The Strata NSC Lumboperitoneal Shunt System provides continued cerebrospinal fluid (CSF) flow from the subarachnoid space into the peritoneal cavity. The Strata NSC Lumboperitoneal Valve allows the physician to non-invasively adjust the pressure/flow performance level pre- and post-implantation in order to address changing patient needs. The Strata NSC Lumboperitoneal Shunt System is designed for management of communicating hydrocephalus and may be used in the treatment of idiopathic intracranial hypertension (pseudotumor cerebri) when shunting is an option.

Device Description

The Strata NSC Lumboperitoneal Valve and Shunt Systems are comprised of lumbar and peritoneal catheters, valves and accessories. The lumboperitoneal valve allows the physician to noninvasively adjust the pressure/flow performance level pre- and post-implantation using magnetic adjustment tools in order to address changing patient needs. The lumbar catheters are available in closed-tip and open-tip configurations and have length markers located at 5 cm intervals. A strain relief provides support to and lessens the potential of catheter kinking at the junction of the lumbar catheter to the valve and fixation tabs are provided to anchor catheters at the incisions.

AI/ML Overview

Section {0} indicates that this 510(k) submission is for an expanded indication for the Medtronic Strata NSC Lumboperitoneal Valve and Shunt System to include the treatment of idiopathic intracranial hypertension (pseudotumor cerebri). The acceptance criteria and performance data described below relate to demonstrating that the device maintains its safety and effectiveness for this new indication.

1. Acceptance Criteria and Reported Device Performance

The provided text {1} states that "retrospective clinical review of data which includes prospective follow-ups is provided to demonstrate that physicians are able to palpate the valve, determine the direction of flow and to accurately read the pressure level setting using the StrataVarius device consistently with radiographic imaging verification when these shunt systems are used for lumboperitoneal applications."

Based on this, the implicit acceptance criteria relate to the consistency and accuracy of clinical assessment (palpation, flow direction, pressure level reading) of the device when compared to radiographic imaging verification. While specific metrics (e.g., percentage agreement, sensitivity/specificity) are not explicitly stated, the FDA's acceptance of the submission implies that the reported performance met their requirements for demonstrating substantial equivalence for the expanded indication.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Physicians are able to palpate the valve consistently.	Demonstrated that physicians are able to palpate the valve.
Physicians are able to determine the direction of flow consistently.	Demonstrated that physicians are able to determine the direction of flow.
Physicians are able to accurately read the pressure level setting using the StrataVarius device consistently with radiographic imaging verification.	Demonstrated that physicians are able to accurately read the pressure level setting using the StrataVarius device consistently with radiographic imaging verification.

2. Sample Size Used for the Test Set and Data Provenance

The text mentions "a retrospective clinical review of data which includes prospective follow ups." However, the exact sample size used for this clinical review (test set) is not specified in the provided document.

Regarding data provenance, the study is a "retrospective clinical review... which includes prospective follow ups." This suggests a combination of retrospective data (likely patient records from previous implantations) and prospective data (follow-up observations on a subset of these or newly enrolled patients). The country of origin of the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used or their qualifications for establishing the ground truth. The ground truth itself is stated as "radiographic imaging verification." This implies that the standard for comparison was consensus or interpretation of these images by presumably qualified medical professionals.

4. Adjudication Method for the Test Set

The document does not specify any explicit adjudication method (e.g., 2+1, 3+1). The ground truth is described as "radiographic imaging verification," suggesting that the radiographic findings served as the definitive reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This section describes a medical device (a shunt system and valve for CSF management), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving AI assistance was not performed and is not applicable in this context. The study focuses on the physicians' ability to clinically assess the device against radiographic verification, not on improvement with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is a medical device, not an algorithm. Therefore, a standalone algorithm performance study was not done and is not applicable. The performance data relates to the device's functionality (readability, adjustability, non-migration) and the ability of physicians to interact with it.

