EM ENT Navigated Suctions

K153555 · Medtronic Navigation, Inc. · PGW · Apr 7, 2016 · Neurology

Device Facts

• Record ID: K153555
• Device Name: EM ENT Navigated Suctions
• Applicant: Medtronic Navigation, Inc.
• Product Code: PGW · Neurology
• Decision Date: Apr 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

EM ENT Instruments are indicated for use in navigated ENT procedures to locate points on a CT-based or MR-based digital model and to remove fluids, semi-fluid substances, tissue, and bone dust. EM ENT Instruments are indicated for use with Medtronic computer-assisted surgery systems. The EM ENT instruments are indicated for use in ENT procedures such as: CSF leak repairs related to ENT procedure Intranasal procedures Orbital decompression procedures Polyposis procedures Endoscopic dacryocystorhinostomy Sinus procedures, such as maxillary antrostomies Ethmoidectomies Sphenoidotomies/sphenoid explorations Turbinate resections and frontal sinusotomies The EM ENT instruments can also be used in the ENT surgical approach for the following procedures: Pituitary tumor removal Skull base procedures Transsphenoidal procedures Optic nerve decompression procedures Encephalocele procedures

Device Story

EM ENT Navigated Suctions are handheld, reusable surgical instruments used with Medtronic computer-assisted surgery systems. A mobile emitter generates a low-energy magnetic field to track the position of an EM ENT Instrument Tracker attached to the suction device. The system displays the instrument tip's location within pre-operative CT or MR image planes and anatomical renderings. Used by surgeons in ENT procedures to navigate anatomy and remove fluids, tissue, and bone dust. Provides real-time visual feedback to the surgeon, aiding in precise localization during complex procedures like skull base or sinus surgery; benefits include improved surgical accuracy and navigation.

Clinical Evidence

Bench testing only. Testing included navigational accuracy (1.54 mm error at 95% confidence in controlled environment; 1.73 mm error in simulated surgical environment), suction functionality, design specification conformance, and electrical safety. No clinical data provided.

Technological Characteristics

Materials: Stainless steel, titanium, and AES Santoprene® 8281-90 (patient-contacting cable). Sensing: Electromagnetic tracking via proximal tracker. Connectivity: Integrates with Medtronic computer-assisted surgery systems. Form factor: Handheld suction with various fixed shaft configurations (straight, 45°, 70°, 90°). Reusable instruments; trackers supplied sterile single-use.

Indications for Use

Indicated for patients undergoing navigated ENT procedures, including CSF leak repair, intranasal, orbital decompression, polyposis, endoscopic dacryocystorhinostomy, sinus procedures (maxillary antrostomies, ethmoidectomies, sphenoidotomies/explorations, turbinate resections, frontal sinusotomies), pituitary tumor removal, skull base, transsphenoidal, optic nerve decompression, and encephalocele procedures.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• Manual Surgical Instruments (non-navigated) (Exempt)
• StealthStation® GoldenEye™ Micro-Magnetic Tracking System Option (K001284)
• StealthStation® System Update (K050438)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human profiles facing right, connected by flowing lines. The symbol 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 Center - WO66-G609 Silver Spring, MD 20993-0002

April 7. 2016

Medtronic Navigation, Inc. Carey Brenner Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, CO 80027

Re: K153555

Trade/Device Name: EM ENT Navigated Suctions Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: March 7, 2016 Received: March 8, 2016

Dear Carey Brenner:

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.

{1}------------------------------------------------

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 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 yours.

