STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES

K981366 · Sensor Medics Corp. · BTY · Oct 30, 1998 · Anesthesiology

Device Facts

• Record ID: K981366
• Device Name: STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES
• Applicant: Sensor Medics Corp.
• Product Code: BTY · Anesthesiology
• Decision Date: Oct 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Basically, this involves performing physicianprescribed pulmonary function and metabolic testing. More-specific intended uses are shown in the table below, along with the predicate SensorMedics product model with the same intended-use labeling. The Static and Dynamic Compliance option is indicated specifically for Evaluation of medication effects, Pulmonary Function testing in adults & children, Pulmonary disability evaluation, Industrial surveillance and Bedside lung function. Prescription

Device Story

Device measures pulmonary function (static/dynamic compliance) via esophageal balloon catheter and flow meter. Patient swallows balloon; operator monitors esophageal pressure, inspiratory/expiratory flow, and volume on computer display to ensure correct placement above diaphragm. System calculates static compliance (no-airflow conditions) and dynamic compliance (during quiet breathing) using pressure/volume/flow inputs. Output provides clinicians with respiratory mechanics data to assess lung disease effects, medication efficacy, and pulmonary disability. Used in clinical settings by trained operators; results assist in diagnostic and therapeutic decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical technological characteristics and measurement techniques to predicate devices.

Technological Characteristics

System includes esophageal balloon catheter, calibrated pressure transducer, and flow meter. Software performs mathematical calculations for pulmonary mechanics (compliance, tidal volume, minute ventilation). Connectivity via computer monitor for real-time signal visualization. Normal ranges derived from Begin et al. (1975) J. Appl. Physio. 38:199.

Indications for Use

Indicated for adults and children requiring pulmonary function testing, including evaluation of medication effects, pulmonary disability assessment, industrial surveillance, and bedside lung function monitoring.

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Predicate Devices

• Vmax Series (2900)
• Vmax Series (2200)

Submission Summary (Full Text)

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## Section 8. Summary of Safety and Effectiveness.

The Static and Dynamic Compliance software product option is identical in safety and effectiveness to the predicate devices listed in the last section. The technique of placing an esophageal balloon and derived measurements are also the same as the predicate devices.

Static and dynamic compliance are measurements of pulmonary function. also commonly referred to as Respiratory Mechanics. The mechanical properties of the respiratory system are important to breathing effectively. In healthy people, the elastic recoil and compliance of the lung are easily managed by the respiratory muscles allowing normal breathing. In some common respiratory diseases, there are changes in recoil and compliance. Static and dynamic compliance are easily measured and can be valuable in determining the effects of lung disease on breathing.

Static and dynamic compliance are performed by having the patient swallow an esophageal balloon that is connected to a calibrated pressure transducer, The patient breathes quietly on a mouthpiece connected to a flow meter. while mouth pressure, esophageal pressure, flow rate and volume changes are measured. The balloon is placed in the esophagus just above the diaphragm. This position is determined by having the patient breath through a flow meter, while the operator views a display of esophageal pressure, inspiratory flow and expiratory flow on a computer monitor. The operator looks for a negative pressure-tracing concomitant to a positive flow tracing. If the pressure tracing is positive, the balloon has passed the level of the diaphragm and needs to be pulled back until a positive tracing is displayed.

When measurements are made under no-airflow conditions, Static Compliance is calculated. When the measurements are made under flow conditions, Dynamic Compliance is calculated.

| Cst | L/kPa | Static Compliance | The change in volume/Trans-<br>pulmonary pressure measured<br>from FRC + 500 mls to FRC<br>against a closed breathing valve |
|------|-----------|--------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Ptp | CmH2<br>O | Trans-pulmonary Pressure | Mouth Pressure - Esophageal<br>Pressure |
| Cdyn | L/kPa | Dynamic Compliance | Change in Volume/Trans-<br>pulmonary pressure measured<br>during quiet breathing |
| f | /min | Breathing Frequency | Breaths/minute |
| Vt | Mls | Tidal Volume | Inspiration or Expiration at Rest |
| MV | Min | Minute Ventilation | Vt * f |

## Calculated Parameters are as follows.

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Normal Ranges for Compliance.

| Males | $Cst = 0.0024 *Age + .00516 * Height - 0.677$ |
|-------------------------------------------------------------------------|-----------------------------------------------|
| Females | $Cst = 0.0019 *Age + .0039 *Height - 0.471$ |
| Reference: Begin, et. al. Flow and age dependence of airway closure and | |
| dynamic compliance. J. Appl. Physio. 38:199, 1975 | |

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 1998

Mr. Larry Murdock SensorMedicss Corporation 22705 Savi Ranch Parkway Yorba Linda, CA 92887

Re: K981366 Static and Dynamic Compliance Regulatory Class: II (two) Product Code: 73 BTY August 8, 1998 Dated: Received: August 10, 1998

Dear Mr. Murdock:

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 qeneral 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 requlatory 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. Larry Murdock

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 requlation (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 requlation 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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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

Enclosure

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## Section 9. Indications for Use.

The indications for use are the same as the Vmax Series to which this product is an option. Quotation from the Indications for Use section of the Vmax premarket notification: "Basically, this involves performing physicianprescribed pulmonary function and metabolic testing. More-specific intended uses are shown in the table below, along with the predicate SensorMedics product model with the same intended-use labeling."

| (This table is from the Vmax premarket notification) | | | |
|------------------------------------------------------|------------|---------------|-------------------|
| Intended Use | Same<br>As | Similar<br>To | Different<br>From |
| Differential diagnosis (heart/lungs) | 2900 | | |
| Disability assessment | 2900 | | |
| Rehabilitative evaluation | 2900 | | |
| Exercise prescription | 2900 | | |
| Sports medicine/research | 2900 | | |
| Energy assessment, substrate<br>utilization | 2900 | | |
| Assessment or supplemental 02<br>requirement | 2900 | | |
| Evaluation of medication effects | 2900 | | |
| Pulmonary Function testing for<br>adults & children | 2200 | | |
| Document effectiveness of<br>bronchodilator therapy | 2200 | | |
| Pulmonary disability evaluation | 2200 | | |
| Industrial surveillance | 2200 | | |
| Broncho-challenge testing | 2200 | | |
| Exercise induced bronchospasm | 2200 | | |
| Pre-surgical risk evaluation | 2200 | | |
| Bedside lung function | 2200 | | |

## (This table is from the Vmax premarket notification)

The Static and Dynamic Compliance option is indicated specifically for Evaluation of medication effects, Pulmonary Function testing in adults & children, Pulmonary disability evaluation, Industrial surveillance and Bedside lung function.

- Prescription

Last mda 10-29-58

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

510(k) Number