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.

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.

AI/ML Overview

This 510(k) summary (K082878) for the Nevoni Classic 6600-PO nebulizer does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the specifics of a study proving device performance. This document is a premarket notification for substantial equivalence, which primarily focuses on comparing the new device to existing legally marketed predicate devices, rather than presenting a full performance study with acceptance criteria.

However, I can extract the available information and highlight what is missing based on your prompt.

Missing Information:
The document does not describe a specific study with acceptance criteria for the Nevoni Classic 6600-PO. Instead, it relies on demonstrating substantial equivalence to pre-existing nebulizers by comparing product properties. Therefore, many of your requested points regarding a specific performance study cannot be answered from this document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present formal "acceptance criteria" and "reported device performance" in the way one would expect from a dedicated performance study. Instead, it provides a "Comparative Product Table" to demonstrate substantial equivalence to predicate devices. The implicit "acceptance" is that the device's performance aligns with, or is comparable to, the predicate devices.

Product Properties	Nevoni Classic Model 6600-PO Compressor	Salter Aire Compressor	DeVilbiss Model 3655 Compressor	Invacare Model IRC 1001 Aerosol Compressor	Implicit "Acceptance Criteria" (based on predicates)	Reported Performance (Nevoni Classic)
Compressor type	Piston	Piston	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	Within typical ranges for nebulizers	110V 50/60Hz, 0.5 Amps
Free flow rate	15 lpm	11 lpm	8 lpm	8.5 lpm	Comparable to or better than predicates (>8 lpm)	15 lpm
Operating flow rate	8 lpm	6.5 lpm	5.5 lpm	4.8 lpm	Comparable to or better than predicates (>4.8 lpm)	8 lpm
Over-heating switch	No	Yes	Yes	Yes	(Not present on this device)	No
Portable	Yes	Yes	Yes	Yes	Yes	Yes
Case material	Plastic	Plastic	Plastic	Plastic	Plastic	Plastic
Warranty	1 year	1 year	5 year	5 year	1 year (matches one predicate)	1 year
Maximum operating temp.	158 °F	128.5 °F	104 °F	158 °F	Comparable to predicates (up to 158 °F)	158 °F
Intended environment use	Home therapy	Home therapy and hospital	Home therapy	Home therapy	Home therapy	Home therapy

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This document does not describe a test set or a formal study with a patient or sample size. The comparison is based on device specifications of the new device and predicate devices.
Data Provenance: Not applicable for a test set. The data presented are product specifications for the Nevoni Classic and three predicate devices (Invacare Model IRC 1001, Sunrise Medical Devilbiss Model 3655, Salter Labs Aire Compressor). There's no mention of country of origin for specific test data or whether it's retrospective/prospective, as no performance study is detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No "ground truth" or expert review of a test set is described in this 510(k) summary.

4. Adjudication method for the test set

Not applicable. No test set or adjudication method is described.

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. This is not an AI-assisted device; it's a nebulizer. No MRMC study was conducted or is relevant here.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not involve an algorithm.

7. The type of ground truth used

Not applicable. No "ground truth" in the clinical or imaging sense is described. The equivalency is based on objective device specifications and intended use.

8. The sample size for the training set

Not applicable. There is no training set for this type of device.

9. How the ground truth for the training set was established

Not applicable. There is no training set or ground truth in this context.

Summary

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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.

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NSR, INDUSTRIA, COMERCIO E REPRESENTACOES LTDA

Equivalent Marketed Predicate Devices:

Legally Marketed Predicate DeviceRegistration #	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 package includes a compressor, air tubing, air filters and adult and child size masks.

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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:

ProductProperties	Nevoni ClassicModel 6600-POCompressor	Salter AireCompressor	DeVilbissModel 3655Compressor	Invacare Model IRC1001 AerosolCompressor
Compressor type	Piston	Piston	Piston	Piston
Voltage	110V 50/60Hz0.5 Amps	110V 60Hz2.5 amps	110V 60Hzamps	115V 60 Hz1.6 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 operatingtemperature	158 °F	128.5 °F	104 °F	158 °F
Intendedenvironment use	Home therapy	Home therapyand 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

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Indications for Use

510(k) Number K082878

Device Name: Nevoni Classic 6600-PO

Indications for Use:

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

Regulation Number and Section

§ 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).