(261 days)
Not Found
No
The device description and performance studies focus on the mechanical function of atomizing a liquid anesthetic. There is no mention of AI or ML in the intended use, device description, or performance testing.
No.
The device is intended for the application of topical anesthetics, which are drugs, not a healing or diagnostic therapeutic action by the device itself.
No
The device is intended for the application of topical anesthetics, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (atomizer tip, tubular extension, luer lock adapter, syringe) and describes a mechanical process for atomizing liquid, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the application of topical anesthetics to the oropharynx and upper airway region. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device's function is to convert a liquid anesthetic into a spray for direct application to a patient's body. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Activity: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic within a biological sample to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is used to deliver a substance to the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CCT
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oropharynx and upper airway region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Environment of Use: hospitals and sub-acute facilities as directed by a physician.
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)
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: Visual Inspection
Test Objective: To visually inspect the device for defects of components or assembly
Acceptance Criteria: Visually observe for: Proper assembly and presence of all components; No cracks in the tip and luer; No short shots in the molded components; The presence of solvent around circumference of bonding surface covering a minimum of one third of the total area; No gaps between the insert post and tubing
Results: Pass
Test: Flow Test
Test Objective: To validate the flow rate of the device
Acceptance Criteria: The flow rate should be greater than or equal to 225 sccm and less than or equal to 700 sccm.
Results: Pass
Test: Leak Test
Test Objective: To validate the leak value of the device
Acceptance Criteria: The leak value should be less than or equal to 0.05psi.
Results: Pass
Test: Hydrostatic Test
Test Objective: To validate the effect of hydrostatic pressure on the device
Acceptance Criteria: The device must remain assembled after being subjected to a minimum 300psi hydrostatic pressure.
Results: Pass
Test: Atomization Test Post Hydrostatic
Test Objective: To validate the atomization function of the device
Acceptance Criteria: Upon atomization there can be no streaming, no excessive dripping, or occlusions.
Results: Pass
Test: Tensile
Test Objective: To validate the tensile strength of the device
Acceptance Criteria: The tensile strength should be greater than or equal to 6.0 lb.
Results: Pass
Specification Verification:
Test: Typical Particle Size
Specification: 30-100 microns
Acceptance Criteria: N/A. Specification Study.
Test: System Dead Space
Specification: MAD600/600OS = 0.24mL; MAD700-730/730OS = 0.18mL; MAD720 = 0.12mL
Acceptance Criteria: N/A. Specification Study.
Test: Tip Diameter
Specification: 0.19 inches (4.8 mm)
Acceptance Criteria: N/A. Specification Study.
Test: Applicator Length
Specification: MAD600/6000S/700 = 8.9 inches; MAD720/730/730OS = 4.9 inches
Acceptance Criteria: N/A. Specification Study.
