(121 days)
Not Found
No
The summary describes a mechanical shunt system with an adjustable valve, and there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is designed to manage communicating hydrocephalus by providing continued cerebrospinal fluid flow, which is a therapeutic intervention.
No
The device, a lumboperitoneal shunt system, is designed for the management and diversion of cerebrospinal fluid, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly lists multiple implantable hardware components, including a valve, catheters, strain relief, and fixation tabs.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Strata NSC Lumboperitoneal Shunt System is an implantable medical device designed to divert cerebrospinal fluid within the body. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it provides "continued cerebrospinal fluid (CSF) flow" and is for the "management of communicating hydrocephalus." This describes a treatment, not a diagnostic test.
- Device Description: The components listed are all implantable parts of a shunt system, not laboratory equipment or reagents used for testing samples.
Therefore, based on the provided information, the Strata NSC Lumboperitoneal Shunt System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Strata NSC Lumboperitoneal (LP) Valve and Shunt System are designed for the management of communicating hydrocephalus, including normal pressure hydrocephalus (NPH), and idiopathic intracranial hypertension (IIH), also known as pseudotumor cerebri.
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 without the need for radiographic confirmation in order to address changing patient needs. The Strata NSC Lumboperitoneal Shunt System is designed for management of communicating hydrocephalus.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
PS Medical® Strata® NSC Lumboperitoneal Valve and Shunt System are designed for diversion of cerebrospinal fluid (CSF) from the lumbar subarachnoid space into the peritoneal cavity.
The shunt's implantable components include:
- Strata NSC Lumboperitoneal Valve ●
- Lumbar Catheter, Closed Tip, Barium Impregnated .
- Lumbar Catheter, Open Tip, Barium Impregnated .
- Peritoneal Catheter, Small Lumen, Open End, Barium Impregnated .
- Strain Relief .
- Fixation Tabs .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar subarachnoid space, peritoneal cavity, intrathecal space of the spine
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
Testing performed on the Strata NSC LP Valve and Shunt System verified that the system met the required specifications and acceptance criteria.
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
7 510(k) Summary
{
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Establishment Registration Number: | 2021898 |
|---|---|
| Address of Manufacturer: | Medtronic Neurosurgery |
| 125 Cremona Drive | |
| Goleta, CA 93117 USA | |
| (805) 571-8445 | |
| Fax: (805) 571-8480 | |
| Contact Person: | Jeffrey Henderson |
| Date: | April 30, 2009 |
| Trade or Proprietary Name: | PS Medical® Strata® NSC Lumboperitoneal Valve and |
| Shunt System | |
| Common Name: | Central Nervous System Flow Control Shunts and |
| Accessories | |
| Classification Name: | Shunt, Central Nervous System and Components |
| (21 CFR 882.5550, Product Code JXG) | |
| Predicate Device Identification: | PS Medical® Strata® NSC Valve and Shunt |
| Assemblies with and without BioGlide (K033850) | |
| CSF-Lumboperitoneal Shunt System (K831396) |
Device Description
PS Medical® Strata® NSC Lumboperitoneal Valve and Shunt System are designed for diversion of cerebrospinal fluid (CSF) from the lumbar subarachnoid space into the peritoneal cavity.
The shunt's implantable components include:
- Strata NSC Lumboperitoneal Valve ●
- Lumbar Catheter, Closed Tip, Barium Impregnated .
- Lumbar Catheter, Open Tip, Barium Impregnated .
- Peritoneal Catheter, Small Lumen, Open End, Barium Impregnated .
- Strain Relief .
- Fixation Tabs .
1
Intended Use
The Strata NSC Lumboperitoneal (LP) Valve and Shunt System are designed for the management of communicating hydrocephalus, including normal pressure hydrocephalus (NPH), and idiopathic intracranial hypertension (IIH), also known as pseudotumor cerebri.
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 pressure/flow performance level pre- and post-implantation without the need for radiographic confirmation in order to address changing patient needs. The Strata NSC Lumboperitoneal Shunt System is designed for management of communicating hydrocephalus.
Technological Comparison and Performance Characteristics
The predicate Strata NSC Valve was cleared in April 2004 (K033850) and was developed to serve those patients who needed an adjustable valve technology but without the siphon control feature. The predicate CSF-Lumboperitoneal Shunt was cleared in August 1983 (K831396). The Strata NSC LP Valve and Shunt System utilize the same fundamental scientific technology, materials, and sterilization method as the predicates. The device combines the Strata-type adjustable technology with geometrical shunt features that are tailored for use in the lumboperitoneal configuration (shunting from the intrathecal space of the spine to the peritoneal cavity).
Test Data
Testing performed on the Strata NSC LP Valve and Shunt System verified that the system met the required specifications and acceptance criteria.
Summary
Based upon the product technical information, intended use, and test data, the Strata NSC LP Valve and Shunt System have been shown to be substantially equivalent to currently marketed predicate 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
Medtronic Neurosurgery c/o Jeffrev Henderson Vice President, Quality & Regulatory Affairs 125 Cremona Drive Goleta, CA 93117-5500
SEP - 2 2009
Re: K091312
Trade Name: PS Medical® Strata® NSC Lumboperitoneal Valve and Shunt System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: Class II Product Code: JXG Dated: July 20, 2009 Received: August 4, 2009
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 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. Jeffrey Henderson
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/CDRH/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Kessa Alexander for
Malvina B. Eydelman, M.I Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
6. Indications for Use Statement
K091312 510(k) Number (if known):
Device Name: _ PS Medical® Strata® NSC Lumboperitoneal Valve and Shunt System
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 pressure/flow performance level pre- and post-implantation without the need for radiographic confirmation in order to address changing patient needs. The Strata NSC Lumboperitoneal Shunt System is designed for management of communicating hydrocephalus.
Prescription Use (Part 21 CFR CFR 801
AND/OR 801 Subpart D) Subpart C)
Over-The-Counter Use
(21
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) JOE HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
KO91312 510(k). Number_