(119 days)
HAKIM PROGRAMMER & TRANSMITTER
Not Found
No
The summary describes a system for adjusting a programmable valve and confirming the setting, relying on physical/mechanical testing and in vitro testing for substantial equivalence. There is no mention of AI, ML, image processing, or data-driven performance metrics.
Yes.
The device itself is designed to adjust a therapeutic device (Codman HAKIM™ Programmable Valve) which is used in the treatment of hydrocephalus. While it doesn't directly treat the patient, it is integral to the function of a therapeutic system.
No
The device is used to adjust a programmable valve and confirm the adjustment, not to diagnose a medical condition. While it aids in treatment, it does not identify diseases or medical conditions.
No
The summary describes a system used to adjust a physical valve (Codman HAKIM™ Programmable Valve) and mentions physical and mechanical testing, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to adjust a programmable valve for treating hydrocephalus by shunting cerebrospinal fluid from the ventricles of the brain. This is a therapeutic intervention performed in vivo (within the living body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing diagnostic information based on the analysis of these samples.
- Mentioning any laboratory procedures or reagents.
The device is a tool used to interact with an implanted medical device (the programmable valve) within a patient's body. This falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Codman VPV System is designed for use only with the Codman HAKIM™ Programmable Valve in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. It is used to adjust the Codman Programmable Valve to the selected setting and provide valve adjustment confirmation. However, radiographic imaging will still be required to confirm the selected setting.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles of the brain
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)
Substantial equivalence for this device was based upon performance testing (physical and mechanical testing) and in vitro testing. All test results demonstrated the substantial equivalence of the product to commercially distributed predicate device for the same 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.
HAKIM PROGRAMMER & TRANSMITTER
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).
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510(k) Summary; K050739
CODMAN® VPV™ System
Submitter/Date
Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350 Date: July 7, 2005
Contact Person
Karen F. Jurczak Director, Regulatory Affairs Telephone Number: (508) 828-3704 Fax Number: (508) 828-2777
Name of Device
| Propriety Name: | CODMAN® VPV™ SYSTEM |
|---|---|
| Common Name: | Hydrocephalus Valve Programmer |
| Predicate Devices: | HAKIM PROGRAMMER & TRANSMITTER |
Device Classification
Class II for Central Nervous System Fluid Shunt and Components devices 21 CFR 882.5550 (84 JXG) – Classification Panel: Neurological
Indications for Use
The Codman VPV System is designed for use only with the Codman HAKIM™ Programmable Valve in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. It is used to adjust the Codman Programmable Valve to the selected setting and provide valve adjustment confirmation. However, radiographic imaging will still be required to confirm the selected setting.
Device Testing _______________________________________________________________________________________________________________________________________________________________
Substantial equivalence for this device was based upon performance testing (physical and mechanical testing) and in vitro testing. All test results demonstrated the substantial equivalence of the product to commercially distributed predicate device for the same intended use.
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Statement of Substantial Equivalence__________________________________________________________________________________________________________________________________________
The Codman® VPV™ System is substantially equivalent to the HAKIM PROGRAMMER & TRANSMITTER based on the subject device's similarity to the predicate device including intended use, physical characteristics, and labeling.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping wave-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2005
Ms. Karen F. Jurczak Director, Regulatory Affairs Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K050739
Trade/Device Name: Codman® VPVTM System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: July 7, 2005 Received: July 8, 2005
Dear Ms. Jurczak:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) in the enactment date of the Medical Device Amendments, or to conimered prior to may 20, 2017 11:31 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). and Cosmetic (1 tor) that the device, subject to the general controls provisions of the Act. The r ou mayy are second of the Act include requirements for annual registration, listing of general voltable profice, 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 If your device is enastined (tional controls. Existing major regulations affecting your device can thay or sate to deem to accurations, 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 r lease be actived that i Dr over device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I vith 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 CI It Fart 6077, labeling (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 - Ms. Karen F. Jurczak
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 premaired 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 If you don't specific at the list 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 other Ectorers, 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 yours,
Signature
Miriam C. Provost, Ph.D. 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): K050739
Device Name:___ CODMAN® VPV™ System
Indications For Use:
"The system is designed for use only with CODMAN HAKIM Programmable Valves in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. It is used to adjust the CODMAN HAKIM Programmable Valve to the selected setting and provide valve adjustment confirmation. However, radiographic imaging will still be required to confirm the selected setting."
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K050739
VPV K050739 Response to FDA
CONFIDENTIAL
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