(456 days)
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Not Found
No
The provided text describes a nebulizer device and its intended use, with no mention of AI or ML capabilities.
Yes
The device is described as delivering "aerosolized medications" for conditions like "Asthma, Pneumonia, COPD," indicating its role in treating medical conditions.
No
The device is described as a nebulizer used to deliver aerosolized medications, which is a treatment function, not a diagnostic one.
No
The device description clearly states "Nebulizer (Direct Patient Interface)", which is a hardware device used to deliver aerosolized medications. The intended use also describes the need for a "45-55 psig source gas of Oxygen or Air" and in the case of Omni~Max™, "10 liters/minute of 80/20 Heliox is added via auxiliary gas port," further indicating a physical device with gas inputs.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Omni
Neb™ and OmniMax™ are nebulizers. Nebulizers are devices that convert liquid medication into a fine mist that can be inhaled by the patient. - Intended Use: The intended use is to deliver aerosolized medications directly to the patient for respiratory conditions. This is a therapeutic function, not a diagnostic one.
- Lack of Diagnostic Testing: There is no mention of the device performing any tests on patient samples or providing diagnostic information.
Therefore, the OmniNeb™ and OmniMax™ are therapeutic medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Omni~Neb™
This device is to be used under medical supervision in hospitals, nursing homes, extended care facilities and outpatient clinics. The Omni~Neb™ INebulizer is a low flow continuous nebulizer to be used to deliver aerosolized medications for up to four hours via direct patient interface on spontaneous breathing patients. Patient population: Asthma, Pneumonia. COPD. or any other conditions in which sympathomimetic ammines, parasympathetic ammines, Steroids, or other appropriate medications would be aerosolized. The Omni-Neb™ requires 45-55 psig source gas of Oxygen or Air.
Omni~Max™
This device is to be used under medical supervision in hospitals. The Omni~Max™ Nebulizer is to be used to deliver aerosolized medications in conjunction with Heliox therapy to sponfaneous breathing patients. Patient population: Asthma, Pneumonia, COPD, or any other condition in which sympathomimetic ammines, parasympathetic ammines, Steroids, or other appropriate medications would be aerosolized, and adjunctive Heliox would be beneficial. The Omni-Max® requires 45-55 psig of Oxygen source gas. 10 liters/minute of 80/20 Heliox is added via auxiliary gas port.
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
Omni~Neb™
medical supervision in hospitals, nursing homes, extended care facilities and outpatient clinics.
Omni~Max™
medical supervision in hospitals.
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its body, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY = 7 2004
Mr. Stephen W. Briggs III, R.R.T. RCP President B & B Medical Technologies, Incorporated 6731 32nd Street, Suite B North Highlands, California 95660
Re: K030396
Trade Name: OmniNeb™ and OmniMax™ Nebulizers Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: II Product Code: CAF Dated: April 8, 2004 Received: April 12, 2004
Dear Mr. Briggs:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
1
Page 2 - Mr. Stephen W. Briggs III, R.R.T. RCP
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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/dsma/dsmamain.html.
Sincerely yours,
Cures
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
Indications for Use
510(k) Number (if known): KO30396
Device Name: Omni-Neb and Omni-Max
Indications For Use:
Omni~Neb™
This device is to be used under medical supervision in hospitals, nursing homes, extended care facilities and outpatient clinics. The Omni~Neb™ INebulizer is a low flow continuous nebulizer to be used to deliver aerosolized medications for up to four hours via direct patient interface on spontaneous breathing patients. Patient population: Asthma, Pneumonia. COPD. or any other conditions in which sympathomimetic ammines, parasympathetic ammines, Steroids, or other appropriate medications would be aerosolized. The Omni-Neb™ requires 45-55 psig source gas of Oxygen or Air.
Omni~Max™
This device is to be used under medical supervision in hospitals. The Omni~Max™ Nebulizer is to be used to deliver aerosolized medications in conjunction with Heliox therapy to sponfaneous breathing patients. Patient population: Asthma, Pneumonia, COPD, or any other condition in which sympathomimetic ammines, parasympathetic ammines, Steroids, or other appropriate medications would be aerosolized, and adjunctive Heliox would be beneficial. The Omni-Max® requires 45-55 psig of Oxygen source gas. 10 liters/minute of 80/20 Heliox is added via auxiliary gas port.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Auy Sulion
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(Division Sian-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devic
510(k) Number: K030346