Common/Usual Name:	Diagnostic spirometer
Classification Name:	Diagnostic spirometer (21 CFR 868.1840)
Regulatory Class:	II
Product Code:	BZG

K100687 -- Vitalograph Model 2120 III. Predicate Device:

IV. Device Description:

The Vitalograph Model 2120 In2itive eDiary is a hand-held, battery-operated spirometer which measures the following lung function parameters FVC, MVV and VC in hospital, clinical and home settings.

It can be configured as a standalone spirometer or connected to a printer. Its primary functions and technology are:

. Spirometry measurements using single breath and multiple-breath testing techniques, the
display and recording of measured lung volumes and flow rates (including FVC, VC, ● MVV) and other parameters which are subsets of these measured parameters.
. Record subject data. Storage of data and test results on unit for later printing or export to Spirotrac software
The Flowhead utilizes a Fleisch Pneumotachograph.
User Interface navigation via five buttons (Up, Down, Enter/Select, Cancel/Esc and . Power On/Off) or an optional touch screen.

V. Indications for Use:

The Vitalograph Model 2120 In2itive eDiary can be configured as a stand-alone spirometer or connected to a printer.

Environments of use: Hospital wards, health centres and private homes

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VI. Modifications

The subject device includes modifications to the predicate. These modifications include:

Mechanical:

• New display and touch panel
- There is a new display which required that the outer housing be revised to o accommodate the larger display and touch panel.

Electrical:

Change of user interface to a 4.3" color LCD with capacitive touch panel (was 2.8" . resistive)
. Inclusion of codec for sound generation, but the unmodified Model 2120 also provided sound
Update to support Linux Operating System

Materials:

Flowhead outer housing material has changed
- o These are patient contacting materials which have been tested via ISO 10993-1

Software:

Support for user interface above ●
Use of an embedded Linux Operating System ●
Support for Codec as above ●

Comparison of Technological Characteristics and Performance with the Predicate VII.

Table 1 is a comparison - Subject Device vs. the Predicate, K100687 including technological characteristics and performance.

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	Predicate	Subject Device	Comparison
	Model 2120	Vitalograph Model 2120 In2itive eDiary
K#	K100687	K200550	-
Product Code	BZG	BZG	Same
CFR	868.1840	868.1840	Same
Classification	Spirometer, diagnostic	Spirometer, diagnostic	Same
Indications for Use	The device is a battery-operated spirometer whichmeasures three basic patient respiratory parameters(FVC, MVV and VC). The Model 2120 is a handheldspirometer designed for lung function testing in avariety of environments such as hospital wards, healthcentres and private homes.The Model 2120 can be configured as a stand-alonespirometer or connected to a printer.	The Vitalograph Model 2120 In2itive eDiary deviceis a battery-operated spirometer which measuresthree basic patient respiratory parameters (FVC,MVV and VC). The Vitalograph Model 2120In2itive eDiary is a handheld spirometer designed forlung function testing in a variety of environmentssuch as hospital wards, health centres and privatehomes. It is intended for Adults and pediatrics, 5years and older.The Vitalograph Model 2120 In2itive eDiary can beconfigured as a stand-alone spirometer or connectedto a printer.	The indications for use for theModel 2120 In2itive eDiary areidentical to the predicate Model2120 with just the device nameupdated.
Fundamentalscientific technology	Fleisch Pneumotachograph type Flowhead isconnected to a transducer, with related signal-processing circuitry.	Fleisch Pneumotachograph type Flowhead isconnected to a transducer, with related signal-processing circuitry.	Same
Parameters measured	FVC, MVV and VC	FVC, MVV and VC	Same
Hand-held	Yes	Yes	Same
Patient Interface	Flowhead cone	Flowhead cone	Same
Cleaning	Unit surface cleaning and 70% alcohol	Unit surface cleaning and 70% alcohol	Same
Patient use	Single Patient, multi-use	Unit surface cleaning and 70% alcohol	Same
Specifications
Back pressure	Less than 0.1kPa/L/second @ 14L/s	Less than 0.1kPa/L/second @ 14L/s	Identical
Volume detection	Flow integration sampling @ 100Hz	Flow integration sampling @ 100Hz	Identical
Maximum displayedvolume	10L	10L	Identical
Volume accuracy+3% or 0.05l	Yes	Yes	Identical
	PredicateModel 2120	Subject DeviceVitalograph Model 2120 In2itive eDiary	Comparison
Min. Volume	0.01L	0.01L	Identical
Flow Accuracy whenoperated in operatingtemperature rangeconditions	Flow ±10% or 0.3 L/sMax. flow rate ±16 L/sMin. flow rate ±0.02 L/s	Flow ±10% or 0.3 L/sMax. flow rate ±16 L/sMin. flow rate ±0.02 L/s	Identical
Linearity	Better than ±3%	Better than ±3%	Identical
Operatingtemperature range	10-40°C	10-40°C	Identical
Performancestandards	ATS/ERS (2005)ISO 23747ISO 26782	ATS/ERS (2005)ISO 23747ISO 26782	Identical
Electrical Safety andEMC	ES 60601-1IEC 60601-1-2	ES 60601-1IEC 60601-1-2IEC 60601-1-11	Similar. Added IEC 60601-1-11 for home use which had notbeen done for the predicate
Storage Temperature	0-50°C	0-50°C	Identical
Storage RelativeHumidity	10%-95%	10%-95%	Identical
Communications	USB x 1 for connection to Spirotrac	USB x 1 for connection to Spirotrac	Identical
Device weight	0.310Kg	0.230Kg	Similar
Dimensions	186 x 110 x 48 mm	160 x 100 x 45mm	Similar
Interface	Touchscreen LCD	Touchscreen LCDButtons, buttons were not used in practice	No.Differences do not raise newconcerns
Power / EnergySource	5V/3.7V Li-ion rechargeable battery	5V/3.7V Li-ion rechargeable battery	Identical
Biocompatibility	Surface Contact, Skin / MucosaLimited Duration	Surface Contact, Skin / MucosaLimited Duration	Identical patient contactNew material tested to ISO10993-1

Table 1: Comparison of the Model 2120 In2itive eDiary vs. the Predicate

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VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility -

The patient contacting materials were identical to the predicate and review of the geometry and processing did not raise new or different concerns. For those that were different they were considered Surface Contact, Intact skin or Mucosa contacting with limited duration of contact and tested to ISO 10993-5 - Cytotoxicity and ISO 10993-10 - Sensitization and Irritation and found to be noncytotoxic, non-irritating and non-sensitizing.

Electrical Safetv and EMC

Electrical safety and EMC testing were conducted on the subject device. The system complies with AAMI ANSI ES 60601-1: 2005 + A1: 2012 and IEC 60601-1-2:2014 for EMC and IEC 60601-1-11:2015 for home use.

Software Verification and Validation Testing

Software verification and validation testing were conducted. The software for this device was considered as a "moderate" level of concern.

Mechanical, Animal, and Clinical Testing

No mechanical, animal or clinical testing was performed.

Bench Testing

Performance testing per ATS/ERS for peak flow and timed forced expired volume per ISO 23747:2015- Peak Flow and ISO 26782:2009 – Timed Forced Expired Volume was performed.

IX. Conclusions

Discussion of Differences -

The identified differences do not raise new or different concerns of safety or effectiveness relative to the predicate.

Substantial Equivalence Conclusion

The performance testing has demonstrated that the subject devise met the applicable standard performance requirements. The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.

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).