IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools

K170312 · Medtronic Powered Surgical Solutions · HBC · May 15, 2017 · Neurology

Device Facts

• Record ID: K170312
• Device Name: IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools
• Applicant: Medtronic Powered Surgical Solutions
• Product Code: HBC · Neurology
• Decision Date: May 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Electric Drill System is a electrically operated surgical instrument system. The electric motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries. Additionally, the Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures: - Lumbar Microdiscectomy - Lumbar Stenosis Decompression - Posterior Lumbar Interbody Fusion (PLIF) - Transforaminal Lumbar Interbody Fusion (TLIF) - Anterior Lumbar Interbody Fusion (ALIF) - Direct Lateral Interbody Fusion (DLIF)

Device Story

Electric surgical instrument system; comprises Integrated Power Console (IPC), electric foot control, connection cables, irrigation/cooling sets, and various electric handpieces/motors. System drives interchangeable rotating surgical cutting tools and attachments. Used in OR settings by surgeons for neurosurgical, spinal, ENT, and orthopedic procedures. Provides power for incision, cutting, removal, drilling, and sawing of bone and soft tissue. IPC also functions as endoscope lens cleaning system. Surgeon operates via foot pedal; output is mechanical rotation of cutting tools. Benefits include precise tissue removal during complex spinal and cranial surgeries.

Clinical Evidence

No clinical trials. Evidence consists of a comprehensive clinical literature review supporting the safety and effectiveness of the system for the expanded spinal indications (LM, PLIF, TLIF, LSD, ALIF, DLIF) and cadaveric testing evaluating user acceptability and performance across these procedures.

Technological Characteristics

Electrically powered surgical drill system. Components include Integrated Power Console, electric handpieces, attachments, and surgical dissecting tools. Operating principle: electric energy supplied to handpiece to drive rotating cutting tools. Materials are similar to predicate devices. System includes irrigation/cooling control. Connectivity via cables to foot control and console.

Indications for Use

Indicated for patients undergoing neurosurgery (craniotomy, spinal), ENT, orthopedic, and general surgical procedures (maxillofacial, craniofacial, sternotomy). Specifically indicated for incision, cutting, removal, drilling, and sawing of soft/hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, including lumbar microdiscectomy, lumbar stenosis decompression, PLIF, TLIF, ALIF, and DLIF.

Regulatory Classification

Identification

An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

Predicate Devices

• Electric Drill System (XPS 4000 System, Midas Rex Legend EHS System, IPC) (K081475)
• Legend EHS Handpieces (K081475, K012457)
• Legend Stylus Touch Handpiece (K081475, K012457)
• Microsaw Handpieces and Blades (K081475)
• Surgical Dissecting Tools (K020069)
• Surgical Dissecting Tools (Curved Bur) (K072315)
• Legend Attachments (K020069)
• Electric Foot Pedal and Y-Splitter (K081475)
• Irrigation Tubing Sets (K081475)
• System Accessories (K081475)
• Triton Electric High Torque Handpiece (K121264)
• Surgical Dissecting Tools (K121264, K870157)
• Attachments (K121264, K870157)
• System Accessories (K121264, K870157)
• Legend Electric High Speed Drill System (K012457)
• Electric Handpiece (K081475, K012457)

Reference Devices

• Surgical Dissecting Tools (K870157)
• Surgical Dissecting Tools (K020069)
• Surgical Dissecting Tools (Curved Bur) (K072315)

Submission Summary (Full Text)

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Medtronic Powered Surgical Solutions % Xiaojian Sun Sr. Regulatory Affairs Specialist Medtronic Neurosurgery 125 Cremona Dr. Goleta, California 93117

Re: K170312

Trade/Device Name: IPC Systems, Legend EHS Handpieces and Legend Stylus Touch Handpiece, Microsaw Handpieces, Triton Electric High Torque Handpiece, Attachments and Surgical Dissecting Tools Regulation Number: 21 CFR 882.4360 Regulation Name: Electric Cranial Drill Motor Regulatory Class: Class II Product Code: HBC, HBE, HRX, HWE, EOJ, ERL, KFK Dated: January 31, 2017 Received: February 1, 2017

May 15, 2017

Dear Xiaojian Sun:

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.

