(72 days)
The Mills Columella is intended to improve or restore hearing by replacing an absent or defective incus and stapes.
The treatment of an absent or defective stapes.
The Mills Columella Prosthesis is manufactured from p.t.f.e., a material which has been used for the reconstruction of the middle ear for many years. It can be combined with an ossicular or cortical bone graft for the treatment of ossicular defects, including loss of stapes arch.
The provided text is a 510(k) premarket notification for the Mills Columella Prosthesis. It does not contain information about a study proving the device meets acceptance criteria or detailed performance data as typically found in a clinical trial report.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided document. A 510(k) submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance against specific acceptance criteria from a dedicated study.
2. Sample Size Used for the Test Set and Data Provenance
This information is not present in the provided document. No specific test set or associated data provenance is discussed.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not present in the provided document. There is no mention of experts establishing a ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not present in the provided document. No test set or adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not present in the provided document. There is no mention of an MRMC study or any analysis of human reader improvement with or without AI assistance. The device is a physical prosthesis, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
This information is not present in the provided document. The device is a physical prosthesis for surgical implantation, not an algorithm.
7. Type of Ground Truth Used
This information is not present in the provided document. The submission focuses on substantial equivalence based on material and intended use compared to predicate devices.
8. Sample Size for the Training Set
This information is not present in the provided document. As this is not an AI/algorithm-based device, there would not be a "training set" in that context.
9. How the Ground Truth for the Training Set Was Established
This information is not present in the provided document.
Summary of Device Information from the Document:
- Device Name: Mills Columella Prosthesis
- Common Name: Prosthesis, Ear, Internal
- Classification Name: Ossicular Replacement Prosthesis
- Intended Use: To improve or restore hearing by replacing an absent or defective incus and stapes, or for the treatment of ossicular defects including loss of stapes arch, often combined with an ossicular or cortical bone graft.
- Material: p.t.f.e. (a non-porous material)
- Predicate Devices: Shea Plasti-Pore, TORP and Austin Off Centered, TORP (both manufactured from Plasti-Pore).
- Comparison with Predicate Devices: The subject device is manufactured from p.t.f.e., which is described as "a non-porous but otherwise very similar material" to Plasti-Pore. The subject device is "on average, smaller than the predicate devices but performs exactly the same function." The p.t.f.e. material has been "used for the reconstruction of the middle ear for many years."
- Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. The substantial equivalence is based on the indications for use.
In essence, the document serves as a regulatory filing demonstrating equivalence to existing devices, not a detailed performance study with 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 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".
for / onghyzer.com
DMR/1/F/47
K98/088
Image /page/0/Picture/4 description: The image contains two logos. The logo on the left is a circular seal with the text "QUALITY ASSURED FIRM" around the top half of the circle and "ISO 9001" in the center. Below the text is "SGS". The logo on the right has a crown at the top and a check mark. Below the check mark is the text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES".
JUN 5 1998
Your Ref:
Our Ref:
MB/PAS/DMR/1/F/47
Contact: Margaret Blackmore
13 March 1998
Ref: DMR/1/F/47
SUMMARY OF SAFETY AND EFFECTIVENESS
Mills Columella Prosthesis
Prosthesis, Ear, Internal
Shea Plasti-Pore, TORP
loss of stapes arch.
incus and stapes.
Austin Off Centered, TORP
Ossicular Replacement Prosthesis
Trade Name:
Common Name
Classification Name:
Predicate Devices:
Description of Device:
Intended Use:
Comparison with Predicate Devices:
Both predicate devices are manufactured from Plasti-Pore. The subject device is manufactured from p.t.f.e., a non-porous but otherwise very similar material. The size of the subject device is, on average, smaller than the predicate devices but performs exactly the same function.
The Mills Columella Prosthesis is manufactured
from p.t.f.e., a material which has been used for the reconstruction of the middle ear for many years. It can be combined with an ossicular or cortical bone graft for the treatment of ossicular defects, including
The Mills Columella is intended to improve or
restore hearing by replacing an absent or defective
Image /page/0/Picture/21 description: The image shows the company information for Exmoor Plastics Ltd. The company is located at Lisieux Way, Taunton, TA1 2LB, U.K. The image also includes the company's phone and fax numbers.
Co. Reg. No: 2075762 (Eng)
Tel: (01823) 276837 Fax: (01823) 334154
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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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol consisting of three stylized human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 5 1998
Margaret Blackmore Regulatory Affairs Exmoor Plastics, Ltd. Lisieux Way Taunton, TA1 2LB U.K. Re:
K981088 Mills Columella Prosthesis Dated: March 19, 1998 Received: March 25, 1998 Regulatory class: II 21 CFR 874.3495/Procode: 77 ETA
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 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 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, 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 questions 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/cdr/dsmaldsmamain.html".
Sincerely yours,
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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kug1088 510(k) Number (if known):
MILLS COLUMELLA PROSTHESIS Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The treatment of an absent or defective stapes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE if NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seijon
(Division Sign-Off) Division of Rep ductive, Abdominal, ENT, and Radiological Device
510(k) Number K991088
Prescription Use_ (Per 21 CFR 801.109)
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OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 874.3495 Total ossicular replacement prosthesis.
(a)
Identification. A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.