1085 ULTIMATE E PLETHYSMOGRAPH

K943259 · Medical Graphics Corp. · CCM · Apr 10, 1995 · Anesthesiology

Device Facts

• Record ID: K943259
• Device Name: 1085 ULTIMATE E PLETHYSMOGRAPH
• Applicant: Medical Graphics Corp.
• Product Code: CCM · Anesthesiology
• Decision Date: Apr 10, 1995
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1750
• Device Class: Class 2

Indications for Use

The indications for use of the 1085 Ultimate plethysmograph are identical to those for the previously identified devices; namely, the quantification of lung capacity and function.

Device Story

The MGC 1085 Ultimate E Plethysmograph is a laboratory instrument for pulmonary function testing. It consolidates features from the 1085 plethysmograph and PF/Dx pulmonary function laboratory. The device measures lung volume subdivisions (via plethysmography for FRC or multibreath nitrogen washout), flow, resistance, conductance, compliance, lung diffusion, and maximal inspiratory/expiratory pressures. It includes an option for measuring airway resistance via electronically compensated quiet breathing. The device uses a common preprocessor (Wave Form Analyzer) and shares the exterior chassis of the 1085. It features a fully disposable patient circuit and meets UL-544 safety standards. Operated by clinicians in a laboratory setting, the device provides quantitative data on lung function to assist in clinical assessment and decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and software validation/verification as described in the submission's internal documentation.

Technological Characteristics

Laboratory-based plethysmograph; utilizes electronically compensated quiet breathing for airway resistance; includes Wave Form Analyzer preprocessor; features fully disposable patient circuit; UL-544 compliant; shares chassis design with 1085 model.

Indications for Use

Indicated for the quantification of lung capacity and function in patients requiring pulmonary function testing.

Regulatory Classification

Identification

A pressure plethysmograph is a device used to determine a patient's airway resistance and lung volumes by measuring pressure changes while the patient is in an airtight box.

Predicate Devices

• 1085 plethysmograph (K852088)
• PF/Dx pulmonary function laboratory (K912906)

Reference Devices

• SensorMedics 6200 Autobox D_L Automated Body Plethysmograph

Submission Summary (Full Text)

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K943259

APR 10 1995

## Section 2 - Safety and Efficacy Summary

MGC 1085 Ultimate E Plethysmograph with EuroPleth option

The hardware and software design of the 1085 Ultimate plethysmograph combines two previously cleared predicate devices, the 1085 plethysmograph (K852088) and the PF/Dx pulmonary function laboratory (K912906). The consolidation of these two predicate devices combines the separate features of each of them, with the exception of portability, into a single laboratory instrument. The 1085 Ultimate plethysmograph is substantially equivalent to its predecessor, the 1085 plethysmograph, and to other legally marketed competitive devices such as the SensorMedics 6200 Autobox D_L Automated Body Plethysmograph.

The indications for use of the 1085 Ultimate plethysmograph are identical to those for the previously identified devices; namely, the quantification of lung capacity and function. The 1085 plethysmograph is able to measure all lung volume subdivisions (using plethysmography to measure FRC), flow, resistance, conductance, and compliance. The PF/DX measures all lung subdivisions (using multibreath nitrogen washout to measure FRC), flow, lung diffusion, and maximal inspiratory and expiratory pressures. The 1085 Ultimate possesses all of the previously enumerated capabilities, including the option to measure airway resistance using the electronically compensated quiet breathing process.

There are several safety features inherent in the mechanical design of 1085 Ultimate plethysmograph. In fact, the 1085 Ultimate and the 1085 share the identical exterior chassis and wave form analyzer. The 1085 Ultimate builds on the safety features designed into the 1085 and adds a fully disposable patient circuit. Additionally, the 1085 Ultimate has received the UL-544 approval. For more detail concerning the hardware safety, please refer to the hardware hazard analysis contained in Section 4 - Device Description.

The software used to operate the 1085 Ultimate plethysmograph is identical to that used to control both the 1085 and the PF/Dx devices. All three devices use the same data and executable files as well as a common preprocessor (Wave Form Analyzer). Specific information with respect to software development, documentation and review of the software process, as well as bench test performance data is contained in Section 8 - Software Validation and Verification.

Section 2 - Safety/Efficacy Summary

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[LOGO]

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

APR 10 1995

Food and Drug Administration

9200 Corporate Boulevard

Rockville MD 20856

Re: K943259

MedGraphics 1085 Ultimate E

Plethysmograph

Dated: January 6, 1995

Received: January 10, 1995

Regulatory Class: II (TWO)

Product Code: 73 CCN

Ms. Kathryn A. Neumann

Medical Graphics Corporation

350 Oak Grove Parkway

St. Paul, Minnesota 55127-8599

Ms. Neumann:

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 to 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.

This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. 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), promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-300) at [phone]. Other general information

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on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone].

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D.
Acting Director

Division of Cardiovascular, Respiratory,
and Neurological Devices

Office of Device Evaluation

Center for Devices and
Radiological Health