STRYKER KWIC NEEDLE

K140868 · Orthovita, Inc. · HAW · Jun 5, 2014 · Neurology

Device Facts

• Record ID: K140868
• Device Name: STRYKER KWIC NEEDLE
• Applicant: Orthovita, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jun 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Stryker KWIC Needle is a manual surgical instrument intended to be used in spine surgery to facilitate placement of guidewires. The device may also be used to aspirate autologous blood or bone marrow by use of a syringe. The blood or bone marrow may be combined with bone graft or bone void filler. The Stryker KWIC Needle may be used as part of a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The KWIC Needle is indicated for use in spinal surgical procedures in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure, such as the skull or vertebra, can be identified relative to medical images.

Device Story

Stryker KWIC (K-wire Insertion Cannulated) Needle is a manual surgical instrument; assists in guidewire placement (e.g., pedicle screws) and aspiration of autologous blood or bone marrow. Used in orthopedic/spine surgery; interfaces with cleared Stryker navigation systems for image-guided procedures. Operates by manual insertion; provides physical access to anatomical sites. Benefits include facilitated hardware placement and bone marrow harvesting for grafting. Used by surgeons in clinical/OR settings.

Clinical Evidence

Bench testing only. Included simulated cadaveric testing for guidewire placement and verification of functionality with the Stryker Navigation System.

Technological Characteristics

Manual cannulated needle; stainless steel construction; compatible with Stryker navigation systems for image-guided surgery. No electronic components, energy sources, or software algorithms. Sterilization method not specified.

Indications for Use

Indicated for use in spine surgery to facilitate guidewire placement and aspiration of autologous blood or bone marrow for combination with bone graft/void filler. Indicated for spinal procedures where image-guided surgery is appropriate and rigid anatomical structures (skull/vertebra) can be referenced to medical images.

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

• Imbibe Needle (K050795)
• Stryker Leibinger's Navigation System Spine & Fluoroscopy Module (K012380)

Submission Summary (Full Text)

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# K140868 Page 1 of 2

# 510(k) SUMMARY Stryker KWIC Needle

May 30th, 2014

JUN 0 5 2014

# 510(k) Number: K140868

# 1. Contact Person

John Urtz Sr. Regulatory Affairs Specialist (e-mail) [e-mail]

Orthovita, Inc. 77 Great Valley Parkway Malvern, PA 19355 (t) 610-640-7450 - (f) 484-323-8803

# 2. Device Name and Classification

| Product Name: | Stryker KWIC Needle |
|-----------------------|----------------------------------------------------------------------|
| Classification Name: | Neurologic Stereotaxic Instrument, Biopsy<br>Instrument, Biopsy |
| Common or Usual Name: | Stereotaxic Instrument<br>Gastroenterology-urology Biopsy Instrument |
| Regulation Number: | 882.4560 |

| Regulation Number: | 882.4560 |
|---------------------|--------------------------|
| | 876.1075 |
| Reviewing Panel(s): | Surgical Devices |
| | Gastroenterology/Urology |
| Device Class: | Class II |
| Product Code: | HAW |
| | KNW |

# 3. Predicate Device(s)

Orthovita Inc.'s Imbibe Needle (K050795) Stryker Leibinger's Navigation System Spine & Fluoroscopy Module (K012380)

# 4. Device Description

The Stryker KWIC (K-wire Insertion Cannulated) Needle is a manually operated needle that is used to assist in the placement of guidewires (e.g. K-wires) and/or the aspiration of autologous blood or bone marrow for orthopedic surgery. The Stryker KWIC Needle is designed to interface with already-cleared Stryker navigation systems.

This device is to be manually calibrated and used with Stryker navigation systems. This device is intended to be used in spine applications to perform general manual functions within the orthopedic environment including the placement of guidewires (e.g. K-wires) or to draw bone

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marrow. Guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.

#### 5. Indications for Use

The Stryker KWIC Needle is a manual surgical instrument intended to be used in spine surgery to facilitate placement of guidewires. The device may also be used to aspirate autologous blood or bone marrow by use of a syringe. The blood or bone marrow may be combined with bone graft or bone void filler.

The Stryker KWIC Needle may be used as part of a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The K WIC Needle is indicated for use in spinal surgical procedures in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure, such as the skull or vertebra, can be identified relative to medical images.

# 6. Substantial Equivalence

Information within this submission supports substantial equivalence. The indications for use contain the indications of the predicate Imbibe Needle and the device description notes compatibility with previously cleared Stryker Navigation Systems. Furthermore, the indication for placing guidewires in orthopedic surgery is typically performed by similarly designed Class I instruments, therefore this additional indication is acceptable for the Stryker KWIC Needle.

The materials and construction of the Stryker KWIC Needle are nearly identical to the predicate Imbibe Needle; therefore, preclinical testing performed utilizing the predicate including simulated bone marrow aspiration and mechanical testing similarly applies to the Stryker KWIC Needle.

# 7. Performance Data

Preclinical bench testing utilizing the Stryker KWIC Needle was performed by way of simulated cadaveric testing including guidewire placement. Further, functionality with the Stryker Navigation System was confirmed. The results from this testing demonstrate that the Stryker KWIC Needle is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 5, 2014

Orthovita Incorporated Mr. John Urtz Senior Regulatory Affairs Specialist 77 Great Valley Parkway Malvern, Pennsylvania 19355

Re: K140868

Trade/Device Name: Stryker KWIC Needle Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW, KNW Dated: April 3, 2014 Received: April 3, 2014

Dear Mr. Urtz:

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 or any I vith 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 - Mr. John Urtz

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" (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/MedicalDeyices/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,

# David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

K140868 510(k) Number (if known):

Device Name: Stryker K WIC Needle

Indications for Use:

The Stryker KWIC Needle is a manual surgical instrument intended to be used in spine surgery to facilitate placement of guidewires. The device may also be used to aspirate autologous blood or bone marrow by use of a syringe. The blood or bone marrow may be combined with bone graft or bone void filler.

The Stryker KWIC Needle may be used as part of a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The KWIC Needle is indicated for use in spinal surgical procedures in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure, such as the skull or vertebra, can be identified relative to medical images.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR Over-The Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation

Neil R Ogden -S 2014.06.05 12:31:09 -04'00'

For BSA