MILLS INCUS HA SLEEVE

K974365 · Exmoor Plastics , Ltd. · ETB · Jan 22, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K974365
• Device Name: MILLS INCUS HA SLEEVE
• Applicant: Exmoor Plastics , Ltd.
• Product Code: ETB · Ear, Nose, Throat
• Decision Date: Jan 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Any gap in the ossicular chain caused by erosion of the incus.

Device Story

Mills Sleeve Prosthesis is a middle ear implant used to reconstruct the ossicular chain. Constructed from hydroxylapatite, the device bridges gaps caused by incus erosion. It is intended for surgical implantation by an ENT surgeon. The device functions as a passive mechanical implant; it does not require active power or software. In the event of reconstruction failure, the design facilitates extrusion from the ear without causing harm. The material is biocompatible and stable over time, ensuring safety and effectiveness for middle ear reconstruction.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by the clinical experience of the surgeon and the known biocompatibility of hydroxylapatite in middle ear applications.

Technological Characteristics

Material: Hydroxylapatite. Form factor: Sleeve prosthesis for ossicular chain reconstruction. Passive mechanical device. No energy source, connectivity, or software.

Indications for Use

Indicated for patients with ossicular chain gaps resulting from incus erosion.

Regulatory Classification

Identification

A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.

Submission Summary (Full Text)

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## K974365

## SUMMARY OF SAFETY & EFFECTIVENESS

JAN 2 2 1998

Based on previous experience of middle ear prostheses, there is no reason to believe that the proposed prosthesis, or the material from which it is constructed, will have any detrimental effect on the condition of the patient. The available data indicate that hydroxylapatite does not alter with time in any way that might have an adverse effect on the patient or on the efficiency of the reconstruction. Should the reconstruction fail, it is likely that the prosthesis would be extruded from the ear without causing any harm. The prosthesis will not be harmful to the user or any third party.

I therefore affirm, as an otologist of many years' experience, that this device will be completely safe and effective in use.

R. P. Mills, MS. MPhil, FRCS Consultant ENT Surgeon

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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 features a stylized eagle with three stripes forming its wing and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

K974365 Mills Sleeve Prosthesis Dated: November 10, 1997 Received: November 19, 1997 Regulatory class: II 21 CFR 874.3450/Procode: 77 ETB JAN 2 2 1998

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 includes) 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; Drag; and Cosmetic Act (Act). "Tou may, therefore, 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 (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 531 through 542 of the Act for devices under 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 question 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/cdrh/dsmamain.html".

Sincerely yours,

hồ tiêu Yri

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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Device Listing Number: A895750 t a first o a other of the start of the s

| 510(k) Number (if known): | K97 4365 |
|---------------------------|-------------------------|
| Device Name: | MILLS SLEEVE PROSTHESIS |

Indications for Use:

Any gap in the ossicular chain caused by erosion of the incus.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(

OR

Over-The-Counter Use

(Optional Format 1-2-96)

David L. Jessop

(Division Sign-Off) Division of Reproductive, Abdominal, ENT) and Radiological Device 510(k) Number