FLOWMATE II PLUS, MODEL #4000 by SPIROMETRICS MEDICAL EQUIPMENT CO.

Intended use for the Flowmate II PLUS is for Pulmonary Function Testing (measuring a person's ability to move air into and out of their lungs). The volume and flow rates measured for the effort and then reported as numerical results with a printout of the results if selected.

Indications For Use: Pulmonary Function Testing

Diagnostic

To evaluate symptoms, signs, or abnormal laboratory tests

Symptoms: dyspnea, wheezing, orthopnea, cough, phlegm production, chest pain
Signs: diminished breath sounds, overinflation, expiratory slowing, cyanosis, chest deformity, unexplained crackles
Abnormal laboratory tests: hypoxemia, hypercapnia, polycythemia, abnormal chest radiographs

To measure the effects of disease on pulmonary function

To screen individuals at risk of having pulmonary diseases

Smokers
Individuals in occupations with exposures to injurious substances
Some routine physical examinations
To assess preoperative risk
To assess prognosis (lung transplant, etc.)
To assess health status before enrollment in strenuous phsical activity programs

Monitoring

To assess therapeutic interventions

Bronchodilator therapy
Steroid treatment for asthma, interstitial lung disease, etc.
Management of congestive heart failure
Other (antibiotics in cystic fibrosis, etc.)
To describe the course of diseases affecting lung function
Pulmonary diseases
Obstructive airways diseases
Interstitial lung diseases
Cardiac diseases
Congestive heart failure
Neuromuscular diseases
Guillain-Barré

To monitor persons in occupations with exposure to injurious agents

To monitor for adverse reactions to drugs with known pulmonary toxicity

Disability / Impairment Evaluations

To assess patients as part of a rehabilitation program

Medical
Industrial
Vocational

To assess risks as part of an insurance evaluation

To assess individuals for legal reasons

Social Security or other government compensation programs
Personal injury lawsuits
Others

Public Health

Epidemiologic surveys

Comparison of health status of populations living in different environments
Validation of subjective complaints in occupational / environmental settings Derivation of reference equations

Device Description

Flow sensing pneumotach and base that measures differential pressure as air passes through it (the same principle as the Flowmate LTE, Flowmate, and PC Flow + devices)
Desktop design molded from high impact UL rated ABS plastic
Automatic calculations of test results, and best test selection based on American Thoracic Society (ATS) criteria
Testing capabilities include; FVC, FEV1, FEV3, FEV1/FVC%, FEF.2-1.2, FEF25-75%, FEF75-85, PEF, FEF50, FIVC, FEF50/FIF50, PIF, MVV, Methacholine Challenge, and Lung Age
Testing Capabilities: Capacity 10 Liters
Volume Accuracy +/- 3% Max. Flow Rate +/- 16 L/s
Back Pressure Less than 1.5 cm H2O
Population Predicted Normals included: Composite Knudson - 1976 Knudson - 1983 Crapo (ITS) ECCS Hsu Lam
Customization allows user to change report format, input temperature and barometric readings, and select internal / external printer and associated driver for printer selected
Reports printed on thermal paper 112mm wide or standard 8 1/2 " x 11" paper
Field calibration with a 1 to 9 Liter calibration syringe
Cross-contamination control via external filter system

AI/ML Overview

The provided document is a 510(k) summary for the Flowmate II PLUS diagnostic spirometer. It describes the device's intended use, its substantial equivalence to predicate devices, and the performance testing conducted.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Device Performance

The primary acceptance criteria are based on conformance with the American Thoracic Society (ATS) 1994 Spirometry criteria. The document explicitly states: "Performance Standard: None applicable from FDA, used conformance with American Thoracic Society (ATS) 1994 Spirometry criteria."

Acceptance Criteria (Based on ATS 1994)	Reported Device Performance (Flowmate II PLUS)
FVC Accuracy and Precision	Exceeded ATS recommendations
FEV1 Accuracy and Precision	Exceeded ATS recommendations
FEF25-75 Accuracy and Precision	Exceeded ATS recommendations
PEF Accuracy and Precision	Exceeded ATS recommendations
MVV Accuracy and Precision	Acceptable results (compared to ATS criteria)
Volume Accuracy	+/- 3%
Max. Flow Rate	+/- 16 L/s
Back Pressure	Less than 1.5 cm H2O

Note: The document only states that the device "exceeded" ATS recommendations for FVC, FEV1, FEF25-75, and PEF accuracy and precision, rather than providing specific numerical targets for the ATS criteria. For MVV, it states "acceptable results compared with the ATS criteria." The specific numerical acceptance criteria from ATS 1994 are not detailed in this document.

