(29 days)
No
The device description and intended use focus on mechanical components and surgical instruments for spinal fixation and procedures. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as an implantable spinal system intended for posterior, non-cervical fixation as an adjunct to fusion for various spinal conditions, and instruments for spinal surgery. It is a surgical device used to correct anatomical issues, not to treat disease or provide therapy in a non-surgical context.
No
The text describes the CD HORIZON® Spinal System as an implantable device used for posterior, non-cervical fixation as an adjunct to fusion for various spinal conditions, and instruments (taps and screw drivers) for spinal surgery. Its stated "Intended Use / Indications for Use" and "Device Description" clearly indicate it is a therapeutic/surgical device and its associated instruments, not a device used to diagnose medical conditions.
No
The device description clearly states that the device consists of physical components such as rods, hooks, screws, plates, staples, connecting components, taps, and screw drivers. It also mentions compatibility with a physical power system (IPC® POWEREASE® System). This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system and associated instruments used for spinal fixation and surgical procedures. This involves direct interaction with the patient's body during surgery.
- Device Description: The device description details rods, hooks, screws, plates, staples, connecting components, taps, and screw drivers – all components and instruments used in surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
CD HORIZON® Spinal System
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fosion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
IPC® POWEREASE® System
IPC® System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
The IPC® POWEREASE® System is indicated for drilling, tapping and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.
Product codes
NKB, OSH, MNH, MNI, KWP, KWQ, HWE
Device Description
-
The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The subject devices include: Taps, Screw Drivers. The subject CD HORIZON® Spinal System device will be available in similar sizes as the predicate systems.
-
IPC® POWEREASE® System. The CD HORIZON® reusable instruments (subject taps and screw drivers) are compatible with Medtronic's IPC® POWEREASE® System, and are spine preparation instruments which are manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. The subject taps and drivers may be connected to the POWEREASE® Driver or used manually if desired. These instruments are also compatible with various Medtronic spinal implant systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1-S1), spine
Indicated Patient Age Range
skeletally mature patients, pediatric patients
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 performance data were provided in support of substantial equivalence.
Biocompatibility
The biocompatibility evaluation for the CD HORIZON® Spinal System devices was conducted in accordance with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" issued April, 23, 2013. The CD HORIZON® Spinal System taps and drivers are up to 24 hours of body contact according to with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". These instruments are manufactured from the same medical grade stainless steel as the predicate devices in accordance with the following ASTM standards: ASTM F899 – Standard Specification for • Wrought Stainless Steel for Surgical Instruments Medical grade stainless steel has a long history of safe and effective use in spinal surgery and biocompatibility testing is not required and no testing was conducted.
Mechanical Testing
In accordance with, "Guidance for Industry and FDA Staff - Spinal System 510(k)'s'', Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices. It was determined that subject devices do not represent a new worst case. Engineering rationales were used to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Ms. Becky Ronner Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
December 30, 2015
Re: K153463
Trade/Device Name: CD HORIZON® Spinal System, IPC® POWEREASE® System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWP, KWQ, HWE Dated: November 30, 2015 Received: December 1, 2015
Dear Ms. Ronner:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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. 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)
Device Name CD HORIZON® Spinal System
Indications for Use (Describe)
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fosion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Indications for Use
510(k) Number (if known)
Device Name IPC®POWEREASE® System
Indications for Use (Describe)
IPC® System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
The IPC®POWEREASE® System is indicated for drilling, tapping and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY
MEDTRONIC Sofamor Danek CD HORIZON® Spinal System
November 2015
| Submitter: | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901)396-3133
Fax: (901) 346-9738 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Becky Ronner
Senior Regulatory Affairs Specialist
Direct Telephone: (901)399-2757 |
| Date Prepared | November 20, 2015 |
| Name of Device | CD HORIZON® Spinal System, IPC® POWEREASE® System |
| Common Name | Taps and Drivers |
| Trade Name | CD HORIZON® Spinal System, IPC® POWEREASE® System |
| Regulatory Class,
Regulation Number,
Regulation Name, and
Device Product Code | 1. CD HORIZON® Spinal System Class III 21 CFR 888.3050 Spinal Interlaminal Fixation
Orthosis; KWP 21 CFR 888. 3060 Spinal Intervertebral Body Fixation
Orthosis; KWQ 21 CFR 888.3070 Pedicle Screw System; MNH, MNI, NKB, OSH 2. IPC® POWEREASE® System. Class II 21 CFR 878.4820 Surgical Instruments Motors and Accessories/Attachments; HWE |
| Predicate Devices | Primary Predicate – K143019 CD HORIZON® Spinal System, IPC® POWEREASE® System (S.E. 04/08/2015) K111520 IPC® POWEREASE® System (S.E. 10/26/2011) K123270 IPC® POWEREASE® System (S.E. 01/11/2013) |
| | K140454 Navigated CD HORIZON® SOLERA®
Screwdriver/Taps (S.E 05/22/2014) The predicates have not been subject to a design related recall. |
| Description of Device | 1. The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The subject devices include: Taps Screw Drivers The subject CD HORIZON® Spinal System device will be available in similar sizes as the predicate systems. |
| | 2. IPC® POWEREASE® System. The CD HORIZON® reusable instruments (subject taps and screw drivers) are compatible with Medtronic's IPC® POWEREASE® System, and are spine preparation instruments which are manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. The subject taps and drivers may be connected to the POWEREASE® Driver or used manually if desired. These instruments are also compatible with various Medtronic spinal implant systems. |
| Indications for Use | 1. CD HORIZON® Spinal System
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non- cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. |
| | |
| Except for hooks, when used as an anterolateral
thoracic/lumbar system, the CD HORIZON® Spinal System
may also be used for the same indications as an adjunct to
fusion. | |
| With the exception of degenerative disc disease, the CD
HORIZON® LEGACY™ 3.5mm rods and the CD
HORIZON® Spinal System PEEK rods and associated
components may be used for the aforementioned indications
in skeletally mature patients as an adjunct to fusion. The
3.5mm rods may be used for the specific pediatric indications
noted below. | |
| When used for posterior non-cervical pedicle screw fixation in
pediatric patients, the CD HORIZON® Spinal System
implants are indicated as an adjunct to fusion to treat
progressive spinal deformities (i.e., scoliosis, kyphosis, or
lordosis) including idiopathic scoliosis, neuromuscular
scoliosis, and congenital scoliosis. Additionally, the CD
HORIZON® Spinal System is intended to treat pediatric
patients diagnosed with the following conditions:
spondylolisthesis/spondylolysis, fracture caused by tumor
and/or trauma, pseudarthrosis, and/or failed previous fusion.
