(135 days)
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes.
The device is intended for the treatment of various acute and chronic instabilities or deformities of the spine and facilitates spinal fusion, indicating a therapeutic purpose.
No
Explanation: The ENNOVATE Spinal System is described as an implant system used to correct spinal deformity and facilitate spinal fusion, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is an "implant system" and lists physical components like "polyaxial screws," "rod-to-rod and cross connectors," and "rods," all manufactured from titanium alloy. This indicates it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- ENNOVATE Spinal System Function: The ENNOVATE Spinal System is an implantable medical device used to stabilize and facilitate fusion of the spine. It is surgically placed inside the patient's body.
- Intended Use: The intended use clearly describes the device's purpose as a surgical implant for treating spinal instabilities and deformities. It does not involve testing biological samples.
- Device Description: The description details the physical components of the implant (screws, rods, connectors) and their material, all of which are designed for surgical implantation.
The information provided clearly indicates that the ENNOVATE Spinal System is a surgical implant, not a device used for in vitro testing of biological samples.
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 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
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. 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, MNI, MNH, 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 system includes polyaxial screws of varying diameters and lengths, rod-to-rod 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.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's polyaxial 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. Rods of this system may be 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, posterior use in the thoracic, lumbar and sacral areas of the spine.
Indicated Patient Age Range
skeletally mature 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: Mechanical Testing
Sample Size: Not specified beyond "All required testing"
AUC: Not Applicable
MRMC: Not Applicable
Standalone Performance: Not Applicable
Key Results: 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 and reference predicates currently on the market.
Tests performed:
- 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K123939, K123352, K112551, K100623, K090657, K071945, K062085, K032219, K082942, K041119, K073364, K070300, K133746, K123549, K090203, K111957
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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2016
Aesculap Implant Systems, LLC Mr. Paul Amudala Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K162134
Trade/Device Name: ENNOVATE Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWQ Dated: November 8, 2016 Received: November 14, 2016
Dear Mr. 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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
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,
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)
K162134
Device Name ENNOVATE Spinal System
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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3
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
| Aesculap Implant Systems ENNOVATE Spinal System
| Nov 08, 2016 | |
|---|---|
| COMPANY: | Aesculap Implant Systems, LLC |
| 3773 Corporate Parkway | |
| Center Valley, PA 18034 | |
| Establishment Registration Number: 300567331 | |
| CONTACT: | Paul Amudala |
| 610-984-9303 (phone) | |
| 610-791-6882 (fax) | |
| TRADE NAME: | ENNOVATE Spinal System |
| COMMON NAME: | ENNOVATE Spinal System |
| REGULATION NUMBER: | 888.3070 - Pedicle screw spinal system |
| PRODUCT CODE: | NKB, MNI, MNH, and KWQ |
| CLASS: | Class III |
| REVIEW PANEL: | Orthopedics |
SUBSTANTIAL EQUIVALENCE
Aesculap Implant Systems, LLC believes that the ENNOVATE Spinal System is substantially equivalent to the Primary Predicate K130291 S4 Spinal System (including K123939, K123352, K112551, K100623, K090657, K071945, K062085, and K032219), and the Additional Predicates EXPEDIUM® Spinal System (K090230,K082942, K041119, K073364, and K070300), and Polaris™ Spinal System (K151974, K133746, K123549, K090203, and K111957).
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 polyaxial screws of varying diameters and lengths, rod-to-rod 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.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's polyaxial 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. Rods of this system may be shaped intraoperatively to correct or maintain proper spinal curvature.
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
4
to be used as an adjunct to fusion using autograft. 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),
-
- Spondvlolisthesis.
-
- 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. 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.
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.
- . 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.
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 and reference predicates currently on the market.
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