Denise L. Hampton -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

## 510(k) Number (if known) K153555

## Device Name

ENT EM Fusion and Supplemental Navigated Instruments

## Indications for Use (Describe)

EM ENT Instruments are indicated for use in navigated ENT procedures to locate points on a CT-based or MR-based digital model and to remove fluids, semi-fluid substances, tissue, and bone dust. EM ENT Instruments are indicated for use with Medtronic computer-assisted surgery systems. The EM ENT instruments are indicated for use in ENT procedures such as:

·CSF leak repairs related to ENT procedure

- •Intranasal procedures
- ·Orbital decompression procedures
- •Polyposis procedures
- ·Endoscopic dacryocystorhinostomy
- ·Sinus procedures, such as maxillary antrostomies
- · Ethmoidectomies
- ·Sphenoidotomies/sphenoid explorations
- ·Turbinate resections and frontal sinusotomies

The EM ENT instruments can also be used in the ENT surgical approach for the following procedures:

•Pituitary tumor removal

·Skull base procedures

·Transsphenoidal procedures

·Optic nerve decompression procedures

•Encephalocele procedures

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
| |

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

Electromagnetic (EM) ENT Navigated Suctions 510(k) Summary December 11, 2015

- I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200
- Carey Brenner Contact: Regulatory Affairs Specialist
- II. Proprietary Trade Name:

EM ENT Navigated Suctions

- III. Classification Name:
Stereotaxic Instrument

- IV. Classification:
21 CFR 882.4560 Stereotaxic Instrument

- V. Product Codes:
PGW

- VI. Product Description
The Electromagnetic Ear Nose & Throat (EM ENT) Navigated Suctions are electromagnetically tracked, handheld, re-usable instruments intended to be used with EM ENT Instrument Trackers and ENT software on a Medtronic computer-assisted surgery system. The EM ENT Instrument Tracker is attached to the EM ENT Navigated Suction to track its position. The navigation system's mobile emitter generates a lowenergy magnetic field to locate the tracker mounted on the instrument. Then, the software displays the location of the instrument's tip within multiple patient image planes and other anatomical renderings.

{4}------------------------------------------------

#### VII. Indications for Use

EM ENT Instruments are indicated for use in navigated ENT procedures to locate points on patient anatomy relative to a CT-based or MR-based digital model and to remove fluids, semi-fluid substances, tissue, and bone dust. EM ENT Instruments are indicated for use with Medtronic computer-assisted surgery systems. The ENT instruments are indicated for use in ENT procedures such as:

- . CSF leak repairs related to ENT procedure
- Intranasal procedures ●
- Orbital decompression procedures
- Polyposis procedures
- Endoscopic dacryocystorhinostomy
- Sinus procedures, such as maxillary antrostomies ●
- Ethmoidectomies ●
- Sphenoidotomies/sphenoid explorations
- Turbinate resections and frontal sinusotomies

The EM ENT instruments can also be used in the ENT surgical approach for the following procedures:

- Pituitary tumor removal
- Skull base procedures
- Transsphenoidal procedures
- Optic nerve decompression procedures .
- . Encephalocele procedures

