(111 days)
No
The summary describes a mechanical device for delivering topical anesthetics and mentions performance testing using image analysis, but there is no mention of AI or ML being used in the device's operation or analysis.
No
The device delivers topical anesthetics, which are drugs, and the device itself does not perform therapy.
No
The device is intended for atomizing topical anesthetics, which is a therapeutic function, not a diagnostic one. Its evaluations focus on drug delivery metrics like dose and particle size, not on detecting medical conditions.
No
The device description explicitly states it incorporates a small tube with an atomizing tip and connects to a syringe, indicating it is a physical hardware device for delivering a substance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to atomize topical anesthetics for direct application to the oropharynx and upper airway. This is a therapeutic or drug delivery function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a topical applicator for delivering solutions. This aligns with a drug delivery device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the delivery characteristics of the device (dose, particle size, spray geometry), which are relevant to a drug delivery system, not an IVD.
Therefore, this device falls under the category of a medical device for drug delivery, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended for atomizing topical anesthetics to the oropharynx and upper airway regions
Product codes (comma separated list FDA assigned to the subject device)
CCT
Device Description
The Topical applicator incorporates a small tube with atomizing tip which can connect to a syringe and when placed in the patient's mouth or throat and / or inside an endotracheal tube or in the nasal passages it then delivers topical anesthetic solutions.
Mentions image processing
Evaluated using digital image and photographic grid measuring spray distance, velocity, dispersion angle all vs. time
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oropharynx and upper airway regions, Nasal, Orotrachael
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Environment of Use: Hospitals, sub-acute settings where topical solutions are needed. Patient Population: Individuals requiring topical anesthetic at the direction and discretion of the clinician.
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)
Performance testing: Comparative using Cascade impactor to measure the following listed criteria
Total Dose: Proposed Device: 2.75 cc - Lidocaine, 2.78 cc - Saline.
Residual Mass (cc) Ave.: Proposed Device: 0.25 cc.
Simulated Clinical Dose %: Proposed Device: 92.3% - Lidocaine, 94.0% - Saline.
Particle Size: Proposed Device: 835 um - Lidocaine, 803 um - Saline.
MMAD (um): Proposed Device: 1.93 um - Lidocaine, 2.00 um - Saline.
GSD (um): Similar.
Plume Geometry: Evaluated using digital image and photographic grid measuring spray distance, velocity, dispersion angle all vs. time. Similar.
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.
Wolfe Tory - MADgic - K002255
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.
Sherwood Monoject syringe - K852544
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
Image /page/0/Picture/1 description: The image shows the text "K070596" in a handwritten style. Below this, the words "Topical Applicator" are printed in a smaller, more formal font. The text appears to be part of a label or identifier, possibly related to a product or item.
Non-Confidential Summary of Safety and Effectiveness Page 1 of 2
25-May-07
| JUN 2 | 1 | 2007 |
|---|---|---|
| ------- | --- | ------ |
Sharn, Inc. 4517 George Rd. # 200 Tel - 813-889-9614 Fax - 813-886-2701 Tampa, FL 33634 Official Contact: Bruce Tomlinson - President Proprietary or Trade Name: Topical applicator Common/Usual Name: Atomizer Classification Name: Laryngo-Tracheal topical applicator Classification Code: CCT - 21 CFR 868.5170 Device: Topical Applicator Predicate Devices: Wolfe Tory - MADgic - K002255 Sherwood Monoject syringe - K852544 Device Description: The Topical applicator incorporates a small tube with atomizing tip which can connect to a syringe and when placed in the patient's mouth or throat and / or inside an endotracheal tube or in the nasal passages it then delivers topical anesthetic solutions. Indications for Use: Intended for atomizing topical anesthetics to the oropharynx and upper airway regions Environment of Use: Hospitals, sub-acute settings where topical solutions are needed. Patient Population: Individuals requiring topical anesthetic at the direction and discretion of the clinician.
