(126 days)
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.
The subject EXPEDIUM™ Spine System components are designed to accept a 4.5mm rod and are available in various geometries and sizes.
The provided text is a 510(k) summary for the EXPEDIUM Spine System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance data and material specifications. It does not contain information about software-based AI or diagnostic algorithms that would typically have the specific acceptance criteria and study details you've requested.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance (in the context of AI/diagnostic algorithms).
- Sample size used for the test set and data provenance.
- Number of experts and qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Here's what the provided text does say about performance and acceptance:
The submission states:
- Performance Data: "Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification."
This indicates that the device's mechanical performance was evaluated according to the standard ASTM F 1717, which is a standard specification for spinal implant constructs in a vertebrectomy model. The acceptance criteria would be defined by the thresholds and methodologies within ASTM F 1717, and the "study" demonstrating this would be the physical testing conducted according to that standard. However, the specific results of that testing or the explicit acceptance criteria (e.g., minimum fatigue life, maximum displacement under load) are not detailed in this summary document.
Essentially, for a mechanical device like a spinal fixation system, "acceptance criteria" relate to its structural integrity, stability, and biomechanical performance under simulated physiological loads, often verified through standardized testing. The "study" proving this is the physical laboratory testing.
In summary, based on the provided text, the device meets its acceptance criteria by demonstrating conformance to ASTM F 1717, a recognized standard for spinal implant testing. However, the detailed numerical acceptance criteria and specific test results are not part of this 510(k) summary.
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Special 510(k) Submission – Additions to EXPEDIUM Spine System
5. 510(K) SUMMARY
| Submitter: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767 | APR - 4 2008 |
|---|---|---|
| Contact Person: | Christopher KlaczykRegulatory Project ManagerVoice: (508) 828-2852Fax: (508) 828-3797E-Mail: cklaczyk@dpyus.jnj.com | |
| Date Prepared: | November 27, 2007 | |
| Device Class: | Class III | |
| Classification Name: | Pedicle screw spinal fixationper 21 CFR §888.3070 | |
| Spinal interlaminar fixation orthosisper 21 CFR §888.3050 | ||
| Spinal intervertebral body fixation orthosisper 21 CFR §888.3060 | ||
| Classification Panel: | Orthopedics | |
| FDA Panel Number: | 87 | |
| Product Code(s): | NKB, MNH, MNI, KWP, KWQ | |
| Proprietary Name: | EXPEDIUM Spine System | |
| Predicate Devices: | EXPEDIUM 4.5mm Spine System (K071495)EXPEDIUM 5.5mm Spine System (K033901)EXPEDIUM 5.5mm Spine System (K041119)MOSS® Miami Spine System (K011182)EXPEDIUM SFX Cross Connector System (K062196) | |
| Device Description: | The subject EXPEDIUM™ Spine System components aredesigned to accept a 4.5mm rod and are available in variousgeometries and sizes. | |
| Intended Use: | The EXPEDIUM Spine System is intended to provideimmobilization and stabilization of spinal segments inskeletally mature patients as an adjunct to fusion in the |
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Special 510(k) Submission - Additions to EXPEDIUM Spine System
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.
Materials: Manufactured from ASTM F 136 implant grade titanium alloy and ASTM F 138 implant grade stainless steel.
Performance Data: Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification.
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Image /page/2/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 an abstract symbol resembling an eagle or bird with three stylized wing segments.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 4 2008
DePuy Spine, Inc. % Mr. Christopher Klaczyk Regulatory Project Manager 325 Paramount Drive Raynham, MA 02767
Re: K073364
Trade/Device Name: EXPEDIUM Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNH, MNI, KWP, KWQ Dated: March 5, 2008 Received: March 6, 2008
Dear Mr. Klaczyk:
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 - Mr. Christopher Klaczyk
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 vours.
Mark M. Millerson
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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Special 510(k) Submission - Additions to EXPEDIUM Spine System
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K073364
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.
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)
| Neil R.P. Ogile for | |
|---|---|
| (Division Sign-Off) | MKM |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K073364 |
§ 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.