(63 days)
No
The description focuses on a manual surgical instrument and its use with existing navigation systems, with no mention of AI or ML capabilities.
No
The device is a manual surgical instrument and needle used to facilitate placement of guidewires and aspirate bodily fluids, not to treat a disease or condition.
No
The device is described as a "manual surgical instrument" used for placing guidewires and aspirating bodily fluids during surgery, rather than for diagnosing conditions.
No
The device description clearly states it is a "manually operated needle" and a "manual surgical instrument," indicating it is a physical hardware device. While it interfaces with software (Stryker navigation systems), the device itself is not software-only.
Based on the provided information, the Stryker KWIC Needle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a manual surgical instrument used in spine surgery to facilitate guidewire placement and aspirate autologous blood or bone marrow. These are surgical procedures performed on the patient, not tests performed on samples taken from the patient to diagnose a condition.
- Device Description: The description reinforces its use as a manually operated needle for surgical procedures and interfacing with navigation systems.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Stryker KWIC Needle's function is entirely focused on facilitating surgical procedures and obtaining samples for potential use within the surgical context (combining with bone graft/filler), not for diagnostic testing.
N/A
Intended Use / 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.
Product codes
HAW, KNW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine, skull or vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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, Biopsy |
| Instrument, Biopsy | |
| Common or Usual Name: | Stereotaxic Instrument |
| 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
1
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.
2
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
3
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
4
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