EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)

K972700 · Exmoor Plastics , Ltd. · KHJ · Jul 16, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K972700
• Device Name: EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)
• Applicant: Exmoor Plastics , Ltd.
• Product Code: KHJ · Ear, Nose, Throat
• Decision Date: Jul 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Attic and Mastoid - Following tympano-mastoid surgery, this implant is placed into the attic and back into the mastoid. It is intended to improve aeration from the middle ear into the attic and the mastoid. 2. Aeration Sheeting - Following middle ear surgery, after removal of middle ear adhesions and following reconstruction of the tympanic membrane and ossicular chain, this implant is inserted into the mouth of the eustachian tube, covering the promontory, under the handle of the malleus and covering the middle ear. This implant is designed to reduce adhesions in the middle ear following surgery.

Device Story

Small, shaped silicone rubber implants; intended for long-term implantation. Attic and Mastoid implant placed in attic and mastoid antrum post-tympanomastoid surgery to improve aeration; narrow end positioned under malleus head. Aeration Sheeting placed in middle ear post-surgery to prevent adhesions between malleus/promontory or eardrum/inner ear. Used in operating room by surgeons. Benefits include improved aeration and reduced post-surgical adhesion formation. Pre-cut shapes save surgical time and reduce material waste.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Implantable silicone rubber sheeting; pre-shaped for specific anatomical placement in the middle ear/mastoid. Non-absorbable, intended for long-term use.

Indications for Use

Indicated for patients undergoing tympanomastoid or middle ear surgery. Attic and Mastoid implant used to improve aeration of the attic and mastoid antrum. Aeration Sheeting used to reduce middle ear adhesions following tympanoplasty and ossicular chain reconstruction.

Regulatory Classification

Identification

Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

Predicate Devices

• Exmoor Plastics SRS/1 (K911503/A)

Submission Summary (Full Text)

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Image /page/0/Picture/10 description: The image shows a logo with the text "Exmoor Plastics" in bold, black font. Above the text, there is a date "JUL 16 1998" in a smaller, less bold font. To the left of the text, there is a drawing of a deer head with large antlers.

eda/cdrh/ode/dmc

4 Mar 90 20 1 2 3 RECEIVEL

Image /page/0/Picture/3 description: The image contains two logos. The logo on the left is a circular logo with the text "QUALITY ASSURED FIRM" around the top and "ISO 9001" in the center. There is a check mark at the bottom of the circle. The logo on the right is a square logo with a crown on top and a check mark inside the square. The text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES" is written below the check mark.

Contact: Margaret Blackmore

Our Ref:

27 April 1998

Your Ref:

K972700 Re:

## Summary of Safety and Effectiveness

MB/PAS

| Trade Name: | 1. Exmoor Attic and Mastoid Antrum Middle Ear Implant<br>2. Exmoor Middle Ear Aeration Sheeting |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | 1. Attic and Mastoid<br>2. Aeration Sheeting |
| Classification Name: | Prosthesis, Ear, Internal |
| Predicate Devices: | Exmoor Plastics SRS/1, 510K number K911503/A |
| Description of Device: | The devices are small, shaped pieces of silicone<br>rubber sheet. They are intended for long term use,<br>i.e. it is not necessary for this material to be<br>removed. |
| Intended Use: | 1. Attic and Mastoid - Following tympano-mastoid<br>surgery, this implant is placed into the attic and<br>back into the mastoid. It is intended to improve<br>aeration from the middle ear into the attic and the<br>mastoid. |

- 2. Aeration Sheeting - Following middle ear surgery, after removal of middle ear adhesions and following reconstruction of the tympanic membrane and ossicular chain, this implant is inserted into the mouth of the eustachian tube, covering the promontory, under the handle of the malleus and covering the middle ear. This implant is designed to reduce adhesions in the middle ear following surgery.

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Comparison with Predicate Devices:

All these devices are cut from exactly the same implantable silicone rubber sheeting as the Exmoor Plastics SRS/1. This is for the convenience of the surgeon, saving time in the operating room and avoiding waste of expensive implantable material in the form of offcuts.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 6 1998

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

RE:

K972700 Exmoor Attic and Mastoid Antrum Middle Ear Plant Exmoor Middle Ear Aeration Sheeting Dated: April 15, 1998 Received: April 20, 1998 Regulatory Class: II 21 CFR 874.3620/Procode: 77 KHJ

Dear Ms. Blackmore:

We have reviewed your Section 510%) 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 II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral 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 (OS) 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 question 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/cdrh/dsmadsmam.html".

Sincerely yours,

William Yin, Ph.D.

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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## 510(k) Number (if known): K972700

## Device Name: 1. EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT

- This implant is designed to aerate the attic and mastoid Indications for Use: antrum following tympanomastoid surgery. This silastic implant is designed to be placed in the attic and back into the mastoid antrum following mastoidectomy/ tympanoplasty surgery. The narrow end is placed under the head of the malleus when present and back into the mastoid antrum to enhance mucosa regrowth.
## Device Name: 2. EXMOOR MIDDLE EAR AERATION SHEETING

Indications for Use: 1.

- This implant is designed to reduce adhesions in the middle ear following tympanoplasty surgery.
- 2. Made with medical grade silicone, this implant was designed to be used following middle ear surgery to prevent middle ear adhesions, especially from the malleus to the promontory, or from the ear drum to the inner ear.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K922700

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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