STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000

K062640 · Stryker Instruments · HAW · Dec 14, 2006 · Neurology

Device Facts

• Record ID: K062640
• Device Name: STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000
• Applicant: Stryker Instruments
• Product Code: HAW · Neurology
• Decision Date: Dec 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Stryker Navigation System - Cranial Module The Stryker Navigation System -- Cranial Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.

Device Story

Stryker Navigation System - Cranial Module provides pre-operative planning and intraoperative guidance for computer-assisted surgery. System utilizes wireless optical tracking to localize instruments relative to rigid anatomical structures. Inputs include medical images for planning; system performs automatic multi-modality correlation and automatic segmentation of brain surface, tumors, and vessels. Used in OR by surgeons and clinical staff to assist in procedures like craniotomies, biopsies, and ENT surgeries. Output is visual guidance displayed to the surgeon, facilitating navigation during procedures. Benefits include enhanced surgical precision and workflow efficiency for complex cranial and ENT interventions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparisons to predicate devices.

Technological Characteristics

System utilizes wireless optical tracking for localization. Features include software for pre-operative planning, automatic multi-modality image correlation, and automatic segmentation of anatomical structures (brain surface, tumors, vessels). Designed and manufactured per QSR 21 CFR 820. Connectivity supports image importation for surgical planning.

Indications for Use

Indicated for ENT procedures (ESS, intranasal, ear implants) and neuro procedures (biopsies, abscess puncture, craniotomies, craniectomies, tumor/lesion resection, foreign object removal, skull base/transnasal/transsphenoidal surgery, shunt placement including pediatric, electrode placement, craniofacial/skull/orbital reconstruction). Contraindicated when increased surgical time is detrimental to the patient. Operated by trained surgeons and clinic staff.

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

• Stryker Navigation - Neuro Module (K993239)
• Stryker Navigation - ENT Module (K002732)
• Medtronic StealthStation System (K050438)

Submission Summary (Full Text)

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4100 E. Milham Avenue
Kalamazoo, MI 49001 t: 269 323 7700 f: 800 965 6505
www.stryker.com

# stryker

## Instruments

:

# K062640

| 510(k) Summary | | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device Sponsor: | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>(p) 269-323-7700<br>(f) 269-324-5412 | DEC 1 4 2006 |
| Registration No.: | 1811755 | |
| Trade Name: | Stryker Navigation System - Cranial Module | |
| Common Name: | Navigation System | |
| Classification Name: | Stereotaxic Instruments | |
| Equivalent to: | K993239 Stryker Navigation - Neuro Module<br>K002732 Stryker Navigation - ENT Module<br>K050438 Medtronic StealthStation System | |
| Device Description: | Stryker Navigation System - Cranial Module is part of the product series of the<br>Stryker Navigation System. The system comprises software for pre-operative surgical<br>planning and supports computer assisted surgery based on a wireless optical tracking<br>localization device for the use in navigated cranial surgery.<br>The Stryker Navigation Cranial Module is a combination of the previously cleared<br>Stryker Navigation System - Neuro Module and ENT Module with the addition of new<br>features. The Cranial module will include automatic multi-modality correlation. The<br>system provides an easy-to-use work flow concept for image importation, FESS,<br>Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor,<br>vessels, etc. are supported. | |
| Intended Use: | Stryker Navigation System - Cranial Module<br>The Stryker Navigation System -- Cranial Module is intended as a planning and<br>intraoperative guidance system to enable open or percutaneous computer assisted<br>surgery. The system is indicated for any medical condition in which the use of<br>computer assisted planning and surgery may be appropriate. The system can be used<br>for intra-operative guidance where a reference to a rigid anatomical structure can be<br>identified. | |
| Indications for Use: | The system should be operated only by trained personnel such as orthopedic surgeons<br>and clinic staff. The Cranial Navigation system supports, but is not limited to, the<br>following surgical procedures: | |
| | ENT Procedures | |
| | Endoscopic Sinus Surgery (ESS)<br>Intranasal procedures | |

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- Ear implant procedures .
### Neuro Procedures

- . Cranial biopsies
- Puncture of abscesses .
- Craniotomies .
- . Craniectomies
- Resection of tumors and other lesions .
- . Removal of foreign objects
- . Skull base procedures
- . Transnasal neurosurgical procedures
- Transsphenoidal pituitary surgery .
- Shunt placement, including pediatric shunt placement .
- Placement of electrodes for recording, stimulation and lesion generation .
- Craniofacial procedures .
- Skull reconstruction procedures .
- Orbital cavity reconstruction procedures .

### Contraindications

- Surgical situation where increasing surgical time may be detrimental to the patient.

| Substantial Equivalence<br>(SE) Rational: | The Stryker Navigation System - Cranial Module is equivalent in intended use, safety, and effectiveness to existing devices being marketed by Stryker and Medtronic. |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and Effectiveness: | The Stryker Navigation System - Cranial Module does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Navigation System - Cranial Module are substantially equivalent to these existing devices. They will be designed and manufactured in accordance with Stryker Leibinger's and Stryker Instrument's Quality Management System covered by QSR 21CFR 820. |
| Submitted by: | Becky Ditty |

| Submitted by: | Becky Ditty |
|-----------------|-----------------------------------|
| | Regulatory Affairs Representative |
| | Signature |
| Date submitted: | 9/5/6 |

Da

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol in the center. The symbol appears to be an stylized representation of a human figure embracing or protecting another, possibly symbolizing care and support.

JAN 2 2 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Corporation % Ms. Becky Ditty Regulatory Affairs Representative Stryker Instruments Division 4100 E Milham Ave Kalamazoo, MI 49001

Re: K062640

Trade/Device Name: Stryker Navigation System - Cranial Module Regulation Number: 21 CFR § 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: December 14, 2006

Dear Ms. Ditty:

This letter corrects our substantially equivalent letter of December 14, 2006.

We have reviewed your Section 510(k) pre-market 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 (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 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 - Ms. Becky Ditty

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 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 continue marketing your device as described in your Section 510(k) pre-market 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

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):-K060313_____________________________________________________________________________________________________________________________________________

Device Name: Stryker Navigation System - Cranial Module

#### Intended Use

The Stryker Navigation System - Cranial Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.

KD62640

#### Indications for Use

The system should be operated only by trained personnel such as surgeons and clinic staff. The Cranial Navigation system supports, but is not limited to, the following surgical procedures:

#### ENT Procedures

- . Endoscopic Sinus Surgery (ESS)
- . Intranasal procedures
- Ear implant procedures .

#### Neuro Procedures

- Cranial biopsies .
- . Puncture of abscesses
- Craniotomies .
- Craniectomies .
- Resection of tumors and other lesions .
- Removal of foreign objects .
- . Skull base procedures
- . Transnasal neurosurgical procedures
- Transphenoidal pituitary surgery .
- . Shunt placement, including pediatric shunt placement
- . Placement of electrodes for recording, stimulation and lesion generation
- Craniofacial procedures .
- . Skull reconstruction procedures
- . Orbital cavity reconstruction procedures

#### Contraindications

- Surgical situation where increasing surgical time may be detrimental to the patient. .

| Prescription Use X<br>(Part 21 CFR 801 Subpart D) | and/or | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)ce of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative,

and Neurological Devices

| 510(k) Number | 1062640 |
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