(64 days)
Not Found
Not Found
No
The description focuses on a mechanical valve with magnetic adjustment, and there is no mention of AI or ML in the text, performance studies, or key metrics.
Yes
The device is designed to manage hydrocephalus by providing continued CSF flow, which is a therapeutic intervention.
No.
The Strata® Valve is a shunt component designed to provide continued cerebrospinal fluid flow. While it has tools for adjusting its performance level, its primary function is therapeutic (managing hydrocephalus) rather than diagnosing a condition. The mention of "Comparison of the Indicator Tool pressure/performance level setting and corresponding x-ray" refers to validating the adjustment tool's setting against a measurement, not using the valve itself for diagnosis.
No
The device description explicitly states it is a "shunt component" and mentions "surgical implantation." It also describes physical "Handtools" (Locator Tool, Indicator Tool, and Adjustment Tool) used to interact with the implanted valve. This indicates a physical, hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a shunt component designed to provide continued Cerebrospinal Fluid (CSF) flow from the brain to other parts of the body. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the mechanical function of the valve and the tools used to adjust its performance in vivo (within the living patient).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, CSF in vitro), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Strata® Valve is a shunt component designed to provide continued Cerebrospinal Fluid (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/flow performance level pre- and post-implantation by using an external magnetic Adjustment Tool without the need for radiographic confirmation.
Product codes
JXG
Device Description
After surgical implantation, the Strata Valve provides a non-invasive method to address changing patient needs in the management of hydrocephalus. The unique valve design allows the physician to adjust the pressure/flow performance level by using a magnetic Adjustment Tool included with the Strata® Valve adjustment kit without the need for radiographic confirmation.
The Strata® Handtools, include the Locator Tool, Indicator Tool and Adjustment Tool. Ail three tools are required to set or change the pressure/performance level setting of the Strata® Valve.
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
The Othata "Varo is oubota.histing, biocompatibility studies, and clinical study data.
Comparison of the Indicator Tool pressure/performance level setting and corresponding x-ray at time of Discharge and during follow-up, yielded the following results:
| Discharge Data | 98.6% |
|---|---|
| ALL IN CORRES Adjustment Data | 98.8% |
Key Metrics
Not Found
Predicate Device(s)
Medtronic PS Medical Strata® Valve
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
JUN 1 5 2004
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 | |
| Telephone: (805) 968-1546 ext. 1770 | |
| Fax: (805) 968-9336 | |
| Contact Person: | Jeffrey Henderson |
| Date: | April 8, 2004 |
| Trade or Proprietary Name: | Medtronic PS Medical Strata ® Valves and |
| Handtools | |
| Common usual or Classification Name: | Central Nervous System Fluid Shunts and |
| Components. 21 CFR 882.5550 |
Description:
After surgical implantation, the Strata Valve provides a non-invasive method to address changing patient needs in the management of hydrocephalus. The unique valve design allows the physician to adjust the pressure/flow performance level by using a magnetic Adjustment Tool included with the Strata® Valve adjustment kit without the need for radiographic confirmation.
The Strata® Handtools, include the Locator Tool, Indicator Tool and Adjustment Tool. Ail three tools are required to set or change the pressure/performance level setting of the Strata® Valve.
Intended Use:
The Strata® Valve is a shunt component designed to provide continued Cerebrospinal Fluid (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/flow performance level pre- and post-implantation by using an external magnetic Adjustment Tool without the need for radiographic confirmation.
Predicate Device Identification:
The Strata® Valve is substantially equivalent to the Medtronic PS Medical Strata® Valve based on the same intended use, materials, design and dimensions.
K040943 1/2
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K040943 2/2
510(k) Summary
Device Testing:
The Strata® Valve is substantially equivalent to the Medical Strata® Valve based The Othata "Varo is oubota.histing, biocompatibility studies, and clinical study data.
Comparison of the Indicator Tool pressure/performance level setting and corresponding x-ray at time of Discharge and during follow-up, yielded the following results:
| Discharge Data | 98.6% | |
|---|---|---|
| ALL IN CORRES | ||
| Adjustment Data | ||
| 98.8% | ||
| Concellential |
ית DJT | And An A C C C C C C . C . C . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . | SERE ENGLE EN LEE MERICAN |
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Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. The words are aligned horizontally and are of similar size. The background is plain white.
Image /page/2/Picture/2 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the upper half of the circle.
JUN 1 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeffrey Henderson Vice President, Quality & Regulatory Affairs Medtronic Neurosurgery 125 Cremona Drive Goleta, California 93117-5500
Re: K040943
Trade/Device Name: PS Medical Strata® Valve Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: April 9, 2004 Received: April 20, 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.
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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) 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 (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 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
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2. Modified Indications for Use Statement
Indications for Use
510(k) Number (if known): K040943
Device Name: PS Medical Strata® Valve
Indications For Use:
"The Strata® Valve is a shunt component designed to provide continued Cerebrospinal Fluid (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/flow ourfly - The don't and post-implantation by using an external 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
iriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number_ K 040943
004