(75 days)
Not Found
No
The 510(k) summary describes a spinal implant system and its associated instruments. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the physical properties and performance of the PEEK cages.
Yes
The device is an implant for interbody fusion in patients with degenerative disc disease, which is designed to treat a medical condition.
No
The device is an implantable interbody fusion device designed to provide support and correction during spinal fusion surgeries. It is used in patients diagnosed with degenerative disc disease, but it does not perform the diagnosis itself. Diagnosis is done via "history and radiographic studies."
No
The device description explicitly states it consists of PEEK and titanium alloy cages, which are physical implants, not software.
Based on the provided information, the CAPSTONE® Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for interbody fusion in patients with degenerative disc disease. This is a surgical procedure involving the implantation of a device into the body.
- Device Description: The device is described as implants (cages) made of PEEK and titanium, designed to be inserted between vertebral bodies. This is a physical implant used within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The CAPSTONE® Spinal System does not perform this function. It is a therapeutic device implanted during surgery.
Therefore, the CAPSTONE® Spinal System is a medical device used for surgical intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. 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. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The purpose of this 510(k) submission is to include additional sizes of PEEK cages, an inserter and to make minor clarifications to the CAPSTONE® Spinal System IFU.
The CAPSTONE® Spinal System consists of Polyetheretherketone (PEEK) cages, titanium alloy and titanium cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to provide support and correction of the lumbar spine during lumbar interbody fusion surgeries. The hollow geometry of the CAPSTONE® implants allows them to hold autogenous bone graft material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar or lumbosacral vertebral bodies)
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)
The subject PEEK cages were tested using bench performance testing (i.e. ASTM F2077-03 and ASTM F2267-04) compared to the predicate device. Testing of the subject PEEK cages supports that the subject devices are as safe, as effective and perform as well as the predicate device(s).
No clinical testing was 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.
K073291, K103731, K120368, K110543, K094025
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.
Not Found
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
CAPSTONE® Spinal System 510(k) Summary
K121760 Page 1 of 3
June 12, 2012
AUG 29 2012
I. Company: Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
Contact:
Mr. Brad Sheals, MS Senior Regulatory Affairs Specialist
II. Proprietary Trade Name: CAPSTONE® Spinal System
III. Classification Name: Intervertebral Body Fusion Device (21 CFR 888.3080)
IV. Product Code: MAX
V. Product Description:
The purpose of this 510(k) submission is to include additional sizes of PEEK cages, an inserter and to make minor clarifications to the CAPSTONE® Spinal System IFU.
The CAPSTONE® Spinal System consists of Polyetheretherketone (PEEK) cages, titanium alloy and titanium cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to provide support and correction of the lumbar spine during lumbar interbody fusion surgeries. The hollow geometry of the CAPSTONE® implants allows them to hold autogenous bone graft material.
VI. Indications:
The subject CAPSTONE® Spinal System has the identical indications for use as the predicate CAPSTONE® Spinal System. The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These 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
1
Page 2 of 3 radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. 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. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
VII. Identification of Legally Marketed Predicate Devices Used to Claim Substantial Equivalence:
The design features, materials and indications for use of the CAPSTONE Spinal System are the same as the predicate CAPSTONE® Spinal System components previously cleared in K073291 (S.E. 04/24/2008). Additional predicates such as the CAPSTONE® Spinal System (i.e. K103731, S.E. 07/18/2011), CAPSTONE CONTROL™ Spinal System (i.e. K120368, S.E. 04/09/2012) and the CRESCENT® Spinal System (i.e. K110543, S.E. 08/09/2011 and K094025, S.E. 04/26/2010) were also utilized to support the safety and effectiveness of the modified subject PEEK cages and inserter within this premarket notification.
VIII. Summary of the Technological Characteristics:
The purpose of this 510(k) is to add additional sizes of PEEK cages, an inserter and to make minor clarifications to the CAPSTONE® Spinal System IFU. The subject and predicate CAPSTONE® PEEK cages and inserter are identical in terms of indications for use, intended use, performance specifications and technological characteristics. The key difference between the subject and predicate device are the additional widths of the PEEK cage and a new inserter specific to the subject device.
IX. Discussion of Non-Clinical Testing:
The subject PEEK cages were tested using bench performance testing (i.e. ASTM F2077-03 and ASTM F2267-04) compared to the predicate device. Testing of the subject PEEK cages supports that the subject devices are as safe, as effective and perform as well as the predicate device(s).
Discussion of Clinical Testing: X.
No clinical testing was performed.
2
XI.
'
Conclusions Drawn from the Non-Clinical Tests:
Based on the test results and additional supporting documentation provided in this premarket notification, the subject devices demonstrated that they are as safe, as effective and perform as well as the predicate device(s).
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated % Mr. Brad Sheals Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
AUG 2 9 2012
Re: K121760
Trade/Device Name: CAPSTONE® Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 15, 2012 Received: August 16, 2012
Dear Mr. Sheals:
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
4
Page 2 - Mr. Brad Sheals
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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/gefault.htm.
Sincerely yours
Mark N. Melkers
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K121760
Device Name: CAPSTONE® Spinal System
Indications for Use:
The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade I 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. These patients should be skeletally mature and have had six months of nonoperative treatment. 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. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIZI760 510(k) Number