(81 days)
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.
Expedium Spine System components are designed to accept a 5.5mm rod and are available in various geometries and sizes. The Expedium Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification
This 510(k) summary is for the Expedium Spine System, a spinal fixation device, and not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific performance metrics (like MRMC studies) is not applicable or cannot be extracted from this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It provides details on the device description, intended use, materials, and a general statement about performance data.
Here's a breakdown of what can be extracted and why otherrequested information is not present:
Section 1: General Device Information
- Acceptance Criteria and Reported Device Performance: This information is not explicitly detailed in the provided 510(k) summary. For spinal fixation devices like the Expedium Spine System, acceptance criteria typically involve mechanical testing (e.g., fatigue strength, static strength, torsional stability) and biocompatibility, as outlined in relevant ASTM standards. The summary only states: "Performance data were submitted to characterize the additional Expedium Spine System components." It does not provide specific performance values against pre-defined acceptance criteria.
Section 2: Study-Specific Information (Not Applicable for this Device Type)
The following points are pertinent to studies of AI/ML devices or diagnostic tools, which the Expedium Spine System is not. Therefore, these sections cannot be fulfilled based on the provided text.
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of Extracted Information:
| Section | Description |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Acceptance Criteria: Not explicitly stated in terms of specific thresholds for the described performance data. For spinal implants, these would typically be based on established mechanical testing standards (e.g., ASTM F1717 for spinal implant constructs).Reported Device Performance: "Performance data were submitted to characterize the additional Expedium Spine System components." No specific numerical results or performance metrics are provided in this summary. The submission likely contained engineering test reports demonstrating compliance with relevant industry standards. |
| 2. Sample size used for the test set and the data provenance | Not applicable. This is a spinal implant, not an AI/ML diagnostic device with a "test set" of patient data. Performance is typically evaluated through mechanical testing of physical samples. |
| 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts | Not applicable. |
| 4. Adjudication method for the test set | Not applicable. |
| 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance | Not applicable. |
| 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done | Not applicable. |
| 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc) | Not applicable. |
| 8. The sample size for the training set | Not applicable. |
| 9. How the ground truth for the training set was established | Not applicable. |
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| IX. 510(k) Summary | K041119 | JUL 1 9 2004 |
|---|---|---|
| SUBMITTER: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02780 | |
| CONTACT PERSON: | Jennifer Mooney | |
| DATE PREPARED: | April 26, 2004 | |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal InterlaminalOrthosis, Spinal Pedicle Fixation, Spinal IntervertebralBody Fixation | |
| PROPRIETARY NAME: | Expedium Spine System | |
| PREDICATE DEVICES: | Expedium Spine System (Merlin Spine System)K033901 | |
| DEVICE DESCRIPTION: | Expedium Spine System components are designed toaccept a 5.5mm rod and are available in variousgeometries and sizes.The Expedium Spine System also contains Class 1manual surgical instruments and cases that areconsidered exempt from premarket notification | |
| INTENDED USE: | The Expedium Spine System is intended fornoncervical pedicle fixation and nonpedicle fixation forthe following indications: degenerative disc disease(defined as back pain of discogenic origin withdegeneration of the disc confirmed by history andradiographic studies); spondylolisthesis; trauma (i.e.,fracture or dislocation); spinal stenosis; curvatures(i.e., scoliosis, kyphosis, and/or lordosis); tumor;pseudoarthrosis; and failed previous fusion inskeletally mature patients. | |
| MATERIALS: | Manufactured from ASTM F-138 and F-1314 implantgrade stainless steel and ASTM F-136 implant gradetitanium alloy. | |
| PERFORMANCEDATA: | Performance data were submitted to characterize theadditonal Expedium Spine System components. |
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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a symbol that looks like three stylized human figures connected at the shoulders. The symbol is black and the background is white.
Public Health Service
JUL 1 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sharon Starowicz Director, Regulatory Affairs DePuy Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K04119
Trade/Device Name: Expedium Spine System Regulation Number: 21 CFR 888.3050; 21 CFR 888.3060; 21 CFR 888.3070 Regulation Name: Spinal interlaminar fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, MNH, MNI, NKB, KWQ Dated: June 25, 2004 Received: June 28, 2004
Dear Ms. Starowicz:
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
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Page 2 - Ms. Sharon Starowicz
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. 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use lll.
04/119 510(k) Number (if known): J
Expedium™ Spine System Device Name:
Indications For Use:
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 8C7 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office ral. Restorative, and Neurological Devices DePuy Spine, Inc. Page 5 Special 510K
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.