(98 days)
K 970289
K 970289
No
The description focuses on the mechanical function of a compressor/nebulizer and does not mention any AI or ML capabilities.
Yes
The device is described as a compressor/nebulizer system that converts liquid medication into an aerosol for inhalation by patients for the treatment of respiratory disorders, which is a therapeutic function.
No
Explanation: The device is described as a compressor/nebulizer used to convert liquid medication into an aerosol for inhalation. Its function is to deliver medication, not to diagnose a condition.
No
The device description explicitly states it is a "small, piston-type air compressor" and mentions compliance with electrical and mechanical safety standards, 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 convert inhalable drugs into an aerosol form for inhalation by a patient for the treatment of respiratory disorders. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as an air compressor used in conjunction with a nebulizer to create an aerosol for inhalation. This aligns with a therapeutic delivery system.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies focus on the aerosol output and particle size, which are relevant to the effectiveness of drug delivery, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver medication, which is a therapeutic action.
N/A
Intended Use / Indications for Use
The DeVilbiss compressor / nebulizer Model 3655 includes an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.
Product codes
73 CAF, 73 BTI
Device Description
The DeVilbiss Model 3655 Compressor/Nebulizer is a small, piston-type air compressor, sized to provide the proper flow and pressure sufficient to power jet (pneumatic) nebulizers. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device (Underwriter's Laboratory Standard UL1431 and IEC 60601-1).
When the compressor is used in conjunction with a therapeutic nebulizer, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The DeVilbiss Model 3655 compressor/nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter.
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
The device can be used with adult or pediatric patients.
Intended User / Care Setting
home health care 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)
Testing performed on the aerosol output and particle size show that the new DeVilbiss Model 3655 is substantially equivalent to the existing legally marketed predicate devices and that all of these devices will produce a similar aerosol treatment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 970289
Reference Device(s)
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
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the word "SUNRISE" in bold, black letters. To the left of the word is a symbol that looks like a stylized sun or window shutter. The symbol is also in black and has a thick outline with horizontal lines inside.
JUN 2 8 2002
11.0 510(k) Summary
| Submitter's Name: | Sunrise Medical HHG, Inc.
Respiratory Products Division
100 DeVilbiss Drive
Somerset PA 15501
Ray Hoffman
(PH)814-443-7442
(Fax)814-443-7571 |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | February 28, 2002 |
| Device Name: | Compressor / Nebulizer FDA Classification CAF |
| Common or Usual Name: | Compressor / Nebulizer |
| DeVilbiss Model Number: | 3655 Series |
| Trade Proprietary Name: | DeVilbiss Pulmo-Aide Compact Compressor |
| Established Registration Number: | DeVilbiss # 2515872 |
| FDA Classification: | Class II |
| Equivalent Legally Marketed Predicate Devices: | |
Legally Marketed Predicate Devices 510(k) Registration # K 970289 DeVilbiss Model 3650
Description of Device:
The DeVilbiss Model 3655 Compressor/Nebulizer is a small, piston-type air compressor, sized to provide the proper flow and pressure sufficient to power jet (pneumatic) nebulizers. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device (Underwriter's Laboratory Standard UL1431 and IEC 60601-1).
1
Image /page/1/Picture/0 description: The image shows the word "SUNRISE" in bold, black letters. To the left of the word is a symbol that resembles a rising sun with horizontal lines representing the sun's rays. The symbol is also in bold, black color, matching the font of the word.
When the compressor is used in conjunction with a therapeutic nebulizer, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The DeVilbiss Model 3655 compressor/nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter.
Statement of Intended Use:
The DeVilbiss compressor / nebulizer Model 3655 includes an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.
Statement of Safety and Effectiveness:
The DeVilbiss Model 3655 aerosol compressor / nebulizer is equivalent in both function and indications for use to the DeVilbiss Model 3650 aerosol compressor / nebulizer legally marketed predicate device.
The DeVilbiss Model 3655 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease. The compressor is constructed of materials, both metal and plastic, that are similar or identical to legally marketed devices. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device
Used in conjunction with a jet (pneumatic) nebulizer, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The DeVilbiss Model 3655 compressor / nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter. This aerosol particle size performance is comparable to other legally marketed devices as noted in the Table of Comparison and the Discussion of Similarities and Performance Data (Sections 4.0 & 5.0),
The Table of Comparison and the Performance Evaluations (Sections 4.0 & 7.0) show that in terms of safety and effectiveness, the new DeVilbiss Model 3655 Compressor / Nebulizer is substantially equivalent to legally marketed predicate devices.
Legally Marketed Predicate Devices DeVilbiss Model 3650
510(k) Registration # K 970289
2
Image /page/2/Picture/0 description: The image shows the word "SUNRISE" in all caps, with a stylized sun icon to the left of the word. The sun icon is a square with a semi-circle at the top and horizontal lines inside the semi-circle. The word "SUNRISE" is in a bold, sans-serif font. The image is in black and white.
Technological Characteristics:
The DeVilbiss Model 3655 aerosol compressor / nebulizer is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all utilize an AC motor driven air compressor to provide a source of compressed air for operating a jet (pneumatic) nebulizer. All of the devices are tested and approved to recognized agency safety standards.
Testing performed on the aerosol output and particle size show that the new DeVilbiss Model 3655 is substantially equivalent to the existing legally marketed predicate devices and that all of these devices will produce a similar aerosol treatment.
3
Image /page/3/Picture/11 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles embedded within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 8 2002
Sunrise Medical HHG. Inc. c/o Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548
Re: K020932
Devilbiss Model 3655 Compressor/Nebulizer Regulation Number: 21 CFR 868.5630 and 21 CFR 868.6250 Regulation Name: Nebulizer and Portable Air Compressor Regulatory Class: II (two) Product Code: 73 CAF and 73 BTI Dated: June 14, 2002 Received: June 18, 2002
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Ned Devine
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control 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) 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
020932
Page 1 of 1
510(k) Number: (if known): ___________________________________________________________________________________________________________________________________________________
Device Name:
Indications For Use:
The DeVilbiss compressor / nebulizer Model 3655 includes an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division/Sign-Off)
Division of Cardiovascular and Respiratory Devices
| 510(k) Number | 14020932 |
|---|---|
| --------------- | ---------- |
X Prescription use
-OR-
Over-the-counter use