ENK FIBEROPTIC ATOMIZER SET

K031966 · Cook, Inc. · EOQ · Oct 16, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K031966
• Device Name: ENK FIBEROPTIC ATOMIZER SET
• Applicant: Cook, Inc.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Oct 16, 2003
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Enk Fiberoptic Atomizer Set is a sterile, single-use topical anesthesia applicator; designed for use by physicians trained in flexible fiberoptic intubation. Device components include a pressure-resistant oxygen tube, connecting tube, three-way side-arm fitting with flow control, introducer catheter, and two 1 ml syringes. Operation involves connecting the device to an oxygen source to deliver anesthetic as a spray mist through the working channel of a bronchoscope. Unlike predicate devices that contact patient tissue directly, this device remains within the bronchoscope channel. Output is a localized anesthetic mist; intended to facilitate intubation procedures. Clinical benefit includes improved patient comfort and procedural success during airway management.

Clinical Evidence

Bench testing only. Performance testing included tightness, air flow, and tensile testing to demonstrate safety and effectiveness for the intended use.

Technological Characteristics

Materials: Polyurethane. Components: Pressure-resistant oxygen tube (225cm, 9.5 Fr), connecting tube, three-way side-arm fitting, introducer catheter, 1 ml syringes. Energy source: External oxygen flow. Form factor: Bronchoscope accessory. Sterilization: Sterile. Connectivity: None.

Indications for Use

Indicated for application of topical anesthetics to the laryngo-tracheal area in patients undergoing flexible fiberoptic intubation. Contraindicated for use in the lower airways below the level of the trachea.

Regulatory Classification

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.

Predicate Devices

• Laryngo-Tracheal Mucosal Atomization Device (MADgicTM) (K002255)

Submission Summary (Full Text)

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OCT 1 6 2003

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# KO31966

Cook Incorporated

P.O. Box 489 Bloomington, IN 47402-0489 Phone: [phone] www.cookgroup.com

### 510(k) SUMMARY

| Submitted By: | COOK INCORPORATED<br>750 Daniels Way<br>Bloomington, In 47404 |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jennifer Bosley, MBA<br>Regulatory Affairs Coordinator<br>Tel: [phone]<br>Fax: [phone] |
| 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<br>(2) Accessory to Bronchoscope, 21 CFR § 874.4680 |
| Class: | Class II |
| Product and Panel Code: | (1) CCT-73—Anesthesiology Device Panel<br>(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<br>(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.

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| Device | COOK<br>Enk Fiberoptic Atomizer Set<br>(Subject of Submission) | Wolfe Tory Medical<br>MADgic™ Laryngo-Tracheal<br>Mucosal Atomization Device<br>(K002255) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Reg No./Code | 868.5170-CCT<br>874.4680—KTI | 868.5170-CCT |
| Intended Use | The Enk Fiberoptic Atomizer Set<br>is a topical anesthesia applicator<br>used to apply topical anesthetics to<br>a patient's laryngo-tracheal area<br>through the working channel of the<br>bronchoscope using oxygen flow.<br>The sterile one-time use device is<br>designed and intended to be used<br>by physicians trained and<br>experienced in flexible fiberoptic<br>intubation techniques. | Intended for the application of<br>topical anesthetics to the<br>oropharynx and upper airway<br>region. |
| Materials | Polyurethane | Polycarbonate and<br>Polyvinyl chloride |
| Method of<br>Operation | Delivery form is a spray mist<br>using oxygen flow through a<br>bronchoscope. Device does not<br>come into direct contact with<br>patient. | Delivery form is a fine spray<br>mist generated by piston syringe.<br>Device comes into direct contact<br>with patient. |
| Specifications | 225cm oxygen tube, 9.5 Fr | 8 inch malleable stylet |
| Accessory<br>Status | Device is an accessory to a<br>bronchoscope. | n/a |
| Reuse | One-Time Use | One-Time Use |
| Sterility | Sterile | Individually packaged clean |

# COMPARISON TO PREDICATE DEVICE

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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

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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 [phone]. 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 [phone] or [phone] 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

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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