(226 days)
The Halm Zielke Instrumentation System is an anterior spinal fixation system indicated for spinal deformities such as scoliosis, kyphosis, and lordosis and thoracolumbar spinal instability caused by fracture.
The principal components of the MICOMED Halm Zielke Instrumentation, which is a low profile spinal fixation system, are as follows: Halm plates, screws, threaded rods, standard hex nut for threaded rods, fluted rods, vertebral clamps (double hole). Additional instrumentation includes: an awi, insertion instruments (Halm plates, threaded rod screws), screw wrench for hex nut, rod pusher for fluted rod, rod benders, in situ rod bender, grip tongs (threaded rod, fluted rod), and hook grasp tong.
The principal components of the MICOMED - Halm Zielke Instrumentation are utilized in the following manner. First, the most cranial and caudal Halm plates are each attached to the lateral aspect of the vertebral body with two screws (countersunk, Zielke), and then additional plates are attached as needed. The threaded rod is then connected to the top of the Zielke screws, and anchored with the standard hex nuts. Once the threaded rod is properly connected to the Halm plates, partial correction of the scoligtic deformity is performed before attaching the pre-bent fluted rod by closing the lid of the Halm plate and securing with the head screws. The secured fluted rod can then be rotated around its longitudinal axis to achieve an appropriate level of derotation and relordosation. If this system is used in the thoracic spine, rod rotation is performed in reverse to produce or enhance physiological kyphosis. Additionally, segmental compression or distraction can be used to increase or decrease lordosis or kyphosis as desired.
The provided 510(k) summary for the MICOMED - Halm Zielke Instrumentation describes a spinal fixation system, not an AI/ML device, and therefore does not contain the information typically required for evaluating the acceptance criteria and study proving an AI/ML device meets those criteria.
However, based on the information available regarding the performance testing of the mechanical device, I can extract and structure the relevant data.
Here's an analysis of the provided text, modified to fit the requested format as much as possible for a mechanical device:
Description of the MICOMED - Halm Zielke Instrumentation
The MICOMED - Halm Zielke Instrumentation is a low-profile anterior spinal fixation system. Its principal components include Halm plates, screws, threaded rods, hex nuts, fluted rods, and vertebral clamps. The system is designed to correct spinal deformities (scoliosis, kyphosis, lordosis) and treat thoracolumbar spinal instability caused by fracture. The components are manufactured from implant-grade stainless steel (316LS) or titanium (ASTM F136).
1. Table of Acceptance Criteria and Reported Device Performance
For a mechanical medical device like this, acceptance criteria typically relate to mechanical strength, durability, and equivalent performance to predicate devices. The document frames performance in terms of "inherent stability (stiffness)" and resistance to "deformational forces" and "fatigue."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Stability (Stiffness): Demonstrates superior or equivalent stability compared to predicate devices under various loads. | Compared to Zielke-VDS: "the calf and artificial spines were much more resistant to various deformational forces (axial compression, flexion, extension, lateral bending, torsion) after the MICOMED - Halm Zielke Instrumentation was applied as opposed to Zielke-VDS." (Implies superior stiffness/stability). |
| Fatigue Resistance/Durability: Withstands physiological loading for a significant number of cycles without device failure. | Fatigue Testing: "when the call spines were subjected to one million cycles of axial compression at loads of 1400 Newtons (N) and 2600 N, none (of the calf spines) exhibited any evidence of device failure." This demonstrates robust fatigue resistance under significant and prolonged stresses. |
| Substantial Equivalence: Performance is at least equivalent to legally marketed predicate devices. | The device is deemed "Substantially Equivalent to the Zielke-Ventral Derotation Spondylodesis, Kaneda SR™ Anterior Spinal System, and Anterior Isola Spinal System." This is a regulatory finding based on the overall data, implying that the performance data supported equivalence to these established devices (which would have their own established performance profiles). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a numerical sample size for "calf and artificial spines." The phrasing "the calf and artificial spines" suggests a limited, but not explicitly quantified, number of specimens were used. For the fatigue testing, it states "when the call spines were subjected to one million cycles of axial compression," implying a set of calf spines.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study seems to be a laboratory-based biomechanical study, which is typical for spinal implant testing. It is a prospective test in the sense that the experiment was designed and conducted to evaluate this specific device's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This question is not applicable to this type of device and study. Biomechanical testing of spinal implants does not typically involve human experts establishing "ground truth" in the way an AI/ML diagnostic device does for image interpretation. The "ground truth" here is the physical measurement of deformation, failure, and resistance, determined by mechanical testing protocols and sensors.
