(131 days)
Not Found
No
The device description and other sections do not mention any AI or ML components or capabilities. The device is a mechanical system for delivering gases and medications.
Yes
The device is intended for the delivery of oxygen or Heliox gas mixtures in combination with aerosolized medications, indicating a therapeutic purpose.
No
The device is intended for the delivery of high concentrations of oxygen or Heliox gas mixtures in combination with aerosolized medications and diagnostic formulations, and for drug administration. This indicates a therapeutic or delivery function, not a diagnostic one.
No
The device description clearly outlines multiple physical components including a mask, wye adaptor, reservoir bag, nebulizer, and tubing, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of gases and aerosolized medications. This is a therapeutic and drug delivery function, not a diagnostic one.
- Device Description: The description details a system for delivering gases and nebulized substances to a patient's respiratory system. It does not describe any components or processes for analyzing biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
- Predicate Devices: The listed predicate devices are all nebulizers, which are devices used for drug delivery, not in vitro diagnostics.
In vitro diagnostics are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on delivering substances into the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
For the delivery of high concentrations of oxygen or Heliox gas mixtures in combination with aerosolized medications and diagnostic formulations. This device has not been tested for use with Pentamidin or the combination of Heliox and metered dose inhaler.
Product codes
CAF
Device Description
The Neb-U-Mask® System is intended to be with oxygen-helium (Heliox) mixtures that include a non-rebreathing mask connected to a wye adaptor featuring a valved port. This valve allows a small volume nebulizer to be connected / disconnected to the wye adapter for drug administration without interrupting primary medical gas flow to patient. Attached to the adaptor is a reservoir bag and a nebulizer, both linked to the gas sources with delivery tubing allowing clinicians to independently control the flow to each side. The Neb-U-Mask® System is comprised of:
- Non-rebreathing oxygen mask (several sizes)
- Wyc is valved, .
- o contains an MDI port,
- connectors for nebulizer and reservoir, and 0
- o inlet port for Heliox mixture
- . Delivery tubing
- Heliox / Oxygen to nebulizer
- Heliox / oxygen to ported wye
- . Small volume nebulizer
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
Adult and pediatric
Intended User / Care Setting
To be used under medical supervision in hospitals, pre-hospital (EMS), nursing homes, extended care facilities and outpatient clinics
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)
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
Premarket Notification 510(k) Section 5 - 510(k) Summary
ﺗ
। महें
ुंह
Non-Confidential Summary of Safety and Effectiveness Page 1 of 2 29-Jan-08
| Teleflex Medical, Inc.
2917 Weck Drive
Research Triangle Park, NC 27709 | Tel - (919) 433-4829
Fax - (919) 433-4989 | JUN - 9 2008 |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Official Contact: | Michael Crader, VP Global RA/QA | |
| Proprietary or Trade Name: | Neb-U-Mask® System | |
| Common/Usual Name: | Nebulizer | |
| Classification Name: | Nebulizer (direct patient interference)
CAF -- 868.5630 | |
| Predicate Devices: | B&B Technology - Hope nebulizer - K980407
DHD Healthcare - Trust nebulizer - K040718
Teleflex Medical / Hudson RCI - Micro Mist Nebulizer
- K930525 | |
Device Description:
The Neb-U-Mask® System is intended to be with oxygen-helium (Heliox) mixtures that include a non-rebreathing mask connected to a wye adaptor featuring a valved port. This valve allows a small volume nebulizer to be connected / disconnected to the wye adapter for drug administration without interrupting primary medical gas flow to patient. Attached to the adaptor is a reservoir bag and a nebulizer, both linked to the gas sources with delivery tubing allowing clinicians to independently control the flow to each side. The Neb-U-Mask® System is comprised of:
- Non-rebreathing oxygen mask (several sizes) �
- Wyc is valved, .
