(189 days)
Not Found
No
The description focuses on sensing magnetic fields and mechanically adjusting a valve setting, with no mention of AI/ML terms or processes.
No
The device is used to non-invasively identify and change the pressure setting of a valve; it does not directly treat a disease or condition.
No
The StrataVarius identifies the current performance level and equivalent pressure reading of a valve and allows for non-invasive adjustment of the valve setting. While it provides "information" about the valve's current setting, its primary function is adjustment, not diagnosis of a medical condition or disease.
No
The device description explicitly states it is a "battery-powered, handheld instrument" and lists several physical components included in the system, indicating it is a hardware device with integrated software, not a software-only medical device.
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 used by physicians to non-invasively identify and change the setting of a valve within the body. It does not involve testing samples of human origin (like blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease.
- Device Description: The description confirms it's a handheld instrument that interacts with a medical device (a valve) implanted in a patient. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
Therefore, the StrataVarius system, as described, falls under the category of a medical device used for adjusting an implanted medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"StrataVarius is intended for use by physicians, to non-invasively identify the Strata-type Stratavance Level (PL) setting and display that information numerically in terms of FL level and the equivalent prossure roading in millimeters of water (mm H2O). The StrataVarius allows the user to change the pressure setting of the valve non-invasively without the need for radiographic confirmation."
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
Medtronic Neurosurgery's StrataVarius™ System is a battery-powered, handheld instrument that senses the location and onemation of the Ridgher of the StrataVarius Adjustment adjustable valves. The StrataVarius™ works in conjunction with the StrataVarius Adjustmant adjustable valves. The Gratavanas - works in conjuntalse Level (PL) setting as Tool to change the magnet orientation, and thus the valve auctors includes Tool to change the magnet onemation, and this the Strativanius system includes and determined by the Cilifican. The complete oyetem in Cards (Smart Cards), a the StrataVarius, an Adjustment Tool, two (or more) Valve Identification 1 First (AA) alkaling the Stratavanus, an Agusthent 150, two (61 more) Premplates, and two 1.5 volt (AA) alkaline batteries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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): 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
SAFETY AND EFFECTIVENESS SUMMARY IX. Medtronic StrataVarius
K04/1992
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87
| Establishment Registration Numer: | 2021898 |
|---|---|
| Address of Manufacturer: | Medtronic Neurosurgery |
| 125 Cremona Drive | |
| Goleta, CA 93117 | |
| (805) 968-1546 | |
| Contact Person: | Jeffrey Henderson |
| Date: | January 26, 2005 |
| Trade or Proprietary Name: | Medtronic StrataVariusTM |
| Common, Usual or Classification Name: | CSF Flow control Shunts and Accessories |
| (21 CFR 882.5550) |
Medtronic Strata Adjustment Kit (K012052, K040943) Predicate Device Identification:
Device Description:
Device Description.
Medtronic Neurosurgery's StrataVarius" System is a battery-powered, handheld instrument that Medironic Neurosurgery S Otratavanas - Systement contained in PS Medical " Strata-type senses the location and onemation of the Ridgher of the StrataVarius Adjustment
adjustable valves. The StrataVarius" works in conjunction with the StrataVarius Adjustmant adjustable valves. The Gratavanas - works in conjuntalse Level (PL) setting as
Tool to change the magnet orientation, and thus the valve auctors includes Tool to change the magnet onemation, and this the Strativanius system includes and determined by the Cilifican. The complete oyetem in Cards (Smart Cards), a
the StrataVarius, an Adjustment Tool, two (or more) Valve Identification 1 First (AA) alkaling the Stratavanus, an Agusthent 150, two (61 more) Premplates, and two 1.5 volt (AA) alkaline batteries.
Intended Use:
Intended Use.
StrataVarius is intended for use by physicians, to non-invasively in terms of PL (ovel of Stratavanus is intended for use by pryolounter to formation numerically in terms of PL level and Performance Level (FL) Setting and display that inform (mm H2O). The StrataVarius allows the same the equivalent pressure reading in millinocers of water (inn. He s).
user to change the pressure setting of the valve non-invasively without the need for radiographic confirmation.
Intended Use of Predicate Device:
Intended Use of Predicate Device.
The Adjustment tool allows the user to change the pressure setting of the valve non-invasively.
Technological Comparison:
l echnological Companson.
The StrataVarius is equivalent to the Strata Adjustment Kit (K012052, K040943). Substantial The Stratavanus is equivalent to the Otrata Aljastment will (1) (1) in the Strations and intended use.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 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 a stylized image of an eagle with its wings spread.
JAN 2 8 2005
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: K041992
Trade/Device Name: Medtronic StrataVarius™ Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: January 20, 2005 Received: January 21, 2005
Dear Mr. Henderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications ferenced above and nave decemined ly marketed predicate devices marketed in interstate for use stated in the encrosure) to regally the enactment date of the Medical Device American Frank Draw commerce phor to May 20, 1978, as vice with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that do nov requesable to the general controls provisions of the Act. The 1 ou may, therefore, thanker the act include requirements for annual registration, listing of general controls provisions of the rice, 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 il your device is classified (see above) mes existing major regulations affecting your device can may be subject to sueli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peachar regerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that 1177 s losaultes of our device complies with other requirements of the Act that FDA has made a determinations administered by other Federal agencies. You must of any I cacal statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the For 8 requirements, while and manufacturing practice requirements as set CFR Part 6077; adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality byticlins (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 – Mr. Jeffrey Henderson
This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the first of a first of a least of your device to a legal This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA midning of substantal equivalian of 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
r and and the may and 115 and 115 and particles and the requiries and the r If you desire specific advice for your de vice on our s. Also, please not the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note the r contact the Office of Complance at (210) 270 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -"Misbranding by reference to premarks. Iountedator.