(161 days)
Not Found
No
The description mentions "a proprietary set of algorithms" but provides no indication of AI/ML techniques being used. The performance studies focus on accuracy and equivalence to a predicate device, not on AI/ML specific metrics or training/testing data.
No
The device aids a surgeon in shaping a spinal rod for implantation, but it does not directly treat or diagnose a medical condition itself. It's a tool for preparing an implant, not a therapeutic device.
No
Explanation: The device is described as a system used to locate spinal implant system instrumentation and generate bend instructions for shaping a spinal rod. It aids in the mechanical bending of a rod, which is a therapeutic intervention, not a diagnostic one. While it acquires data about the relative location of anatomical landmarks, this data is used for surgical planning and execution (shaping a rod), not for identifying a disease, condition, or anomaly.
No
The device description explicitly lists hardware components like a computer with a touch screen display, a 6DOF optical and electromagnetic localizer system, and localized pointers or styluses, indicating it is not solely software.
Based on the provided information, the Bendini™ Spinal Rod Bending System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to locate spinal implant instrumentation and generate bend instructions for shaping a spinal rod for use in surgery. This is a surgical planning and execution tool, not a diagnostic test performed on biological samples.
- Device Description: The device uses optical and electromagnetic localization to determine the relative location of surgical implants and anatomical landmarks. It processes this spatial data to generate instructions for a mechanical rod bender. This process does not involve analyzing biological samples to diagnose a condition or provide information about a patient's health status.
- Lack of IVD Characteristics: The description does not mention any analysis of blood, tissue, urine, or any other biological sample. It focuses on spatial measurements and mechanical manipulation.
In summary, the Bendini™ Spinal Rod Bending System is a surgical planning and assistance device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bendini™ Spinal Rod Bending System is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The NuVasive Bendini Spinal Rod Bending System consists of components that are used to locate spinal implant system instrumentation (screws, hooks), determine their relative location to one another, and generate bend instructions that are used along with the Bendini bender to accurately shape a rod for use in spinal surgery applications.
The Bendini Spinal Rod Bending System shares the following components with the predicate device: a computer with touch screen display, a 6DOF optical and electromagnetic localizer system, and localized pointers or styluses used to digitize intraoperative anatomical landmarks. Both the Bendini Spinal Rod Bending System and the predicate device intraoperatively digitize the relative location of anatomical landmarks with a localized pointer or stylus in order to acquire data that is then interpreted by a proprietary set of algorithms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, clinical settings
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)
Nonclinical testing was performed to demonstrate that the Bendini Spinal Rod Bending System is substantially equivalent to a predicate device. This testing performed was determined to be necessary in establishing substantial equivalence and included evaluation of software performance per predetermined specifications outlined in the SRS, GUI functionality, error handling, system accuracy during data acquisition, verification of instrument performance in combination with the software, verification of software algorithms, and cadaver testing to demonstrate performance under anticipated clinical settings.
The results of the studies performed demonstrate that the subject Bendini Spinal Rod Bending System meets the performance of the predicate device, and the subject device was therefore found to be substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized, abstract shape on the left, resembling a curved or partial circle with a small extension at the bottom. To the right of the shape is the word "NUVASIVE" in bold, sans-serif font. Below "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font size.
510(k) Premarket Notification Bendini™ Spinal Rod Bending System
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR $807.92, the following summary of information is provided:
A. Submitted by:
Elias Ketchum Regulatory Affairs Associate NuVasive. Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-4588 Fax: (858) 320-4688
Date Prepared: August 26, 2011
B. Device Name
Trade or Proprietary Name: NuVasive® Bendin™ Spinal Rod Bending System ' Common or Usual Name: Stereotaxic Instrument
Classification Name: Device Class: Classification: Product Code:
Instrument, Stereotaxic Class II 8882.4560 OLO
C. Predicate Devices
The subject Bendini Spinal Rod Bending System is substantially equivalent to the following device:
· K050438 - StealthStation® System, Medtronic, Inc.
D. Device Description
The NuVasive Bendini Spinal Rod Bending System consists of components that are used to locate spinal implant system instrumentation (screws, hooks), determine their relative location to one another, and generate bend instructions that are used along with the Bendini bender to accurately shape a rod for use in spinal surgery applications.
E. Intended Use
The Bendini™ Spinal Rod Bending System is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.
F. Technological Characteristics
As was established in this submission, the subject Bendini Spinal Rod Bending System is substantially equivalent to a predicate device cleared by the FDA for commercial distribution in the United States.
1
Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized black and white graphic to the left of the company name. Below the company name is the tagline "Speed of Innovation".
The Bendini Spinal Rod Bending System shares the following components with the predicate device: a computer with touch screen display, a 6DOF optical and electromagnetic localizer system, and localized pointers or styluses used to digitize intraoperative anatomical landmarks. Both the Bendini Spinal Rod Bending System and the predicate device intraoperatively digitize the relative location of anatomical landmarks with a localized pointer or stylus in order to acquire data that is then interpreted by a proprietary set of algorithms.
The main technological differences between the Bendini Spinal Rod Bending System and the predicate device is that the Bendini Spinal Rod Bending System does not integrate or overlay acquired data into patient data contained in radiographic images nor is it used to generate surgical intervention plans/approaches based on traiectories and/or other identified anatomical structures observed in radiographic images. Any differences in technology do not raise questions or issues regarding safety and effectiveness of the Bendini Spinal Rod Bending System.
Based on the comparison above, the subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate device in areas including design, intended use, material composition, and function.
G. Performance Data
Nonclinical testing was performed to demonstrate that the Bendini Spinal Rod Bending System is substantially equivalent to a predicate device. This testing performed was determined to be necessary in establishing substantial equivalence and included evaluation of software performance per predetermined specifications outlined in the SRS, GUI functionality, error handling, system accuracy during data acquisition, verification of instrument performance in combination with the software, verification of software algorithms, and cadaver testing to demonstrate performance under anticipated clinical settings.
The results of the studies performed demonstrate that the subject Bendini Spinal Rod Bending System meets the performance of the predicate device, and the subject device was therefore found to be substantially equivalent.
H. Conclusions
Based on the indications for use, technological characteristics, performance testing, and comparison to a predicate device, the subject Bendini Spinal Rod Bending System has been shown to be substantially equivalent to a legally marketed predicate device.
2
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 depiction of an abstract caduceus, which is a symbol often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
o
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NuVasive, Inc. % Mr. Elias Ketchum Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121
DEC - 5 2011
Re: K111811
Trade/Device Name: Nu Vasive® Bendini™ Spinal Rod Bending System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: November 11, 2011 Received: November 14, 2011
Dear Mr. Ketchum:
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
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Page 2 - Mr. Elias Ketchum
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.ida.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/MedicalDevices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KII/811 510(k) Number (if known):
Device Name: NuVasive® Bendini™ Spinal Rod Bending System
Indications For Use:
The Bendini™ Spinal Rod Bending System is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender,
Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (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 (ODE)
Nil R^Dolen for mxm
Division Sign-Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number