### VIII. Summary of the Technological Characteristics

| | Subject Device:<br>EM ENT Navigated Suction Devices | | Predicate Devices: |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | EM ENT Navigated Suctions<br>and Trackers<br>EM ENT Instruments are<br>indicated for use in navigated<br>ENT procedures to locate points<br>on patient anatomy relative to a<br>CT-based or MR-based digital<br>model and to remove fluids,<br>semi-fluid substances, tissue,<br>and bone dust. EM ENT<br>Instruments are indicated for use<br>with Medtronic computer-<br>assisted surgery systems. The<br>EM ENT instruments are<br>indicated for use in ENT<br>procedures such as:<br>•CSF leak repairs related to ENT | The EM ENT instruments can<br>also be used in the ENT surgical<br>approach for the following<br>procedures:<br>• Pituitary tumor removal<br>• Skull base procedures<br>• Transsphenoidal procedures<br>• Optic nerve decompression<br>procedures<br>• Encephalocele procedures | Medtronic Manual Suctions (non-<br>navigated) Class I, 510k Exempt<br>Same intended use<br>StealthStation® System GoldenEye™<br>Micro-Magnetic Tracking System<br>Option<br>Same Indications for use<br>StealthStation® System Update<br>Same Indications for use |
| | procedure | | |
| | •Intranasal procedures | | |
| | •Orbital decompression<br>procedures | | |
| | •Polyposis procedures | | |
| | •Endoscopic<br>dacryocystorhinostomy | | |
| | •Sinus procedures, such as<br>maxillary antrostomies | | |
| | •Ethmoidectomies | | |
| | •Sphenoidotomies/sphenoid<br>explorations | | |
| | •Turbinate resections and frontal<br>sinusotomies | | |
| | Localization<br>Technology | Electromagnetic (proximal tracker attached) | |
| | | | |
| | | | |
| | | | |
| | | StealthStation® System Update<br>Same | |
| | | | |
| System or<br>Instrument<br>Accuracy<br>Requirements | EM ENT Navigated Suctions | StealthStation® System GoldenEye™<br>Micro-Magnetic Tracking System | |
| | Within a standard controlled environment: navigated peg errors of<br>1.54 mm at 95% confidence and 99% reliability | Option<br>Equivalent | |
| | Within a simulated surgical environment: navigated peg errors of<br>1.73 mm at 5% confidence and 99% reliability | StealthStation® System Update<br>Equivalent | |
| | | | |
| Suction<br>Functionality | Yes | Medtronic Manual Suctions (non-<br>navigated) Class I, 510k Exempt<br>Substantially Equivalent | |
| Instrument Tip<br>Configurations | Standard (straight) | Medtronic Manual Suctions (non- | |
| | Angle<br>Olive<br>Ball/Angle | navigated) Class I, 510k Exempt<br>Substantially Equivalent | |
| Materials | EM ENT Navigated Suctions | Medtronic Manual Suctions (non- | |
| | Stainless Steel, titanium | navigated) Class I, 510k Exempt<br>Same Material as Suction | |
| | Patient and Instrument Trackers | | |
| | Patient contacting cable: AES Santoprene® 8281-90 material with<br>Colorant Pantone 301C | StealthStation® System Update<br>Same Material as Tracker Cable | |
| Instrument<br>Shaft<br>Configurations | Fixed- Straight, Small Straight, 45° frontal, 70° curve, 90° curve, 90°<br>frontal | Medtronic Manual Suctions (non-<br>navigated) Class I, 510k Exempt<br>Substantially equivalent | |
| | | | |
| Supplied as<br>"Reusable Use" | EM ENT Navigated Suctions | Medtronic Manual Suctions (non- | |
| | Yes | navigated) Class I, 510k Exempt<br>reusable | |
| | Patient and Instrument Trackers<br>Supplied Sterile Single Use | | |

{5}------------------------------------------------

{6}------------------------------------------------

### IX. Identification of Legally Marketing Devices (Predicate Devices)

| Description<br>(Substantial Equivalence Characteristic) | 510(k) Number | Clearance<br>Date |
|--------------------------------------------------------------------------------------------------------|---------------|---------------------|
| Manual Surgical Instruments (non-navigated), Class I<br>(product code: LRC Regulation: 21CFR 874.4420) | Exempt | Not<br>Applicable a |
| StealthStation® GoldenEye™ Micro-Magnetic Tracking<br>System Option | K001284 | 06/12/2000 |
| StealthStation® System Update | K050438 | 06/02/2005 |

a The Class I Medtronic ENT suction devices were released to market on June 6, 1997. They were recently sold to another company in 2014.

### X. Discussion of the Performance Testing

Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. Specifically, testing with the StealthStation® System and EM ENT Suction instruments was conducted to ensure acceptable navigational accuracy, suction capability, conformance to design specifications and electrical safety testing. Test samples were subjected to simulated real-life use conditions including repeated functional testing.

### XI. Conclusions

The EM ENT Navigated Suction Instruments have been shown through comparative and bench testing to be substantially equivalent to the identified predicate devices.