(261 days)
The MADgic™ Laryngo-Tracheal Mucosal Atomization Device is intended for the application of topical anesthetics to the oropharynx and upper airway region.
The MADgic™ Laryngo-Tracheal Mucosal Atomization Device is a disposable nonsterile device that converts a solution of topical anesthetic into a fine particle spray for application to mucosal surfaces. The device consists of an atomizer tip, a semirigid tubular extension, a standard luer lock adapter and a syringe. The clinician draws up the desired volume of topical anesthetic into the syringe, attaches it to the luer lock fitting of the atomizer, and manipulates the tubing extensions into the desired position. As the syringe plunger is compressed, the anesthetic is forced into the tubular extension and out of the atomizer tip. The tip takes the pressurized fluid column and begins spinning it, allowing the fluid to exit the small hole at the end in a cone shaped spray. The anesthetic mist is gently distributed onto the mucosal surface in front of this tip. Topical anesthesia application can begin in the mouth and pharynx, and then proceed to the hypopharynx, epiglottis and vocal cords, larynx and trachea via direct visualization using a laryngoscope.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the MADgic™ Laryngo-Tracheal Mucosal Atomization Device:
Device: MADgic™ Laryngo-Tracheal Mucosal Atomization Device
FDA 510(k) Number: K153470
Predicate Device: MADgic™ Laryngo-Tracheal Mucosal Atomization Device (K002255)
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | ||
| Cytotoxicity - L929 MEM Elution Assay | Grade of 0, 1, or 2 (not more than 50% of cells are round, devoid of intracytoplasmic granules, and no extensive cell lysis) | Acceptable |
| Sensitization - Kligman Maximization Assay | Difference between test article mean score and vehicle control mean score is 1.0 or less (non-irritant). | Acceptable |
| Irritation - Intracutaneous Injection Assay | Grade of 1, 0 or less using the Kligman scoring system. | Acceptable |
| Performance Data (Non-Clinical) | ||
| Visual Inspection | Proper assembly, presence of all components, no cracks in tip and luer, no short shots in molded components, solvent presence around bonding surface covering minimum one third total area, no gaps between insert post and tubing. | Pass |
| Flow Test | Flow rate ≥ 225 sccm and ≤ 700 sccm. | Pass |
| Leak Test | Leak value ≤ 0.05 psi. | Pass |
| Hydrostatic Test | Device must remain assembled after being subjected to a minimum 300 psi hydrostatic pressure. | Pass |
| Atomization Test Post Hydrostatic | No streaming, no excessive dripping, or occlusions upon atomization. | Pass |
| Tensile | Tensile strength ≥ 6.0 lb. | Pass |
| Specification Verification (Not direct performance, but conformance) | ||
| Typical Particle Size | 30-100 microns | N/A. Specification Study. |
| System Dead Space | MAD600/600OS = 0.24mL; MAD700-730/730OS = 0.18mL; MAD720 = 0.12mL | N/A. Specification Study. |
| Tip Diameter | 0.19 inches (4.8 mm) | N/A. Specification Study. |
| Applicator Length | MAD600/6000S/700 = 8.9 inches; MAD720/730/730OS = 4.9 inches | N/A. Specification Study. |
| Conical Fittings with 6% Taper | Clauses 4.1-4.1 of ISO 540-2:1998 | Certificate of Conformance from the Supplier |
| Sterile Hypodermic Syringes of Single Use | ISO 7886-1:1993 | Certificate of Conformance from the Supplier |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for any of the biocompatibility or performance tests. The data provenance is not explicitly mentioned, but these are all non-clinical, bench-top tests conducted to verify product specifications and safety, likely performed internally by the manufacturer (Teleflex Medical). No human or animal data is described for these tests; they are related to material properties and device functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the described tests are non-clinical and do not involve expert interpretation or human ground truth. They are objective measurements against defined chemical, physical, and engineering criteria.
4. Adjudication method for the test set
This section is not applicable as the described tests are objective measurements against defined criteria, not subjective assessments 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
There is no mention of an MRMC comparative effectiveness study, nor is there any AI component to this device. This device is a manual, single-use medical device for topical anesthetic application.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is not an algorithm or AI-based system. It is a physical medical device.
7. The type of ground truth used
The "ground truth" for the biocompatibility tests is established by recognized international standards (ISO 10993-1) and specific grading scales (e.g., Kligman scoring system). For performance tests, the "ground truth" is the predefined quantitative and qualitative acceptance criteria based on engineering specifications and functional requirements. For specification verification, it's conformance to established international standards (e.g., ISO 540-2, ISO 7886-1) or internal product specifications.
8. The sample size for the training set
This section is not applicable as there is no training set mentioned for this type of device.
9. How the ground truth for the training set was established
This section is not applicable as there is no training set described.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 19, 2016
Teleflex Medical Kristen Bisanz Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, NC 27560
Re: K153470
Trade/Device Name: MADgic™ Laryngo-Tracheal Mucosal Atomization Device Regulation Number: 21 CFR 868.5170 Regulation Name: Laryngotracheal Topical Anesthesia Applicator Regulatory Class: Class II Product Code: CCT Dated: July 22, 2016 Received: July 25, 2015
Dear Kristen Bisanz:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, James J. Lee -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153470
Device Name
MADgic Laryngo-Tracheal Mucosal Atomization Device
Indications for Use (Describe)
The MADgic Laryngo-Tracheal Mucosal Atomization Device is intended for the application of topical anesthetics to the oropharynx and upper airway region.
