(146 days)
No
The document describes a standard spirometer measuring basic respiratory parameters using established technology (Fleisch Pneumotachograph) and does not mention any AI or ML components or capabilities.
No.
The device measures lung function parameters but does not provide therapy or treatment.
Yes
The device measures patient respiratory parameters (FVC, MVV, VC) which are indicators of lung function. The measurement and display of these parameters help in assessing a patient's respiratory health, which is a key aspect of diagnosis.
No
The device is described as a "battery-operated spirometer" and a "handheld spirometer," explicitly mentioning hardware components like a "Flowhead utilizes a Fleisch Pneumotachograph" and physical buttons or an optional touch screen for user interface. This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the Vitalograph Model 2120 In2itive eDiary device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The device description clearly states that the Vitalograph Model 2120 In2itive eDiary is a spirometer that measures respiratory parameters (FVC, MVV, VC) directly from the patient's breath. It does not analyze blood, urine, tissue, or any other sample taken from the body.
- The intended use and device description focus on measuring physiological parameters. The device measures lung function, which is a physiological process, not the analysis of a biological sample.
- The performance studies are related to the accuracy of the measurement of respiratory parameters. The bench testing described focuses on meeting standards for peak flow and timed forced expired volume, which are direct measurements of lung function.
Therefore, the Vitalograph Model 2120 In2itive eDiary is a medical device used for physiological measurement, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
BZG
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.
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 centres 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)
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 Safety 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.
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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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
1
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
2
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 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.
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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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301)
3
| Date Prepared: | 27-July-2020 |
|---|---|
| ---------------- | -------------- |
I. Submitter Vitalograph Ireland Ltd. Gort Road Business Park Ennis Co Clare V95 HFT4 Ireland Tel - +353-65-6864100
| Submitter Contact: | Tony O'Hanlon
Regulatory 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 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.
Environments of use: Hospital wards, health centres and private homes
4
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 which | ||
| measures three basic patient respiratory parameters | |||
| (FVC, MVV and VC). The Model 2120 is a handheld | |||
| 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 connected to a printer. | 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. | The indications for use for the | ||
| Model 2120 In2itive eDiary are | |||
| identical to the predicate Model | |||
| 2120 with just the device name | |||
| updated. | |||
| Fundamental | |||
| scientific technology | Fleisch Pneumotachograph type Flowhead is | ||
| connected to a transducer, with related signal- | |||
| processing circuitry. | Fleisch Pneumotachograph type Flowhead is | ||
| connected 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 displayed | |||
| volume | 10L | 10L | Identical |
| Volume accuracy | |||
| +3% or 0.05l | Yes | Yes | Identical |
| Predicate | |||
| Model 2120 | Subject Device | ||
| Vitalograph Model 2120 In2itive eDiary | Comparison | ||
| Min. Volume | 0.01L | 0.01L | Identical |
| Flow Accuracy when | |||
| operated in operating | |||
| temperature range | |||
| conditions | Flow ±10% or 0.3 L/s | ||
| Max. flow rate ±16 L/s | |||
| Min. flow rate ±0.02 L/s | 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 range | 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 and | |||
| EMC | ES 60601-1 | ||
| IEC 60601-1-2 | ES 60601-1 | ||
| IEC 60601-1-2 | |||
| IEC 60601-1-11 | Similar. Added IEC 60601-1- | ||
| 11 for home use which had not | |||
| been done for the predicate | |||
| 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 |
| Device weight | 0.310Kg | 0.230Kg | Similar |
| Dimensions | 186 x 110 x 48 mm | 160 x 100 x 45mm | Similar |
| Interface | Touchscreen LCD | Touchscreen LCD | |
| Buttons, buttons were not used in practice | No. | ||
| Differences do not raise new | |||
| concerns | |||
| Power / Energy | |||
| Source | 5V/3.7V Li-ion rechargeable battery | 5V/3.7V Li-ion rechargeable battery | Identical |
| Biocompatibility | Surface Contact, Skin / Mucosa | ||
| Limited Duration | Surface Contact, Skin / Mucosa | ||
| Limited Duration | Identical patient contact | ||
| New material tested to ISO | |||
| 10993-1 |
Table 1: Comparison of the Model 2120 In2itive eDiary vs. the Predicate
6
7
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.