(95 days)
Not Found
No
The summary describes a passive interbody fusion device made of PEEK and Tantalum markers, with no mention of software, algorithms, or any AI/ML related terms or functionalities.
Yes
The device is intended for use in spinal fusion procedures to treat conditions like Degenerative Disc Disease, which falls under the definition of a therapeutic intervention.
No
The device is described as an implantable spinal system intended for spinal fusion procedures, providing support and correction during interbody fusion surgeries, rather than for diagnosing a condition.
No
The device description clearly states the device consists of physical implants made of Polyetheretherketone and Unalloy Tantalum markers, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Capstone Control™ Spinal System is a physical implant (interbody fusion device) used in surgical procedures to provide support and correction during spinal fusion. It is implanted directly into the patient's body.
- Intended Use: The intended use describes a surgical procedure for treating Degenerative Disc Disease and degenerative scoliosis. It does not involve testing biological samples.
- Device Description: The description details the physical components and materials of the implant.
- Performance Studies: The performance studies focus on mechanical testing, biocompatibility, bacterial endotoxin testing, and MRI compatibility – all related to the physical properties and safety of an implantable device. There are no studies related to analyzing biological samples.
Therefore, the Capstone Control™ Spinal System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Capstone Control™ Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 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 Control™ Spinal System, is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Additionally, the Capstone Control™ 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 6 months of nonoperative treatment. The Capstone Control™ 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 or transforaminal approach.
The 18mm Capstone Control™ Spinal System implant can only be implanted via a Posterior (PLIF) approach. When using the 18mm Capstone Control™ Spinal System implant, a minimum of 2 implants are required per spinal level.
Product codes
MAX
Device Description
The Capstone Control™ Spinal System consists of convex cages with a bullet nose and angular teeth. The implants are made of Polyetheretherketone. The cages also contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The Capstone Control™ Interbody Fusion Devices are provided in various widths, heights, and lordosis, which can be inserted between two vertebral bodies to give support and correction during interbody fusion surgeries. The hollow geometry of the implants also allows the implants to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1, lumbar spine
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)
Mechanical Testing
In order to demonstrate substantial equivalence, Medtronic used to following FDA guidance document: Class II Special Controls Guidance Document: Intervertebral Body Fusion Device issued June 12, 2007 Design verification testing for the worst-case subject interbody fusion device was completed in accordance with the following: ASTM F2077: Test Methods for Intervertebral Fusion Devices ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression The verification tests completed were the following: Static compression (ASTM F2077) Static compression-shear (ASTM F2077) Compression fatigue (ASTM F2077) Compression-shear fatigue (ASTM F2077) Subsidence (ASTM F2267) The acceptance criteria was met for all tests. Please see the Bench Performance Testing section of this submission for more detail.
Biocompatibility
Identical to the predicate devices, the sterile interbody fusion devices in the subject devices are made of Polyetheretherketone (PEEK) and contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The nonsterile trials in the subject devices are manufactured from stainless steel, which is identical to the material used to manufacture the instruments cleared in the predicate devices. The materials mentioned above are considered biocompatible due to their long history of clinical use in medical devices.
Bacterial Endotoxin Testing
The bacterial endotoxin test, also known as Limulus amebocyte lysate (LAL) test, was performed utilizing worst case subject interbody fusion devices to verify that the subject devices meet the 20 endotoxin units (EU)/device pyrogen limit specification. Testing was successfully performed, and it was confirmed that the subject devices meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing and USP , Medical Devices - Bacterial Endotoxin and Pyrogen Tests.
Magnetic Resonance Imaging (MRI)
The subject interbody fusion devices are part of the Capstone Control™ Spinal System that was cleared as MR-Conditional in Primary Predicate 1 (K171107, S.E. 09/26/2017). In accordance with the Guidance for Industry and FDA Staff - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, Medtronic re-evaluated the MRI compatibilty of the subject implants and determined that they do not present a new worst case to the existing Capstone Control™ Spinal System. Therefore, the Capstone Control™ Spinal System with the addition of the subject interbody fusion devices, remains classified as MR-Conditional.
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.
K171107, K120368, K090353, K073291
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
May 6, 2019
Medtronic Sofamor Danek USA, INC. Mr. Justin O'Connor Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K190165
Trade/Device Name: Capstone Control™ Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: January 31, 2019 Received: January 31, 2019
Dear Mr. O'Connor:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190165
Device Name Capstone ControlTM Spinal System
Indications for Use (Describe)
The Capstone Control™ Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 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 Control™ Spinal System, is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Additionally, the Capstone Control™ 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 6 months of nonoperative treatment. The Capstone Control™ 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 or transforaminal approach.
The 18mm Capstone Control™ Spinal System implant can only be implanted via a Posterior (PLIF) approach. When using the 18mm Capstone Control™ Spinal System implant, a minimum of 2 implants are required per spinal level.
