(233 days)
This procedural device is intended to make a myringotomy incision, aspirate middle ear fluid, and transport and insert aural ventilation tube(s)
Requirement for myringotomy, with or without the insertion of aural ventilation tube(s).
This single-use device is composed of any combinations of the components included within attachment numbers: 2b, 2c, 2d, 2f, 2h 2, 2a, 2e, 2g. Note: all kits shall contain a myringotome and an instrument for inserting the ventilation tube/ grommet. It has been sterilised by gamma irradiation and is ready for use. The ventilation tubes have been sterilised by steam.
The provided document is a 510(k) premarket notification for the Exmoor Myringotomy Kit. It does not contain information on acceptance criteria for a specific device performance study, nor does it detail a study proving the device meets particular acceptance criteria. Instead, it describes:
- Device Description: The components of the Exmoor Myringotomy Kit, which is a single-use device for myringotomy incision, middle ear fluid aspiration, and insertion of aural ventilation tubes.
- Intended Use: Making a myringotomy incision, aspirating middle ear fluid, and transporting and inserting aural ventilation tube(s).
- Predicate Devices: The Exmoor Myringotomy Kit is compared to two predicate devices:
- Richards Set-Op Myringotomy Kit Cat. No. 89-0205 and 89-0206
- Exmoor Tympanocentesis Kit
- Substantial Equivalence: The FDA's letter indicates that the device has been determined to be "substantially equivalent to legally marketed predicate devices." This determination is based on comparisons of intended use, technological characteristics (materials, sterilization methods), and safety/effectiveness with the predicate devices.
Therefore, I cannot fulfill the request as the document does not contain the information necessary to construct a table of acceptance criteria, describe a study proving the device meets such criteria, or provide details on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set ground truth.
The document's purpose is to demonstrate substantial equivalence to existing devices, not to present a de novo clinical or performance study with predefined acceptance criteria.
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Image /page/0/Picture/0 description: The image shows the logo for Exmoor Plastics. On the left is a black and white 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".
OCT 2 2 1998
Image /page/0/Picture/2 description: The image contains two logos. The logo on the left is a circular seal with the text "QUALITY ASSURED FIRM" around the top and "ISO 9001" in the center. There is a checkmark at the bottom of the seal and the letters "BGB". The logo on the right has a crown at the top and a checkmark inside a square. Underneath the checkmark is some text that is difficult to read.
| Your Ref | |
|---|---|
| Our Ref: | MB/PAS/K980828 |
| Contact: | Margaret Blackmore |
| 24 July 1998 | |
| Ref: | K980828 |
29 JUN 98 105 07
SUMMARY OF SAFETY AND EFFECTIVENESS
Exmoor Myringotomy Kit
Trade Name:
Common Name: Myringotomy Kit
Classification Name: Inserter, Myringotomy Tube
- Predicate Devices: Richards Set-Op Myringotomy Kit Cat. No. 89-0205 and 89-0206 Exmoor Tympanocentesis Kit
Description of Device: This single-use device is composed of any combinations of the components included within attachment numbers:
2b, 2c, 2d, 2f, 2h 2, 2a, 2e, 2g,
Note: all kits shall contain a myringotome and an instrument for inserting the ventilation tube/ grommet.
It has been sterilised by gamma irradiation and is ready for use.
- The ventilation tubes have been sterilised by steam.
Fax: (01823) 334154
Intended Use: This procedural device is intended to make a myringotomy incision, aspirate middle ear fluid, and transport and insert aural ventilation tube(s)
Image /page/0/Picture/19 description: The image shows a drawing of a deer head with antlers. The deer's head is facing forward, and its antlers are large and branching. The drawing is simple and stylized, with black lines on a white background. To the right of the deer head is the text 'Ex'.
Exmoor Plastics Ltd., Lisieux Way, Taunton, TA1 2LB, U.K.
Tel: (01823) 276837
copy
2075762 (Eng)
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Comparisons with Predicate Devices:
The Richards Set-Op Myringotomy Kit 1.
