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 provides confirmation of the valve adjustment, without the need for radiographic imaging when an "Adjustment Complete" message is displayed.

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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the CODMAN® VPV™ System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics in the way modern AI/ML device submissions typically do.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this document. This document is a regulatory submission for a medical device that predates the widespread use of AI/ML in medical devices and the associated requirements for rigorous performance studies as requested in the prompt.

Here's what can be extracted and what cannot:

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

Not present. The document states that "Substantial equivalence for this device was based upon performance testing (physical and mechanical testing) and in vitro testing." However, specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity values) and numerical performance results are not provided. The entire premise of this 510(k) is that the new device is "identical" to a previously cleared VPV device (K050739) and "substantially equivalent" to another device (Medtronic's PS Medical Strata® Valves) in terms of indications for use and labeling.

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

Not present. No information about a "test set" or "data provenance" is included.

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 present. No ground truth establishment is described, as the evaluation method emphasizes physical/mechanical testing and equivalence to existing devices, not clinical performance metrics based on expert assessments.

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

Not present.

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

Not present. This is not an AI/ML device, and no MRMC study is mentioned.

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

Not applicable / Not present. This device is a system for non-invasively adjusting and confirming settings on programmable valves, not an AI algorithm.

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

Not present.

8. The sample size for the training set

Not present.

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

Not present.

Summary based on the provided text:

The CODMAN® VPV™ System is seeking clearance as substantially equivalent to a predicate device (CODMAN® VPV™ System, K050739) and another device (Medtronic's PS Medical Strata® Valves and Handtools, K040943). The basis for this equivalence is "performance testing (physical and mechanical testing) and in vitro testing." The document explicitly states: "The CODMAN VPV System is identical to the currently marketed predicate VPV device (K050739) in terms of physical characteristics, programming and procedure."

There is no mention of AI/ML, clinical studies with human readers, or performance metrics like sensitivity, specificity, or accuracy that would require a ground truth established by experts. The focus is on the device's physical and functional equivalence to already cleared devices.

Summary

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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

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OCT 16 2006

061876

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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.

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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 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.

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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

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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

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).