(35 days)
Not Found
No
The summary describes a mechanical valve with non-invasive pressure adjustment, with no mention of AI or ML.
Yes
The device, a shunt component, is designed to provide continued cerebrospinal fluid (CSF) flow and allows for noninvasive adjustment of pressure/flow performance levels to address changing patient needs, which directly contributes to the treatment and management of a patient's medical condition.
No
The device is a shunt component used to manage CSF flow, not to diagnose a condition. Its function is therapeutic (to provide continued CSF flow), not diagnostic (to identify a disease or condition).
No
The device description clearly states it is a "valve," which is a physical hardware component. The summary does not mention any software functionality.
Based on the provided information, 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.
- Device Function: The Strata Burr Hole valve is a shunt component designed to manage cerebrospinal fluid flow within the body. It is an implantable device used for treatment, not for analyzing samples taken from the body.
- Intended Use: The intended use clearly describes a therapeutic function (managing CSF flow) and a mechanism for adjusting that function, not a diagnostic test performed on a sample.
Therefore, the Strata Burr Hole valve falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Strata 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. The Strata Burr Hole valve allows the physician to noninvasively adjust the pressure/ flow performance level ore- 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® Burr Hole 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 / Not Found
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
NOV 20 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: | October 14, 2008 |
| Trade or Proprietary Name: | PS Medical® Strata® 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 II Valves and |
| Shunt Assemblies with and without | |
| BioGlide (K042465) | |
| • PS Medical Strata NSC Burr Hole Valves | |
| and Shunt Assemblies (K082127) |
Description:
The PS Medical® Strata® Burr Hole Valve is an adjustable valve designed for non-invasive pressure flow adjustment.
Intended Use:
-
· The Strata 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 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.
Intended Use of Predicate Device(s): -
· 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
Page 31 of 127
fig 1 of 2
1
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 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.
Technological Comparison:
Medtronic Neurosurgery submits that the Strata 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 II Valves and Shunt Assemblies with and without BioGlide (K042465)
- . PS Medical Strata NSC Burr Hole Valves and Shunt Assemblies (K082127).
Based upon the summary above, Medtronic Neurosurgery has determined that the proposed Strata Burr Hole Valves and Shunt Assemblies are safe and effective and substantially equivalent to the predicate and currently marketed devices.
Page 32 of 127
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2
Public Health Service
Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
Medtronic Neurosurgery % Mr. Jeffrey Henderson VP, Quality and Regulatory Affairs 125 Cremona Drive Goleta, California 93117
NOV 2 0 2008
Re: K083076
Trade/Device Name: PS Medical® Strata® 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: October 15, 2008 Received: October 21, 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.
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol. The logo is presented in black and white.
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 1 legally marketed predicate device results in a classification for your device and thus, permitts 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 survillance, 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 remance tystems
4 of 6 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 M. Mullen
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):
083076
Device Name: PS Medical® Strata® Burr Hole Valves and Shunt Assemblies
Indications for Use:
The Strata 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. The Strata Burr Hole valve allows the physician to noninvasively adjust the pressure/ flow performance level ore- 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)
Nil of the for mkn
(Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number K083076
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