EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) by EXMOOR PLASTICS LTD.

EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT
This implant is designed to aerate the attic and mastoid 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.
EXMOOR MIDDLE EAR AERATION SHEETING
This implant is designed to reduce adhesions in the middle ear following tympanoplasty surgery.
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.

Device Description

The devices are small, shaped pieces of silicone rubber sheet. They are intended for long term use, i.e. it is not necessary for this material to be removed.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Exmoor Attic and Mastoid Antrum Middle Ear Implant" and "Exmoor Middle Ear Aeration Sheeting." This regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and detailed device performance results.

Therefore, the document does not contain the information needed to fill out a table of acceptance criteria and reported device performance or address most of the requested points.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

Not available. The document does not describe specific performance metrics, acceptance criteria, or the results of a study designed to meet such criteria. It primarily focuses on the device description, intended use, and comparison to a predicate device for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not available. No test set or data provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not available. No ground truth establishment is described.

4. Adjudication method for the test set:

Not available. No adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable/Not available. This device is a physical implant (silicone rubber sheeting), not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/Not available. As mentioned above, this is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not available. No ground truth information is provided as there's no diagnostic study described. The basis for approval is "substantial equivalence" to a predicate device already on the market.

8. The sample size for the training set:

Not available. No training set is mentioned as this is not an AI/algorithmic device.

9. How the ground truth for the training set was established:

Not available. No training set or ground truth establishment is described.

Summary of what is present in the document:

Trade Name: Exmoor Attic and Mastoid Antrum Middle Ear Implant, Exmoor Middle Ear Aeration Sheeting
Common Name: Attic and Mastoid, Aeration Sheeting
Classification Name: Prosthesis, Ear, Internal
Predicate Devices: Exmoor Plastics SRS/1, 510K number K911503/A
Description of Device: Small, shaped pieces of silicone rubber sheet intended for long-term use.
Intended Use:
- Attic and Mastoid: Following tympano-mastoid surgery, placed into the attic and mastoid to improve aeration from the middle ear.
- Aeration Sheeting: Following middle ear surgery (adhesion removal, tympanic membrane/ossicular chain reconstruction), inserted into the mouth of the eustachian tube, covering the promontory, under the handle of the malleus, and covering the middle ear, to reduce adhesions.
Comparison with Predicate Devices: "All these devices are cut from exactly the same implantable silicone rubber sheeting as the Exmoor Plastics SRS/1." The convenience for the surgeon (saving time and material) is highlighted as the primary difference.
Regulatory Outcome: Found "substantially equivalent" to predicate devices marketed prior to May 28, 1976.

In conclusion, the provided document is a 510(k) summary for a physical medical device. It focuses on regulatory approval through substantial equivalence, not on detailed performance studies against specific acceptance criteria.

Summary

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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 Implant2. Exmoor Middle Ear Aeration Sheeting
Common Name:	1. Attic and Mastoid2. 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 siliconerubber sheet. They are intended for long term use,i.e. it is not necessary for this material to beremoved.
Intended Use:	1. Attic and Mastoid - Following tympano-mastoidsurgery, this implant is placed into the attic andback into the mastoid. It is intended to improveaeration from the middle ear into the attic and themastoid.

1. 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 (301) 594-4613. Additionally, for question on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.
1. 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.

(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 Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K922700

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
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.(b)
Classification. Class II.