(15 days)
K# 992643
K# 992643
No
The device description explicitly states it "contains no other electronic components" beyond the motor-driven piston compressor and a switch, and the document contains no mentions of AI, ML, or related concepts.
Yes
The device is described as "intended to provide a source of compressed air for medical purposes" and is "to be used with a pneumatic nebulizer to produce aerosol particles of medication for respiratory therapy". This directly indicates its use in providing therapy.
No
The device is a nebulizer compressor, which provides compressed air for medically prescribed nebulizers to deliver medication. It does not perform any diagnostic functions.
No
The device description clearly outlines a physical hardware device (piston compressor, motor, plastic cabinet) and its physical operation, not a software-only solution.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide compressed air for a nebulizer to deliver medication for respiratory therapy. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a compressor that generates compressed air. It does not interact with biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples or providing diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This nebulizer compressor does not fit that definition.
N/A
Intended Use / Indications for Use
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.
Product codes
CAF, BTI
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 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.
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
both children and adults.
Intended User / Care Setting
Not Found
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 Inspiration Elite conforms or will conform to the electromagnetic compatibility, mechanical/environmental, and electrical testing components, described in the Reviewer Guidance for Premarket Notification Submissions (November 1993). Testing information for safety and effectiveness of the Inspiration Elite Nebulizer Compressor, with Nebulizer, Model HS456 in the intended environment of use is supported 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
InvaCare Envoy Jr., K# 992643
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
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:
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.
1
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.
2
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".
3
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.
4
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
5
Exhibit B
Indications for Use
510(k) Number (if known): __ K042655
Device Name:
Inspiration Nebulizer Compressor, with Nebulizer, Model HS456
Indications for Use:
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.
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