(123 days)
Not Found
No
The document describes a surgical handpiece and software module for a power console, focusing on mechanical function and performance. There is no mention of AI, ML, image processing, or data-driven decision-making.
No
The device is described as an IPC System with a handpiece used for surgical procedures (cutting, drilling, sawing), not for therapeutic purposes.
No
The device is described as an "IPC System with the TRITON Electric High-Torque Handpiece" indicated for "incision / cutting, removal, drilling, and sawing of soft and hard tissue and biomaterials" in various surgical procedures. This description points to a surgical tool used for treatment, not for diagnosing conditions.
No
The device description explicitly states the submission is for a new handpiece (hardware) and an accompanying software module. The handpiece is powered by a previously cleared console (hardware). The software module is described as driving the handpiece, indicating it controls hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical procedures involving the cutting, removal, drilling, and sawing of soft and hard tissue and biomaterials within the body. This is a surgical device, not a device used to examine specimens outside the body.
- Device Description: The description focuses on a handpiece and console used for surgical tasks like sawing, drilling, and driving screws, wires, and pins. This aligns with surgical instrumentation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to perform tests on specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely surgical intervention.
N/A
Intended Use / Indications for Use
The TRITON Electric High-Torque Handpiece 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.
Product codes (comma separated list FDA assigned to the subject device)
HBC, HBE, HRX, HWE
Device Description
The purpose of this submission is to add a new handpiece and an accompanying software module as a line extension to the current Integrated Power Console IPC® System. The handpiece is powered by the previously cleared integrated Powered Console. In order to operate the TRITON Electric Handpiece, the IPC will be equipped with the appropriate software module to drive the handpiece. The handpiece is used for sawing, drilling, driving and placing screws, wires and pins when used in conjunction with various attachments previously cleared for use during spinal surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
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 IPC System with the TRITON Electric High Torque Handpiece demonstrates substantially equivalent performance characteristics to the predicate devices currently on the market.
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
§ 882.4310 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
K12/264
5. 510(k) Summary
AUG 2 7 2012
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Address of Manufacturer: | Medtronic Powered Surgical Solutions
4620 North Beach Street
Fort Worth, TX 76137
(817) 788-6400 Phone |
| -------------------------- | ----------------------------------------------------------------------------------------------------------------- |
|---|
(817) 788-6222 Facsimile
Establishment Registration Number: 1625507
Contact Person:
Date:
Trade or Proprietary Name:
Jeffrey Henderson VP, Quality, Clinical & RA
August 10, 2012
TRITON Electric High Torque Handpiece and Software Module
IPC System with the TRITON High Torque Handpiece
Common usual or Classification Name:
21 CFR 882.4360, Product Code HBC, Class II - Electric cranial drill motor
21 CFR 882.4310, Product Code HBE, Class II - Powered simple cranial drills, burrs, trephines, and their accessories
21 CFR 888.1100, Product Code HRX, Class II - Arthroscope
21CFR 878.4820, Product Code HWE, Class I - Surgical instrument motors and accessories/attachments
Description:
The purpose of this submission is to add a new handpiece and an accompanying software module as a line extension to the current Integrated Power Console IPC® System. The handpiece is powered by the previously cleared integrated Powered Console. In order to operate the TRITON Electric Handpiece, the IPC will be equipped with the appropriate software module to drive the handpiece. The handpiece is used for sawing, drilling, driving and placing screws, wires and pins when used in conjunction with various attachments previously cleared for use during spinal surgery.
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The TRITON Electric High Torque Handpiece has the identical attachment connecting interfacing components as the handpiece cleared under K870157. As a result, the TRITON Electric High Torque Handpiece utilizes the same Attachments and Blades as those cleared under K870157.
Indications for Use:
The TRITON Electric High-Torque Handpiece 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.
Predicate Device Identification:
The Medtronic TRITON Electric High Torque Handpiece and Software Module is substantially equivalent to the following predicate devices:
| Device | Manufacturer | 510(k) Number | Clearance Date |
|---|---|---|---|
| XPS 4000 System, Midas Rex | |||
| Legend EHS System, Integrated | |||
| Power Console (IPC) | Medtronic Xomed, Inc. | K081475 | 10/17/2008 |
| XPS 4000 System, Midas Rex | |||
| Legend EHS System, Integrated | |||
| Power Console (IPC) | Medtronic Xomed, Inc. | K081277 | 09/05/2008 |
| IPC® POWEREASETM System | |||
| 510(k) K111520 | Medtronic Xomed, Inc. | K111520 | 10/26/2011 |
Table 1: Predicate Devices for the IPC System with TRITON High Torque Handpiece
Comparison to Predicate Device:
The TRITON Electric High Torque Handpiece and Software Module are similar in device design, function, intended use and fundamental scientific technology to the previously cleared devices listed above.
