(41 days)
No K/DEN numbers found in the "Predicate Device(s)" section.
Not Found
No
The document describes a mechanical shunt system with valves and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as shunting cerebrospinal fluid (CSF) from the brain to the peritoneum, which is a medical intervention designed to treat a condition (likely hydrocephalus) and improve patient health. This fits the definition of a therapeutic device.
No
Explanation: The device is a shunt system designed to drain cerebrospinal fluid, which is a therapeutic function, not a diagnostic one. It does not identify or characterize a disease.
No
The device description clearly outlines physical components (valves) that are part of the shunt system, indicating it is a hardware-based medical device.
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 implant designed to manage fluid flow within the body.
- Device Description: The description details a valve system and its components, which are physical devices implanted in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body. This device is a therapeutic implant.
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
84 JXG
Device Description
The components of the Miethke Shunt System can include the Paedi-GAV-Valve, a "ballin-cone" valve in line with a gravitational valve. The modified device, is a slightly larger version of the Paedi-GAV-Valve and has slightly higher opening pressures. This modified device will be known as the Gravity Assisted Valve (GAV) and will also be offered as a part of the Miethke Shunt System.
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 applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
our currently marketed Miethke Shunt System with Paedi-Gav-Valve and DualSwitch Valve.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5550 Central nervous system fluid shunt and components.
(a)
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.(b)
Classification. Class II (performance standards).
0
JUN - 4 2003
Aesculap - Miethke Shunt System
Page 1 of 1
C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (in Accordance with SMDA of 1990)
AESCULAP - MIETHKE SHUNT SYSTEM W/ GRAVITY ASSISTED VALVE (GAV)
| 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 Paedi-GAV-Valve, a "ballin-cone" valve in line with a gravitational valve. The modified device, is a slightly larger version of the Paedi-GAV-Valve and has slightly higher opening pressures. This modified device will be known as the Gravity Assisted Valve (GAV) and will also be offered as a part of the Miethke Shunt System.
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 the GAV is substantially equivalent to our currently marketed Miethke Shunt System with Paedi-Gav-Valve and DualSwitch Valve.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
JUN - 4 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: K031303
Trade/Device Name: Aesculap - Miethke Shunt System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: April 23, 2003 Received: May 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.
Sincerely yours,
O. Mark-N-Millman
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: | K031303 |
|---|---|
| ---------------- | --------- |
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)
for
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | |
| Prescription Use | |
| or Over-the-Counter Use | |
| (per 21 CFR 801.109) |