(148 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description is for a standard intermittent positive pressure aerosol treatment device.
Yes
The device is used for "delivering intermittent positive pressure aerosol treatment on patients," which describes a therapeutic intervention.
No
Explanation: The device is used for delivering aerosol treatment, which is a therapeutic intervention, not a diagnostic one. It doesn't mention identifying, assessing, or monitoring medical conditions.
No
The summary describes a physical device ("Piper IPPB™ Model 2055") used for delivering aerosol treatment, which is a hardware-based function. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use in delivering intermittent positive pressure aerosol treatment on patients with a body weight greater than 30 kg (adults)." This describes a therapeutic treatment delivered directly to a patient, not a test performed on a sample taken from a patient to diagnose or monitor a condition.
- Device Description: The device is described as "Piper IPPB™ Model 2055," which is consistent with a medical device used for respiratory therapy.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic or monitoring information based on sample analysis
Therefore, the Piper IPPB™ Model 2055 is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use in delivering intermittent positive pressure aerosol treatment on patients with a body weight greater than 30 kg (adults).
Product codes (comma separated list FDA assigned to the subject device)
73 NHJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
patients with a body weight greater than 30 kg (adults).
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
Page 1 of 1
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) |
|---|
| -------------------------------------------------------- |
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
3
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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)
OR
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