(100 days)
The CAPSTONE® Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CAPSTONE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the CAPSTONE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE® Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach.
The CLYDESDALE® Spinal System is intended to be used in interbody fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CLYDESDALE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the CLYDESDALE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of nonoperative treatment. The CLYDESDALE® Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via a minimally invasive lateral approach.
CLYDESDALE® Spinal System: The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The purpose of this 510(k) submission is to expand the indications of the CLYDESDALE® Spinal System to allow the device to be used with the aforementioned allogenic bone graft.
CAPSTONE® Spinal System: The CAPSTONE® Spinal System consists of PEEK cages, titanium alloy cages and titanium cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The CAPSTONE® Spinal System includes various instruments, including trials used to assist in placement of the implants. The purpose of this 510(k) submission is to expand the indications of the CAPSTONE® Spinal System to allow the device to be used with the aforementioned allogenic bone graft.
This document describes a 510(k) premarket notification for the Medtronic Sofamor Danek USA CLYDESDALE® Spinal System and CAPSTONE® Spinal System. The purpose of this submission is to expand the indications for these intervertebral body fusion devices to allow the use of allogenic bone graft.
Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
This submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing specific performance acceptance criteria for a novel device. The "acceptance criteria" here relate to demonstrating that the expanded indication (use with allogenic bone graft) does not introduce new safety or effectiveness concerns.
| Acceptance Criteria (Implicit for 510(k) with expanded indication) | Reported Device Performance (Summary of evidence) |
|---|---|
| No new risks to patients with the expanded indication (allogenic bone graft) | Published retrospective clinical data for similar lumbar interbody fusion devices demonstrate that the use of allogenic bone graft in interbody fusion procedures for the specified patient population poses no new risks. |
| Maintenance of substantial equivalence to predicate devices with the expanded indication | The devices are identical in design to their respective predicates (K133577 for CLYDESDALE®, K133650 for CAPSTONE®). No changes were made to the existing devices or new components added. The only change is the inclusion of allogenic bone graft as an option. |
| Design and material consistency with predicates | Both systems are manufactured from the same materials as their respective predicates. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a separate "test set" for a new study. The submission refers to "Published retrospective clinical data." The sample size of these published studies is not provided in this document.
- Data Provenance: The data is "retrospective clinical data" from published sources. The country of origin is not specified but implicitly refers to data relevant to demonstrating the use of allogenic bone graft in lumbar interbody fusion.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to a 510(k) submission that relies on demonstrating substantial equivalence to predicate devices and referencing published clinical literature. The "ground truth" here is derived from the established surgical outcomes and safety profiles reported in professional medical literature concerning the use of allogenic bone graft in spinal fusion. There isn't a specific "test set" with ground truth established by a panel of experts for this particular submission.
4. Adjudication Method for the Test Set
Not applicable. As noted above, there isn't a specific test set requiring adjudication in the context of this 510(k) submission.
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. This submission concerns spinal fusion devices and bone graft materials, not AI-assisted reading or diagnostic imaging.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This submission does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The ground truth used is based on:
- Clinical Outcomes/Safety Data: As reported in "published retrospective clinical data" regarding the use of allogenic bone graft in interbody fusion procedures. This data serves as evidence for the safety and effectiveness of the expanded indication.
- Established Predicate Device Performance: The primary ground truth for a 510(k) is the demonstrated safety and effectiveness of the legally marketed predicate devices. The submission asserts that the subject devices are identical in design and materials to the predicates, and the expanded indication does not alter this fundamental equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that would involve a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a stylized representation of three human profiles. The profiles are stacked on top of each other, creating a sense of unity and connection. The seal is simple, yet recognizable, and represents the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pyramid Place Memphis, Tennessee 38132
Re: K151128
Trade/Device Name: CLYDESDALE® Spinal System and CAPSTONE® Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 30, 2015 Received: July 8, 2015
August 6, 2015
Dear Mr. Grant:
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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Page 2 - Mr. Lee Grant
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 vours.
