(447 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and sterilization of a pedicle screw system, with no mention of AI or ML capabilities.
No.
The device is a pedicle screw system that provides temporary internal fixation and stabilization during bone graft healing and fusion, rather than directly providing therapy itself.
No
The Dyflex-II is a pedicle screw system used for internal fixation and stabilization of the spine during fusion, not for diagnosing medical conditions.
No
The device description explicitly states it is a "pedicle screw and rod system" consisting of "screws, rods, cross-link connectors, and bolts" fabricated from titanium alloy, which are physical hardware components.
No, the Dyflex-II is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This includes things like blood, urine, tissue, etc., to provide information about a physiological state, health, disease, or congenital abnormality.
- The Dyflex-II is a surgical implant. It is a pedicle screw system designed to be surgically implanted into the spine to provide stabilization and support during bone fusion.
The description clearly states the device's purpose is for internal fixation and stabilization within the body, not for testing or analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The Dyflex-II is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Dyflex-II is intended to provide immobilization 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).
Product codes
NKB
Device Description
The Dyflex-II is a non-cervical pedicle screw and rod system intended to facilitate the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The Dyflex-II of screws, rods, cross-link connectors, and bolts that can be implanted via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F 136). The implants will be provided non-sterile and the user need to sterilize them before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and sacral spine (L3 to sacrum), thoracic, lumbar and sacral 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)
- Sterilization Validation Tests in accordance with ISO 17665-1 and ISO 17665-2
- Performance Tests in accordance with ASTM 1717 including the following test items.
- Static Torsion Test
- Static Compression Bending test
- Dynamic Compressive Fatigue Test
The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
November 15, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Taeyeon Medical Co., Ltd. % Priscilla Chung Official Correspondent LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, California 92612
Re: K212700
Trade/Device Name: Dyflex-II Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: September 23, 2022 Received: September 26, 2022
Dear Priscilla Chung:
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
1
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) 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 (OS) 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 mediation-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,
Colin O'neill -S
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) K212700
Device Name
Dyflex-II
Indications for Use (Describe)
The Dyflex-II is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Dyflex-II is intended to provide immobilization 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).
| 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)
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3
510(k) Summary (K212700)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Oct 20, 2022
1. 510K Applicant / Submitter:
TAEYEON MEDICAL Co., Ltd. 132-1 Donghwagongdan-Ro. Munmak-eup Wonju-Si, Gangwon-do, 26365, Republic of Korea
Tel:+82-33-742-7555 Fax:+82-33-742-2227
2. Submission Contact Person
LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160, Irvine CA 92612 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com
3. Device
- Proprietary Name: Dyflex-II ●
- Common Name: Pedicle Screw Spinal Fixation System ●
- Classification: Class II (21 CFR 888.3070) ●
- Product Code: NKB ●
4. Predicate Device
4STM Spinal System (K063708) by TAEYEON Medical Co., Ltd.
5. Description:
The Dyflex-II is a non-cervical pedicle screw and rod system intended to facilitate the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The Dyflex-II of screws, rods, cross-link connectors, and bolts that can be implanted via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F 136). The
4
implants will be provided non-sterile and the user need to sterilize them before use.
8. Indications for Use
The Dyflex-II is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the Dyflex-II is 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
9. Substantial Equivalence Discussion:
| Subject Device | Predicate Device | |
|---|---|---|
| Trade Name | Dyflex-II | 4STM Spinal System |
| Manufacturer | TAEYEON Medical Co., Ltd. | TAEYEON Medical Co., Ltd. |
| 510(k) Number | K212700 | K063708 |
| Product Code | NKB | MNI, KWQ, MNH |
| Indications for Use | The Dyflex-II is a pedicle screw | |
| system indicated for the treatment of | ||
| severe Spondylolisthesis (Grade 3 and |
- of the L5-S1 vertebra in skeletally
mature patients receiving fusion by
autogenous bone graft having implants
attached to the lumbar and sacral spine
(L3 to sacrum) with removal of the
implants after the attainment of a solid
fusion.
In addition, the Dyflex-II is 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:
degenerative Spondylolisthesis with
objective evidence of neurological
impairment fracture dislocation | The 4STM Spinal System is a pedicle
screw system indicated for the treatment
of severe Spondylolisthesis (Grade 3 and
4) of the L5-S1 vertebra in skeletally
mature patients receiving fusion by
autogenous bone graft having implants
attached to the lumbar and sacral spine
(L3 to sacrum) with removal of the
implants after the attainment of a solid
fusion.
In addition, the 4STM Spinal System is
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: degenerative
Spondylolisthesis with objective evidence
of neurological impairment, fracture
dislocation scoliosis kyphosis spinal |
9.1. Comparison table of the general device characteristics between the proposed and predicate device
5
| | scoliosis, kyphosis, spinal tumor and
failed previous fusion (pseudarthrosis). | tumor and failed previous fusion
(pseudarthrosis). |
|--------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Materials | Titanium Alloy
(ASTM F 136) | Titanium Alloy
(ASTM F 136) |
| Components | Screw, Cross-link Connector, Rod,
Bolt | Screw, Cross-link Connector, Rod, Bolt |
| Screw Size | Diameters : 5.0, 5.5, 6.0, 6.5, 7.0, 7.5,
8.0,8.5, 9.0mm
Lengths : 30 to 50mm | Diameters : 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0,
8.5, 9.0mm
Lengths : 30 to 55mm |
| Rod Size | Diameter : 5.5, 6.0mm
Lengths : 30 to 200mm | Diameters : 5.5, 6.0mm
Lengths: 30 to 200mm |
| Mechanical Testing | Performed according to ASTM F 1717 | Performed according to ASTM F 1717 |
*Note: Mechanical testing for the subject device and the predicate device was performed according to ASTM F 1717.
9.2. Substantial Equivalence Discussion
The Dyflex-II has the same indications for use, technological characteristics, material, and principles of operation as the predicate device. It is substantially equivalent to the predicate device in design and function. The size range of the predicate device covers the subject device range as well.
The exterior design of the subject device is slightly different from the predicate device but the test results of the performance tests support that the subject device is substantially equivalent to the predicate device.
10. Performance Tests (Non-clinical)
- Sterilization Validation Tests in accordance with ISO 17665-1 and ISO 17665-2
- Performance Tests in accordance with ASTM 1717 including the following test items.
- = Static Torsion Test
- · Static Compression Bending test
- · Dynamic Compressive Fatigue Test
The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences.
11. Conclusions:
Based on the information provided in this premarket notification, TAEYEON MEDICAL Co., Ltd. concludes that the Dyflex-II is substantially equivalent to the predicate device as described herein in.