(87 days)
K# 914251
Not Found
No
The device description explicitly states it contains "no microprocessors or other electronic components" and the "Mentions AI, DNN, or ML" section is marked as "Not Found". The device is a simple mechanical compressor.
Yes
The device is used in conjunction with a nebulizer to produce an aerosol mist of medication for respiratory therapy to treat various respiratory disorders.
No
This device is a nebulizer compressor, which is used to deliver medication in the form of an aerosol mist for respiratory therapy. It is a therapeutic device, not a diagnostic one, as it does not perform any assessment or diagnosis of a medical condition.
No
The device description clearly outlines a physical hardware device (piston compressor, motor, fuse, switch, plastic cabinet) with specific dimensions and weight, and it undergoes hardware-specific performance testing (environmental, safety, EMC). It does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an AC-powered air compressor used to provide compressed air for medical purposes in conjunction with a pneumatic nebulizer. Its purpose is to deliver medication as an aerosol mist for respiratory therapy.
- Device Description: The description details a mechanical compressor that generates compressed air. It does not involve any testing of biological samples or analysis of bodily fluids or tissues.
- Lack of IVD Characteristics: The description does not mention any components or functions typically associated with IVDs, such as reagents, test strips, analyzers, or the detection of specific analytes in biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This nebulizer compressor's function is to facilitate the delivery of medication, not to perform diagnostic testing on a biological sample.
N/A
Intended Use / Indications for Use
This nebulizer compressor is an AC-powered air compressor intended to provide a source of compressed air for medical purposes for use in home health care. This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders such as asthma, allergies, COPD, etc.
Product codes
BTI
Device Description
This line-powered piston compressor is housed in a plastic cabinet (case). Dimensions are 7.3 in. x 6.9 in. x 4.0 in. and weighs 3.3 lbs. It consists of a motor-driven piston compressor, an in-line fuse, and a switch; it contains no microprocessors or other electronic components. It operates from 115 VAC, 60 Hz. It is supplied with tubing, an instruction manual, and a 510(k) cleared 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
for both children and adults
Intended User / Care Setting
home health care
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 following Environmental and Safety Testing was conducted: Testing information demonstrating safety and effectiveness of the Mister Neb™ Nebulizer Compressor, with Nebulizer, Model HS123 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. The following testing was conducted:
- Maximum pressure and flow under all combinations of the following:
- Temperatures of +5° and +20°C, and 40°C with 95% RH:
- Line voltage of 95, 115, and 132 V
- Storage at -20°C and at +60°C
- Fluid spill resistance
- Surface and air temperatures
- Sinusoidal vibration
- Impact (drop) resistance
- Leakage current and dielectric withstand (electrical safety)
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the Mister Neb™ Nebulizer Compressor, with Nebulizer, Model HS123, device sample(s) tested met all relevant requirements of the aforementioned test. In addition, the following EMC testing was conducted:
- Radiated and Conducted Emission per CISPR 11
- Magnetic Field Emission per MIL-STD-462D, Method RE101
- Fast surges per Reviewer Guidance document
Because the compressor contains no electronic components (e.g., microprocessors), the radiated and conducted immunity tests were not applicable. The device was tested as described in the EMC Testing Results to simulate, as closely as possible, actual operating conditions. The device tested met the EMC criteria recommended by the FDA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
InvaCare Envoy Jr., K# 914251
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
0
EXHIBIT #1
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is: KO13 0 2 7
1. Submitter's Identification:
Respironics HealthScan, Inc. 41 Canfield, Road Cedar Grove, NJ 07009
Contact: Ms. Lauren R. Ziegler, Senior Manager, Technical Services
Date Summary Prepared: August 8, 2001
2. Name of the Device:
Mister Neb™ Nebulizer Compressor, with Nebulizer, Model HS123
Predicate Device Information: 3.
