(470 days)
The EZ-Mister is indicated for use in atomizing topical anesthetics to the oropharynx and upper airway regions.
The EZ-Mister consists of a plastic atomizer used to deliver topical anesthetic solutions. The device includes a receptacle intended to contain a single container of topical anesthetic; the atomizer housing has a plastic tube that extends into the anesthetic solution. The device uses oxygen flow to achieve atomization.
The E-Z Mister device is a topical anesthetic atomizer. The study performed to demonstrate its performance focused on particle size testing. However, the document does not include a table of acceptance criteria, the specific results of the particle size testing, or the other requested details regarding the study methodology.
Based on the provided information, I can answer some of the points:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided document. It's only mentioned that "Performance data provided in this submission consists of particle size testing." Without specific thresholds or target ranges for particle size, it's impossible to create this table.
- Reported Device Performance: Not explicitly provided in the document. The document only states that particle size testing was performed, but the results of this testing are not given.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the particle size testing.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable as the study involved particle size testing, not a clinical assessment requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable as the study involved particle size testing, not a clinical assessment 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
- No, a multi-reader multi-case comparative effectiveness study was not done. The study was focused on the physical characteristics (particle size) of the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This question is not applicable as the study involved particle size testing through laboratory measurements, not a clinical assessment requiring ground truth established by experts or pathology.
8. The sample size for the training set
- This question is not applicable as the device is a physical medical device, not an algorithm or AI system that requires a training set.
9. How the ground truth for the training set was established
- This question is not applicable as the device is a physical medical device, not an algorithm or AI system that requires a training set.
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N.M. Beale Co., Inc. K093584/Amendment 1 September 13, 2010 E-Z Mister
510(k) Summary
MAR - 4 2011
General Information
Owner's Name: Address:
Telephone Number: Contact Person: Date Prepared:
N.M. Beale Co., Inc. P.O. Box 494 Harvard, MA 01451 (800) 989-9558 Nathaniel Beale, President September 13, 2010
Subject Device:
Trade Name: Classification/Regulation:
EZ-Mister CCT - Applicator, laryngo-tracheal, topical anesthesia 21 CFR 868.5170; Class II
Predicate Devices:
Trade Name: Classification/Regulation: Laryngeal Atomizer (Sharn, Inc); CCT - Applicator, laryngo-tracheal, topical anesthesia 21 CFR 868.5170; Class II K070596
Premarket Notification:
Device Description
The EZ-Mister consists of a plastic atomizer used to deliver topical anesthetic solutions. The device includes a receptacle intended to contain a single container of topical anesthetic; the atomizer housing has a plastic tube that extends into the anesthetic solution. The device uses oxygen flow to achieve atomization.
Indications for Use
The EZ-Mister is indicated for use in atomizing topical anesthetics to the oropharynx and upper airway regions.
Performance Testing
Performance data provided in this submission consists of particle size testing.
Substantial Equivalence
The EZ-Mister is substantially equivalent to the currently marketed Sharm Inc. Laryngeal Atomizer, which was cleared for marketing in K070596, and which has the same indications for use as the EZ-Mister. The essential technological characteristics of the proposed and predicate devices are the same - both are disposable atomizers intended for use to deliver topical anesthetics via atomization achieved via pressurized gas flow. The predicate Sharn Laryngeal Atomizer consists of a plastic tube with an atomizer tip and a 3 mL piston syringe. The topical anesthetic is drawn up into the syringe; the user then depresses the syringe plunger to deliver the
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atomized anesthetic to the desired location in the patient's oropharynx / upper airway. The EZ-Mister described in this submission does not incorporate a syringe. To achieve atomization, the EZ-Mister is attached to an oxygen source that has been set to a specified flow rate; gas flow through the atomizer mechanism draws the anesthetic up through the tube where it is mixed with the gas to create a mist. The user can control the flow of anesthetic for both the E-Z Mister and the Sharn Laryngeal Atomizer.
Conclusion
The EZ-Mister is substantially equivalent to the predicate device.
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
N.M. Beale Company, Incorporated C/O Ms. Pamela Papineau Regulatory Affairs Consultant Delphi Medical Device Consulting, Incorporated 5 Whitcomb Avenue Ayer, Massachusetts 01432
Re: K093584
MAR - 4 2011
Trade/Device Name: EZ-Mister Regulation Number: 21 CFR 868.5170 Regulation Name: Laryngotracheal Topical Anesthesia Applicator Regulatory Class: II Product Code: CCT Dated: February 25, 2011 Received: March 1, 2011
Dear Ms. Papineau:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Papineau
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony O. Anwat
Anthony D. Watson, B.S., M.S., M.B.A. 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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N M. Regle C Jovember 12, 200
Section 4 - Indications for Use Statement
510(k) Number (if known): K093584
Device Name:
EZ-Mister
Indications for Use:
The EZ-Mister is indicated for use in atomizing topical anesthetics to the oropharynx and upper airway regions.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-the -Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L Schalthum
(Division Sign-Off) (Division of A esthesiology. General Hospital Infection Control, Dental Devices
510(k) Number:
000014
§ 868.5170 Laryngotracheal topical anesthesia applicator.
(a)
Identification. A laryngotracheal topical anesthesia applicator is a device used to apply topical anesthetics to a patient's laryngotracheal area.(b)
Classification. Class II (performance standards).