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

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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K170312

### Device Name

IPC Systems, Legend EHS Handpieces and Legend Stylus Touch Handpieces, Triton Electric High Torque Handpiece, Attachments and Surgical Dissecting Tools

## Indications for Use (Describe)

The Electric Drill System is a electrically operated surgical instrument system. The electric motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

Additionally, the Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

- Lumbar Microdiscectomy
- Lumbar Stenosis Decompression
- Posterior Lumbar Interbody Fusion (PLIF)
- Transforaminal Lumbar Interbody Fusion (TLIF)
- Anterior Lumbar Interbody Fusion (ALIF)
- Direct Lateral Interbody Fusion (DLIF)

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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# SECTION 9: 510(k) SUMMARY

This summary is submitted in accordance with the requirements of 21CFR807.92.

#### 9.1 DATE PREPARED

January 31, 2017

#### 9.2 NAME AND ADDRESS OF MANUFACTURER

# Table 4: Manufacturer information

| Establishment Name | Establishment Registration Number |
|---------------------------------------------------------------------------------------------|-----------------------------------|
| Medtronic Powered Surgical Solutions<br>4620 North Beach Street<br>Fort Worth, TX 76137 USA | 1625507 |
| Medtronic Xomed, Inc.<br>6743 Southpoint Drive North<br>Jacksonville, FL 33216 USA | 1045254 |

#### 9.3 CONTACT PERSON

Xiaojian Sun Senior Regulatory Affairs Specialist 805.571.8758 Telephone: E-Mail: [e-mail]

#### 9.4 PROPRIETARY NAME OF THE PROPOSED DEVICES

IPC Systems, Legend EHS Handpieces and Legend Stylus Touch Handpiece, Microsaw Handpieces, Triton Electric High Torque Handpiece, Attachments and Surgical Dissecting Tools

#### 9.5 COMMON/USUAL NAME

Surgical Drill Motors and Accessories

#### 9.6 DEVICE CLASSIFICATION NAME

# Table 5: FDA device classification information

| Description | FDA Code | Regulation Number |
|-----------------------------------------------------------------------------|----------|-------------------|
| Drills, burrs, trephines and accessories (simple, powered) | HBE | 21CFR882.4310 |
| Motor, drill, electric | HBC | 21CFR882.4360 |
| Arthroscope | HRX | 21CFR888.1100 |
| Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | HWE | 21CFR878.4820 |
| Bur, ear, nose and throat | EQJ | 21CFR874.4140 |
| Drill, surgical, ent (electric or pneumatic) including handpiece | ERL | 21CFR874.4250 |
| Saw, pneumatically powered | KFK | 21CFR878.4820 |

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#### 9.7 PREDICATE DEVICE IDENTIFICATION

| SUBJECT SYSTEM DESCRIPTION | PREDICATE | |
|------------------------------------------|------------------------------------------------------------------------------|------------------|
| | SYSTEM DESCRIPTION | 510(k) NUMBER |
| Medtronic Electric Drill System | Electric Drill System [XPS 4000 System, Midas<br>Rex Legend EHS System, IPC) | K081475 |
| - IPC (Integrated Power Console) | - IPC (Integrated Power Console) | K081475 |
| - Legend EHS Handpieces | - Legend EHS Handpieces | K081475, K012457 |
| - Legend Stylus Touch Handpiece | - Legend Stylus Touch Handpiece | K081475, K012457 |
| - Microsaw Handpieces and Blades | - Microsaw Handpieces and Blades | K081475 |
| - Surgical Dissecting Tools | Surgical Dissecting Tools | K020069 |
| - Surgical Dissecting Tools (Curved Bur) | - Surgical Dissecting Tools (Curved Bur) | K072315 |
| - Legend Attachments | - Legend Attachments | K020069 |
| - Electric Foot Pedal and Y-Splitter | - Electric Foot Pedal and Y-Splitter | K081475 |
| - Irrigation Tubing Sets | - Irrigation Tubing Sets | K081475 |
| - System Accessories | - System Accessories | K081475 |
| Triton Electric High Torque Handpiece | Triton Electric High Torque Handpiece | K121264 |
| - Triton Electric High Torque Handpiece | - Triton Electric High Torque Handpiece | K121264 |
| - Surgical Dissecting Tools | Surgical Dissecting Tools | K121264, K870157 |
| - Attachments | - Attachments | K121264, K870157 |
| - System Accessories | - System Accessories | K121264, K870157 |
| Legend Electric High Speed Drill System | Legend Electric High Speed Drill System | K012457 |
| - Electric Handpiece | Electric Handpiece | K081475, K012457 |
| - Surgical Dissecting Tools | Surgical Dissecting Tools | K020069 |
| - Surgical Dissecting Tools (Curved Bur) | - Surgical Dissecting Tools (Curved Bur) | K072315 |
| - Legend Attachments | - Legend Attachments | K020069 |

