This nebulizer compressor is an AC-powered air compressor nebulizer system intended to provide a source of compressed air for medical purposed for use in home health care. It is to be used with a pneumatic nebulizer to produce aerosol particles of medication for respiratory therapy for both children and adults.

Device Description

This line-powered piston compressor is housed in a plastic cabinet (case). Dimensions are 7.5" (L) x 7.49" (W) x 4.18" (H) and weighs 3.3 lbs. It consists of a motor-driven piston compressor and a switch; it contains no consists of a noter electronic components. It operates from 115 VAC, 60 Hz. It is supplied with tubing, an instruction manual, and a Sidestream (510(k) cleared) nebulizer. The Inspiration Elite, Model HS456 is not be used without the nebulizer.

In use, the compressor is placed on a flat surface and the nebulizer tubing is connected to the hose barb. The unit is then turned on. Inlet air to the compressor passes through a replaceable filter.

AI/ML Overview

The provided text describes a medical device submission (510(k)) for a nebulizer compressor but does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods for such a study.

The document is a summary of the 510(k) submission for the "Inspiration Elite Nebulizer Compressor with Nebulizer, Model HS456". It focuses on demonstrating substantial equivalence to a predicate device (InvaCare Envoy Jr., K# 992643) rather than proving performance against specific acceptance criteria through a clinical study.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

Acceptance Criteria and Reported Device Performance: The document provides a "Functional Comparison Chart" (Section 8) comparing the subject device to the predicate device based on specifications like dimensions, weight, electrical requirements, average power consumption, and average flow rate. This chart does not present "acceptance criteria" in the sense of predefined thresholds for performance, but rather shows how the subject device's specifications align with those of the predicate.
Study That Proves the Device Meets Acceptance Criteria: Section 9 explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical study was performed to "prove the device meets acceptance criteria." Instead, the submission relies on non-clinical tests to demonstrate substantial equivalence.
Sample size for the test set and data provenance: No test set is described as no clinical study was performed.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no clinical study with a ground truth was performed.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
Standalone (algorithm-only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of available information related to performance/equivalence:

A table of acceptance criteria and the reported device performance:
The document includes a "Functional Comparison Chart" which outlines specifications for the subject device and its predicate. While not framed as "acceptance criteria," these are the performance characteristics presented for comparison:

FUNCTION	INSPIRATION ELITE (Reported Performance)	ENVOY JR. (Predicate Performance)
Model	HS456	1001RC
Dimension	4.2" x 7.5" x 7.5"	4.1"x 7.0"x 7.0"
Weight	3.3 lbs	3.5 lbs
Electrical requirements	115VAC/60Hz	115VAC/60Hz
Avg. Power consumption	89 -90 watts*	88 -89 watts*
Avg. Flow Rate @ 10-15 psig	7.6 -6.8 Lpm*	7.6 -6.8 Lpm*
Power Indication	No	No
Intensity Control	No	No
Intensity Indication	No	No
Turn ON/OFF switch	Yes (switch)	Yes (switch)
*Reference Exhibit #2 (Rietschle Thomas Compressor Comparison Data Table dated 8/10/04)

Study that proves the device meets the acceptance criteria:
The submission explicitly states: "Discussion of Clinical Tests Performed: Not Applicable." The basis for demonstrating safety and effectiveness and substantial equivalence is non-clinical testing: "electrical, mechanical, environmental and EMC testing results outlined in the FDA DCRND November 1993 Draft 'Reviewer Guidance for Premarket Notification Submissions'."

The remaining points about sample sizes, data provenance, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are not present in the provided text because no clinical or AI performance study, as typically understood in those contexts, was conducted or reported. The device's approval hinges on its substantial equivalence to a legally marketed predicate based on non-clinical performance characteristics and adherence to relevant standards and guidance documents.

Summary

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OCT 1 3 2004

EXHIBIT #1

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in Fills Sunmitary of 5 8 r requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: __ K042655__.

Submitter's Identification: 1.

Respironics New Jersey, Inc. 41 Canfield Road Cedar Grove, NJ 07009

Contact: Ms. Lauren R. Ziegler, Senior Manager, Technical Services Phone: 973-571-2608; Fax: 973-857-9521

Date Summary Prepared: September 8, 2004

Name of the Device: 2.

