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

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Stryker KWIC Needle based on the provided 510(k) summary:

This device is a manual surgical instrument and not a software-driven AI device. Therefore, many of the typical questions for AI devices regarding statistical metrics, ground truth, expert adjudication, MRMC studies, and standalone performance are not applicable. The performance data focuses on demonstrating mechanical and functional equivalence to predicate devices, as is common for physical medical instruments.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence:	The device must be able to:
- Facilitate guidewire placement	- Simulated cadaveric testing demonstrated guidewire placement.
- Aspiration of blood/bone marrow	- Preclinical testing on the predicate device (Imbibe Needle) included simulated bone marrow aspiration, and this testing "similarly applies" to the KWIC Needle due to nearly identical materials and construction. The KWIC Needle description also explicitly states it can "draw bone marrow."
- Compatibility with Stryker Navigation Systems	- Functionality with the Stryker Navigation System was confirmed.
Material/Constructional Equivalence:	The materials and construction of the Stryker KWIC Needle must be substantially equivalent to the predicate Imbibe Needle.
Mechanical Integrity (Implied):	The device must be mechanically sound for its intended use.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated with a numerical value. The study refers to "simulated cadaveric testing." It does not specify the number of cadavers or individual tests performed.
Data Provenance: Not explicitly stated. Given the nature of a 510(k) submission for a physical device, the testing would have been conducted internally by the manufacturer or a contracted lab. The location (e.g., country of origin) of the cadaveric testing is not provided. The testing is retrospective in the sense that it's performed as part of the device development and submission process, not as a real-world, prospective clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. For a manual surgical instrument, the "ground truth" is typically established by the physical verification of its function (e.g., did the guidewire pass, did the system recognize the instrument). There is no mention of human experts interpreting data or images to establish ground truth in the way one would for an AI diagnostic device. The performance is assessed by direct observation of the device's mechanical and functional capabilities.

4. Adjudication method for the test set:

Not Applicable. There is no mention of an adjudication process, as the performance tests are functional and objective (e.g., the needle either works with the navigation system or it doesn't; the guidewire either can be placed or it cannot).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a manual surgical instrument, not an AI or imaging device that involves human readers interpreting diagnostic results. Therefore, an MRMC study is not relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This device is a physical instrument, not an algorithm. Its performance is always tied to human use (manual operation) and, in some cases, integration with other systems (Stryker Navigation System), which themselves are tools for human surgical guidance.

7. The type of ground truth used:

For the functional testing (guidewire placement, navigation system compatibility): The ground truth is established by direct observation and successful completion of the intended physical function in a simulated environment (cadaveric testing).
For the aspiration function: The ground truth is derived from demonstrated capability of the predicate device paired with material/constructive equivalence of the current device.

8. The sample size for the training set:

Not Applicable. This is not an AI or machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not Applicable. As there is no training set mentioned or implied for this physical device.

Summary

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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) john.urtz@stryker.com

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, BiopsyInstrument, Biopsy
Common or Usual Name:	Stereotaxic InstrumentGastroenterology-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

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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 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

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

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
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.(b)
Classification. Class II (performance standards).