(133 days)
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.
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
The provided text describes the regulatory clearance of the Vitalograph Model 6000 Alpha spirometer and details its comparison to a predicate device. It primarily focuses on the device's technical specifications, regulatory compliance, and non-clinical performance testing rather than a study proving the device meets acceptance criteria in the context of an AI/ML model for clinical decisions.
Based on the provided document, here's an analysis of the acceptance criteria and study that proves the device meets them:
This document is for a diagnostic spirometer, which is a physical medical device that measures lung function. It is not an AI/ML device for clinical decisions. Therefore, many of the typical "acceptance criteria" and "study types" associated with AI/ML devices (like MRMC studies, ground truth establishment by experts, adjudication, sample size for training sets, etc.) do not apply in this context.
The "acceptance criteria" for a physical diagnostic device like a spirometer primarily revolve around its technical performance specifications, electrical safety, EMC, and compliance with relevant international standards.
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal "acceptance criteria" table in the AI/ML sense. Instead, it provides a "Comparison of Subject and Predicate Devices" (Table 1) which implicitly serves as a comparison against established performance benchmarks and standards for spirometers. The performance data section further details the testing performed to demonstrate compliance.
Here's an attempt to derive "acceptance criteria" from the Specifications reported in the comparison table and the Performance Data section:
| Acceptance Criteria (Derived from Standards/Predicate) | Reported Device Performance (Vitalograph Model 6000 Alpha) |
|---|---|
| Spirometry Measurement Parameters | FVC, FEV1, FEV6, PEF, MVV, VC |
| Back pressure | Less than 0.1kPa/L/second @ 14L/s |
| Volume detection | Flow integration sampling @ 100Hz |
| Maximum displayed volume | 10L |
| Volume accuracy | ± 2.5% |
| Flow Accuracy | Flow ± 10% or 0.3 L/s |
| Max. flow rate | ± 16 L/s |
| Min. flow rate | ± 0.02 L/s |
| Operating temperature range | 10 – 40 °C |
| Biocompatibility | Acceptable per ISO 10993-5, 10, 18, and ISO 18562-2, 3 (with toxicological risk assessment) |
| Electrical Safety | Complies with AAMI ANSI ES 60601-1: 2005 + A1: 2012 |
| EMC | Complies with IEC 60601-1-2:2014 |
| Software Level of Concern | Moderate |
| Performance Standards Compliance | ATS/ERS (2019), ISO 23747, ISO 26782 |
2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of patient data or clinical test sets for AI/ML validation. The testing described is bench testing using standardized methods and controlled inputs (e.g., flow/volume simulators, environmental chambers).
- Data Provenance: Not applicable as it's not a data-driven AI/ML study. The "data" here comes from direct measurements by the device itself under test conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for device performance (e.g., whether a spirometer accurately measures volume) is established by calibration against known, traceable standards and instruments, not by human expert interpretation of results. The "ground truth" for spirometry measurements comes from the physical and engineering principles of the measurement itself and the standards against which it is calibrated and tested.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication is a process used in studies where human interpretation or clinical judgment is involved, particularly for establishing a consensus "ground truth" from multiple readers. This is a technical device performance test, not a reader study.
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:
- No. An MRMC study is relevant for AI/ML diagnostic aids where human readers interpret medical images or data. This is a fundamental diagnostic device, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a "standalone" diagnostic instrument. Its performance is evaluated intrinsically through bench testing against specified standards and its predicate, rather than being an "algorithm only" being evaluated for clinical decision support. Its core function is to measure parameters directly, not to provide an automated clinical interpretation that would fall under "algorithm only" performance in the AI/ML sense.
7. The type of ground truth used:
- The "ground truth" for the device's technical performance is based on established engineering standards and reference measurements, such as those defined by ATS/ERS (2019), ISO 23747, and ISO 26782. These standards specify how spirometers should measure flow and volume and define the acceptable accuracy limits. For electrical safety and EMC, the ground truth is compliance with the relevant IEC/AAMI standards.
8. The sample size for the training set:
- Not applicable. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for machine learning.
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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.
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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
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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'HanlonRegulatory 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 ●
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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 eDiarydevice is a battery-operated spirometer whichmeasures three basic patient respiratoryparameters (FVC, MVV and VC). TheVitalograph Model 2120 In2itive eDiary is ahandheld spirometer designed for lung functiontesting in a variety of environments such ashospital wards, health centers and private homes.The Vitalograph Model 2120 In2itive eDiary canbe configured as a stand-alone spirometer orconnected to a printer. | The intended use of the Vitalograph Model 6000Alpha is the simple assessment of respiratoryfunction through the measurement of dynamic lungvolumes i.e. spirometry. The device measurespatient respiratory parameters including FVC,FEV1, FEV6, PEF, MVV and VC. The device isdesigned to be operated by medical professionalstrained in respiratory and lung function testing onadults and pediatrics, 5 years and older, in a varietyof professional healthcare environments, e.g.primary care, hospitals and occupational healthcenters. | Equivalent |
| Fundamentalscientifictechnology | 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. | Similar |
| Parametersmeasured | 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 differentform |
| 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 | PredicateModel 2120 In2itive eDiary | Subject DeviceModel 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 |
| Maximumdisplayed 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 Accuracywhen operated inoperatingtemperature rangeconditions | Flow $\pm$ 10% or 0.3 L/sMax. flow rate $\pm$ 16 L/sMin. flow rate $\pm$ 0.02 L/s | Flow Accuracy $\pm$ 10%Max. flow rate $\pm$ 16 L/sMin. flow rate $\pm$ 0.02 L/s | Similar |
| Operatingtemperature range | 10 $-$ 40 $\degree$ C | 10 $-$ 40 $\degree$ C | Similar |
| Performancestandards | ATS/ERS (2005)ISO 23747ISO 26782 | ATS/ERS (2019)ISO 23747ISO 26782 | Similar, the subject devicecomplies with the latest version ofATS/ERS |
| Electrical Safetyand EMC | ES 60601-1IEC 60601-1-2IEC 60601-1-11 | ES 60601-1IEC 60601-1-2 | Similar but subject device is notintended for home use |
| Communications | USB | USB, Ethernet, WiFi | Similar, additional connectivity insubject 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 / EnergySource | 5V/3.7V Li-ion rechargeable battery | 7.2V, 2.2Ahr NiMH | Similar |
| Biocompatibility | Surface Contact, Skin / Mucosa, LimitedDuration | Externally Communicating, Tissue and SurfaceContact, 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.
§ 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).