(33 days)
Not Found
No
The summary describes a mechanical valve with a magnetic adjustment mechanism. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes
This device is designed to treat hydrocephalus by shunting cerebrospinal fluid, which directly addresses a disease state.
No
The device is a shunt component for draining cerebrospinal fluid, not for diagnosing a condition.
No
The device description explicitly states the valve is manufactured of silicone elastomer and polypropylene, indicating it is a physical hardware component.
Based on the provided information, the Strata NSC Valve is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Strata NSC Valve Function: The description clearly states the Strata NSC Valve is a shunt component designed to drain cerebrospinal fluid from the brain to another body cavity. It is an implanted device that directly interacts with the patient's internal systems.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens in vitro (outside the body).
Therefore, the Strata NSC Valve falls under the category of an implanted medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles of the brain, peritoneal cavity, right atrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Neurosurgery |
| 125 Cremona Drive | |
| Goleta CA, 93117 | |
| (805) 968-1546 ext. 1773 | |
| Fax: (805) 968-9336 | |
| Contact Person: | Jeffrey Henderson |
| Date: | December 8, 2003 |
| Trade or Proprietary Name: | Medtronic PS Medical Strata NSC Valve and |
| Shunt Assemblies with and without BioGlide | |
| Common usual or Classification Name: | Central Nervous System Flow Control Shunts and |
| Accessories (882.5550) | |
| Predicate Device Identification: | Medtronic PS Medical Strata Valve and Shunt |
| Assemblies 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
1
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.
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 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.
3
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
4
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