(30 days)
Not Found
No
The summary describes a mechanical shunt system for CSF drainage and contains no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The device is intended to shunt cerebrospinal fluid (CSF) from the brain, which is a treatment for a medical condition.
No
Explanation: The device is intended to shunt cerebrospinal fluid, which is a treatment, not a diagnostic function.
No
The device description clearly states it is a "ventricular catheter" and part of a "Shunt System," which are physical medical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum." This describes a surgical procedure involving the direct manipulation of bodily fluids within the body for therapeutic purposes (relieving excess CSF pressure).
- Device Description: The device is a "ventricular catheter" used to "gain access to the cavities of the brain for removal of excess CSF." This further reinforces its role as a surgical tool for fluid drainage.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The description of the Miethke Shunt System does not involve any such ex vivo analysis of specimens.
Therefore, the Miethke Shunt System is a medical device used for a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
Product codes (comma separated list FDA assigned to the subject device)
JXG, HCA
Device Description
The ventricular catheter is a part of the Miethke Shunt System. It is used to gain access to the cavities of the brain for removal of excess CSF.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral ventricles of the brain, peritoneum
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)
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new Miethke Shunt System conforms to applicable ASTM and ISO standards.
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.
K980778, K961859, K911410, K902783, K932429, K861377
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
§ 882.4100 Ventricular catheter.
(a)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.(b)
Classification. Class II (performance standards).
0
APR - 5 M
Miethke Shunt System
Kolo728
Page 1 of 1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
in Accordance with SMDA of 1990
MIETHKE SHUNT SYSTEM
November 26, 2001
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Joyce Kilroy, Director of Regulatory Affairs/Quality Assurance
800-258-1946 (phone)
610-791-6882 (fax)
joyce.kilroy @ aesculap.com (email) |
| TRADE NAME: | Central Nervous System Fluid Shunt and Components |
| COMMON NAME: | Miethke Shunt System |
| DEVICE CLASS: | Shunt System - Class II
Ventricular Catheter - Class II |
| PRODUCT CODE: | Shunt System - JXG
Ventricular Catheter - HCA |
| CLASSIFICATION: | Shunt System - 882.5550
Ventricular Catheter - 882.4100 |
| REVIEW PANEL: | Neurology |
INTENDED 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 ventricular catheter is a part of the Miethke Shunt System. It is used to gain access to the cavities of the brain for removal of excess CSF.
PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new Miethke Shunt System conforms to applicable ASTM and ISO standards.
SUBSTANTIAL EQUIVALENCE
The Aesculap Miethke Shunt System is essentially identical to the J & J Hakim Micro Programmable Valve System (K980778), Heyer-Schulte Novus (K961859), P/S Medtronic Bulton (K911410), P/S Medtronic Delta (K902783), Cordis NMT Gravity Compensating Accessory (K932429) and the Cordis NMT Hakim Standard/Pediatric Valves (K861377).
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville . MD 20850
Ms. Joyce Kilroy Director, Regulatory Affairs and Quality Assurance Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034
2002 APR
Re: K020728
Trade/Device Name: Miethke Shunt System Regulation Number: 882.4100 Regulation Name: Ventricular Catheter Regulatory Class: II Product Code: HCA Dated: March 4, 2002 Received: March 6, 2002
Dear Ms. Kilroy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 9 ro(x) premained in substantially equivalent (for the indications for use stated in the enclosure) the devices the devices marketed in interstate for use stated in the encrosule) to regally mancted producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Food Frya commerce prior to May 28, 1770, the enactions with the provisions of the Federal Food. Drug, devices that have been reclassified in accerative will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket of the Ac and Cosmetic Act (Act) that to hot require approvide on trols provisions of the Act. The Act. The You may, therefore, market the devices, belyer to the more of registration, listing of general controls provisions of the 110th line, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into etails rates in the major regulations affecting your device can
may be subject to such additional controls. Existing major regu may be subject to such additional controller a marketing and to 898. In addition, FDA may be found in the Code of I sacka 11.5gmming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualled of woulderice complies with other requirements of the Act that IDA has made a decommation administered by other Federal agencies. You must of ally Federal statutes and regulations adminding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, mercaing, and manufacturing practice requirements as set CFK Fart 807), adomig (21 CFR Part 820); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1000-1050 forth in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping human figures. The image is in black and white.
2
Page 2 - Ms. Joyce Kilroy
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,
R. Mark N. Millican
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
Special 510(k) Premarket Notification
Miethke Shunt System
Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
020728
Device Name: 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.
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| In the control of the consisted on the commended to comments of the many of the many of the many of the many of the many world and the many would be comments of the many of t |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) Division of General. Restorative and Neurological Devices 020728
510(k) Number__
Prescription Use X or Over-the-Counter Use _
(per 21 CFR 801.109)
(Optional Format 3-10-98)