BODY BOX 5500

K022636 · Morgan Scientific, Inc. · JEH · Jan 13, 2003 · Anesthesiology

Device Facts

• Record ID: K022636
• Device Name: BODY BOX 5500
• Applicant: Morgan Scientific, Inc.
• Product Code: JEH · Anesthesiology
• Decision Date: Jan 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1760
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Body Box 5500 when used in conjunction with a computer and the ComPAS pulmonary function software is intended to perform plethysmography, diffusion and spirometry to provide pulmonary function testing in adult and pediatric patients.

Device Story

Body Box 5500 is a volume plethysmograph system used for pulmonary function testing. Device operates in conjunction with a computer running ComPAS pulmonary function software. System measures lung volumes and capacities via plethysmography, gas diffusion, and spirometry. Used in clinical settings by healthcare professionals to assess respiratory health in adult and pediatric populations. Output data assists clinicians in diagnosing and monitoring pulmonary conditions. System provides objective measurements of lung function to support clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Volume plethysmograph system; includes hardware for plethysmography, diffusion, and spirometry testing; integrates with computer and ComPAS software for data processing and analysis.

Indications for Use

Indicated for pulmonary function testing, including plethysmography, diffusion, and spirometry, in adult and pediatric patients.

Regulatory Classification

Identification

A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing right, with a stylized ribbon-like element flowing beneath them.

JAN 1 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Patrick F. Morgan President Morgan Scientific, Incorporated 151 Essex Street Haverhill, Massachusetts 01832

Re: K022636

Trade/Device Name: Body Box 5500 Regulation Number: 868.1760 Regulation Name: Volume Plethysmograph Regulatory Class: II Product Code: JEH Dated: November 26, 2002 Received: December 2, 2002

Dear Mr. Morgan:

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. 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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.

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

## Page 2 - Mr. Morgan

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincer e v vol

Timothy Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Morgan Scientific, Inc. 151 Essex Street Haverhill, MA 01832

Establishment Registration Number: 8020734

7" November 2002

510(k) Number (if known): Ko226e 310

Device Name: Body Box 5500

Indications For Use:

The Body Box 5500 when used in conjunction with a computer and the ComPAS pulmonary function software is intended to perform plethysmography, diffusion and spirometry to provide pulmonary function testing in adult and pediatric patients.

Concurrence of CDRH, Office of Device Evaluation (ODE)

LaClifford

(Division Sign-Off) Division of Anesthesiology General H Infection Control. Dental I

510(k) Number K022636

Confidential Appendix B