(36 days)
The Medtronic PS Medical Strata™ II Valve and shunt assemblies with and without BioGilde are shunt components designed to provide continued CSF flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design allows the physician to non-invasively adjust the pressure/flow performance level pre- and post-implantation by using a special magnetic adjustment tool without the need for radiographic confirmation.
The PS Medical Strata II Valve is an adjustable Valve designed for noninvasive pressure-flow adjustment.
The provided text is a 510(k) summary for the Medtronic PS Medical® Strata II Valve™ and Shunt Assemblies. It states that the device is substantially equivalent to a predicate device and relies on that equivalence rather than providing a detailed study with specific acceptance criteria and performance data for the new device.
Therefore, many of the requested details about a specific study proving the device meets acceptance criteria are not available in this document.
Here's an assessment based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as numerical criteria within this document. The basis for acceptance is substantial equivalence to legally marketed predicate devices. | The document states that the Strata II Valve and Shunt Assemblies are substantially equivalent to the predicate devices (Medtronic PS Medical Strata and Strata NSC Valve and Shunt Assemblies). This implies that its performance, characteristics, and intended use are considered to be the same as the cleared predicate devices. |
Explanation: The 510(k) summary explicitly states: "Medtronic Neurosurgery submits that the materials of fabrication, intended use, performance characteristics and design specifications of the Strata II Valve and Shunts with and without BioGlide are the same as the previously reviewed and cleared Strata and Strata NSC Valve and Shunt Assemblies with and without BioGlide. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Strata products based upon the predicate and currently marketed devices."
This indicates that the "acceptance criteria" were met by demonstrating that the new device is fundamentally the same as its legally marketed predicate, rather than through new, independent performance studies with their own defined numerical acceptance thresholds.
Study Details (Based on available information in the document)
- Sample size used for the test set and the data provenance: Not applicable. No new performance testing data comparing the Strata II to specific acceptance criteria is described. The approval is based on substantial equivalence to predicate devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set requiring expert ground-truthing is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 applicable. This is not an AI-assisted diagnostic device, but a physical medical implant.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for the new device's independent evaluation. The "ground truth" for its acceptance is its demonstrated similarity to previously cleared devices.
- The sample size for the training set: Not applicable. This is not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
ATTACHMENT 2
OCT 1 9 2004
042465 1/2
510k Summary 4.
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) 968-1546 ext. 1773Fax: (805) 968-9336 |
| Contact Person: | Jeffrey Henderson |
| Date: | September 10, 2004 |
| Trade or Proprietary Name: | Medtronic PS Medical® Strata II Valve™ andShunt Assemblies with and without BioGlide |
| Common usual or Classification Name: | Central Nervous System Flow Control Shunts andAccessories ( 882.5550) |
| Predicate Device Identification: | Medtronic PS Medical Strata and Strata NSCValve and Shunt Assemblies with and withoutBioGlide (K0120052, K040943, K033850) |
Description: The PS Medical Strata II Valve is an adjustable Valve designed for noninvasive pressure-flow adjustment.
Intended Use: The Medical Strata™ II Valve and shunt assemblies with and without Intended Use. The Mediforne Formsale continued CSF flow from the ventricles of the Bloodiae are shint components assigned to the peritoneal cavity. The design allows the physician to brain mo the ngm athum of the noal. offormance level pre- and post-implantation by using a non invaoly adjustment tool without the need for radiographic confirmation.
Intended Use of predicate device(s): The PS Medical Strata and Strata NSC valve are michaea ooo er provide continued 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 into into non-invasively adjust the pressure/flow performance level pre- and post implantation to address the changing patient needs.
{1}------------------------------------------------
K042465 2/2
Technological comparison: Medtronic Neurosurgery submits that the materials of fabrication, intended use, performance characteristics and design specifications of the Strata II Valve and Shunts with and without BioGlide are the same as the previously reviewed and cleared Strata and Strata NSC Valve and Shunt Assemblies with and without BioGlide. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Strata products based upon the predicate and currently marketed devices.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2004
Mr. Jeffrey Henderson Vice President, Quality and Regulatory Affairs Medtronic Neurosurgery 125 Cremona Drive Goelta, California 93117
Re: K042465
Trade/Device Name: PS Medical Strata II Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: September 10, 2004 Received: September 23, 2004
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}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) rmoreteet 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
ATTACHMENT 1
K042465 510(k) Number (if known):
Device Name: PS Medical Strata II
Indications For Use:
The Medtronic PS Medical Strata™ II Valve and shunt assemblies with and without BioGilde are I he Meditoric i S Medical Oliata - It Valvo included CSF flow from the venticles of the brain into the shurt components dosigned to provide sonantes of the design allows the physician to non-invasively nght athum of the ficult of the portionsal very - and post-implantation by using a special magnetic adjustment tool without the need for radiographic confirmation.
× Prescription Use __ (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)
Page 1 of __ 1__
Miriam C Provost
storative. Division of G and Neurological Dev
510(k) Number K042465
§ 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).