(92 days)
None
No
The description details a purely mechanical process of air compression and nebulization, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for inhalation treatment of medicine, indicating a therapeutic purpose.
No
Explanation: The device is a nebulizer designed for delivering medication as an inhalable mist, not for diagnosing medical conditions. Its function is therapeutic (treatment delivery), not diagnostic (identifying diseases or conditions).
No
The device description clearly outlines physical hardware components like a compressor, motor, piston, diaphragm, air tubing, filters, and masks, indicating it is a hardware device with mechanical functions, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Nevoni Classic Nebulizer Function: The Nevoni Classic nebulizer is a device that delivers medication to a patient's lungs in the form of an aerosolized mist. It does not analyze or test any biological specimens from the patient.
The device description clearly outlines its function as a respiratory device for delivering inhaled medication based on a physician's prescription. This falls under the category of a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Nevoni Classic 6600-PO nebulizer is an ac powered portable compressor. This portable device uses a pneumatic piston that compresses uir, forcing it to flow into the nebulizer cup. The force of the air flowing into the nebulizer cup disperses the medicine into fine mist particles for the inhalation treatment based on a physician's prescription. This device is intended for single patient home therapy.
Product codes
CAF
Device Description
The Nevoni Classic nebulizer is a portable AC-powered respiratory device used for home therapy. It uses a compressor to process medicine into a breathable aerosolized mist which is collected into a facial mask and inhaled by the patient.
The device's nebulization process is achieved through a small wired AC-electric motor that forces an oil-free piston into motion. This motion oscillates a sealed diaphragm and compresses air into a small chamber. Air intake is supplied to the compressor using a felt filter. The compressed air flow is conducted through a thin flexible tube into a nebulizer cup in which a fine particle mist is created by the medicine's highly pressurized contact. The nebulizer cup is attached to an anatomical mask made of soft, non-toxic material. The medicine's mist accumulates within this mask where it is ready for inhalation by the patient.
The Nevoni Classic nebulizer package includes a compressor, air tubing, air filters and adult and child size masks.
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
Not Found
Intended User / Care Setting
single patient home therapy.
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
Not Found
Key Metrics
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
DEC 3 0 2008
510(k) SUMMARY
- Submitter's Name: NSR Comercio e Representacoes Ltda Av. Gupe, Bloco C Galpao 16 Jardim Belval Barueri, SP 06422-120 Brazil
- Edvino Carbone Owner Name: Phone#: (5511) 4619-2066 Fax#: (5511) 4619-2066
- Polly E. Scherman Contact Name: NSR Trading LLC. 11 Perry Drive, Unit G Foxboro, MA 02035 Phone#: 508-543-9300 Fax#: 508-543-9399
- Date Prepared: May 13, 2008
- Regulation Number: 21 CFR 868.5630 Product Classification: Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF
- Nevoni Model Number: Nevoni Classic 6600-PO
- Purpose for Submission: New device that has never been marketed in the US. The Nevoni Classic 6600-PO is packaged so that it is ready for consumer use.
1
NSR, INDUSTRIA, COMERCIO E REPRESENTACOES LTDA
Equivalent Marketed Predicate Devices:
| Legally Marketed Predicate Device
| Registration # | 510(k) |
|---|---|
| Invacare Model IRC 1001 Aerosol Compressor | K992643 |
| Sunrise Medical Devilbiss Model 3655 | K020932 |
| Salter Labs Aire Compressor | K992285 |
Intended Use
The Nevoni Classic 6600-PO nebulizer is an ac powered portable compressor. This portable device uses a pneumatic piston that compresses air, forcing it to flow into the nebulizer cup. The force of the air flowing into the nebulizer cup disperses the medicine into fine mist particles for the inhalation treatment based on a physician's prescription. This device is intended for single patient home therapy.
Device Description:
The Nevoni Classic nebulizer is a portable AC-powered respiratory device used for home therapy. It uses a compressor to process medicine into a breathable aerosolized mist which is collected into a facial mask and inhaled by the patient.
The device's nebulization process is achieved through a small wired AC-electric motor that forces an oil-free piston into motion. This motion oscillates a sealed diaphragm and compresses air into a small chamber. Air intake is supplied to the compressor using a felt filter. The compressed air flow is conducted through a thin flexible tube into a nebulizer cup in which a fine particle mist is created by the medicine's highly pressurized contact. The nebulizer cup is attached to an anatomical mask made of soft, non-toxic material. The medicine's mist accumulates within this mask where it is ready for inhalation by the patient.
The Nevoni Classic nebulizer package includes a compressor, air tubing, air filters and adult and child size masks.
2
Substantial Equivalence:
The Nevoni Classic compressor is substantially equivalent to:
- Invacare Model IRC 1001 Aerosol Compressor . FDA 510k Registration# K992643
- . DeVilbiss Model 800 FDA 510k Registration# K993492
- . Salter Labs Salter Aire Compressor FDA 510k Registration# K992285
Comparative Product Table:
| Product
Properties | Nevoni Classic
Model 6600-PO
Compressor | Salter Aire
Compressor | DeVilbiss
Model 3655
Compressor | Invacare Model IRC
1001 Aerosol
Compressor |
|----------------------------------|-----------------------------------------------|------------------------------|---------------------------------------|--------------------------------------------------|
| Compressor type | Piston | Piston | Piston | Piston |
| Voltage | 110V 50/60Hz
0.5 Amps | 110V 60Hz
2.5 amps | 110V 60Hz
amps | 115V 60 Hz
1.6 amps |
| Free flow rate | 15 lpm | 11 lpm | 8 lpm | 8.5 lpm |
| Operating flow rate | 8 lpm | 6.5 lpm | 5.5 lpm | 4.8 lpm |
| Over-heating switch | No | Yes | Yes | Yes |
| Portable | Yes | Yes | Yes | Yes |
| Case material | Plastic | Plastic | Plastic | Plastic |
| Warranty | 1 year | 1 year | 5 year | 5 year |
| Maximum operating
temperature | 158 °F | 128.5 °F | 104 °F | 158 °F |
| Intended
environment use | Home therapy | Home therapy
and hospital | Home therapy | Home therapy |
Substantial Equivalence Statement:
The Nevoni Classic compressor nebulizer is equivalent to FDA registered predicate marketed devices. These devices are similar in that they deliver medicine in the form of aerosol within acceptable parameters. The Nevoni Classic nebulizer delivers similar durability and performance as existing legally marketed predicate devices.
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEC 30 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NSR, Comercio, Industria e Representacoes, Ltda C/O Ms. Polly Scherman Business Manager NSR Trading LLC 11 Perry Drive, Unit G Foxboro, Massachusetts 02035
Re: K082878
Trade/Device Name: Nevoni Classic 6600-PO Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: September 23, 2008 Received: October 1, 2008
Dear Ms. Scherman:
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.
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Page 2 - Ms. Scherman
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 «ouivalence 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours.
Chisholm, 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
5
Indications for Use
510(k) Number K082878
Device Name: Nevoni Classic 6600-PO
Indications for Use:
The Nevoni Classic 6600-PO nebulizer is an ac powered portable compressor. This portable device uses a pneumatic piston that compresses uir, forcing it to flow into the nebulizer cup. The force of the air flowing into the nebulizer cup disperses the medicine into fine mist particles for the inhalation treatment based on a physician's prescription. This device is intended for single patient home therapy.
Prescription Use X AND/OR
. .. . . . . . . . .
Over-The-Counter Use (21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of
(Posted November 13, 2003)
Qre
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K-082878