(294 days)
Not Found
No
The summary describes a mechanical spinal fixation system with no mention of AI/ML capabilities or related data/performance metrics.
Yes
The device is described as a 'posterior spinal fixation system' intended to provide 'immobilization and stabilization of spinal segments' for various 'acute and chronic instabilities or deformities'. These are direct therapeutic actions on the human body to treat disease or injury.
No
This device is a spinal fixation system, indicated for providing immobilization and stabilization of spinal segments as an adjunct to fusion. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a "multiple component posterior spinal fixation system which consists of pedicle screws, rods, and connectors," all of which are hardware components made from specific materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to provide immobilization and stabilization of spinal segments as an adjunct to fusion. This is a therapeutic device used in vivo (within the body).
- Device Description: The description details physical components (pedicle screws, rods, connectors) made from specific materials (Ti-6AL-4V ELI, cobalt chrome). This aligns with a surgical implant, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The DIPLOMAT® Spinal System, when used as a posterior pedicle screw 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture
- Dislocation
- Scoliosis
- Kyphosis
- Spinal tumor
- Pseudoarthrosis
- Failed previous fusion
In addition, the DIPLOMAT® Spinal System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
The DIPLOMAT® Spinal System is intended to be used with autograft and/or allograft.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNI, MNH
Device Description
The DIPLOMAT® Spinal System is a multiple component posterior spinal fixation system which consists of pedicle screws, rods, and connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are manufactured from Ti-6AL-4V ELI per ASTM F136 and cobalt chrome per ASTM F75. The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine; L5-S1 vertebra; lumbosacral spine and/or ilium
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 DIPLOMAT® has been tested in the following test modes:
- Static Compression-Bending Test per ASTM 1717-14 .
- . Static Torsion Test per ASTM 1717-14
- Dynamic Compression-Bending Test per ASTM F1717-14 .
The results of this non-clinical testing show that the strength of the Diplomat is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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.
K000236, K131820, K103490, K033901, K955348, K081080, K020279, K051971, K024096, K102870, K120838, K110280, K123717
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.
0
Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2016
SIGNUS Medizintechnik GmbH % Mr. Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K151704
Trade/Device Name: DIPLOMAT® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: April 13, 2016 Received: April 13, 2016
Dear Mr. Maxwell:
This letter corrects our substantially equivalent letter of April 13, 2016.
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
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical 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,
Caroline Rhim -S for
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 on last page.
510(k) Number (if known) K151704
Device Name
DIPLOMAT® Spinal System
Indications for Use (Describe)
The DIPLOMAT® Spinal System, when used as a posterior pedicle screw 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
-
Spondylolisthesis
-
Spinal stenosis
-
Fracture
-
Dislocation
-
Scoliosis
-
Kyphosis
-
Spinal tumor
-
Pseudoarthrosis
-
Failed previous fusion
In addition, the DIPLOMAT® Spinal System is intended for treatment of severe
spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
The DIPLOMAT® Spinal System is intended to be used with autograft and/or allograft.
Type of Use (Select one or both, as applicable)
Z Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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."
4
5.510(K) SUMMARY
| Submitter's Name: | SIGNUS Medizintechnik GmbH |
|---|---|
| Submitter's Address: | Industriestr. 2 |
| 63755 Alzenau / Germany | |
| Submitter's Telephone: | +49 6023 9166-213 |
| Contact Person: | Kenneth C. Maxwell |
| Empirical Testing Corp. | |
| 719.291.6874 | |
| Date Summary was Prepared: | 29 January 2016 |
| Trade or Proprietary Name: | DIPLOMAT® Spinal System |
| Common or Usual Name: | Orthosis, Spinal Pedicle Fixation |
| Orthosis, Spondylolisthesis Spinal Fixation | |
| Orthosis, Spinal Pedicle Fixation, For Degenerative Disc | |
| Disease | |
| Appliance, Fixation, Spinal Interlaminal | |
| Classification: | Class III per 21 CFR §888.3070 Pedicle screw spinal |
| system | |
| Product Code: | NKB, MNI, MNH |
| Classification Panel: | 87 Orthopedics Panel |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The DIPLOMAT® Spinal System is a multiple component posterior spinal fixation system which consists of pedicle screws, rods, and connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are manufactured from Ti-6AL-4V ELI per ASTM F136 and cobalt chrome per ASTM F75. The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye
INDICATIONS FOR USE
The DIPLOMAT® Spinal System, when used as a posterior pedicle screw 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
-
Spondylolisthesis
-
Spinal stenosis
-
Fracture
-
Dislocation
-
Scoliosis
-
Kyphosis
5
- Spinal tumor
- Pseudoarthrosis
- Failed previous fusion
In addition, the DIPLOMAT® Spinal System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
The DIPLOMAT® Spinal System is intended to be used with autograft and/or allograft.
The indications for use for the Diplomat™ system is similar to that of the predicate device noted below in Table 5-1.
TECHNOLOGICAL CHARACTERISTICS
The SIGNUS Medizintechnik GmbH DIPLOMAT® is made from Ti-6AL-4V ELI per ASTM F136. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- Indications for Use
- Materials of manufacture ●
- Structural support mechanism .
- Sterilization ●
- . Principles of Operation
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Type |
|---------------------------------------|---------------------------------------|------------------|------------|
| K000236 | Synergy VLS Open | Interpore | Primary |
| K131820, K103490, K033901,
K955348 | Moss Miami Titanium | DePuy Spine Inc. | Additional |
| K081080 | TSRH | Medtronic | Additional |
| K020279, K051971, K024096 | OPTIMA™ | U&I Corporation | Additional |
| K102870 | Spine Proliant Screw
System | Exactech | Additional |
| K120838 | Matrix System | Synthes | Additional |
| K110280 | Revlok | Globus | Additional |
| K123717 | UCentum | Ulrich | Additional |
| Table 5-1 Predicate Devices | ||
|---|---|---|
6
PERFORMANCE DATA
The DIPLOMAT® has been tested in the following test modes:
- Static Compression-Bending Test per ASTM 1717-14 .
- . Static Torsion Test per ASTM 1717-14
- Dynamic Compression-Bending Test per ASTM F1717-14 .
The results of this non-clinical testing show that the strength of the Diplomat is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the DIPLOMAT® Spinal System is substantially equivalent to the predicate device.