(132 days)
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No
The description focuses on the mechanical and electrical components of a standard air compressor for nebulization, with no mention of AI or ML capabilities.
No.
The device is an air compressor used to create an aerosol mist of liquid medication; it does not directly administer therapy, but rather facilitates the nebulization of a prescribed medication.
No
Explanation: The device is an air compressor used to create an aerosol mist for medication delivery, not to diagnose a condition.
No
The device description explicitly lists hardware components such as a motor, cylinder and piston assembly, case, switch, electrical cord, and a printed circuit board.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce an air source for a nebulizer to create an aerosol mist of prescribed medication for inhalation. This is a therapeutic delivery method, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the mechanical components of an air compressor. There is no mention of reagents, assays, or any process that would involve analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, this device is an air compressor intended for use with a nebulizer for drug delivery, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
This product is an air compressor that when used in conjunction with a hand held nebulizer, produces the nebulization of a liquid prescribed medication. The compressor produces an air source that is channeled through tubing into the hand held nebulizer. The nebulizer creates an aerosol mist by forcing the compressed air through the nebulizer baffle. This creates negative pressure in which the liquid medication is vacuumed into the air, creating the aerosol mist.
Product codes
73 CAF
Device Description
This product contains the exact same technological characteristics of similar devices currently on the market. The product functions exactly as these similar devices.
The product is designed with similar performance characteristics as devices currently on the market. The performance of the device allows it to be used in conjunction with various hand held nebulizers that are currently in distribution in the United States and Europe.
The components found within this product are common items. The product consists of a thermally protected motor, a cylinder and piston assembly (the compressor) attached to the motor, the case, a switch, an electrical cord, and a printed circuit board. The circuit board makes the wiring more stable and organized, thus ensuring higher quality and safety.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1997
Bremed Italia c/o.Mr. Mark Hebenstreit 1337 Rockwood Forest Drive Arnold, Missouri 63010
K970542 Re : Master Neb II Requlatory Class: II (two) Product Code: 73 CAF Dated: May 15, 1997 Received: May 16, 1997
Dear Mr. Hebenstreit:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFK Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Mark Hebenstreit
This letter will allow you to begin marketing your device as described in your 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. " " war
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
510(k) Number: Pending
Device Name: Master Neb II
Indications for Use:
This product is an air compressor that when used in conjunction with a hand held nebulizer, produces the nebulization of a liquid prescribed medication. The compressor produces an air source that is channeled through tubing into the hand held nebulizer. The nebulizer creates an aerosol mist by forcing the compressed air through the nebulizer baffle. This creates negative pressure in which the liquid medication is vacuumed into the air, creating the aerosol mist.
This product contains the exact same technological characteristics of similar devices currently on the market. The product functions exactly as these similar devices.
The product is designed with similar performance characteristics as devices currently on the market. The performance of the device allows it to be used in conjunction with various hand held nebulizers that are currently in distribution in the United States and Europe.
The components found within this product are common items. The product consists of a thermally protected motor, a cylinder and piston assembly (the compressor) attached to the motor, the case, a switch, an electrical cord, and a printed circuit board. The circuit board makes the wiring more stable and organized, thus ensuring higher quality and safety.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use XXXXX
OR
Over-The-Counter
Richard N. Phillips
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number _