VITAL PEP

K984468 · Vital Signs, Inc. · BWF · Jun 1, 1999 · Anesthesiology

Device Facts

• Record ID: K984468
• Device Name: VITAL PEP
• Applicant: Vital Signs, Inc.
• Product Code: BWF · Anesthesiology
• Decision Date: Jun 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vital PEP™ positive expiratory pressure device indicated for facilitating the opening of airways in patients suffering from COPD , Cystic Fibrosis, Asthma and other diseases with ... coretory groblems.

Device Story

Vital PEP is a positive expiratory pressure (PEP) device; used to facilitate airway opening in patients with respiratory conditions like COPD, Cystic Fibrosis, and Asthma. Device operates by providing resistance during expiration; creates positive pressure within airways to assist in mucus clearance and prevent airway collapse. Used in clinical or home settings; operated by patients under physician guidance. Healthcare providers use the device to improve patient respiratory function and secretion clearance. Benefits include reduced airway obstruction and improved lung hygiene.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Positive expiratory pressure (PEP) device; mechanical design for airway resistance. No electronic components, software, or energy source described.

Indications for Use

Indicated for patients with COPD, Cystic Fibrosis, Asthma, or other respiratory conditions requiring airway clearance.

Regulatory Classification

Identification

An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1999

Mr. Anthony Martino Vital Signs, Inc. 20 Campus Road Totowa, NJ 07512

Re: K984468 Vital PEP™ Regulatory Class: II (two) Product Code: 73 BWF Dated: March 12, 1999 Received: March 15, 1999

Dear Mr. Martino:

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, Druq, 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. Anthony Martino

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,

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 III

## INDICATION FOR USE STATEMENT

Product : Vital Signs Inc.s' Vital PEPTM

## "Indication for Use"

The Vital PEP™ positive expiratory pressure device indicated for facilitating the opening of airways in patients suffering from COPD , Cystic Fibrosis, Asthma and other diseases with ... coretory groblems.

un Ruy

(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices 199,4 510(k) Number

Prescription Use