(112 days)
Not Found
No
The device description and performance studies focus on physical characteristics and aerosol delivery metrics, with no mention of AI or ML.
Yes
The device is indicated to aerosolize medication to or through the patient's pulmonary system, which points to a therapeutic use of delivering medication for treatment.
No
The device is described as a nebulizer used to aerosolize medication for delivery to the pulmonary system, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "miniaturized jet nebulizer" fabricated of "polymers," indicating it is a physical hardware device used to aerosolize medication.
Based on the provided information, the Healthline RediNeb® Small Volume Medication Nebulizer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aerosolize medication approved for nebulization by a physician" and deliver it to the patient's pulmonary system. This is a therapeutic delivery device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on its function as a miniaturized jet nebulizer for delivering medication.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is clearly intended for the administration of medication to a patient, which falls under the category of therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Healthline RediNeb® Small Volume Medication Nebulizer (SVN) is indicated to aerosolize medication approved for nebulization by a physician. The Healthline RediNeb® Medication Nebulizer is intended for adult and pediatric patients consistent with the indications for aerosolized medication to or through the patient's pulmonary system.
The RediNeb® Nebulizer device is for patient use in all areas where the administration of medication by aerosol means is warranted. This includes hospital/institutional settings, home care use, schools and long term care facilities.
Product codes
CAF
Device Description
The RediNeb® is basically a miniaturized jet nebulizer, functioning very similarly to both of the predicate devices. Physical differences are that the maximum fill volume is 3 ml versus 6ml and design is such that the RediNeb® can be incorporated with breath enhanced features of a manifold delivery body. The RediNeb® nebulizer, though very small in size (creating minimal waste if used once and discarded), is fabricated of polymers such that it may be properly cleaned for reuse multiple times.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's pulmonary system
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
patient use in all areas where the administration of medication by aerosol means is warranted. This includes hospital/institutional settings, home care use, schools and long term care facilities.
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)
| Feature / Specification | Predicate | ||
|---|---|---|---|
| Salter NebuTech | Medi/Nuclear Neb-3A SVN | Healthline RediNeb® | |
| Particle Size (MMAD) | 1.0 to 1.1 μm | 0.8 to 1.2 μm | 0.8 to 1.1 μm |
| Aerosol Generation Rate (AGR) | 0.4 ml/min | 0.3 ml/min | 0.33 ml/min |
| Load Volume | .75 ml | .75 ml | .5 ml |
| tive Gas Flow rate | 6-8 LPM Air or Oxygen | 6-8 LPM Air or Oxygen | 6-8 LPM Air or Oxygen |
| ended Use | Same | Same | Same |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
page 1 of 2
510(k) Premarket Notification (K080969) 010(k) 1 Temailto: Notines Small Volume Medication Nebulizer
510(k) SUMMARY For
RediNeb® Small Volume Medication Nebulizer
JUL 2 5 2008
SUBMITTER INFORMATION: 1.
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 RedNeb® will be private-labeled for Healthline Medical upon receipt of clearance to market.
ri DEVICE NAME:
| Classification Name: | Nebulizer (CAF), direct patient interface |
|---|---|
| Regulation: | 21CFR868.5630 |
| Proprietary Name: | Healthline RediNeb Small Volume Medication Nebulizer (SVN), Hereinafter referred to as "RediNeb®" |
3. PREDICATE DEVICE:
We hereby designate the Medi/Nuclear Neb-3A Patient Nebulizer (K915075) and Salter Labs Model 8660 NebuTech HDN Nebulizer (K962879) as predicate devices for the RediNeb® medication Nebulizer. Medi/Nuclear will manufacture the RediNeb® for its affiliate company, Healthline Medical, and the RediNeb® will carry the Healthline brand name.
1
k) Premarket Notification (K080969) edi/Nuclear RediNeb® Small Volume Medication Nebulizer
DESCRIPTION OF DEVICE: 4.
