(89 days)
Not Found
No
The document describes a mechanical spinal implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on biocompatibility, sterilization, packaging, and mechanical testing of the physical device.
Yes
The device is intended to provide immobilization and stabilization of spinal segments for posterior, non-cervical pedicle fixation as an adjunct to fusion for various medical indications such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion. These actions directly address or alleviate a disease or condition, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a "Pedicle Screw System" used for immobilization and stabilization of spinal segments, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of "a variety of Pedicle screws and rods in different sizes," which are physical hardware components made of ASTM F136 (Ti-6Al-4V ELI). The performance studies also detail mechanical testing of these physical implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the MIS Z-Pedicle Screw System is a surgical implant intended for the immobilization and stabilization of spinal segments. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are characteristic of IVDs.
Therefore, the MIS Z-Pedicle Screw System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MIS Z-Pedicle Screw System is intended to provide immobilization and stabilization of the spinal segments for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications:
- degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- spondylolisthesis (grades 3 and 4) at L5-S1
- trauma (i.e., fracture or dislocation)
- spinal stenosis
- curvatures (i.e.,scoliosis, kyphosis, and/or lordosis)
- tumor
- pseudoarthrosis
- failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNI, MNH
Device Description
The MIS Z - Pedicle Screw System consists of a variety of Pedicle screws and rods in different sizes. The devices are intended to provide immobilization of the spinal segments for posterior, noncervical pedicle fixation in skeletally mature patients as an adjunct to fusion.
The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g. osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.
Z-Pedicle Screws: Material: ASTM F136 (Ti-6Al-4V ELI) Length: 35mm to 55 mm Diameter: 5, 6, 7, 8 mm
Z- Rods: Material: ASTM F136 (Ti-6Al-4V ELI) Length: 35mm to 300mm Diameter: 5,5 mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal segments, non-cervical
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)
The following testing was done to show safety and effectiveness of our system:
-
biocompatibility
Materials that come into contact with the patient were identified as well as products that might contaminate the implants and instruments during manufacturing processes. Materials are listed and viewed, testing according EN ISO 10993-5 -
sterilization
Microbiological performance qualification of gamma radiation (basic qualification, method VDmax25) was performed according EN ISO 11137-1 and showed that the products are sterile with SAL of 10-6 -
packaging / shelf life
Shelf life of packaging was performed by Puracon with a packaging validation. With the PA/PE bags we use, we're superior to the worst case product -
bench testing - mechanical
Testing in order to help establish safety and effectiveness of Z-Medical's MIS Pedicle Screw System has been performed accordingly and results are conforming to the respective requirements. Mechanical tests:
- static compression bending
- static tension bending
- static torsion
- dynamic compression bending
- ASTM F1798 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants The following testing was performed: static gripping capacity
Result: the results of the testing exceed the values we defined in our rational for the worst case scenario based on literature.
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be a single, continuous line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
February 3, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Z-Medical GmbH & Company KG Mr. Alexander Henninger Quality Manager Gansacker 38 78532 Tuttlingen GERMANY
Re: K143200
Trade/Device Name: MIS Z-Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: November 1, 2014 Received: November 6, 2014
Dear Mr. Henninger:
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 (reporting of medical
1
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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below
510(k) Number (if known) K143200
Device Name MIS Z-Pediele Serew System
Indications for Use (Describe)
The MIS Z-Pedicle Screw System is intended to provide immobilization and stabilization of the spinal segments for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies):
· spondy lolisthesis (grades 3 and 4) at L5-S1
- · trauma (i.e., fracture or dislocation)
- · spinal stenosis
- · curvatures (i.e.,scoliosis, kyphosis, and/or lordosis)
- · tumor
- · pseudoarthrosis
- · failed previous fusion.
