CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM

K022126 · Medtronic Surgical Navigation Technologies · HAW · Jan 3, 2003 · Neurology

Device Facts

• Record ID: K022126
• Device Name: CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM
• Applicant: Medtronic Surgical Navigation Technologies
• Product Code: HAW · Neurology
• Decision Date: Jan 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System 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, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

Device Story

Catheter Introducer for StealthStation® System is an image-guided surgical instrument accessory. It utilizes the existing StealthStation® tracking infrastructure, employing active (LEDs), passive reflective markers, or electromagnetic coils to track instrument position relative to a patient's anatomical reference frame. Input data consists of pre-operative or intra-operative CT, MR, or fluoroscopic images. The system correlates tracked instrument coordinates with these images, providing real-time visualization of the instrument's position within the patient's anatomy. Used in clinical settings (OR) by surgeons to assist in precise placement of catheter shunts and other surgical tools. Output is visual guidance on a display, enabling surgeons to navigate complex anatomical structures, potentially increasing procedural accuracy and reducing invasiveness.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and verification/validation activities as required by risk analysis.

Technological Characteristics

System utilizes optical (LED/passive reflective) or electromagnetic tracking technology. Integrates with CT, MR, or fluoroscopic imaging modalities. Designed for use as an accessory to the StealthStation® navigation platform. No specific materials or software architecture details provided beyond reliance on the existing StealthStation® navigation infrastructure.

Indications for Use

Indicated for patients requiring stereotactic surgery where rigid anatomical structures (skull, long bone, vertebra) can be registered to CT, MR, or fluoroscopic images. Applicable for cranial, spinal, ENT, and orthopedic procedures including biopsies, tumor resections, shunt placements, joint replacements, and fracture repairs.

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® System (K022126)
• Radionics Optical Tracking System

Submission Summary (Full Text)

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### Summary of Safety and Effectiveness Catheter Introducer for the StealthStation® System

#### I. Manufacture:

Medtronic Surgical Navigation Technologies 826 Coal Creek Circle Louisville, CO 80027 USA Telephone Number: [phone] Fax Number: [phone]

JAN 0 3 2003

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#### II. Contact:

Victoria G. Rendon Clinical and Regulatory Affairs Associate Medtronic Surgical Navigation Technologies

#### III. Product Name/ Classification Name:

Product Name: Catheter Introducer for the StealthStation® System Classification Name: Stereotaxic Instrument (21 CFR 882.4560) Classification Panel: 84 HAW

#### Date Summary Submitted IV.

June 28, 2002

#### V. Description of Device Modification:

This submission allows a surgeon an image guided instrument to place catheter shunts. The Catheter Introducer for the StealthStation® System is technically equivalent to the StealthStation® System. All systems use either active(LED's), passive reflective markers or electromagnetic coils to track surgical instruments in relation to an image guided reference frame. This information is correlated to the patient's CT, MR or fluoroscopic images of the anatomy.

This submission provides new indications that are substantially equivalent to the named predicate devices' indications statement.

#### VI. Substantial Equivalence:

The Catheter Introducer for the StealthStation® System was substantially equivalent to the StealthStation® System cleared in previous 510(k)'s. Additionally, the Catheter Introducer was determined to be substantially equivalent to the Radionics Optical Tracking System. As required by risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence.

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#### 622226 2/2

### VII. Indications For Use:

The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System 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, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

Example procedures include, but are not limited to:

(Including but not Limited to Acetabular Fractures)

| Cranial Procedures: | Spinal Procedures: | ENT Procedures: | Orthopedic Procedures: |
|------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Cranial Biopsies | Spinal Implant Procedures, such as Pedicle Screw | Transphenoidal Procedures | Total Knee Arthroplasty (Primary and Revision) |
| Placement | | Intranasal Procedures | Unicompartmental Knee Arthroplasty |
| Tumor Resections | | Orbital Nerve Decompression Procedures | Minimally Invasive Orthopedic Procedures |
| Craniotomies/ Craniectomies | | Optic Nerve Decompression Procedures | Pediatric Orthopedics |
| Skull Base procedures | | Polyposis Procedures | Total Hip Replacement (Primary and Revision) |
| Thalamotomies/Pallidotomies | | Endoscopic Dacryocystorhinostomy | Periacetabular Osteotomies |
| Pituitary Tumor Removal | | Encephalocele Procedures | Tumor Resection and Bone/Joint Reconstruction |
| CSF Leak Repair | | Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies | Femoral Revision |
| Pediatric Catheter Shunt Placement | | | Stabilization and Repair of Pelvic Fractures |
| General Catheter Shunt Placement | | | |

0459

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized eagle symbol. The eagle is depicted with three lines forming its body and wings, representing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

JAN 0 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Surgical Navigation Technologies Victoria G. Rendon Clinical and Regulatory Affairs Associate 826 Coal Creek Circle Louisville, Colorado 80027

Re: K022126

Trade/Device Name: Catheter Introducer for the StealthStation® System Regulation Number: 882.4560 Regulation Name: Stereotactic system and accessories Regulatory Class: Class II Product Code: HAW Dated: October 4, 2002 Received: October 7, 2002

Dear Ms. Rendon:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in

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Page 2 - Ms. Victoria G. Rendon

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 1(022126

Device Name: Catheter Introducer for the StealthStation® System

### Indications For Use:

The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System 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, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

Example procedures include, but are not limited to:

### Cranial Procedures:

Cranial Biopsies Placement Tumor Resections Craniotomies/ Craniectomies Skull Base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair Pediatric Catheter Shunt Placement General Catheter Shunt Placement

### Orthopedic Procedures:

Total Knee Arthroplasty (Primary and Revision) Ethmoidectomies, Sphenoidotomies/Sphenoid Unicompartmental Knee Arthroplasty Minimally Invasive Orthopedic Procedures Pediatric Orthopedics Total Hip Replacement (Primary and Revision) Periacetabular Osteotomies Tumor Resection and Bone/Joint Reconstruction Femoral Revision Stabilization and Repair of Pelvic Fractures (Including but not Limited to Acetabular Fractures)

#### Spinal Procedures:

Spinal Implant Procedures, such as Pedicle Screw

### ENT Procedures:

Transphenoidal Procedures Intranasal Procedures Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary Antrostomies, Explorations, Turbinate Resections.and Frontal Sinusotomies

Mark N Melleuson

Division of General, Restorative and Neurological Devices

510(k) Number _

K022126

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Concurrence of CDRH, Office Of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)