The DeVilbiss compressor / nebulizer Model 3655 includes an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.

Device Description

The DeVilbiss Model 3655 Compressor/Nebulizer is a small, piston-type air compressor, sized to provide the proper flow and pressure sufficient to power jet (pneumatic) nebulizers. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device (Underwriter's Laboratory Standard UL1431 and IEC 60601-1). When the compressor is used in conjunction with a therapeutic nebulizer, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The DeVilbiss Model 3655 compressor/nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter.

AI/ML Overview

The provided documents describe a 510(k) premarket notification for the DeVilbiss Model 3655 Compressor/Nebulizer. The primary objective of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This is achieved by comparing the new device's technological characteristics, performance, and indications for use to those of the predicate device.

Based on the provided text, a direct acceptance criteria table and a detailed study report proving the device meets specific performance criteria are not present in the typical format one might expect for a clinical study on diagnostic accuracy or treatment efficacy. Instead, the documents focus on demonstrating substantial equivalence to a predicate device (DeVilbiss Model 3650, K970289).

Here's an analysis based on the information provided, framed to address your questions as much as possible within the context of a 510(k) submission for sub-equivalence:

1. A table of acceptance criteria and the reported device performance

The document doesn't present an explicit "acceptance criteria" table with numerical targets, but rather discusses equivalence. The criteria for acceptance in a 510(k) for this type of device typically revolve around demonstrating that the new device performs similarly or no worse than the predicate device in key functional areas.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (DeVilbiss Model 3655)
Intended Use Equivalence: Provide compressed air for jet nebulizers to convert liquid medication into aerosol for inhalation by adult or pediatric patients for respiratory disorders.	"Includes an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients."
Aerosol Particle Size Performance: Produce an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter.	"The DeVilbiss Model 3655 compressor / nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter."
Safety and Effectiveness: Comparable to legally marketed predicate devices.	"The DeVilbiss Model 3655 aerosol compressor / nebulizer is equivalent in both function and indications for use to the DeVilbiss Model 3650 aerosol compressor / nebulizer legally marketed predicate device." "The Table of Comparison and the Performance Evaluations (Sections 4.0 & 7.0) show that in terms of safety and effectiveness, the new DeVilbiss Model 3655 Compressor / Nebulizer is substantially equivalent to legally marketed predicate devices."
Technological Characteristics: Equivalent functional characteristics to existing legally marketed predicate devices (AC motor driven air compressor for jet nebulizer operation).	"The DeVilbiss Model 3655 aerosol compressor / nebulizer is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all utilize an AC motor driven air compressor to provide a source of compressed air for operating a jet (pneumatic) nebulizer."
Compliance with Safety Standards: Comply with electrical and mechanical safety standards (e.g., UL1431, IEC 60601-1).	"The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device (Underwriter's Laboratory Standard UL1431 and IEC 60601-1)." "All of the devices are tested and approved to recognized agency safety standards."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of clinical trials or AI/algorithm evaluation. For a compressor/nebulizer, testing would typically involve engineering and bench testing, not human patient studies for performance metrics like accuracy. The "aerosol output and particle size" testing mentioned would be benchtop measurements.

Sample Size: Not applicable in the context of human subject testing for performance. The "sample" would be the manufactured devices undergoing testing. The number of units tested is not specified.
Data Provenance: Not applicable in the sense of geographic origin of data from subjects. The testing described (aerosol output, particle size, safety) would be performed in a laboratory setting, likely at the manufacturer's facility (Sunrise Medical HHG, Inc., Somerset PA, USA) or a certified testing lab. This would be considered prospective testing of the device units.

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

This question is not applicable to this type of device and submission. "Ground truth" for a compressor/nebulizer is established through physical measurements (e.g., particle size analysis using instruments, airflow measurements, pressure measurements) and compliance with engineering standards, not expert clinical consensus on interpreting medical images or outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept relates to expert review and consensus, which is not the method for determining the performance or safety of a mechanical device like a nebulizer. Performance is determined by objective measurements and adherence to specifications.

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 device is a medical compressor/nebulizer, not an AI-powered diagnostic tool. Therefore, MRMC studies are irrelevant.

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

Not applicable. This refers to AI algorithm performance and is not relevant to a mechanical device. The device's "standalone" performance means its function in compressing air and producing aerosol, which is evaluated through bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for a device like this is based on:

Physical measurements: For aerosol output, particle size, airflow, pressure.
Engineering specifications & standards: Compliance with recognized safety standards (UL1431, IEC 60601-1).
Comparison to predicate device: The predicate device's established performance serves as the benchmark for "equivalence."