Type of Use (Select one or both, as applicable)|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
MADgicTM Laryngo-Tracheal Mucosal Atomization Device
Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919.433.4932 919.433.4996 Fax:
Contact Person
Kristen Bisanz Regulatory Affairs Specialist
Date Prepared
December 01, 2015
Device Name
| Trade Name: | MADgic™ Laryngo-Tracheal Mucosal AtomizationDevice |
|---|---|
| Classification Name: | Applicator, Laryngo-Tracheal, Topical Anesthesia |
| Product Code: | CCT |
| Regulation Number: | 868.5170 |
| Classification: | II |
| Classification Panel: | Anesthesiology |
Predicate Device
This submission demonstrates substantial equivalence to the predicate device MADgic™ Laryngo-Tracheal Mucosal Atomization Device which was cleared in submission K002255.
Device Description
The MADgic™ Laryngo-Tracheal Mucosal Atomization Device is a disposable nonsterile device that converts a solution of topical anesthetic into a fine particle spray for application to mucosal surfaces. The device consists of an atomizer tip, a semirigid tubular extension, a standard luer lock adapter and a syringe. The clinician draws up the desired volume of topical anesthetic into the syringe, attaches it to the luer lock fitting of the atomizer, and manipulates the tubing extensions into the desired position. As the syringe plunger is compressed, the anesthetic is forced into the tubular extension and out of the atomizer tip. The tip takes the pressurized fluid column and begins spinning it, allowing the fluid to exit the small hole at the end in a
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cone shaped spray. The anesthetic mist is gently distributed onto the mucosal surface in front of this tip. Topical anesthesia application can begin in the mouth and pharynx, and then proceed to the hypopharynx, epiglottis and vocal cords, larynx and trachea via direct visualization using a laryngoscope.
Indications for Use
The MADgic™ Laryngo-Tracheal Mucosal Atomization Device is intended for the application of topical anesthetics to the oropharynx and upper airway region.
Patient Population
This device is for patients requiring topical anesthetic before intubation.
Environments of use
The environments of use are hospitals and sub-acute facilities as directed by a physician.
Contraindications
There are no contraindications for this device.
Substantial Equivalence
The proposed device is substantially equivalent to the predicate device:
| Predicate Device | Manufacturer | 510(k) Number | Date Cleared | System Dead Space | MAD600/600OS = 0.25mLMAD700-730/730OS =0.19mLMAD720 = 0.13mL | MAD600/600OS= 0.24mLMAD700-730/730OS= 0.18mLMAD720 = 0.12mL | Equivalent |
|---|---|---|---|---|---|---|---|
| MADgic™ Laryngo-TrachealMucosal Atomization Device | Wolfe ToryMedical | K002255 | September19, 2000 | Tip Diameter | 0.19 inches (4.8mm) | 0.19 inches (4.8mm) | Identical |
| PredicateK002255MADgicTM Laryngo-Tracheal MucosalAtomization Device | Proposed MADgicTMLaryngo-TrachealAtomization Device | Equivalence | Applicator Length | MAD600/600OS= 8.5 inches (21.6cm)MAD720/730/730OS= 4.5 inches (11.4cm) | MAD600/600OS= 8.9 inches (22.6cm)MAD720/730/730OS= 4.9 inches (12.4cm) | Equivalent | |
| Classification Name | Applicator, Laryngo-Tracheal, Topical Anesthesia | Applicator, Laryngo-Tracheal, Topical Anesthesia | Identical | Sterilization | Non-Sterile | Non-Sterile | Identical |
| Device Name | MADgic™ Laryngo-Tracheal MucosalAtomization Device | MADgic™ Laryngo-Tracheal MucosalAtomization Device | Identical | Packaging | Packaged individually inpolyethylene pouches withtwenty-five (25) devicesper inner carton, four (4)cartons per case (for a totalof 100 devices) | Packaged individually inpolyethylene pouches withtwenty-five (25) devicesper inner carton, four (4) | Identical |
| Common Name | Atomizer | Atomizer | Identical | Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Identical |
| Product Code | 73CCT | 73CCT | Identical | Dosage Amount | User Controlled | User Controlled | Identical |
| Classification | Class II | Class II | Identical | Material for Tubing | Alpha Gary 2222R-90 | Colorite PolymersUnichem, 9088-015, Clear,DEHP-Free PVC | Equivalent |
| Regulation Number | 868.5170 | 868.5170 | Identical | Material for LuerAdaptor | Polycarbonate | Polyvinyl Chloride 2014 G-010 | Equivalent |
| Indications for Use | The MADgic™ Laryngo-Tracheal MucosalAtomization Device isintended for the applicationof topical anesthetics to theoropharynx and upperairway region. | The MADgic™ Laryngo-Tracheal MucosalAtomization Device isintended for the applicationof topical anesthetics to theoropharynx and upper airwayregion. | Identical | Material for Wire | 302 Stainless Steel | 302 Stainless Steel | Identical |
| Prescription | Yes | Yes | Identical | Material for SprayTip | Dow Calibre 2081-15,Polycarbonate | Dow Calibre 2081-15,Polycarbonate | Identical |