The RediNeb® is basically a miniaturized jet nebulizer, functioning very similarly to both of the predicate devices. Physical differences are that the maximum fill volume is 3 ml versus 6ml and design is such that the RediNeb® can be incorporated with breath enhanced features of a manifold delivery body. The RediNeb® nebulizer, though very small in size (creating minimal waste if used once and discarded), is fabricated of polymers such that it may be properly cleaned for reuse multiple times.
5. INDICATIONS for USE:
The Healthline RediNet® Small Volume Medication Nebulizer (SVN) is indicated to aerosolize medication approved for nebulization by a physician. The Healthline RediNeb® Medication Nebulizer is intended for adult and pediatric patients consistent with the indications for aerosolized medication to or through the patient's pulmonary system.
The RediNeb® Nebulizer device is for patient use in all areas where the administration of medication by aerosol means is warranted. This includes hospital/institutional settings, home care use, schools and long term care facilities.
SUBSTANTIAL EQUIVALENCE: 6.
The Healthine RediNeb® Medication Nebulizer is substantially equivalent to the Medi/Nuclear NEB-3A and the Salter Labs Model 8660 NebuTech HDN nebulizer devices.
TECHNOLOGICAL CHARACTERISTICS: 7.
The Healthline RediNeb Medication Nebulizer operates with the same technology as the predicate devices. It is a jet nebulizer driven by air or oxygen. The basic technology of design is that the drive gas passes through the nebulizer's jet. The jet is covered by the venturi tube. The venturi tube is in close proximity to the jet causing a vacuum as the drive gas passes through the venturi tube which in turn causes the liquid to be drawn from the cup. As the liquid is drawn up, it is aerosolized as the liquid is accelerated by the drive gas. The aerosolized medication is then made available to the patient through a delivery device for inhalation.
SUMMARY OF TESTING: 8.
| Feature / Specification | Predicate | ||
|---|---|---|---|
| Salter NebuTech | Medi/Nuclear | ||
| Neb-3A SVN | Healthline | ||
| RediNeb® | |||
| Particle Size (MMAD) | 1.0 to 1.1 μm | 0.8 to 1.2 μm | 0.8 to 1.1 μm |
| Aerosol Generation Rate (AGR) | 0.4 ml/min | 0.3 ml/min | 0.33 ml/min |
| Load Volume | .75 ml | .75 ml | .5 ml |
| tive Gas Flow rate | 6-8 LPM Air or Oxygen | 6-8 LPM Air or Oxygen | 6-8 LPM Air or Oxygen |
| ended Use | Same | Same | Same |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design resembling an abstract caduceus or a symbol representing health and human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2008
Mr. Jerry Schoen Chief Operating Officer Medi/Nuclear Corporation 4610 Littlejohn Street Baldwin Park, California 91706
Re: K080969
Trade/Device Name: RediNeb Small Volume Medication Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: July 22, 2008 Received: July 24, 2008
Dear Mr. Schoen:
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. Schoen
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
VKLnmnelsfend, and for //
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
Premarket Notification (K080969) clear RediNeb® Small Volume Medication Nebulizer
Medi/Nuclear Corporation, Inc. Healthline Medical, Inc. 4610 Littlejohn Street Baldwin Park, CA 91706-2267
Indications for Use Statement
510(k) Number K080969
Device Name: RediNeb® Small Volume Medication Nebulizer
Indications for Use:
The Healthline RediNeb® Small Volume Medication Nebulizer (SVN) is indicated to aerosolize medication approved for nebulization by a physician. The Healthline RediNeb® Medication Nebulizer is intended for adult and pediatric patients consistent with the indications for aerosolized medication to or through the patient's pulmonary system.
The RediNeb® Nebulizer device is for patient use in all areas where the administration of medication by aerosol means is warranted. This includes hospital/institutional settings, home care use, schools and long term care facilities.
V. Kormuller Ludmer // for CL.
(Division Sign-O Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K080969
Concurrence of CDRH, Office of Device Evaluation (ODE):
Prescription Use
OR
Over-The-Counter Use
Page 2 of 11 RediNeb® Submission