(48 days)
Not Found
No
The summary describes a mechanical shunt system and its components, with no mention of AI or ML technology. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as "implantable" and provides "constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus," directly treating a medical condition.
No
The device, a Codman Hakim Shunt System, is an implantable device for managing hydrocephalus by draining cerebrospinal fluid and regulating intraventricular pressure. It is a therapeutic device, not one designed to diagnose a condition.
No
The device description explicitly states it is an "implantable device" and discusses "dimensional modification to the predicate valves," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "implantable device that provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus." This describes a therapeutic device used within the body to manage a medical condition.
- Device Description: The description reinforces that it's a "Shunt System" with components like valves and catheters, all designed for internal use.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVDs are typically used to analyze samples to detect diseases, conditions, or infections. This device is a surgical implant used to manage a physical condition directly within the patient's body.
N/A
Intended Use / Indications for Use
Codman Hakim Shunt Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus.
Codman Hakim Shunt Systems are available with or without CODMAN BACTISEAL Catheters, which are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid is indicated.
Codman Hakim Shunt Systems are also available with or without SIPHONGUARD. The SIPHONGUARD device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
The Codman Hakim Shunt System incorporates all the possible shunt system features commercially available in the Codman Hakim line of products. The proposed device is adding a dimensional modification to the predicate valves listed above that are part of the Codman Hakim Shunt System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Bench testing has been completed and supports the safety and effectiveness of the proposed device for its intended use.
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.
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
§ 882.5550 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
SECTION 11 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
A. Submitter Information
| A. Submitter Information | ||
|---|---|---|
| Submitter's name: | Codman & Shurtleff, Inc. | |
| Address: | 325 Paramount Drive | |
| Raynham, MA 02767 | ||
| Telephone: | 508-828-3571 | |
| Fax: | 508-828-2777 | |
| Contact Person: | Brian A. Kanerviko | |
| Date of Submission: | December 1, 2005 | |
| B. Trade/Device Name: | Codman Hakim Shunt Systems. | |
| Common Name: | Shunt | |
| Classification Name: | Central Nervous System Fluid Shunt and Component | |
| Regulation Number: | 882.550 | |
| C. Predicate Device: | Codman Hakim Shunt Systems (K020667). | |
| Codman Hakim Programmable Valve (K974739) |
-
D. Device Description: The Codman Hakim Shunt System incorporates all the possible shunt system features commercially available in the Codman Hakim line of products. The proposed device is adding a dimensional modification to the predicate valves listed above that are part of the Codman Hakim Shunt System.
Codman Hakim Precision Valve (K944222) -
E. Intended Use: Codman Hakim Shunt Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus.
Codman Hakim Shunt Systems are available with or without CODMAN BACTISEAL Catheters, which are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid is indicated.
Codman Hakim Shunt Systems are also available with or without SIPHONGUARD. The SIPHONGUARD device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.
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- F. Summary of technological characteristics of the proposed to the predicate device. The technological characteristics of the proposed device are the exact same as the predicate device.
G. Performance Data
Bench testing has been completed and supports the safety and effectiveness of the proposed device for its intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 9 2006
Mr. Brian A. Kanerviko Senior Regulatory Affairs Specialist Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K053350
Trade/Device Name: Codman Hakim Shunt Systems Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: December 22, 2005 Received: December 23, 2005
Dear Mr. Kanerviko:
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.
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Page 2 - Mr. Kanerviko
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 (240) 276-0115. 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 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/industry/support/index.html.
Sincerely vours.
Barbara Buchner
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):K053350
Device Name: Codman Hakim Shunt Systems: Addition of a silicone platform to the base of the Codman Hakim Programmable and Precision Valve
Indications For Use:
Codman Hakim Shunt Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus.
Codman Hakim Shunt Systems are available with or without CODMAN BACTISEAL Catheters, which are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid is indicated.
Codman Hakim Shunt Systems are also available with or without SIPHONGUARD. The SIPHONGUARD device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Darbar Buelind to mykl
Division of General, Restorative, and Neurological Devices
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510(k) Number K053350