QUADCUT

K130608 · Medtronic Navigation, Inc. · HAW · Aug 7, 2013 · Neurology

Device Facts

• Record ID: K130608
• Device Name: QUADCUT
• Applicant: Medtronic Navigation, Inc.
• Product Code: HAW · Neurology
• Decision Date: Aug 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The XPS/IPC System is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery. The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy. The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

Device Story

Quadcut is a sterile, single-use surgical blade accessory for the StraightShot M4 handpiece, part of Medtronic's XPS and IPC systems. Each blade features an integrated tracker for electromagnetic navigation. During ENT procedures, a mobile emitter generates a low-energy magnetic field to locate the tracker; the system's Fusion ENT software then displays the blade tip's position within patient image planes (CT/MR) or anatomical renderings. Used by surgeons in clinical settings, the device provides real-time visual guidance to assist in precise tissue/bone removal. It serves as an adjunct to surgical judgment, enhancing accuracy during open or percutaneous procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing focused on functional performance, compatibility with Medtronic Navigation systems and Fusion software, and navigational accuracy within simulated real-life use conditions.

Technological Characteristics

Materials: 304L stainless steel blade, ABS hub. Sensing: Electromagnetic tracking via integrated blade tracker and mobile emitter. Connectivity: Integrates with Medtronic XPS/IPC systems and Fusion ENT software. Sterilization: Ethylene Oxide. Form factor: Surgical blade accessory for M4 handpiece.

Indications for Use

Indicated for patients undergoing otorhinolaryngology, head and neck, or otoneurological surgery requiring incision/removal of soft/hard tissue or bone where stereotactic surgical guidance is appropriate and rigid anatomical structures (e.g., skull) can be referenced to CT/MR models or digitized landmarks.

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

• StealthStation Golden Eye Micro-Magnetic Tracking System Option (K001284)
• Quadcut (non-navigated) (Exempt)

Submission Summary (Full Text)

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# <130608

# 510(k) Summary

## February 27, 2012

- I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville. Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500
- Contact: Sharon McDermott Senior Regulatory Affairs Specialist

### Proprietary Trade Name:

Quadcut®, 3.0 mm x 13 cm Quadcut®, 3.4 mm x 13 cm Quadcut®, 4.3 mm x 13 cm

- II. Common Name: Stereotaxic Instrument
- III. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- IV. Classification: Class II (21 CFR 882.4560)
- V. Product Code: HAW

#### VI. Product Description:

The navigated Quadcut® is a sterile, single use surgical instrument intended for the incision and removal of soft and hard tissue or bone in general otothinolaryngology, head and neck and otoneurological surgery. Quadcut® is an accessory component of the StraightShot M4 handpiece, which is an integral part of the XPS and IPC Systems. The XPS and IPC systems provide power to drive the blades during ENT procedures.

Quadcut® is intended for attachment to the M4 hand piece for use in conjunction with Fusion ENT software on a Medtronic computer-assisted surgery system. Each blade has a tracker mounted on it to allow for navigation during the ENT surgical procedure. The system's mobile emitter generates a low-energy magnetic field to locate the tracker mounted on the blade. Then, the software displays the location of the blade's tip within multiple patient image planes and other anatomical renderings.

**AUG 07 2013**

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#### VII. Indications for Use:

The XPS/IPC System is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.

The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT - or MR-based model, or digitized landmarks of the anatomy.

The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

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

| Description | 510(k) Number | Clearance<br>Date |
|---------------------------------------------------------------------|---------------|-------------------|
| StealthStation Golden Eye Micro-<br>Magnetic Tracking System Option | K001284 | 06/12/2000 |
| Quadcut® (non-navigated), Class I<br>(Product code: EQJ) | Exempt | NA |

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| Item | Subject Devices | Predicate Devices |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Quadcut Blades<br>Indications for Use | The XPS/IPC System is intended for the incision and removal<br>of soft and hard tissue or bone in general otorhinolaryngology,<br>head and neck, and otoneurological surgery.<br>The Medtronic computer-assisted surgery system and its<br>associated applications are intended as an aid for precisely<br>locating anatomical structures in either open or percutaneous<br>procedures. Their use is indicated for any medical condition in<br>which the use of stereotactic surgery may be appropriate, and<br>where reference to a rigid anatomical structure, such as the<br>skull, can be identified relative to a CT- or MR-based model,<br>or digitized landmarks of the anatomy.<br>The system and its associated applications should be used<br>only as an adjunct for surgical guidance. They do not replace<br>the surgeon's knowledge, expertise, or judgment. | Medtronic Xomed Quadcut<br>Blades (non-navigated)<br>Class I, 510(k) Exempt<br>Same intended use<br>StealthStation Golden Eye<br>Micro-magentic System.<br>K001284<br>Same intended use |
| Establishment of<br>Stereotactic<br>Coordinates<br>(Tracking Method) | Electromagnetic | StealthStation Golden Eye<br>Micro-magentic System.<br>K001284<br>Same |
| System Accuracy<br>Requirement | Benchtop and simulated environment:<br>95% confidence / 99.5% reliability, as dictated by risk analysis,<br>of $<=$ 3.00 mm. | StealthStation Golden Eye<br>Micro-magentic System.<br>K001284<br>Equivalent |
| Materials - blade | 304L stainless steel | Medtronic Xomed Quadcut<br>Blades (non-navigated)<br>Class 1, 510(k) Exempt<br>Same material |
| M4 Hub | ABS hub | Medtronic Xomed Quadcut<br>Blades (non-navigated)<br>Class I, 510(k) Exempt<br>Same materials |
| Sterilization Method | Ethylene Oxide sterilization | Medtronic Xomed Quadcut<br>Blades (non-navigated)<br>Class 1, 510(k) Exempt<br>Same sterilization method |

#### IX. Comparison of the Technological Characteristics:

The subject devices have the same intended use and technological characteristics as the predicate devices.

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#### X. Discussion of the Performance Testing

Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. Specifically, testing with Medtronic Navigation systems and Fusion software was conducted to ensure acceptable navigational accuracy. Test samples were subjected to simulated real-life use conditions during functional testing.

#### XI. Conclusions

.

The navigated Quadcut® has been shown through comparison and testing to be substantially equivalent to the identified predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

August 7, 2013

Medtronic Navigation % Ms. Sharon McDermott Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, CO 80027

Re: K130608

Trade/Device Name: Quadcut Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: June 25, 2013 Received: June 25, 2013

Dear Ms. McDermott:

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 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

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Page 2 - Ms. Sharon McDermott

forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalTroblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Eric A. Mann -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

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# Indications for Use

510(k) Number: K130608

Device Name:

Quadcut®, 3.0 mm x 13 cm Quadcut®, 3.4 mm x 13 cm Quadcut®, 4.3 mm x 13 cm

Quadcut® is an accessory component of the StraightShot M4 handpiece, which is an integral part of the XPS and IPC Systems.

### Indications for Use:

The XPS/IPC System is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.

The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy.

The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

| Prescription Use X | AND/OR | Over-The-Counter Use |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>(Part 21 CFR 801 Subpart D) | | (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)

# Eric A. Mann -S

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number_