(131 days)
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.
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 o
- . Small volume nebulizer
Here's an analysis of the provided 510(k) summary regarding the Neb-U-Mask® System, focusing on acceptance criteria and supporting studies, based only on the provided text.
Important Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed clinical study results in the way one might find for a novel device requiring a PMA. Therefore, some of the requested information (like specific performance metrics from a dedicated study, sample sizes for test/training sets, expert qualifications, and MRMC study details) is not present in this type of document. The acceptance criteria here are primarily based on equivalence to predicate devices and general performance characteristics of nebulizers.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Neb-U-Mask® System are primarily established through direct comparison to legally marketed predicate devices, demonstrating substantial equivalence in function, indications for use, and basic operational characteristics. The performance is "reported" implicitly by stating "Yes" for attributes that match the predicate devices or are considered standard for this device type.
| Acceptance Criteria (Based on Predicate Device Equivalence & Device Type Standards) | Reported Device Performance (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. Indication for high concentrations of oxygen via a non-rebreather mask is an exempt indication." |
| Compatibility with Heliox (80/20 and 70/30 mixtures): | Yes |
| Environments of Use: Home care, nursing home, sub-acute, hospitals, pre-hospital (EMS) | Yes |
| Patient Population: Pediatric, Adult | Yes |
| Nebulizer Technology: Jet nebulizer | Jet nebulizer |
| Usage: Single patient, disposable | Yes |
| Operational Flow Rates: Standard Oxygen 8 Lpm | Standard oxygen 8 Lpm |
| Operational Flow Rates: Heliox up to 12 Lpm | Heliox up to 12 Lpm |
| Used with face mask: | Yes |
| Materials Common to Gas and Fluid Pathway: | Yes |
| Particle Size Characterization via Cascade Impactor: | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a separate "test set" in the context of a clinical study with a specific sample size. The primary method of demonstrating performance is through comparison to existing predicate devices. The data provenance is implicitly from the characteristics of these predicate devices and general industry standards for nebulizers. It does not specify country of origin or whether "testing" was retrospective or prospective in the clinical study sense. The document refers to "This device has not been tested for use with Pentamidine or the combination of Heliox and metered dose inhaler," which suggests some elements were tested, but details are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. The "ground truth" for this type of device (a nebulizer) is generally based on engineering and performance specifications (e.g., aerosol output, particle size, flow rates) rather than expert consensus on diagnostic images.
4. Adjudication Method for the Test Set
This information is not provided as there is no described test set in the sense of a clinical study requiring adjudication.
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.
An MRMC study is relevant for AI-powered diagnostic devices. The Neb-U-Mask® System is a medical device (nebulizer), not an AI diagnostic device. Therefore, an MRMC study was not performed or described as it is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done.
This question is also relevant for AI algorithms. The Neb-U-Mask® System is a physical medical device. Therefore, a standalone algorithm performance study was not done or described.
7. The Type of Ground Truth Used
The "ground truth" for this device seems to be established through:
- Comparison to the established performance and characteristics of legally marketed predicate nebulizer devices.
- Engineering specifications and tests (e.g., "Particle size characterization via Cascade Impactor" is mentioned, implying technical testing was performed to establish this characteristic).
- Intended use and safety profiles of similar devices.
There is no mention of pathology, expert consensus (in a diagnostic sense), or outcomes data for a specific clinical study in this summary.
8. The Sample Size for the Training Set
This information is not provided and is not applicable to this type of device submission, which relies on engineering and comparative performance, not machine learning models with training sets.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable.
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Premarket Notification 510(k) Section 5 - 510(k) Summary
ﺗ
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Non-Confidential Summary of Safety and Effectiveness Page 1 of 2 29-Jan-08
| Teleflex Medical, Inc.2917 Weck DriveResearch Triangle Park, NC 27709 | Tel - (919) 433-4829Fax - (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 - K980407DHD Healthcare - Trust nebulizer - K040718Teleflex 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 gasmixtures in combination with aerosolized medications and diagnosticformulations. This device has not been tested for use with Pentamidinor 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:
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| Premarket Notification 510(k)Section 5 - 510(k) Summary | Neb-U-Mask® SystemNon-Confidential Summary of Safety and EffectivenessPage 2 of 229-Jan-08 | Formatted: Top: 78 pt | |||
|---|---|---|---|---|---|
| Attribute | ProposedNeb-U-Mask® System | Teleflex Medical/Hudson RCInebulizerK930525Used as a nebulizer | B&B HopeK980407 | DHD TrustK040718 | |
| Indications for Use(all are not for use withpentamidine) | For the delivery of high concentrations ofoxygen or Heliox gas mixtures incombination with aerosolized medications.This device has not been tested for use withPentamidine or the combination of Helioxand metered dose inhaler.Indication for high concentrations of oxygenvia a non-rebreather mask is an exemptindication | High output nebulizer tobe used to deliveraerosolized medicationsand diagnostic formulas. | Uses as a nebulizeraerosolized medicationsand diagnosticformulations | ||
| Used with Heliox80/20 and 70/30 mixtures | Yes | No | Yes | Yes | |
| Environments of use home care,nursing home, sub-acute institutionsor hospitals, pre-hospital (EMS) | Yes | Yes | Yes | Yes | |
| Patient population | PediatricAdult | Not listed | Asthma, pneumonia,COPD and generalconditions | Asthma, pneumonia,COPD and generalconditions | |
| Nebulizer technology | Jet nebulizer | Jet nebulizer | Jet nebulizer | Jet nebulizer | |
| Single patient, disposable | Yes | Yes | Yes | Yes | |
| Operational Flow Rates | Standard oxygen 8 LpmHeliox up to 12 Lpm | Standard oxygen8 Lpm | Not listed | Not listed | |
| Used with face mask | Yes | Yes | Yes | Yes | |
| Materials Common materials incontact with gas and fluid pathway | Yes | Yes | N/A | N/A | |
| Particle size characterization viaCascade 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
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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.
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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
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Indications for Use Statement
Page 1 of 1
510(k) Number:
Device Name:
ి ప్రాథమైన భూమి: 100
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(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:
§ 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).