MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)

K080339 · Medsource International, LLC · BTR · Oct 27, 2008 · Anesthesiology

Device Facts

• Record ID: K080339
• Device Name: MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
• Applicant: Medsource International, LLC
• Product Code: BTR · Anesthesiology
• Decision Date: Oct 27, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for oral or nasal intubation and for airway management.

Device Story

MedSource Endotracheal Tube and Pre-Loaded Endotracheal Tube with Stylet are sterile, single-use devices constructed of polyvinyl chloride. The system consists of a single lumen tube (cuffed or uncuffed) featuring a tapered tip with a Murphy Eye, graduations for depth monitoring, and a connector with a check valve. The pre-loaded version includes a stylet with a low-friction coating to facilitate insertion. Used by clinicians in clinical settings for oral or nasal intubation, the device provides a patent airway for patients. The healthcare provider inserts the tube into the trachea to manage ventilation; the stylet aids in maintaining tube shape during placement. The device benefits patients by securing the airway and enabling controlled gas exchange.

Clinical Evidence

No clinical studies were conducted for safety or effectiveness. Bench testing was performed to demonstrate compliance with ISO 5361:1999 (anaesthetic and respiratory equipment) and ISO 10993-1:1997 (biological evaluation).

Technological Characteristics

Constructed of medical-grade polyvinyl chloride. Features include single lumen, tapered tip with Murphy Eye, pilot balloon, and connector with check valve. Pre-loaded version includes a low-friction coated stylet. Compliant with ISO 5361:1999 and ISO 10993-1:1997. Sterile, single-use, manual operation.

Indications for Use

Indicated for oral or nasal intubation and airway management in patients requiring mechanical ventilation or airway protection.

Regulatory Classification

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.

Predicate Devices

• Rusch™ Flexi-Set® Cuffed ET Tube and Stylet Set (K925505, K925506)
• EndoFlex™ Tracheal Tube (K952100, K031794)
• Well Lead™ ET Tube (K042683)

Submission Summary (Full Text)

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Koro39

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5346 Shoreline Drive, Mound, MN 55364

# October 26, 2008 | | | | | | | | |

SECTION 510(K) Summary র্বাচন করে পার্টি করে একটি পার্টি পাট করে না বিশ্বকাপ করে আমার প্রকল্পে করে আমার প

This 510(K) Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

| Submitter's | MedSource International, LLC |
|-------------------------------------|-----------------------------------------|
| Information: | 5346 Shoreline Drive<br>Mound, MN 55364 |
| O: | [phone] |
| F: | [phone] |
| FDA Establishment Registration No.: | 3003674698 |

OCT 2 7 2008

Contact Person: Howard Cooper Quality Consultant EQACT, INC. 317-826-4398 (0) 317-523-2314 (C) [e-mail]

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### SECTION 510(K) Summary

| Device Names: | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--|
| Trade/Proprietary<br>Names: | (1) MedSource Endotracheal Tube<br>(with and without cuff), (stylet sold separately) | | |
| | (2) MedSource Pre-Loaded Endotracheal Tube and Stylet<br>(Pre-loaded ET Tube with Stylet; with and without cuff). | | |
| Common/Usual<br>Name: | Endotracheal Tube; Tracheal Tube; Trach Tube; ET Tube.<br>(with and without connector), (cuffed and uncuffed),<br>(with and without stylet) | | |
| Common/Usual<br>Name: | Stylet. | | |
| Classifications: | | | |
| | Endotracheal Tube | Stylet | |
| Panel:<br>Regulatory Reference:<br>Classification Name:<br>Product Code:<br>Device Class | Anesthesiology<br>21 CFR §868.5730<br>Tracheal Tube<br>BTR<br>Class II | Anesthesiology<br>21 CFR §868.5790<br>Tracheal Tube Stylet<br>BSR<br>Class I; 510k Exempt | |
| Description: | | | |
| MedSource Pre-Loaded Endotracheal Tube (Cuffed & Uncuffed) with and without Stylet:<br>• Constructed of Polyvinylchloride<br>• Single lumen tube with or without a cuff;<br>• Tapered tip with Murphy Eye;<br>• Clear medical-grade tubing(polyvinyl) with graduations;<br>• Connector with check valve;<br>• Pre-loaded with Stylet having a low friction coating;<br>• Various sizes<br>• Sterile Single-Use Device | | | |
| Intended Use: | | | |

### Indications for Use: MedSource Endotracheal Tube:

The device is intended for oral or nasal intubation and for airway management.

