(379 days)
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.
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.
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.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specification) | Reported Device Performance (Proposed AeroSol™ System (K063716)) |
|---|---|
| Indications for Use | The AeroSol™ Radioaerosol System is intended to deliver an aerosol of diagnostic nuclear medicine to the lung for imaging. |
| Patient Populations | 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. |
| Performance | Nebulize radioaerosols |
| Nebulizer Performance tested via Malvern Laser Diffraction | Yes (Stated as "Yes" under the Proposed AeroSol™ System column, indicating the performance was tested and met the criteria based on predicate device similarity) |
| Circuit with conduits, valves, nebulizer, mouthpieces, and various adapters and connectors and aerosol trapping filter | Yes (Stated as "Yes" under the Proposed AeroSol™ System column, indicating the system features these components, mirroring the predicate device) |
| Materials - PVC, LDPE, K-Resin, Bromobutyl etc. | Yes (Stated as "Yes" under the Proposed AeroSol™ System column, indicating the materials used are similar to the predicate device) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not mention a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a clinical study comparing the AeroSol™ Radioaerosol System against a gold standard or human readers. The submission relies on substantial equivalence to predicate devices, rather than a de novo clinical performance study with a test set of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As no clinical test set is described, there's no information regarding experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set
Not applicable. Since no clinical test set is described, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. The device is a radioaerosol system for delivering diagnostic medicine, not an AI-powered diagnostic imaging interpretation device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm, but a medical delivery system. Its performance evaluation focuses on its ability to nebulize radioaerosols and its structural and material equivalence to predicate devices.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on demonstrating substantial equivalence to existing legally marketed predicate devices, specifically the CIS-US Aerotech Aerosol Delivery System (K873930) and the AMICI Xenon System (K865084).
The "truth" for this 510(k) submission is that the proposed device shares the same indications for use, patient populations, environment of use, performance characteristics (e.g., ability to nebulize radioaerosols, nebulizer performance tested by Malvern Laser Diffraction), circuit components, and materials as the predicate devices. The document explicitly states: "There are no significant differences that affect the safety, use or effectiveness of the intended device as compared to the predicate devices."
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, no ground truth was established for it.
{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 | PredicateCIS-US AeroTech System(K873930)AMICI Xenon System(K865084) | Proposed AeroSol™ System(K063716) |
|---|---|---|
| Indications for use | To diagnose or rule out lungventilation (airways) versus lungperfusion (blood supply) diseasesin patients with breathingdifficulties. | The AeroSol™ RadioaerosolSystem is intended to deliver anaerosol of diagnostic nuclearmedicine to the lung for imaging. |
| Patient populations | For patients with breathingdifficulties suspected of airwaysdiseases. | For patients undergoingdiagnostic nuclear lungventilation imaging in a hospitalor settings where nuclearmedicine clinical testing isperformed. |
| Environment of use | Hospitals or settings wherenuclear medicine clinical testingis performed | Hospitals or settings wherenuclear medicine clinical testingis performed |
| Performance | Nebulize radioaerosols | Nebulize radioaerosols |
| Nebulizer Performancetested via Malvern LaserDiffraction | Yes | Yes |
| Circuit with conduits,valves, nebulizer,mouthpieces, and variousadapters and connectorsand aerosol trapping filter | YesAMICI Xenon System(K865084) | Yes |
| Materials - PVC, LDPE,K-Resin, Bromobutyl etc. | YesAMICI 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
§ 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).