(107 days)
Not Found
No
The description focuses on a magnetic tool for mechanical adjustment of a valve and does not mention any computational or learning capabilities.
No
The device is an adjustment tool for a valve and does not directly provide therapy. It is used to adjust another device (the Strata-type Valve) which likely has a therapeutic function.
No
The device is described as an adjustment tool used to non-invasively adjust a valve, which is a therapeutic or interventional function, not a diagnostic one. It does not gather information about the patient's health status or condition.
No
The device is described as a "magnetic tool" and its function involves physical interaction with a valve, indicating it is a hardware device.
Based on the provided information, the Medtronic M2 Adjustment Tool is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Medtronic M2 Adjustment Tool Function: The description clearly states that the tool is a magnetic tool used to non-invasively adjust a valve implanted in a patient. It directly interacts with an implanted medical device within the body, not with a specimen taken from the body.
The function and intended use of the Medtronic M2 Adjustment Tool fall under the category of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medtronic M2 Adjustment Tool is a magnetic tool that is used to non-invasively adjust the Strata-type Valve when a stronger magnet is warranted by the surgeon. The Medtronic M2 Adjustment Tool is used in conjunction with Strata® handtools.
Product codes
JXG
Device Description
The Medtronic M2 Adjustment Tool is a magnetic tool that is used to non-invasively adjust the Strata-type Valve when a stronger magnet is warranted by the surgeon. External adjustment of the valve prevents the need for an invasive revision procedure. To adjust the operating pressure of the valve, the adjustment tool is used in close proximity to the valve to move the rotor within the valve.
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
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
DEC 16 2005 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) 968-1546 ext. 1773 | |
| Fax: (805) 968-9336 | |
| Contact Person: | Jeffrey Henderson |
| Date: | August 25, 2005 |
| Trade or Proprietary Name: | Medtronic M2 Magnet Adjustment Tool |
| Common usual or Classification Name: | Central Nervous System Flow Control |
| Shunts and Accessories (882.5550) | |
| Predicate Device Identification: | Adjustment tools for Medtronic PS |
| Medical® Strata® Valve and Shunt | |
| Assemblies (K012052, K033850, and | |
| K042465) |
Description: The Medtronic M2 Adjustment Tool is a magnetic tool that is used to non-invasively adjust the Strata-type Valve when a stronger magnet is warranted by the surgeon. External adjustment of the valve prevents the need for an invasive revision procedure. To adjust the operating pressure of the valve, the adjustment tool is used in close proximity to the valve to move the rotor within the valve.
Intended Use: The Medtronic M2 Adjustment Tool is a magnetic tool that is used to non-invasively adjust the Strata-type Valve when a stronger magnet is warranted by the surgeon. The Medtronic M2 Adjustment Tool is used in conjunction with Strata® handtools.
Intended Use of predicate device(s): The adjustment tools for the PS Medical Strata Valve and shunt component are used to non-invasively change the performance level (pressure/flow characteristics) of the Strata type valve.
Technological comparison: Medtronic Neurosurgery submits that the materials of fabrication, intended use, and the fundamental scientific technology of the M2
1
Magnet Adjustment Tool are the same as the previously reviewed and cleared Magnet Adjustmont 1001 are the Strata Valve and Shunt Assemblies. Based upon the adjustment tools for the Strater Party determines substantial equivalence, Summary above, Medironio Noarouaryony and until the predicate and currently marketed devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an abstract eagle design with three curved lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.
Public Health Service
DEC 16 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeffery Henderson Mr. JoHory Int, Quality & Regulatory Affairs Medtronic Neurosurgery 125 Cremona Drive Goleta, California 93117-5000
Re: K052386
KU52380
Trade/Device Name: Medtronic M2 Magnet Adjustment Tool Regulation Number: 21 CFR 882.5550 Regulation Name: 21 CF IC 60215990
Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: October 20, 2005 Received: October 24, 2005
Dear Mr. Henderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQ(x) premaince is substantially equivalent (for the indications
referenced above and have determined the device is substantially interstate referenced above and have detenmined the devices marketed in interstate for use stated in the enclosite) to regally manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Pedical Device American of the Feder commerce prior to May 28, 1976, the enactinent and of the Federal Food, Drug, devices that have been reclassified in accordance with the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmetic Act (Act) that do not require approval or upcome provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mender requirements.
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), If your device is classified (see adove) nno entire) in the regulations affecting your device
it may be subject to such additional controls. Existing major regulations affec it may be subject to such additional controls: "Directory of South All All All All All All All All All All All All All All All All All All All All All All All All All All can be found in the Couc of I cacral regending your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA S Issualier of a subscribed with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA nas made a decertimation alla your de roll be receins agencies. You must or any Federal statutes and regulations administered of other to registration and listing (21
comply with all the Act's requirements, including, and isoners areas as set comply with all the Act s requirements, monamis, was ice requirements as se
CFR Part 807); labeling (21 CFR Part 801); good manufacturing plactice the electronic CFR Part 807); labeling (21 CFR Part 801); good manata 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000); 11 CFR 1000 1050 forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
3
Page 2 – Mr. Henderson
This letter will allow you to begin marketing your device as described in your Section 510(k)
In a legal This letter will allow you to begin marketing your article equivalence of your device to a legally
premarket notification. The FDA finding of substantial end this permits v premarket notification. The PDA miding of bassanian or 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
rs the same of the support of 10, 276 0115 - Also - places note the regulat If you desire specific advice for your de not on on on on the regulation entitled, the regulation entitled, would of the may obtain, contact the Office of Collipilalice at (240) 270 or 177 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You "Misbranding by reference to premarket notificanon" (the Act from the Division of Small other general information on your responsionities and the efect manber (800) 638-204 or 1 Manufacturers, International and Consumer Pisolouitor Provice Provice Provincial Propport/index.html.
Sincerely yours,
Barbara Buehrig
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- Statement of Indications for Use ll.
510(k) Number (if known): K052386
Device Name: Medtronic M2 Adjustment Tool
Indications for Use:
The Medtronic M2 Adjustment Tool is a magnetic tool that is used to non-The Meditorile MZ Adjustmont Tool is a meginvasively adjust the Orata type and the sed in conjunction with Strata® handtools.
X 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)
of Device Evaluation (ODE) Concurrenge of
(Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K052256