(78 days)
Not Found
Not Found
No
The summary describes a simple physical shunt device made of silicone rubber and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is designed to continuously drain endolymphatic sac fluid, which is a therapeutic intervention for Meniere's disease. The comparison to predicate devices, which are also shunts, further supports its classification as a therapeutic device.
No
Explanation: The device is described as a "shunt" designed to act as a "continuous drain" for endolymphatic sac fluid. Its purpose is to treat a condition (Meniere's disease) by diverting fluid, not to identify, monitor, or analyze a disease or condition.
No
The device description clearly states it is a physical, T-shaped piece of silicone rubber, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states that this device is a shunt designed to be surgically implanted to drain fluid within the body (from the endolymphatic sac to the mastoid). It is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of analyzing samples, performing tests on bodily fluids, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of an implantable surgical device rather than an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
77 ESZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Endolymphatic Sac, Mastoid
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.
Richards Endolymphatic Shunt Tube (Austin Modification), Richards Silicone Elastomer Endolymphatic Shunt Tube (House type)
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
§ 874.3820 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.
0
| 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
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
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
2
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)