(129 days)
No
The document describes a mechanical spine implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are mechanical tests, not software validation.
Yes
The device is intended to treat instabilities or deformities of the spine through immobilization and stabilization, which aligns with the definition of a therapeutic device.
No
The EXPEDIUM Spine System is described as an implantable device (rod-based and plate-based system, screws, hooks, etc.) intended for immobilization and stabilization of spinal segments as an adjunct to fusion, not for diagnosing medical conditions.
No
The device description clearly outlines a system composed of various physical components like screws, rods, plates, and connectors made of titanium and stainless steel. It also describes mechanical testing of these physical components. There is no mention of software as a component of this system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "immobilization and stabilization of spinal segments... as an adjunct to fusion." This describes a surgical implant used in vivo (within the body) to treat structural issues of the spine.
- Device Description: The description details various components like screws, rods, plates, and connectors, which are all physical implants designed for surgical placement.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); · tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
Product codes
NKB, KWO, KWP, MNH, MNI
Device Description
The EXPEDIUM Spine System is a 5.5mm rod-based and platebased system offered in both titanium and stainless steel. The system consists of monoaxial screws, polyaxial screws, uni-planar screws, reduction screws, reduction hooks, hooks, extended tab implants, sacral extenders, lateral connectors, washers, fixed bolts, polyaxial bolts, closed screws, slotted connectors, plates, nuts, washers, drop-entry connectors, modular cross connectors, transverse rod connectors, and wires.
The proposed addition to the EXPEDIUM 5.5mm Spine System is an increased favored angle polyaxial screw. The polyaxial screw head opens posteriorly for placement of a rod which is secured to a screw by either a dual inner or unitized set screw. This additional component is available in various geometries and sizes to accommodate patient anatomy. It will be provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine
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
Nonclinical Test Summary: . Static cantilever beam in accordance with ASTM F1798-97 test standard Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spine Arthrodesis Implants. The acceptance criteria was/were met. : Static axial slip in accordance with ASTM F1798-97 test . standard Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spine Arthrodesis Implants. The acceptance criteria was/were met. Dynamic cantilever beam in accordance with ASTM F1798-97 test standard Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spine Arthrodesis Implants. The acceptance criteria was/were met. Clinical Test No clinical tests were performed.
Key Metrics
Not Found
Predicate Device(s)
EXPEDIUM Spine System (K033901, K051024, K062174, K070387), ISOLA Spine System (K980485)
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
Special 510(k) Submission - Additions to the EXPEDIUM 5.5mm Spine Systems
5. 510(K) SUMMARY
| Submitter: | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02767 | DEC 16 2010 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Daphney Germain
Regulatory Affairs Associate
DePuy Spine, Inc.
Voice:
(508) 880-8395
Fax:
(508) 828-3797
E-Mail:
dgermain@its.jnj.com | |
| Date Prepared: | August 6, 2010 | |
| Device Class: | Class III | |
| Tradename: | EXPEDIUM® Spine System | |
| Common Name: | Appliance, Fixation, Spinal Interlaminal;
Orthosis, Spondyloisthesis Spinal Fixation;
Orthosis, Spinal Pedicle Fixation;
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease | |
| Classification Name: | Spinal interlaminar fixation orthosis
per 21 CFR §888.3050 | |
| | Spinal intervertebral body fixation orthosis
per 21 CFR §888.3060 | |
| | Pedicle screw spinal fixation
per 21 CFR §888.3070 | |
| Classification Panel: | Orthopedics | |
| FDA Panel Number: | 87 | |
| Product Code(s): | NKB, KWO, KWP, MNH, MNI | |
Proprietary Name: EXPEDIUM® Spine System
Device Description: The EXPEDIUM Spine System is a 5.5mm rod-based and platebased system offered in both titanium and stainless steel. The system consists of monoaxial screws, polyaxial screws, uni-planar screws, reduction screws, reduction hooks, hooks, extended tab implants, sacral extenders, lateral connectors, washers, fixed bolts, polyaxial bolts, closed screws, slotted connectors, plates, nuts,
1
washers, drop-entry connectors, modular cross connectors, transverse rod connectors, and wires.
The proposed addition to the EXPEDIUM 5.5mm Spine System is an increased favored angle polyaxial screw. The polyaxial screw head opens posteriorly for placement of a rod which is secured to a screw by either a dual inner or unitized set screw. This additional component is available in various geometries and sizes to accommodate patient anatomy. It will be provided non-sterile.