Table 2: Comparison of Subject Device to Predicate Device
| Feature | Proposed IPC TM System w/ TRITON
High Torque Handpiece | Predicate Devices |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Integrated Powered Console System w/
TRITON Handpiece
The IPC® system 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® provides power
to various drills and saws to drive | Integrated Powered Console - K081475
The IPC® system 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®
provides power to various drills and saws
to drive attachments and tools during
surgical procedures. |
| Feature | Proposed IPC™ System w/ TRITON
High Torque Handpiece | Predicate Devices |
| | attachments and tools during surgical
procedures. | |
| Indication for
Use | Integrated Powered Console w/
TRITON Handpiece
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 | Integrated Powered Console - K081475
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 |
| Operating
Principle | Integrated Powered Console w/
TRITON Handpiece
The IPC® System is an electric
powered instrument system consisting
of multiple handpieces which are
powered by the IPC® console. The
handpieces are intended to drive
various types of interchangeable
attachments and instruments used in
various surgical procedures. When
active, the motor of the handpiece
rotates to drive the connected
attachment. | Integrated Powered Console - K081475
The IPC® System is an electric powered
instrument system consisting of multiple
handpieces which are powered by the
IPC® console. The handpieces are
intended to drive various types of
interchangeable attachments and
instruments used in various surgical
procedures. When active, the motor of the
handpiece rotates to drive the connected
attachment. |
| Software | Integrated Powered Console w/
TRITON Handpiece
The IPC software is designed to
recognize and control position, torque
and direction of the following
handpieces, POWEREASE Driver,
Stylus, Stylus Touch, EHS, Visao,
Skeeter and Indigo drills, the
Oscillating, Reciprocating and Sagittal
saws, and Triton driver and the M4,
SC1 microdebriders and the TRITON
High Torque Handpiece. | Integrated Powered Console - K081475
The IPC software is designed to
recognize and control position, torque and
direction of the following handpieces,
Stylus, Stylus Touch, EHS, Visao,
Skeeter and Indigo drills, the Oscillating,
Reciprocating and Sagittal saws, and
Triton driver and the M4 and SC1
microdebriders |
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:
3
Handpiece Comparison
| Metric | IPC® with TRITON Electric High Torque
Handpiece | | Predicate Device |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Image: Free Run | Image: With
Attachment | |
| Maximum
Applied Torque | 1.6 Nm | 3.1 Nm(1) | 7 Nm |
| Range of
Speed | 0 to max free run speed of
1250 - 1800 rpm | 0 - 250 rpm | 0 - 250 rpm |
| Range of Safe
Working
Temperatures | Max temperature through the entire operating
range at any external surface location on
handpiece shall be less than 51 °C for less than
1 minute and shall not exceed 48 °C for less
than 10 minutes | | 48°C max |
| Duty Cycle | Cycle Time: 20 seconds on maximum / 20
seconds off minimum
Maximum number of cycles before resting
handpiece: 6
Maximum number of cycles before resting
attachment: 3
Minimum rest period: 25 minutes | | Continuous Operation |
| Intended Use | The TRITON Electric High Torque Handpiece is
intended to remove hard and soft tissue, drill
pilot holes, drive screws, wires, and pins
during, but not limited to, spinal, cranial, and
small bone surgical procedures. The TRITON
Electric High Torque Handpiece is intended to
be used in both open and minimally invasive
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. |
ក្រុង
4
Testing:
Laboratory bench testing conducted on the IPC System with the TRITON Electric High Torque Handpiece demonstrates substantially equivalent performance characteristics to the predicate devices currently on the market.
Conclusion/Summary:
Based upon the laboratory bench test summaries, intended use, and the successful completion of design control activities; the IPC System with the TRITON Electric High Torque Handpiece and software module is shown to be substantially equivalent to currently marketed predicate devices.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 27 2012
Medtronic Surgical Technologies c/o Mr. Jeffrey Henerson VP, Quality, Clinical & RA 4620 North Beach Street Fort Worth, TX 76137
Re: K121264
Trade/Device Name: TRITON Electric High Torque Handpiece and Software Module Regulation Number: 21 CFR 882.4360 Regulation Name: Electric Cranial Drill Motor Regulatory Class: Class II Product Code: HBC, HBE, HRX, HWE Dated: August 10, 2012 Received: August 13, 2012
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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Page 2 - Mr. Jeffrey Henerson
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); 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/ResourcesforYou/Industry/default.htm.
ர்ட
.
Sincerely vours.
Kesia Alexander
Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
K121264 510(k) Number (if known):
Device Name: __ TRITON Electric High Torque Handpiece and Software Module
Indications for Use:
The IPC System with the TRITON Electric High-Torque Handpiece is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
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)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K121264
Prescription Use (Per 21 CFR 801.109)
Medtronic TRITON Electric High-Torque Handpiece
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