(184 days)
Not Found
No
The description focuses on a mechanical valve with non-invasive magnetic adjustment, with no mention of AI or ML capabilities.
Yes
The device is designed to provide continued cerebrospinal fluid (CSF) flow, addressing a medical condition (hydrocephalus) and therefore providing therapy.
No
The device is a shunt component designed to provide continued CSF flow, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "valve" and "shunt components," which are physical hardware devices implanted in the body. The summary also mentions an "external magnetic adjustment tool," which is also a hardware component. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Medtronic PS Medical® Strata® Valves are implantable medical devices designed to manage cerebrospinal fluid flow within the body. They are surgically placed and function mechanically to regulate pressure.
- Lack of Specimen Analysis: The description clearly states the device's function is to provide CSF flow and allows for external adjustment of the valve pressure. There is no mention of analyzing any biological specimens in vitro (outside the body).
Therefore, based on the provided information, this device falls under the category of an implantable medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Medtronic PS Medical® Strata® Valve and Strata® NSC Valve 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 peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using an external magnetic adjustment tool without the need for radiographic confirmation.
The Medtronic PS Medical® Strata® II Valve and shunt assemblies with and without BioGlide 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 valve pressure/performance level pre- and post-implantation by using a special magnetic adjustment tool without the need for radiographic confirmation.
Product codes
JXG
Device Description
The Medtronic PS Medical® Strata® Type Valve is an adjustable valve 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, right atrium of the heart, peritoneal cavity
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)
K012052, K033850, K040943, K042465
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
60681
4. 510(k) Summary
SEP 15 2006
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: | March 10, 2006 |
| Trade or Proprietary Name: | Medtronic PS Medical® Strata® Type Valve |
| Common usual or Classification Name: | Central Nervous System Flow Control Shunts and |
| Accessories (882.5550) | |
| Predicate Device Identification: | K012052 - Medtronic PS Medical® Strata® Valve |
| K033850 - PS Medical® Strata® NSC Valve | |
| K040943 - Strata® Valve Adjustment and Indicator Tools | |
| K042465 - PS Medical® Strata® II Valve |
Description: The Medtronic PS Medical® Strata® Type Valve is an adjustable valve designed for non-invasive pressure-flow adjustment.
Intended Use of the device and the predicate device(s) : The intended use of the Medtronic PS Medical® Strata® Type Valve in this substantially equivalent to those previously cleared under K012052, K042465, and K033850.
The Medtronic PS Medical® Strata® Valve and Strata® NSC Valve 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 peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using an external magnetic adjustment tool without the need for radiographic confirmation.
The Medtronic PS Medical® Strata® II Valve and shunt assemblies with and without BioGlide 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 valve pressure/performance level pre- and post-implantation by using a special magnetic adjustment tool without the need for radiographic confirmation.
1
Technological comparison: Medtronic Neurosurgery submits that the materials of fabrication, intended use, and the fundamental scientific technology of the Medtronic PS Medical® Strata® Type Valves are the same as the previously reviewed and cleared Stratatype valves. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Medtronic PS Medical® Strata® Type Valves compared to the predicate and currently marketed devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four abstract human profiles facing to the right, stacked on top of each other. The profiles are rendered in black against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 2006
Medtronic Neurosurgery % Mr. Jeffrey Henderson Vice President, Quality & Regulatory Affairs 125 Cremona Drive Goleta, California 93117-5500
Re: K060681
Trade/Device Name: Medtronic Neurosurgical Implants Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: August 15, 2006 Received: August 16, 2006
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 sct
3
Page 2 - Mr. Jeffrey Henderson
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.
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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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): ____________________________________________________________________________________________________________________________________________________
15060681
Device Name: Medtronic Neurosurgical Implants
Indications for Use:
Medtronic PS Medical® Strata® Valve and Strata® NSC Valve The Medtronic PS Medical® Strata® Valve and Strata® NSC Valve 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 peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using an external magnetic adjustment tool without the need for radiographic confirmation.
Medtronic PS Medical® Strata® II Valve
The Medtronic PS Medical® Strata® II Valve and shunt assemblies with and without BioGlide 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 valve pressure/performance level pre- 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CORN, Office of Device Evaluation (ODE)
K060691
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K060641 |
|---|---|
| --------------- | --------- |