Indications for Use: MedSource Pre-Loaded Endotracheal Tube and Stylet: The device is intended for oral or nasal intubation and for airway management.

Prescription Use: (21 CFR 801(D)) Yes

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# Technological Characteristics: 10 comments of 1 comments of 1

| Characteristics | MedSource | Predicate Devices |
|---------------------------|-----------------------|-------------------|
| Materials of Construction | Polyvinyl Chloride | Equivalent |
| Sizes | Typical product sizes | Same |
| Method of Use | Manual | Manual |
| Murphy's Eye | Yes | Yes |
| Pilot Balloon | Yes | Yes |
| With & Without Stylet | Yes | Yes |

# Standards

| Standard | Title | Status of Compliance |
|----------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------|
| ISO 5361:1999 | ISO 5361:1999, Anaesthetic and respiratory equipment - Tracheal tubes and connectors | Compliant to applicable sections |
| ISO10993-1<br>edition-1997-12-15 | (2nd Biological Evaluation Of Medical Devices—<br>Part 1: Evaluation and Testing | Compliant to applicable sections per testing |

| Substantial Equivalence Discussion | | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | MedSource | Predicate Devices |
| Device | (1) MedSource Endotracheal Tube<br>(with and without cuff), (stylet sold separately)<br><br>(2) MedSource Pre-Loaded Endotracheal Tube and Stylet<br>(Pre-loaded ET Tube with Stylet; with and without cuff). | K925505; K925506<br>Rusch™ Flexi-Set® Cuffed ET Tube and Stylet Set<br><br>K952100 K031794<br>EndoFlex™ Tracheal Tube<br><br>K042683<br>Well Lead™ ET Tube |
| Intended Use | The device is intended for oral or nasal intubation and for airway management. | Exact or similar wording |
| Materials of<br>Construction | Polyvinyl Chloride | Equivalent |
| Single Use/Sterile | Yes | Yes |
| Murphy's Eye | Yes | Yes |
| Pilot Balloon | Yes, as applicable to product | Yes, as applicable to product |
| With & Without<br>Stylet | Yes | Yes |
| Instructions for<br>Use | Similar or identical wording for all devices | |

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#### October 26, 2008

# Conclusion:

Based on the following, it can be concluded that the MedSource Endotracheal Tube is substantially equivalent to the predicate devices listed above:

- 1. Intended use is the same.
- 2. Materials of construction or the same or equivalent.
- 3. Both the MedSource and the predicate devices have product features such as a Murphy's Eye and Pilot balloon.
- 4. Instructions for use are the same.

# Clinical Studies .

No clinical studies were conducted for safety or effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 2 7 2008

MedSource International, LLC C/O Mr. Howard T. Cooper President EQACT, Incorporated 11715 Fox Road, Suite 400-180 Indianapolis, Indiana 46236

Re: K080339

Trade/Device Name: MedSource Endotracheal Tube (with and without Cuff), (Stylet Sold Separately) MedSource Pre-Loaded Endotracheal Tube and Stylet (with and without Cuff)

Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: September 24, 2008 Received: September 24, 2008

Dear Mr. Cooper:

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.

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#### Page 2 - Mr. Cooper

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely vours.

Himmelsfrend und frey

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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# Indications for Use Statement

SECTION 4

510(k) Number: Initial Submission Device Names: Common or Usual Names: Endotracheal Tube; ET Tube; Tracheal Tube; Trach Tube Proprietary Names: (1) MedSource Endotracheal Tube (with and without cuff), (stylet sold separately); (2) MedSource Pre-Loaded Endotracheal Tube and Stylet (with and without cuff). Indications for Use: MedSource Endotracheal Tube: The device is intended for oral or nasal intubation and for airway management.

Indications for Use: MedSource Pre-Loaded Endotracheal Tube and Stylef: The device is intended for oral or nasal intubation and for airway management.

Prescription Use: (21 CFR 801 (D)) Yes

Over-the-Counter Use: (21 CFR 801 (C)} No

Please do not write below this line. Continue on another page if needed. Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K080339