Study Information

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

Sample Size:
- For FVC, FEV1, FEF25-75, and PEF accuracy and precision: 24 waveforms (under BTPS conditions), and 26 PEF waveforms.
- For FVC, FIVC, PEF, and PIF accuracy and precision (exponential waveforms): Four progressively faster exponential waveforms.
- For MVV testing: Not explicitly stated, but implies multiple tests with simulated MVV waveforms.
Data Provenance: The tests were conducted using a "Pulmonary Waveform Generator (PWG)." This indicates the data is simulated/synthetic (generated by a machine), not from human subjects. The country of origin of this simulated data is not specified, but it's likely created in the US given the company's location.

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

No human experts were used to establish the ground truth for the test set. The ground truth was established by the known inputs/outputs of the Pulmonary Waveform Generator (PWG) and physical measurements (e.g., a 3-liter syringe for volume accuracy).

3. Adjudication method for the test set:

Not applicable/None. The ground truth was based on the objective outputs of the PWG and known physical inputs, not on expert consensus requiring adjudication.

4. 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. This is a performance study for a diagnostic spirometer, which primarily measures physiological parameters. It is not an AI-assisted diagnostic tool that would involve human readers interpreting images or data alongside AI. Therefore, an MRMC study is not relevant here.

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

Yes, implicitly. The entire performance testing described was "standalone." The device (Flowmate II PLUS) was tested against a Pulmonary Waveform Generator (PWG) and physical inputs (like a calibration syringe) to assess its accuracy and precision in measuring various spirometric parameters. This represents the algorithm/device's performance without human interaction in the measurement process itself, beyond setup and data collection.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Known physical inputs/outputs and pre-defined standards.
- For volume accuracy, a known 3-liter syringe input was used.
- For waveforms (FVC, FEV1, PEF, etc.), the "known" characteristics of the waveforms generated by the Pulmonary Waveform Generator (PWG) served as the ground truth.
- The ATS 1994 Spirometry criteria served as the benchmark for acceptable performance.

7. The sample size for the training set:

Not applicable. This device is a measurement instrument, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its functionality is based on physical principles (differential pressure measurement) and programmed calculations, not learned patterns from data.

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

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the date November 24, 1998. The month is abbreviated to NOV. The numbers are clearly printed in a bold, sans-serif font. The date is likely extracted from a document or photograph.

K982956

Image /page/0/Picture/2 description: The image shows the logo for Spirometrics Medical Equipment Company. The logo consists of a stylized graphic on the left, followed by the company name in a stylized font. Below the company name is the address "415 Rodman Road Auburn, Maine 04210".

510(k) SUMMARY

Submitted by: New VED Inc. d.b.a. Spirometrics Medical Equipment Co. 415 Rodman Road Auburn, ME 04210 207-784-0906, Fax 207-784-1481

Donald Henton, Official Correspondent Contact Person: August 21, 1998 Date Prepared:

Classification Name: Diagnostic Spirometer �
Common or Usual Name: Diagnostic or Screening Spirometer �
Proprietary Name: Flowmate II PLUS �
Establishment Registration Number: 1720605 �
Classification: Diagnostic Spirometers have been classified as Class II devices. �
� Performance Standard: None applicable from FDA, used conformance with

American Thoracic Society (ATS) 1994 Spirometry criteria

Spirometrics has been marketing flow sensing pneumotachs with models Flowmate, Flowmate LTE, and PC Flow + devices. This listed product is substantially equivalent to the Flowmate 2500LTE premarket notification number K954759, Flowmate 2500 premarket notification number K863953/A, and PC Flow + 3350 premarket notification number K900673 manufactured by Spirometrics, the Renaissance from Puritan Bennett premarket notification number K911143, and the Presto Flash Portable Spirometry System from Burdick Inc. premarket notification number K894997.

For a description of the device see Summary Exhibit 1.

Description of the device:

� Flow sensing pneumotach and base that measures differential pressure as air passes through it (the same principle as the Flowmate LTE, Flowmate, and PC Flow + devices)
510(k) SUMMARY

"Dedicated to Improving the Quality of Life"

{1}------------------------------------------------

Desktop design molded from high impact UL rated ABS plastic �
Automatic calculations of test results, and best test selection based on � American Thoracic Society (ATS) criteria
Testing capabilities include; FVC, FEV1, FEV3, FEV1/FVC%, FEF.2-1.2, � FEF25-75%, FEF75-85, PEF, FEF50, FIVC, FEF50/FIF50, PIF, MVV, Methacholine Challenge, and Lung Age
Testing Capabilities: Capacity 10 Liters �

