(65 days)
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to treat various acute and chronic instabilities or deformities of the spine.
No
The provided text describes an implant system (ENNOVATE Spinal System) used to correct spinal deformity and facilitate spinal fusion. Its intended use is for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation, and it is indicated for treating conditions like degenerative disc disease, spondylolisthesis, and trauma. While these conditions are typically diagnosed by medical professionals, the device itself is a treatment or corrective system, not a tool for diagnosis.
No
The device description clearly states it is an "implant system" and describes physical components made of titanium alloy, such as screws and rods. This indicates it is a hardware medical device, not software-only.
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 system for spinal fixation and fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a spinal implant system (screws, rods, connectors) made of titanium alloy. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies listed are mechanical tests (compression, torsion, bending, pull out strength) relevant to the structural integrity and function of a spinal implant, not diagnostic accuracy.
In summary, the ENNOVATE Spinal System is a surgical implant designed to treat spinal conditions, not to diagnose them.
N/A
Intended Use / Indications for Use
The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograff or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities.
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
- Spondylolisthesis,
- Trauma (i.e., fracture or dislocation)
- Spinal Stenosis.
- Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- Tumor.
- Pseudoarthrosis, and
- Failed previous fusion
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWQ
Device Description
The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This submission includes modified polyaxial screws, additional multiaxial-cross-connectors, offset connectors and additional components in sterile version. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ISO 5832-3.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's polyaxial screws can be locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. Rods of this system are shaped intraoperatively to correct or maintain proper spinal curvature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical pedicle and non-pedicle fixation, thoracic, lumbar and sacral areas 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)
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the guidance "Spinal System 510(k)s May 3, 2004" was completed where applicable.
- Dynamic/Static compression tests and static torsion tests per ASTM F1717-15.
- Dynamic compression/tension test per ASTM F2193-14.
- Dynamic/Static flexion bending tests, Static rod grip and Static rod/cross rod torsion tests per ASTM F1798-13.
- Axial compression, pull out strength, driving torque test per ASTM F543-13/17.
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.
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. The words "U.S. Food & Drug Administration" are written in blue to the right of the square.
April 26, 2018
Aesculap Implant Systems, LLC Ms. Melanie Burkert Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K180433
Trade/Device Name: ENNOVATE® Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWQ Dated: April 10, 2018 Received: April 11, 2018
Dear Ms. Burkert:
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
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean -S
for 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) K180433
Device Name ENNOVATE®
Indications for Use (Describe)
The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograff or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities.
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
-
- Spondylolisthesis,
-
- Trauma (i.e., fracture or dislocation)
-
- Spinal Stenosis.
-
- Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
- Tumor.
-
- Pseudoarthrosis, and
-
- Failed previous fusion
| 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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| COMPANY: | Aesculap Implant Systems, LLC
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 300567331 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------|
| PRIMARY CONTACT: | Melanie Burkert
610-984-9249 (phone)
melanie.burkert@aesculap.de |
| SECONDARY CONTACT: | Lisa Boyle
610-984-9274 (phone)
lisa.boyle@aesculap.com |
| TRADE NAME: | ENNOVATE® |
| COMMON NAME: | ENNOVATE Spinal System |
| REGULATION NUMBER: | 888.3070 – Pedicle screw spinal system |
| PRODUCT CODE: | NKB, KWQ |
| REVIEW PANEL: | Orthopedics |
Aescular Implant Systems ENNOVATE Sninal System
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, LLC believes that the ENNOVATE Spinal System is substantially equivalent to the Primary Predicate K162134 - Aesculap ENNOVATE Spinal System and the Reference Predicates K130291, K062085 and K071945 - Aesculap S4 Spinal System.
DEVICE DESCRIPTION
The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This submission includes modified polyaxial screws, additional multiaxial-cross-connectors, offset connectors and additional components in sterile version. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ISO 5832-3.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's polyaxial screws can be locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. Rods of this system are shaped intraoperatively to correct or maintain proper spinal curvature.
4
INDICATIONS FOR USE
The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior. non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities.
-
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies),
-
- Spondylolisthesis,
-
- Trauma (i.e., fracture or dislocation)
-
- Spinal Stenosis.
-
- Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
- Tumor.
-
- Pseudoarthrosis, and
-
- Failed previous fusion
TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s))
The components of the ENNOVATE Spinal System are offered in similar configuration as the predicate and reference devices. All of the implants are made from a Titanium Alloy (Ti-6Al-4V). The instruments are made of medical grade silicone, stainless steel, titanium alloy and PEEK which are the same materials as the primary and reference predicate devices. The modification of the system do not change the intended use / technical characteristics of the ENNOVATE system.
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the guidance "Spinal System 510(k)s May 3, 2004" was completed where applicable.
- Dynamic/Static compression tests and static torsion tests per ASTM F1717-15.
- Dynamic compression/tension test per ASTM F2193-14. ●
- o Dynamic/Static flexion bending tests, Static rod grip and Static rod/cross rod torsion tests per ASTM F1798-13.
- Axial compression, pull out strength, driving torque test per ASTM F543-13/17. ●
CONCLUSION:
Aesculap believes that based on the completed testing, the Ennovate Spinal System presented in this submission is substantially equivalent in design, materials, intended use, and performs as safely and effectively as the primary predicate currently on the market.