(65 days)
The DVX Spine System is intended for posterior, noncervical, pedicle fixation in order 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, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal turnor; and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the DVX Spine System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attaimment of solid fusion.
The DVX Spine System consists of four or more pedicle screws and two DVX solid rods in a symmetric, bilateral arrangement. The pedicle screws are placed axially in the pedicles with two screws in the cephalad position and two screws in the caudad position. The DVX rods are secured in the heads of the pedicle screws so that fixed stabilization is provided between the cephalad and caudad vertebrae. Cross-links can be used if additional stabilization is necessary. The DVX Spine System is fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to the ASTM F136 -02a, Standard Specifications for Wrought Titanium-6Aluminum-4VanadiumELI (Extra Low Interstitial) Alloy or Surgical Implant Applications (UNS R56401
The provided text describes a 510(k) submission for the DVX Spinal System, a medical device for spinal fusion. However, it does not include information about acceptance criteria or a study proving the device meets said criteria in the context of device performance, clinical efficacy, or AI system-specific metrics.
Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices (NFix Fusion System, K053623, and MEGA Spine System, K072436). The basis for substantial equivalence is the similarity in materials, design, indications for use, operational principles, and source manufacturer.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The submission does not detail specific acceptance criteria for a new performance study or report new device performance metrics. Its claim is based on substantial equivalence to predicate devices, implying that the predicate devices' performance (which met their own acceptance criteria) is sufficient.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No new performance testing in a "test set" (clinical or otherwise) is described for the DVX Spinal System. The evaluation relies on the equivalence to existing devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No new test set requiring expert ground truth establishment is mentioned.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is mentioned.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. The document does not describe any MRMC study, nor does it refer to an AI device that would typically be evaluated in such a study.
6. Standalone (i.e. algorithm only without human-in-the loop performance) Study
No. The document describes a physical medical device (spinal system) and does not refer to an algorithm or AI system for which a standalone performance study would be relevant.
7. Type of Ground Truth Used
Not applicable. Since no new performance studies are detailed, there is no mention of ground truth (expert consensus, pathology, or outcomes data) being used for the DVX Spinal System itself. The evaluation is based on the characteristics of the device and its predicate devices.
8. Sample Size for the Training Set
Not applicable. The DVX Spine System is a physical medical device. It does not involve machine learning or AI, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this question is not relevant.
Summary of the Study (and its absence) described in the document:
The provided document describes a 510(k) submission for substantial equivalence. The "study" in this context is primarily a design and materials comparison between the DVX Spinal System and its predicate devices (NFix Fusion System and MEGA Spine System).
The key statement is: "No additional testing is required because the test results applicable to the N SPINE System and MEGA spinal system components are directly applicable to the DVX Spine System since they are virtually identical in design and materials. Designs are directly compared to demonstrate equivalence."
This means that:
- The acceptance criteria for the DVX Spinal System are implicitly those that were met by the predicate devices during their own clearance processes.
- No new study data is presented for the DVX Spinal System, as it is considered substantially equivalent based on design and material identity to already cleared devices.
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510(k) Summary
Submitted on behalf of:
BK MEDITECH Co., Ltd. 215-5 Yodang-Li, Yanggam-Myun, Hwasung-Si, Kyunggi-Do, Republic of Korea
| by: | Elaine Duncan, M.S.M.E., RAC |
|---|---|
| President, Paladin Medical, Inc. | |
| PO Box 560 | |
| Stillwater, MN 55082 | |
| Telephone: | 715-549-6035 |
| Fax: | 715-549-5380 |
| CONTACT PERSON: | Elaine Duncan |
| DATE PREPARED: | March 28, 2008; revised May 28, 2008 |
| TRADE NAME: | DVX Spinal System |
| COMMON NAME: | Spinal System, Fusion |
| CLASSIFICATION NAME: | Posterior Spinal Fusion System with solid rod and pedicle screw |
| REGULATION and CLASS | 21 CFR § 888.3070, Class 2 |
| PANEL and PRO CODE: | Orthopedic; MNH |
SUBSTANTIALLY EQUIVALENT TO: The DVX Spine System, is substantially equivalent to the NFix Fusion System cleared for market by N Spine, Inc. under K053623, and to MEGA Spine System (K072436) for the cross-link member. The DVX Spine System is equivalent to the N Spine system and the MEGA Spine cross-link member with respect to materials, design, indications for use, operational principles and source manufacturer. There are no substantial differences between the subject devices and the predicate devices and thus no differences which could affect safety or efficacy.
DESCRIPTION of the DEVICE: The DVX Spine System consists of four or more pedicle screws and two DVX solid rods in a symmetric, bilateral arrangement. The pedicle screws are placed axially in the pedicles with two screws in the cephalad position and two screws in the caudad position. The DVX rods are secured in the heads of the pedicle screws so that fixed stabilization is provided between the cephalad and caudad vertebrae. Cross-links can be used if additional stabilization is necessary. The DVX Spine System is fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to the ASTM F136 -02a, Standard Specifications for Wrought Titanium-6Aluminum-4VanadiumELI (Extra Low Interstitial) Alloy or Surgical Implant Applications (UNS R56401
INDICATIONS FOR USE: The DVX Spine System is intended for posterior, noncervical, pedicle fixation in order 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, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal turnor; and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the DVX Spine System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attaimment of solid fusion.
BASIS for SUBSTANTIAL EQUIVALENCE: No additional testing is required because the test results applicable to the N SPINE System and MEGA spinal system components are directly applicable to the DVX Spine System since they are virtually identical in design and materials. Designs are directly compared to demonstrate equivalence.
510K Submission: BKMEDITECH Co., Ltd
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Image /page/1/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three bars extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 2008
BK Meditech Co., LTD. % Paladin Medical Inc. Ms. Elaine Duncan P.O. Box 560 Stillwater, MN 55082
Re: K080876
Trade/Device Name: DVX Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI Dated: March 28, 2008 Received: March 31, 2008
Dear Ms. Duncan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Elaine Duncan
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Ko80876
Device Name: DVX Spine System
The DVX Spine System is intended for posterior, noncervical, pedicle fixation in order 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, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the DVX Spine System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil R.P. Ogle for mxm
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K080876
§ 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.