(33 days)
The Strata NSC Valve is a shunt component designed to provide continued The Utrain NOO Varve is a onal from the ventricles of the brain to the right atrium of the Ocrobroopinal Hall (Cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using a special magnetic adjustment tool.
The PS Medical Strata NSC Valve is an adjustable non-siphon control Valve. The valve is manufactured of silicone elastomer and polypropylene (tissue contact materials). The valve is used as a shunt component. The adjustable valve is designed for non-invasive pressure-flow adjustment.
This 510(k) summary describes a medical device, the Medtronic PS Medical Strata NSC Valve, a shunt component. This document does NOT contain a study or data to establish acceptance criteria or demonstrate device performance based on a study.
Instead, this submission is a claim of substantial equivalence to a previously cleared predicate device (Medtronic PS Medical Strata Valve and Shunt Assemblies with and without BioGlide, K012052). The summary states:
"Medtronic Neurosurgery submits that the materials of fabrication, intended use, performance characteristics and design specifications... are the same as the previously reviewed and cleared Strata Valve and Shunt Assemblies with and without BioGlide. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Strata NSC products based upon the predicate and currently marketed devices."
Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance studies, and training set details cannot be provided from the given document.
The document primarily focuses on:
- Device Description: The PS Medical Strata NSC Valve is an adjustable non-siphon control valve made of silicone elastomer and polypropylene, intended as a shunt component for non-invasive pressure-flow adjustment.
- Intended Use: To provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity, with the ability to non-invasively adjust pressure/flow pre- and post-implantation.
- Technological Comparison: Directly states the new device is the "same" in materials, intended use, performance characteristics, and design specifications as the predicate device.
- FDA Clearance: The FDA's letter confirms substantial equivalence to legally marketed predicate devices, allowing the device to be marketed.
In summary, there is no performance study or acceptance criteria explicitly detailed in this document. The basis for clearance is substantial equivalence to a predicate device, implying that the performance and safety of the new device are considered equivalent to the already cleared predicate device, which would have undergone its own clearance process and likely associated testing.
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4. 510k Summary
033850
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: | December 8, 2003 |
| Trade or Proprietary Name: | Medtronic PS Medical Strata NSC 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 Valve and ShuntAssemblies with and without BioGlide (K012052) |
Description: The PS Medical Strata NSC Valve is an adjustable non-siphon control Valve. The valve is manufactured of silicone elastomer and polypropylene (tissue contact materials). The valve is used as a shunt component. The adjustable valve is designed for non-invasive pressure-flow adjustment.
Intended Use: The PS Medical Strata NSC valve is a shunt component designed to inconde controlled CSF flow from the ventricles of the brain into the peritoneal cavity. The Strata NSC valve allows the physician to non-invasively adjust the pressure/flow performance level pre- and post implantation to address the changing patient needs.
Intended Use of predicate device(s): The PS Medical Strata valve is a shunt component designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity. The Strata valve allows the physician to non-invasively adjust the pressure/flow performance level pre- and post implantation to address the changing patient needs. Additionally the Strata valve minimizes the excessive reduction of intraventricular pressure and volume due to excessive drainage of CSF that may be caused by the siphoning effect of hydrostatic pressure of the distal catheter. The siphon effect may be created by the
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elevation of the ventricular catheter with respect to the distal catheter (i.e. when the patient sits, stands or is held erect).
Technological comparison: Medtronic Neurosurgery submits that the materials of fabrication, intended use, performance characteristics and design specifications of the labhoutin, monobulars, with and without BioGlide are the same as the previously reviewed and cleared Strata Valve and Shunt Assemblies with and without BioGlide. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Strata NSC products based upon the predicate and currently marketed devices.
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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 representation of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2004
Mr. Jeffrey Henderson Vice President, Quality and Regulatory Affairs Medtronic Neurosurgery 125 Cremona Drive Goleta, California 93117
Rc: K033850
Trade/Device Name: PS Medical Strata NSC Valve Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: December 10, 2003 Received: December 15, 2003
Dear Mr. Henderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & no review 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 docs not mean that FDA has made a determination that your device complics 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 - Mr. Jeffrey Henderson
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and the FDA finding of substantial cquivalence of your device to a legally promated prodicate 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 desire specific as not any and (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
. Mula N. Millman
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
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Indications for Use
510(k) Number (if known): K033850
Device Name: PS Medical Strata NSC Valve
Indications For Use:
The Strata NSC Valve is a shunt component designed to provide continued The Utrain NOO Varve is a onal from the ventricles of the brain to the right atrium of the Ocrobroopinal Hall (Cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using a special magnetic adjustment tool.
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)
for Mark M. Mulkern
Page 1 of 1 eral. Restorative Devices
§ 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).