(168 days)
No
The description focuses on a manual, navigated instrument that requires manual calibration and relies on third-party navigation systems. There is no mention of AI/ML in the device description, intended use, or performance studies.
No
The device is described as a "reusable manual screwdriver for insertion of VIPER PRIME screws" and does not directly treat or mitigate a disease or condition; instead, it is an instrument used during a surgical procedure.
No
This device is a surgical instrument (navigated inserter/screwdriver) used for inserting screws during spinal procedures, not for diagnosing conditions. It uses navigation systems that process imaging data but the device itself is an instrument for treatment, not diagnosis.
No
The device is described as a "reusable manual screwdriver" with "attachment sites for universal tracking arrays," indicating it is a physical instrument and not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The VIPER PRIME navigated inserter is a surgical instrument used during a surgical procedure to physically insert screws into the spine. It uses navigation technology to guide the surgeon, but it does not analyze biological samples.
- Intended Use: The intended use clearly describes a surgical procedure involving the insertion of screws, not the analysis of patient samples.
Therefore, the VIPER PRIME navigated inserter falls under the category of a surgical instrument or a navigated surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The VIPER PRIME navigated inserter is a navigated instrument for insertion of VIPER PRIME screws in open or percutaneous procedures. The VIPER PRIME navigated inserter is indicated for use in spinal surgical procedures, in which:
- use of the VIPER System is indicated,
- use of stereotactic surgery may be appropriate, and
- where reference to a rigid anatomical structure, such as the pelvis or a vertebrae 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 using a navigation system which includes universal tracking arrays supplied by the navigation manufacturer.
These procedures include but are not limited to spinal fusion. The VIPER PRIME navigated inserter requires manual calibration.
Product codes
OLO
Device Description
The VIPER PRIME™ navigated inserter is a reusable manual screwdriver for insertion of the VIPER PRIME screws of the VIPER System in open and percutaneous procedures. The VIPER PRIME navigated inserter also features attachment sites for universal tracking arrays supplied by the navigation manufacturer to enable use with the respective spine navigation system. The VIPER PRIME navigated inserter must be manually calibrated with the third-party navigation system.
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
pelvis or a vertebrae (spinal surgical procedures)
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
Non-clinical sawbones testing was conducted to confirm device performance for the intended use. The testing consisted of assembly of the VIPER PRIME navigated inserter with the third party universal tracking arrays, manual calibration and navigated insertion of VIPER PRIME screws in a sawbones model. Final screw position in the software was confirmed using a second imaging modality.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a wing-like shape extending above them.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medos International, SARL % Laura Bleyendaal Senior Regulatory Affairs Specialist DePuy Synthes 325 Paramount Drive Raynham, Massachusetts 02767
September 14, 2017
Re: K170937
Trade/Device Name: VIPER PRIME navigated inserter Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 5, 2017 Received: May 8, 2017
Dear Laura Bleyendaal:
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 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
1
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 contact the Division of Industry and Consumer Education (DICE) 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" (21 CFR 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/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 (DICE) 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170937
Device Name VIPER PRIME™ navigated inserter
Indications for Use (Describe)
The VIPER PRIME navigated inserter is a navigated instrument for insertion of VIPER PRIME screws in open or percutaneous procedures. The VIPER PRIME navigated inserter is inspinal surgical procedures, in which:
· use of the VIPER System is indicated,
· use of stereotactic surgery may be appropriate, and
· where reference to a rigid anatomical structure, such as the pelvis or a vertebrae 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 using a navigation system which includes universal tracking arrays supplied by the navigation manufacturer. These procedures include but are not limited to spinal fusion. The VIPER PRIME navigated inserter requires manual calibration.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
B.
C.
A. Submitter Information
| 510(k) Sponsor: | Medos International, SARL |
|---|---|
| Contact Person: | Laura Bleyendaal |
| DePuy Synthes | |
| 325 Paramount Drive | |
| Raynham, MA 02767 | |
| Telephone number: | |
| Fax number: | |
| Email: | (508) 828-3267 |
| (508) 828-3797 | |
| Lbleyend@its.jnj.com | |
| Date Prepared | September 13, 2017 |
| Device Name | |
| Trade/Proprietary Name: | VIPER PRIME™ navigated inserter |
| Common/Usual Name: | Orthopedic stereotaxic instrument |
| Device Classification | |
| and Regulation: | Class II per 21 CFR § 882.4560 |
Classification Product and Panel OLO; Orthopedic Code:
D. Predicate Device Name
Primary Predicate Device: Synthes Navigable Pedicle Preparation Instruments (K122211)
Reference Devices: Stryker SpineMap® 3D Navigation System (K141941) Medtronic StealthStation『System (K133444) Brainlab (K070106)
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E. Device Description
The VIPER PRIME™ navigated inserter is a reusable manual screwdriver for insertion of the VIPER PRIME screws of the VIPER System in open and percutaneous procedures. The VIPER PRIME navigated inserter also features attachment sites for universal tracking arrays supplied by the navigation manufacturer to enable use with the respective spine navigation system. The VIPER PRIME navigated inserter must be manually calibrated with the third-party navigation system.
F. Indications for Use
The VIPER PRIME navigated inserter is a navigated instrument for insertion of VIPER PRIME screws in open or percutaneous procedures. The VIPER PRIME navigated inserter is indicated for use in spinal surgical procedures, in which:
- use of the VIPER System is indicated,
- use of stereotactic surgery may be appropriate, and
- where reference to a rigid anatomical structure, such as the pelvis or a ● vertebrae 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 using a navigation system which includes universal tracking arrays supplied by the navigation manufacturer.
These procedures include but are not limited to spinal fusion. The VIPER PRIME navigated inserter requires manual calibration.
G. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
The technological characteristics, including materials, design and performance of the VIPER PRIME navigated inserter are consistent with those of the primary predicate device. In brief, both the primary predicate and subject devices are indicated for use in open or percutaneous spinal surgical procedures in which the use of stereotactic surgery may be appropriate. The Synthes Navigable Pedicle Preparation instruments include awls, probes, taps, screwdrivers, a dilator, a guide tube and a pedicle access cannula while the VIPER PRIME navigated inserter is a screwdriver. The Synthes Navigable Pedicle Preparation instruments are manufactured from surgical grade metals, silicone and polyetheretherketone (PEEK), while the VIPER PRIME navigated inserter is manufactured from stainless steel, titanium alloy (Ti-6Al-4V) and polyphenylsulfone (RADEL"). Both the Synthes Navigable Pedicle Preparation instruments and VIPER PRIME navigated inserter feature attachment sites for universal tracking arrays supplied by the navigation manufacturer to enable use with the respective spine navigation system. The VIPER PRIME navigated inserter requires manual calibration and similarly, the Synthes
5
Navigable Pedicle Preparation instruments include instruments which may be manually calibrated with the spine navigation systems.
H. Materials
The VIPER PRIME navigated inserter is manufactured from stainless steel, titanium alloy (Ti-6Al-4V) and RADEL .
l. Performance Data
Non-clinical sawbones testing was conducted to confirm device performance for the intended use. The testing consisted of assembly of the VIPER PRIME navigated inserter with the third party universal tracking arrays, manual calibration and navigated insertion of VIPER PRIME screws in a sawbones model. Final screw position in the software was confirmed using a second imaging modality.
J. Conclusion
The indications for use and intended use of the VIPER PRIME navigated inserter are consistent with those of the primary predicate device. The technological characteristics of the VIPER PRIME navigated inserter in terms of design, materials and performance are consistent with those of the predicate device. The VIPER PRIME navigated inserter is substantially equivalent to the primary predicate device.