| Environment of Use | Hospitals, Sub-acutefacilities, and emergencymedical services | Hospitals, Sub-acutefacilities, and emergencymedical services | Identical | Material for SprayTip Insert | Chevron K-Resin, KR03 | Chevron K-Resin, KR03 | Identical |
| Patient Population | Patients requiring topicalanesthesia before intubation | Patients requiring topicalanesthesia before intubation | Identical | Material for Syringe | Polypropylene and Non-Latex Rubber | Polypropylene and Non-Latex Rubber | Identical |
| Contraindications | None | None | Identical | Material forAdhesive | Cyclohexanone | Cyclohexanone | Identical |
| Shelf Life | Three (3) years from dateof manufacture | Three (3) years from dateof manufacture | Identical | Material for FoilHot Stamp | Not present | 100% Virgin, high claritypolyethylene film | Equivalent |
| Typical Particle Size | 30-100 microns | 30-100 microns | Identical |
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Comparison to Predicate Device
The proposed device has the same indications for use, operating principles, classification, function, and general design as the predicate device. Biocompatibility testing and performance testing have been performed on the proposed device in order to establish substantial equivalence to the predicate device. The proposed changes to the device do not impact the safety or effectiveness of the MADgic™ Laryngo-Tracheal Mucosal Atomization Device.
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Materials
All patient contacting materials, including those with indirect patient contact, are in compliance with ISO 10993-1. Biocompatibility testing has been performed on the proposed device and meets the acceptance criteria.
| Test | Acceptance Criteria | Results |
|---|---|---|
| Cytotoxicity - L929MEM Elution Assay | The test article will meet the requirements of the test if itobtains a Grade of 0,1,or 2 (not more than 50% of the cellsare round, devoid of intracytoplasmic granules, and noextensive cell lysis) | Acceptable |
| Sensitization -KligmanMaximization Assay | The test article will be considered a non-irritant if thedifference between the test article mean score and thevehicle control mean score is 1.0 or less. | Acceptable |
| Irritation -IntracutaneousInjection Assay | The test article will meet the requirements of the test if itreceives a Grade of 1, 0 or less using the Kligman scoringsystem. | Acceptable |
Performance Data
Non-clinical performance testing has been conducted in order to support that the proposed device performs as intended and the product conforms to user needs.
| Test | Test Objective | Acceptance Criteria | Results |
|---|---|---|---|
| Visual Inspection | To visually inspect thedevice for defects ofcomponents or assembly | Visually observe for:- Proper assembly and presence of allcomponents- No cracks in the tip and luer- No short shots in the moldedcomponents- The presence of solvent aroundcircumference of bonding surfacecovering a minimum of one third ofthe total area- No gaps between the insert post andtubing | Pass |
| Flow Test | To validate the flow rateof the device | The flow rate should be greater thanor equal to 225 sccm and less than orequal to 700 sccm. | Pass |
| Leak Test | To validate the leakvalue of the device | The leak value should be less than orequal to 0.05psi. | Pass |
| Hydrostatic Test | To validate the effect ofhydrostatic pressure onthe device | The device must remain assembledafter being subjected to a minimum300psi hydrostatic pressure. | Pass |
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| Atomization TestPost Hydrostatic | To validate theatomization function ofthe device | Upon atomization there can be nostreaming, no excessive dripping, orocclusions. | Pass |
|---|---|---|---|
| Tensile | To validate the tensilestrength of the device | The tensile strength should be greaterthan or equal to 6.0 lb. | Pass |
The testing below summarizes the specification verification.
| Test | Specification | Acceptance Criteria |
|---|---|---|
| Typical Particle Size | 30-100 microns | N/A. Specification Study. |
| System Dead Space | MAD600/600OS = 0.24mLMAD700-730/730OS = 0.18mLMAD720 = 0.12mL | N/A. Specification Study. |
| Tip Diameter | 0.19 inches (4.8 mm) | N/A. Specification Study. |
| Applicator Length | MAD600/6000S/700 =8.9 inchesMAD720/730/730OS =4.9 inches | N/A. Specification Study. |
| Conical Fittings with6% Taper | Clauses 4.1-4.1 of ISO 540-2:1998 | Certificate of Conformancefrom the Supplier |
| Sterile HypodermicSyringes of Single Use | ISO 7886-1:1993 | Certificate of Conformancefrom the Supplier |
Conclusion
Based on the performance and comparative test results, the proposed MADgic™ Laryngo-Tracheal Mucosal Atomization Device is substantially equivalent to the predicate device cleared to market in K002255. The modifications made to the MADgic™ Laryngo-Tracheal Mucosal Atomization Device do not introduce any new issues of safety and effectiveness.
§ 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).