Differences Between Other Legally Marketed Predicate Devices
The Sharn Topical Applicator when compared in performance testing for particle size and plume geometry to the predicate, Wolfe Tory MADgic - K002255 was found to be substantially equivalent.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
Page 6
pg 1 of 4
1
:
Topical Applicator
Non-Confidential Summary of Safety and Effectiveness
25-May-07
| Features | Predicate
Wolfe Tory MADgic K002255 | Proposed Device |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Intended for the application of
topical anesthetics to the
oropharynx and upper airway region | Intended for the application of topical
anesthetics to the oropharynx and
upper airway region |
| Types of medications used | Topical solutions, i.e.,
Topical anesthetics
Vasoconstrictors | Topical solutions, i.e.,
Topical anesthetics
Vasoconstrictors |
| Environment of Use /
Patient population | Not disclosed | Locations where topical anesthetics
solutions are used.
Individuals requiring topical
anesthetic at the direction and
discretion of the clinician. |
| Disposable, non-sterile | Yes | Yes |
| Components | Syringe
Flexible, malleable, semi-rigid tube
Atomizer tip / nozzle | Syringe (K852544)
Flexible, semi-rigid tube
Atomizer tip / nozzle |
| Places inserted | Nasal, Orotrachael | Nasal. Orotrachael |
| Dosage Amount | User controlled | User controlled |
| Delivery form | Fine particle spray mist | Fine particle spray mist |
| Spray generated by | Piston syringe | Piston syringe |
| Basic dimensions | Tip diameter - 0.157" OD
Tube length - 8.25" overall | Tip diameter - 0.31" OD (7.9 mm)
Tube length - 8.25" overall |
| Materials | Polycarbonate
Polyvinylchloride (PVC) | Acetal/ Delrin, K-resin
Polyethylene, Polyvinylchloride |
| Biocompatibility | Unknown | Tested to ISO 10993-1 |
| Performance testing | Comparative using Cascade impactor to measure the following listed
criteria | |
| Total Dose | 2.88 cc - Lidocaine | 2.75 cc - Lidocaine |
| Delivered max 3 cc | 2.87 cc - Saline | 2.78 cc - Saline |
| Residual Mass (cc) Ave. | 0.12 cc | 0.25 cc |
| Simulated Clinical Dose % | 94.7% - Lidocaine
95.0% - Saline | 92.3% - Lidocaine
94.0% - Saline |
| Particle Size | 470 um - Lidocaine
470 um - Saline | 835 um - Lidocaine
803 um - Saline |
| MMAD (um) | 1.87 um - Lidocaine
1.90 um - Saline | 1.93 um - Lidocaine
2.00 um - Saline |
| GSD (um) | Similar | Similar |
| Plume Geometry
Evaluated using digital
image and photographic grid
measuring spray distance,
velocity, dispersion angle all
vs. time | | |
Page 7
pg 2 of 4
2
Topical Applicator
Discussion and Table of the Comparison and Differences
. I
| Features | Predicate | Proposed Device |
|---|---|---|
| Wolfe Tory MADgic K002255 | ||
| Indications for use | Intended for the application of | |
| topical anesthetics to the | Intended for the application of topical | |
| anesthetics to the oropharynx and | ||
| oropharynx and upper airway region | upper airway region | |
| Types of medications used | Topical solutions, i.e., | |
| Topical anesthetics, | ||
| Vasoconstrictors | Topical solutions, i.e., | |
| Topical anesthetics | ||
| Vasoconstrictors | ||
| Environment of Use / | ||
| Patient population | Not disclosed | Locations where topical anesthetics |
| solutions are used. | ||
| Individuals requiring topical | ||
| anesthetic at the direction and | ||
| discretion of the clinician. | ||
| Disposable, non-sterile | Yes | Yes |
| Components | Syringe | |
| Flexible, malleable, semi-rigid tube | ||
| Atomizer tip / nozzle | Syringe (K852544) | |
| Flexible, semi-rigid tube | ||
| Atomizer tip / nozzle | ||
| Places inserted | Nasal, Orotrachael | Nasal, Orotrachael |
| Dosage Amount | User controlled | User controlled |
| Delivery form | Fine particle spray mist | Fine particle spray mist |
| Spray generated by | Piston syringe | Piston syringe |
| Device dead space (ml) | 0.12 ml device only | 0.13 ml device only |
| Basic dimensions | Tip diameter - 0.157" OD | |
| Tube length - 8.25" overall | Tip diameter – 0.31" OD (7.9 mm) | |
| Tube length - 8.25" overall | ||
| Materials | Polycarbonate | |
| Polyvinylchloride (PVC) | Acetal / Delrin, K-resin | |
| Polyethylene | ||
| Polyvinylchloride (PVC) | ||
| Biocompatibility | Unknown | Tested to ISO 10993-1 |