Volume Accuracy +/- 3% Max. Flow Rate +/- 16 L/s

Back Pressure Less than 1.5 cm H2O

� Population Predicted Normals included: Composite
Knudson - 1976 Knudson - 1983 Crapo (ITS) ECCS Hsu Lam
� Customization allows user to change report format, input temperature and barometric readings, and select internal / external printer and associated driver for printer selected
� Reports printed on thermal paper 112mm wide or standard 8 1/2 " x 11" paper
� Field calibration with a 1 to 9 Liter calibration syringe
Cross-contamination control via external filter system �

Waveform performance testing was conducted using a Pulmonary Waveform Generator (PWG), and showed that the Flowmate II PLUS exceeded the ATS recommendations for FVC, FEV1, FEF 25-75 and PEF accuracy and precision at all of the 24, testing under Body Temperature Pressure Saturated with water (BTPS) (see Summary Exhibit 2), and the 26 PEF waveforms (see Summary Exhibit 5).

The exhale / inhale performance of the device was tested using exponential waveforms created by the PWG using the same exponential curve in both exhale / inhale maneuvers. FVC, FIVC, PEF and PIF were recorded from four progressively faster exponential waveforms, with the accuracy and precision compared against the known three (3) liter syringe inputs. See Summary Exhibit 3 & 4.

MVV testing with the PWG also showed acceptable results compared with the ATS criteria for accuracy and precision to the delivered values (See Exhibit 3 & 4).

510(k) SUMMARY

{2}------------------------------------------------

EMC and safety testing has shown the device to meet the EN60601-1-2 for emmissions and immunity, and the IEC 601-1 and UL 2601 safety standard for medical equipment. See Summary Exhibit 6.

Our conclusion is that the Flowmate II PLUS is substantially equivalent to the predicate device the FlowmateLTE. It is also substantially equivalent to the Flowmate, PC Flow+, Renaissance, and Presto Flash Portable Spirometry System.

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 1998

Mr. Donald Henton Spirometrics Medical Equipment Company 415 Rodman Road Auburn, ME 04210

K982956 Re: Flowmate II PLUS Regulatory Class: II (two) Product Code: 73 BZG Dated: October 30, 1998 Received: November 5, 1998

Dear Mr. Henton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2 - Mr. Donald Henton

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callehan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number: K982956

Device Name: Flowmate II PLUS

The intended environments for use are hospitals, physician / clinician offices, and industrial health screening locations.

The intended patient population is from children to adults.

Indications For Use: Pulmonary Function Testing

Diagnostic

To evaluate symptoms, signs, or abnormal laboratory tests

Symptoms: dyspnea, wheezing, orthopnea, cough, phlegm production, chest pain
Signs: diminished breath sounds, overinflation, expiratory slowing, cyanosis, chest deformity, unexplained crackles
Abnormal laboratory tests: hypoxemia, hypercapnia, polycythemia, abnormal chest radiographs

To measure the effects of disease on pulmonary function

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Prescription Use

illone

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

{6}------------------------------------------------

510(k) Number: K982956

Device Name: Flowmate II PLUS

Indications For Use: Pulmonary Function Testing - continued

Diagnostic - continued

To screen individuals at risk of having pulmonary diseases

Smokers
Individuals in occupations with exposures to injurious substances
Some routine physical examinations
To assess preoperative risk
To assess prognosis (lung transplant, etc.)
To assess health status before enrollment in strenuous phsical activity programs

Monitoring

To assess therapeutic interventions

Bronchodilator therapy
Steroid treatment for asthma, interstitial lung disease, etc.
Management of congestive heart failure
Other (antibiotics in cystic fibrosis, etc.)
To describe the course of diseases affecting lung function
- Pulmonary diseases
  - Obstructive airways diseases
  - Interstitial lung diseases
- Cardiac diseases

Congestive heart failure

Neuromuscular diseases
Guillain-Barré

To monitor persons in occupations with exposure to injurious agents

To monitor for adverse reactions to drugs with known pulmonary toxicity

Disability / Impairment Evaluations

To assess patients as part of a rehabilitation program

Medical
Industrial
Vocational

To assess risks as part of an insurance evaluation

To assess individuals for legal reasons

Social Security or other government compensation programs
Personal injury lawsuits
Others

krame

{7}------------------------------------------------

510(k) Number: K982956

Indications For Use: Pulmonary Function Testing - continued

Public Health

Epidemiologic surveys

Comparison of health status of populations living in different environments
Validation of subjective complaints in occupational / environmental settings Derivation of reference equations

American Thoracic Society. 1995. Standardization of Spirometry 1994 Update. Am. J. Respir. Crit. Care. Med. 152:1108.

ert thanle

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).