ENDOFLEX TRACHEAL TUBE

• K Number: K031794
• Device Name: ENDOFLEX TRACHEAL TUBE
• Manufacturer: MERLYN ASSOCIATES INC.
• Date Cleared: 2004-03-12 ( 276 days)
• Product Code: BTR
• Regulation Number: 868.5730
• Type: Traditional
• Panel: Anesthesiology
• Reference & Predicate Devices: K871204
• Predicate For: K080339

Intended Use

The EndoFlex Tracheal Tube is intended for airway management by oral/nasal intubation.

Device Description

The EndoFlex Tracheal Tube is sterile, single use device for airway management during anesthesia and mechanical ventilation. The tube is made in fifteen sizes; 3.0mm through 10.0mm in 0.5 mm increments. The EndoFlex Tracheal tube is identical to the predicate devices in terms of material composition, biocompatibility, and sterilization. The EndoFlex Tracheal tube has a beveled tip, high volume/low pressure cuff, inflation system, and 15mm connector equivalent to the predicate devices. The EndoFlex Tracheal tube differs from the predicate device in the following ways: The EndoFlex Tracheal tube has an articulating tip that can be flexed to facilitate intubation. The flexing tip eliminates the need for intubation stylets.

AI/ML Overview

The provided document describes the predicate device and the new device being submitted for 510(k) clearance, the EndoFlex Tracheal Tube. It explicitly states that no clinical performance data has been collected for the EndoFlex Tracheal Tube.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such study was performed or documented in the provided text.

Here is the information that can be extracted from the document based on your request, highlighting the lack of clinical study data:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria for Non-Clinical Performance: Conformance to ASTM 1242-96 performance standard.
     • Materials
     • Cuffs
     • Inflation system
     • Radius of curvature
     • Marking materials
     • Packaging
     • Tube collapse
     • Cuff materials
     • Radiopaque markers
     • Leak test
   • Reported Device Performance: The EndoFlex Tracheal Tube conforms to all of the performance standard criteria for materials, cuffs, inflation system, radius of curvature, marking materials, and packaging. The tube passes all performance tests for tube collapse, cuff materials, and packaging, radiopaque markers, and leak test.
   • Clinical Performance Data: To date, no clinical data has been collected.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable as no clinical study was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable as no clinical study was performed.

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

   • Not applicable as no clinical study was performed.

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:

   • Not applicable as this is a medical device (tracheal tube), not an AI diagnostic/imaging device, and no clinical study was performed.

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

   • Not applicable as this is a medical device (tracheal tube), not an algorithm.

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

   • Not applicable as no clinical study was performed. For non-clinical testing, the ground truth was presumably defined by the ASTM 1242-96 standard.

8. The sample size for the training set:

   • Not applicable as no clinical study was performed and this is not an AI/machine learning device.

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

   • Not applicable as no clinical study was performed and this is not an AI/machine learning device.

Summary of Clinical Data: The document explicitly states: "To date, no clinical data has been collected." The substantial equivalence assessment is based on non-clinical testing results against a predicate device.

Summary

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Section E - 510(k) Summary

June 2, 2003

Applicant:	Merlyn Associates Inc.11 Bayleaf LaneIrvine, CA 92620Phone: [phone] Fax: [phone]Email: [e-mail]
Application Preparer &Correspondent	Thomas E. FerariMedical Device Consultant181 Dixon RoadQueensbury, NY 12804Phone - 518-792-2258 Fax: [phone]Email - [e-mail]
Proprietary Device Name:	EndoFlex Tracheal Tube
Common Device Name:	Endotracheal Tube
Classification Name:	Tracheal Tube (Class II Device Ref 21CFR 868.5730)
Predicate Devices:	Cuffed Tracheal TubeMallinckrodt Critical Care K871204

Device Description: The EndoFlex Tracheal Tube is sterile, single use device for airway management during anesthesia and mechanical ventilation. The tube is made in fifteen sizes; 3.0mm through 10.0mm in 0.5 mm increments. The EndoFlex Tracheal tube is identical to the predicate devices in terms of material composition, biocompatibility, and sterilization. The EndoFlex Tracheal tube has a beveled tip, high volume/low pressure cuff, inflation system, and 15mm connector equivalent to the predicate devices. The EndoFlex Tracheal tube differs from the predicate device in the following ways:

• The EndoFlex Tracheal tube has an articulating tip that can be flexed to facilitate . intubation. The flexing tip eliminates the need for intubation stylets.
  Intended Use: The EndoFlex Tracheal Tube is intended for airway management by oral/nasal intubation.

Non-Clinical Performance Data: The EndoFlex Tracheal Tube was evaluated using the ASTM 1242-96 performance standard. The EndoFlex Tracheal Tube conforms to all of the performance standard criteria for materials, cuffs, inflation system, radius of curvature, marking

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materials, and packaging. The tube passes all performance tests for tube collapse, cuff materals, and paekaging - Netwees we/volume/diameter assessment, radiopaque markers, and leak test.

Clinical Performance Data: To date, no clinical data has been collected.

Substantial Equivalence Assessment: Based on the non-clinical testing of the EndoFlex Substantial Liqurulent to the predicate devices and both safe and effective for clinical usc.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2004

Merlyn Associates Incorporated c/o Dr. Ching Ching Seah, Ph.D. Amsino International, Incorporated 4501 Brickell Privado Ontario, CA 91761

Re: K031794

Trade/Device Name: EndoFlex Tracheal Tube Regulation Number: 863.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: January 8, 2004 Received: January 12, 2004

Dear Dr. Seah:

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r hat 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

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Page 2 - Dr. Ching Ching Seah, Ph.D.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Charles

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

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Section D - Statement of Indications for Use

510(k) Number:	K031794
Applicant:	Merlyn Associates Inc.11 Bayleaf LaneIrvine, CA 92620Phone: [phone] Fax: [phone]

EndoFlex Tracheal Tube Proprietary Device Name:

Intended Use: The EndoFlex Tracheal Tube is intended for airway management by oral/nasal intubation.

Prescription USE

510(k) Number:

fth

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

Regulation Number and Section

§ 868.5730 Tracheal tube.

(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).