Test: Conical Fittings with 6% Taper
Specification: Clauses 4.1-4.1 of ISO 540-2:1998
Acceptance Criteria: Certificate of Conformance from the Supplier
Test: Sterile Hypodermic Syringes of Single Use
Specification: ISO 7886-1:1993
Acceptance Criteria: Certificate of Conformance from the Supplier
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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
1
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
2
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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3
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 Atomization
Device |
|-----------------------|--------------------------------------------------------|
| 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
4
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 = 0.25mL
MAD700-730/730OS =
0.19mL
MAD720 = 0.13mL | MAD600/600OS
= 0.24mL
MAD700-730/730OS
= 0.18mL
MAD720 = 0.12mL | Equivalent |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------|
| MADgic™ Laryngo-Tracheal
Mucosal Atomization Device | Wolfe Tory
Medical | K002255 | September
19, 2000 | Tip Diameter | 0.19 inches (4.8mm) | 0.19 inches (4.8mm) | Identical |
| | Predicate
K002255
MADgicTM Laryngo-
Tracheal Mucosal
Atomization Device | Proposed MADgicTM
Laryngo-Tracheal
Atomization 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 Mucosal
Atomization Device | MADgic™ Laryngo-
Tracheal Mucosal
Atomization Device | Identical | Packaging | Packaged individually in
polyethylene pouches with
twenty-five (25) devices
per inner carton, four (4)
cartons per case (for a total
of 100 devices) | Packaged individually in
polyethylene pouches with
twenty-five (25) devices
per 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 Polymers
Unichem, 9088-015, Clear,
DEHP-Free PVC | Equivalent |
| Regulation Number | 868.5170 | 868.5170 | Identical | Material for Luer
Adaptor | Polycarbonate | Polyvinyl Chloride 2014 G-
010 | Equivalent |
| 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. | The MADgic™ Laryngo-
Tracheal Mucosal
Atomization Device is
intended for the application
of topical anesthetics to the
oropharynx and upper airway
region. | Identical | Material for Wire | 302 Stainless Steel | 302 Stainless Steel | Identical |
| Prescription | Yes | Yes | Identical | Material for Spray
Tip | Dow Calibre 2081-15,
Polycarbonate | Dow Calibre 2081-15,
Polycarbonate | Identical |
| Environment of Use | Hospitals, Sub-acute
facilities, and emergency
medical services | Hospitals, Sub-acute
facilities, and emergency
medical services | Identical | Material for Spray
Tip Insert | Chevron K-Resin, KR03 | Chevron K-Resin, KR03 | Identical |
| Patient Population | Patients requiring topical
anesthesia before intubation | Patients requiring topical
anesthesia before intubation | Identical | Material for Syringe | Polypropylene and Non-
Latex Rubber | Polypropylene and Non-
Latex Rubber | Identical |
| Contraindications | None | None | Identical | Material for
Adhesive | Cyclohexanone | Cyclohexanone | Identical |
| Shelf Life | Three (3) years from date
of manufacture | Three (3) years from date
of manufacture | Identical | Material for Foil
Hot Stamp | Not present | 100% Virgin, high clarity
polyethylene film | Equivalent |
| Typical Particle Size | 30-100 microns | 30-100 microns | Identical | | | | |
5
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.
6
7
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 - L929 | ||
| MEM Elution Assay | The test article will meet the requirements of the test if it | |
| obtains a Grade of 0,1,or 2 (not more than 50% of the cells | ||
| are round, devoid of intracytoplasmic granules, and no | ||
| extensive cell lysis) | Acceptable | |
| Sensitization - | ||
| Kligman | ||
| Maximization Assay | The test article will be considered a non-irritant if the | |
| difference between the test article mean score and the | ||
| vehicle control mean score is 1.0 or less. | Acceptable | |
| Irritation - | ||
| Intracutaneous | ||
| Injection Assay | The test article will meet the requirements of the test if it | |
| receives a Grade of 1, 0 or less using the Kligman scoring | ||
| system. | 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 the | ||
| device for defects of | |||
| components or assembly | Visually observe for: |
- Proper assembly and presence of all
components - No cracks in the tip and luer
- No short shots in the molded
components - The presence of solvent around
circumference of bonding surface
covering a minimum of one third of
the total area - No gaps between the insert post and
tubing | Pass |
| Flow Test | To validate the flow rate
of the device | The flow rate should be greater than
or equal to 225 sccm and less than or
equal to 700 sccm. | Pass |
| Leak Test | To validate the leak
value of the device | The leak value should be less than or
equal to 0.05psi. | Pass |
| Hydrostatic Test | To validate the effect of
hydrostatic pressure on
the device | The device must remain assembled
after being subjected to a minimum
300psi hydrostatic pressure. | Pass |
8
| Atomization Test
Post Hydrostatic | To validate the
atomization function of
the device | Upon atomization there can be no
streaming, no excessive dripping, or
occlusions. | Pass |
|--------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------|------|
| Tensile | To validate the tensile
strength of the device | The tensile strength should be greater
than 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 = 0.24mL | |
| 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 |
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.