(119 days)
Not Found
No
The description focuses on the mechanical components and intended use of a spinal fixation system, with no mention of AI or ML capabilities.
No
The device is described as an implantable system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, primarily for mechanical support rather than directly treating a disease or condition with therapeutic effect.
No
Explanation: The device is an implantable system for spinal fixation and stabilization, not for diagnosing medical conditions.
No
The device description explicitly states it is a multiple component system comprised of non-sterile, single-use implantable components fabricated from titanium alloy and cobalt chrome, which are physical hardware components.
No, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Baxano Surgical MIS Pedicle Screw System is described as a system of implantable components (screws, rods, etc.) used for posterior, non-cervical pedicle fixation of the spine. These components are physically implanted into the patient's body.
- Intended Use: The intended use is to provide immobilization and stabilization of spinal segments as an adjunct to fusion. This is a surgical procedure performed directly on the patient's anatomy.
The device is a surgical implant used for structural support within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Baxano Surgical MIS Pedicle Screw System is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion for the following indications: (1) Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) Spondylolisthesis, (3) Trauma (i.e. fracture or dislocation), (4) Spinal stenosis, (5) Curvatures (i.e. scoliosis, and/or lordosis), (6) Tumor, (7) Pseudoarthrosis and (8) Failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI, NKB
Device Description
The Baxano Surgical MIS Pedicle Screw System is a multiple component system comprised of non-sterile, single-use implantable components fabricated from titanium alloy and cobalt chrome. When assembled, the components are implanted via a percutaneous, mini-open or open delivery to create a rigid structure to provide stabilization and promote spinal fusion. The system consists of an assortment of polyaxial cannulated pedicle screws, rods, cross connectors and locking caps, and associated instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical pedicle fixation of the spine
Indicated Patient Age Range
skeletally-mature patients
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical mechanical testing for the Baxano Surgical MIS Pedicle Screw System was performed on the worst case subject device in accordance with ASTM standards. Comparative testing was also performed including components of the Baxano Surgical MIS Pedicle Screw System and the predicate Conquest Pedicle Screw System.
Test: Static Compression
Standard: ASTM F1717-13
Test: Static Torsion
Standard: ASTM F1717-13
Test: Dynamic Compression
Standard: ASTM F1717-13
Test: Axial Pullout
Standard: ASTM F543-07
Test: Torque to Failure
Standard: ASTM F543-07
Test: Axial Grip
Standard: ASTM F1798-97
Test: Torsional Grip
Standard: ASTM F1798-97
Test: Flexural Grip
Standard: ASTM F1798-97
For all test methods, the subject devices met or exceeded the requirements as established by the test protocol and applicable ASTM standards. The results demonstrated that the Subject device is substantially equivalent to the Predicate.
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.
Life Spine® Conquest® Spinal System (K090320), CD Horizon® SOLERA™ Spinal System (K113174)
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Image /page/0/Picture/1 description: The image shows the logo for BAXANO SURGICAL. The logo is in black and white. The word "BAXANO" is in large, bold letters, and the word "SURGICAL" is in smaller letters below it. To the right of the word "BAXANO" is a symbol that looks like a circle with three lines coming out of it.
APR 0 7 2014
510(k) Summary Baxano Surgical MIS Pedicle Screw System
| Submitter: | Baxano Surgical, Inc.
110 Horizon Drive, Ste 230
Raleigh, NC 27615 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristen Allen
Regulatory Project Manager
910-332-1733 (P)
910-332-1701 (F)
kristen.allen@baxsurg.com (e-mail) |
| Date Prepared: | February 4, 2014 |
| Trade Name: | Baxano Surgical MIS Pedicle Screw System |
| Common Name: | Spinal Pedicle Fixation Device |
| Device Product Code
and Classification: | MNH, 888.3070, Class II, Spondylolisthesis
Spinal Fixation Device System
MNI, 888.3070, Class II, Pedicle Screw
Spinal System
NKB, 888.3070, Class III, Pedicle Screw Spinal
System, For Degenerative Disc Disease |
| Predicate Device: | Life Spine® Conquest® Spinal System (K090320)
CD Horizon® SOLERA™ Spinal System (K113174) |
Device Description:
The Baxano Surgical MIS Pedicle Screw System is a multiple component system comprised of non-sterile, single-use implantable components fabricated from titanium alloy and cobalt chrome. When assembled, the components are implanted via a percutaneous, mini-open or open delivery to create a rigid structure to provide stabilization and promote spinal fusion. The system consists of an assortment of polyaxial cannulated pedicle screws, rods, cross connectors and locking caps, and associated instruments.