4. Adjudication Method for the Test Set
This question is not applicable. There is no "adjudication method" in the context of mechanical testing. The results are quantitative measurements from instruments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This question is not applicable. This is a biomechanical performance study of a physical implant, not a study involving human readers or AI assistance.
6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)
This question is not applicable. There is no algorithm or AI component to this device. The performance study refers to the standalone mechanical performance of the implant itself.
7. Type of Ground Truth Used
For the biomechanical study:
- Mechanical Measurement Data: The "ground truth" is derived from direct physical measurements of mechanical properties such as resistance to deformational forces (axial compression, flexion, extension, lateral bending, torsion) and assessment of device integrity after fatigue cycling (absence of device failure).
8. Sample Size for the Training Set
This question is not applicable. As a mechanical device, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. There is no "training set" for this mechanical device.
{0}------------------------------------------------
K98 2006
MICOMED - HALM ZIELKE INSTRUMENTATION; 510(k) Summary
Schafer MICOMED GmbH Company: Box 1664 73606 Schomdorf, Germany Phone: 0 49 71 61 94 96 43 0 49 71 61 94 96 46 Fax:
MICOMED - Halm Zielke Instrumentation Tradename:
Classification: Spinal Intervertebral Body Fixation Orthosis
-
The principal components of the MICOMED Halm Zielke Description: Instrumentation, which is a low profile spinal fixation system, are as follows: Halm plates, screws, threaded rods, standard hex nut for threaded rods, fluted rods, vertebral clamps (double hole). Additional instrumentation includes: an awi, insertion instruments (Halm plates, threaded rod screws), screw wrench for hex nut, rod pusher for fluted rod, rod benders, in situ rod bender, grip tongs (threaded rod, fluted rod), and hook grasp tong.
The principal components of the MICOMED - Halm Zielke Instrumentation are utilized in the following manner. First, the most cranial and caudal Halm plates are each attached to the lateral aspect of the vertebral body with two screws (countersunk, Zielke), and then additional plates are attached as needed. The threaded rod is then connected to the top of the Zielke screws, and anchored with the standard hex nuts. Once the threaded rod is properly connected to the Halm plates, partial correction of the scoligtic deformity is performed before attaching the pre-bent fluted rod by closing the lid of the Halm plate and securing with the head screws. The secured fluted rod can then be rotated around its longitudinal axis to achieve an appropriate level of derotation and relordosation. If this system is used in the thoracic spine, rod rotation is performed in reverse to produce or enhance physiological kyphosis. Additionally, segmental compression or distraction can be used to increase or decrease lordosis or kyphosis as desired. -
The components of the MICOMED Halm Zielke Instrumentation are Material: manufactured from implant grade stainless steel (316LS) conforming to ASTM F1314 specifications or implant grade titanium conforming to ASTM F136.
-
The Halm Zielke Instrumentation System is an anterior spinal fixation Indications: system indicated for spinal deformities such as scollosis, kyphosis, and fordosis and thoracolumbar spinal instability caused by fracture.
Performance: The inherent stability (stiffness) of the MICOMED - Halm Zielke
{1}------------------------------------------------
TO
- Instrumentation has been compared to Zielke-VDS in two different Data: models. In addition, fatigue testing was performed. The results demonstrate that the calf and artificial spines were much more resistant to various deformational forces (axial compression, flexion, extension, lateral bending, torsion) after the MICOMED - Halm Zielke Instrumentation was applied as opposed to Zielke-VDS. Moreover, when the call spines were subjected to one million cycles of axial compression at loads of 1400 Newtons (N) and 2600 N, none exhibited any evidence of device failure.
The MICOMED - Halm Zielke Instrumentation is equivalent Substantial to the Zielke-Ventral Derotation Spondylodesis, Kaneda SR™ Anterior Equivalence: Spinal System, and Anterior Isola Spinal System.
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
JAN 2 0 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Micomed c/o Ms. Charmaine Henderson 511 Catalina Road 92835 Fullerton, California
K982006 Re: Halm Zielke Instrumentation Trade Name: Regulatory Class: II Product Code: KWQ October 23, 1998 Dated: Received: October 30, 1998
Dear Ms. Henderson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
{3}------------------------------------------------
Page 2 - Ms. Charmaine Henderson
This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
K982006 510k:
Halm Zielke Instrumentation System Device:
Indications for Use:
The Halm Zielke Instrumentation System is an anterior spinal fixation system indicated for spinal deformities such as scoliosis, kyphosis, and lordosis and thoracolumbar spinal instability caused by fracture.
eede
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
ﻧﻴﺔ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﻛﺰ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﺘﺮﺍﺗﺐ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻊ
Prescription use
Over the Counter Use
TO
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.