(189 days)
StrataVarius is intended for use by physicians, to non-invasively identify the Strata-type valve Performance Level (PL) setting and display that information numerically in terms of PL level and the equivalent pressure reading in millimeters of water (mm H2O). The StrataVarius allows the same user to change the pressure setting of the valve non-invasively without the need for radiographic confirmation.
Medtronic Neurosurgery's StrataVarius" System is a battery-powered, handheld instrument that senses the location and orientation of the magnet contained in PS Medical " Strata-type adjustable valves. The StrataVarius" works in conjunction with the StrataVarius Adjustment Tool to change the magnet orientation, and thus the valve Performance Level (PL) setting as determined by the Clinician. The complete system includes the StrataVarius, an Adjustment Tool, two (or more) Valve Identification Cards (Smart Cards), a Quick Reference Guide, two StrataVarius Templates, and two 1.5 volt (AA) alkaline batteries.
The Medtronic StrataVarius is a battery-powered, handheld instrument designed to non-invasively identify and display the Performance Level (PL) setting of Strata-type adjustable valves (used in CSF shunts) and the equivalent pressure reading in millimeters of water (mm H2O). It also allows users to non-invasively change the valve's pressure setting without requiring radiographic confirmation.
Here's an analysis of the acceptance criteria and the study as described in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria in a dedicated section. However, the FDA's "substantially equivalent" determination implies that the device's performance met the criteria for equivalence to its predicate device, the Strata Adjustment Kit (K012052, K040943). The technological comparison states: "The StrataVarius is equivalent to the Strata Adjustment Kit (K012052, K040943). Substantial equivalence as demonstrated in the StrataVarius 510(k) is based on the similarities in the technological characteristics and intended use."
Given the intended use, the key performance aspects that would have been evaluated for "substantial equivalence" are:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Accuracy of PL Setting Identification: The ability to correctly identify and display the Strata-type valve's Performance Level (PL) setting. | Demonstrated to be accurate and consistent with the established method, as implied by FDA's substantial equivalence finding for its intended use. |
| Accuracy of Pressure Equivalent Display: The ability to accurately display the equivalent pressure reading in mm H2O corresponding to the identified PL setting. | Demonstrated to be accurate and consistent with the established method, as implied by FDA's substantial equivalence finding for its intended use. |
| Reliability of Non-Invasive Setting Change: The ability to reliably and safely change the valve's pressure setting non-invasively without requiring radiographic confirmation. | Demonstrated to reliably and safely change the valve's pressure setting non-invasively, eliminating the need for radiographic confirmation, as implied by FDA's substantial equivalence finding for its intended use. |
| Safety: No new safety concerns compared to the predicate device. | No new safety concerns identified, as implied by FDA's substantial equivalence finding. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective). The FDA decision is based on a 510(k) Pre-Market Notification, which generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with specific sample sizes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information regarding the number of experts used, their qualifications, or how ground truth was established for any test set. For a 510(k) submission, the "ground truth" often refers to the performance of the predicate device.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned. This device is not an AI-assisted diagnostic tool for human readers but rather a tool to interact with and read settings from a medical device (CSF shunt valve). Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to a device that performs its function directly. The StrataVarius is a standalone device in the sense that its primary function is to directly identify and display valve settings and change them non-invasively. Its performance as a mechanical/electronic tool (reading and adjusting) would be evaluated in a standalone manner, but the document does not detail the specific studies that established its standalone performance other than the general declaration of substantial equivalence.
7. The Type of Ground Truth Used
The ground truth for demonstrating the safety and effectiveness of the Medtronic StrataVarius is implicitly the established and accepted performance of its predicate device, the Strata Adjustment Kit (K012052, K040943). The StrataVarius claims "substantial equivalence" based on "similarities in the technological characteristics and intended use" to this predicate. This suggests that the ground truth for its function would be derived from the known and validated performance of the predicate in identifying and adjusting valve settings.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. This type of device (a medical instrument for reading and adjusting another device) typically does not involve "training sets" in the machine learning sense. The "training" would be more akin to engineering development and testing to ensure its mechanical and electronic functions perform as intended.
9. How the Ground Truth for the Training Set Was Established
As there's no mention of a "training set" in the context of machine learning, there is no information on how ground truth for such a set was established. Development and validation of such a device would involve rigorous engineering testing, calibration against known valve settings, and verification of its ability to perform its intended functions repeatedly and accurately. The "ground truth" for these tests would be the actual physical settings of the Strata-type valves.
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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 Neurosurgery125 Cremona DriveGoleta, 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.
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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.
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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)
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. < < < e Act from the Division of Small
other general information on your responsibilities under the Act from worker (800) other general information on your responsion its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number (index html Manufacturers, international and Consumer Assistance arovedrh/industry/support/index.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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Indications for Use
K041992 510(k) Number (if known):
Device Name:
Medtronic StrataVarius™
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 valve i enormance Lever (r E) Southig and adding in millimeters of water (mm H2O). The of FL level and the equivalent prossure roading in the valve non-invasively without the need for radiographic confirmation."
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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 1
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
1641992 510(k) Number.
StrataVarius™ 510(K) K041992 Amend 1 01/20/05
§ 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).