(133 days)
No
The description focuses on standard spirometry measurements and data handling, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is used for the assessment of respiratory function by measuring lung volumes and flow rates, which is a diagnostic function, not a therapeutic one.
Yes
This device is a diagnostic device because its "Intended Use" states that it is for "simple assessment of respiratory function" through "measurement of dynamic lung volumes i.e. spirometry," measuring "patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC." These measurements are used to diagnose respiratory conditions.
No
The device description explicitly states it is a "desktop spirometer" and details hardware components such as a power supply, rechargeable battery, thermal printer, USB port, SD card slot, ethernet, Wi-Fi, and a Fleisch Pneumotachograph Flowhead. This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the Vitalograph Model 6000 Alpha is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Vitalograph Model 6000 Alpha Function: The description clearly states that this device measures respiratory parameters directly from the patient's breath (dynamic lung volumes). It does not analyze specimens taken from the body.
- Intended Use: The intended use is the "simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry." This involves direct interaction with the patient's breathing, not the analysis of a biological sample.
Therefore, the Vitalograph Model 6000 Alpha falls under the category of a medical device used for physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the Vitalograph Model 6000 Alpha is the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry. The device measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The device is designed to be operated by medical professionals trained in respiratory and lung function testing on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers.
Product codes
BZG
Device Description
The Vitalograph Alpha Model 6000 is a desktop spirometer which measures the following lung function parameters FVC, FEV1, FEV6, PEF, MVV and VC in professional healthcare environments, e.g., primary care, hospitals and occupational health centers.
It is externally powered from a Class II, IEC 60601-1 compliant medical power supply. It contains a rechargeable battery powered from the external supply. The device also contains an integral 4 inch thermal printer.
The device has a USB port for connection to other devices and an SD card slot for backup of stored data. The device also has wired ethernet and Wi-Fi for connection to a hospital network.
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, FEV1, FEV6, PEF, MVV and VC) are identical to the predicate device
- Record subject data
- Storage of data and test results on unit for later printing or export to Spirotrac software which was cleared under 510(k) K201562
- . The Flowhead utilizes a Fleisch Pneumotachograph. The operating principle is identical to the predicate K200550
- User Interface navigation via touch screen display ●
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 pediatrics, 5 years and older
Intended User / Care Setting
medical professionals trained in respiratory and lung function testing
professional healthcare environments, e.g. primary care, hospitals and occupational health centers.
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 following performance data were provided in support of the substantial equivalence determination.
Biocompatibility - The patient contacting materials were evaluated using: ISO 10993-5(2009) – Cytotoxicity, ISO 10993-10 (2010) - Sensitization and Irritation, ISO 10993-18 (2020) - Chemical Characterization, ISO 18562-2 (2017) - Particulate Materials, ISO 18562-3(2017) - VOC, with a toxicological risk assessment. The material were found to be acceptable for their intended use.
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.
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 - Cleaning validation, aging. There was no animal or clinical testing was performed.
Bench Testing - Performance testing per ATS/ERS (2019) for peak flow and timed forced expired volume per ISO 23747:2015- Peak Flow and ISO 26782:2009 - Timed Forced Expired Volume was performed.
Conclusion - The performance testing has demonstrated that the subject devise met the applicable standard performance requirements. Through performance testing, design and features, and non-clinical testing, the proposed device and predicate are found to be substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 26, 2022
Vitalograph Ireland Ltd. % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K212938
Trade/Device Name: Vitalograph Model 6000 Alpha Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: December 21, 2021 Received: December 22, 2021
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.
1
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 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.
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
Vitalograph Model 6000 Alpha Indications for Use (Describe)
The intended use of the Vitalograph Model 6000 Alpha is the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry. The device measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The device is designed to be operated by medical professionals trained in respiratory and lung function testing on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (6/20)
Page 1 of 1
EF PSC Publishing Services (301) 443-6740
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Page 1 of 5
| Date Prepared: | 25-January-2022 |
|---|---|
| ---------------- | ----------------- |
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 6000 Alpha |
|---|---|
| Common/Usual Name: | Diagnostic spirometer |
| Classification Name: | Diagnostic spirometer (21 CFR 868.1840) |
| Regulatory Class: | II |
| Product Code: | BZG |
III. Predicate Device:
K200550 - Vitalograph Model 2120 In2itive eDiary
| 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 |
IV. Device Description:
The Vitalograph Alpha Model 6000 is a desktop spirometer which measures the following lung function parameters FVC, FEV1, FEV6, PEF, MVV and VC in professional healthcare environments, e.g., primary care, hospitals and occupational health centers.
It is externally powered from a Class II, IEC 60601-1 compliant medical power supply. It contains a rechargeable battery powered from the external supply. The device also contains an integral 4 inch thermal printer.
The device has a USB port for connection to other devices and an SD card slot for backup of stored data. The device also has wired ethernet and Wi-Fi for connection to a hospital network.
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, FEV1, FEV6, PEF, MVV and VC) are identical to the predicate device
- Record subject data
- Storage of data and test results on unit for later printing or export to Spirotrac software which was cleared under 510(k) K201562
- . The Flowhead utilizes a Fleisch Pneumotachograph. The operating principle is identical to the predicate K200550
- User Interface navigation via touch screen display ●
4
V. Indications for Use:
The intended use of the Vitalograph Model 6000 Alpha is the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry. The device measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The device is designed to be operated by medical professionals trained in respiratory and lung function testing on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers.