Inspiration Elite Nebulizer Compressor, with Nebulizer, Model HS456 Common Name or Classification Name (21 CFR Part 807.87) of Device: Nebulizer Compressor, 21 CFR Part 868.6250, Portable Air Compressor

Predicate Device Information: 3.

InvaCare Envoy Jr., K# 992643

4. Device Description:

In use, the compressor is placed on a flat surface and the nebulizer tubing is connected to the hose barb. The unit is then turned on. Inlet air to the compressor passes through a replaceable filter.

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Intended Use: ഗ്

This nebulizer compressor is an AC-powered air compressor nebulizer system This neountzer compressor is an 110 personal air for medical purposed for use in home health care. It is to be used with a pneumatic nebulizer to produce nome ficallif care. Tt is to or assor as trespiratory therapy for both children and adults.

Comparison to Predicate Devices: 6.

The subject (Inspiration Elite) and predicate device (InvaCare Envoy Jr., The subject (msphaton Ento) a same intended use, are AC-powered, meet Environmental Safety and EMC requirements, and have similar compressor coperating pressure and flow ranges. Performance characteristics are basically the same, and both units are lightweight.

Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:

The Inspiration Elite conforms or will conform to the electromagnetic compatibility, mechanical/environmental, and electrical testing companisms, described in the Reviewer Guidance for Premarket Notification Submissions (November 1993). Testing information Horfication Sation offectiveness of the Inspiration Elite Nebulizer Compressor, with Nebulizer, Model HS456 in the intended environment of Comprossor, with I voorted by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.

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Functional Comparison Chart 8.

FUNCTION	INSPIRATION ELITE	ENVOY JR.
Model	HS456	1001RC
Dimension	4.2" x 7.5" x 7.5"	4.1"x 7.0"x 7.0"
Weight	3.3 lbs	3.5 lbs
Electrical requirements	115VAC/60Hz	115VAC/60Hz
Avg. Power consumption	89 -90 watts*	88 -89 watts*
Avg. Flow Rate @ 10-15 psig	7.6 -6.8 Lpm*	7.6 -6.8 Lpm*
Power Indication	No	No
Intensity Control	No	No
Intensity Indication	No	No
Turn ON/OFF switch	Yes (switch)	Yes (switch)

*Reference Exhibit #2 (Rietschle Thomas Compressor Comparison Data Table dated 8/10/04)

Discussion of Clinical Tests Performed: 9.

Not Applicable

Conclusions: 10.

We have demonstrated that the Inspiration Elite Nebulizer Compressor, with Nebulizer, Model HS456 is as safe and effective as predicate devices Nobulzer, moder ribet, based on electrical, mechanical, environmental and EMC testing results outlined in the FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions". We also adhered to FDA's DCRND "Reviewer Guidance for Home Use Respiratory Devices".

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Image /page/3/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes. The symbol is black and the background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 3 2004

Respironics New Jersey, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue SE Grand Rapids, Michigan 49548

Re: K042655

R042099
Trade/Device Name: Inspiration Elite Nebulizer Compressor with Nebulizer, Model HS456 Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF, BTI Dated: October 6, 2004 Received: October 7, 2004

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have roved 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendmont, of to workend Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provinces or 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 If your device is classinod (soo as a difional controls. Existing major regulations affecting (1 NIX), it may of easyon in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can or readlish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Devine

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualled of a beat start complies with other requirements mean that FDA nas made a decemmarie for administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally rederal statues and reguirements, including, but not limited to: registration You must comply with an the Fict b roquits and may be and 801); good manufacturing practice and ifiling (21 CFR Part 607), laceming (21 CFR Part 820), and if 1 CFR Part 820); and if requirents as set forth in the quality ajon 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) This letter will anow you to ough finding of substantial equivalence of your device to a premarket nothfeation. The PDF Imaling or colossification 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), If you desire specific authority for your 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Burns

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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Exhibit B

Indications for Use

510(k) Number (if known): __ K042655

Device Name:

Inspiration Nebulizer Compressor, with Nebulizer, Model HS456

Indications for Use:

Prescription Use X (Per 21 CFR 801 Subpart D)

Over -The-Counter Use OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Aver Sogeem

(Division Sign-Off) Division of Anesthesiolor Jeneral Hospital, Infection Control, Dental 510(k) Number

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).