(291 days)
PCS414
Not Found
No
The summary describes a standard air compressor for nebulization and does not mention any AI or ML capabilities.
Yes
Explanation: The device is intended to nebulize medications for the treatment of various respiratory conditions, which is a therapeutic purpose.
No
The device is described as an air compressor used to nebulize water or medication for respiratory treatment, not to diagnose a condition.
No
The device description clearly states it is an "AC powered air compressor" with a "metal housing," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide humidification and nebulize medications for respiratory conditions. This involves delivering a substance to the patient's airways, not analyzing a sample taken from the patient's body.
- Device Description: The device is an air compressor that powers a nebulizer. It's a mechanical device for delivering therapy, not a device for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is therapeutic delivery.
N/A
Intended Use / Indications for Use
The DeVilbiss 8650D is used with a pneumatic nebulizer to administer humidified air or medication into the airways to treat respiratory disorders. The device is intended for home health care and institutional use. Users of this device are adult and pediatric patients with tracheostomies or suffer from asthma, cystic fibrosis, and chronic obstructive pulmonary disease.
The 8650D will be used as the air source to nebulize sterile water to provide humidification to patients with tracheostomies.
The 8650Dxmay also be used to nebulize medications in the treatment of Asthma, Cystic Fibrosis, and chronic obstructive pulmonary disease.
Product codes
73 BTI
Device Description
The DeVilbiss 8650D Compressor is a portable AC powered air compressor that will act as an air source to operate a pneumatic nebulizer. The device has an internal cooling fan to allow continuous use operation. It uses a metal housing with sound barrier foam to provide a low noise level.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
home health care and institutional use.
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)
The DeVilbiss 8650D was tested for pressure and flow output, sound pressure level, temperature rise, and shipping performance.and he tromay ne fre compartibulity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Allied Healthcare/Timeter PCS414
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
0
510(k) SUMMARY STATEMENT
13 1501
Submitter:
DeVilbiss Health Care, Inc. 1200 East Main Street P.O. Box 635 Somerset, Pa 15501-0635 USA
Contact:
Matt Smith 814-443-7531 814-443-7571 FAX
| Date of 510(k) Submittal: | August 26, 1996 |
|---|---|
| Classification Name: | Pump, Nebulizer, Electrically Powered |
| Common Name: | Compressor used for nebulization and humidification |
| Proprietary Name: | 8650D |
| Equivalent to Device: | Allied Healthcare/Timeter PCS414 |
Description of Device:
The DeVilbiss 8650D Compressor is a portable AC powered air compressor that will act as an air source to operate a pneumatic nebulizer. The device has an internal cooling fan to allow continuous use operation. It uses a metal housing with sound barrier foam to provide a low noise level.
Intended Use of Device:
The DeVilbiss 8650D is used with a pneumatic nebulizer to administer humidified air or medication into the airways to treat respiratory disorders. The device is intended for home health care and institutional use. Users of this device are adult and pediatric patients with tracheostomies or suffer from asthma, cystic fibrosis, and chronic obstructive pulmonary disease.
Performance Testing:
The DeVilbiss 8650D was tested for pressure and flow output, sound pressure level, temperature rise, and shipping performance.and he tromay ne fre compartibulity.
Agency Approvals:
The DeVilbiss 8650D will meet UL-544 Standard for Safety, Medical and Dental Equipment.
Conclusion:
The results of the above testing do not indicate any safety and effectiveness concerns as compared to the Allied Healthcare PCS 414.
1
Image /page/1/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 an abstract symbol resembling a stylized caduceus or a group of people.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 1997
Mr. Matt Smith DeVilbiss Health Care, Inc. 1200 East Main Street · ····· P.O. Box 635 Somerset, Pennsylvania 15501-0635
Re: %K963349 DeVilbiss 8650D Requlatory Class: II (two) Product Code: 73 BTI Dated: May 18, 1997 Received: May 19, 1997
Dear Mr. Smith:
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 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, qood 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 Good Manufacturing Practice for Medical Devices: General (GMP) requiation (21 CFR Part 820) and that, through periodic GMP 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.
2
Page 2 - Mr. Matt Smith
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) 594-4646. 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/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of
510(k) Number (if known):_ K963349
Device Name: DeVilbiss Health Care, Inc. 8650D Compressor
Indications For Use:
The 8650D will be used as the air source to nebulize sterile water to provide humidification to patients with tracheostomies.
The 8650Dxmay also be used to nebulize medications in the treatment of Asthma, Cystic Fibrosis, and chronic obstructive pulmonary disease.
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Curtis A. Tinsdale
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Number
Prescription Use V (Per 21 CFR 801.109)
૦ર્ત
Over-The-Counter Use
(Optional Format 1-2-96)