← Product Code [JXG](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG) · K030698 # AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV (K030698) _Aesculap, Inc. · JXG · Mar 20, 2003 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG/K030698 ## Device Facts - **Applicant:** Aesculap, Inc. - **Product Code:** [JXG](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG.md) - **Decision Date:** Mar 20, 2003 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 882.5550 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for Use The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. ## Device Story Hydrocephalus shunt system; diverts cerebrospinal fluid (CSF) from lateral ventricles to peritoneum. Features NPH-DualSwitch Valve; proximal diaphragm valve design. Includes two chambers; provides low pressure setting (5 cmH2O) for patients in lying position. Used by neurosurgeons in clinical/surgical settings to manage hydrocephalus. Output is mechanical fluid regulation; assists in maintaining intracranial pressure balance. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Central nervous system fluid shunt; proximal diaphragm valve (NPH-DualSwitch Valve). Features two-chamber design with 5 cmH2O low-pressure setting. Mechanical operation. ## Regulatory Identification A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt. ## Predicate Devices - Miethke Shunt System with DualSwitch-Valve ([K030698](/device/K030698.md)) - Codman Hakim Micro Precision Valve ## 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}------------------------------------------------ MAR 2 0 2003 K050698 Page 1 of 1 # C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (in Accordance with SMDA of 1990) ### AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV | COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 | |-----------------|---------------------------------------------------------------------------------------------------------------------| | CONTACT: | Matthew M. Hull
800-258-1946 x 5072 (phone)
610-791-6882 (fax) | | TRADE NAME: | Aesculap - Miethke Shunt System | | COMMON NAME: | Hydrocephalus Shunt System | | DEVICE CLASS: | Class II | | PRODUCT CODE: | 84 JXG | | CLASSIFICATION: | 882.5550 - Central Nervous System fluid shunt and
components. | | REVIEW PANEL: | Neurology | # INDICATIONS FOR USE The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. ### DEVICE DESCRIPTION The components of the Miethke Shunt System can include the NPH-DualSwitch® -Valve, a proximal diaphraqm valve. The modified NPH-DualSwitch® - Valve consists of two chambers and is offers a new low pressure setting (5 cmH2O) for patients in the lying position. #### PERFORMANCE DATA No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system. # SUBSTANTIAL EQUIVALENCE Aesculap®, Inc. believes that the Miethke Shunt System with NPH-DualSwitch® – Valve is substantially equivalent to our currently marketed Miethke Shunt System with DualSwitch® - Valve. The low pressure setting is also equivalent to the setting on the Codman Hakim Micro Precision Valve. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is rendered in black and white. MAR 2 0 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Matthew M. Hull Senior Regulatory Affairs Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034 Re: K030698 Trade/Device Name: Aesculap - Meithke Shunt System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: March 5, 2003 Received: March 6, 2003 Dear Mr. Hull: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - Mr. Matthew M. Hull This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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. Mark n Melbern Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page 1 of 1 #### INDICATIONS FOR USE STATEMENT B. 510(k) Number: k030698 Device Name: Aesculap - Miethke Shunt System Indication for Use: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ***_*** or Over-the-Counter Use **_** (per 21 CFR 801.109) for Mark N Millenn Division Sign-Off Division of General, Restorative and Neurological Devices K030698 Number **__** --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG/K030698](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG/K030698) **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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