InvaCare Envoy Jr., K# 914251
4. Device Description:
This line-powered piston compressor is housed in a plastic cabinet (case). Dimensions are 7.3 in. x 6.9 in. x 4.0 in. and weighs 3.3 lbs. It consists of a motor-driven piston compressor, an in-line fuse, and a switch; it contains no microprocessors or other electronic components. It operates from 115 VAC, 60 Hz. It is supplied with tubing, an instruction manual, and a 510(k) cleared 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.
5. Intended Use:
This nebulizer compressor is an AC-powered air compressor intended to provide a source of compressed air for medical purposes for use in home health care.
1
This device is used in conjunction with a pneumatic nebulizer to produce a fine This as nos to t medication for respiratory therapy, for both children and adults suffering from respiratory disorders such as asthma, allergies, COPD, etc.
Comparison to Predicate Devices: 6.
The subject (Mister Neb™) and predicate device (InvaCare Envoy Jr., 110 Sabjoon (microl for the same intended use, are AC-powered, meet Environmental Safety and EMC requirements, and have similar compressor operating 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 following Environmental and Safety Testing was conducted:
Testing information demonstrating safety and effectiveness of the Mister Neb™ Nebulizer Compressor, with Nebulizer, Model HS123 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.
The following testing was conducted:
- Maximum pressure and flow under all combinations of the following: a.
- Temperatures of +5° and +20°C, and 40°C with 95% RH: ।
- Line voltage of 95, 115, and 132 V
- Temperatures of +5° and +20°C, and 40°C with 95% RH: ।
- Storage at -20°C and at +60°C b.
- Fluid spill resistance C.
- Surface and air temperatures ರೆ.
- Sinusoidal vibration e.
- Impact (drop) resistance f.
- Leakage current and dielectric withstand (electrical safety) g.
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the Mister Neb™ Nebulizer Compressor, with Nebulizer, Model HS123, device sample(s) tested met all relevant requirements of the aforementioned test.
In addition, the following EMC testing was conducted:
- Radiated and Conducted Emission per CISPR 11 a.
2
- Magnetic Field Emission per MIL-STD-462D, Method RE101 b.
- Fast surges per Reviewer Guidance document C.
Because the compressor contains no electronic components (e.g., microprocessors), the radiated and conducted immunity tests were not applicable. The device was tested as described in the EMC Testing Results to simulate, as closely as possible, actual operating conditions.
The device tested met the EMC criteria recommended by the FDA
8. Discussion of Clinical Tests Performed:
Not Applicable
9. Conclusions:
We have demonstrated that the Mister Neb™ Nebulizer Compressor, with Nebulizer, Model HS123 is as safe and effective as predicate devices presently on the market, 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/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2001
Respironics HealthScan, Inc. c/o Mr. Robert Mosenkis Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298
Re: K013027
Mister NebTM Nebulizer Compressor, Model HS123 Regulation Number: 868.6250 Regulation Name: Portable Air Compressor Regulatory Class: Class II (two) Product Code: BTI Dated: November 20, 2001 Received: November 21, 2001
Dear Mr. Mosenkis:
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.
4
Page 2 - Mr. Robert Mosenkis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase of action and i rermination that your device complies with other requirements of the Act that I Dr Has intates and regulations administered by other Federal agencies. You must or any I odotal buttor and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fat 607); adoning (21 CFR regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by states (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 lotter will and in yourse of substantial equivalence of your device to a legally prematic notineatem " rice 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 11 you deelie by cents and 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of ICP at 0646. Additionally, for questions on the promotion and advertising of Compliance at (301) 59 - 1 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,
X. Oolga Tell
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exhibit B
Page __ 1 __ of __ 1 __ 1 __
510(k) Number (if known): _ K 0 | 3 O2 7
Device Name: Mister Neb™ Nebulizer Compressor, with Nebulizer, Model HS123
Indications For Use:
This nebulizer compressor is an AC-powered air compressor intended to provide a source of compressed air for medical purposes for use in home health care. This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders such as asthma, allergies, COPD, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dale Till
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | K013027 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) |
|
| --------------------------------------- | -------------------- |
|---|
OR
| Over-The-Counter Use (Optional Format 1-2-96) | |
|---|---|
| ----------------------------------------------- | -- |