(123 days)
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).
Not Found
The provided text is a 510(k) premarket notification approval letter for a medical device (air compressor for use with a nebulizer). It does not contain information about acceptance criteria for a study, reported device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, or any comparative effectiveness studies.
The document primarily focuses on:
- Device Name: Schuco Mist and Schuco Deluxe Mist (Trade/Device Name), and AIR COMPRESSOR FOR USE WITH A NEBULIZER (Indicated Device Name).
- Regulation Number: 21 CFR 868.5630 (Nebulizer).
- Regulatory Class: II.
- FDA's finding: Substantial equivalence to legally marketed predicate devices.
- 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 an operating temperature 10 C to 40 C ( 50 F to 104 F)."
- Prescription Use: Yes.
To answer your specific questions, information about acceptance criteria, study details, and data specifics would need to be found in a separate performance study report or clinical trial documentation, which is not part of this 510(k) approval letter. The document only lists the technical specifications the device has (flowrate, pressure, temperatures) as part of its Indications for Use, but these are not presented as "acceptance criteria" against which a study's results are compared in this text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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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§ 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).