7. The Type of Ground Truth Used

The ground truth used for the clinical review was radiographic imaging verification. This implies that imaging studies (e.g., X-rays, CT scans) were used to objectively confirm the valve's setting, flow direction, or position, against which the physicians' clinical assessments were compared.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. The clinical review described is a performance evaluation, not a machine learning model development, so the concept of a training set as typically understood in AI is not directly applicable. The "retrospective clinical review" itself served as the evidence base.

9. How the Ground Truth for the Training Set Was Established

Since there is no explicit "training set" as understood in machine learning contexts, the question of how its ground truth was established is not applicable. The evidence provided is for the device's clinical performance, with radiographic imaging serving as the objective standard for validation.

Summary

{0}------------------------------------------------

510(k) Premarket Notification (Traditional), Strata NSC LP Shunt Indications Expansion Medtronic Neurosurgery

510(k) Summarv

K123524

Company Medtronic Neurosurgery 125 Cremona Drive Goleta, CA 93117
FEB 1 3 2013
Contact Donovan Mav Senior Requlatory Affairs Specialist Telephone: (805) 571-8758 Fax: (805) 571-8480 Email: donovan.may@medtronic.com
Date Prepared November 14, 2012

Medtronic Strata® NSC Lumboperitoneal Valve and Shunt System Device Name

Common Name Central Nervous System Flow Control Shunts and Accessories

Classification Name

Central Nervous System Fluid Shunt and Components (21 CFR 882.5550, Product Code JXG)

Predicate Devices

. PS Medical Strata NSC Lumboperitoneal Valve and Shunt System (K091312)
. PS Medical CSF-Lumboperitoneal Shunt (K831396)

Device Description:

Technological Characteristics: The Strata NSC Lumboperitoneal Valve and Shunt Systems incorporate the same technological characteristics as that of the predicate devices and are identical to the currently marketed versions. Each of these devices is intended for draining of cerebral spinal fluid (CSF) from the lumbar subarachnoid space.

Indications for Use:

The Strata NSC Lumboperitoneal Shunt System provides continued cerebrospinal fluid (CSF) flow from the subarachnoid space into the peritoneal cavity. The Strata NSC Lumboperitoneal Valve allows the physician to non-invasively adjust the pressureflow performance level pre- and post-implantation in order to address changing patient needs. The Strata NSC Lumboperitoneal Shunt System is designed for management of communicating hydrocephalus and may be used in the treatment of idiopathic intracranial hypertension (pseudotumor cerebri) when shunting is an option.

The Indications for Use statements cleared in the predicate submission K091312 did not contain language specific to the use of the subject devices for treatment of idiopathic intracranial hypertension (pseudotumor cerebri). The intent of this premarket submission is to expand the indications to include reference to this specific use when warranted.

{1}------------------------------------------------

Performance Data: Performance data demonstrating that the Strata NSC LP valves can be read and adjusted and that they do not migrate when properly implanted in an ovine model is included in this submission to support the indications expansion. Additionally a retrospective clinical review of data which includes prospective follow ups is provided to demonstrate that physicians are able to palpate the valve, determine the direction of flow and to accurately read the pressure level setting using the StrataVarius device consistently with radiographic imaging verification when these shunt systems are used for lumboperitoneal applications.

Conclusion: The Strata NSC Lumboperitoneal Valve and Shunt Systems are as safe and effective for the intended use of draining cerebrospinal fluid for the treatment of idiopathic intracranial hypertension (pseudotumor cerebri) as they are for other procedures for this intended use.

{2}------------------------------------------------

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 stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

Public Health Service

February 13, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Medtronic Neurosurgery c/o Donovan May Senior Regulatory Affairs Specialist 125 Cremona Drive Goleta, CA 93117

Re: K123524

Trade/Device Name: Medtronic Strata NSC Lumboperitoneal Valve and Shunt System Regulation Number: 21 CFR 882.5550 Regulation Name: Shunt, Central Nervous System and Components Regulatory Class: Class II Product Code: JXG Dated: November 14, 2012 Received: November 15, 2012

Dear Mr. May:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Mr. Donovan May

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

Indications for Use

510(k) Number: K123524

Device Name: Strata® NSC Lumboperitoneal Valve and Shunt System

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M. Whang

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number: K123524

Page 1 of 1

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).