PIPER IPPB MODEL 2055 by VORTRAN MEDICAL TECHNOLOGY 1, INC.

I am sorry, but the provided text only contains an FDA 510(k) clearance letter and an "Indication for Use" statement for the Piper IPPB™ Model 2055. It does not include any information about acceptance criteria or a study proving that the device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailing performance studies and their acceptance criteria.

Summary

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES • USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FFB 2 6 2002

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

Re: K982016

Piper IPPB™ Model 2055 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 November 3, 1998, regarding the Piper IPPB™ Model 2055. 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 we nave reviewed your bocusil 310(s) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate ' for use stated in the encreations of the enactment date of the Medical Device Amendments, or to Conniered proc to May 20, 1977, in accordance with the provisions of the Federal Food, Drug, devices mat have ocon require approval of a premarket approval application (PMA). and Oosmeter Hory I 100 has the device, subject to the general controls provisions of the Act. The r ou may, dierelere, mains of the Act include requirements for annual registration, listing of general controls proving 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 If your device is classified (600 as cotrols. Existing major regulations affecting your device can may be subject to suen dacided Regulations, Title 21, Parts 800 to 898. In addition, FDA may ou loand inther 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 I reast of advised that I Driv issuality or our device complies with other requirements of the Act that I Dri has made a acted regulations administered by other Federal agencies. You must or any it cacal statutes and registments, including, but not limited to: registration and listing (21 Comply will an the 11ct 82 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in and quand by would 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) I mis letter will and w your finding of substantial equivalence of your device to a legally prematics notification. "The stars 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 11 you desire specific aa 1809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFT Far 6648. Additionally, for questions on the promotion and advertising of Compinatee at (301) on and the Office of Compliance at (301) 594-4639. 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 Other general mightlasters, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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K98261 6 510(k) Number (if known): Piper IPPB™ Device Name:

Indication for Use:

For use in delivering intermittent positive pressure aerosol treatment on patients with a body weight greater than 30 kg (adults).

VORTRANIME Propramilian with the with the states of the comments of the comments of the mail of the mail of

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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mark Kronie

Prescription Use :		OR	Over-the-Counter Use
(Per 21 CFR 810.109)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number

(Optional Format 1-2-96)

IPK2-IU.DOC

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Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Piper IPPB™ Device Name:

Indication for Use:

For use in delivering intermittent positive pressure aerosol treatment on patients with a body weight greater than 30 kg (adults).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kione

Prescription Use : (Per 21 CFR 810.109)

Over-the-Counter Use

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

510(k) Number .

(Optional Format 1-2-96) રું ત

IPK2-IU.DOC

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
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.(b)
Classification. Class II (performance standards).