(36 days)
The DePuy Synthes T-PAL Ti Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacers should be packed with autogenous bone graft (i.e. autograft).
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.
The T-PAL Spacers are intended to be used with DePuy Synthes supplemental fixation.
The DePuy Synthes T-PAL Ti Spacer is an interbody fusion device used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. Previously, only T-PAL Spacers manufactured from PEEK (With TAN marker pins) material were available. The subject T-PAL Ti spacers will be manufactured entirely of TAN per ASTM F1295. The T-PAL Ti Spacer is available in two footprints and a range of heights and is angulated 5° to accommodate the lordotic curve (except for the smallest height of each footprint, which does not have a lordotic angle). Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. These teeth are oriented along a contour that follows the curve of the implant to assist in implantation. A bullet-nose design also facilitates self-distraction and ease of insertion. The open architecture of the devices allows them to be packed with autogenous bone graft material, i.e. autograft.
This document is a 510(k) premarket notification decision letter from the FDA regarding the DePuy Synthes T-PAL Ti Spacer. It is not a study demonstrating acceptance criteria or device performance in the context of an AI/algorithm-driven medical device.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and the reported device performance: This document does not contain performance metrics that would be applicable to an AI device. The "performance data" mentioned (Section H) refers to a Finite Element Analysis of the physical implant, not an AI algorithm's performance.
- Sample size for the test set and data provenance: No such data is presented.
- Number of experts and qualifications for ground truth: Not applicable to this type of device submission.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not conducted as this is a physical implant, not an AI device.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: No training data for an algorithm is mentioned.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document does provide:
The document concerns the regulatory clearance (510(k)) of a new version of an existing intervertebral body fusion device, the DePuy Synthes T-PAL Ti Spacer. The key aspects are:
- Device: DePuy Synthes T-PAL Ti Spacer (an intervertebral body fusion device).
- Changes from predicate: The main changes are a material change (from PEEK to Ti-6Al-7Nb (TAN) ASTM F-1295 titanium alloy), a sterilization modality change, and a minor design modification.
- Intended Use: For patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, requiring interbody fusion with supplemental fixation. The spacers must be packed with autogenous bone graft. DDD is defined by back pain of discogenic origin, confirmed by history and radiographic studies, in skeletally mature patients who have had six months of non-operative treatment.
- Predicate Device: Synthes T-PAL Spacer (K100089) and Patriot Signature® Ti Spacer (K122097).
- Demonstration of Equivalence: The submission asserts that the new device is substantially equivalent to the predicate devices because the intended use, performance, and technology remain "identical" despite the material and minor design changes.
- Performance Data (for the physical implant): A Finite Element Analysis (FEA) simulating static/dynamic axial compression and compression shear was performed to demonstrate that the proposed modifications do not introduce a "new worst case" regarding the physical implant's mechanical performance. This is not performance data for an AI algorithm.
- Conclusion: The FDA determined substantial equivalence based on the unchanged intended use and similar technological characteristics, with FEA and post-market data supporting that the changes do not raise new questions of safety and effectiveness.
In essence, this document is a regulatory approval letter for a medical implant, not a study of an AI device's performance against acceptance criteria.
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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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
June 18, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Synthes USA Products, LLC Mr. Eric Zhu Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
Re: K151276
Trade/Device Name: DePuy Synthes T-PAL Ti Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 12, 2015 Received: May 13, 2015
Dear Mr. Zhu:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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" (21CFR 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
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Indications for Use Statement
510(k) Number: K151276
Device Name: DePuy Synthes T-PAL Ti Spacer
Indications For Use:
The DePuy Synthes T-PAL Ti Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacers should be packed with autogenous bone graft (i.e. autograft).
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.
The T-PAL Spacers are intended to be used with DePuy Synthes supplemental fixation.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
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A. Submitter Information Manufacturer:
Submitter:
Mezzovico, CH-6805 Switzerland
Zona Industriale 4
Synthes Production GmbH
Synthes USA Products, LLC 325 Paramount Drive, Raynham MA 02767
Contact Person:
Telephone number: Fax number: Email:
B. Date Prepared
C. Device Name
Trade/Proprietary Name:
Common/Usual Name:
Classification Name:
D. Predicate Device Name
Predicate Trade name: Reference Device:
Device Description E.
Eric Zhu 325 Paramount Drive Raynham, MA 02767 508-828-3730 508-828-3797 Ezhu@its.jnj.com
June 17, 2015
DePuy Synthes T-PAL Ti Spacer
Spinal Intervertebral Body Fusion Device
Intervertebral Fusion Device with Bone Graft, Lumbar Intervertebral Body Fusion Device per 21 CFR §888.3080 Product Code MAX (Intervertebral body fusion device)
Synthes T-PAL Spacer (K100089) Patriot Signature® Ti Spacer (K122097)
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The DePuy Synthes T-PAL Ti Spacer is an interbody fusion device used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. Previously, only T-PAL Spacers manufactured from PEEK (With TAN marker pins) material were available. The subject T-PAL Ti spacers will be manufactured entirely of TAN per ASTM F1295. The T-PAL Ti Spacer is available in two footprints and a range of heights and is angulated 5° to accommodate the lordotic curve (except for the smallest height of each footprint, which does not have a lordotic angle). Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. These teeth are oriented along a contour that follows the curve of the implant to assist in implantation. A bullet-nose design also facilitates self-distraction and ease of insertion. The open architecture of the devices allows them to be packed with autogenous bone graft material, i.e. autograft.
F. Intended Use
The DePuy Synthes T-PAL Ti Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacers should be packed with autogenous bone graft (i.e. autograft).
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The T-PAL Spacers are intended to be used with DePuy Synthes supplemental fixation.
Summary of Similarities and Differences in Technological Characteristics, F. Performance and Intended Use
The proposed modifications to the Synthes T-PAL Spacer are identical to the predicate device (K100089) except for the material change, sterilization modality change, and a minor modification to the design. The indications, performance, and technology remain identical to the predicate systems. We are not replacing the predicate device with the proposed Titanium Spacer device, but we are making additional T-PAL Ti Spacers available for the market.
G. Materials
T-PAL Ti Spacers will be manufactured from Ti-6Al-7Nb (TAN) ASTM F-1295 implant grade titanium alloy.
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H. Performance Data
The minor modification to the design of the device and material change do not change the technological characteristics of the device. A Finite Element Analysis simulating Static/Dynamic Axial Compression and Compression Shear testing demonstrated that the proposed modifications do not introduce a new worst case.
I. Conclusion
The Substantial Equivalence Justification demonstrate that the subject devices are substantially equivalent to the predicate devices because the intended use remain unchanged and technological characteristics of the subject device are similar to the predicate. The Finite Element Analysis and post market data further demonstrates that the material change and modification to the design do not introduce any new questions of safety and effectiveness.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.