Intended Use: The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Manufactured from ASTM F 136 implant grade titanium alloy.
Predicate Devices:
Materials:
EXPEDIUM Spine System (K033901, K051024, K062174, K070387) ISOLA Spine System (K980485)
Summary of Technological Differences:
The purpose of this submission is to obtain market clearance for the proposed additional component to the EXPEDIUM 5.5mm Spine Systems which consists of a favored angle polyaxial screw. The proposed component has the same intended use, design characteristics, performance, and packaging as the predicate devices. The key differences between the subject and predicate devices are:
- The Medial/Lateral (M/L) degree increase of the . favored angle head
- . The increase in polyaxial head height.
2
Nonclinical Test The following mechanical tests were conducted: Summary: . Static cantilever beam in accordance with ASTM F1798-97 test standard Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spine Arthrodesis Implants. The acceptance criteria was/were met. : Static axial slip in accordance with ASTM F1798-97 test . standard Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spine Arthrodesis Implants. The acceptance criteria was/were met. Dynamic cantilever beam in accordance with ASTM � F1798-97 test standard Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spine Arthrodesis Implants. The acceptance criteria was/were met. Clinical Test No clinical tests were performed. Summary: Based on the predicate comparison and testing, the subject addition Conclusion: to the EXPEDIUM 5.5mm Spine Systems is substantially equivalent to the predicate device. :
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Spine, Inc. % Ms. Daphney Germain Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
DEC 16 2010
Re: K102249
R102249
Trade/Device Name: EXPEDIUM® Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWQ, KWP, MNH, MNI Dated: December 03, 2010 Received: December 06, 2010
Dear Ms. Germain:
We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we have reviewed your Scctorn 5 ro(t) premained is substantially equivalent (for the indications referenced and nave determined the actrose are arrooms of the devices marketed in interstate for use stated in the encrosule) to regary manotes profithe Medical Device Amendments, or to commerce prior to May 28, 1970, the chacinent with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, subject to the general its .
general controls provisions of the Act include requirements for answer misbranding and general controls provisions of the Act mensibitions against misters and devices, good manufacturing placece, not evaluate information related to contract liability.
adulteration. Please note: CDRH does not evaluate information related to traile adulteration. Please note: CDRFI does not evaluate information of the truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it is If your device is classified (see au0v) mio enase regulations affecting your device can be
may be subject to additional controls. Title Regulations affecting your addition. F may be subject to additional controls: "Existing and to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Facts 800 to Begister found in the Code of I cocharters, concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issualle of a substantial of a varies with other requirements of the Act
that FDA has made a determination that your device complies with other r
4
Page 2 - Ms. Daphney Germain
or any Federal statutes and regulations administered by other Federal agencies. You must or any Federal statules and regulations administered of registration and listing (21)
comply with all the Act's requirements, including, but not series of medical comply with all the Act STEquirements, increasing of ever reporting of medical CFR Part 807); labeling (21 CFR 807); intention activery mag (tipes mag (stjer requirements as set
device-related adverse events (21 CFR 803); good manufacturing practice req device-related adverse evenis) (2) CFR Pat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patt 820); and if applicable, the elec forth in the quality systems (QS) regulation (DF-SF-S-C-S-F-S-C-S-2-5-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2-2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
ly of the specific advice and and and and and in a column LSS00 htm for If you desire specific advice for your acvice of var sicontribution of Commission of Compliance. go to http://www.rda.gov/Abour12/0Cchiccs Office.of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH) starter resifiestion" (21CFR Part the Center for Devices and Radiological Treater of premarket notification" (21CFR Part
note the regulation entitled, "Misbranding by reference to athe MDP regulation (2 note the regulation ennited, "Misoranung of reference to promises
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
CFR Parl 803), picesse go to http://www.ida.gov/Nicaletrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
(800) 038-2041 01 (301) 770 1100 0100 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000
Sincerely yours,
Mark A. Millers
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Special 510(k) Submission - Additions to the EXPEDIUM 5.5mm Spine System
INDICATIONS FOR USE STATEMENT 4.
510(k) Number (if known):
DEC 16 2010
Device Name: EXPEDIUM® Spine System
Indications For Use:
The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); · tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
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)
(Division Sign-off)
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K 102249 |
|---|---|
| --------------- | ---------- |