← Product Code [ESZ](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESZ) · K974224 # ENDOLYMPHATIC SAC TO MASTOID T-SHUNT (K974224) _Exmoor Plastics , Ltd. · ESZ · Jan 27, 1998 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESZ/K974224 ## Device Facts - **Applicant:** Exmoor Plastics , Ltd. - **Product Code:** [ESZ](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESZ.md) - **Decision Date:** Jan 27, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.3820 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## 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. ## Device Story Device is a T-shaped silicone rubber shunt (8.5mm x 1mm x 0.125mm; 5mm T-bar). Used in surgical treatment of Meniere's disease to drain excess endolymphatic sac fluid into the mastoid. Implanted by surgeons during sac decompression and dural procedures. T-bar remains in the sac; long portion exits through a separate incision to prevent extrusion. Flat, anatomical design facilitates insertion and retention compared to traditional shunts. Does not require subarachnoid space insertion. Provides continuous drainage to manage fluid accumulation, potentially reducing symptoms associated with Meniere's disease attacks. ## Technological Characteristics Material: Silicone rubber. Form factor: T-shaped sheet, 8.5mm x 1mm x 0.125mm with 5mm T-bar. Passive drainage mechanism. Non-electronic, non-software device. ## Regulatory 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. ## Predicate Devices - Richards Endolymphatic Shunt Tube (Austin Modification) - Richards Silicone Elastomer Endolymphatic Shunt Tube (House type) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESZ/K974224](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESZ/K974224) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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