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 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.

AI/ML Overview

The provided text describes a 510(k) submission for the "Enk Fiberoptic Atomizer Set" and its substantial equivalence to a predicate device, the "MADgic™ Laryngo-Tracheal Mucosal Atomization Device" (K002255). The assessment of this device is based on performance testing and similarity to the predicate, rather than clinical study results. As such, the information required for a comprehensive acceptance criteria and study description, particularly for AI/machine learning devices, is not fully present.

However, based on the Test Data section, we can infer the acceptance criteria and the type of study conducted to "prove the device meets the acceptance criteria."

Here's the breakdown of the information requested, as much as can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from Test Data)	Reported Device Performance
Safety & Effectiveness	Device exhibits tightness.	Pass
Safety & Effectiveness	Device demonstrates adequate airflow.	Pass
Safety & Effectiveness	Device withstands tensile forces.	Pass
Safety & Effectiveness	Maintains sterility (implied).	Sterile (stated in comparison table)
Intended Use	Functions as a topical anesthesia applicator for laryngo-tracheal area through bronchoscope.	Functions as described (implied by substantial equivalence and intended use statement)

Note: The document states that "Performance testing, which includes tightness, air flow and tensile testing, provides reasonable assurance of safety and effectiveness for the device's intended use." This implies that the device met these performance standards. The specific quantitative values or thresholds for "tightness," "air flow," and "tensile testing" are not provided in this document.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document simply states "Performance testing." It does not provide the number of units tested for tightness, airflow, or tensile strength.
Data Provenance: Not specified. This would typically be a laboratory setting, but no country of origin or whether the tests were retrospective or prospective is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a medical instrument and its performance is evaluated through physical and functional testing, not by expert review of patient data to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See explanation for #3.

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

No. This is not an AI/imaging device. The study described is performance testing of a physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. See explanation for #5.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For a physical device, the "ground truth" for performance testing is typically defined by engineering specifications, validated test methods, and industry standards for physical properties (e.g., specific pressure values for tightness, flow rates for airflow, force values for tensile strength).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable. See explanation for #8.

Summary of Device Evaluation Approach:

The evaluation for the Enk Fiberoptic Atomizer Set is based on:

Performance Testing: Focusing on physical and functional attributes like tightness, airflow, and tensile strength. The explicit acceptance criteria (e.g., "must withstand X PSI" or "flow rate must be Y L/min") are not detailed but are implied to have been met.
Substantial Equivalence: The primary regulatory pathway is demonstrating substantial equivalence to a legally marketed predicate device (Wolfe Tory Medical MADgic™ Laryngo-Tracheal Mucosal Atomization Device, K002255) in terms of intended use, general material composition, and design features. The comparison table (in {1}) highlights specific differences and similarities, arguing that any differences do not significantly affect safety and effectiveness.

Summary

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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 INCORPORATED750 Daniels WayBloomington, In 47404
Contact:	Jennifer Bosley, MBARegulatory Affairs CoordinatorTel: (812) 339-2235Fax: (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:

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	COOKEnk Fiberoptic Atomizer Set(Subject of Submission)	Wolfe Tory MedicalMADgic™ Laryngo-TrachealMucosal Atomization Device(K002255)
Reg No./Code	868.5170-CCT874.4680—KTI	868.5170-CCT
Intended Use	The Enk Fiberoptic Atomizer Setis a topical anesthesia applicatorused to apply topical anesthetics toa patient's laryngo-tracheal areathrough the working channel of thebronchoscope using oxygen flow.The sterile one-time use device isdesigned and intended to be usedby physicians trained andexperienced in flexible fiberopticintubation techniques.	Intended for the application oftopical anesthetics to theoropharynx and upper airwayregion.
Materials	Polyurethane	Polycarbonate andPolyvinyl chloride
Method ofOperation	Delivery form is a spray mistusing oxygen flow through abronchoscope. Device does notcome into direct contact withpatient.	Delivery form is a fine spraymist generated by piston syringe.Device comes into direct contactwith patient.
Specifications	225cm oxygen tube, 9.5 Fr	8 inch malleable stylet
AccessoryStatus	Device is an accessory to abronchoscope.	n/a
Reuse	One-Time Use	One-Time Use
Sterility	Sterile	Individually packaged clean

COMPARISON TO PREDICATE DEVICE

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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

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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 (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

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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 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

Regulation Number and Section

§ 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.