(146 days)
No
The document describes a powered surgical driver system with nerve stimulation capabilities, focusing on mechanical functions and integration with existing consoles. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as performing surgical actions like cutting, drilling, and driving screws, and it has nerve stimulation capabilities, which are typically used for monitoring or mapping, not for delivering therapeutic treatment.
No
Explanation: The device is described as an surgical tool for cutting, drilling, and driving screws, with nerve stimulation capabilities. While nerve stimulation can be used in a diagnostic context, in this case, it is described as a function of the surgical tool (POWEREASE™ Driver) used in conjunction with a separate system (Medtronic NIM-ECLIPSE® System) during surgical procedures. The primary intended use of the IPC® System and the IPC® POWEREASE™ System is for surgical interventions, not for diagnosing conditions.
No
The device description explicitly details hardware components like a driver handpiece, cables, and a powered console, in addition to the software module.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases or other conditions.
- Device Function: The description clearly states the device is used for surgical procedures involving cutting, removal, drilling, and sawing of tissue and bone, as well as driving screws and other surgical tasks. These are all in vivo (within the living body) procedures.
- Intended Use: The intended use describes surgical applications, not laboratory testing of samples.
The device is a surgical tool used directly on the patient during surgery, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The IPC® System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
The IPC® POWEREASE™ System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in the placement of screws, or cutting of screws, posts, and rods.
Product codes
HBE, HWE, GWF
Device Description
The purpose of this submission is to add a new driver and an accompanying software module to the IPC® . The new system is the IPC® POWEREASE™System. The IPC® POWEREASE™ System provides a powered driver that performs multiple functions and also has nerve stimulation capabilities. The IPC® POWEREASE™ System consists of the Integrated Powered Console (K081475, 10/17/2008), a driver handpiece, and cables to connect the driver, IPC® and NIM-ECLIPSE® System together. The driver is powered by the previously cleared Integrated Powered Console equipped with the appropriate software to operate the driver. The driver is used for drilling, tapping and driving screws in the pedicle, placing screws, and driving working end attachments capable of breaking set screw heads, cutting posts, and cutting rods during spinal surgery. The POWEREASE™ Driver also has nerve stimulation capabilities when connected to the Medtronic NIM -ECLIPSE® System (K061113 - 05/23/2006; K061639 -11/01/2006). An external POWEREASE™NIM Cable that connects the NIM-ECLIPSE® System to the driver enables the driver to have nerve stimulating capability. It should be noted that the IPC® does not provide the stimulation. The stimulation used with the IPC® POWEREASE™ is provided by the Medtronic NIM-ECLIPSE® System.
The driver is equipped with a quick connect feature which allows for easy and secure attachment of different working end attachments compatible with the IPC® POWEREASE™ Driver to perform the various functions mentioned above.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, Cranial, Craniofacial, Orthopedic, Arthroscopic, Sternotomy
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)
Laboratory bench testing conducted on the POWEREASE™ System demonstrates substantially equivalent performance characteristics to the predicate devices currently on the market. Testing was performed according to IEC 60601 Medical Electrical Equipment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081475, K063305, K032303, K061113, K061639, K081277
Reference Device(s)
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
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).
0
111520
pg 1 of 3
OCT 2 6 2011
5. 510(k) Summary
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Medtronic Xomed, Inc. Address of Manufacturer: 6743 Southpoint Drive Jacksonville, FL 32216 (817) 788-6685 Phone (817) 788-6222 Facsimile Establishment Registration Number: 1625507 Contact Person: Rishi Sinha Senior Regulatory Affairs Specialist
Date:
Trade or Proprietary Name:
IPC® POWEREASE™ System IPC System with POWEREASE TM POWEREASE™ System
Common usual or Classification Name:
21 CFR 882.4310 - Powered simple cranial drills, burrs, trephines, and their accessories 21CFR 878.4820 - Surgical instrument motors and accessories/attachments 21CFR882.1870 - Evoked Response Electrical Stimulator
Description:
The purpose of this submission is to add a new driver and an accompanying software module to the IPC® . The new system is the IPC® POWEREASE™System. The IPC® POWEREASE™ System provides a powered driver that performs multiple functions and also has nerve stimulation capabilities. The IPC® POWEREASE™ System consists of the Integrated Powered Console (K081475, 10/17/2008), a driver handpiece, and cables to connect the driver, IPC® and NIM-ECLIPSE® System together. The driver is powered by the previously cleared Integrated Powered Console equipped with the appropriate software to operate the driver. The driver is used for drilling, tapping and driving screws in the pedicle, placing screws, and driving working end attachments capable of breaking set screw heads, cutting posts, and cutting rods during spinal surgery. The POWEREASE™ Driver also has nerve stimulation capabilities when connected to the Medtronic NIM -ECLIPSE® System (K061113 - 05/23/2006; K061639 -11/01/2006). An external POWEREASE™NIM Cable that connects the NIM-ECLIPSE® System to the driver enables the driver to have nerve stimulating capability. It should be noted that the IPC® does not provide the stimulation. The stimulation used with the IPC® POWEREASE™ is provided by the Medtronic NIM-ECLIPSE® System.
