(105 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on mechanical adjustment and confirmation without mentioning any AI/ML capabilities.
No.
The device is an accessory used to non-invasively adjust a programmable valve, which is the therapeutic device.
No
The device is used to adjust a programmable valve and confirm the adjustment; it does not diagnose a condition.
No
The device description explicitly states the system is comprised of a program unit, transmitter unit, power cord, carrying case, and ultrasound gel, 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 device is used to non-invasively adjust a programmable valve implanted in the brain to manage hydrocephalus. This is a therapeutic and monitoring function, not a diagnostic one.
- Device Description: The device is an accessory for a shunting system, used to adjust the valve setting. It does not analyze biological samples (like blood, urine, or CSF) to provide diagnostic information.
- Mechanism of Action: The device uses ultrasound to interact with the implanted valve and adjust its setting. This is a physical interaction with an implanted medical device, not an in vitro analysis of a biological sample.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The CODMAN® VPV™ 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 non-invasively adjust the CODMAN HAKIM Programmable Valve to the selected setting and orovides confirmation of the valve adjustment, without the need for radiographic imaging whos on "Adjustment Complete" message is displayed.
Product codes
JXG
Device Description
The CODMAN® VPV™ System (VPV) is an accessory (multiple use) indicated 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. The system is comprised of the program unit, transmitter unit, a power cord, carrying case, and ultrasound gel. The VPV System allows the clinician to noninvasively increase or decrease the valve setting to meet the patient's particular clinical needs.
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
clinician
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. Test results demonstrate substantial equivalence of the product to commercially distributed predicate devices for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Premarket Notification CODMAN® VPV™ System
SECTION 6. - 510(k) Summary (As Required By 21 CFR 807.92(a))
A. Company Information
Codman & Shurtleff, Inc. 325 Paramount Drive Raynham. MA 02767-0350 Establishment Registration Number: 1226348
B. Contact Person
Susan Kagan Senior Regulatory Affairs Specialist Telephone Number: 508-880-8097 Fax Number: 508-828-2777
DATE: June 30, 2006
C. Device Information
Propriety / Trade Name: CODMAN® VPV™ System Common Name: Hydrocephalus Shunt System Predicate Device: CODMAN® VPV™ System (K050739)
D. Classification
This device has been placed in Class II for Central Nervous System Fluid Shunt and Components devices per 21 CFR 882.5550 (84JXG). Classification Panel: Neurology
E. Device Description
The CODMAN® VPV™ System (VPV) is an accessory (multiple use) indicated 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. The system is comprised of the program unit, transmitter unit, a power cord, carrying case, and ultrasound gel. The VPV System allows the clinician to noninvasively increase or decrease the valve setting to meet the patient's particular clinical needs.
- 1 of 2
OCT 16 2006
061876
1
Li Indications For Use
The CODMAN® VPV™ 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 noninvasively adjust the CODMAN HAKIM Programmable Valve to the selected setting and provides confirmation of the valve adjustment, without the need for radiographic imaging when an "Adjustment Complete" message is displayed.
G. Device Testing
Substantial equivalence for this device was based upon performance testing (physical and mechanical testing) and in vitro testing. Test results demonstrate substantial equivalence of the product to commercially distributed predicate devices for the same intended use.
H. Statement of Substantial Equivalence
The CODMAN VPV System is identical to the currently marketed predicate VPV device (K050739) in terms of physical characteristics, programming and procedure. The CODMAN VPV System is substantially equivalent to Medtronic's PS Medical Strata® Valves and Handtools (K040943) with regard to Indications for Use and labeling.
P. 2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three parallel lines instead of a single staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2006
Codman & Shurtleff, Inc. % Ms. Susan Kagan Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K061876
Trade/Device Name: CODMAN® VPV™ System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: September 6, 2006 Received: September 7, 2006
Dear Ms. Kagan:
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 udicions 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 Cometic Act (Act) that do not require approval of a premarket approval application (PMA). You mosil 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 adulterstion.
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.
3
Page 2 - Ms. Susan Kagan
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
for
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 5. Indication for Use Statement
Indications for Use
KO61876 510(k) Number (if known):
Device Name: CODMAN® VPV™ System
Indications For Use:
The CODMAN® VPV™ 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 non-invasively adjust the CODMAN HAKIM Programmable Valve to the selected setting and orovides confirmation of the valve adjustment, without the need for radiographic imaging whos on "Adjustment Complete" message is displayed.
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 Page 1 of 1
| CONFIDENTIAL | 510(k) Number: 4061876 | June 30, 2006 |
|---|---|---|
| 14 |