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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| 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 below. | |
| K151128 | Page 1 of 2 |
| 510(k) Number (if known) | K151128 |
| Device Name | CAPSTONE® Spinal System |
| Indications for Use (Describe) | |
| The CAPSTONE® Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CAPSTONE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. | |
| Additionally, the CAPSTONE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. | |
| These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE® Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. | |
| Type of Use (Select one or both, as applicable) | |
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| 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." | |
| FORM FDA 3881 (8/14) | Page 1 of 1 |
| PSC Publishing Services (301) 443-6740 | EF |
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| 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 below. | |
| K151128 | |
| Page | 2 of 2 |
| 510(k) Number ( if known ) | K151128 |
|---|---|
| Device Name | CLYDESDALE® Spinal System |
| Indications for Use (Describe) | |
| The CLYDESDALE® Spinal System is intended to be used in interbody fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CLYDESDALE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. | |
| Additionally, the CLYDESDALE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. | |
| These patients should be skeletally mature and have had six months of nonoperative treatment. The CLYDESDALE® Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via a minimally invasive lateral approach. |
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
"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."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| PSC Publishing Services (301) 443-6740 EF |
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510(k) Summary - K151128
August 2015
| Company: | Medtronic Sofamor Danek USA1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738 |
|---|---|
| Contact: | Lee GrantDistinguished Regulatory Affairs Advisor |
| Common Name: | Lumbar interbody fusion device, interbody cage |
| Device Trade Name: | (1) CLYDESDALE® Spinal System; (2) CAPSTONE® SpinalSystem |
| Regulatory Class: | II |
| Regulation Number: | 21CFR Section 888.3080 |
| Classification Name(s): | Intervertebral Body Fusion Device |
| Product Code: | MAX |
| Predicate Devices: | Primary Predicate: CLYDESDALE® Spinal System (K133577,SE 09/26/14) Class II, 21 CFR 888.3080, MAX; AdditionalPredicate: CAPSTONE® Spinal System (K133650, SE12/20/13) Class II, 21 CFR 888.3080, MAX |
Description:
CLYDESDALE® Spinal System: The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The purpose of this 510(k) submission is to expand the indications of the CLYDESDALE® Spinal System to allow the device to be used with the aforementioned allogenic bone graft.
CAPSTONE® Spinal System: The CAPSTONE® Spinal System consists of PEEK cages, titanium alloy cages and titanium cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with
{5}------------------------------------------------
autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The CAPSTONE® Spinal System includes various instruments, including trials used to assist in placement of the implants. The purpose of this 510(k) submission is to expand the indications of the CAPSTONE® Spinal System to allow the device to be used with the aforementioned allogenic bone graft.
Indications for Use:
CLYDESDALE® Spinal System:
The CLYDESDALE® Spinal System is intended to be used in interbody fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CLYDESDALE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Additionally, the CLYDESDALE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.
These patients should be skeletally mature and have had six months of nonoperative treatment. The CLYDESDALE® Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via a minimally invasive lateral approach.
CAPSTONE® Spinal System: The CAPSTONE® Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CAPSTONE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
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Additionally, the CAPSTONE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.
These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE® Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach.
Summary of the Technological Characteristics: The purpose of this bundled 510(k) application is to allow for the usage of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to be allowed as a graft material option for these devices. All subject devices found within this bundled submission have the same fundamental scientific technology. They are intended to provide correction and stabilization during intervertebral body fusion procedures for the aforementioned indications. They are all manufactured from the same materials as their respective predicates and there have been no changes to the implants' designs. With the exception of the inclusion of the allogenic bone graft material option, there have been no changes to either system's offerings and they are therefore substantially equivalent to their predicates.
Identification of Legally Marketed Devices: The subject CLYDESDALE® Spinal System is identical in design to the CLYDESDALE® Spinal System cleared in K133577 (SE 09/26/14), the primary predicate for this set of implants. No new CLYDESDALE® Spinal System implants are contained in this application. The subject CAPSTONE® Spinal System implants included in this application are identical in design to the CAPSTONE® Spinal System implants cleared in K133650 (SE 12/20/13). The aforementioned K133650 CAPSTONE® Spinal System application serves as an additional predicate for the implants contained in this application. No new CAPSTONE® Spinal System implants are included in this application.
Discussion of Supporting Retrospective Clinical Data and Non-Clinical Testing: Published retrospective clinical data for the lumbar interbody fusion devices similar to the CLYDESDALE® Spinal System and the CAPSTONE® Spinal System were provided in support of this application. The published clinical outcomes demonstrated that the use of allogenic bone graft in interbody fusion procedures to treat the patient population referenced in the indications statement, poses no new risks to the patients. No changes were made to the existing devices, nor
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were any new components added to the systems. Therefore, no additional testing was required or performed. This submission also referenced the ANATOMIC™ PEEK Cervical Fusion System (K130177), as it was recently cleared by the FDA for usage with allogenic bone graft.
Conclusion: The subject CLYDESDALE® Spinal System and the CAPSTONE® Spinal System are substantially equivalent to the primary predicate devices cleared in K133577 for the CLYDESDALE® Spinal System and in the additional predicate, K133650 application, for the CAPSTONE® Spinal System. The published clinical outcomes demonstrate these devices may be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
§ 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.