(393 days)
K911503/A
There are no Reference Devices listed in the provided text. The text explicitly states "Not Found" for the Reference Device(s).
No
The 510(k) summary describes a passive silicone implant for surgical use and makes no mention of AI or ML technology.
Yes
The device is intended to aerate the attic and mastoid antrum and reduce adhesions in the middle ear following surgery, which are therapeutic functions.
No
The device is an implant designed for therapeutic purposes (aeration, reducing adhesions) after surgery, not for diagnosing a condition.
No
The device description explicitly states the devices are "small, shaped pieces of silicone rubber sheet," indicating they are physical implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an implant designed to be placed in the body (middle ear, attic, mastoid antrum) following surgery. It's used to aerate or reduce adhesions.
- Device Description: The description confirms it's a physical implant made of silicone rubber sheet intended for long-term use within the body.
- Anatomical Site: The anatomical sites are internal parts of the ear.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. It doesn't analyze blood, urine, tissue samples, or any other biological material in a lab setting.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used to physically modify or support structures within the body.
N/A
Intended Use / Indications for Use
-
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. 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.
-
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. 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.
Product codes (comma separated list FDA assigned to the subject device)
77 KHJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
attic, mastoid, middle ear, tympanic membrane, eustachian tube, promontory
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Exmoor Plastics SRS/1, K911503/A
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
2. Exmoor Middle Ear Aeration Sheeting |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | 1. Attic and Mastoid
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
rubber sheet. They are intended for long term use,
i.e. it is not necessary for this material to be
removed. |
| 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. |
-
- 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.
1
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.
2
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
3
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.
-
- 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)
OR