(379 days)
No
The summary describes a system for delivering a radioaerosol for lung imaging, focusing on the physical components and function of the nebulizer. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device description or performance studies.
No
The device is intended for diagnostic imaging of the lung, not for treating a disease or condition.
Yes
The device is described as delivering a diagnostic nuclear medicine and is intended for patients undergoing diagnostic nuclear lung ventilation imaging. This directly indicates its role in diagnosis.
No
The device description clearly outlines physical components like an injection site, nebulizer, aerosol conduit, and aerosol trapping, indicating it is a hardware device that delivers a substance.
Based on the provided information, the AeroSol™ Radioaerosol System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver an aerosol of diagnostic nuclear medicine to the lung for imaging." This describes a device used in vivo (within the living body) to facilitate a diagnostic imaging procedure.
- Device Description: The description focuses on generating and administering an aerosol to the lungs for imaging. This is an in vivo delivery system.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to obtain information about a patient's health. The AeroSol™ system does not process or analyze biological specimens.
Therefore, the AeroSol™ Radioaerosol System is a device used in vivo for diagnostic imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AeroSol™ Radioaerosol System is intended to deliver an aerosol of diagnostic nuclear medicine to the lung for imaging. The device is intended for patients undergoing diagnostic nuclear lung ventilation imaging in a hospital or settings where nuclear medicine clinical testing is performed.
Product codes
CAF
Device Description
The AeroSol™ Radioaerosol System generates and administers a fine droplet aerosol to the breathing areas of the lungs for diagnostic imaging. It has an injection site, a nebulizer, aerosol conduit, aerosol trapping and is manufactured of materials and components used in previously cleared 510(k) devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals or settings where nuclear medicine clinical testing is performed.
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 device's performance includes nebulizing radioaerosols, and nebulizer performance was tested via Malvern Laser Diffraction. The circuit includes conduits, valves, nebulizer, mouthpieces, and various adapters and connectors, and an aerosol trapping filter. The materials used are PVC, LDPE, K-Resin, Bromobutyl etc. These specifications are identical to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CIS-US (1219718) Aerotech Aerosol Delivery System (K873930), AMICI Xenon System (K865084)
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
Image /page/0/Picture/1 description: The image shows the word "AMICI" in a bold, sans-serif font. To the right of the word is a circular logo. Inside the circle is a square shape with a design that includes horizontal lines and three black shapes resembling triangles or wedges.
YOUR GUARANTEE OF EXCELLENCE
518 Vincent Street, Spring City, PA 19475 USA PN: +1 (610) 948-7100, FX: +1 (610) 948-2018 Internet: amici-inc.com, e-mail: info@amici-inc.com
510(k) Summary Page 1 of 2
December 20, 2007
Owner's Name, Address, Phone and FAX: See the above letterhead
Contact Person: Michael Bono, President
510(k) Number: K063716
DEC 2 8 2007
Trade Name: AeroSol™ Radioaerosol System
Common Name: Nebulizer / Aerosolizer
Classification Name: Nebulizer (Direct Patient Interface) [21CFR868.5630]
Product Code: CAF
Predicate Device: CIS-US (1219718) Aerotech Aerosol Delivery System (K873930 licensed from Cadema Medical Products) and AMICI Xenon System (K865084)
Device Description: The AeroSol™ Radioaerosol System generates and administers a fine droplet aerosol to the breathing areas of the lungs for diagnostic imaging. It has an injection site, a nebulizer, aerosol conduit, aerosol trapping and is manufactured of materials and components used in previously cleared 510(k) devices.
Indications for Use: The AeroSol™ Radioaerosol System is intended to deliver an aerosol of diagnostic nuclear medicine to the lung for imaging.
Patient Population: For patients undergoing diagnostic nuclear lung ventilation imaging.
Environment of Use: Hospitals or settings where nuclear medicine clinical testing is performed.
1
510(k) Summary Page 2 of 2
| Specification | Predicate
CIS-US AeroTech System
(K873930)
AMICI Xenon System
(K865084) | Proposed AeroSol™ System
(K063716) |
|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | To diagnose or rule out lung
ventilation (airways) versus lung
perfusion (blood supply) diseases
in patients with breathing
difficulties. | The AeroSol™ Radioaerosol
System is intended to deliver an
aerosol of diagnostic nuclear
medicine to the lung for imaging. |
| Patient populations | For patients with breathing
difficulties suspected of airways
diseases. | For patients undergoing
diagnostic nuclear lung
ventilation imaging in a hospital
or settings where nuclear
medicine clinical testing is
performed. |
| Environment of use | Hospitals or settings where
nuclear medicine clinical testing
is performed | Hospitals or settings where
nuclear medicine clinical testing
is performed |
| Performance | Nebulize radioaerosols | Nebulize radioaerosols |
| Nebulizer Performance
tested via Malvern Laser
Diffraction | Yes | Yes |
| Circuit with conduits,
valves, nebulizer,
mouthpieces, and various
adapters and connectors
and aerosol trapping filter | Yes
AMICI Xenon System
(K865084) | Yes |
| Materials - PVC, LDPE,
K-Resin, Bromobutyl etc. | Yes
AMICI Xenon System
(K865084) | Yes |
Differences Between Other Legally Marketed Predicate Devices: The proposed device is viewed as substantially equivalent to the predicate devices, K873930 and K865084. There are no significant differences that affect the safety, use or effectiveness of the intended device as compared to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wings, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 8 2007
Mr. Michael Bono President AMICI. Incorporated 518 Vincent Street Spring City, Pennsylvania 19475
Re: K063716
Trade/Device Name: AeroSol™ Radioaerosol System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: December 13, 2007 Received: December 14, 2007
Dear Mr. Bono:
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 Eederal Register.
3
Page 2 - Mr. Bono
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely vours,
Dinh H. Nguyen, BS/MS, Chiu Lin, Ph.D.
Chiu Lin, Ph.D Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Page 1 of 1
K063716 510(k) Number:
AeroSol™ Radioaerosol System Device Name:
Indications for Use:
The AeroSolling Radioaerosol System is intended to deliver an aerosol of diagnostic nuclear medicine to the lung for imaging. The device is intended for patients undergoing diagnostic nuclear lung ventilation imaging in a hospital or settings where nuclear medicine clinical testing is performed.
Prescription Use XX Over-The-Counter Use _ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nul J. Dda
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K063716