- o contains an MDI port,
- connectors for nebulizer and reservoir, and 0
None
- o inlet port for Heliox mixture
- . Delivery tubing
- Heliox / Oxygen to nebulizer ం
- Heliox / oxygen to ported wye o
- . Small volume nebulizer
| Indications for Use: | For the delivery of high concentrations of oxygen or Heliox gas
mixtures in combination with aerosolized medications and diagnostic
formulations. This device has not been tested for use with Pentamidin
or the combination of Heliox and metered dose inhaler. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population: | Adult and pediatric |
| Environment of Use: | To be used under medical supervision in hospitals, pre-hospital (EMS),
nursing homes, extended care facilities and outpatient clinics |
Contraindications:
1
| Premarket Notification 510(k)
Section 5 - 510(k) Summary | Neb-U-Mask® System
Non-Confidential Summary of Safety and Effectiveness
Page 2 of 2
29-Jan-08 | | | | Formatted: Top: 78 pt |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------|
| Attribute | Proposed
Neb-U-Mask® System | Teleflex Medical/
Hudson RCI
nebulizer
K930525
Used as a nebulizer | B&B Hope
K980407 | DHD Trust
K040718 | |
| Indications for Use
(all are not for use with
pentamidine) | For the delivery of high concentrations of
oxygen or Heliox gas mixtures in
combination with aerosolized medications.
This device has not been tested for use with
Pentamidine or the combination of Heliox
and metered dose inhaler.
Indication for high concentrations of oxygen
via a non-rebreather mask is an exempt
indication | | High output nebulizer to
be used to deliver
aerosolized medications
and diagnostic formulas. | Uses as a nebulizer
aerosolized medications
and diagnostic
formulations | |
| Used with Heliox
80/20 and 70/30 mixtures | Yes | No | Yes | Yes | |
| Environments of use home care,
nursing home, sub-acute institutions
or hospitals, pre-hospital (EMS) | Yes | Yes | Yes | Yes | |
| Patient population | Pediatric
Adult | Not listed | Asthma, pneumonia,
COPD and general
conditions | Asthma, pneumonia,
COPD and general
conditions | |
| Nebulizer technology | Jet nebulizer | Jet nebulizer | Jet nebulizer | Jet nebulizer | |
| Single patient, disposable | Yes | Yes | Yes | Yes | |
| Operational Flow Rates | Standard oxygen 8 Lpm
Heliox up to 12 Lpm | Standard oxygen
8 Lpm | Not listed | Not listed | |
| Used with face mask | Yes | Yes | Yes | Yes | |
| Materials Common materials in
contact with gas and fluid pathway | Yes | Yes | N/A | N/A | |
| Particle size characterization via
Cascade Impactor | Yes | Yes | N/A | N/A | |
| Differences Between Other Legally Marketed Predicate Devices:
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices. | | | | | |
| Page 5.2 | | | | | |
ాలు విద్యాల
i ::
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 image of an eagle, with its wings forming three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Teleflex Medical, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958
Re: K080230
Trade/Device Name: Neb-U-Mask® System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: June 2, 2008 Received: June 3, 2008
Dear Mr. Dryden:
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.
JUN - 9 2008
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. Dryden
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
Indications for Use Statement
Page 1 of 1
510(k) Number:
Device Name:
ి ప్రాథమైన భూమి: 100
:"你" 我:!吧"
(To be assigned)
Neb-U-Mask® System
Indications for Use:
For the delivery of high concentrations of oxygen or Heliox gas mixtures in combination with aerosolized medications and diagnostic formulations. This device has not been tested for use with Pentamidine or the combination of Heliox and metered dose inhaler.
Patients include pediatric and adult.
Environment of Use:
To be used under medical supervision in hospitals, pre-hospital (EMS), nursing homes, extended care facilities and outpatient clinics.
Prescription Use XX (Part 21 CFR 801 Subpart D) 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)
Mis Vhnd
(Division Sign-Off) Division of Anesthesiology, General Hospltal Infection Control, Dental Devices
510(k) Number: