(110 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and intended use of a spinal implant system, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is described as an "implant system used to correct spinal deformity and facilitate the biological process of spinal fusion," and is "intended for treatment of the following acute and chronic instabilities or deformities." This directly aligns with the definition of a therapeutic device as one that provides treatment or correction for medical conditions.
No
This device is an implant system used to correct spinal deformity and facilitate spinal fusion, as stated in the 'Device Description'. It treats existing conditions rather than identifying them.
No
The device description clearly states it is an "implant system" and lists various hardware components like screws, hooks, and rods made of titanium and CoCr alloys. This indicates it is a physical 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 for spinal fixation and fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of the system (screws, rods, hooks, etc.) and their function in correcting spinal deformities and facilitating fusion. This aligns with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies described are biomechanical tests related to the physical properties and strength of the implant, which are relevant for a surgical device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ENNOVATE Spinal System does not fit this description.
N/A
Intended Use / Indications for Use
The ENNOVATE® Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and nonpedicle 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
Product codes
NKB, KWQ, KWP
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 system includes screws of varying types, diameters and lengths, hooks, rods, rod-to-rod connectors, lateral offset and cross connectors of various styles and lengths. 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 as well as CoCr alloy conforming to ISO 5832-12.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's screws can be rigidly locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. All screws within this system are not intended for use with bone cement. Rods of this system may be shaped intraoperatively to correct or maintain proper spinal curvature. The hooks have curved blades underneath the head portion of the implant that wrap around posterior anatomy of the spine to provide an alternative method of anchoring the rod to the spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thoracic, lumbar and sacral areas of the spine. Non-cervical.
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)
To support substantial equivalence, biomechanical testing was completed per the "Spinal System 510(k)s May 3, 2004" for the products within this submission where applicable.
- Dynamic/Static compression tests and static torsion tests per ASTM F1717.
- Dynamic compression/tension test per ASTM F2193.
- Dynamic/Static flexion bending tests, Static rod grip and Static rod/cross rod torsion tests per ASTM F1798.
- Axial compression, pull out strength, driving torque test per ASTM F543.
The presence of endotoxins is tested with the LAL gel clot method with the acceptance criteria of
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA acronym is in a blue square, and the full name is in blue text. The seal features an emblem with a staff and serpent, symbolizing healing and medicine.
Aesculap Implant Systems, LLC Paul Amudala Sr. Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K210963
Trade/Device Name: ENNOVATE® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWQ, KWP Dated: May 20, 2021 Received: May 21, 2021
Dear Paul Amudala:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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
July 19, 2021
1
801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K210963
Device Name ENNOVATE® Spinal System
Indications for Use (Describe)
The ENNOVATE® Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and nonpedicle 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
| 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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3
510(k) SUMMARY (as required by 21 CFR 807.92)
| Aesculap Implant Systems ENNOVATE Spinal System
| Mar 30, 2021 | |
|---|---|
| COMPANY: | Aesculap Implant Systems, LLC |
| 3773 Corporate Parkway | |
| Center Valley, PA 18034 | |
| Establishment Registration Number: 3005673311 | |
| CONTACT: | Paul Amudala |
| Sr. Regulatory Affairs Specialist | |
| 610-984-9303 (phone) | |
| 610-791-6882 (fax) | |
| TRADE NAME: | ENNOVATE® Spinal System |
| COMMON NAME: | Thoracolumbosacral pedicle screw system |
| REGULATION | |
| NUMBER: | Thoracolumbosacral pedicle screw system (21 CFR 888.3070) |
| Spinal interlaminal fixation orthosis (21 CFR 888.3050) | |
| Spinal intervertebral body fixation orthosis (21 CFR 888.3060) | |
| PRODUCT CLASS: | Class II |
| PRODUCT CODE: | NKB, KWQ, KWP |
| REVIEW PANEL: | Orthopedics |
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, LLC believes that the ENNOVATE Spinal System is substantially equivalent to the Primary Predicate S4 Spinal System (K130291) and Additional Predicates ENNOVATE Spinal System (K180433), Everest Spinal System (K151727), EXPEDIUM® Spinal System (K130877), and Polaris™ Spinal System (K151974).
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 system includes screws of varying types, diameters and lengths, hooks, rods, rod-to-rod connectors, lateral offset and cross connectors of various styles and lengths. 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 as well as CoCr alloy conforming to ISO 5832-12.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's screws can be rigidly locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. All screws within this system are not intended for use with bone cement. Rods of this system may be shaped intraoperatively to correct or maintain proper spinal curvature. The hooks have curved blades underneath the head portion of the implant that wrap around posterior anatomy of the spine to provide an alternative method of anchoring the rod to the spine.
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 devices. The implants are made from a Titanium Alloy (Ti-6A1-4V) and CoCr alloy. The instruments are made of medical grade silicone, stainless steel, titanium allov, polypropylene, and PEEK which are the same materials as the Aesculap Primary and Additional Predicate devices.
PERFORMANCE DATA
To support substantial equivalence, biomechanical testing was completed per the "Spinal System 510(k)s May 3, 2004" for the products within this submission where applicable.
- Dynamic/Static compression tests and static torsion tests per ASTM F1717. ●
- Dynamic compression/tension test per ASTM F2193. ●
- Dynamic/Static flexion bending tests, Static rod grip and Static rod/cross rod torsion ● tests per ASTM F1798.
- Axial compression, pull out strength, driving torque test per ASTM F543. .
The presence of endotoxins is tested with the LAL gel clot method with the acceptance criteria of