These devices are to be used with autograft and/or allograft.
Pediatric pedicle screw fixation is limited to a posterior
approach. | |
| The CD HORIZON® SPIRE™ Plate is a posterior, single-
level, non-pedicle supplemental fixation device intended for
use in the non-cervical spine (T1-S1) as an adjunct to fusion
in skeletally mature patients. It is intended for plate
fixation/attachment to spinous processes for the purpose of
achieving supplemental fixation in the following conditions:
degenerative disc disease (as previously defined),
spondylolisthesis, trauma, and/or tumor. | |
| In order to achieve additional levels of fixation, the CD
HORIZON® Spinal System rods may be connected to the
VERTEX® Reconstruction System with the VERTEX® rod
connector. Refer to the VERTEX® Reconstruction System | |
| | Package Insert for a list of the VERTEX® indications of use. |
| | 2. IPC® POWEREASET™ Systems
IPC® System is indicated for the incision/cutting, removal,
drilling and sawing of soft and hard tissue and bone, and
biomaterials in Neurosurgical (Cranial, Craniofacial),
Orthopedic, Arthroscopic, Spinal, Sternotomy, and General
surgical procedures. |
| Comparison of
Technological
Characteristics with the
Predicate Devices: | The IPC®POWEREASE® System is indicated for drilling,
tapping and driving screws and working end attachments
during spinal surgery, including open and minimally invasive
procedures. It is also used in placement or cutting of screws,
posts and rods. |
| | The subject Medtronic CD HORIZON® Reusable taps and drivers
that are for use with the IPC® POWEREASE® System
have the same fundamental technology and stainless steel
materials as the predicate devices. |
| | The CD HORIZON® Reusable manual or powered taps and
drivers that are compatible with Medtronic's IPC®
POWEREASE® System are intended for use in surgical
procedures to manipulate tissue, bone, or for use with other
devices in orthopedic surgery. An instrument may be used for
tapping or driving screws. An instrument may incorporate a
measuring function which has uses as described on the label and
the instrument. |
| Performance Data: | The following performance data were provided in support of
substantial equivalence.
Biocompatibility
The biocompatibility evaluation for the CD HORIZON®
Spinal System devices was conducted in accordance with
FDA's Draft Guidance for Industry and FDA Staff "Use of
International Standard ISO-10993, Biological Evaluation of
Medical Devices Part 1: Evaluation and Testing" issued April,
23, 2013.
The CD HORIZON® Spinal System taps and drivers are |
5
6
7
8
up to 24 hours of body contact according to with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". These instruments are manufactured from the same medical grade stainless steel as the predicate devices in accordance with the following ASTM standards: ASTM F899 – Standard Specification for ● Wrought Stainless Steel for Surgical Instruments Medical grade stainless steel has a long history of safe and effective use in spinal surgery and biocompatibility testing is not required and no testing was conducted. Mechanical Testing In accordance with, "Guidance for Industry and FDA Staff -Spinal System 510(k)'s'', Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices. It was determined that subject devices do not represent a new worst case. Engineering rationales were used to demonstrate substantial equivalence. Based on the risk analysis and additional supporting documentation provided in the pre-market notification, the subject CD HORIZON® Reusable Instruments compatible with IPC® POWEREASE® System are substantially equivalent to the following predicates: ● Primary Predicate – K143019 CD HORIZON® Spinal System, IPC® POWEREASE® System (S.E. 04/08/2015) Conclusion: K111520 IPC® POWEREASE® System (S.E. o 10/26/2011) K123270 IPC® POWEREASE® System (S.E. o 01/11/2013) o K140454 Navigated CD HORIZON® SOLERA® Screwdriver/Taps (S.E 05/22/2014) The subject instruments are not navigable.