(93 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of the screws, and there is no mention of AI or ML in the provided text.
Yes
The device is intended to stabilize the spine and treat various spinal conditions, which are therapeutic functions.
No
The device is a surgical implant designed to stabilize the spine and aid in fusion, not to diagnose medical conditions.
No
The device description explicitly states it consists of "non-sterile, single use screws manufactured from titanium alloy," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to stabilize the spine for fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a system of screws made from titanium alloy, intended for surgical implantation. This aligns with a medical device used in surgery, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies listed (bending, pullout, torque) are mechanical tests relevant to the structural integrity and function of a surgical implant, not diagnostic performance metrics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Proficient™ Facet Screw Spine System does not fit this description.
N/A
Intended Use / Indications for Use
The Proficient™ Facet Screw Spine System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, without bone graft, at single or multiple levels, from C2 to S1. The Proficient™ Facet Screw Spine System is intended for transfacet fixation, in which the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. The Proficient™ Facet Screw Spine System is indicated for treatment of any or all of the following:
• Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity
- · Spondylolisthesis
- · Spondylolysis
· Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies - · Degeneration of the facets with instability
- · Trauma including spinal fractures and/or dislocations
Product codes
MRW
Device Description
The Proficient™ Facet Screw Spine System consists of a selection of non-sterile, single use screws manufactured from titanium alloy conforming to ASTM F136. The screws are provided in multiple diameters and various lengths to accommodate variations in patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 to S1 (Spine)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The following tests were performed to demonstrate the substantial equivalence of the Proficient™ Facet Screw Spine System to its predicate:
- Static and dynamic three-point bending (ASTM F1264) ●
- Axial pullout (ASTM F543)
- Torque to failure (ASTM F543) ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2015
Spine Wave, Incorporated Ms. Roaida Johnson Senior Regulatory Affairs Manager 3 Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K142980
Trade/Device Name: Proficient™ Facet Screw Spine System Regulatory Class: Unclassified Product Code: MRW Dated: December 30, 2014 Received: December 31, 2014
Dear Ms. Johnson:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Ms. Roaida Johnson
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/Resourcesfor You/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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K142980
Device Name Proficient™ Facet Screw Spine System
Indications for Use (Describe)
The Proficient™ Facet Screw Spine System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, without bone graft, at single or multiple levels, from C2 to S1. The Proficient™ Facet Screw Spine System is intended for transfacet fixation, in which the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. The Proficient™ Facet Screw Spine System is indicated for treatment of any or all of the following:
• Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity
- · Spondylolisthesis
- · Spondylolysis
· Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies
- · Degeneration of the facets with instability
- · Trauma including spinal fractures and/or dislocations
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| ☑ Beneficial Use (Part 61 SER 001 Subpart D) | ☐ On-Site Composting (61 SER 001 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Spine Wave. The text "Spine Wave" is written in a bold, sans-serif font, with the word "Spine" appearing above the word "Wave". A blue wave graphic is underneath the word "Wave", adding a visual element to the logo.
510(k) Summary Proficient™ Facet Screw Spine System
1. Submitter Information
| Submitter: | Spine Wave, Inc. |
|---|---|
| Address: | Three Enterprise Drive |
| Suite 210 | |
| Shelton, CT 06484 | |
| Telephone: | 203-712-1839 |
| Telefax: | 203-944-9493 |
| Contact: | Roaida R. Johnson |
| Date Prepared: | December 30, 2014 |
2. Device Information
| Trade Name: | Proficient™ Facet Screw Spine System |
|---|---|
| Common Name: | Facet Screw Spinal System |
| Classification: | Unclassified |
| Product Code: | MRW |
3. Purpose of Submission
The purpose of this submission is to gain clearance for a new facet screw system.
4. Predicate Device Information
The Proficient™ Facet Screw Spine System described in this submission is substantially equivalent to the following predicates:
| Primary Predicate Device | Manufacturer | 510(k) Number |
|---|---|---|
| TranS1® Facet Screws | Trans1® | K073515 |
| Additional Predicate Devices | Manufacturer | 510(k) Number |
|---|---|---|
| Venus Facet Screw System | Apollo Spine | K120340 |
| CS Facet Compression Device | Triage Medical, Inc | K052043 |
4
5. Device Description
The Proficient™ Facet Screw Spine System consists of a selection of non-sterile, single use screws manufactured from titanium alloy conforming to ASTM F136. The screws are provided in multiple diameters and various lengths to accommodate variations in patient anatomy.
6. Indications for Use
The Proficient™ Facet Screw Spine System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1. The Proficient™ Facet Screw Spine System is intended for transfacet fixation, in which the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The Proficient™ Facet Screw Spine System is indicated for treatment of any or all of the following:
- . Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity
- . Spondylolisthesis
- . Spondylolysis
- Degenerative Disc Disease (DDD) as defined by neck and/or back pain of ● discogenic origin as confirmed by radiographic studies
- Degeneration of the facets with instability ●
- . Trauma including spinal fractures and/or dislocations
7. Comparison of Technological Characteristics
The substantial equivalence of the Proficient™ Facet Screw Spine System to the predicates is shown by similarity in intended use, indications for use, materials and performance.
8. Performance Data
The following tests were performed to demonstrate the substantial equivalence of the Proficient™ Facet Screw Spine System to its predicate:
- Static and dynamic three-point bending (ASTM F1264) ●
- Axial pullout (ASTM F543)
- Torque to failure (ASTM F543) ●
9. Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the Proficient™ Facet Screw Spine System has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present any new issues of safety or effectiveness.