(115 days)
Not Found
No
The description details a mechanical nebulization process based on gas flow and particle physics, with no mention of AI or ML.
Yes
The device is used for the "treatment of respiratory and related diseases and conditions including, but not necessarily limited to asthma, COPD, bronchiolitis and cystic fibrosis." This indicates a therapeutic purpose.
No
Explanation: The device is described as a nebulizer used for administering medication to patients, which is a therapeutic function, not a diagnostic one. It doesn't mention any capability for identifying, monitoring, or predicting diseases.
No
The device description clearly describes a physical nebulizer that aerosolizes liquid medication using a gas source and baffles. This is a hardware device, not software.
Based on the provided text, the Neb-90™ Large Volume Medication Nebulizer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the administration of medication to a patient for the treatment of respiratory conditions. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device description explains how it aerosolizes liquid medication for inhalation. This process is about delivering a substance into the body, not analyzing a sample from the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly designed for drug delivery, which falls under the category of medical devices used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The Neb-90™ Large Volume Medication Nebulizer is indicated for the continuous aerosol administration of respiratory medication (inhalable solution) including, but not necessarily limited to, beta adrenergic bronchodilator (albuterol sulfate) and/or a wetting agent such as sodium chloride solution (saline) that is used for the treatment of respiratory and related diseases and conditions including, but not necessarily limited to asthma, COPD, bronchiolitis and cystic fibrosis.
The Neb-90™ Large Volume Medication Nebulizer is for use in hospital Emergency Department, ICU or other similar settings for delivery of aerosolized medication to patients undergoing severe respiratory distress.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The Nebulizer is a single patient/single use device which is filled with a fluid, typically respiratory medication and connected to a gas source via flexible tubing. The nebulizer works by Pavipng a cluid come into contact with the stream of gas. The gas shatters the liquid into small particles. These particles then impact a baffle that further reduces the size of the particles. The majority of the larger particles settle inside the nebulizer as a result of gravity and inertia, returning the mist to liquid to repeat the nebulization process. The smaller particles are then administered as the patient inhales. The treatment is completed when the majority of liquid has been nebulized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Neb-90™ Large Volume Medication Nebulizer is for use in hospital Emergency Department, ICU or other similar settings for delivery of aerosolized medication to patients undergoing severe respiratory distress.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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).
Not Found
§ 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
510(k) SUMMARY for
JUN 3 0 2008
Neb-90™ Large Volume Medication Nebulizer
1. SUBMITTER INFORMATION:
Medi/Nuclear Corporation, Inc. 4610 Littlejohn Street Baldwin Park, CA 91706-2267
| Establishment | |
|---|---|
| Registration Number: | 2050098 |
| Primary contact: | Jerry Schoen |
| Chief Operating Officer | |
| Medi/Nuclear & Healthline Medical | |
| Telephone Number: | (800) 321-5981 (corporate toll-free) |
| (626) 960-9822 (Los Angeles local) | |
| Fax: | (626) 960-8700 (corporate fax) |
| E-mail: | jschoen@medinuclear.com |
| Secondary contact: | Russell King |
| Owner/Chairman, Medi/Nuclear & Healthline Medical | |
| Telephone Number: | (800) 321-5981 (corporate toll-free) |
| (626) 960-9822 (Los Angeles local) | |
| Fax: | (626) 960-8700 (corporate fax) |
Note: Medi/Nuclear Corporation, Inc. markets the products it manufacturers to the nuclear medicine industry under its own name. However, it also markets some of the same products to the respiratory therapy industry under the name of its affiliate company, Healthline Medical. Both companies share the same building, facilities, staff and management team at the above-listed address. The Neb-90 will be private-labeled for Healthline Medical upon receipt of clearance to market.
2. DEVICE NAME:
| Classification Name: | Nebulizer (CAF), direct patient interface |
|---|---|
| Regulation: | 21CFR868.5630 |
| Proprietary Name: | Healthline Neb-90™ Large Volume Medication Nebulizer (LVN), Hereinafter referred to as "Neb-90" |
3. PREDICATE DEVICE:
Medi/Nuclear Neb-3A Patient Nebulizer (K915075) Smiths Medical - DHD Health Flo-Mist [B&B Medical Technologies Inc. Hope Nebulizer (K980407)
1
DESCRIPTION OF DEVICE:
The Nebulizer is a single patient/single use device which is filled with a fluid, typically respiratory medication and connected to a gas source via flexible tubing. The nebulizer works by Pavipng a cluid come into contact with the stream of gas. The gas shatters the liquid into small particles. These particles then impact a baffle that further reduces the size of the particles. The majority of the larger particles settle inside the nebulizer as a result of gravity and inertia, returning the mist to liquid to repeat the nebulization process. The smaller particles are then administered as the patient inhales. The treatment is completed when the majority of liquid has been nebulized.
General Questions & Answers
Specific issues, as mentioned in "CDRH Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators; October 1, 1993" are addressed herewith:
| Question | Yes | No | |
|---|---|---|---|
| 1 | Is the device life-supporting or life-sustaining? | X | |
| 2 | Is the device an implant (short-term or long-term)? | X | |
| 3 | Is the device sterile? | X | |
| 4 | Is the device for single use? | X | |
| 5 | Is the device prescription use? | X | |
| 6 | Is the device for home use or portable? | X | |
| 7 | Does the device contain a drug or biological product as a component? | X | |
| 8 | Is this device a kit? * | X | |
| 9 | Is the device software-driven? | X | |
| 10 | Is the device electrically operated? | X | |
| 11 | Are there applicable standards for this device to which conformance has been | ||
| demonstrated in addition to those already mentioned (e.g., IEC, ANSF, ASTM, | |||
| etc)? | X |
*The Neb-90™ in of itself is not a kit; however it will be marketed as a component of a kit, ARK-1, LG-ARK-1, ARK-5, LG-ARK-5, AM-690A and AM-690P.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2008
Mr. Michael McPeck Director, Aerosol Medicine Medi/Nuclear Corporation, Incorporated 4610 Littlejohn Street Baldwin Park, California 91706
Re: K080657
Trade/Device Name: Neb-90TM Large Volume Medication Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: June 19, 2008 Received: June 23, 2008
Dear Mr. McPeck:
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.
3
Page 2 - Mr. McPeck
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 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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours.
Clare
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
4
Medi/Nuclear Corporation, Inc. 4610 Littlejohn Street Baldwin Park, CA 91706-2267
Indications for Use Statement
510(k) Number K080657
Neb-90™ Large Volume Medication Nebulizer Device Name:
Indications for Use:
The Neb-90™ Large Volume Medication Nebulizer is indicated for the continuous aerosol administration of respiratory medication (inhalable solution) including, but not necessarily limited to, beta adrenergic bronchodilator (albuterol sulfate) and/or a wetting agent such as sodium chloride solution (saline) that is used for the treatment of respiratory and related diseases and conditions including, but not necessarily limited to asthma, COPD, bronchiolitis and cystic fibrosis.
The Neb-90™ Large Volume Medication Nebulizer is for use in hospital Emergency Department, ICU or other similar settings for delivery of aerosolized medication to patients undergoing severe respiratory distress.
Concurrence of CDRH, Office of Device Evaluation (ODE):
Prescription Use X Over-The-Counter Use
Prescription Use __
Min-Xh
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Amol, Dental Devices
-10(k) Number: K0840657
Page 2 of 39 Neb-90 Submission
OR