Indications and Intended use:
The Baxano Surgical MIS Pedicle Screw System is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion for the following indications: (1) Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) Spondylolisthesis, (3) Trauma (i.e. fracture or dislocation), (4) Spinal stenosis, (5)
1
Curvatures (i.e. scoliosis, and/or lordosis), (6) Tumor, (7) Pseudoarthrosis and (8) Failed previous fusion.
Summary of Technological Characteristics:
The Baxano Surgical MIS Pedicle Screw System shares the same technological characteristics as the predicate device Life Spine Conquest® Spinal System, including design, materials, cleaning/sterilization process, range of sizes, performance characteristics and indication for use. The Baxano Surgical MIS Pedicle Screw System implant components are supplied non-sterile and are single-use. The Cannulated, selftapping pedicle screw implants are fabricated from Titanium alloy (Ti6Al4V ELI, ASTM F136) and Cobalt-chromium-molybdenum alloy (ASTM F1537). The subject device system also contains implantable rods (straight and lordosed), locking caps and cross connectors, which are fabricated from Titanium alloy (Ti6Al4V ELI, ASTM F136). The device provides correction and rigid stabilization of the spine during development of solid bone fusion following corrective spine surgery for a number of indications (listed above). The Baxano Surgical MIS Pedicle Screw System is designed to be implanted via a percutaneous, mini-open or open delivery method.
Summary of Performance Testing:
Non-clinical mechanical testing for the Baxano Surgical MIS Pedicle Screw System was performed on the worst case subject device in accordance with ASTM standards. Comparative testing was also performed including components of the Baxano Surgical MIS Pedicle Screw System and the predicate Conquest Pedicle Screw System.
| Test | Standard |
|---|---|
| Static Compression | ASTM F1717-13 |
| Static Torsion | ASTM F1717-13 |
| Dynamic Compression | ASTM F1717-13 |
| Axial Pullout | ASTM F543-07 |
| Torque to Failure | ASTM F543-07 |
| Axial Grip | ASTM F1798-97 |
| Torsional Grip | ASTM F1798-97 |
| Flexural Grip | ASTM F1798-97 |
For all test methods, the subject devices met or exceeded the requirements as established by the test protocol and applicable ASTM standards. The results demonstrated that the Subject device is substantially equivalent to the Predicate.
Substantial Equivalence:
Based on the comparison and performance testing analysis provided in this premarket notification submission, the Baxano Surgical MIS Pedicle Screw System has been shown to be substantially equivalent to the Life Spine® Spinal System Pedicle Screw System (K090320) in indications for use, design, materials used, and device functional scientific technology as the cleared predicate Conquest System.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
April 7, 2014
Baxano Surgical, Incorporated Ms. Kristen Allen Regulatory Project Manager 301 Government Center Drive, Suite 100 Wilmington, North Carolina 28403
Re: K133743
Trade/Device Name: Baxano Surgical MIS Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: February 4, 2014 Received: February 5, 2014
Dear Ms. Allen:
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.
1
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Kristen Allen
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/Safetv/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133743
Device Name
Baxano Surgical MIS Pedicle Screw System
Indications for Use (Describe)
The Baxano Surgical MIS Pedicle Screw System is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal in skeletally-mature patients as an adjunct to fusion for the following indications: (1) Degenerative Dise Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiogruphic studies), (2) Spondylolisthesis, (3) Trauma (i.e. fracture or dislocation), (4) Spinal stenosis, (5) Curvatures (i.e. scoliosis, kyphosis, and/or fordosis). (6) Tumor, (7) Pseudoarthrosis and (8) Failed previous fusion.
Type of Use (Select one or both, as applicable)
[ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpant C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
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