(90 days)
This product is an ultrasonic nebulizer that is used to provide acrosolized broncho dialator medication to persons with asthma and emphysema. The device creates acrosolized particles of the prescribed medication via ultrasound that is forced via a vacuum or draw into disposable tubing. The aerosolized medication travels up the lubing and into either a nasal or oral mask. The patient then inhales the medication as per his/her physician's orders.
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 nasal and oral masks 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, simplistic circuit board, a piczcoelectric ceramic, a medicine cup, an ABS plastic case, a switch, an electrical cord.
This is a 510(k) premarket notification for a medical device called ULTRANEB ULTRASONIC, an ultrasonic nebulizer. The provided documents are primarily an FDA clearance letter and an "Indications for Use Statement." These documents do not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that "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 nasal and oral masks that are currently in distribution in the United States and Europe." However, it does not detail specific quantitative acceptance criteria (e.g., aerosol particle size, nebulization rate) or the reported performance data against those criteria. This information would typically be in a more comprehensive testing report or a summary thereof, which is not included here.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. The documents do not describe any specific test set or clinical study conducted for this 510(k) submission, nor do they specify sample sizes or data provenance. The 510(k) process for this device appears to rely on substantial equivalence to existing devices rather than new clinical trials demonstrating performance against specific criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable / Cannot be provided. Since no specific test set or clinical study with ground truth establishment is described in these documents, this information is not available.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Cannot be provided. As no test set with expert adjudication is described, this information is not available.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an ultrasonic nebulizer, not an AI-assisted diagnostic or imaging device used by human "readers." Therefore, an MRMC study or AI assistance is not relevant to its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical nebulizer; there is no "algorithm" in the sense of AI or image processing that would have standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Cannot be provided. As no specific data or ground truth establishment is described, this information is not available. The submission likely relied on engineering and performance data to demonstrate equivalence, not clinical ground truth in the context of diagnostic accuracy.
8. The sample size for the training set
- Not applicable / Cannot be provided. This device is not an AI/ML-based device that would require a training set.
9. How the ground truth for the training set was established
- Not applicable / Cannot be provided. This device is not an AI/ML-based device that would require a training set.
Summary of available information:
The provided documents indicate that the ULTRANEB ULTRASONIC device received 510(k) clearance from the FDA based on its substantial equivalence to devices already marketed in interstate commerce.
- Device Description: An ultrasonic nebulizer that creates aerosolized particles of prescribed bronchodilator medication (for asthma and emphysema) via ultrasound, forced through disposable tubing into a nasal or oral mask for patient inhalation.
- Technological Characteristics: The manufacturer states that the product "contains the exact same technological characteristics of similar devices currently on the market" and "functions exactly as these similar devices."
- Performance Characteristics: The product "is designed with similar performance characteristics as devices currently on the market" and its "performance... allows it to be used in conjunction with various nasal and oral masks that are currently in distribution in the United States and Europe."
- Components: Described as "common items" including a thermally protected circuit board, a piezoelectric ceramic, a medicine cup, an ABS plastic case, a switch, and an electrical cord.
The FDA's finding of substantial equivalence means that the device is as safe and effective as a legally marketed predicate device, typically without requiring new clinical trials or detailed performance studies in the same way a novel device might. The "performance characteristics" and "technological characteristics" being "similar" to predicate devices served as the basis for clearance, but the specific metrics used for this comparison are not elaborated in these documents.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1998
Bremed Italia, S.R.L. c/o Mr. Mark Hebensteit Consultant 1337 Rockwood Forest Drive Arnold, MO 63010
Re : K974379 ULTRANEB Regulatory Class: II (Two) Product Code: 73 CAF Dated: October 24, 1997 Received: November 20, 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 reqistration, 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 - 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.
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 requlation 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.qov/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
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INDICATIONS FOR USE STATEMENT
510(k) Number: Pending K4743 79
Device Name: ULTRANEB ULTRASONIC Indications for Use:
This product is an ultrasonic nebulizer that is used to provide acrosolized broncho dialator medication to persons with asthma and emphysema. The device creates acrosolized particles of the prescribed medication via ultrasound that is forced via a vacuum or draw into disposable tubing. The aerosolized medication travels up the lubing and into either a nasal or oral mask. The patient then inhales the medication as per his/her physician's orders.
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 nasal and oral masks 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, simplistic circuit board, a piczcoelectric ceramic, a medicine cup, an ABS plastic case, a switch, an electrical cord.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use XXXXX 1
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Over-The-Counter
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number__ K474379
§ 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).