1
pg 2 of 3
The driver is equipped with a quick connect feature which allows for easy and secure attachment of different working end attachments compatible with the IPC® POWEREASE™ Driver to perform the various functions mentioned above.
Indications for Use:
The IPC® is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
The IPC® POWEREASE™ System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC® POWEREASE™ System is also used in the placement of screws, or cutting of screws, posts, and rods.
Predicate Device Identification:
The Medtronic IPC® POWEREASE™ System is substantially equivalent to the following predicate devices:
| Device | Manufacturer | 510(k)
Number | Clearance
Date |
|------------------------------------------------------------------------------------|-----------------------|------------------|-------------------|
| Integrated Powered Console (Electric
Drill System) | Medtronic Xomed, Inc. | K081475 | 10/17/2008 |
| Stimulating Bur Guard | Medtronic Xomed, Inc. | K063305 | 11/29/2006 |
| Stryker Consolidated Operating Room
Equipment (CORE) System | Stryker Instruments | K032303 | 1/16/2004 |
| Orthomon | Axon Systems, Inc. | K061113 | 05/23/2006 |
| Eclipse TCD Neurvascular Workstation | Axon Systems, Inc. | K061639 | 11/01/2006 |
| XPS 4000 System, Midas Rex Legend
EHS System, Integrated Power Console
(IPC) | Medtronic Xomed, Inc. | K081277 | 09/05/2008 |
Table 1: Predicate Devices for the IPC® POWEREASE™ System
Comparison to Predicate Device:
The IPC® POWEREASE™ System is similar in device design, function, intended use and fundamental scientific technology to the previously cleared devices listed above.
| Features | IPC® POWEREASE™ System | IPC® System (K081475) |
|---|---|---|
| Indications | The IPC® is indicated for the incision / | |
| cutting, removal, drilling, and sawing of | ||
| soft and hard tissue and bone, and | ||
| biomaterials in Neurosurgical (Cranial, | ||
| Craniofacial), Orthopedic, Arthroscopic, | ||
| Spinal, Sternotomy, and General | ||
| surgical procedures. |
The IPC® POWEREASE™ System is
indicated for drilling, tapping and driving | The IPC® is indicated for the incision /
cutting, removal, drilling, and sawing of
soft and hard tissue and bone, and
biomaterials in Neurosurgical (Cranial,
Craniofacial) Orthopedic, Arthroscopic,
Spinal, Sternotomy, and General surgical
procedures |
Table 2: Comparison of Subject Device to Predicate Device
2
| | screws and working end attachments
during spinal surgery, including open
and minimally invasive procedures.
The IPC® POWEREASE™ System is
also used in the placement of screws,
or cutting of screws, posts, and rods. | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Handpiece
Driver
Compatibility | Drills including the POWEREASE™
Driver, Saws, Microdebriders. All Class
II devices in the IPC® System other
than the POWEREASE™ Driver are
cleared via K081475. | Drills, Saws, Microdebriders - All Class II
devices cleared via K081475 |
| Nerve
Monitoring
Capability | Yes - allows for connection to nerve
monitoring systems | Yes - allows for connection to nerve
monitoring systems |
Testing:
Laboratory bench testing conducted on the POWEREASE™ System demonstrates substantially equivalent performance characteristics to the predicate devices currently on the market. Testing was performed according to IEC 60601 Medical Electrical Equipment.
Conclusion/Summary:
Based upon the laboratory bench test summaries, intended use, and the successful completion of design control activities; the IPC® POWEREASE™ System has been shown to be substantially equivalent to currently marketed predicate devices.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 6 2011
Medtronic Xomed, Inc. % Mr. Rishi Sinha Senior Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216
Re: K111520
Trade/Device Name: IPC POWEREASE System Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: Class II Product Code: HBE, HWE, GWF Dated: September 29, 2011 Received: October 03, 2011
- Dear Mr. Sinha:
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, Trug 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. Please note: CDRH does not evaluate information related to contract and warranties. We remind you; however, that device labeling must be truthful and not muclery,
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
4
Page 2 – Mr. Rishi Sinha
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erine Keith
Jos Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
- Indications for Use Statement
pg i of l
510(k) Number (if known):
® 2024 Experian
Device Name: IPC® POWEREASE™ System
Indications for Use:
The IPC® System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
The IPC® POWEREASE™ System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in the placement of screws, or cutting of screws, posts, and rods.
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)
Nail RPE Ogden for uxm
(Division Sign Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111520
Medtronic IPC® POWEREASE™ System