(87 days)
Not Found
No
The summary describes a mechanical spinal fixation system and its components, with no mention of software, algorithms, or any features that would suggest the use of AI or ML.
Yes.
The device is intended to provide immobilization of the posterior, noncervical spine as an adjunct to fusion for various medical conditions, indicating a therapeutic purpose.
No
Explanation: The device is an implant system used as an adjunct to fusion for spinal immobilization, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly details physical implant components made of titanium alloy and instruments made of stainless steel and aluminum alloy. It also describes performance studies related to the mechanical properties and biological evaluation of these physical components.
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.
- Device Description: The EDEN Spinal Fixation MIS System is a surgical implant and associated instruments used to stabilize the spine. It is physically implanted into the body.
- Intended Use: The intended use is to provide immobilization of the spine as an adjunct to fusion. This is a surgical procedure, not a diagnostic test performed on a specimen.
The provided text clearly describes a surgical implant system, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The EDEN Spinal Fixation MIS System is intended to provide immobilization of the posterior, noncervical spine as an adjunct to fusion in skeletally mature patients 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 and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
The EDEN Spinal Fixation MIS System can be used in an open approach and a percutaneous approach.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The purpose of this special 510(k) submission is to add MIS components and instruments to the previously cleared EDEN Spinal Fixation System. The EDEN Spinal Fixation MIS System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The EDEN Spinal Fixation MIS System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI- 4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the EDEN Spinal Fixation MIS System. The EDEN Spinal Fixation MIS System will also offer a wide variety of instruments that range from bone awls to occipital screwdrivers. These instruments will be made from various grades of stainless steel with aluminum alloy being used in a few handles. All items are supplied "NON-STERILE" and must be sterilized prior to use. The orthopedic instruments are Class I, 510k exempt, and discussed here for informational purpose only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Test Conclusion
The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
o ASTM F1717-18 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- Static compression bending
- Static tension bending
- · Static torsion
- · Dynamic compression bending
o FDA Guidance Document - Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
o ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
o ISO 10993-3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
o ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity o ISO 10993-6 Biological evaluation of medical devices, Tests for local effects after implantation.
o ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
o ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
o ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation
o ISO 10993-18 Biological evaluation of medical devices, Chemical characterization of medical device materials within a risk management process
Bench test results conclude that EDEN Spinal Fixation MIS System is substantially equivalent to the predicate devices for its intended use.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
June 15, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font and enclosed in a blue square.
JMT Co., Ltd. % Dave Kim Medical Regulatory Affairs Mtech Group 7505 Fannin St. Suite 610 Houston, Texas 77054
Re: K230762
Trade/Device Name: EDEN Spinal Fixation MIS System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: May 12, 2023 Received: May 18, 2023
Dear Dave Kim:
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
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 Advice (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,
Eileen
Digitally signed
by Eileen Cadel -
S
Cadel -S Date: 2023.06.15
13:31:33 -04'00'
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230762
Device Name EDEN Spinal Fixation MIS System
Indications for Use (Describe)
The EDEN Spinal Fixation MIS System is intended to provide immobilization of the posterior, noncervical spine as an adjunct to fusion in skeletally mature patients 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 and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
The EDEN Spinal Fixation MIS System can be used in an open approach and a percutaneous approach.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
The following 510(k) summary is being submitted as required by 21 CFR Part 807.92;
| Submitter: | JMT Co., Ltd. | |
|---|---|---|
| 70-39, Gwonyul-ro 1203beon-gil, Baekseok-eup, Yangju-si, | ||
| Gyeonggi-Do, Republic of Korea | ||
| Tel : +82-31-868-0951 | ||
| International : +82-70-4287-8353 | ||
| Fax : +82-31-868-0952 | ||
| Contact Person: | ||
| (Official | ||
| Correspondent) | Mtech Group | |
| Dave Kim | ||
| 7505 Fannin St. Suite 610, Houston, TX 77054, US | ||
| Tel: 713-467-2607 | ||
| Email: davekim@mtechgroupllc.com | ||
| Date Prepared: | February 23, 2023 | |
| Device Identification | ||
| Device Trade Name | EDEN Spinal Fixation MIS System | |
| Common Name | Pedicle Screw Spinal System |
| Device Trade Name | EDEN Spinal Fixation MIS System |
|---|---|
| Common Name | Pedicle Screw Spinal System |
| Classification Name, Number | Thoracolumbosacral Pedicle Screw System |
| (21 CFR 888.3070) | |
| Device Classification | II |
| Product Code | NKB |
Predicate or legally marketed devices which are substantially equivalent
Primary predicate device: K201788, "EDEN Spinal Fixation System", manufactured by "JMT Co., Ltd."
Device Description
The purpose of this special 510(k) submission is to add MIS components and instruments to the previously cleared EDEN Spinal Fixation System. The EDEN Spinal Fixation MIS System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The EDEN Spinal Fixation MIS System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI- 4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the EDEN Spinal Fixation MIS System. The EDEN Spinal Fixation MIS System will also offer a wide variety of instruments that range from bone awls to occipital screwdrivers. These instruments will be made from various grades of stainless steel with aluminum alloy being used in a few handles. All items are supplied "NON-STERILE" and must be sterilized prior to use. The orthopedic instruments are Class I, 510k exempt, and discussed here for informational purpose only.
Indications for Use
The EDEN Spinal Fixation MIS System is intended to provide immobilization and stabilization of the posterior, non- cervical spine as an adjunct to fusion in skeletally mature patients for the following indications:
degenerative disc disease (defined as back pain of discogenic origin with degeneration of the
4
disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
The EDEN Spinal Fixation MIS System can be used in an open approach and a percutaneous approach.
Non-clinical Test Conclusion
The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
o ASTM F1717-18 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- Static compression bending
- Static tension bending
- · Static torsion
- · Dynamic compression bending
o FDA Guidance Document - Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
o ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
o ISO 10993-3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
o ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity o ISO 10993-6 Biological evaluation of medical devices, Tests for local effects after implantation.
o ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
o ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
o ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation
o ISO 10993-18 Biological evaluation of medical devices, Chemical characterization of medical device materials within a risk management process
Bench test results conclude that EDEN Spinal Fixation MIS System is substantially equivalent to the predicate devices for its intended use.
Technological Characteristics and Substantial Equivalence
The EDEN Spinal Fixation MIS System does not have a new intended use. It shows the exact same raw materials and specifications in terms of poly screw angulation, as the predicate device.
The EDEN Spinal Fixation MIS System and EDEN Spinal Fixation System (K201788) have been demonstrated as substantially equivalent in dimensional and performance criteria to the primary predicate device.
Conclusion
Based on the testing results, JMT Co., Ltd. concludes that the subject device is substantially equivalent to the predicate device.