This is an instrumentation kit, which consists of a curette, a myringotome, an aural ventilation tube inserter and a set of aural specula. (Please see Attachment 7).
The Exmoor Myringotomy Kit is a complete procedure pack with instrumentation similar, but more comprehensive than, the predicate device, including instruments to make a myringotomy incision, to aspirate, to transport and insert aural ventilation tubes, together with fenestrated ear drape, a sterile drape, a dust cover, a mop, a curette, surgical gloves and means of disposing safely of a sharp instrument and a disposal bag.
The materials used for both sets of instruments are essentially the same, being stainless steel and various plastics.
Note: the Attachments 2 through 2k comprise an exhaustive selection list of components, including the elements which make up the sub-assemblies. :
2. The Exmoor Tympanocentesis Kit.
This predicate procedure pack comprises many of the same components as the subject Myringotomy Kit, as clarified below:
| Component | Present inPredicate (TK/1) | Present inSubject (MK/) | |
|---|---|---|---|
| MP180331 | Cream Ointment Ear Syringe | x | ✓ |
| MP180038 | White crepe sterilisation paper | ✓ | ✓ |
| MP180133 | Green crepe sterilisation paper | ✓ | ✓ |
| MP180083 | Finex latex gloves | ✓ | ✓ |
| MP180241/180242 | Aural Specula | ✓ | ✓ |
| MP170714 | Mal Mop | ✓ | ✓ |
| MP180045 | Curette | ✓ | ✓ |
| Various | Single Use Suction Tube | ✓ | ✓ |
| MP170315/180124 | Myringotome/Suction Inserter | ✓ | ✓ |
| MP180024 | Specimen Trap | ✓ | x |
| Various | Aural Ventilation Tubes | x | ✓ |
| MP180070 | Cotton Wool Swab | ✓ | ✓ |
| MP180240 | Disposal Bag | ✓ | ✓ |
| MP180062 | Disposafe | ✓ | ✓ |
| MP180148 | Moulded Tray | ✓ | ✓ |
| MP180088 | Peel Pouch | ✓ | ✓ |
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Both the predicate and subject kits are intended to perform myringotomy procedures but differ in that the TK/1 is designed to trap fluids aspirated from the middle ear for infection typing, a diagnostic procedure akin to myringotomy, while the MK/- devices are treatment kits which include myringotomy and allow for the insertion of aural ventilation tubes, if the surgeon should so wish. The former includes a myrinqotome/suction tube combination, for incising and aspirating via the tympanum, while the latter, being offered in three basic forms, provides:
- MK/5 a myringotome + suction tube + Pop-Pin inserter instrument. (See a) Attachment 64
- b) MK/6 a myringotome + suction tube grommet inserter, in the form of a notched sucker end.
- MK/7 a myringotome + suction tube + micro alligator forceps C)
Please note that both the predicate device and the subject device are packed in the same way, in the same environment, by the same operatives, under the same quality system and are subject to the same rigorous, sealing, bioburden and (AAMI validated) gamma sterilisation processes.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 1998
Margaret Blackmore Regulatory Affairs Exmoor Plastics Ltd. Lisieux Way, Taunton TA1, 2LB, United Kingdom
Re: K980828
Exmoor Myringotomy Kit MK/5, MK/6, and MK/7 Regulatory class: II/21 CFR 874.3880 & 21 CFR 880.6740 Procode: 77 ETD & 80 JOL Dated: July 24, 1998 Received: July 29, 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 to legally marketed predicate 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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 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.
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Page 2 - Margaret Blackmore
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/dsma/dsmamain.html".
Sincerely yours,
William Yin
Lillian 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
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Exmoor Myringotomy Kit
Indications for Use:
Requirement for myringotomy, with or without the insertion of aural ventilation tube(s).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elinil Ci. Sijam
Division Sign Off
vision Sign-Off) ion of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 874.3880 Tympanostomy tube.
(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.