(29 days)
Not Found
No
The summary describes a mechanical valve with adjustable pressure/flow settings, and there is no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain to other parts of the body, and its pressure/flow performance can be adjusted to address changing patient needs, which directly treats a physiological condition (hydrocephalus or similar CSF flow issues).
No
The device is a shunt component designed to provide continued cerebrospinal fluid flow and allows for non-invasive adjustment of pressure/flow performance levels. It does not diagnose any condition or disease.
No
The device description explicitly states the device is manufactured of silicone elastomer and polypropylene, indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide continued cerebrospinal fluid (CSF) flow from the brain to other parts of the body (heart or peritoneal cavity). This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical component (valve and shunt assembly) implanted in the body. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
The device is clearly a surgically implanted medical device used to manage a medical condition (hydrocephalus or other conditions requiring CSF shunting).
N/A
Intended Use / Indications for Use
The Strata NSC Burr Hole Valves and Shunt Assemblies 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 the peritoneal cavity. The Strata NSC Burr Hole 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.
Product codes
JXG
Device Description
The PS Medical® Strata® NSC Burr Hole Valve is an adjustable non-siphon control valve. The valve is manufactured of silicone elastomer and polypropylene. 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
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)
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
Kof2127
AUG 2 7 2008
4. 510(k) Summary
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) 571-8445 | |
| Fax: (805) 571-8480 | |
| Contact Person: | Jeffrey Henderson |
| Date: | July 28, 2008 |
| Trade or Proprietary Name: | PS Medical® Strata® NSC Burr Hole |
| Valves and Shunt Assemblies | |
| Common Usual or Classification Name: | Central nervous system fluid shunt and |
| components (882.5550) | |
| Predicate Device Identification: | • Medtronic PS Medical Strata NSC Valve |
| and Shunt Assemblies (K038850) | |
| • Medtronic PS Medical Strata II Valves and | |
| Shunt Assemblies with and without | |
| BioGlide (K042465) | |
| • CSF-Flow Control Valve, Burr Hole | |
| (K831678) |
Description:
The PS Medical® Strata® NSC Burr Hole Valve is an adjustable non-siphon control valve. The valve is manufactured of silicone elastomer and polypropylene. The valve is used as a shunt component. The adjustable valve is designed for non-invasive pressure flow adjustment.
Intended Use:
- · The Strata NSC Burr Hole Valves and Shunt Assemblies 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 the peritoneal cavity. The Strata NSC Burr Hole Valve 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 in order to address changing patient needs.
Page 31 of 90
f. 1 of z
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Intended Use of Predicate Device(s):
- The Strata NSC Valves and Shunt Assemblies 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 the peritoneal cavity. The Strata NSC Valve 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 in order to address changing patient needs.
- · The Strata II Valves and Shunt Assemblies 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 the peritoneal cavity. The Strata II Valve 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 in order to address changing patient needs.
- · The CSF-Flow Control Burr Hole 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.
Technological Comparison:
Medtronic Neurosurgery submits that the Strata NSC Burr Hole Valves and Shunt Assemblies included in this submission are manufactured of identical materials, and have the same intended use and fundamental scientific technology as the previously reviewed and cleared:
- Medtronic PS Medical Strata NSC Valve and Shunt Assemblies (K038850) .
- Medtronic PS Medical Strata II Valves and Shunt Assemblies with and without . BioGlide (K042465)
- . PS Medical CSF Flow Control Valve, Burr Hole (K831678).
Based upon the summary above, Medtronic Neurosurgery has determined that the proposed Strata NSC Burr Hole Valves and Shunt Assemblies are safe and effective and substantially equivalent to the predicate and currently marketed devices.
Page 32 of 90
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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2008
Medtronic Neurosurgery % Mr. Jeffrey Henderson VP, Quality & Regulatory Affairs 125 Cremona Drive Goleta, California 93117
Re: K082127
Trade/Device Name: PS Medical® Strata® NSC Burr Hole Valves and Shunt Assemblies Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: July 28, 2008 Received: July 29, 2008
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.
3
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Mark N Milliman
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):
Device Name: PS Medical® Strata® NSC Burr Hole Valves and Shunt Assemblies
Indications for Use:
The Strata NSC Burr Hole Valves and Shunt Assemblies 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 the peritoneal cavity. The Strata NSC Burr Hole 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.
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 CDRH, Office of Device Evaluation (ODE)
and Ne
510(k) Number