(85 days)
Not Found
Not Found
No
The device description and intended use focus on a mechanical speaking valve for tracheostomy patients. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device aids in vocalization, facilitates decannulation assessment, and improves comfort/confidence for tracheostomized patients, indicating a therapeutic purpose.
No
The text states the device is "an assessment device for physicians" and its primary function is "providing vocalization without finger occlusion" for tracheostomized patients, not diagnosing a medical condition.
No
The device description clearly describes a physical tracheostomy speaking valve and an adapter, which are hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used to facilitate vocalization and assess upper airway usage in tracheostomized patients. This is a direct interaction with the patient's respiratory system, not an in vitro test performed on biological samples.
- Device Description: The description details a physical valve and adapter used with tracheostomy tubes. This is a medical device used for patient care, not for diagnostic testing of samples.
- Lack of IVD Characteristics: The text 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 information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device described is a medical device used for patient management and assessment related to vocalization and airway function.
N/A
Intended Use / Indications for Use
The PMV 2020 (Clear) JIT is designed to be used in conjunction with the Passy-Muir Adapter PMA-S JIT 4-6 for use on the Pilling Weck metal Jackson Improved tracheostomy tubes sizes #4, #5 and #6 or equivalent in providing vocalization without finger occlusion for both short-term and long-term tracheostomized patients. It is appropriate for neonatal, pediatric and adult patients and is ideal for use in decannulation as an assessment device for physicians, as well as providing the patient comfort and confidence in upper airway usage. The PMV 2020 (Clear) JIT Valve is also designed to be used without an adapter on the Bivona (Non-Foam Filled Cuffed) tracheostomy tubes currently on the market.
Indications for Use - Including but not limited to the following:
- For Sleep Apnea patients who are tracheostomized as an alternative to plugging when awake
- Bilateral Vocal Cord Paralysis without significant airway obstruction
- Tracheomalacia
- Mild Tracheal and Laryngeal Stenosis
- Non-Obstructive Laryngeal Tumors (can include patients who have intact vocal cords following surgical resection of the tumor)
- Neuromuscular Disease
- Chronic Obstructive Pulmonary Disease
- Brain Injury
- Non-Ventilator Dependent Quadriplegics
- Patients who emotionally or physically are unable to tolerate plugging
Product codes
JOH
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
neonatal, pediatric and adult patients
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
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 11 1999
Ms. Patricia E. Passy Passy-Muir, Inc. 4521 Campus Drive, Suite 273 Irvine, CA 92612
K990905 Re : Passy-Muir Low-Profile Tracheostomy Speaking Valve PMV 2020 JIT Regulatory Class: II (two) Product Code: JOH Dated: March 18, 1999 Received: March 18, 1999
Dear Ms. Passy:
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, Drug, 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 Requlation (QS) for Medical Devices: General requlation (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 requlatory 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.
1
Page 2 - Ms. Patricia E. Passy
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
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
2
STATEMENT OF INTENDED USE
1290805 510(k) Number (if known): _
Device Name: Passy-Muir Low-Profile Tracheostomy Speaking Valve PMV 2020 (Clear) JIT to be used in conjunction with the Passy-Muir Adapter PMA 2020-S JIT 4-6 for use on Pilling Weck metal Jackson Improved tracheostomy tubes sizes #4. #5 and #6 or equivalent, and also for use without an adapter on the Bivona (Non-Foam Filled Cuffed) tracheostomy tubes currently on the market.
Intended for Use:
The PMV 2020 (Clear) JIT is designed to be used in conjunction with the Passy-Muir Adapter PMA-S JIT 4-6 for use on the Pilling Weck metal Jackson Improved tracheostomy tubes sizes #4, #5 and #6 or equivalent in providing vocalization without finger occlusion for both short-term and long-term tracheostomized patients. It is appropriate for neonatal, pediatric and adult patients and is ideal for use in decannulation as an assessment device for physicians, as well as providing the patient comfort and confidence in upper airway usage. The PMV 2020 (Clear) JIT Valve is also designed to be used without an adapter on the Bivona (Non-Foam Filled Cuffed) tracheostomy tubes currently on the market.
Indications for Use - Including but not limited to the following:
- For Sleep Apnea patients who are tracheostomized as an alternative to plugging when awake ●
- Bilateral Vocal Cord Paralysis without significant airway obstruction ●
- Tracheomalacia ●
- Mild Tracheal and Laryngeal Stenosis �
- Non-Obstructive Laryngeal Tumors (can include patients who have intact vocal cords following . surgical resection of the tumor)
- . Neuromuscular Disease
- . Chronic Obstructive Pulmonary Disease
- Brain Injury
- Non-Ventilator Dependent Quadriplegics .
- Patients who emotionally or physically are unable to tolerate plugging
A. A. A.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K990905
TC