| 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) |
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3
K190165 - 510(k) Summary
MEDTRONIC Capstone Control™ Spinal System
April 2019
| I. Submitter | Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901)396-3133
Fax: (901) 346-9738 |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Justin O'Connor
Sr. Regulatory Affairs Specialist
Direct Telephone: (901)399-2480 |
| Date Prepared | April 2019 |
| II. Name of Device | Capstone Control™ Spinal System |
| Common Name | Intervertebral Body Fusion Device |
| Classification Name | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Classification | Implants: Class II
Instrument Trials: Class II |
| Product Codes | MAX (21 CFR 888.3080) |
| III. Predicate Devices | Predicate 1 (Primary Predicate): Capstone Control™ Spinal
System - K171107 (S.E. 09/26/2017)
Predicate 2 (Additional Predicate): Capstone Control™ Spinal
System - K120368 (S.E. 04/09/2012)
Predicate 3 (Additional Predicate): Perimeter® Interbody
Fusion Device – K090353 (S.E. 08/29/2009)
Predicate 4 (Additional Predicate): Capstone® Spinal System -
K073291 (S.E. 04/24/2008) |
| IV. Description | The Capstone Control™ Spinal System consists of convex cages with a bullet nose and angular teeth. The implants are made of Polyetheretherketone. The cages also contain Unalloy Tantalum markers, which allow for radiographic visualization during the surgical procedure. The Capstone Control™ Interbody Fusion Devices are provided in various widths, heights, and lordosis, which can be inserted between two vertebral bodies to give support and correction during interbody fusion surgeries. The hollow geometry of the implants also allows the implants to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. |
| V. Indications for Use | The Capstone Control™ Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 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 Control™ Spinal System, is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Additionally, the Capstone Control™ 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 6 months of nonoperative treatment. The Capstone Control™ 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 or transforaminal approach.
The 18mm Capstone Control™ Spinal System implant can only be implanted via a Posterior (PLIF) approach. When using the 18mm Capstone Control™ Spinal System implant, a minimum of 2 implants are required per spinal level. |
| VI. Comparison of
Technological | The subject CAPSTONE CONTROL™ Spinal System has the same intended use, indications, materials, technological characteristics, spinal location, surgical approach, and sterilization |
| Characteristics with
the Predicate Devices | method as its predicates. Both the subject and predicate Capstone
Control™ devices are based on the same technological
characteristics of providing fusion support for patients diagnosed
with Degenerative Disc Disease (DDD) at one to two contiguous
levels from L2 to S1, as well as used to provide anterior column
support in patients diagnosed with degenerative scoliosis as an
adjunct to pedicle screw fixation. The only difference between the
subject and predicate Capstone Control™ devices is the subject
devices have a length, which falls outside the cleared range of the
Capstone Control™ Spinal System but does not raise any issues of
safety and effectiveness. Please see the Substantial Equivalence
section of this submission for more detail. |
| VII. Performance Data | Mechanical Testing
In order to demonstrate substantial equivalence, Medtronic used to
following FDA guidance document: Class II Special Controls Guidance Document:
Intervertebral Body Fusion Device issued June 12, 2007 Design verification testing for the worst-case subject interbody
fusion device was completed in accordance with the following: ASTM F2077: Test Methods for Intervertebral Fusion
Devices ASTM F2267: Standard Test Method for Measuring Load
Induced Subsidence of Intervertebral Body Fusion Device
under Static Axial Compression The verification tests completed were the following: Static compression (ASTM F2077) Static compression-shear (ASTM F2077) Compression fatigue (ASTM F2077) Compression-shear fatigue (ASTM F2077) Subsidence (ASTM F2267) The acceptance criteria was met for all tests. Please see the
Bench Performance Testing section of this submission for
more detail. |
| | Biocompatibility
Identical to the predicate devices, the sterile interbody fusion
devices in the subject devices are made of Polyetheretherketone
(PEEK) and contain Unalloy Tantalum markers, which allow for
radiographic visualization during the surgical procedure. The non-
sterile trials in the subject devices are manufactured from stainless
steel, which is identical to the material used to manufacture the
instruments cleared in the predicate devices. The materials
mentioned above are considered biocompatible due to their long
history of clinical use in medical devices. |
| | Bacterial Endotoxin Testing
The bacterial endotoxin test, also known as Limulus amebocyte
lysate (LAL) test, was performed utilizing worst case subject
interbody fusion devices to verify that the subject devices meet the
20 endotoxin units (EU)/device pyrogen limit specification.
Testing was successfully performed, and it was confirmed that the
subject devices meet the 20 EU/device testing limit for general
medical devices that are implanted as outlined in ANSI/AAMI
ST72, Bacterial endotoxins – Test methods, routine monitoring,
and alternatives to batch testing and USP , Medical Devices
- Bacterial Endotoxin and Pyrogen Tests. |
| | Magnetic Resonance Imaging (MRI)
The subject interbody fusion devices are part of the Capstone
Control™ Spinal System that was cleared as MR-Conditional in
Primary Predicate 1 (K171107, S.E. 09/26/2017). In accordance
with the Guidance for Industry and FDA Staff - Establishing
Safety and Compatibility of Passive Implants in the Magnetic
Resonance (MR) Environment, Medtronic re-evaluated the MRI
compatibilty of the subject implants and determined that they do
not present a new worst case to the existing Capstone Control™
Spinal System. Therefore, the Capstone Control™ Spinal System
with the addition of the subject interbody fusion devices, remains
classified as MR-Conditional. |
| VIII. Conclusion | Based on the supporting evidence provided, Medtronic believes the
subject devices are substantially equivalent to the below predicates,
as well as, the 5th percentile of PLIF devices that have been cleared
by the FDA for market release. |
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5
6
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| Predicate 1 (Primary Predicate): Capstone Control™
●
| Spinal System - K171107 (S.E. 09/26/2017) |
|---|
| Predicate 2 (Additional Predicate): Capstone Control™ |
| ● |
| Spinal System - K120368 (S.E. 04/09/2012) |
| Predicate 3 (Additional Predicate): Perimeter® |
| ● |
| Interbody Fusion Device - K090353 (S.E. 08/29/2009) |
| Predicate 4 (Additional Predicate): Capstone® Spinal |
| ● |
| System - K073291 (S.E. 04/24/2008) |
K190165 510k Summary Page 5 of 5