FLOWMATE II PLUS, MODEL #4000

K982956 · Spirometrics Medical Equipment Co. · BZG · Nov 24, 1998 · Anesthesiology

Device Facts

• Record ID: K982956
• Device Name: FLOWMATE II PLUS, MODEL #4000
• Applicant: Spirometrics Medical Equipment Co.
• Product Code: BZG · Anesthesiology
• Decision Date: Nov 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

Flowmate II PLUS is a desktop diagnostic spirometer used in hospitals, clinics, and industrial screening. Device utilizes a flow-sensing pneumotach base to measure differential pressure as air passes through; calculates pulmonary function parameters including FVC, FEV1, FEV1/FVC%, FEF25-75%, PEF, and MVV. System performs automatic test calculations and selects best test results based on ATS 1994 criteria. Clinicians operate device to assess lung function; results are displayed and printed on thermal or standard paper. Cross-contamination is managed via external filter system. Device provides objective data to assist physicians in diagnosing respiratory conditions, monitoring therapeutic efficacy, and evaluating disability or occupational health status.

Clinical Evidence

Bench testing only. Performance validated using a Pulmonary Waveform Generator (PWG) to simulate 24 BTPS waveforms and 26 PEF waveforms. Accuracy and precision for FVC, FEV1, FEF 25-75, PEF, and MVV compared against known 3-liter syringe inputs and ATS 1994 criteria. Results showed device met or exceeded ATS recommendations for accuracy and precision.

Technological Characteristics

Desktop design; molded high-impact UL-rated ABS plastic. Flow-sensing pneumotach; measures differential pressure. Capacity 10L; volume accuracy +/- 3%; max flow rate +/- 16 L/s; back pressure < 1.5 cm H2O. Connectivity: internal/external printer support. Calibration: field-calibrated via 1-9L syringe. Safety: IEC 601-1, UL 2601, EN60601-1-2. Software: automatic calculation and best-test selection based on ATS 1994 criteria.

Indications for Use

Indicated for pulmonary function testing in children and adults. Used for diagnostic evaluation of respiratory symptoms (dyspnea, wheezing, cough, chest pain), signs (cyanosis, diminished breath sounds), or abnormal lab results. Used to measure disease effects, screen high-risk individuals (smokers, occupational exposure), assess preoperative risk, prognosis, and fitness for physical activity. Used for monitoring therapeutic interventions (bronchodilators, steroids), disease progression (obstructive/interstitial lung, cardiac, neuromuscular), and drug toxicity. Used for disability/impairment evaluations (rehabilitation, insurance, legal) and public health/epidemiologic surveys.

Regulatory Classification

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.

Predicate Devices

• Flowmate 2500LTE (K954759)
• Flowmate 2500 (K863953/A)
• PC Flow + 3350 (K900673)
• Renaissance (K911143)
• Presto Flash Portable Spirometry System (K894997)

Submission Summary (Full Text)

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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 [phone]

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"

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- 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 �

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.

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

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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.

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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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

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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

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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

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

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