(112 days)
No
The device description and performance studies focus on mechanical properties and function as an applicator, with no mention of AI/ML or data processing.
No.
The device is used to apply topical anesthetics, which are drugs, and is not inherently therapeutic itself.
No
The device is described as a topical anesthesia applicator, used to apply anesthetics, not to diagnose a condition. Its stated purpose is for medical intervention (anesthesia application), not diagnosis.
No
The device description clearly outlines physical components like tubes, fittings, a catheter, and syringes, 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 intended use is to apply topical anesthetics to a patient's laryngo-tracheal area. This is a therapeutic application, not a diagnostic one.
- Device Description: The device components (tubes, fittings, syringes, catheter) are designed for delivering a substance, not 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.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for drug delivery during a medical procedure.
N/A
Intended Use / Indications for Use
The Enk Fiberoptic Atomizer Set is a topical anesthesia applicator used to apply topical anesthetics to a patient's laryngo-trachea area through the working channel of the bronchoscope using oxygen flow. The sterile one-time use device is designed and intended to be used by physicians trained and experienced in flexible fiberoptic intubation techniques.
The safety and effectiveness of this device for use in the performance of topical anesthesia of the lower airways (below the level of the trachea) have not been established.
Product codes
CCT-73, KTI-77, EOQ
Device Description
The Enk Fiberoptic Atomizer Set consists of a pressure resistant oxygen tube and a connecting tube connected by a three-way side-arm fitting with a small flow control opening. The set also contains an introducer catheter and two 1 ml syringes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
laryngo-trachea area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians trained and experienced in flexible fiberoptic intubation techniques.
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
Performance testing, which includes tightness, air flow and tensile testing, provides reasonable assurance of safety and effectiveness for the device's intended use as an applicator for laryngo-tracheal topical anesthesia.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
OCT 1 6 2003
Image /page/0/Picture/1 description: The image shows the word "COOK" in a bold, serif typeface. A small registered trademark symbol is located to the upper right of the letter K. The text is black against a white background. The font is classic and easily readable.
KO31966
Cook Incorporated
P.O. Box 489 Bloomington, IN 47402-0489 Phone: 800 468-1379 www.cookgroup.com
510(k) SUMMARY
| Submitted By: | COOK INCORPORATED
750 Daniels Way
Bloomington, In 47404 |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jennifer Bosley, MBA
Regulatory Affairs Coordinator
Tel: (812) 339-2235
Fax: (812) 332-0281 |
| Date Prepared: | June 25, 2003 |
| 510(k) #: | |
| Device: | |
| Trade Name: | Enk Fiberoptic Atomizer Set |
| Common/Usual Name Proposed Classification Name: | Laryngo-Tracheal Topical Anesthetic Applicator |
| Classification Name: | (1) Applicator (Laryngo-Tracheal), Topical Anesthesia, 21 CFR § 868.5170
(2) Accessory to Bronchoscope, 21 CFR § 874.4680 |
| Class: | Class II |
| Product and Panel Code: | (1) CCT-73—Anesthesiology Device Panel
(2) KTI-77—Ear Nose & Throat Device Panel |
Intended Use:
The Enk Fiberoptic Atomizer Set is a topical anesthesia apply topical anesthetics to a patient's laryngo-tracheal area through the working channel of the bronchoscope using oxygen flow. The sterile one-time use device is designed and intended to be used by physicians trained and experienced in flexible fiberoptic intubation techniques.
Predicate Device:
The subject device is similar to the predicate device in terms of intended use, and general material composition. Any differences that may exist do not significantly affect the safety and effectiveness of the device.
| MANUFACTURER | DEVICE | 510(K) NUMBER |
|---|---|---|
| Wolfe Tory Medical | Laryngo-Tracheal Mucosal Atomization Device | |
| (MADgicTM) | K002255 |
Device Description:
The Enk Fiberoptic Atomizer Set consists of a pressure resistant oxygen tube and a connecting tube connected by a three-way side-arm fitting with a small flow control opening. The set also contains an introducer catheter and two 1 ml syringes.
Substantial Equivalence:
The subject device is similar with respect to indications for use and design features to the predicate device in terms of section 510(k) substantial equivalence.
Test Data:
Performance testing, which includes tightness, air flow and tensile testing, provides reasonable assurance of safety and effectiveness for the device's intended use as an applicator for laryngo-tracheal topical anesthesia.
1
| Device | COOK
Enk Fiberoptic Atomizer Set
(Subject of Submission) | Wolfe Tory Medical
MADgic™ Laryngo-Tracheal
Mucosal Atomization Device
(K002255) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Reg No./Code | 868.5170-CCT
874.4680—KTI | 868.5170-CCT |
| Intended Use | The Enk Fiberoptic Atomizer Set
is a topical anesthesia applicator
used to apply topical anesthetics to
a patient's laryngo-tracheal area
through the working channel of the
bronchoscope using oxygen flow.
The sterile one-time use device is
designed and intended to be used
by physicians trained and
experienced in flexible fiberoptic
intubation techniques. | Intended for the application of
topical anesthetics to the
oropharynx and upper airway
region. |
| Materials | Polyurethane | Polycarbonate and
Polyvinyl chloride |
| Method of
Operation | Delivery form is a spray mist
using oxygen flow through a
bronchoscope. Device does not
come into direct contact with
patient. | Delivery form is a fine spray
mist generated by piston syringe.
Device comes into direct contact
with patient. |
| Specifications | 225cm oxygen tube, 9.5 Fr | 8 inch malleable stylet |
| Accessory
Status | Device is an accessory to a
bronchoscope. | n/a |
| Reuse | One-Time Use | One-Time Use |
| Sterility | Sterile | Individually packaged clean |
COMPARISON TO PREDICATE DEVICE
2
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 stylized eagle with three lines representing its wings and head. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2003
Cook Incorporated c/o Jennifer Bosley, MBA PO Box 489 Bloomington, IN. 47402-0489
Re: K031966
Trade/Device Name: Enk Fiberoptic Atomizer Set Regulation Number: 874.4680 Regulation Name: Bronchoscope and accessories Regulatory Class: Class II Product Code: EOQ Dated: September 25, 2003 Received: September 26, 2003
Dear Ms. Bosley:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of this device for use in the performance of topical anesthesia of the lower airways (below the level of the trachea) have not been established.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the
3
Page 2 - Jennifer Bosley, MBA
market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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); 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.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4692. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K031966
Device Name: Enk Fiberoptic Atomizer Set
FDA's Statement of the Indications for Use for device:
The Enk Fiberoptic Atomizer Set is a topical anesthesia applicator used to apply topical anesthetics to a patient's laryngo-trachea area through the working channel of the bronchoscope using oxygen flow. The sterile one-time use device is designed and intended to be used by physicians trained and experienced in flexible fiberoptic intubation techniques.
The safety and effectiveness of this device for use in the performance of topical anesthesia of the lower airways (below the level of the trachea) have not been established.
Prescription Use
(Per 21 CFR 801.109)
Karin Bahr
Division Sian-Off Division of Ophthalmic Ear. Nose and Throat Devis
510(k) Number K031766