(251 days)
The ATOMISOR AL + NL9 NEBULIZER is an aerosol generator for the delivery of aerosol to the airways. Because they have been designed to be operated together, the ATOMISOR NL9 nebulizer and the ATOMISOR AL compressor should never be used separately.
The ATOMISOR AL is a small and easy to use portable compressor for jet nebulizer aerosol generator. The pump inside is a diaphragm pump and the casing of the compressor is made of metal with a plastic carrying handle on top. In order to ease its' transportation, in case of rental for example, the ATOMISOR AL can be sold with a PVC carrying case in which both the compressor and the nebulizer can be placed. When used, the compressor is removed from the carrying-case.
The provided information describes a Premarket Notification [510(k)] for the ATOMISOR AL + NL9 NEBULIZER. This is a submission to demonstrate substantial equivalence to a predicate device, not a study performing a rigorous evaluation against acceptance criteria as outlined in your request for new medical imaging AI/ML devices.
Therefore, this document does not contain the information needed to answer your questions regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
Instead, the provided text focuses on the device's description, intended use, and a comparison of its physical and performance specifications (e.g., size, weight, nebulization rate, particle size) to a legally marketed predicate device (PRONEB). The "study" mentioned is implicitly the comparison of these specifications to determine "substantial equivalence" for a nebulizer, which is a mechanical device, not an AI/ML diagnostic.
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2. Premarket Notification [510(k)] Summary
Date of application : Feb-28-1997
NOV 1 3 1997
Applicant and manufacturer : LA DIFFUSION TECHNIQUE FRANCAISE 114/120 Rue Bergson, B.P. 132 42003 SAINT ETIENNE Cedex 1 FRANCE
Michel MASSARDIER, General Manager. Contact person :
Telephone : (33) 4.77.74.51.11 Fax : (33) 4.77.79.67.72
Device trade name : ATOMISOR
Reference :
AL with NL9 Nebulizer
Device common or usual name or classification :
Intended use :
Delivery of aerosol to the airways
AEROSOL GENERATOR
Marketed device to which equivalence is claimed : PRONEB (Pariboy)
The ATOMISOR AL is a small and easy to use portable compressor for jet nebulizer aerosol generator. The pump inside is a diaphragm pump and the casing of the compressor is made of metal with a plastic carrying handle on top. In order to ease its' transportation, in case of rental for example, the ATOMISOR AL can be sold with a PVC carrying case in which both the compressor and the nebulizer can be placed. When used, the compressor is removed from the carrying-case.
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| COMPRESSORS | PRONEB | ATOMISOR AL |
|---|---|---|
| Size | 3 ¼" x 6 ½" x 8 ¼" | 8.2" x 5.5" x 6.6" |
| Weight | 4.2 pounds | 9.7 pounds |
| Sound level | 49 decibels | 65 decibels |
| Electrical Requirements | 120 V AC, 0.8 A, 60 Hz | 110 V AC, 0.55 A, 60 Hz |
| Ambient Temperature Range | 10 °C-40 °C -(50 ° F-104 °F) | 10°C- 40° C (50° F - 104° F) |
| Power Wattage | 45 W (96 VA) | 60 VA |
| Safety systems | Thermal protection against overheating | Not necessary |
| Replaceable, External Fuses | NO | YES |
| Compressor | Diaphragm type, oil free | Diaphragm type, oil free |
| Replaceable, External filter | Cellulose | N/A |
| NEBULIZERS | PARI LC | ATOMISOR NL9 |
| Average Nebulization Time | 5.5 - 7 minutes | 10 minutes |
| Nebulizer Output Rate | 0.32 ml/minute | 0.2 ml/minute |
| M.M.A.D. | 4.0 microns | 1.8 microns |
| Particle Size Range | 0.5 - 5 microns | 80% between 0.5 and 5.5 microns |
| Nebulizer Type | Reusable | Reusable |
| Cleaning | Handwash, dishwasher | Handwash, boiling water, dishwasher |
| Autoclave | Autoclave at 277°F, 10 minutes | Autoclave at 277°F |
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이 대한민국 대학교 문학교
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Image /page/2/Picture/10 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three figures in profile, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 1997
LA Diffusion Technique Francaise c/o Ms. Cheryl Ward Medical Consulting Service, Inc. P.O. Box 162283 Altamonte Springs, Florida 32716-2283
Re: K970844 Atomisor Regulatory Class: II (two) Product Code: 73 CAF February 28, 1997 Dated: Received: March 7, 1997
Dear Ms. Ward:
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, Drug, 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, qood 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 regulation (21 CFR 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.
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Page 2 - Ms. Cheryl Ward
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.
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. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) : _
Device Name : ATOMISOR AL + NL9 NEBULIZER
Indications For Use :
The ATOMISOR AL + NL9 NEBULIZER is an aerosol generator for the delivery of aerosol to the airways. Because they have been designed to be operated together, the ATOMISOR NL9 nebulizer and the ATOMISOR AL compressor should never be used separately.
Caution : Federal law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AA. Ciorlowski.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_
Prescription Use
(Per 21 CFR 801.109)
OR
Over the Counter Use ________
§ 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).