(123 days)
Not Found
Not Found
No
The summary describes a simple air compressor with physical specifications, with no mention of AI, ML, or related concepts.
No
The device provides compressed air to a nebulizer, which then delivers medication. The air compressor itself does not directly treat a condition; it is an accessory to a therapeutic device (the nebulizer).
No
Explanation: The device is an air compressor intended to provide compressed air to nebulizer medication cups. It delivers therapy (compressed air for medication delivery), not diagnosis.
No
The device description explicitly states it is an "air compressor," which is a hardware component, not software.
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 air compressor for use with a nebulizer to provide compressed air to medication cups and delivery systems. This describes a device used to deliver medication to a patient, not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Lack of IVD Characteristics: The description 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 those samples
- Providing diagnostic information
- Mentioning reagents, calibrators, or controls
The device is a piece of equipment used in the delivery of a therapeutic treatment (nebulized medication), not a diagnostic test.
N/A
Intended Use / Indications for Use
The air compressor for use with a nebulizer is a device intended to provide a source of compressed air to nebulizer medication cups and delivery systems. These air compressors have a flowrate of 11 +/- 2 LPM, minimum pressure of 35 psi, a storage temperature of 5 C to 50 C (41F to 122F) and a operating temperature 10 C to 40 C ( 50 F to 104 F).
Product codes
CAF
Device Description
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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.)
Not Found
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.
Not Found
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.
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).
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 2005
Mr. Wayne Karcher Regulatory Affairs Coordinator Allied Healthcare Products, Inc. 1720 Sublette Avenue St. Louis, Missouri 63110
Re: K051260
Trade/Device Name: Schuco Mist and Schuco Deluxe Mist Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: September 2, 2005 Received: September 2, 2005
Dear Mr. Karcher:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enoroute) to regard cate of the Medical Device Amendments, or to commerce provide to they 2017 ?)
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 I ou may, therefore, mailer and act include requirements for annual registration, listing of general controls provision 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 If your device is classified (soonal controls. Existing major regulations affecting your device can may be subject to sacer access Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Karcher
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dri bridge over device complies with other requirements of the Act that FDA has made a decormination in administered by other Federal agencies. You must of any Federal statutes and regulations and assisted to: registration and listing (21 comply with an the Aot 8 requirements)01); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Setting your device as described in your Section 510(k) This iciter will anow you'll ought mains of substantial equivalence of your device to a legally premarket notincation. The PDF mailing sir cation 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), please If you desire specific acries ion your and (240) 276-0120. Also, please note the regulation entitled, Colliati the Office of Come of Come of Colling to the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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/industry/support/index.html.
Sincerely yours,
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
2
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FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH
Indications for Use
510(k) Number (if known): _ K O 5 | 2 60
Device Name: AIR COMPRESSOR FOR USE WITH A NEBULIZER
Indications for Use:
The air compressor for use with a nebulizer is a device intended to provide a source of compressed air to nebulizer medication cups and delivery systems. These air compressors have a flowrate of 11 +/- 2 LPM, minimum pressure of 35 psi, a storage temperature of 5 C to 50 C (41F to 122F) and a operating temperature 10 C to 40 C ( 50 F to 104 F).
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Prescription Use Same (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, Infection Control, Dental Devices | Concurrence of CDRH, Office of Device Evaluation (ODE) |
| 510(k) Number: | K051260 |
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