The Strata NSC Burr Hole Valves and Shunt Assemblies are shunt components designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The Strata NSC Burr Hole Valve allows the physician to non-invasively adjust the pressure/ flow performance level pre- and post-implantation without the need for radiographic confirmation in order to address changing patient needs.

Device Description

The PS Medical® Strata® NSC Burr Hole Valve is an adjustable non-siphon control valve. The valve is manufactured of silicone elastomer and polypropylene. The valve is used as a shunt component. The adjustable valve is designed for non-invasive pressure flow adjustment.

AI/ML Overview

The provided text is a 510(k) summary for the PS Medical® Strata® NSC Burr Hole Valves and Shunt Assemblies. This document focuses on demonstrating substantial equivalence to predicate devices and does not describe a clinical study with acceptance criteria and device performance results as typically found for new device approvals or AI/software-as-a-medical-device submissions.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not applicable (N/A) because the submission is for a device based on substantial equivalence to existing technology, rather than a novel device requiring a de novo clinical performance study against specific metrics.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Device is substantially equivalent to predicate devices.	Medtronic Neurosurgery states the device is manufactured of identical materials, and has the same intended use and fundamental scientific technology as the predicate devices: - Medtronic PS Medical Strata NSC Valve and Shunt Assemblies (K038850)- Medtronic PS Medical Strata II Valves and Shunt Assemblies with and without BioGlide (K042465)- PS Medical CSF Flow Control Valve, Burr Hole (K831678)
Safety and Effectiveness	Based on the technological comparison and substantial equivalence to legally marketed predicate devices, the device is considered safe and effective.
Primary Design Function	To provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The valve allows non-invasive adjustment without radiographic confirmation.
Material Composition	Manufactured of silicone elastomer and polypropylene; identical to predicate devices.

2. Sample size used for the test set and the data provenance

N/A. This submission is based on substantial equivalence to predicate devices, not a clinical study on a test set. There is no mention of a test set or data provenance in the context of device performance evaluation against specific metrics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. No test set or ground truth establishment by experts is described for this type of submission.

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

N/A. No test set or adjudication method is described.

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

N/A. This device is a fluid shunt, not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant or described.

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

N/A. This is a hardware medical device (a shunt valve), not a standalone algorithm.

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

Ground truth, in the context of this 510(k) submission, is implied by the established safety and effectiveness of the legally marketed predicate devices. The "truth" is that the core technology and functional performance are already proven and therefore the new device, being substantially equivalent, is also considered safe and effective. No specific ground truth data for a novel performance evaluation is mentioned.

8. The sample size for the training set

N/A. No training set is described, as this is not an AI/machine learning device. The design, materials, and functional principles are based on existing, proven technologies.

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

N/A. Not applicable, as there is no training set described.

Summary

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

Kof2127

AUG 2 7 2008

4. 510(k) Summary

This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87.

Establishment Registration Number:	2021898
Address of Manufacturer:	Medtronic Neurosurgery125 Cremona DriveGoleta CA, 93117(805) 571-8445Fax: (805) 571-8480
Contact Person:	Jeffrey Henderson
Date:	July 28, 2008
Trade or Proprietary Name:	PS Medical® Strata® NSC Burr HoleValves and Shunt Assemblies
Common Usual or Classification Name:	Central nervous system fluid shunt andcomponents (882.5550)
Predicate Device Identification:	• Medtronic PS Medical Strata NSC Valveand Shunt Assemblies (K038850)• Medtronic PS Medical Strata II Valves andShunt Assemblies with and withoutBioGlide (K042465)• CSF-Flow Control Valve, Burr Hole(K831678)

Description:

Intended Use:

· The Strata NSC Burr Hole Valves and Shunt Assemblies are shunt components designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The Strata NSC Burr Hole Valve allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using a special magnetic adjustment tool without the need for radiographic confirmation in order to address changing patient needs.
Page 31 of 90

f. 1 of z

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

Intended Use of Predicate Device(s):

The Strata NSC Valves and Shunt Assemblies are shunt components designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The Strata NSC Valve allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using a special magnetic adjustment tool without the need for radiographic confirmation in order to address changing patient needs.
· The Strata II Valves and Shunt Assemblies are shunt components designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The Strata II Valve allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using a special magnetic adjustment tool without the need for radiographic confirmation in order to address changing patient needs.
· The CSF-Flow Control Burr Hole Valve is a shunt component designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity.

Technological Comparison:

Medtronic Neurosurgery submits that the Strata NSC Burr Hole Valves and Shunt Assemblies included in this submission are manufactured of identical materials, and have the same intended use and fundamental scientific technology as the previously reviewed and cleared:

Medtronic PS Medical Strata NSC Valve and Shunt Assemblies (K038850) .
Medtronic PS Medical Strata II Valves and Shunt Assemblies with and without . BioGlide (K042465)
. PS Medical CSF Flow Control Valve, Burr Hole (K831678).

Based upon the summary above, Medtronic Neurosurgery has determined that the proposed Strata NSC Burr Hole Valves and Shunt Assemblies are safe and effective and substantially equivalent to the predicate and currently marketed devices.

Page 32 of 90

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

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 symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2008

Medtronic Neurosurgery % Mr. Jeffrey Henderson VP, Quality & Regulatory Affairs 125 Cremona Drive Goleta, California 93117

Re: K082127

Trade/Device Name: PS Medical® Strata® NSC Burr Hole Valves and Shunt Assemblies Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: July 28, 2008 Received: July 29, 2008

Dear Mr. Henderson:

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.

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 – Mr. Jeffrey Henderson

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.

Mark N Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

II. Statement of Indications for Use

510(k) Number (if known):

K082127

Device Name: PS Medical® Strata® NSC Burr Hole Valves and Shunt Assemblies

Indications for Use:

Prescription Use (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)

and Ne

510(k) Number

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).