(167 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is for a simple positive expiratory pressure device, which typically does not incorporate AI/ML.
Yes
The device is indicated for facilitating the opening of airways in patients suffering from COPD, Cystic Fibrosis, Asthma, and other diseases, which are therapeutic interventions.
No
The device is described as facilitating the opening of airways for therapeutic purposes, rather than detecting or diagnosing a disease or condition.
No
The description explicitly states "Vital PEP™ positive expiratory pressure device," which implies a physical device used for positive expiratory pressure, not solely software.
Based on the provided information, the Vital PEP™ positive expiratory pressure device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used to facilitate the opening of airways in patients with respiratory conditions. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description simply states it's a positive expiratory pressure device, which is a type of medical device used for respiratory therapy.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
IVDs are devices used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Vital PEP™ device directly interacts with the patient's respiratory system for therapeutic purposes.
N/A
Intended Use / Indications 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.
Product codes
73 BWF
Device Description
Vital PEP™ positive expiratory pressure device
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways
Indicated Patient Age Range
Not Found
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
§ 868.5690 Incentive spirometer.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines that suggest the shape of a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
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.
1
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 (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,
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
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