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI that requires a "training set."

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

Not applicable. No training set is used for this type of device.

Summary of the Study:

The "study" presented here is not a clinical trial in the traditional sense, nor is it an AI performance evaluation. It is a 510(k) Premarket Notification submission to the FDA, which aims to demonstrate substantial equivalence of a new medical device (DeVilbiss Model 3655 Compressor/Nebulizer) to an already legally marketed predicate device (DeVilbiss Model 3650).

The "proof" that the device meets "acceptance criteria" (which are implied and based on equivalence to the predicate) comes from:

Benchtop Testing: Measuring parameters like aerosol output and particle size, and showing they are comparable to the predicate. While specific data is not in this summary, it refers to "Performance Evaluations (Sections 4.0 & 7.0)" which would contain this data.
Compliance with Recognized Standards: Demonstrating adherence to electrical and mechanical safety standards (UL1431, IEC 60601-1).
Comparison of Specifications: Showing that intended use, technological characteristics (e.g., piston-type air compressor, AC powered), and materials are similar or identical to the predicate device.

The FDA's review of this submission and the subsequent "substantially equivalent" determination (as indicated by the letter from Donna-Bea Tillman, Ph.D. in K020932) confirms that the device has met the regulatory requirements for market entry based on this comparative assessment.

Summary

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K020932

JUN 2 8 2002

11.0 510(k) Summary

Submitter's Name:	Sunrise Medical HHG, Inc.Respiratory Products Division100 DeVilbiss DriveSomerset PA 15501Ray Hoffman(PH)814-443-7442(Fax)814-443-7571
Date Prepared:	February 28, 2002
Device Name:	Compressor / Nebulizer FDA Classification CAF
Common or Usual Name:	Compressor / Nebulizer
DeVilbiss Model Number:	3655 Series
Trade Proprietary Name:	DeVilbiss Pulmo-Aide Compact Compressor
Established Registration Number:	DeVilbiss # 2515872
FDA Classification:	Class II
Equivalent Legally Marketed Predicate Devices:

Legally Marketed Predicate Devices 510(k) Registration # K 970289 DeVilbiss Model 3650

Description of Device:

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When the compressor is used in conjunction with a therapeutic nebulizer, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The DeVilbiss Model 3655 compressor/nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter.

Statement of Intended Use:

Statement of Safety and Effectiveness:

The DeVilbiss Model 3655 aerosol compressor / nebulizer is equivalent in both function and indications for use to the DeVilbiss Model 3650 aerosol compressor / nebulizer legally marketed predicate device.

The DeVilbiss Model 3655 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease. The compressor is constructed of materials, both metal and plastic, that are similar or identical to legally marketed devices. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device

Used in conjunction with a jet (pneumatic) nebulizer, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The DeVilbiss Model 3655 compressor / nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter. This aerosol particle size performance is comparable to other legally marketed devices as noted in the Table of Comparison and the Discussion of Similarities and Performance Data (Sections 4.0 & 5.0),

The Table of Comparison and the Performance Evaluations (Sections 4.0 & 7.0) show that in terms of safety and effectiveness, the new DeVilbiss Model 3655 Compressor / Nebulizer is substantially equivalent to legally marketed predicate devices.

Legally Marketed Predicate Devices DeVilbiss Model 3650

510(k) Registration # K 970289

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Technological Characteristics:

The DeVilbiss Model 3655 aerosol compressor / nebulizer is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all utilize an AC motor driven air compressor to provide a source of compressed air for operating a jet (pneumatic) nebulizer. All of the devices are tested and approved to recognized agency safety standards.

Testing performed on the aerosol output and particle size show that the new DeVilbiss Model 3655 is substantially equivalent to the existing legally marketed predicate devices and that all of these devices will produce a similar aerosol treatment.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 8 2002

Sunrise Medical HHG. Inc. c/o Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548

Re: K020932

Devilbiss Model 3655 Compressor/Nebulizer Regulation Number: 21 CFR 868.5630 and 21 CFR 868.6250 Regulation Name: Nebulizer and Portable Air Compressor Regulatory Class: II (two) Product Code: 73 CAF and 73 BTI Dated: June 14, 2002 Received: June 18, 2002

Dear Mr. Devine:

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 - Mr. Ned Devine

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

020932

Page 1 of 1

510(k) Number: (if known): ___________________________________________________________________________________________________________________________________________________

Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division/Sign-Off)

Division of Cardiovascular and Respiratory Devices

510(k) Number	14020932
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X Prescription use
-OR-
Over-the-counter use

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).