BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES

K062385 · Grace Medical, Inc. · ETD · Sep 27, 2006 · Ear, Nose, Throat

Device Facts

• Record ID: K062385
• Device Name: BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES
• Applicant: Grace Medical, Inc.
• Product Code: ETD · Ear, Nose, Throat
• Decision Date: Sep 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Chronic otitis media with effusion (serous, mucoid, or purulent) Recurrent episodes of acute otitis media despite conventional medical treatment A record of persistent high negative middle ear pressure associated with one or more of the following system: 1. Conductive hearing loss that is symptomatic 2. Persistent or recurrent otalgia 3. Persistent or recurrent vertigo, tinnitus, or both Atelectasis resultant from retraction pocket of the tympanic membrane or eustachian tube dysfunction.

Device Story

Tympanostomy tubes (ventilation tubes) designed for surgical placement in the tympanic membrane. Device facilitates middle ear ventilation and drainage of fluid. Used by otolaryngologists in clinical or surgical settings to treat chronic otitis media, recurrent acute otitis media, and eustachian tube dysfunction. Manufactured from blue PTFE (fluoroplastic). Device is supplied sterile. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Blue PTFE (fluoroplastic). Form factor: Tympanostomy tube. Sterilization: Sterile. No software, electronics, or energy source.

Indications for Use

Indicated for patients with chronic otitis media with effusion, recurrent acute otitis media, persistent high negative middle ear pressure with associated symptoms (conductive hearing loss, otalgia, vertigo, or tinnitus), or atelectasis due to tympanic membrane retraction or eustachian tube dysfunction.

Regulatory Classification

Identification

A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.

Predicate Devices

• Fluoroplastic Ventilation Tubes (K992222)
• Tympanostomy Tubes (K943325)

Submission Summary (Full Text)

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## SEP 2 7 2006

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Grace Medical Adjustable Length and Fixed Length Partial and Total Ossicular Replacement Prostheses

| Trade Name: | Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes | |
|----------------------|-----------------------------------------------------------|--|
| Common Name: | Tympanostomy Tubes | |
| Classification Name: | Tympanostomy Tubes (CFR 21 § 874.3880) | |
| Official Contact: | Jeff Cobb | |
| | Vice President of Regulatory Affairs & Quality | |
| | Grace Medical, Inc. | |
| | 8500 Wolf Lake Drive, Suite 110 | |
| | Memphis, TN 38133 | |
| Telephone: | [phone] | |
| Telefax: | [phone] | |
| Date Prepared: | August 14, 2006 | |

Predicate Devices - The Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes are substantially equivalent to the predicate devices listed below.

| Predicate Device | Manufacturer | 510(k) Number<br>(if known) |
|---------------------------------|--------------------|-----------------------------|
| Fluoroplastic Ventilation Tubes | Gyrus ENT | K992222 |
| Tympanostomy Tubes | Grace Medical Inc. | K943325 |

Intended Use -- The Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes have the same primary intended use as the predicate devices which consist of:

- Chronic otitis media with effusion (serous, mucoid, or purulent) ●
- . Recurrent episodes of acute otitis media despite conventional medical treatment
- A record of persistent high negative middle ear pressure associated with one or more of the . following system:
- 1. Conductive hearing loss that is symptomatic
- 2. Persistent or recurrent otalgia
- 3. Persistent or recurrent vertigo, tinnitus, or both

:

- . Atelectasis resultant from retraction pocket of the tympanic membrane or eustachian tube dysfunction.
Materials - The Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes are manufactured from the same materials as the Gyrus ENT Fluoroplastic Ventilation Tubes.

Design Features - Various designs of Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes are available to meet physician preference. The design features of the Grace Medical PTFE Ventilation Tubes should not raise new safety or effectiveness issues.

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## Comparison Charts

| | GRACE MEDICAL BLUE PTFE (FLUOROPLASTIC)<br>VENTILATION TUBES | GRACE MEDICAL<br>VENTILATION TUBES<br>(K943325) | GYRUS ENT FLUOROPLASTIC<br>VENTILATION TUBES<br>(K992222) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-----------------------------------------------------------|
| Intended Use | Chronic otitis media with effusion (serous, mucoid, or<br>purulent) Recurrent episodes of acute otitis media despite<br>conventional medical treatment A record of persistent high negative middle ear pressure<br>associated with one or more of the following system: 1. Conductive hearing loss that is symptomatic 2. Persistent or recurrent otalgia 3. Persistent or recurrent vertigo, tinnitus, or both Atelectasis resultant from retraction pocket of the<br>tympanic membrane or eustachian tube dysfunction. | Same | Same |
| Primary<br>Material(s) | Blue (PTFE) Fluoroplastic<br>(Same as Gyrus ENT) | Fluoroplastic | Blue (PTFE) Fluoroplastic |
| How Supplied | Sterile | Sterile | Sterile |

Differences between the Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes and the predicate devices should not raisc new issues regarding safety or effectiveness.

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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 depiction of a human figure with three flowing lines above it, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Grace Medical, Inc. c/o Jeff Cobb Vice President Regulatory Affairs & Quality 8500 Wolf Lake Drive, Suite 110 Memphis. TN 38133

SEP 27 2006

Re: K062385

Trade/Device Name: Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy tube Regulatory Class: Class II Product Code: ETD Dated: August 14, 2006 Received: August 15, 2006

Dear Mr. Cobb:

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 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.

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Page 2 - Jeff Cobb

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/industry/support/index.html.

Sincerely yours,

M.B. Eychler-Siwd

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Food and Drug Administration 5 10(k) Notification - Blue PTFE (Fluoroplastic) Ventilation Tubes August 14, 2006

510(k) Number:

062385

Device Name:

Blue PTFE (Fluoroplastic) Ventilation Tubes

## Indications for Use:

- " "Chronic otitis media with effusion (serous, mucoid, or purulent)
- Recurrent episodes of acute otitis media despite conventional medical treatment .
- A record of persistent high negative middle ear pressure associated with one or . more of the following system:
- 1. Conductive hearing loss that is symptomatic
- 2. Persistent or recurrent otalgia
- 3. Persistent or recurrent vertigo, tinnitus, or both
- Atelectasis resultant from retraction pocket of the tympanic membrane or . eustachian tube dysfunction.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2/96)

Dhalhot

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devise

510(k) Number.