MILLS COLUMELLA PROSTHESIS

K981088 · Exmoor Plastics , Ltd. · ETA · Jun 5, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K981088
• Device Name: MILLS COLUMELLA PROSTHESIS
• Applicant: Exmoor Plastics , Ltd.
• Product Code: ETA · Ear, Nose, Throat
• Decision Date: Jun 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3495
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mills Columella is intended to improve or restore hearing by replacing an absent or defective incus and stapes.

Device Story

The Mills Columella Prosthesis is an internal ear implant used to restore hearing in patients with ossicular chain defects. It functions as a mechanical bridge to replace an absent or defective incus and stapes. The device is implanted by an otolaryngologist during middle ear surgery. It can be used in conjunction with ossicular or cortical bone grafts. By providing a structural link within the middle ear, the prosthesis facilitates sound conduction, thereby improving or restoring hearing for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: p.t.f.e. (polytetrafluoroethylene). Form factor: Columella prosthesis for middle ear reconstruction. Non-porous construction. Designed for surgical implantation.

Indications for Use

Indicated for the treatment of an absent or defective stapes.

Regulatory Classification

Identification

A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.

Predicate Devices

• Shea Plasti-Pore, TORP
• Austin Off Centered, TORP

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Exmoor Plastics. On the left is a drawing of a deer head with large antlers. To the right of the deer head is the text "Exmoor Plastics" in a bold, sans-serif font. The word "Exmoor" is on top of the word "Plastics".

for / onghyzer.com

DMR/1/F/47

K98/088

Image /page/0/Picture/4 description: The image contains two logos. The logo on the left is a circular seal with the text "QUALITY ASSURED FIRM" around the top half of the circle and "ISO 9001" in the center. Below the text is "SGS". The logo on the right has a crown at the top and a check mark. Below the check mark is the text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES".

JUN 5 1998

Your Ref:

Our Ref:

MB/PAS/DMR/1/F/47

Contact: Margaret Blackmore

13 March 1998

Ref: DMR/1/F/47

## SUMMARY OF SAFETY AND EFFECTIVENESS

Mills Columella Prosthesis

Prosthesis, Ear, Internal

Shea Plasti-Pore, TORP

loss of stapes arch.

incus and stapes.

Austin Off Centered, TORP

Ossicular Replacement Prosthesis

Trade Name:

Common Name

Classification Name:

Predicate Devices:

Description of Device:

Intended Use:

Comparison with Predicate Devices:

Both predicate devices are manufactured from Plasti-Pore. The subject device is manufactured from p.t.f.e., a non-porous but otherwise very similar material. The size of the subject device is, on average, smaller than the predicate devices but performs exactly the same function.

The Mills Columella Prosthesis is manufactured

from p.t.f.e., a material which has been used for the reconstruction of the middle ear for many years. It can be combined with an ossicular or cortical bone graft for the treatment of ossicular defects, including

The Mills Columella is intended to improve or

restore hearing by replacing an absent or defective

Image /page/0/Picture/21 description: The image shows the company information for Exmoor Plastics Ltd. The company is located at Lisieux Way, Taunton, TA1 2LB, U.K. The image also includes the company's phone and fax numbers.

Co. Reg. No: 2075762 (Eng)

Tel: [phone] Fax: [phone]

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol consisting of three stylized human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 5 1998

Margaret Blackmore Regulatory Affairs Exmoor Plastics, Ltd. Lisieux Way Taunton, TA1 2LB U.K. Re:

K981088 Mills Columella Prosthesis Dated: March 19, 1998 Received: March 25, 1998 Regulatory class: II 21 CFR 874.3495/Procode: 77 ETA

Dear Ms. Blackmore:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note; this response to your premarket notification. submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdr/dsmaldsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear. Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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kug1088 510(k) Number (if known):

MILLS COLUMELLA PROSTHESIS Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The treatment of an absent or defective stapes.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE if NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seijon

(Division Sign-Off) Division of Rep ductive, Abdominal, ENT, and Radiological Device

510(k) Number K991088

Prescription Use_ (Per 21 CFR 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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