Environments of use: Professional healthcare environments, e.g., primary care, hospitals and occupational health centers.
VI. Comparison of Technological Characteristics and Performance with the Predicate
Table 1 is a comparison - Subject Device vs. the Predicate, K200550.
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Page 3 of 5
| Predicate | Subject Device | Comparison | |
|---|---|---|---|
| Model 2120 In2itive eDiary | Model 6000 Alpha | ||
| K# | K200550 | K212938 | - |
| Product Code | BZG | BZG | Identical |
| CFR | 868.1840 | 868.1840 | Identical |
| Classification | Spirometer, diagnostic | Spirometer, diagnostic | Identical |
| 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 centers and private homes. | |||
| The Vitalograph Model 2120 In2itive eDiary can | |||
| be configured as a stand-alone spirometer or | |||
| connected to a printer. | The intended use of the Vitalograph Model 6000 | ||
| Alpha is the simple assessment of respiratory | |||
| function through the measurement of dynamic lung | |||
| volumes i.e. spirometry. The device measures | |||
| patient respiratory parameters including FVC, | |||
| FEV1, FEV6, PEF, MVV and VC. The device is | |||
| designed to be operated by medical professionalstrained in respiratory and lung function testing on | |||
| adults and pediatrics, 5 years and older, in a variety | |||
| of professional healthcare environments, e.g. | |||
| primary care, hospitals and occupational health | |||
| centers. | Equivalent | ||
| 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. | Similar | ||
| Parameters | |||
| measured | FVC, FEV1, FEV6, PEF, MVV and VC | FVC, FEV1, FEV6, PEF, MVV and VC | Identical parameters |
| Hand-held | Yes | Not a desktop | Same functionality in a different |
| form | |||
| Patient Interface | Flowhead cone | Flowhead cone | Similar |
| Cleaning | Unit surface cleaning and 70% alcohol | Unit surface cleaning and 70% alcohol | Similar |
| Patient use | Unit surface cleaning and 70% alcohol | Unit surface cleaning and 70% alcohol | Similar |
Table 1 - Comparison of Subject and Predicate Devices
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Page 4 of 5
| Specifications | Predicate
Model 2120 In2itive eDiary | Subject Device
Model 6000 Alpha | Comparison |
|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Back pressure | Less than 0.1kPa/L/second @ 14L/s | Less than 0.1kPa/L/second @ 14L/s | Similar |
| Volume detection | Flow integration sampling @ 100Hz | Flow integration sampling @ 100Hz | Similar |
| Maximum
displayed volume | 10L | 10L | Similar |
| Volume accuracy | $\pm$ 3% or 0.05L ( $\pm$ 2.5% for device and $\pm$ 0.5% for syringe) | $\pm$ 2.5% | Similar |
| Flow Accuracy
when operated in
operating
temperature range
conditions | Flow $\pm$ 10% or 0.3 L/s
Max. flow rate $\pm$ 16 L/s
Min. flow rate $\pm$ 0.02 L/s | Flow Accuracy $\pm$ 10%
Max. flow rate $\pm$ 16 L/s
Min. flow rate $\pm$ 0.02 L/s | Similar |
| Operating
temperature range | 10 $-$ 40 $\degree$ C | 10 $-$ 40 $\degree$ C | Similar |
| Performance
standards | ATS/ERS (2005)
ISO 23747
ISO 26782 | ATS/ERS (2019)
ISO 23747
ISO 26782 | Similar, the subject device
complies with the latest version of
ATS/ERS |
| Electrical Safety
and EMC | ES 60601-1
IEC 60601-1-2
IEC 60601-1-11 | ES 60601-1
IEC 60601-1-2 | Similar but subject device is not
intended for home use |
| Communications | USB | USB, Ethernet, WiFi | Similar, additional connectivity in
subject device |
| Device weight | 0.230 kg | 1.5 kg | Not critical too equivalence |
| Dimensions | 160 x 100 x 45mm | 204mm (length) x 253mm (width) | Not critical too equivalence |
| Interface | Touchscreen LCD | Color touchscreen | Similar |
| Power / Energy
Source | 5V/3.7V Li-ion rechargeable battery | 7.2V, 2.2Ahr NiMH | Similar |
| Biocompatibility | Surface Contact, Skin / Mucosa, Limited
Duration | Externally Communicating, Tissue and Surface
Contact, Skin / Mucosa, Limited Duration | Similar |
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Page 5 of 5
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility -
The patient contacting materials were evaluated using: ISO 10993-5(2009) – Cytotoxicity, ISO 10993-10 (2010) - Sensitization and Irritation, ISO 10993-18 (2020) - Chemical Characterization, ISO 18562-2 (2017) - Particulate Materials, ISO 18562-3(2017) - VOC, with a toxicological risk assessment. The material were found to be acceptable for their intended use.
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.
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
Cleaning validation, aging. There was no animal or clinical testing was performed.
Bench Testing
Performance testing per ATS/ERS (2019) for peak flow and timed forced expired volume per ISO 23747:2015- Peak Flow and ISO 26782:2009 - Timed Forced Expired Volume was performed.
Conclusion IX.
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. Through performance testing, design and features, and non-clinical testing, the proposed device and predicate are found to be substantially equivalent.