(145 days)
No
The summary describes manual surgical instruments that interface with existing navigation systems. There is no mention of AI/ML in the device description, intended use, or performance studies.
No
This device consists of manual surgical instruments designed to assist in precisely locating anatomical structures during spinal procedures. It does not directly provide therapy or treatment.
No
Explanation: The device is a set of manual surgical instruments designed to assist surgeons in precisely locating anatomical structures during spinal procedures by interfacing with surgical navigation systems. It is used for surgical guidance, not for diagnosing conditions or diseases.
No
The device description explicitly states that the Navigable Pedicle Preparation Instruments are "manual surgical instruments" and are designed to "interface with already-cleared surgical navigation systems." This indicates the device is a physical instrument, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Synthes Navigable Pedicle Preparation Instruments are surgical instruments used during a surgical procedure to assist the surgeon in locating anatomical structures. They are used directly on the patient's body, not on specimens taken from the body.
- Intended Use: The intended use clearly states they are for "surgical spinal procedures" to "assist the surgeon in precisely locating anatomical structures." This is an in-vivo (within the living body) application, not an in-vitro (in glass/outside the living body) application.
The device's function and intended use are entirely focused on guiding surgical actions within the patient's body, which is the opposite of what an IVD does.
N/A
Intended Use / Indications for Use
The Synthes Navigable Pedicle Preparation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion.
Product codes
OLO, HAW
Device Description
The Navigable Pedicle Preparation Instruments are manual surgical instruments which are designed to interface with already-cleared surgical navigation systems. Instruments in this system may be pre-calibrated to already-cleared surgical navigation systems, or may be manually calibrated to already-cleared surgical navigation systems using manufacturers' instructions. These instruments are intended to be used in spine applications to perform general manual functions within the orthopaedic surgical environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction
Anatomical Site
Spinal, pelvis or a vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Synthes conducted validation activities including usability testing. The Navigable Pedicle Preparation Instruments met the performance requirements, providing assurance of device performance for their intended use. No safety or effectiveness issues were raised by the performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K070106 BrainLab VectorVision Fluoro3D System, K050438 Medtronic StealthStation, K003111 Stryker SpineMap
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
122211
@ SYMTHES® Spine
DEC 1 7 2012
5 510(k) Summary
| 510(k) Summary | |
|---|---|
| Name of Firm: | DePuy Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Hemal Mehta |
| Regulatory Affairs Specialist | |
| Telephone: 610-719-5424 | |
| Facsimile: 610-719-5102 | |
| Email: mehta.hemal@synthes.com | |
| Date Prepared: | December 14, 2012 |
| Trade Name: | Synthes Navigable Pedicle Preparation Instruments |
| Classification: | Sec. 882.4560 |
| Class II | |
| Orthopaedic | |
| Product Code: OLO, HAW | |
| Predicate | |
| Devices: | K070106 BrainLab VectorVision Fluoro3D System |
| K050438 Medtronic StealthStation | |
| K003111 Stryker SpineMap | |
| Device | |
| Description: | The Navigable Pedicle Preparation Instruments are manual surgical |
| instruments which are designed to interface with already-cleared surgical | |
| navigation systems. Instruments in this system may be pre-calibrated to | |
| already-cleared surgical navigation systems, or may be manually | |
| calibrated to already-cleared surgical navigation systems using | |
| manufacturers' instructions. These instruments are intended to be used in | |
| spine applications to perform general manual functions within the | |
| orthopaedic surgical environment. | |
| Intended Use/ | |
| Indications for | |
| Use: | The Synthes Navigable Pedicle Preparation Instruments are intended to |
| assist the surgeon in precisely locating anatomical structures in either | |
| open, minimally invasive, or percutaneous procedures. These are | |
| indicated for use in surgical spinal procedures, in which the use of | |
| stereotactic surgery may be appropriate, and where reference to a rigid | |
| anatomical structure, such as the pelvis or a vertebra can be identified | |
| relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D | |
| fluoroscopic image reconstruction) and/or an image data based model of | |
| the anatomy. These procedures include but are not limited to spinal | |
| fusion. |
P. 1/2
1
| ® SYNTHES® | |
|---|---|
| Spine |
| 510(k) Summary
Comparison of
the device to
predicate
device(s): | The design features, materials, and indications for use of the subject
Synthes Navigable Pedicle Preparation Instruments are substantially
equivalent to the predicate devices identified. |
|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Data
(Non-Clinical
and/or Clinical): | Synthes conducted validation activities including usability testing. The
Navigable Pedicle Preparation Instruments met the performance
requirements, providing assurance of device performance for their
intended use. No safety or effectiveness issues were raised by the
performance testing. Clinical data was not needed for the Navigable
Pedicle Preparation Instruments. |
Par(2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2012
Synthes Spine % Mr. Hemal Mehta Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K122211
Trade/Device Name: Synthes Navigable Pedicle Preparation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO, HAW Dated: October 23, 2012 Received: October 24, 2012
Dear Ms. Guerin:
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 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.
3
Page 2 - Ms. Heather Guerin
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
@ SYNTHES® Spine
Indications for Use Statement 4
K122211 510(k) Number: (if known)
Synthes Navigable Pedicle Preparation Instruments Device Name:
Indications for Use:
The Synthes Navigable Pedicle Preparation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion.
X Prescription Use (21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 801 Subpart C).
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
[2017-12-09] 14:23:06 -05'00'
(Division Sign-off) Division of Surgical Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________ K122211