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
K143200
510(k) Summary
DATE OF PREPARATION: 2015-02-02
Z-Medical GmbH & Co. KG APPLICANT: Gänsäcker 38 78532 Tuttlingen Germany Tel.: +49 7462 9455 40 Fax: +49 7462 9455 49
E-Mail: info@z-medical.de www.z-medical.de
- CONTACT PERSON: Alexander Henninger Quality Manager Tel.: +49 7462 9455 40 Fax: +49 7462 9455 49
4
1. Device Name
MIS Z-Pedicle Screw System 1.1.
| Trade Names: | MIS Z-Pedicle Screw System |
|---|---|
| Common Name: | Pedicle Screw System |
| Classification Name: | Pedicle screw spinal System |
2. Classification Product Code / Subsequent Code
2.1. MIS Z-Pedicle Screw System
| Device | Medical
Specialty | Review Panel | Product Code | Device
Class | Regulation
Number | Classification
name |
|----------------------------------|----------------------|--------------|------------------|-----------------|----------------------|--------------------------------|
| Pedicle screw
spinal fixation | Part 888 | Orthopedic | NKB, MNI,
MNH | III | 888.3070 | Pedicle Screw
Spinal System |
Predicate Device 3.
Z-Medical's MIS Pedicle Screw System is substantially equivalent to the following predicate devices, most recently cleared by the FDA:
| Z-Medical Product | Primary
Predicate Device | 510(k) Number | 510(k) Holder |
|-----------------------------|--------------------------------|---------------|---------------|
| MIS Z- Pedicle Screw System | CD HORIZON | K031655 | Medtronic |
| | Additional
Predicate Device | 510(k) Number | 510(k) Holder |
| | VIPER 2 | K090648 | DePuy Spine |
| | EXPEDIUM / VIPER
/ VIPER 2 | K131802 | DePuy Spine |
Description of the Device ব
4.1. MIS Z-Pedicle Screw System
The MIS Z - Pedicle Screw System consists of a variety of Pedicle screws and rods in different sizes. The devices are intended to provide immobilization of the spinal segments for posterior, noncervical pedicle fixation in skeletally mature patients as an adjunct to fusion.
The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g. osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.
Z-Pedicle Screws: Material: ASTM F136 (Ti-6Al-4V ELI) Length: 35mm to 55 mm Diameter: 5, 6, 7, 8 mm
5
Z- Rods: Material: ASTM F136 (Ti-6Al-4V ELI) Length: 35mm to 300mm Diameter: 5,5 mm
5. Indications for Use
5.1. MIS Z- Pedicle Screw System
The MIS Z-Pedicle Screw System is intended to provide immobilization and stabilization of the spinal segments for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications:
- . degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- . spondylolisthesis (grades 3 and 4) at L5-S1
- . trauma (i.e., fracture or dislocation)
- spinal stenosis
- curvatures (i.e.,scoliosis, kyphosis, and/or lordosis)
- tumor
- pseudoarthrosis
- . failed previous fusion.
6. Testing
The following testing was done to show safety and effectiveness of our system:
-
- biocompatibility
Materials that come into contact with the patient were identified as well as products that might contaminate the implants and instruments during manufacturing processes. Materials are listed and viewed, testing according EN ISO 10993-5
- biocompatibility
-
- sterilization
Microbiological performance qualification of gamma radiation (basic qualification, method VDmax25) was performed according EN ISO 11137-1 and showed that the products are sterile with SAL of 10°
- sterilization
-
ന് packaging / shelf life
Shelf life of packaging was performed by Puracon with a packaging validation. With the PA/PE bags we use, we're superior to the worst case product
- bench testing - mechanical
Testing in order to help establish safety and effectiveness of Z-Medical's MIS Pedicle Screw System has been performed accordingly and results are conforming to the respective requirements. Mechanical tests:
- . ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model The following testing was performed:
6
- static compression bending
- static tension bending
- static torsion
- dynamic compression bending -
- ASTM F1798 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection . Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants The following testing was performed: static gripping capacity
Result: the results of the testing exceed the values we defined in our rational for the worst case scenario based on literature.
7. Substantial Equivalence Summary / Conclusion
Based on available 510(k) information provided herein, Z-Medical's MIS Pedicle Screw System is considered substantial equivalent to the predicate devices in terms of indications for use, material, technology, design and performance specifications.
There are no differences between the devices which would raise new issues of safety or effectiveness.