| Performance testing | Comparative using Cascade impactor to measure the following listed | |
| criteria | ||
| Total Dose | 2.88 cc - Lidocaine | 2.75 cc - Lidocaine |
| Delivered max 3 cc | 2.87 cc - Saline | 2.78 cc - Saline |
| Residual Mass (cc) Ave. | 0.12 cc | 0.25 cc |
| Simulated Clinical Dose % | 94.7% - Lidocaine | |
| 95.0% - Saline | 92.3% - Lidocaine | |
| 94.0% - Saline | ||
| Particle Size | 470 um - Lidocaine | 835 um - Lidocaine |
| MMAD (um) | 470 um - Saline | 803 um - Saline |
| GSD (um) | 1.87 um - Lidocaine | |
| 1.90 um - Saline | 1.93 um - Lidocaine | |
| 2.00 um - Saline | ||
| Plume Geometry | Similar see Section 18 | Similar see Section 18 |
| Evaluated using digital | ||
| image and photographic | ||
| grid measuring spray | ||
| distance, velocity, | ||
| dispersion angle all vs. time |
Page 8
pg 3 of 4
3
Image /page/3/Picture/0 description: The image shows a sequence of characters that appear to be handwritten. The characters are 'K070596'. The characters are written in a simple, slightly irregular style, giving them a casual appearance. The image is in black and white.
Premarket Notification 510(k) Section 5 - 510(k) Summary
Topical Applicator
Discussion:
Particle Size:
While the difference represents a measurable difference, it would not be classified as "substantially different." The intent of the device is to deliver a topical medication to a specific sight in close proximity to the tip. Therefore bigger particles are important, otherwise the medication may be inhaled to another location that is not intended (alveolar). Both particle sizes of the respective devices are sufficiently large to insure this.
The simulated clinical dose for both devices were equal, and almost exactly equal to the "filled dose" minus the "residual", is further verification of this position (i.e., all medication was accounted for at the sight of delivery or remaining in the device. none was inhaled).
Therefore both devices equally performed their function and are "substantially equivalent."
Tube malleable wire:
The proposed device does not include a malleable wire in the tubing as this is a patented feature. We believe that the intent of the malleable wire was to allow the tube to hold a curve or shape for insertion into the patient's throat. However this feature is not a requirement for any atomizer to be functional.
The lack of a malleable wire does not introduce or create any new safety or performance issues in fact one might consider our design as "safer" as the tube is less stiff. This is not a claim which is proposed to be used or demonstrated.
The use of K-resin for our tubing allows the clinician to bend the tube and for it to "hold" some curve or shape, anatomical, during the intended use.
Therefore there are no significant differences between the proposed device and the predicate.
It is our view that there are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.
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pq4 of 4
4
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like bird with outstretched wings, symbolizing protection and care. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The overall design is simple and conveys a sense of authority and service.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sharn, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court # 102 Bonita Springs, Florida 34134-2015
JUN 2 1 2007
Re: K070596
Trade/Device Name: Topical Applicator Regulation Number: 21 CFR 868.5170 Regulation Name: Laryngotracheal Topical Anesthesia Applicator Regulatory Class: II Product Code: CCT Dated: June 11, 2007 Received: June 12, 2007
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.
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.
5
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.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
Page 1 of 1
510(k) Number: K070596 Device Name: Topical applicator Indications for Use: Intended for atomizing topical anesthetics to the oropharynx and upper airway regions
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)
signature
(k) Number: .................................................................................................................................................................
...
ാന Sign-Off) sion of Anesthesiology, General Hospital, i Control, Dental Devices
Ko70596
Page 4