(87 days)
Not Found
No
The device description focuses on ultrasonic technology for nebulization and does not mention any AI/ML components or functions.
Yes
The device is used for the treatment of various respiratory conditions, delivering aerosol medication to patients.
No
This device is used for delivering medication, not for diagnosing medical conditions. The 'Intended Use / Indications for Use' section clearly states its purpose is for "the delivery of aerosol medication for treatment of various respiratory conditions."
No
The device description clearly describes a physical device (nebulizer) that converts liquid medication to aerosol form using ultrasound technology and a fan. This involves hardware components and is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device's function is to "convert liquid medication to aerosol form, and deliver it to the patient through inhalation." This is a drug delivery device, not a diagnostic test performed on a sample.
- Intended Use: The intended use is for "delivery of aerosol medication for treatment of various respiratory conditions," which is a therapeutic purpose, not a diagnostic one.
The device is a medical device used for treatment, specifically a nebulizer, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use of the Invacare Model IRC 1199 Scout Nebulizer is to convert liquid medication to aerosol form, and deliver it to the patient through inhalation.
Prescription device only.
Used for the delivery of aerosol medication for treatment of various respiratory conditions, such as asthma, on patients from adolescence through adults. Intended for indoor and outdoor use (50°F - 104°F, 15%-95% non condensing humidity)
Product codes
73 CAF
Device Description
The Invacare Ultrasonic Nebulizer is a portable, light weight device designed for use in the home . Its' intended function and use is to convert liquid medication to aerosol form, and deliver it to the patient through inhalation. The conversion from liquid to aerosol form is achieved using ultrasound technology. Ultrasonic energy is transmitted through the conducting chamber to the medication cup, which contains the medication. The high intensity sound waves break the medication into fine particles suitable for inhalation. Room air drawn in by a fan, propels the nebulized medication to the mouthpiece for the patient to inhale.
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
adolescence through adults
Intended User / Care Setting
home 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 Model IRC 1199 Scout Ultrasonic Nebulizer was tested in accordance with the electrical, mechanical and environmental performance requirements for home use respiratory devices set forth in the Anesthesiology and Respiratory Devices Branch's March 1992 document entitled "Draft Reviewer Guidance for Home Use Respiratory Devices" In all instances the Scout met the required performance criteria and functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
Invacare Corporation's MODEL IRC 1199 ULTRASONIC NEBULIZER
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Invacare Corporation 899 Cleveland Street Elyria, Ohio 44035 Phone: (440) 329-6000 Facsimile: (440) 366-9724
DEC - 8 1997
Contact Person:Edward A. Kroll Director, TQM and Regulatory Affairs
Date Prepared:September 8. 1997
Name of Device and Name/Address of Sponsor
Invacare Corporation 899 Cleveland Street Elyria, Ohio 44035 Phone: (440) 329-6000 Facsimile: (440) 366-9724
Common or Usual Name
Nebulizer
Classification Name
Nebulizer
Predicate Devices
Medox Model Champion Ultrasonic Nebulizer (K954327 December 1995) DeVilbiss Model 5500 Ultrasonic Nebulizer (K946095 August 24, 1995)
Intended Use
The intended use of the Invacare Model IRC 1199 Scout Nebulizer is to convert liquid medication to aerosol form, and deliver it to the patient through inhalation.
1
Technological Characteristics and Substantial Equivalence
A. Device Description
. come and diams
The Invacare Ultrasonic Nebulizer is a portable, light weight device designed for use in the home . Its' intended function and use is to convert liquid medication to aerosol form, and deliver it to the patient through inhalation. The conversion from liquid to aerosol form is achieved using ultrasound technology. Ultrasonic energy is transmitted through the conducting chamber to the medication cup, which contains the medication. The high intensity sound waves break the medication into fine particles suitable for inhalation. Room air drawn in by a fan, propels the nebulized medication to the mouthpiece for the patient to inhale.
B. Substantial Equivalence
The Scout Untrasonic Nebulizer submission is substantially equivalent to other legally marketed ultrasonic nebulizers intended for home use. Specifically, the Scout Nebulizer is substantially equivalent to the Medox Corporations' Model "Champion" Compact Nebulizer (K954327 December 19, 1995), and DeVilbiss Health Care Inc. Model 5500 Ultrasonic Nebulizer (K946095, August 24, 1995).
Fach of these devices are portable, hand held, ultrasonic nebulizers with the same intended function and use. They consist of the same basic materials, are of similar construction, and each device is operable using an AC power adapter, or optional battery pack power source. Additionally, each device delivers medication upon demand by the patient, and uses ultrasound technology as the means for converting the liquid medication to aerosol form.
Performance Data
The Model IRC 1199 Scout Ultrasonic Nebulizer was tested in accordance with the electrical, mechanical and environmental performance requirements for home use respiratory devices set forth in the Anesthesiology and Respiratory Devices Branch's March 1992 document entitled "Draft Reviewer Guidance for Home Use Respiratory Devices" In all instances the Scout met the required performance criteria and functioned as intended.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 8 199
Mr. Edward A. Kroll Invacare Corporation 899 Cleveland Street P.O. Box 4028 Elyria, Ohio 44036-2125
Re : K973468 Model IRC 1199 "Scout", Nebulizer Regulatory Class: II (two) Product Code: 73 CAF Dated: September 10, 1997 Received: September 12, 1997
Dear Mr. Kroll:
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, 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 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 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.
3
Page 2 - Mr. Edward A. Kroll
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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Ca llahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K973468
Device Name: Invacare Model IRC 1199 Scout Nebulizer
dications For Use:
Prescription device only.
Used for the delivery of aerosol medication for treatment of various respiratory conditions, such as asthma, on patients from adolescence through adults. Intended for indoor and outdoor use (50°F - 104°F, 15%-95% non condensing humidity)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use
M. Pryl=
(Optional Format 1-2-96)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K973468 510(k) Number.