(287 days)
Not Found
No
The document describes a pneumatically powered nebulizer and its performance metrics, with no mention of AI or ML.
Yes
The device is described as being used "for the treatment of respiratory disorders" and "for inhalation therapy or medication," indicating its direct role in medical treatment.
No
The device is a nebulizer designed to deliver medication. Its performance metrics (MMAD, FPF, DD, DDR) measure the effectiveness of medication delivery, not the diagnosis of a condition.
No
The device description clearly states that the device is a "hand-held, reusable, single patient use and pneumatically powered nebulizer," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are used to deliver medication as an aerosol mist directly to a patient's respiratory system. They are a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states the device is for "delivering a fine aerosol mist of medication to a patient for the treatment of respiratory disorders." This is a treatment function, not a diagnostic one.
The information provided describes a medical device used for drug delivery, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are reusable single patient use nebulizers which are used where a fine aerosol mist of medication must be delivered to a patient for the treatment of respiratory disorders. The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are intended to be used for both adult and pediatric patients who have been prescribed inhalation therapy or medication in both home health care and hospital use. The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers may be used with compressed air or an air gas source providing air flow between 4 to 10 lmin.
Product codes
CAF
Device Description
The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are hand-held, reusable, single patient use and pneumatically powered nebulizers. Both devices are made using similar materials and are used by patients with the same accessories set (mouthpiece, masks etc ... ). The primary difference between the two devices is that the RF6 Plus is equipped with inspiration and expiration valves while the RF6 Basic is not.
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
adult and pediatric patients
Intended User / Care Setting
Home health care and hospital 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 performance tests performed by Flaem Nuova, as required by the "Reviewer guidance for nebulizers, metered dose inhalers, spacers and actuators" issued on October 1993, demonstrate that the Flaem Nuova RF6 Basic and RF6 Plus Nebulizers have the same effectiveness as the identified predicate devices because they have equivalent performance parameters as the predicate devices including: MMAD, FPF, DD and DDR. MMAD, FPF, DD and DDR are the parameters used to evaluate the performance of nebulizers. Clinical data are not submitted because they are not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MMAD, FPF, DD, and DDR.
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
FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS CONFIDENTIAL
510(k) Summary of Safety and Effectiveness for the Flaem Nuova RF6 Basic and RF6 Plus Nebulizers
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
Contact Person:
| Submitter: | FLAEM NUOVA |
|---|---|
| Via Colli Storici 221, 223, 225 | |
| S. Martino della Battaglia | |
| Brescia 25010 Italy |
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Telephone: 978-207-1245 Fax: 978-207-1246
Summary Preparation Date:
August 23, 2006
- Names
Device Name:
RF6 Basic RF6 Plus
Classification Name:
Nebulizer Regulation number: 868.5630 Product Code: CAF
3. Predicate Devices
The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are substantially equivalent to a combination of the following devices:
- Salter Labs, 8660 Series- K962879
- V Pari LC STAR Reusable Nebulizer 22F50 K963924
- V Medic-Aid - Sidestream Nebulizer - K991725
4. Device Description
The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are hand-held, reusable, single patient use and pneumatically powered nebulizers. Both devices are made using similar materials and are used by patients with the same accessories set (mouthpiece, masks etc ... ). The primary difference
1
FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS
between the two devices is that the RF6 Plus is equipped with inspiration and expiration valves while the RF6 Basic is not.
5. Indications for Use
The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are reusable single patient use nebulizers which are used where a fine aerosol mist of medication must be delivered to a patient for the treatment of respiratory disorders. The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are intended to be used for both adult and pediatric patients who have been prescribed inhalation therapy or medication in both home health care and hospital use. The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers may be used with compressed air or an air gas source providing air flow between 4 to 10 lmin.
6. Performance Data
The performance tests performed by Flaem Nuova, as required by the "Reviewer guidance for nebulizers, metered dose inhalers, spacers and actuators" issued on October 1993, demonstrate that the Flaem Nuova RF6 Basic and RF6 Plus Nebulizers have the same effectiveness as the identified predicate devices because they have equivalent performance parameters as the predicate devices including: MMAD, FPF, DD and DDR. MMAD, FPF, DD and DDR are the parameters used to evaluate the performance of nebulizers. Clinical data are not submitted because they are not required.
7. Comparison to Predicate Devices
The Flaem Nuova RF6 nebulizers and their predicate devices are indicated for the same intended use and have equivalent design solutions as the predicate devices. They have the same atomization principle used by all the nebulizers. The RF6 Plus has the same the valve system as that used in the Pari LC STAR (K963924). The RF6 Basic is similar to the Medic-Aid SIDESTREAM Nebulizer (K991725). In addition, the Flaem Nuova RF6 Nebulizers performance is equivalent to the predicate devices as shown in the bench tests presented.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 8 2007
FLAEM NUOVA S.p.A. C/O Maureen O'Connell Regulatory Consultant O'Connell Regulatory Consultants, Incorporated 5 Timber Lane North Reading, Massachusetts 01864
Re: K062484
Trade/Device Name: Flaem Nuova RF6 Basic and RF6 Plus Nebulizers Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: June 05, 2007 Received: June 06, 2007
Dear Mr. O'Connell:
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.
3
Page 2 - Mr. O'Connell
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 vour 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sigute Y. Michaud MD
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Flaem Nuova RF6 Basic and RF6 Plus Nebulizers
Indications for Use:
The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are reusable single patient use nebulizers which are used where a fine aerosol mist of medication must be delivered to a patient for the treatment of respiratory disorders. The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers are intended to be used for both adult and pediatric patients who have been prescribed inhalation therapy or medication in both home health care and hospital use. The Flaem Nuova RF6 Basic and RF6 Plus Nebulizers may be used with compressed air or an air gas source providing air flow between 4 and 10 lmin.
NOTE
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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)
010(k) Number ...
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Asion of Anesthesiology, General Hospital Inston Control, Dental Devices
KO6248
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510(K) FILE