(100 days)
No
The document describes spinal implants and their intended use, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The devices are intended for use in spinal fusion procedures to treat conditions like Degenerative Disc Disease and degenerative scoliosis, which are therapeutic medical interventions.
No
Explanation: The device is an interbody fusion system designed to provide support and correction during lumbar interbody fusion surgeries, not to diagnose medical conditions.
No
The device description explicitly states that the devices consist of physical implants (PEEK and titanium cages) and instruments, which are hardware components.
Based on the provided text, the CAPSTONE® Spinal System and the CLYDESDALE® Spinal System are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The descriptions clearly state that these systems consist of PEEK and titanium cages that are inserted between vertebral bodies during spinal fusion surgery. They are physical implants used to provide support and correction.
- Intended Use: The intended use is for spinal fusion procedures in patients with Degenerative Disc Disease and degenerative scoliosis. This involves surgical implantation, not the analysis of biological specimens.
Therefore, these devices are surgical implants, not IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
MAX
Device 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar or lumbosacral vertebral bodies, L2 to S1
Indicated Patient Age Range
skeletally mature
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 were any new components added to the systems. Therefore, no additional testing was required or performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
| 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 |
3
| 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 |
4
510(k) Summary - K151128
August 2015
| Company: | Medtronic Sofamor Danek USA
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901) 396-3133
Fax: (901) 346-9738 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Lee Grant
Distinguished Regulatory Affairs Advisor |
| Common Name: | Lumbar interbody fusion device, interbody cage |
| Device Trade Name: | (1) CLYDESDALE® Spinal System; (2) CAPSTONE® Spinal
System |
| 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; Additional
Predicate: CAPSTONE® Spinal System (K133650, SE
12/20/13) 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.
6
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
7
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.