(115 days)
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes.
The device is clearly indicated for the treatment of various medical conditions, including degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, and failed previous fusion, and is used for immobilization and stabilization of the spine as an adjunct to fusion. This indicates a therapeutic purpose.
No
Explanation: This device is a spinal fixation system, which is an implantable medical device used to stabilize the spine, not to diagnose a condition. Its indications for use describe conditions it helps treat, not conditions it diagnoses.
No
The device description explicitly states it is comprised of physical components like screws, set screws, rods, crosslink, and connectors made of Titanium and CoCrMo alloys. This indicates it is a hardware-based medical device, not software-only.
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 for diagnosis, monitoring, or screening.
- Dali Spinal Fixation System Function: The description clearly states that the Dali Spinal Fixation System is a spinal implant used for immobilization and stabilization of the spine as an adjunct to fusion. It is a physical device implanted in the body, not used to test samples outside the body.
The information provided describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Dali Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use:
- 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);
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
- tumor;
- stenosis, and;
- failed previous fusion (pseudoarthrosis)
Product codes
NKB, KWP, KWQ, MNH, MNI
Device Description
This system is comprised of screws, set screws, rods, crosslink and connectors. The components of this system are manufactured of Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal (T1-S2/ilium, T8-L5)
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)
Bench testing results demonstrate that Dali Spinal Fixation System performs equivalently to the predicates in static compression bending, static torsion, static torsion, dynamic compression bending (in accordance with ASTM F1717-10) and gripping-push down (in accordance with ASTM F1798).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K120270, K100706, K103085, K091717, K062513, K092825, K102488, K071373, K083393, K091291, K022949, K082572
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
CAccessPINE
SEP 21 2012
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
| Submitter: | Accel SPINE |
|---|---|
| 14850 Quorum Dr.Suite220 Dallas, TX 75254 | |
| Contact Person: | Daniel Chon |
| Telephone. 800.713.9489 | |
| FAX .888.831.4892 | |
| dchon(@AccelSpine LLC LLC.com | |
| Prepared Date | May 22, 2012 |
2. Device Identification
| Trade Name: | Dali Spinal Fixation System |
|---|---|
| Common Name: | Spinal Fixation Appliances |
| Product Code: | NKB, KWP, KWQ, MNH, MNI |
| Class | Class III |
| Classification | |
| Name: | l } Spinal Interlaminal Fixation Orthosis, 21 CFR §888.3050 |
| 2) Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.3060 | |
| 3) Pedicle Screw Spinal System, 21 CFR §888.3070 |
3. Identification of Legally Marketed Devices
L&K BIOMED: Venus Spinal Fixation System (K120270) L&K BIOMED: Venus Basic Spinal Fixation System (K100706,K103085) GS Medical: Anyplus Spinal Fixation System (K091717) Spine Craft: APEX Spine System (K062513,K092825, K102488) Stryker Spine: Xia@III Spinal System (K071373,K083393,K091291) Synthes Spine: USS Polyaixal and Synthes USS Iliosacral System (K022949,K082572)
4. Device Description
This system is comprised of screws, set screws, rods, crosslink and connectors. The components of this system are manufactured of Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm.
5. Intended use / Indications for Use
The Dali Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System
1
AccelSPINE
components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use:
- 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);
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
- tumor;
.
- stenosis, and;
- failed previous fusion (pseudoarthrosis)
6. Comparison of the Technology Characteristics
The Dali Spinal Fixation System shares technological characteristics similar to the predicate devices. These characteristics include similar design, the same materials, substantially equivalent performance characteristics and the same intended use.
7. Performance Data
Non-Clinical Performance and Conclusions:
Bench testing results demonstrate that Dali Spinal Fixation System performs equivalently to the predicates in static compression bending, static torsion, static torsion, dynamic compression bending (in accordance with ASTM F1717-10) and gripping-push down (in accordance with ASTM F1798).
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
8. Conclusion
The Dali Spinal Fixation System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Accel SPINE % L & K Biomed Company, Limited Ms. Ki Hyang Kim Vice President 1104-ho, 145, Gasandigital 1-ro, Geumcheon-gu Seoul, 153-787, Korea
Re: K121568
Trade/Device Name: Dali Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, KWQ, MNH, MNI Dated: August 18, 2012 Received: August 20, 2012
Dear Ms. 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. 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
SEP 21 2012
3
Page 2 - Ms. Ki Hyang Kim
device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
CAccessPINE
510(k) Number : K 121568 Device Name: Dali Spinal Fixation System Indications For Use:
The Dali Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle fixation systems (TI-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use:
- degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
- spondy lolisthesis;
- trauma (i.e. fracture or dislocation);
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
- tumor:
- stenosis, and;
- failed previous fusion (pseudoarthrosis)
| Prescription Use | √ |
|---|---|
| (Part 21 CER801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CER801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concyptence of CDRH, Office of Device Evaluation (OED)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_
Page 1/1
Dali Spinal Fixation System 510(K)