Table 6: Subject Devices that are in the scope of this Submission

#### 9.8 DEVICE DESCRIPTION

The Electric Drill System consists of an electric Integrated Power Console, Electric Foot Control unit with Y-Splitter, Connection Cables, Irrigation/Cooling Sets including a remote Irrigation Control Unit, and various Electric Handpieces and/or electric motors and Attachments to drive various Surgical Dissecting Tools. The Integrated Power Console device of the Electric Drill System can also function as an endoscope lens cleaning system.

The device design, function, the intended use and the general operating principles, and conditions of use of the overall Medtronic Electric Drill System remain similar to those cleared under K012457, K081475, and K121264.

The surgical dissecting tools and attachments remain similar to those covered under K870157, K020069, and K072315.

#### 9.9 INDICATIONS FOR USE

The Electric Drill System is a electrically operated surgical instrument system. The electric motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

Additionally, the Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine

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procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

- Lumbar Microdiscectomy O
- Lumbar Stenosis Decompression o
- Posterior Lumbar Interbody Fusion (PLIF) o
- Transforaminal Lumbar Interbody Fusion (TLIF) o
- Anterior Lumbar Interbody Fusion (ALIF) O
- Direct Lateral Interbody Fusion (DLIF) O

#### 9.10 COMPARISON OF INTENDED USE

The expanded indication of the subject device did not alter the intended use of the device, which is to remove soft and hard tissue, bone, and biomaterials during surgical procedures. The cadaveric study demonstrated that the addition of the proposed indications do not present any new issues of safety or effectiveness, and the systems perform as intended during surgical use, similar to the use during other various surgical procedures on currently cleared indications. Therefore it is concluded that the subject device has the same intended use as the predicate device.

#### 9.11 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Electrically powered drill system, designed to remove soft and hard tissue, and bone, and biomaterials is the technological principle for both the subject and predicate systems.

The subject and predicate systems are based on the following same technological elements:

- A Electric Drill System Application: Designed to remove soft and hard tissue, bone, and biomaterials during various surgical applications.
- > Operating Principle: The electric energy is supplied to the Handpiece to provide power to operate interchangeable Surgical Dissecting Tools supported by Attachments and intended for use in various surgical procedures to remove soft and hard tissue, bone, and biomaterials.

In terms of the materials used in manufacturing of the patient contacting components of the subject Electric Drill System, the subject Attachments, Surgical Dissecting Tools, and irrigation tubing sets are similar to the predicates.

#### DISCUSSION OF THE PERFORMANCE TESTING 9.12

| TEST | DESCRIPTION | RESULTS |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical<br>Literature<br>Review | A comprehensive clinical literature<br>search was conducted and reviewed<br>regarding the safe and effective use<br>of the Electric Drill System for the<br>expanded indications for use, which<br>is the subject of this submission. | The review of supporting literature<br>supports the use of the Medtronic<br>Electric Drill System in LM, PLIF,<br>TLIF, LSD, ALIF, and DLIF spinal<br>surgical procedures, as well as any<br>variations of these procedures. |

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| Cadaveric<br>Testing | Users evaluated the acceptability of<br>the subject electric drill system to its<br>intended use on a variety of<br>procedures using cadavers. | The Medtronic Electric Drill System<br>is acceptable for its intended use in<br>various surgical procedures. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|

#### CONCLUSION 9.13

The subject Medtronic Electric Drill Systems when compared to the predicate Drill Systems have same intended use, where the subject and the predicate drill systems are intended for use in various surgical procedures to remove soft and hard tissue, and biomaterials. Results of cadaveric testing have demonstrated that the addition of the proposed indications do not present any new issues of safety or effectiveness, and the systems perform as intended during surgical use, similar to the use during various other surgical procedures on currently cleared indications.