(78 days)
Endolymphatic Sac fluid increases during Meniere's disease attacks. This simple 'T' type endolymphatic sac shunt is designed to act as a continuous drain, allowing endolymphatic sac fluid to be shunted into the Mastoid. The shunt is placed in the sac along with decompression of the sac and the adjacent dura.
This device is a small, T-shaped piece of silicone rubber sheet, approximately 8.5mm x 1mm x 0.125mm. The T-bar is 5mm wide.
The provided documents describe a 510(k) pre-market notification for a medical device called the "Endolymphatic Sac to Mastoid T-Shunt." This type of submission relies on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical trials with acceptance criteria for device performance.
Therefore, the information you've requested regarding acceptance criteria and a study proving the device meets them is not present in these documents. The 510(k) process does not typically involve detailed performance metrics and studies as would be seen for new or high-risk devices.
Here's how the provided information relates to your request:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. The 510(k) submission for the Endolymphatic Sac to Mastoid T-Shunt does not include a table of acceptance criteria or performance metrics derived from a study. The focus is on demonstrating similar function and safety to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No test set or associated data provenance is mentioned in the context of device performance. The submission relies on a comparison to predicate devices, which would have had their own historical data or clinical use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or 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. This device is a physical shunt, not an AI-assisted diagnostic tool. An MRMC study is irrelevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical shunt. Standalone algorithmic performance studies are irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No specific ground truth for performance evaluation is described. The "truth" in a 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices.
8. The sample size for the training set:
- Not Applicable. There is no mention of a training set as this is a physical medical device, not an algorithm that requires training.
9. How the ground truth for the training set was established:
- Not Applicable. No training set or associated ground truth establishment is described.
Summary based on the provided documents:
The Endolymphatic Sac to Mastoid T-Shunt (K974224) was cleared by the FDA through the 510(k) process because it was deemed substantially equivalent to existing predicate devices: the Richards Endolymphatic Shunt Tube (Austin Modification) and the Richards Silicone Elastomer Endolymphatic Shunt Tube (House type).
The submission states that the new device's function is the same as the predicates, and it differs primarily in its form ("T-bar stays in the sac and the long portion comes out through a separate incision...preventing extrusion. The flat form is easier to insert and stays in place...more anatomical"). The fit is described as "very similar" but does not require insertion into the subarachnoid space, which implies a potential safety or ease-of-use improvement.
The FDA's letter explicitly states that the finding of substantial equivalence permits the device to proceed to market, highlighting that this process relies on comparison to predicate devices rather than independent performance studies with acceptance criteria during the 510(k) review.
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| Your Ref: | |
|---|---|
| Our Ref: | MB/PAS/A895748 |
| K974224 | |
| Contact: Margaret Blackmore |
JAN 27 1998
| 4 November 1997 | Summary of Safety and Effectiveness |
|---|---|
| 510K Pre-Market Notification Summary | |
| Trade Name:' | Endolymphatic Sac to Mastoid T-Shunt |
| Classification Name: | Shunt Endolymphatic |
| Predicate Devices: | Richards Endolymphatic Shunt Tube (Austin Modification) |
| Richards Silicone Elastomer Endolymphatic Shunt Tube (House type) | |
| Description of Device: | This device is a small, T-shaped piece of silicone rubber sheet, approximately 8.5mm x 1mm x 0.125mm. The T-bar is 5mm wide. |
| Intended Use: | Endolymphatic Sac fluid increases during Meniere's disease attacks. This simple 'T' type endolymphatic sac shunt is designed to act as a continuous drain, allowing endolymphatic sac fluid to be shunted into the Mastoid. The shunt is placed in the sac along with decompression of the sac and the adjacent dura. |
| Comparison with Predicate Devices: | This shunt differs from the House type and the Austin modification in its form. The 'T bar stays in the sac and the long portion comes out through a separate incision in the sac, thus preventing extrusion. The flat form is easier to insert and stays in place, since it is more anatomical, like the flatness of the sac. The fit of this device is very similar except that it does not require insertion into the subarachnoid space. |
The function of this device is the same as the two predicates.
Exmoor Plastics Ltd., Lisieux Way, Taunton, TA1 2LB, U.K.
彩票
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 27 1998
Margaret Blackmore Regulatory Affairs Exmoor Plastics Ltd. Lisieux Way Taunton, TA1 2LB, U.K. Re:
K974224 Endolymphatic T-Shunt Dated: December 18, 1997 Received: December 29, 1997 Regulatory class: II 21 CFR 874.3820/Procode: 77 ESZ
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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 requirement, 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 531 through 542 of the Act for devices under 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 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/dsmamain.html",-------
Sincerely yours,
W. 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
Enclosure
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RAM/19/A/1
A.875748
公共
510(k) Number (if known): K974224
ENDOLYMPHATIC SAC TO MASTOID T-SHUNT Device Name:
Indications for Use:
Endolymphatic Sac fluid increases during Meniere's disease attacks. This simple 'T' type endolymphatic sac shunt is designed to act as a continuous drain, allowing endolymphatic sac fluid to be shunted into the Mastoid. The shunt is placed in the sac along with decompression of the sac and the adjacent dura.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Le Sequer
(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 874.3820 Endolymphatic shunt.
(a)
Identification. An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to relieve the symptons of vertigo. The device permits the unrestricted flow of excess endolymph from the distended end of the endolymphatic system into the mastoid cavity where resorption occurs. This device is made of polytetrafluoroethylene or silicone elastomer.(b)
Classification. Class II.