PERCUSSIVETECH HF, MODEL 2001

K981726 · Vortran Medical Technology 1, Inc. · NHJ · Sep 17, 1998 · Anesthesiology

Device Facts

• Record ID: K981726
• Device Name: PERCUSSIVETECH HF, MODEL 2001
• Applicant: Vortran Medical Technology 1, Inc.
• Product Code: NHJ · Anesthesiology
• Decision Date: Sep 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in the removal of mucus from the lungs of patients with retained endobronchial secretions.

Device Story

PercussiveTech HFTM is a noncontinuous ventilator used for airway clearance. Device functions by delivering percussive air pulses to the lungs to assist in the mobilization and removal of retained endobronchial secretions. Operated by healthcare professionals in clinical settings; device provides mechanical assistance to patients unable to clear mucus effectively. Output consists of controlled percussive airflow; clinical benefit includes improved airway patency and reduced risk of complications associated with retained secretions.

Clinical Evidence

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

Technological Characteristics

Noncontinuous ventilator; classified under 21 CFR 868.5905; Product Code 73 NHJ. Device utilizes percussive air delivery mechanism for airway clearance.

Indications for Use

Indicated for patients with retained endobronchial secretions requiring mucus removal from the lungs.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gordon A. Wong, M.D. Vortran Medical Technology 1, Inc. 3941 J St., Suite 354 Sacramento, CA 95819-3633

Re: K981726 PercussiveTech HFTM Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II (two) Product Code: 73 NHJ

Dear Dr. Wong:

This letter corrects our substantially equivalent letter of September 17, 1998, regarding the PercussiveTech HFTM. Our letter identified the product code as 73 BZD. This is in error; the correct product code is 73 NHJ as indicated above.

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.

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## Page 2 - Gordon A. Wong, M.D.

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Sincerely yours,

Da. G. Telle

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Page 1 of 1

510(k) Number (if known):
`K981726`
Device Name: `PercussiveTech HFTM`
Indication for Use:
For use in the removal of mucus from the lungs of
patients with retained endobronchial secretions.

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER
PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use :
(Per 21 CFR 810.109)
OR
Over-the-Counter Use **__**

`Mark Framer`
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices `K981726`
510(k) Number

(Optional Format 1-2-96)

PTK2-IU.DOC

K981726

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Page 1 of 1

K981726 510(k) Number (if known): _ PercussiveTech HFTM Device Name:

Indication for Use:

For use in the removal of mucus from the lungs of patients with retained endobronchial secretions.

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

A Prescription Use : (Per 21 CFR 810.109)

OR

Over-the-Counter Use

Mark Kramer

(Division Sign-Off) Division of Cardiovascular, Re and Neurological Devices 510(k) Number _

(Optional Format 1-2-96)

PTK2-IU.DOC