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 Description

Not Found

AI/ML Overview

This 510(k) submission (K050739) for the CODMAN® VPV™ System, a Hydrocephalus Valve Programmer, does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and the comprehensive study design you are looking for.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided document. The submission focuses on demonstrating "substantial equivalence" rather than specific performance metrics against pre-defined acceptance criteria.
Reported Device Performance: The document only broadly states: "All test results demonstrated the substantial equivalence of the product to commercially distributed predicate device for the same intended use." No specific performance values (e.g., accuracy, precision) are provided.

Table Placeholder (based on available information):

Acceptance Criteria (Not explicitly stated)	Reported Device Performance
e.g., Accuracy of pressure setting	Achieved substantial equivalence to predicate device.
e.g., Reliability of adjustment	Achieved substantial equivalence to predicate device.
e.g., Confirmation of selected setting	Achieved substantial equivalence to predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The document only mentions "performance testing (physical and mechanical testing) and in vitro testing" but does not detail the number of devices or tests performed.
Data Provenance: Not specified. No information on country of origin, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. This type of device (hydrocephalus valve programmer) does not typically involve human expert interpretation for "ground truth" in the way an AI diagnostic algorithm would. The device's function is to adjust a physical valve and confirm the setting, not to interpret medical images or patient data. Its performance would be assessed against the actual physical setting of the valve.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers (often radiologists or pathologists) interpret data and their interpretations need to be reconciled to establish a consensus ground truth, especially for AI diagnostic devices. This device does not fall into that category.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is not an AI diagnostic tool and does not involve human readers for interpretation in the context of an MRMC study. It's a medical instrument used to program a hydrocephalus valve.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable / Partially applicable, but not an "algorithm." The "device" in this context is a physical programmer with its internal mechanisms. The performance testing would be of the device itself (its ability to correctly program and confirm settings). There isn't an "algorithm" in the sense of an AI model being independently tested. The "standalone" performance would be the device functioning correctly as designed. The document states "performance testing (physical and mechanical testing) and in vitro testing," which implies testing the device's inherent functionality.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Implied Physical Measurement/Verification: For a device that programs a valve to a selected setting and provides confirmation, the "ground truth" would likely be the actual physical setting of the valve as measured independently or verified by the valve's design specifications. The document mentions that "radiographic imaging will still be required to confirm the selected setting," which suggests real-world verification is part of the clinical use, but not necessarily "ground truth" for the device's internal performance testing. The "in vitro testing" would likely involve comparing the device's reported setting to the actual setting achieved on a test fixture or a valve in a controlled environment.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. This is not an AI/machine learning device that requires a training set.

Summary of Device and Study Type:

The CODMAN® VPV™ System is an electro-mechanical device for programming hydrocephalus valves. The 510(k) submission for this device relies on demonstrating substantial equivalence to a predicate device (HAKIM PROGRAMMER & TRANSMITTER) through physical, mechanical, and in vitro performance testing. It is not an AI or diagnostic imaging device, so the criteria typically associated with such devices (like expert adjudication, MRMC studies, training/test sets, and detailed performance metrics beyond equivalence) are not relevant or provided in this type of submission. The focus is on the device's ability to mechanically perform its intended function safely and effectively, similar to an existing device.

Summary

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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

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

Regulation Number and Section

§ 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).